DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. The claims entered Oct. 21, 2025 have been entered. Claims 1-24 are under consideration. Claims 25-60 are cancelled.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 5, 2023, Nov. 9, 2023 and Aug. 20,2025 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
4. Applicant’s election without traverse of Group I in the reply filed on October 21, 2025 is acknowledged. Claims 18-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Oct. 21, 2025.
Claim Objections
5. Claim 1 is objected to because of the following informalities: Claim 1 separates the method steps using a period. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). There may be plural indentations to further segregate subcombinations or related steps. Therefore, the periods should be removed and only the period at the completion of the claim should remain. See MPEP 608.01(m). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of ameliorating atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a selected Bifidobacterium to the breastfed infant; does not reasonably provide enablement for a method of preventing atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a selected Bifidobacterium to the breastfed infant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
The specification teaches the use of a questionnaire will also capture mother-reported information about the infant's first degree relatives having a history of atopic disease, for example current or prior history of AD (including age of onset and details of diagnostic testing), allergic rhinitis/hay fever (including identification of allergens), asthma, food reaction/allergy (such as type of food and reaction; details of any other formal allergy testing), other skin conditions, or an immune-mediated disease. The specification does not disclose prevention of infantile atopic dermatitis and/or eczema. The specification does not describe an infants who received treatment and atopic dermatitis did not return. Instead the specification describes improvement in the severity of atopic dermatitis may be measured using the Eczema Area and Severity Index (EASI). Results of studies conducted in the art thus far have been inconsistent, with probiotics reducing the incidence and severity of AD in some, but not all, studies. The pathophysiology of AD is complex and multifactorial, involving elements of skin barrier dysfunction, alterations in cell-mediated immune responses, IgE-mediated hypersensitivity, and environmental factors. The gut microbiome participates in the pathophysiology of inflammatory disorders of the skin including psoriasis and AD. The specification identifies the subject’s genetic profile. However the prevention of AD, cannot fully prevent AD due to its genetic component. Additionally, there are numerous triggers, such as immune system issues, stress, environmental factors, and hormones.
There is no teaching within the specification of preventing AD. The specification fails to teach examples of preventing atopic dermatitis, infantile dermatitis, and/or eczema in the manner instantly claimed. Therefore, the specification fails to enable a method for fully preventing AD in an infant.
Applicants’ have provided no guidance to enable one of ordinary skill in the art as to how determine, without undue experimentation, a method of preventing Atopic diseases in an infant. Given the lack of guidance contained in the specification and the unpredictability for preventing AD in an infant, one of skill in the art could not make or use the broadly claimed invention without undue experimentation. The specification fails to provide an enabling disclosure for a prevention of AD method as recited in the claims. In view of the lack of guidance contained in the specification and the unpredictability for the prevention of AD method within an infant, one skilled in the art could not make or use the broadly claimed invention without undue experimentation.
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.
7. Claim 16 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. The metes and bounds of claim 16 are unclear. It is unclear how to determine when an infant is a increased risk for developing an atopic disease. The claims do not provide a comparison to determine whether an infant’s risk is increased or not. Clarification is required to overcome the rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Frese et al., (WO2019232513 published 2019-12-05; priority to 2019-06-03)
The claims are drawn to a method of preventing, delaying or ameliorating atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a selected Bifidobacterium to the breastfed infant.
Frese et al,, disclose all applications of this invention may be used for preventing and/or improving inappropriate responses to conditions resulting from pregnancy, birth, prematurity, and atopic disease [para 70]. The Atopic March refers to the typical development and progression of allergic diseases early in life. These include atopic dermatitis (eczema), food allergy, atopic wheeze, asthma, and allergic rhinitis. It is also commonly referred to as the Allergic March [para 136]. Example 7 describe the prevention of atopic march. Infants are enrolled at birth and randomized into 4 groups: 1) placebo; 2) B. infantis //VC 001 with exclusive human milk diet; 3) B. infantis EVC001 and exclusive feeding with formula containing 8 g/L LNT; and 4) B. infantis EVC001 and exclusive formula feeding with 8 g/L released N-glycans from bovine whey proteins [para 203]. Therapeutic outcomes include decreased atopic wheeze, asthma, eczema and the reduced incidence of atopic diseases including atopic wheeze, asthma [para 204]. Therefore, Frese et al., disclose a method of preventing, delaying or ameliorating atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a Bifidobacterium.
Frese et al., disclose compositions for use in foods or therapeutic applications comprising, Bifidobacterium [para 7]. The composition may comprise a Bifidobacterium. The Bifidobacterium may be Bifidobacterium adolescentis, Bifidobacterium animalis, Bifidobacterium animalis subsp. animalis, Bifidobacterium animalis subsp. lactis, B. bifidum, Bifidobacterium breve, Bifidobacterium catenulatum, , Bifidobacterium longum subsp. infantis, B. pseudocatanulatum, Bifidobacterium pseudolongum, or a combination thereof. The composition may comprise an activated Bifidobacterium. The B. longum may be B. longum subsp. infantis (B. infantis) [para 116]. Thus teaching claims 1-4. Example 1 is drawn to Feeding B. infantis EVC001 to infants consuming HMO rich diet [0142]. Thus teaching claim 17. This trial was designed to show the effect of probiotic supplementation with Bifidobacterium longum subsp. Infantis (B. infantis EVC001) in healthy, term, nursing infants compared to an unsupplemented group. A dry composition of lactose and activated Bifidobacterium longum subsp. infantis was prepared starting with the cultivation of a purified isolate (Strain EVC001 ATCC Accession No. PTA-125180) [para 142]. Thus teaching claim 10. This composition then was loaded into individual sachets at about 0.625 g/sachet and provided to breast-fed infants starting on or about day 7 of life and then provided on a daily basis for the subsequent 21 days [para 142]. Thus teaching claims 13-15. Starting with Day 7 postnatal, and for 21 consecutive days thereafter, infants in the supplemented group were given a dose of at least 1.8 xlO10 cfu of B. infantis suspended in 5 mL of their mother’s breastmilk, once daily. Because the provision of HMO via breastmilk was critical for supporting the colonization of B. infantis, all participants received breast feeding support at the hospital and at home and maintained exclusive breast feeding through the first 60 days of life [para 143] Thus teaching claim 7.
In any of the foregoing embodiments, the composition may comprise Bifidobacterium in an amount of 5-20 billion Colony Forming Units (CFU) per gram of composition or 5-20 billion Colony Forming Units per gram of composition [para 16]. Thus teaching claim 11. The Bifidobacterium may be administered on a daily basis can include from 1 billion to 100 billion CFU/day or from 5 billion to 20 billion CFU/day [para 49]. Thus teaching claim 12. The composition can be administered in a food composition, such as mammalian milk, mammalian milk-derived product, mammalian donor milk, human milk product, infant formula [para 22]. The composition may further comprise a food, and the food can comprise partial or the complete nutritional requirements to support life of a healthy mammal, where that mammal may be an infant. The food composition can include mammalian milk, mammalian milk derived product, mammalian donor milk, an infant formula, milk replacer, an enteral nutrition product, or meal replacer [para 113]. Thus teaching claim 6. Participants will receive B. infantis EVC001 or placebo once daily for a total of 12 months, which will be delivered at home by a parent/guardian or other caregiver. A single dose sachet (containing 8 billion CFU of activated B. infantis EVC001+ lactose) will be administered daily. At the time of dosing, a single sachet of B. infantis EVC001 will be mixed with a few tablespoons of expressed breast milk, which will then be delivered to the infant’s mouth at the time of initiation of the feed [para 210]. Thus teaching claim 5. All mothers were encouraged and supported to continue breast feeding for at least 6 months, and if possible through the entire 12-month treatment period [para 212]. Thus teaching claims 8-9.
Therefore Frese et al., describe each and every rejected limitation.
Claim Rejections - 35 USC § 102
9. Claims 1-6, 10-11, and 13-16 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Blanchard et al., (WO2017129644 published 2017-08-03; priority to 2017-01-26).
The claims are drawn to a method of preventing, delaying or ameliorating atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a selected Bifidobacterium to the breastfed infant.
Blanchard et al., describe a nutritional composition for preventing and/or treating allergy symptoms in an infant or a young child [abstract]. This invention relates to nutritional compositions such as infant formula for infants or young children with a normal risk of developing allergy or with a higher risk of developing allergy because one first degree family member have or have had allergy or infants or young children who are allergic and in need[para 1]. Thus teaching claim 16.The expression “allergy” or “allergic response” or “allergic symptoms” or “allergic disease” can be used interchangeably. Such terms include, allergic sensitization, atopic dermatitis and eczema, wheezing, asthma [para 48]. The nutritional composition of can comprise at least one probiotic (or probiotic strain), such as a probiotic bacterial strain [para 88]. The probiotic microorganisms most commonly used are principally bacteria such as Bifidobacterium spp [para 89]. Suitable probiotic strains include Bifidobacterium lactis, Bifidobacterium animalis, Bifidobacterium longum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium adolescentis or any mixture thereof [para 91]. Thus describing claims 1-4. The nutritional composition according to the invention may contain from 103 to 1012 cfu of probiotic strain, more preferably between 108 and 1010 cfu of probiotic strain per g of composition on a dry weight basis [para 93]. Thus teaching claim 11.
The nutritional composition generally contains a carbohydrate source. This is particularly preferable in the case where the nutritional composition of the invention is an infant formula. In this case, any carbohydrate source conventionally found in infant formulae such as lactose may be used, although one of the preferred sources of carbohydrates is lactose [para 110]. Thus teaching claim 10.
Since the nutritional composition may be used for prevention purposes (prevention of a later in life health disorder), it can be for example given immediately after birth of the infants. Thus teaching claim 13. The composition of the invention can also be given during the first week of life of the infant, or during the first 2 weeks of life, or during the first 3 weeks of life, or during the first month of life, or during the first 2 months of life, or during the first 3 months of life, or during the first 4 months of life, or during the first 6 months of life, or during the first 8 months of life [para 126]. Thus teaching claims 13-15. The term “fortifier” refers to liquid or solid nutritional compositions suitable for mixing with breast milk or infant formula [para 42]. The nutritional composition can be for example an infant formula, a starter infant formula, a follow-on or follow-up formula, a baby food, an infant cereal composition, a fortifier such as a human milk fortifier, or a supplement. In some particular embodiments, the composition is an infant formula, a fortifier or a supplement intended for the first 4 or 6 months of age [para 96]. The nutritional composition is a fortifier. The fortifier can be a breast milk fortifier (e.g. a human milk fortifier) or a formula fortifier such as an infant formula fortifier or a follow-on/follow-up formula fortifier [para 97]. The “mother's milk” should be understood as the breast milk or the colostrum of the mother [para 52]. The composition is given to the infant as a supplementary composition to the mother's milk. In some embodiments the infant receives the mother's milk during at least the first 2 weeks, first months. In one embodiment the nutritional composition is given to the infant together with mother's milk. In another embodiment the composition is given to the infant as the sole or primary nutritional composition during at least one period of time, e.g. after the 1st, 2nd or 4th month of life, during at least 1, 2, 4 or 6 months [para 128]. .Thus teaching claims 5-6.
Therefore Blanchard et al., describe each and every rejected limitation.
Claim Rejections - 35 USC § 102
10. Claims 1-2, and 11 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Speelmans et al., (WO2006091103 published 2006-08-31; priority to 2006-02-28).
The claims are drawn to a method of preventing, delaying or ameliorating atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a selected Bifidobacterium to the breastfed infant.
Speelmans et al., disclose a composition comprising Bifidobacterium breve, a non-digestible saccharide A and a non-digestible saccharide B, optionally combined with Lactobacillus paracasei and the use of said composition for the treatment and/or prevention of gastro-intestinal disorder, immune disorder and/or endocrine disorder [Abstract]. The composition according to the present invention has been found to be particularly useful as an infant nutrition [Applications]. In a preferred embodiment, the present invention provides a method for the treatment and/or prevention of atopic dermatitis, eczema, allergy and/or infection [Application]. The reduced occurrence of these diseases is due to the optimized intestinal flora, particularly the optimized Bifidobacterium species population [Application]. The present invention provides the use of the present composition for normalization of the Bifidobacterium species population in the gastro-intestinal tract of fed with non-human milk- or partially human milk to the Bifidobacterium of infants fed with human milk [Description of Invention]. Most preferably the composition contains from 107 to 5xlO10 colony forming units (cfu) B. breve per g of the total of saccharide A and B [Bifidobacterium breve]. Thus teaching claims 1-2, and 11.
Bifidobacterium breve is a Gram-positive, anaerobic, branched rod-shaped bacterium which can be included within the composition for treatment and/or prevention of atopic dermatitis, eczema, allergy and/or infection.
Therefore Speelmans et al., describe each and every rejected limitation.
Pertinent Art
11. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Smilowitz et al., (BMC Pediatr. 2017 May 30;17:133) teach Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants.
Soh SE, Aw M, Gerez I, et al. (Clin Exp Allergy. 2009;39(4):571–578) describe Probiotic Supplementation in the First 6 Months of Life in at Risk Asian Infants: Effects on Eczema and Atopic Sensitization where subjects were randomly assigned to receive ≥60 mL/day of commercially available cow's milk–based formula either with or without probiotic supplementation from birth to the age of 6 months. The probiotics used included Bifidobacterium longum (107 colony-forming units per g).
Kwon et al., (Pediatr Allergy Immunol. 2010 Mar;21(2 Pt 2):e386-93. Epub 2009 Oct 14) describe the effect of probiotic mix (Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus) in the primary prevention of eczema: a double-blind, randomized, placebo-controlled trial.
Mansfield et al., teach Comparative Probiotic Strain Efficacy in the Prevention of Eczema in Infants and Children: A Systematic Review and Meta-Analysis (Military Medicine, Volume 179, Issue 6, June 2014, Pages 580–592) specifically drawn to the use of probiotic supplements during pregnancy and/or during infancy creates a statistically significant decline in the incidence of eczema.
Navarro et al., (WO2018015388 published 2018-01-25; priority to 2016-07-19)
describe the use of a probiotic infant formula composition comprising Bifidobacterium animalis subs, lactis (B. lactis), Bifidobacterium longum, particularly the strains B. lactis CECT 8145, B. longum CECT 7347, in the treatment and/or prevention of atopic dermatitis.
WO2001097822 teach probiotics in primary prevention of atopic diseases comprising - administering to a pregnant woman a daily dose of live probiotic bacteria, Bifidobacterium lactis Bb-12. for at least two weeks before delivery, and - after delivery, administering to the newborn infant a daily dose of live probiotic bacteria for at least 2 months.
Conclusion
12. No claims allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANA A HINES/Primary Examiner, Art Unit 1645