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 Amendment
2. The amendment filed April 21, 2026 have been entered. Claims 1 and 4 were amended. Claims 25-60 were cancelled. Claims 18-24 were withdrawn without traverse from consideration. Claims 1-17 are under consideration in this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 27, 2026 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.
Withdrawal of Claim Objections
4. The objection of claim 1 is withdrawn in view of Applicants amendments to claim 1.
Withdrawal of Claim Rejection
5. The scope of enablement rejection over claims 1-17 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of Applicants amendments to claim 1.
Maintained Grounds of Rejection
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.
6. 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 at 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.
Response to Arguments
7. Applicant's arguments filed April 21, 2026 have been fully considered but they are not persuasive. Applicants stated that claim 16 now particularly points out and distinctly claims the subject matter that Applicant regards as the invention. However, claim 16 was not amended. Claim 16 still does not describe the metes and bounds for determining any kind of risk for developing atopic diseases such as Atopic dermatitis, Allergic rhinitis, Asthma, Allergic conjunctivitis, IgE-mediated food allergies and atopic keratoconjunctivitis. The claims do not describe determining an increased risk. Therefore, the rejection is maintained.
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 delaying or ameliorating atopic dermatitis in a breastfed infant, the method comprising administering a composition comprising an effective amount of a selected from the instantly recited group of 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 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 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 x1010 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.
Response to Arguments
9. Applicant's arguments filed April 21, 2026 have been fully considered but they are not persuasive. The rejection of claims 1-17 under 35 U.S.C. 102(a)(2) as being anticipated by Frese et al., is maintained for reasons of record.
Applicants assert that each and every limitation is not found within the Frese et al., reference. Frese et al., teach a method of delaying or ameliorating atopic dermatitis such as allergic march, which includes atopic dermatitis (eczema) in breastfed infants. Frese et al., described 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]. Frese et al., described the administration of Bifidobacterium longum subsp. infantis thereby teaching the instantly claimed strains of claims 1-4. Therefore, each and every claimed limitation has been taught by Frese et al.
Applicants state that Frese et al., do not teach B. sp900551485, B. sp003952945, B. sp003952025, B. sp003952005, B. simiarium, B. sp002742445, B. vansinderenii, B. kashiwanohense A. However, Applicants attention is directed to claim 1 which recites administering a composition comprising an effective amount of a selected from the instantly recited group of Bifidobacterium. The claim does not recite administering every single Bifidobacterium species recited by claim 1. Instead, the claim recites a Bifidobacterium selected from the group. Frese et al., recites the Bifidobacterium longum. There is no requirement that every single Bifidobacterium recited by claim 1 be administered to a breast feed infant. Therefore, Applicants arguments are not found persuasive. Thus, the rejection is maintained.
Claim Rejections - 35 USC § 102
10. 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 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. 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. The infant receives the mother's milk during at least the first 2 weeks, first months. The nutritional composition is given to the infant together with mother's milk. 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.
Response to Arguments
11. Applicant's arguments filed April 21, 2026 have been fully considered but they are not persuasive. The rejection of claims 1-6, 10-11, and 13-16 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Blanchard et al., is maintained for reasons of record.
Applicants argue that Blanchard et al., is relies on teachings from different embodiments described within the single reference. The Office directs Applicants attention to MPEP section 2123 teaches that patents are relevant as prior art for all they contain, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir.1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Therefore applicant’s argument is not persuasive especially when Applicants have not provided any evidence that the examples off Blanchard et al., embodiments are not usable together. Blanchard et al’s embodiments are the nutritional composition can be an infant and/or starter infant formula. The nutritional composition is given to the infant as a supplementary composition to the mother's milk. The nutritional composition is given to the infant together with mother's milk. 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. All of Blanchard et al., overlapping and collaborative embodiments. There is no evidence to the contrary. Furthermore, Applicants failed to point to any limitation which Blanchard et al., did not describe. Therefore, Applicants arguments are not found persuasive and the rejection is maintained.
Claim Rejections - 35 USC § 102
12. 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 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.
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.
Response to Arguments
13. Applicant's arguments filed April 21, 2026 have been fully considered but they are not persuasive. The rejection of claims 1-2 and 11 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Speelmans et al., is maintained for reasons of record.
Applicants again argue that Speelmans et al., is relies on teachings from different embodiments described within the single reference. The Office directs Applicants attention to MPEP section 2123 teaches that patents are relevant as prior art for all they contain, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In this case, Speelmans et al., disclose a composition comprising Bifidobacterium breve, useful as an infant nutrition for the treatment and/or prevention of atopic dermatitis, and/or eczema. There is no teaching that Speelmans et al., embodiments are mutually exclusive. Therefore, Applicants arguments are not supported by the Speelmans reference. In fact, Speelmans et al., clearly and specifically teach a method of delaying or ameliorating atopic dermatitis and/or eczema in a breastfed infant, by administering an infant nutritional composition comprising an effective amount of Bifidobacterium breve to the breastfed infant. Therefore, each and every instantly rejected claimed limitation is described by the Speelmans et al., reference. Applicants have not pointed to any limitations not described by Speelmans et al. Therefore, Applicants arguments are not found persuasive and the rejection of record is maintained.
Pertinent Art
14. 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
15. No claims allowed.
16. 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.
17. 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 Peter Paras, can be reached on 571-272-4517. 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
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