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 .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 5, 2026 has been entered.
Claim Amendment
3. The amendment filed Aug 5, 2026 have been entered. Claims 1 and 10 were amended. Claims 7, 14-16 and 25-60 were cancelled. Claims 18-24 were withdrawn without traverse from consideration. Claims 61-73 were newly added. Claims 1-6, 8-13, 17 and 61-73 are under consideration in this Office Action.
Withdrawal of Claim Rejection
4. The rejection of claim 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicants amendments to claim 16.
5. The rejection of claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Frese et al., is withdrawn in view of Applicants amendments to claims including claims 7 and 14-16.
6. 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of claims 1-6, 10-11, and 13-16 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Blanchard et al., is withdrawn in view of Applicants amendments to the claims.
7. 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rejection of claims 1-2 and 11 under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Speelmans et al., is withdrawn in view of Applicants amendments to the claims.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 1-6, 8-13, 17 and 61-73 are rejected under 35 U.S.C. 103 as being unpatentable over Frese et al., (WO2019232513 published 2019-12-05; priority to 2019-06-03) in view of Blanchard et al., (WO2017129644 published 2017-08-03; priority to 2017-01-26).
The claims are drawn to a method of delaying or ameliorating an atopic disease in a breastfed infant, the method comprising: identifying a breastfed infant that has a first-degree relative with a history of an atopic disease and administering a composition comprising an effective amount of a selected from the instantly recited group of Bifidobacterium to the breastfed infant wherein the composition is mixed with about 3 to about 5 mL of breastmilk prior to administration to the breastfed infant and wherein the composition is first administered to the breastfed infant within the first three days of life until at least twelve weeks of life.
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]. Frese et al., teach 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]. The B. longum may be B. longum subsp. infantis (B. infantis) [para 15]. Monitoring the status of the some or all of the metabolites may be used to identify persons at risk of developing diseases in the future [para 88]. Therefore, teaching the administration of B. longum, where the composition is mixed with 5ml of breastmilk prior to administration wherein the infant is 7 days old just as instantly claimed.
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]. Thus teaching claim 63 and 73. 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 and 71. 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 and 70-71. 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 claim 13.
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 and 69. 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]. Thus teaching claim 69. 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. The OS may be in the form of a powder or liquid (water-based or oil-based), gel or paste [para 115]. Thus teaching claim 68.
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 and 70. 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, 61 and 70.
Therefore Frese et al., describe a method of delaying or ameliorating an atopic disease in a breastfed infant, the method comprising: identifying an at risk infant and administering a composition comprising an effective amount of a selected from the instantly recited group of Bifidobacterium to the breastfed infant wherein the composition is mixed with about 3 to about 5 mL of breastmilk prior to administration to the breastfed infant and wherein the composition is first administered to the breastfed infant within the first three days of life until at least twelve weeks of life; but does not teach identifying the risk as having a first degree relative.
Blanchard et al., teach identifying an at risk infant. Blanchard et al., teach the nutritional compositions of the invention are aimed at allergy prevention and allergy treatment. In the first case, infants or young children are healthy 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. In the second case, infants or young children are allergic or in needs, hence sick [Field of Invention]. The nutritional composition according to the invention is for use in infants or young children at risk of developing allergy. In some embodiments the nutritional composition of the present invention is for use in infants or young children born from allergic women. Indeed, scientific evidence continues to suggest that infants born to allergic mothers have a greater risk of becoming allergic later in life than infants born to mothers who are not allergic [para 124]. Blanchard et al., describe a nutritional composition for preventing and/or treating allergy symptoms in an infant [abstract]. The nutritional composition of can comprise at least one probiotic (or probiotic strain), such as a probiotic bacterial strain such as 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 preferably contain between 108 and 1010 cfu of probiotic strain and a carbohydrate source such as lactose.
Therefore, it would have been prima facie obvious at the time of applicants’ invention to apply Blanchard infant identification to Frese et al., describe a method of delaying or ameliorating an atopic disease in a breastfed infant, the method already comprises administering to an at risk infant the probiotic containing composition in order to identify infants having higher allergy risk because those infants were born to allergic mothers. Furthermore, Blanchard et al., teach a higher risk of developing allergy because one first degree family member have or have had allergy. One of ordinary skill in the art would have a reasonable expectation of success by incorporating the identification of infants who are at risk for atopic dermatitis. Finally it would have been prima facie obvious to combine the invention of Frese et al., in view of Blanchard et al.,
to advantageously achieve the identification of at risk infants.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". It is well known to take a method of treatment, comprising and identification and administration steps, wherein the disease is atopic dermatitis and there is no change in the respective function of the Bifidobacterium, thus the combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
9. Applicant's arguments filed Aug 5, 2026 have been fully considered but they are not persuasive. Applicant’s arguments, filed Aug. 5, 2026, with respect to the rejections of claims 1-17 under Frese et al., have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Blanchard et al.
Applicants assert that Frese et al., teach method for reducing the risk of atopic dermatitis; but does not teach identifying a breastfed infant that has a first-degree relative with a history of an atopic disease. However, Frese et al., do teach a method of delaying or ameliorating an atopic disease in a breastfed infant, the method comprising: identifying a breastfed infant with high risk of developing an atopic dermatitis and administering a composition comprising an effective amount of a selected from the instantly recited group of Bifidobacterium to the breastfed infant wherein the composition is mixed with about 3 to about 5 mL of breastmilk prior to administration to the breastfed infant and wherein the composition is first administered to the breastfed infant within the first three days of life until at least twelve weeks of life. Additionally Blanchard et al., taught identifying a breastfed infant that has a first-degree relative with a history of an atopic disease. Therefore, Frese et al., in view of Blanchard et al., teach a method of delaying or ameliorating an atopic disease in a breastfed infant, the method comprising: identifying a breastfed infant that has a first degree relative with a history of an atopic disease and administering the instantly claimed composition.
Pertinent References
10. 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
11. No claims allowed.
12. 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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