Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/06/2026 has been entered. The amendment filed 02/04/2026 with the RCE is also entered.
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.
Claim(s) 15, 14, 2-7, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak-Wegrzyn et al, “Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides”, Nutrient, 06/26/2019 (cited on IDS filed 10/29/2025).
Nowak discloses an extensively hydrolyzed formula (EHF) supplemented with LNnT and 2’FL (abstract) and discloses administering the formula to infants having a cow’s milk protein allergy (page 1). The test formula was a 100% whey-based EHF and was confirmed to be hypoallergenic. Whey is protein derived from one or more cow’s milk protein. The test formula is supplemented with 1.0 g/L 2’FL and 0.5g/L LNnT (test and control infant formulas). These ranges fall within the ranges of claims 4-6. The test formula contains 2.2g/100kcal of protein which falls within the ranges of claims 7 and 9.
Regarding the claimed benefits cited in claims 14 and 15, the claims refers to “inducing a microbiota that is less diverse at 12 months age compared [to] the microbiota at 12 months of age of an infant receiving a conventional formula not comprising 2’FL and LNnT, and/or inducing a lower gut microbiota at 12 months of age compared to an infant receiving a conventional infant not comprising 2’FL and LNnT” (claim 15), “inhibiting or reducing premature maturation of the gut microbiota and/or delaying maturation of the gut microbiota in an infant in need thereof” (claim 14), and claims 2 and 3 further define the benefit of claim 15 stating “wherein a lower microbiota age at 12 months age means having a gut microbiome enriched in early-type faecal community type (FCT) clusters” (claim 2), and “wherein a lower microbiota age at 12 months age means having a gut microbiome diminished in late-type faecal community type (FCT) clusters (claim 3). Here, the method steps carried out by Nowak are identical to that of the claims, but the benefit of reducing maturation of the gut microbiota and enriching early-type FCT clusters or lowering late-type FCT clusters is not expressly recognized.
However, Nowak states that HMOs in the EHF have beneficial synergistic effects on the developing gut microbiome and immune system and that the benefits of HMOs have been known for several decades and that two types of HMOs have been added to infant formula (2’FL and LNnT) and that HMO form the preferred substrate for bifidobacteria and provide beneficial effects on the developing microbiome of breastfed infants. Nowak states that HMO suppress potential gut pathogens, such as Enterobacteriaceae and enteric viruses, thereby providing protection against enteric infection. Nowak explains that HMO are absent from cow’s milk and HMO supplementation of milk-based infant formulas might reduce the risk of enteric infection. And in addition, HMO have been shown to positively affect gut epithelial integrity, apoptosis, and intestinal permeability. Based upon the express disclosure of the benefits of the addition of HMO, specifically 2’FL and LNnT, and the inclusion of these HMOs in the claimed amounts, one of ordinary skill would have reasonable expected the claimed benefits to be gained by following the same method steps disclosed by Nowak. In other words, Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Also, "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.") (MPEP 2145 (II)). Thus, the recitation of a benefit as the purpose for following the same method steps of administering the same EHF with the same amounts of 2’FL and LNnT to an infant with a cow’s milk allergy disclosed by Nowak is considered obvious as the benefits recited as the purpose of executing the steps are an advantage that would naturally flow from following the suggestion of Nowak.
Alternatively, one of ordinary skill would reasonably expect the claimed effects (cited purposes for administering the claimed formulas) and thus purposefully administer the formulas of Novak as evidenced by mBio. mBio
Regarding claims 10 and 11, Nowak does not positively recite the inclusion of MCTs and none appear to be present in their example formulations, and Nowak does not indicate the need for the presence of MCTs. Therefore, MCTs are presumed to be absent and not required by the composition.
Regarding claim 12, Nowak discloses the same infant formula, Althera (without HMO) as the control but for the amount of protein is lower in the test formula (2.2g/100 kcal vs 2.47 g/100 kcal) and is expected to have similar carbohydrate and fat contents as claimed since Nowak discloses that the macro and micronutrient profiles are otherwise almost identical. Moreover, Nowak discloses that both formulas contain lactose which provided 52% of the total carbohydrates and is stated as 29g lactose in 100 g powder which indicates a total carbohydrate approximating 59 g/carbohydrates which is comparative to the EHF used in the instant application (page 26) and overlaps the claimed range.
Claim(s) 15, 14, 2-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over
WO 2017/021476 (Berger) (cited on IDS filed 04/13/2023) in view of US 2011/0195153 (Valenta).
Regarding independent claim 15, Berger teaches a nutritional composition with 2FL and LNnT. The nutritional composition is an infant formula (page 9) and is given to infants or young children which includes administration to an infant (claim 1, page 12, page 28, page 36) and also teaches that the proteins may be hydrolyzed and specifies that the proteins may be “extensively” (fully) hydrolyzed for infants or young children believed to be at risk for developing cow’s milk allergy (page 24). Berger additional states that the nutritional composition is a hypoallergenic nutritional composition which means a nutritional composition which is unlikely to cause allergic reactions and also discloses that in a particular embodiment 100% of the proteins are hydrolyzed (pages 8 and 24). While Berger does not expressly disclose administering the formula to an infant with a cow’s milk allergy, the type of formula disclosed (hypoallergenic, EHF) is known in the art to be administered to consumers with cow’s milk allergy. For instance, Valenta states that in order to avoid allergic reactions upon exposure to cow's milk in a cow's milk allergic subject, and in particular in infants having a cow's milk allergy, mostly milk substitute formulas are presently used which replace nutrition with cow's milk. These formulas additionally provide the subject with a complete source of nutrition. Milk substitutes include hypoallergenic formulas based on partially or extensively hydrolyzed protein. Hence, most of today's cow's milk substitute formulas on the market are based on cow's milk that has been hydrolyzed to various degrees and/or on amino acid formulations. These cow's milk formulas are used to replace cow milk and thereby reduce allergic reactions in cow's milk allergic subjects [003-004]. Finally, Valenta states that an extensively hydrolyzed cow's milk peptide-containing hydrolysate is preferably hypoallergenic [0048]. As Berger discloses that the nutritional composition is hypoallergenic and 100% of the proteins may be hydrolyzed (EHF), and Valenta discloses that one of ordinary skill in the art is aware that these milk substitutes can be utilized to avoid allergic reactions in a cow’s milk allergic subject, one of ordinary skill would have found it obvious to administer the formula of Berger to a consumer with an allergy to cow’s milk with a reasonable expectation that they hypoallergenic formula of Berger would not illicit an allergic reaction and thus be suitable for use for such a consumer.
Regarding the limitation “inducing a microbiota that is less diverse at 12 months age compared to the microbiota at 12 months age of an infant receiving a conventional infant formula not comprising 2’FL and LNnT” is taught by Berger by stating that the method of administration of the formula enhances a good balance in the overall gut microbiota of infants, especially by down-regulating or repressing the growth of pathogenic bacteria and that the effects are effective immediately or later in life (top of page 5). Moreover, Berger teaches the reduction of pathogens and/or virulence factors in comparison to the global microbiota in the guts of infants that are not fed the 2’FL and LNnT (page 33). Berger teaches that the use of the nutritional composition involves a decrease in the bacterial pathogen Clostridium difficile and others (page 33).
Regarding independent claim 14, Berger teaches the result of administering to an infant the nutritional composition is being closer to a microbiota of a breast-fed infant. This is considered to teach reducing premature maturation since the microbiota of a breast-fed infant is the earliest microbiota associated with growth.
Regarding claims 4-6, in Example 2, the test formula for comparison is the control formula but for part of the lactose is preplaced with 2FL and LNnT with ranges of 1.0-1.2 g/L (2FL) and 0.5-0.6 g/L (LNnT) (top of page 39). These ranges fall within the claimed ranges. The term “about” in claim 6 indicates that the ranges are 0.9-1.1 for 2FL and 0.45-0.55 for LNnT. The amounts of Example 2 are seen to anticipate these ranges with sufficient specificity. Moreover, Example 1 provides precisely 1g/L 2FL and 0.5g/l LNnT.
Regarding claim 7, the nutritional composition of Berger has a protein content of 1.8-2.1 g/100 kcal (page 23).
Regarding claim 9, the claim recites “about 2.2 g protein per 100 kcal”. The instant specification states that “about” is above and below the stated value by 10%. Thus, “about 2.2” is 1.98-2.44. Berger teaches a range of 1.9-2.1 g/100 kcal (page 23) which is seen to overlap the claimed range with sufficient specificity so as to anticipate “about 2.2”. Alternative to anticipation of the teaching of “about 2.2 g protein per100 kcal” above, it would have been obvious to one of ordinary skill based upon the teaching of protein in the range of 1.9-2.1 to provide “about 2.2” when taking into account “about” provides a range that overlaps. Furthermore, Berger teaches a broader range of 1.6-3 g per 100 kcal which overlaps and obviates the claimed range. See MPEP 2144.05.
Regarding claims 2 and 3, Berger teaches that administration of the nutritional composition results in the gut microbiota being closer to that of breast-fed infants and the effects are measured in stool samples. The claimed “early” type clusters are discloses as associated with young breast-fed infants. Thus, Berger’s teaching that the administration of the nutritional composition with identical amounts of 2FL and LNnT with those claimed would be expected to affect the microbiota of the recipient by displaying a gut microbiota closer to that of breast-fed infant. Inspection of the stool to measure the effect would be expected to display more “early” type faecal community type clusters and less “late” type clusters since the effect taught by Berger changes the microbiota to be closer to a breast-fed infant. This would inherently result in a change in the faecal testing and be expected to be closer to that seen in a breast-fed infant as well. Moreover, as stated above, Berger teaches administration of the exact same amounts as claimed and disclosed, thus the effect is reasonable expected to also be the same. Note also, the claims do not require any quantification of a change, thus any measurable change is seen to meet the claim, and as explained above, is inherent based upon the teachings of Berger and the precise amounts are identical to that of the instant disclosure and claims.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Berger in view of Valenta as applied to claim 15 above, and further in view of US 2011/0217402 (van Tol).
Berger teaches a nutritional composition given to infants as discussed above and states that the formula is preferably an infant formula. Berger also states that the nutritional composition is hypoallergenic and that hydrolyzed proteins can be used for infants at risk for developing cow’s milk and in light of Valenta would have been obvious to use with infants having a cow’s milk allergy. Also, Berger teaches fats and carbohydrates, but does not expressly teach the amounts in g per 100 kcal.
Van Tol discloses an infant formula which may be nutritionally complete and contain suitable types and amounts of lipid, carbohydrate, protein, vitamins and minerals. Van Tol discloses that the amount of lipid (fat) may vary from about 3-7 g/kcal, protein may vary from 1-5g/kcal and may be an EHF, and carbohydrate may vary from 8-12g/kcal. This disclosure is taken as an indication of known amounts for each of these materials in a nutritionally complete infant formula. It would have been obvious to one of ordinary skill to provide these ranges of lipids and carbohydrates in the infant formula of Berger to provide a nutritionally complete composition for infants. The ranges of van Tol overlap with the claimed ranges and present a prima facie case for obviousness.
Claims 8, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Berger as applied to claim 15 above, and further in view of Borschel, “Comparison of Growth of Healthy Term Infants…”, 2018 (cited on IDS filed 04/13/2023).
Berger teaches a nutritional composition as discussed above but does not teach that the formula is an amino acid formulation (AAF) and does not address MCTs.
Regarding claim 8, Borschel discloses amino-acid based infant formulas are clinically important formulas for the management of infants with food allergies and various gastrointestinal conditions (page 1). Borschel lists known amino acid formulas in Table 1 including Nutramigen AA, Alfamino and Neo-Syn, each of which have 2.8 g protein per 100 kcal which is within the range claimed. It would have been obvious to use these AAF formulations as the base formula in Berger in order to provide a formula that is useful for infants with food allergies or other GI conditions with a reasonable expectation of also delivering the benefits to the microbiota of Berger.
Regarding claims 10 and 11, Nutramigen has no fat present as MCT (Table 1).
Additionally, Borschel discloses that infants fed with formula without MCT gained significantly more weight as compared to infants fed a formula with 50% of fat from MCT and the caloric efficiency was lower with the MCT-containing formula (page 12/15). It would have been obvious to one of ordinary skill to eliminate MCTs as a fat source in the infant formula to expedite weight gain and caloric efficiency as disclosed by Borschel.
Response to Arguments
Applicant’s amendment to claims 14 and 15 has overcome the 102 rejection of claims 15, 14, 2-7 and 9 over Berger and the 103 rejection of claim 12 over Berger in view of Schuh or alternatively Schuh in view of Berger.
Applicant's arguments filed 02/04/2026 have been fully considered but they are not persuasive in light of the new grounds of rejection cited above.
With regard to Berger, Applicant argues that one of ordinary skill would not have been motivated to administer the infant formula of Berger to an infant with cow’s milk allergy. However, as discussed above, Berger discloses 100% hydrolyzed whey protein (cow’s milk protein) and a hypoallergenic formula that will not cause allergic reactions. Valenta further discloses hypoallergenic and EHF formulas are known to be used with consumers (infants) having cow’s milk allergy. Thus, one of ordinary skill would find it obvious to administer the hypoallergenic, extensively hydrolyzed protein containing formula of Berger to consumers (infants) having cow’s milk allergy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793