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 .
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, 2-6, 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).
Regarding claims 14, 15 and 4-6, 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 range recited in claim 14 and claim 15 for an eHF.
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 HMO 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 (page 7). 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 (page 7). 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.
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 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, 2-6, 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 additionally 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 the hypoallergenic formula of Berger would not illicit an allergic reaction and thus be suitable for use for such a consumer. Berger discloses the nutritional composition has a protein content of 1.8-2.1 g/100 kcal (page 23) which falls within the claimed ranges.
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”, Berger is considered to disclose this 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 as 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 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 disclosed 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 results 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 reasonably 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 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Berger in view of US 2011/0195153 (Valenta) 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 address MCTs.
Regarding claims 10 and 11, Nutramigen has no fat present as MCT (Table 1).
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 arguments filed 05/28/2026 have been fully considered but they are not persuasive.
Regarding the 103 over Nowak, Applicant argues that while Nowak discloses an eHF comprising 2’FL and LNnT for infants with cow’s milk protein allergy (CMPA), it does not disclose the claimed therapeutic effects of independent claims 14 and 15 and does not disclose identical method steps. Specifically, applicant argues that the objective of Nowak was to determine tolerance of the test formula in infants with CMPA and that the period of testing of 1 month is in infants from 2 months to 4 years old. Thus, applicant concludes that Nowak is completely unrelated to modulating gut microbiota and the study is over a very short period of time and includes infants too young or too old to assess the effect at 12 months of age.
These arguments are not persuasive as they are not commensurate in scope with the claims and because the 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 instant claims do not require a time period of administering the formula. The instant claims do not require that the administration is solely to infants of a specific age. Notably, Nowak does disclose administration to infants as noted by applicant. The instant claims do not quantify the extent of any inhibition or delaying (claim 15) or extent of diversity at 12 months of age (claim 14). Nowak discloses administering the same formula as claimed with the same amounts of 2’FL and LNnT to infants. While the purpose of the administration may not specifically refer to the claimed intended use, as noted above, the recognition of a latent property does not render nonobvious an otherwise known invention. As Nowak concludes that the formula is successful for use in infants with CMPA, it is clearly an obvious conclusion that the formula is usable for such a purpose and recognition of latent properties arrived at from such use are not seen to render the use non-obvious. Applicant’s use of the same formula for a period of time (extent of time is not required in the claims) and recognition of other properties do not render nonobvious the use of the formula itself in the manner disclosed by Nowak, specifically as a formula for infants with CMPA.
Applicant argues that the properties are not latent properties of the test formula of Nowak since the method steps are not identical. However, as noted above, the use of the formula of Nowak by administration to an infant meets the claim limitation of administering the formula to an infant. There is no period of time claimed and the instant disclosure does not limit the amount of time period of use to obtain an effect. Moreover, there is no extent to which the effect must be observed required in the claims. In other words, administering the formula for a period of time is seen to meet the claimed method which is not limited to a period of time of administration and which effect is not limited in quality or quantity.
Applicant argues that the study of Nowak includes infants too young or too old to assess an effect at 12 months of age. The claims refer only to “infant” which is also disclosed by Nowak. The claims do not require any particular quantity of effect or extent of the quality of an effect that would necessarily require any assessment at any point. Moreover, as there is no requirement on the particular extent of the use of the formula, and even if there were, there is no indication that the time period of use dictates the observation of the effects of the formula.
Applicant argues that the study of Nowak is not set up to assess the effect on gut microbiota, thus any effect would not have been realized. As noted above, the mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.
Applicant refers to Example 2 of the instant specification as confirming 2’FL and LNnT are capable of lowering the alpha diversity and enriching in early type FCT at 12 months old and that applicant has identified a new use for the formula described in Nowak and that this new use is not taught and could not have been predicted. Applicant argues that Nowak is not set up to assess the effect of 2’FL and LNnT and no assessment of the stool samples is performed, thus any effect would not have been realized and a person skilled in the art would have no reason to believe the test formula of Nowak would provide the therapeutic effects claimed.
This argument is not persuasive as Nowak discloses administering the claimed formula to infants and recognition of another advantage that 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). Here the advantage is the purpose of administering. Moreover, as noted above, there is no extent of the advantage claimed. Still further, as iterated above, Nowak states that HMOs in the eHF have beneficial synergistic effects on the developing gut microbiome and immune system and that the benefits of HMO 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 (page 7). 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 (page 7). Thus, Nowak discloses positive effects of HMO on the gut biome have been known for decades thus clearly suggesting benefits can be gained regarding gut microbiota in infants.
Finally, applicant argues that even taking into account Nowak’s disclosure of HMOs having a beneficial synergistic effect on developing gut microbiome and immune system, none of the references cited in this section of Nowak refer to 2’FL and LNnT’s effect on gut microbiota, let alone effect of an eHF supplemented with HMO in infants with CMPA. Applicant states that while reference [17] does relate to a study of 2’FL and LNnT and their effect on stool microbiota, it fails to discuss an effect over a 12-month period of time.
These arguments are not persuasive. Nowak acknowledges in its citation to reference [18] that supplementation of standard infant formula with 2’FL and LNnT has been shown to increased the number of bifidobacteria and production of short chain fatty acids in the gut. Thus, it was known to use these specific HMOs and that they produce beneficial effects on the gut microbiota of infants. Nowak determines the tolerance of these HMOs in eHF and determines that in fact they are tolerable for infants with CMPA. An ordinary artisan would clearly understand that this conclusion supports use of these specific HMOs in an eHF. The claims do not require any particular time period of use and even if they did have such a requirement, the use of 2’FL and LNnT in an eHF formula for administration to an infant was found to be tolerable by Nowak and used the same amounts as claimed. Thus, the normal use of such a formula for an infant would be warranted and any benefits, recognized or not, would have been obvious (Ex parte Obiaya). There is no reason to expect the HMOs to provide different results in an eHF as opposed to a regular formula as the general ingredients are the same.
Regarding Berger, applicant argues that Berger refers to standard conventional infant formula must mean intact protein and any conclusion based on eHF or AAFs effect is not known. As noted in the rejection, Berger discloses that the proteins may be extensively (fully) hydrolyzed which is known, as demonstrated by Valenta, are the proteins used in a hypoallergenic formula. Berger also refers to a hypoallergenic nutritional formula which means the formula is unlikely to cause allergic reactions and discloses 100% hydrolyzed proteins. Thus, one of ordinary skill would reasonably conclude that the formula of Berger may be used with infants having allergies and Valenta demonstrates that extensively hydrolyzed proteins are used for infants with CMPA.
Applicant argues that the disclosure in Berger of balance of the overall gut microbiota of infants by downregulating the growth of pathogenic bacteria and that the effects are effective immediately or later in life are in a section that demonstrates a need in the art rather than demonstrated effects of Berger and that Berger is silent to effects at 12 months of age. Page 5 of Berger states that the present inventors have found that a composition comprising at least one fucosylated oligosaccharide (2’FL) and at least one N-acetylated oligosaccharide (LNnT) can advantageously be used to provide in infants a global microbiota in the gut that is closer to the one of infants fed exclusively with human breast milk, in comparison to the global microbiota in the gut of infants fed with a conventional infant formula not comprising said oligosaccharides. Together the stool microbiota and metabolic signature show that the addition of 2 individual and structurally very specific human milk oligosaccharides (HMOs), shifts the overall gut microbiota, evaluated in stools, both in terms of composition and function towards that observed in breast-fed infants. Without wishing to be bound by theory it is believed that these oligosaccharides act synergistically for getting such an impact on the global microbiota in the gut. Applicant’s specification on page 23 states that the formula containing 2’FL and LNnT can advantageously be used to inhibit or reduce premature shift towards an adult-type gut microbiome previously described in infants receiving no or only some breast milk. In other words, applicant also seeks to counter the effects of infants having received no or only some breast milk by providing a formula that is augmented with 2’FL and LNnT which is the same goal of Berger by using milk formula that will provide a gut microbiota closer to infants fed with breast milk by using formula that is augmented with 2’FL and LNnT. Page 35 of Berger recognizes that the beneficial effects can be short term or long-term effects and may be immediate after the administration or later in life e.g. from 1 week to several months up to 2 to 12 months after administration. Berger also discloses that the effect of the augmented formula can be preventative for example avoiding imbalance of the gut microbiota, avoiding gut infections, maintaining a healthy intestinal microbiota and inducing a healthy intestinal microbiota; or curative such as restoring a healthy gut microbiota when it is impaired, helping eliminate or decrease pathogenic populations in the gut/intestine, and inducing a healthy microbiota after impairments due to diarrhea or infections (pages 32-33). Thus, Berger recognizes the positive effects the augmented formula has on the gut microbiota from short term to long term effects and preventative and curative effects.
Applicant argues that there are several differences between Example 2 of Berger and claims 14 and 15. Regarding the eHF and AAF, the eHF is addressed above. Regarding hypoallergenic, Berger refers to hypoallergenic and states “In a particular embodiment the nutritional composition of the present invention is a hypoallergenic nutritional composition. The expression "hypoallergenic nutritional composition" means a nutritional composition which is unlikely to cause allergic reactions.” (page 8). Berger refers again to hypoallergenic compositions on page 24. Thus, while the example is not limited to a hypoallergenic formula, Berger clearly discloses that such a formula is within the scope of the disclosure. Regarding disclosure of the effects over a 12-month period, as explained above, Berger discloses short-term and long-term effects which are seen to encompass 12-month period of time. Moreover, Berger refers to a time frame of 2 to 12 months after administration. Regarding CMPA, as noted above the disclosure of hypoallergenic formulas and the combination with Valenta address this limitation. As noted in the rejection, page 23 of Berger discloses a protein amount from 1.8-2 g/100kcal which falls within the ranges of the claims. Berger is not limited to the examples alone.
Applicant reiterates that it is unknown what the long-term effects of 2’FL and LNnT are, it remains unknown how an eHF or AAF will impact the gut with these HMOs and affects on a gut microbiome of an infant with CMPA. As noted above, the effects need to be recognized. Here, the claimed subject matter is prima facie obvious, thus advantages 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. Moreover, the prior art establishes that it was known that augmenting infant formula, with a clear suggestion for use with hypoallergenic formulas, provides benefits to the gut microbiota that are both short-term and long-term benefits, latent properties in the prior art does not render nonobvious an otherwise known invention.
Applicant argues that Berger fails to teach or suggest that the same effect would be seen in an infant with CWMP. Berger clearly discloses hypoallergenic formulas are within the scope of the formula used (cited above), and there is no indication that one of ordinary skill would expect there to be a difference whether used with a regular formula or a hypoallergenic formula. Berger provides a clear suggestion to one of ordinary skill to use 2’FL and LNnT with a hypoallergenic formula and no suggestion is found that use with hydrolyzed proteins or non-hydrolyzed proteins would negate the effects thereof.
Applicant appears to argue unpredictability based on a comparison of Figure 3 of Berger and Figure 2 (taken to be Figures 2A and 2B) of the instant application. Figure 3 of Berger notes that the alpha diversity of the BF group is significantly lower than the diversity of both formula groups, the diversity of the Test group is significantly reduced (the mean is reduced by 0.19 units) compared to the Control group and is therefore closer to the BF group. Figures 2A and 2B of Applicant’s disclosure notes that at 12 months the HMO group (e.g. eHF supplemented with 2’FL and LNnT) infants had a lower alpha diversity than the control group. Thus, in both cases, the HMO augmented group had lower alpha diversity than the control group. As noted, the claims do not require a quantification or qualification of the extent of the intended use claimed. Here, both Berger and applicant observe an alpha diversity that is lower than the control group and Berger notes that while this is not quite as low as the breast-fed group, it is still reduced as compared to the control group. Moreover, the comparison set forth by applicant is limited to observations at 3 months whereas the claims are not limited to a 3-month observation and Berger indicates that benefits are observed long-term and is not limited to the data collected at 3 months. The divergence at 6 months as shown in applicant’s Figures 2A and 2B is more significant.
Applicant argues that effects at 3-4 month and 12 months are not possible to extrapolate. As noted above, there is no quantification or qualification of the effects claimed. As noted in the rejection, Berger uses in Example 2 the exact amounts of 2’FL and LNnT claimed (claims 4-6). The effects are expected to be similar and there is nothing in the record to demonstrate that using a formula disclosed by Berger for a period of time would not provide the same benefit as recited in the preamble of the claim.
Applicant argues that the date confirms that despite the introduction of more diverse food sources, smaller proportions of formula, the presence of the HMOs in the infant formula delays maturation during this period. The claims require only administration of the claimed formula to an infant. Berger also discloses administration of the claimed formula to an infant and obviates its use in a hypoallergenic formula that is known for use with infants with CMPA. There are no requirements in the claim for diverse food sources, smaller proportions of formula or any quantification or qualification of the effects. Berger notes both short-term and long-term microbiota effects of providing a gut microbiota of an infant that is closer to that of a breast-fed infant. The effects are similar to that illustrated by applicant as shown by alpha diversity. There is no indication that different effects would be observed as Berger clearly indicates that effects may be long-term.
Applicant argues that Valenta is silent regarding HMOs. Valenta is relied upon to illustrate that it is known to use hypoallergenic (fully hydrolyzed proteins) for infants with CMPA and not for HMOs.
Applicant argues that Berger discloses a range of 1.6-3 g/100kcal and that the type of protein is not critical provided that the minimum requirements for essential amino acid content are met. Applicant argues that for eHFs typically contain 2.6-2.8 g/100kcal of protein and AAFs typically contain 2.8-3.1 g/100kcal. However, claims 14 and 15 require 1.8-2.4 g/100kcal for eHFs and 1.8-2.9 g/100kcal for AAFs. Berger discloses a preferred range of 1.8-2.1 g/100kcal which falls within these ranges (page 23).
Regarding Borschel, applicant argues that the abstract of Borschel confirms that the studies followed the infants during the first four months, and cannot provide information about an effect at 12 months. Applicant argues that extrapolations from 3-4 months to 12 months are inappropriate. As explained above, Berger notes both short-term and long-term microbiota effects of providing a gut microbiota of an infant that is closer to that of a breast-fed infant. The effects are similar to that illustrated by applicant as shown by alpha diversity. There is no indication that different effects would be observed as Berger clearly indicates that effects may be long-term.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1723
/Jennifer McNeil/Primary Examiner, Art Unit 1723
Prosecution Insights