DETAILED ACTION
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response and Amendment filed 10/15/2025 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 16, 17, and 21-23
Withdrawn claims: None
Previously canceled claims: 1-15, 18-21
Newly canceled claims: None
Amended claims: 16
New claims: None
Claims currently under consideration: 16, 17, 22, and 23
Currently rejected claims: 16, 17, 22, and 23
Allowed claims: None
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/15/2025 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16, 17, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Schroven et al. (U.S. 2015/0183814 A1) in view of Di Leo et al. (U.S. 2011/0027230 A1).
Regarding claim 16, Schroven et al. discloses a nutritional composition comprising a spray-dried powder ([0037], [0040]) comprising a mixture of structurally distinct human milk oligosaccharides, the powder as comprising at least 85 wt% HMOs ([0025], [0031], [0038], where the powder is produced from HMOs, water, and solvents, and where substantially all of the water and solvents are removed), comprising 2’-FL, 3-FL, LNT, LNnT, LNFPI, 3’-SL, and 6’-SL ([0025], [0032], [0034]) and a monosaccharide that is L-fucose ([0033]), and wherein the spray-dried powder is free of genetically engineered microorganisms and free of nucleic acid molecules derived from genetically engineered microorganisms ([0011], [0047], where no genetically engineered microorganisms are involved in the provision of the HMOs) and the spray-dried powder contains ≤ 7 wt% water ([0038], “a spray-dried powder of the HMO or HMO precursor or blend is obtained with substantially all…of its water content removed”). Schroven et al. also discloses the nutritional composition as being an infant formula ([0040]) that is configured to provide nutrition to a subject ([0040]).
As for concentrations of components, the claim requires the HMO concentrations as being relative to the mixture of HMOs, rather than the overall spray-dried powder or nutritional composition. Schroven et al. discloses a mixture of HMOs in the following amounts: 3.38 g 2’-FL; 0.87 g 3-FL; 1.20 g LNT; 0.35 g LNnT, 0.27 g 3’-SL, and 0.72 g 6’-SL ([0065]). The total amount of HMOs is thus 6.79 g. The amount of each HMO relative to the total amount of HMOs is: 49.8% 2’-FL; 12.8% 3-FL; 17.7% LNT; 5.15% LNnT; 3.98% 3’-SL; and 10.60% 6’-SL. Such disclosed relative concentrations anticipate the claimed concentration ranges of 30-55 wt% 2’-FL; 10-15 wt% 3-FL; 0-5 wt% LNnT; and 2-4 wt% 3’-SL. The absence of LNFPI in the mixture anticipates the claimed range of 0-20 wt.% LNFPI.
Schroven et al. does not specifically disclose (i) LNT, 6’-SL, or fucose as being at the claimed concentrations or that all the HMOs are produced by microbial fermentation, (ii) the nutritional composition as containing tyndalized probiotic bacteria, or (iii) the tyndalized bacteria/nutritional composition as being for stimulating the immune system of a subject.
However, the disclosure of Schroven et al. that the HMOs may be added individually or in a blend ([0025], [0032], [0034]) effectively renders a range of concentrations of 0-100% obvious for any individual HMO relative to the total HMO concentration. As such, the claimed concentrations of 20-30 wt% LNT and 4-6 wt% 6’-SL are considered obvious. MPEP 2144.05 II A also states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” There is no evidence that the claimed HMO concentrations are critical, which further supports the conclusion that the claimed concentrations are properly deemed obvious. Further still, since the claimed concentrations are directed only to the “mixture of structurally distinct human milk oligosaccharides” yet the claim overall is directed to nutritional composition comprising a powder comprising multiple ingredients, there is no requirement in the claim precluding the addition of other HMOs that would not be considered to be a part of the “mixture”, thus limiting any criticality of any of the claimed HMO concentrations. Such a conclusion is further supported by the lack of any required amount of the mixture in the powder.
As for the fucose concentration, Schroven et al. discloses that it is an optional ingredient ([0025], [0033]), which constitutes an implicit disclosure that the concentration of the fucose may range from 0 wt% to some concentration above 0 wt%. As such, the claimed concentration range of 0-6 wt% L-fucose is considered obvious.
As for the method of production of the HMOs, MPEP 2113 I states: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Claim 16 is a product claim, and the requirement that the HMOs are produced by microbial fermentation is a process limitation that does not patentably distinguish the claimed product from that of the prior art.
As for the presence of tyndalized probiotic bacteria, Di Leo et al. discloses tyndalized lactobacilli and/or bifidobacteria as being probiotic material ([0040]).
It would have been obvious to one having ordinary skill in the art to include tyndalized probiotic bacteria in the composition of Schroven et al. First, Schroven et al. discloses the addition of probiotic bacteria, including lactobacteria and bifidobacteria ([0041], [0043]). Absent more specific instruction, a skilled practitioner would be motivated to consult an additional reference, such as Di Leo et al., for detail regarding the probiotic material. Since Di Leo et al. discloses the use of lactobacilli and/or bifidobacteria that has been tyndalized as a probiotic ([0040]), a skilled practitioner would find the addition of tyndalized probiotic bacteria to the composition of Schroven et al. to be obvious. MPEP 2144.06 II.
As for the effect of tyndalized bacteria/nutritional composition, MPEP 2144 IV states: “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Since the claimed inclusion of tyndalized probiotic bacteria was shown to be obvious, including adequate motivation for including the component, the claimed effect of being “for immune system stimulation” need not be specifically disclosed in the prior art. A composition produced according to Schroven et al. and Di Leo et al. will necessarily result in stimulation of the immune system to the same extent the claimed nutritional composition would produce such an effect. The claimed effect of being for stimulating an immune system is thus considered obvious to a skilled practitioner.
As for claim 17, Schroven et al. discloses the nutritional composition as further comprising a probiotic microorganism ([0043]).
As for claim 22, Schroven et al. discloses the powder as comprising at least 90 wt% HMOs ([0025], [0031], [0038], where the powder is produced from HMOs, water, and solvents, and where substantially all of the water and solvents are removed).
As for claim 23, Schroven et al. discloses the powder as containing less than 5% water ([0038]).
Response to Arguments
Claim Rejections - 35 U.S.C. § 103 of claims 16, 17, 22, and 23 over Schroven et al. and Di Leo et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that Schroven et al. does not provide guidance as to why probiotics would be added and what benefits would be produced, including stimulation of the immune system (Applicant’s Remarks, p. 4, ¶6 – p. 5, ¶1).
However, the disclosure in Schroven et al.—the primary reference—that probiotics may be added to the composition ([0041], [0043]) is adequate motivation to add such components. Probiotics would be recognized by a skilled practitioner as being beneficial components in a food product for the consumer; no additional guidance as to why such supplemental ingredients may be added is necessary. The additional context of those paragraphs, wherein the probiotics are discussed together with other beneficial components, such as prebiotics, proteins, carbohydrates, starch, vitamins and minerals, further supports the determination that probiotics would be recognized as simply being beneficial food additives.
Further, as discussed in the claim rejection, MPEP 2144 IV states: “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Since the claimed inclusion of tyndalized probiotic bacteria was shown to be obvious, including adequate motivation for including the component, the claimed effect of being “for immune system stimulation” need not be specifically disclosed in the prior art. A composition produced according to Schroven et al. and Di Leo et al. will necessarily result in stimulation of the immune system to the same extent the claimed nutritional composition would produce such an effect.
Applicant next argued that Di Leo must be considered as a whole (Applicant’s Remarks, p. 5, ¶2). Applicant asserted that “one of skill in the art, looking to obtain a nutritional composition with elements to increase nutrition and stimulate an immune response in a subject, would not have applied a tyndalized probiotic bacteria of Di Leo to a composition of Schroven without the benefit of hindsight”. Id.
Examiner maintains that the present claim rejections do not insufficiently consider or improperly limit the disclosure of Di Leo et al. Again, Di Leo et al. is relied on only for its instruction regarding the nature of bacteria when used as a probiotic. The rejection does not rely on producing the same type of final product as in Di Leo et al. and does not rely on otherwise incorporating any other aspect of the compositions of Di Leo et al. into that of Schroven et al. Applicant’s premise that a practitioner “looking to obtain a nutritional composition with elements to increase nutrition and stimulate an immune response in a subject, would not have applied a tyndalized probiotic bacteria of Di Leo to a composition of Schroven” mischaracterizes the approach of a practitioner producing a composition as taught in Schroven et al., since it would not be necessary for a practitioner to consider whether an immune response would be stimulated or not. MPEP 2144 IV (“It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.”). Examiner maintains that a skilled practitioner would be motivated to combine the references in the manner described in the claim rejection and that the rejection does not rely on improper hindsight.
The rejections of claims 16, 17, 22, and 23 have been maintained herein.
Conclusion
Claims 16, 17, 22, and 23 are rejected.
No claims are allowed at this time.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793