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 .
DETAILED ACTION
Pursuant to the amendment dated 06/10/2026, claims 20, 23, 26, 26, and 33 were amended, claims 1-19 were cancelled, and claims 34-37 were newly added. Claims 20-37 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2022/061824, filed on 05/03/2023 and claims foreign priority to European Patent Office (EPO) 21171884.6 filed on 05/03/2021.
Withdrawn Objections
Applicant’s amendment, filed on 06/10/2026, with respect to the objection of claims 20 has been fully considered and is persuasive. Applicant has removed the second “galactosyllactose”. The objection is hereby withdrawn.
Withdrawn Rejections
Applicant’s amendment, filed on 06/10/2026, with respect to the rejection of claims 23, 26,30, and 33 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 has been fully considered and is persuasive. Applicant has amended claims 23, 26,30, and 33 to remove the phrase “preferably”. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 06/10/2026, with respect to the rejection of claims 20-33 under 35 U.S.C. 112(a), because the specification, while being enabling for decreasing the B cell adaptive immune response to vaccination with an antigen that is derived from a virus in a subject, the method comprising administering galacto-oligosaccharides to a subject, it does not reasonably provide enablement for ameliorating the B cell adaptive immune response to vaccination with an antigen that is derived from a virus in a subject, has been fully considered and is persuasive. Applicant has amended claim 20 to remove the phrase “preventing”. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) necessitated by Applicants' amendment, filed on 06/10/2026, wherein instant independent claim 20 was amended to alter the breadth and scope of the claim and wherein the remaining pending claims 21-33 depend from said independent claim 20 and claims 34-37 were newly added.
Modified and Maintained Grounds of Rejection
Claim Rejections – 35 USC § 103
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.
Claims 20-37 are rejected under 35 U.S.C. 103 as being unpatentable over Garssen et al. (US 9,782,422 B2, published 10/10/2017, see PTO-892), Stahl et al. (US 8,591,919 B2, published 11/26/2013, see PTO-892), and Frese (WO 2019/246316 A1, published 12/26/2019, see PTO-892).
Garssen is drawn to compositions comprising a non-digestible oligosaccharide for the treatment of a trichothecene mycotoxin exposure associated condition. The non-digestible oligosaccharide may comprise a short chain galacto-oligosaccharide (abstract). The non-digestible oligosaccharide may comprise galacto-oligosaccharides
with β(1,4), β (1,3) and/or β (1,6) glycosidic bonds and a terminal glucose (abstract). A galacto-oligosaccharide with β (1,3) glycosidic bonds and a terminal glucose would be β (1,3) -galactosyllactose. The trichothecene mycotoxin exposure associated condition may be associated with exposure to deoxynivalenol (abstract). Garssen teaches that the condition may be selected from a list of including modulation of serum immunoglobulin levels or immunosuppression (claim 9). Garssen teaches that trichothecenes are acutely cytotoxic and strongly immunosuppressive (column 13). Garssen teaches that the use of oligosaccharides to restrict the pathological effects of DON related to intestinal epithelial is promising for mycotoxin exposure intervention (columns 24-25). Garssen teaches that mycotoxin contamination is unavoidable as mycotoxins can appear in the food chain as a result of fungal infection of plants that can be consumed by humans or livestock and that mycotoxins resist decomposition during digestion so they remain in the food chain in edible products. Further, temperature treatments such as cooking and freezing are not adequate methods of decreasing the prevalence of mycotoxins (column 1). Garssen teaches that trichothecenes occur in cereal grains and in derived products such as breakfast cereals (column 14). Garssen teaches that the non-digestible oligosaccharide may be present in the composition at any suitable concentration such as 0.01g-1.0g per 100 mL in a liquid formula (column 12). Garssen teaches that the non-digestible oligosaccharide composition may comprise a cereal component. Garssen teaches that the composition may be administered to babies, infants which are in the adaptation period to solid food, toddlers, children, teenagers, or adults (column 22). Garssen teaches that the compositions may comprise an infant and/or toddler nutrition, such as an infant and/or toddler formula (column 17 and claim 17).
Garssen does not teach the administration of the composition for inhibiting a food contaminant induced decrease of the B cell adaptive immune response to vaccination. Garssen does not teach that the composition comprises at least 20% beta 1,3’ -galactosyllactose. Garssen does not teach that the composition comprises at least 1 wt% galacto-oligosaccharides based on dry of the nutritional composition.
Stahl is drawn to a nutritional composition comprising at least two different beta-galacto-oligosaccharides (BGOS) A and B wherein the majority of linkages between two galactose residues in BGOS A are beta 1,4 and/or beta 1,6, and the majority of linkages between two galactose residues in BGOS B are beta 1,3 (abstract). Stahl teaches that the BGOS B have a structure of Galn-Glu and/or Galm, with n=2-6 and m=2-6. Stahl teaches that a Gal-Gal-Glu may have a % linkage between the two galactose residues up to 100% beta 1,3. A Gal-Gal-Glu with a beta 1,3 linkage is a beta 1,3’-galactosyllactose (column 2). The mixture of BGOS had an improved effect on stimulating the immune system (column 1) and an increased Th1 response was observed which was indicative of an increased vaccination response (column 1). Stahl teaches the method of stimulating the immune system comprising administering to a human subject the composition comprising GOS wherein the human subject is a human infant (claims 9 and 10). Stahl teaches that the composition may comprise a sum of the BGOS up to 20 wt. % based on dry weight (column 3).
Frese is drawn to novel structures in mare’s milk that may be synthesized or purified for use in a variety of applications related to the gut microbiome and mammalian health (abstract). Frese teaches a composition comprising Gal(β l-3)Gal(β -4)Glc (claim 1). Gal(β l-3)Gal(β -4)Glc is beta 1,3’-galactosyllactose. Frese teaches that the oligosaccharide may be provided in its own composition or as part of a food composition. The composition may be administered to an infant, an adolescent, an adult, or a geriatric adult (paragraph 0055). The treatment may be designed to stimulate the immune system for the purpose of improving host defense, including but not limited to improving mucus production and/or reducing mucus degradation, B cell responsiveness and/or expanding or altering the T Regulatory and Helper T cell profile. The composition may result in induction of oral tolerance and improved vaccine efficacy (paragraph 0049). The composition may be used on a mammal to treat vaccine responsiveness (paragraph 0050).
It would have been prima facie obvious to combine the teachings of Garssen, Stahl, and Frese before the effective filing date of the invention by applying the method of treating a mycotoxin exposure associated condition with a composition comprising a galacto-oligosaccharide as taught by Garssen to inhibit an induced decrease of the B cell adaptive immune response to vaccination as taught by Frese to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to apply the method of treating a mycotoxin exposure associated condition with a composition comprising beta 1,3’-galactosyllactose because Garssen teaches that mycotoxin exposure is unavoidable and that a composition that may comprise beta 1,3’-galactosyllactose may be used to treat a mycotoxin exposure associated condition and that the condition may be immunosuppression, Stahl teaches that BGOS had an improved effect on stimulating the immune system and an increased vaccination response, and Frese teaches that a composition comprising beta 1,3’-galactosyllactose may stimulate B cell responsiveness and improve vaccine efficacy. One of ordinary skill in the art would have a reasonable expectation of success because Garssen teaches mycotoxin exposure is unavoidable and that a composition that may comprise beta 1,3’-galactosyllactose may be used to treat a mycotoxin exposure associated condition and that the condition may be immunosuppression, Stahl teaches that BGOS had an improved effect on stimulating the immune system and an increased vaccination response, and Frese teaches that a composition comprising beta 1,3’-galactosyllactose may stimulate B cell responsiveness and improve vaccine efficacy.
It would have been prima facie obvious to combine the teachings of Garssen, Stahl, and Frese before the effective filing date of the invention by optimizing the composition comprising beta 1,3’-galactosyllactose for the treatment of a trichothecene mycotoxin exposure associated condition to comprise at least 20% of the galacto-oligosaccharides to be beta 1,3’-galactosyllactose as taught by Stahl to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the composition to comprise at least 20% of the galacto-oligosaccharides to be beta 1,3’-galactosyllactose because Stahl teaches that the composition may comprise up to 100% beta 1,3’-galactosyllactose. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Regarding instant claims 25 and 32, it would have been prima facie obvious to combine the teachings of Garssen, Stahl, and Frese before the effective filing date of the invention by optimizing the composition to compromise at least 1 wt% galacto-oligosaccharides based on dry weight of the nutritional composition in the composition as taught by Stahl to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the amount to compromise at least 1 wt% galacto-oligosaccharides based on dry weight of the nutritional composition because Stahl teaches that the composition may comprise a sum of the BGOS up to 20 wt. % based on dry weight. One of ordinary skill in the art would have a reasonable expectation of success by the amount to compromise at least 1 wt% galacto-oligosaccharides based on dry weight of the nutritional composition taught by Stahl because Stahl teaches that the composition may comprise a sum of the BGOS up to 20 wt. % based on dry weight. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered, but they are not persuasive.
Applicant argues that the combined teachings of Garssen, Stahl and Freese does not teach a method for ameliorating a food contaminant induced decrease of the B cell adaptive immune response to vaccination with an antigen that is derived from a virus in a subject, the method comprising administering galacto-oligosaccharides comprising at least 20% beta 1,3 '-galactosyllactose. Applicant argues that Stahl does not teach anything on inhibiting a decrease of the B cell adaptive immune response to vaccination and was only tested on healthy individuals, and that Frese does not cure the deficiency as Frese is related to novel oligosaccharides uniquely identified in mare’s milk which did not include beta 1,3 '-galactosyllactose (Frese Table 4). The argument is not persuasive. Garssen teaches a method of administering a composition comprising beta 1,3 '-galactosyllactose and that the use of oligosaccharides to restrict the pathological effects of DON related to intestinal epithelial is promising for mycotoxin exposure intervention. As Garssen teaches that mycotoxin exposure is unavoidable, one could reasonably conclude that any subject being vaccinated has been exposed to mycotoxin. Frese specifically discloses a composition may comprise beta 1,3 '-galactosyllactose (Frese claim 1) and teaches that the composition may be used for to stimulate the immune system for the purpose of improving host defense, including but not limited to improving mucus production and/or reducing mucus degradation, B cell responsiveness and/or expanding or altering the T Regulatory and Helper T cell profile and improve vaccine responsiveness. Regarding the absence of beta 1,3 '-galactosyllactose in Frese Table 4, it would not be present as beta 1,3 '-galactosyllactose is not unique to mare’s milk and Table 4 disclosed only oligosaccharides that were unique to mare’s milk. Stahl further teaches that administering compositions comprising beta 1,3 '-galactosyllactose may stimulate the immune system and improve vaccination response. Stahl was not relied upon to teach inhibiting a decrease of the B cell adaptive immune response to vaccination as Frese teaches the reduction of B cell responsiveness and to treat vaccine responsiveness.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.L.S./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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