DETAILED ACTION
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 .
Status of the Claims
Claims 1, 3-5, 15, and 17-20 are pending (claim set as filed on 02/13/2026).
Priority
This application is a 371 of PCT/EP2020/055767 filed on 03/05/2020, which has foreign applications to: (1) EP 19160876.9 filed on 03/05/2019, (2) EP 19161023.7 filed on 03/06/2019, and (3) EP 19214414.5 filed on 12/09/2019.
Withdrawal of Rejections
The response and amendments filed on 02/13/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
Briefly, the previous obviousness rejections have been modified with a new reference.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejections Necessitated by Amendment
Claim Rejections - 35 USC §103, Obviousness
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 1, 3-5, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dong (WO 2016/146789 A1 - cited by the ISA and in the IDS filed on 08/30/2021) in view of Renshaw (US 2010/0041621 A1 - newly cited) and Prieto (US Patent no. 6,045,854 - previously cited).
Dong’s general disclosure relates to the use of nutritional composition comprising sialylated oligosaccharides for enhancing cognitive development and learning skills in mammals (see abstract & page 1, lines 6-11).
Regarding the base claims, Dong teaches administering “a nutritional composition comprising 3'-Siallylactose (3'-SL) and 6'-Siallylactose (6'-SL) in a weight ratio between 10:1 and 1:10 for use in enhancing learning skills and/or enhancing memory function in an individual, especially by increasing the sialic acid (Neu5Ac) concentration in the brain of said individual” (see page 4, lines 18-22, and page 32, lines 9-12, and claim 25). Dong discloses “the expression ‘learning skills’ is to be understood as referring to the information processing abilities of an individual, including perception, learning, remembering, judging and problem solving. ‘Learning skills’ also include the ability of an individual to acquire new, or modify and reinforce, existing knowledge, behaviors, skills, values, or preferences and may involve generating different types of information” (see page 33, lines 17-30). Claim interpretation: ‘learning skills’ as disclosed by Dong reads on the claim limitation of “wherein the executive function comprises at least one of recognizing, evaluating, or making choices among a variety of alternative options and/or strategies”.
Dong teaches “the nutritional composition can further comprise at least one non-digestible oligosaccharide (e.g. prebiotics) other than the sialylated oligosaccharides previously mentioned. Examples of prebiotics include certain oligosaccharides, such as fructo-oligosaccharides (FOS), galactooligosaccharides (GOS), fucosylated oligosaccharides (such as 2'-fucosyllactose, 3'fucosyllactose, difucosyllactose, lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-N-fucopentaose Ill, lacto-Nfucopentaose V, lacto-N-fucohexaose, lacto-N-difucohexaose I, fucosyllacto-N-hexaose, fucosyllacto-N-neohexaose I, fucosyllacto-N-neohexaose II, difucosyllactoN-hexaose I, difucosyllacto-N-neohexaose I, difucosyllacto-N-neohexaose II, fucosylpara-Lacto-N-hexaose, and any combination thereof), N-acetylated oligosaccharides (such as lacto-N-tetraose (LNT), N-neotetraose (LNnT) and any combination thereof)” (see page 48, lines 20-30).
Regarding claims 3-4 and 17, Dong teaches the nutritional composition is administered to the individual during the early age of said individual, and preferably during the infant phase of said individual (see page 5, lines 12-19). Dong teaches a preterm or small for gestational age (see page 31, lines 6-14).
Regarding claim 5, Dong teaches “the composition is an infant formula, such as a starter infant formula, a follow-on formula (or follow-up formula) or a preterm infant formula, a milk fortifier, preferably a human milk fortifier, a growing-up milk, a baby food formula, a medical food product for clinical nutrition, a complement, a supplement, yogurt, juice, or a cereal bar. Even more preferably, said composition is an infant formula, a human milk fortifier, or a supplement” (see page 8, lines 5-11, and page 28, lines 24-30).
However, Dong does not teach: assessing the subject by Dimensional Change Card Sort (DCCS) task or Wisconsin Card Sorting Task; and the claimed combination of oligosaccharides and total amount thereof.
Renshaw’s general disclosure relates to the fields of brain health and cognitive function where “cognition encompasses the high-level intellectual functions carried out by the brain, including comprehension, speech, visual perception, calculation, attention, memory, problem-solving, and self-monitoring. The frontal brain serves important executive functions in cognition (see ¶ [0002]-[0003]). Renshaw teaches methods and compositions for improving cognitive performance to a neuropsychologically healthy human (see abstract & ¶ [0010]-[0023]). Renshaw further teaches “cognitive functions may be measured by a wide variety of neuropsychological tests known in the art including the following: … Wisconsin Card Sorting Task (WCST)” (see ¶ [0051]-[0054]).
Prieto’s general disclosure relates to compositions of “synthetic nutritional products containing oligosaccharides from human milk. More specifically, the synthetic nutritional product contains at least one of the following oligosaccharides: 3’-fucosyllactose, lacto-N-fucopentaose III, lacto-N-fucopentaose II, difucosyllactose, 2’-fucosyllactose, lacto-N-fucopentaose I, lacto-N-neotetraose, lacto-N-fucopemaose V or lacto-N-tetraose” (see col. 1, lines 16-24). Prieto teaches oligosaccharides in the concentration ranges: from about 130-3500 mg/L of 3’-fucosyllactose and from about 350-4500 mg/L of 2’-fucosyllactose (see col. 2, lines 32-51, and col. 4, lines 50-64).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the subject by Wisconsin Card Sorting Task such as taught by Renshaw in the method of Dong. The ordinary artisan would have been motivated to do so is because Renshaw teaches that cognitive functions may be measured by a wide variety of neuropsychological tests known in the art including Wisconsin Card Sorting Task. To an ordinary artisan, performing cognitive tests or assessments allows for the identifications or diagnoses of conditions as well as establishes a baseline for therapeutic intervention and progress (i.e., patient evaluation of test scores for a type and age of the subject to determine if a subject is suffering from a sub-optimal executive function or not). The selection of a well-known neuropsychological test for performing an assessment of executive function is considered to be a common or a routine practice in the art within the purview of the ordinary artisan. Thus, the claimed elements would have been readily apparent as (a) combining prior art elements according to known methods to yield predictable results, within the guidelines for making the determination of obviousness (MPEP 2141 (III)).
Moreover, it would have been secondly obvious to employ the claimed combination of oligosaccharides because Dong suggests the oligosaccharides may be any combination thereof (see Dong at page 48, lines 20-30). The MPEP 2141 also provides examples of rationales that may support a conclusion of obviousness which includes: obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “An ‘obvious to try’ rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103” (MPEP 2145(X)(B)).
Regarding the claimed oligosaccharide concentrations, one of ordinary skill in the art would have reasonably envisaged or arrive at the claimed invention with the oligosaccharide concentrations thereof following the guidance of the cited references of Dong and Prieto. The MPEP at 2144.05 (I) states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close” wherein, for example, Dong teaches an amount effective and in various dosages throughout the disclosure. Additionally, the MPEP at 2144.05 (II) further states:
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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. "[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."
One of ordinary skill in the art would recognize that the concentration is a result effective variable dependent on various factors. For example, the prior art discloses variable parameters:
Prieto discloses “The amounts of such ingredients will vary depending on whether the formulation is intended for use with normal, healthy infants, children, adults or subjects having specialized needs such as those accompany certain pathological conditions” (see col. 3, lines 50-57). Prieto teaches “Actual dosage levels of the oligosaccharides in the formulations of the present invention may be varied so as to obtain an amount of active ingredient that is effective to obtain a desired response for a particular composition and method of administration. The selected dosage level therefore depends upon the desired therapeutic effect, on the route of administration, on the desired duration of administration and on other factors” (see col. 4, lines 37-45).
This is motivation for someone of ordinary skill in the art to practice or test the parameter values widely to find those that are functional or optimal which then would be inclusive or cover those values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 (II)). The ordinary artisan would have had a reasonable expectation of success because the references are directed to the use of human milk oligosaccharides and its administration thereof. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art at the time of invention.
Claims 1, 3-5, 15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (US Patent no. 11,026,444 B2, which has a PCT publication date of 11/29/2018 - previously cited) in view of Renshaw (US 2010/0041621 A1 - newly cited) and Prieto (US Patent no. 6,045,854 - previously cited).
Yan’s general disclosure relates to a composition for use in the improvement of short-term memory and/or the development of optimum short-term memory and other related cognitive benefits, especially, in infants and young children (see abstract & col. 1, lines 19-22).
Regarding the base claims, Yan discloses “cognitive deficits in terms of lower IQ, lower attention and working memory abilities, and problems in executive functions may persist into school-age and adolescence” (see col. 1, lines 35-36, and col. 2, lines 41-44, and col. 3, lines 11-21). Yan teaches “a nutritional composition comprising a Human Milk Oligosaccharide (HMO) having an effect on the promoting, enhancement or improvement of the short-term memory of the subjects in infants and/or young children. The composition can be an infant formula. The HMO may be 2FL, DiFL and/or LNT and or LNnT or combinations thereof” (see abstract). Yan teaches “the composition according to the invention, in some embodiments, can comprise one or more sialylated oligosaccharides. The sialylated oligosaccharides may be selected from the group comprising 3'-sialyllactose and 6'-sialyllactose” (see col. 8, lines 28-33, and col. 9, lines 6-14). The administration of a specific oligosaccharide, especially human milk oligosaccharides is particularly effective in the enhancement and/or promotion and/or improvement of the short-term memory and/or the declarative memory and/or the working memory, in particular in young subjects such as infants and/or young children. The administration can be done as part of a nutritional intervention (see col. 5, lines 15-23). Yan discloses “The term ‘short term memory’ (STM) refers to a system for temporarily storing and managing information required to carry out complex cognitive tasks such as learning, reasoning, and comprehension” (see col. 6, lines 26-29). Claim interpretation: although not explicit, it is implicit that Yan is directed to the main purpose of improving executive function including, e.g., evaluating (i.e., reasoning reads on evaluating).
Regarding claims 3-4 and 17, Yan teaches the subject is a “preterm or term born neonates, infants, toddlers, children or young adults or young animals” (see col. 4, lines 20-23, and col. 5, lines 47-53, and col. 2, lines 20-60).
Regarding claim 5, Yan teaches “the composition of the invention can for example be a starter infant formula, an infant formula, a baby food, an infant cereal composition, a follow-on formula or a growing-up milk, and said composition is preferably a starter infant formula” (see col. 11, lines 21-31).
However, Yan does not teach: assessing the subject by Dimensional Change Card Sort (DCCS) task or Wisconsin Card Sorting Task; and the claimed combination of oligosaccharides and total amount thereof.
Renshaw’s general disclosure relates to the fields of brain health and cognitive function where “cognition encompasses the high-level intellectual functions carried out by the brain, including comprehension, speech, visual perception, calculation, attention, memory, problem-solving, and self-monitoring. The frontal brain serves important executive functions in cognition (see ¶ [0002]-[0003]). Renshaw teaches methods and compositions for improving cognitive performance to a neuropsychologically healthy human (see abstract & ¶ [0010]-[0023]). Renshaw further teaches “cognitive functions may be measured by a wide variety of neuropsychological tests known in the art including the following: … Wisconsin Card Sorting Task (WCST)” (see ¶ [0051]-[0054]).
Prieto’s general disclosure relates to compositions of “synthetic nutritional products containing oligosaccharides from human milk. More specifically, the synthetic nutritional product contains at least one of the following oligosaccharides: 3’-fucosyllactose, lacto-N-fucopentaose III, lacto-N-fucopentaose II, difucosyllactose, 2’-fucosyllactose, lacto-N-fucopentaose I, lacto-N-neotetraose, lacto-N-fucopemaose V or lacto-N-tetraose” (see col. 1, lines 16-24). Prieto teaches oligosaccharides in the concentration ranges: from about 130-3500 mg/L of 3’-fucosyllactose and from about 350-4500 mg/L of 2’-fucosyllactose (see col. 2, lines 32-51, and col. 4, lines 50-64).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to assess the subject by Wisconsin Card Sorting Task such as taught by Renshaw in the method of Yan. The ordinary artisan would have been motivated to do so is because Renshaw teaches that cognitive functions may be measured by a wide variety of neuropsychological tests known in the art including Wisconsin Card Sorting Task. To an ordinary artisan, performing cognitive tests or assessments allows for the identifications or diagnoses of conditions as well as establishes a baseline for therapeutic intervention and progress (i.e., patient evaluation of test scores for a type and age of the subject to determine if a subject is suffering from a sub-optimal executive function or not). The selection of a well-known neuropsychological test for performing an assessment of executive function is considered to be a common or a routine practice in the art within the purview of the ordinary artisan. Thus, the claimed elements would have been readily apparent as (a) combining prior art elements according to known methods to yield predictable results, within the guidelines for making the determination of obviousness (MPEP 2141 (III)).
Moreover, it would have been secondly obvious to employ the claimed combination of oligosaccharides because Yan suggests the oligosaccharides may be any combination thereof. The MPEP 2141 also provides examples of rationales that may support a conclusion of obviousness which includes: obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “An ‘obvious to try’ rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103” (MPEP 2145(X)(B)).
Furthermore, one of ordinary skill in the art would have reasonably envisaged or arrive at the claimed invention with the oligosaccharide concentrations thereof following the guidance of the cited references of Yan and Prieto. The MPEP at 2144.05 (I) states “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. Additionally, the MPEP at 2144.05 (II) further states:
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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. "[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."
One of ordinary skill in the art would recognize that the concentration is a result effective variable dependent on various factors. For example, the prior art discloses variable parameters:
Prieto discloses “The amounts of such ingredients will vary depending on whether the formulation is intended for use with normal, healthy infants, children, adults or subjects having specialized needs such as those accompany certain pathological conditions” (see col. 3, lines 50-57). Prieto teaches “Actual dosage levels of the oligosaccharides in the formulations of the present invention may be varied so as to obtain an amount of active ingredient that is effective to obtain a desired response for a particular composition and method of administration. The selected dosage level therefore depends upon the desired therapeutic effect, on the route of administration, on the desired duration of administration and on other factors” (see col. 4, lines 37-45).
This is motivation for someone of ordinary skill in the art to practice or test the parameter values widely to find those that are functional or optimal which then would be inclusive or cover those values as instantly claimed. Absent any teaching of criticality by the Applicant concerning the concentration, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variable which can be met as a matter of routine optimization (MPEP 2144.05 (II)). The ordinary artisan would have had a reasonable expectation of success because the references are directed to the use of human milk oligosaccharides and its administration thereof. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art at the time of invention.
Maintained Rejections - Double Patenting
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 1, 3-4, and 15 are rejected on the ground of non-statutory double patenting as being unpatentable over at least claim 1 of U.S. Patent no. 12,458,052 B2 (application no. 17/435,944) Although the claims at issue are not identical, they are not patentably distinct from each other because ‘052 teaches a method for enhancing executive function comprising providing a composition consisting of human milk oligosaccharide of 2’-FL, DFL, LNT, LNnT, 3’-SL, and 6’-SL (see claim 1).
Examiner’s note: the double patenting rejection is being maintained in light of Applicant’s request for said rejection to be held in abeyance until the claims are allowable.
Conclusion
No claims were 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 extension fee 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 date of this final action.
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653