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 .
Election/Restrictions
Applicant's election without traverse of Group II, claim(s) 19 and 21-25 and the election of species for claim 19 (an infant) in the reply filed on March 12, 2026 is acknowledged. The election of species for claim 19 will be applied to the remainder of the claims.
In addition, based on applicant’s remarks filed June 09, 2026, claim(s) 1-12 and 28-30 are canceled and new claim(s) 32-39 are added.
Based on applicant’s newly added claim(s) (namely, claim(s) 32-39), the claim(s) are being examined based on the species selected (i.e. infant) in the response to election on March 12, 2026 and any other species that was not elected is withdrawn from consideration.
Claim(s) 19, 21-25 and 32-39 are examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statement (IDSs) submitted on November 27, 2023, August 21, 2025 and August 07, 2026 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Pending Rejection(s)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19, 21-25, 32-36 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolster (U.S. Pub. No. 2014/0105875 A1).
Bolster teaches a nutritional composition [that includes] milk fat globule membrane components ("MFGM") that can come from cow milk or human milk (abstract and paragraph 0057). Bolster teaches that milk fat globule membrane components ("MFGM") can provide several health benefits to other individuals suffering from, or at risk for, conditions including, for example, cognitive decline (paragraph 0083 and claim 14). Bolster teaches that the ingredient combinations within the nutritional composition can increase cognitive health (paragraph 0114). Bolster teaches [that the] "individual in need" means any infant, baby, child, adolescent or adult having particular physiological needs in regard to the physio-pathological conditions considered (paragraph 0053). Bolster teaches [that the] skilled artisan will appreciate, however, that the present nutritional compositions and methods need not be administered to an elderly individual and may be administered to any individual in need of same (paragraph 0079). Bolster teaches the nutritional compositions are oral nutritional supplements (paragraph 0153). Bolster teaches the nutritional compositions are in a form selected from the group consisting of tablets, capsules, liquids, chewables, soft gels, sachets, powders, syrups, liquid suspensions, emulsions, solutions, or combinations thereof (paragraph 0152). Bolster teaches [that] the terms "individual" and "patient" refer to any animal, mammal or human having or at risk for a medical condition that can benefit from the treatment ([thus, individuals who are healthy and are at risk can also ingest the composition]) (paragraph 0052). Bolster teaches [that] the terms "treatment" and "treat" also refer to the maintenance and/or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition ([thus marking the ingestion of the composition optional]) (paragraph 0076). Bolster teaches [that] the MFGM of the present nutritional compositions may originate from a source selected from the group consisting of butter milk, butter milk fractions, defatted butter milk, delactosylated buttermilk, buttermilk fraction obtained by microfiltration, or ultrafiltration, fractions recovered from whey protein concentrate, sweet whey, acid whey, whey cream or fat associated fraction from whey containing phospholipids (paragraph 0116). Bolster teaches [that] the probiotic bacterial strain may be any lactic acid bacteria or Bifidobacteria with established probiotic characteristics (paragraph 0127). Bolster teaches [that] the MFGM includes gangliosides or phospholipids able to bind with or biologically interact with the probiotic, the gangliosides or phospholipids being present in an amount between 0.03% and 5% by weight of total proteins (paragraph 0008). Bolster teaches [that] the MFGM may include proteins or bioactive proteins able to bind with or biologically interact with the probiotic (paragraph 0007).
The Bolster reference does not specifically teach said need is identified through testing (as mentioned in claim 22 of the present invention). However, the Bolster reference does teach that the individual in need can be an infant that has physiological needs, therefore, there has to be a need assessed (e.g. physio-pathological conditions condition(s)) prior to the administration of the nutritional composition because this nutritional composition is targeting a specific population. In addition, the Bolster reference does not specifically teach that the composition comprising MFGM improves memory or short-term memory (as mentioned in claim(s) 19, 21 and 34 of the present invention), however, the reference does teach that the composition containing MFGM can improve cognitive decline which, in general, would also include improving memory and short-term memory. Moreover, although the Bolster reference does not explicitly teach the age of the infant in the months provided within claim 39, it is known in the art that an infant’s age can be anywhere from the time of birth and up to 12 months. Lastly, the composition containing MFGM within the Bolster reference can be used to improve cognitive function in infants, therefore, the improvement is not therapeutic (as mentioned in claim 24 of the present invention).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Bolster (U.S. Pub. No. 2014/0105875 A1) in view of Gurnida et al (Early Human Development, (Year: 2012), vol. 88, issue. 08, pp. 595-601).
The teachings of Bolster are above.
Bolster does not teach the method according to claim 19, wherein administration of said composition increases serum ganglioside levels in an infant optionally wherein levels of any one or more of GM3, GD3, GM1, GD1a and GD1b are increased (as stated within claim 37 of the present invention). Bolster does not teach the method according to claim 19, wherein said MFGM components comprise any one or more of GM3, GD3, GM1, GD1a and GD1b, optionally in a formulation comprising at least about 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9% or at least about 1% gangliosides w/w on a dry weight basis, or at least about 1mg, 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg, 10mg, 11mg, 12mg, 13mg, 14mg, 15mg, 16mg, 17mg, 18mg, 19mg, 20mg, 30mg, 40mg, 50mg, 60mg, 70mg, 80mg, 90mg, 100mg, 150mg, 200mg, 250mg, 300mg, 350mg, 400mg, 450mg, 500mg, 550mg, 600mg, 650mg, 700mg, 750mg, 800mg, 850mg, 900mg, 950mg, 1000mg, 2000mg, 3000mg, 4000mg, 5000mg, 6000mg, 7000mg, 8000mg, 9000mg, or at least about 10000 mg or more gangliosides per 100g dry weight (as stated within claim 38 of the present invention).
Gurnida et al teaches that serum ganglioside was increased in infants that were breast-fed (reference group) [focusing on the serum levels of GM3, GD3 and total ganglioside (GM3 + GD3)] (table 5 (pg. 600) and last par. on pg. 598).
Regarding claim(s) 37-38, the composition that can be administered to infants as taught by Bolster can include additional information that the source of MFGM, can be from human breast milk as taught by Bolster with Gurnida et al’s data and information to show that breast milk (which intrinsically contains MFGM) is capable of increasing serum ganglioside levels (namely GM3 and GD3) within infants as taught by Gurnida et al. In addition, although the combination of the aforementioned references does not explicitly teach that the MFGM components comprise any one or more of GM3, GD3, GM1, GD1a and GD1b, optionally in a formulation comprising at least 0.01% [to] at least about 1% gangliosides w/w on a dry weight basis (as stated within claim 38 of the present invention), the Bolster reference does teach that MFGM includes the gangliosides being present in an amount between 0.03% and 5% by weight of total proteins and that MFGM can be present in a powder (i.e. dry) form. Thus, one would reasonably expect that if MFGM can be present within a dry form, then the gangliosides present (which can include any one or more of GM3, GD3, GM1, GD1a and GD1b) would intrinsically also be present in a dry form. In addition, if necessary, one of ordinary skill within the field of molecular biology could optionally, isolate the gangliosides from the MFGM in order to quantitate the total of gangliosides in between 0.03% and 1% as appropriate, in order to administer the ideal composition to a subject in need.
Response to Arguments
Applicant’s arguments filed June 09, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. § 102 for anticipation are found to be non-persuasive.
Regarding the 35 U.S.C. § 102 rejection for anticipation, beginning on page 6 of applicant’s arguments, applicant states “Bolster teaches nutritional compositions comprising MFGM and at least one nutrient for treating conditions typically found in the elderly, such as low-grade inflammation, loss of lean body mass, skeletal muscle cell membrane instability and joint inflammation. The nutrients may include whey protein micelles, citrulline, branched chain fatty acids, and alpha-hydroxycaproic acid (α-HICA). See abstract of the publication. It is important to reiterate that Bolster teaches nutritional compositions comprising MFGM and at least one nutrient. In contrast, the technical effects of the present invention rely only on MFGM or its components. See page 20 of the specification, lines 14-15… [Bolster also teaches that] the “individual in need” includes patients of all age suffering from a physio-pathological condition. It is submitted that neither social-emotional behavior nor memory, as presently claimed, constitute a “physio-pathological condition””. Moving into page 7 of applicant arguments, applicant further states “Further still, the feature of cognitive decline taught by Bolster does not equate to an improvement in memory in a healthy infant or child subject, as presently claimed. To distinguish more clearly from the "cognitive decline" taught by Bolster, the presently amended claims specify improving memory in a healthy infant or child…Applicant respectfully disagrees with the Examiner's position and submits that an improvement in cognitive health encompasses a wide range of features which may or may not include improvements in memory. For example, features such as executive function, processing speed, attention, perception, decision-making, reasoning, learning, etc. may all constitute an improvement in "cognitive health", none of which necessarily require or equate to an improvement in memory. It is noted that no definition of cognitive health appears to have been provided in Bolster, let alone any exemplification of any memory improvement in infants. Therefore, it is submitted that an improvement in cognitive health does not automatically constitute an improvement in memory… For the reasons mentioned above, it is submitted that treating cognitive decline (a feature of adult health) is not the same as improving memory in a healthy infant or child subject, as required by the amended claims.” Lastly, on page 8 of applicant arguments, applicant states “In view of the above, it is submitted that there is no clear and unambiguous teaching of an improving memory in a healthy infant or child, as required by the presently amended claims. There is also no mention at all of social-emotional behaviour in the cited art”. Going in order and beginning on page 6 of applicant’s arguments, given that the claims of the present invention are drawn to a method of using a composition that “comprises” MFGM, based on interpretation and MPEP 2111.03, “comprising” is considered an open-ended term and therefore, anything can be included within the composition and it would still meet the claim limitations of the present invention and therefore, the Bolster reference does suffice in meeting those limitations. In addition, given that the amended claims of the present invention are directed to a subject being a “healthy” infant, the Bolster reference above teaches that the maintenance and/or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition, thus, based on examiner’s interpretations marks the ingestion of Bolster’s composition optional and open to healthy infants. All in all, a subject who is healthy or may possess a physio-pathological condition can ingest the composition. Moreover, given that the independent claim, claim 19 is directed to “a method for improving social-emotional behaviour in an infant or child and/or memory in a healthy infant or child…”, it is acceptable for the examiner to only consider memory; “and/or” means that a person can select both options or one of the options thus meeting the claim limitation. Additionally, it is well known in the art that the term “cognitive decline” can be seen as synonymous with the terms brain health or neurological wellness in which, all of the terms encompass improvements in memory. Moreover, cognitive decline is not only limited to adults; based on what is currently known in the art, it is very well known that infants can experience cognitive decline for a variety of reasons whether it is environmental or based on genetics although it may be not as common but is still possible as a result of no human being born 100% the same. For example, Zero To Three (https://www.zerotothree.org; published on February 09, 2025 and accessed on August 20, 2026) establishes that “Cognitive growth doesn’t happen in a vacuum. It’s fueled by interaction. Eye contact, shared smiles, storytelling, and back-and-forth exchanges all build cognitive skills like language, attention, and memory. Nurturing environments, serve-and-return interactions and secure attachment all contribute to positive cognitive development in babies and toddlers. Understanding early brain development stages is also important. Early childhood experiences shape brain architecture” (page 4). Furthermore, applicant’s argument that “cognitive decline” does not equate to “improvement in memory” and that cognitive decline is only limited to adults is not persuasive. The applicant is reminded that Bolster does teach that the composition that comprises MFGM can be for those who suffer from cognitive decline, and based on examiner interpretations, that would mean to reverse cognitive decline, therefore meaning improving cognitive capabilities. Lastly, the Bolster reference does effectively teach that the administration of the composition that contains MFGM would help with cognitive decline within a subject, which can be an infant in which the cognitive decline directly correlates to improving memory whether it is short term or long-term memory thus making the Bolster reference a clear teaching of improving memory within an infant that is sick or healthy. Therefore, the rejection under 35 U.S.C. § 102 for anticipation is maintained.
In addition, based on the newly added claim(s) to the claim(s) of the present invention, a 35 U.S.C. § 103 for obviousness was included in order to state the obviousness of gangliosides, which intrinsically could be GM3, GD3, GM1, GD1a or GD1b that when an infant is being breastfed, it is known in the art that there will be an increase in serum ganglioside concentration as taught within the Gurnida et al reference in which, when combined with the Bolster reference, one of ordinary skill in the art would reasonably expect that the administration of the composition that comprises MFGM would intrinsically increase specific serum ganglioside molecules within an infant.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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