DETAILED ACTION
STATUS OF THE APPLICATION
Receipt is acknowledged of Applicants claimed invention, filed 19 December, 2025, in the matter of Application N 18/695,446. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after December 19, 2025, is being examined under the first inventor to file provisions of the AIA .
Thus, claims 1, 3, 4, 5, 6, 8, 11, 15, and 16, represent all claims currently under consideration.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: Composition to Improve Nutritional Content of Human Breast Milk.
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.
Claims 1, 3, 4, 5, 6, 8, 11, 15, and 16, are rejected under 35 U.S.C. 103 as being unpatentable over Ameye et al. (US20170332691A1).
Regarding claims 1, 3, 4, 5, 6, and 8, Ameye et al. teach nutritional compositions for babies comprising non-limiting examples of functional fatty acids including alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) (See paragraph 0102, and claim 7). The invention’s nutritional content may additionally include all vitamins and minerals in nutritionally relevant quantities that are known to be necessary for a daily diet. For some vitamins and minerals, minimum needs have been set. vitamin A, vitamin B1, vitamin B2, vitamin B6, and phosphorous, are a few examples of minerals, vitamins, and other nutrients that may be included in the invention’s composition (See paragraph 0177). Table 1 provides an example of an infant formula’s composition in accordance with the current invention (See paragraph 0225). A maternal supplement with “at least one” component stated in an exemplary amount is the subject of claim 1. It should be highlighted that any infant formula that contains just one of the specified substances in an arbitrary quantity is novelty destroying for a claim with such phrasing. Additional vitamins may include vitamin D, vitamin E, vitamin K1, vitamin C, and vitamin B12 (See paragraph 0225, and Table 1). A technique that involves giving a nutritional composition including sn-1(3) monoacylglycerols to a baby or young child in need in order to improve lipid absorption and/or delivery, as well as to boost energy or mineral bioavailability (See paragraph 0001, and claim 2). The nutritional composition of the invention may comprise a lipid source with a protein source, a carbohydrate source or both (See paragraph 0165). At least one probiotic, such as a probiotic bacterial strain, may also be included in the nutritional composition of the current invention (See paragraph 0183).
Regarding claims 11, and 15, Ameye et al. teach a baby or young child who was delivered by caesarean (at the moment of birth) is referred to as “infant or young child born by C-section” or “infant or young child caesarian delivered.” (See paragraph 0028). The nutritional composition of the present invention can provide an infant or young child with at least one additional specific benefit in addition to the benefits mentioned in the present invention (i.e. treatment/prevention of maldigestion and/or malabsorption, increase of lipid absorption and or delivery, increase of energy or mineral bioavailability). This could be the development of any organ or the growth promotion (i.e. the size, of the infant/young child body) (See paragraph 0155). Delivering essential or conditionally essential fatty acids, which are particularly crucial for cellular growth and functioning in vital organs like the brain or the eyes, or bioactive fatty acids with, for example, anti-inflammatory qualities, is therefore crucial in these conditions because these fatty acids may help to reduce the inflammatory response or to ensure proper neurodevelopment (See paragraph 0005). Additionally, Ameye et al. teach a composition consisting of sn-1(3)-monoacylglycerol, where the acyl group is a fatty acid with anti-inflammatory properties for use in the treatment or prevention of inflammatory disorders. The composition is intended to be given to individuals with lipid maldigestion or malabsorption conditions (See paragraph 0076). Human milk oligosaccharides are referred to as “HMOs” by Ameye et al. because of their extreme resistance to enzymatic hydrolysis, these carbohydrates may perform vital tasks unrelated to their calorie content. They have been shown to be essential to newborns and young children’s early development, including immune system maturation. Every single oligosaccharide is derived from a mixture of glucose, galactose, sialic acid, etc. (See paragraph 0063).
Regarding claim 16, Ameye et al. teach the nutritious content is given to the nursing mother rather than the infant or young kid directly; that is, the infant will receive the composition indirectly through the mother’s breast milk. In the same way, the mother can get the invention’s nutritional composition for a few days or years, depending on her needs (See paragraph 0216). The phrase “treatment of maldigestion and or malabsorption” in an infant or young child should be interpreted as including either a reduction in the severity of maldigestion and/or malabsorption or a reduction in the number of days, weeks, or years that the infants or young children will experience these symptoms. The alleviation of maldigestion and/or malabsorption symptoms, such as intolerance to enteral feeding, diarrhea, constipation, nutrient deficiencies, growth delay, small or underdeveloped organs or tissues, compromised organ function, cognitive, motor, and/or emotional skills, is also included in this expression. The decrease of complications caused by maldigestion and/or malabsorption on the infant or young child health/quality of life, such as the decrease of pain, and the decrease of tiredness, and the ease of the sleep and the stabilization of the activity or the improved social skills and socio-economic success of the infants or young kids suffering from maldigestion and malabsorption (See paragraph 0043). Non-limiting examples of functional fatty acids include alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) (See paragraph 0102, and claim 7). For some vitamins and minerals, minimum needs have been set. vitamin A, vitamin B1, vitamin B2, vitamin B6, and phosphorous ion, are a few examples of minerals, vitamins, and other nutrients that may be included in the invention’s composition (See paragraph 0177).
It would have been obvious to one of ordinary skill in the art before the effective filing date at the time of the invention to include any combination of the disclosed functional fatty acids, vitamins, minerals, and lipid forms (including sn-1(3) monoacylglycerols) in an infant formula composition, as these components are taught by Ameye et al. to be nutritionally beneficial and routinely used in infant nutrition to promote absorption, growth, and bioavailability of nutrients.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615