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
1. Applicant’s preliminary amendment filed on January 5, 2024 is acknowledged. Claims 1, 5-7, 10, 13-17 and 19 have been canceled. Claims 2-4, 11-12 and 18 have been amended. Claims 2-4, 8-9, 11-12, and 18 are currently pending and under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on January 5, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Specification
3. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see for example, pages 1, 20 and 39). Applicant is required to delete any embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
4. Dependent claims 2-4 and 11-12 each recite “Method according to”. An indefinite article should start each sentence. This objection can be obviated by adding the indefinite article “A” to begin the sentence.
5. Claim 2 is objected to because of the following informalities: in the fourth line of said claim ‘strain selected in’ should recite ‘strain selected from’. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Deposit Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Dependent claim 2 is drawn to a method according to claim 9, wherein the Bifidobacterium longum microorganism has an Average Nucleotide Identity (ANI) of at least 96% with at least one Bifidobacterium longum strain selected from the group consisting of CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686, and CNCM I-5687, and any combination thereof.
Because it is not clear that cell lines possessing the properties of Bifidobacterium longum strain CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686, and CNCM I-5687 are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims require the use of a suitable deposit for patent purposes a deposit in a public repository is required. Without a publicly available deposit of the above Bifidobacterium longum strain CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686, and CNCM I-5687, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event.
Applicant’s referral to the deposit of Bifidobacterium longum strain CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686, and CNCM I-5687 on page 20 and Table 1 of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR 1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by the International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application. These requirements are necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of the deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring: (a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request; (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application; (c) the deposits will be maintained in the public repository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the repository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of biological material not made under the Budapest Treaty must be filed in the application and must contain: 1) The name and address of the depository; 2) The name and address of the depositor; 3) The date of deposit; 4) The identity of the deposit and the accession number given by the depository; 5) The date of the viability test; 6) The procedures used to obtain a sample if test is not done by the depository; and 7) A statement that the deposit is capable of reproduction. As well as a statement that removes restrictions to provide access to this strain upon granting of a patent has not made, either in the instant Specification, nor in Applicant's Remarks.
One of the critical conditions of Deposit is defined in 37 CFR 1.808 requires that the deposit of biological material be made under two conditions: (A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and (B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent. Upon making this statement, the rejection under 35 USC 112, first paragraph will be withdrawn. This rejection can be obviated through perfection of the Deposit and amendment of the claims to clearly set forth the Deposited strains.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the Bifidobacterium longum strain CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686, and CNCM I-5687 described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Applicant’s attention is directed to In re Lundack, 773 F.2d.1216, 227 USPQ (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
Claim Rejections - 35 USC § 112
Written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 2-4, 8-9, 11-12 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
Independent claim 8 is drawn to a method of promoting the growth of a Bifidobacterium longum transitional microorganism to modulate the gut microbiota of an infant and/or of a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Independent claim 9 is drawn to a method of promoting or assisting the transition from a milk-based diet to solid food in an infant and/or in a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Independent claim 18 is drawn to a method of promoting the growth of the Bifidobacterium longum transitional microorganism that preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL) to modulate the gut microbiota of an infant and/or of a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
The specification, specifically, the examples, describe a list of strains (NCC 5000-5004), which grew better on 3’FL than 2’FL and reached a higher cell density. Further, said fecal batch fermentation was evaluated and shown that the strains modulates short chain fatty acids (SCFAs) production by the complex infant microbiome. After 48 hours of fermentation with 2FL, the supplementation of NCC5002 increased propionate and butyrate production and NCC5004 supplementation increased acetate and total SCFAs by comparison. Altogether, the results indicate that supplementation of B. longum transitional strains promote SCFAs production of the infant microbiome during HMO formation.
However, the specification does not adequately support the claims as currently drafted. The specification says that the present invention may be capable of promoting or assisting the transition from a milk-based diet to solid food in an infant and/or in a young child. Further noting that it is believed that this preferential utilization of 3-FL over 2’-FL can promote or assist the weaning. There is no data to support promoting the growth of a Bifidobacterium longum transitional microorganism to modulate the gut microbiota of an infant and/or of a young child; promoting or assisting the transition from a milk-based diet to solid food in an infant and/or in a young child; or promoting the growth of the Bifidobacterium longum transitional microorganism that preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL) to modulate the gut microbiota of an infant and/or of a young child. Moreover, there is no data to support accomplishing said methods administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL). Nor does it provide support for the methods as claimed further comprising Bifidobacterium longum microorganism having an Average Nucleotide Identity (ANI) of at least 96% with at least one Bifidobacterium longum strain selected in the group consisting of CNCM I-5683, CNCM I-5684, CNCM I-5685, CNCM I-5686 and CNCM I-5687, and any combination thereof; or Bifidobacterium longum transitional microorganism comprises a glycosyl hydrolase family 95 (GH95, α-L-galactosidase; α-L-fucosidase; α-1,2-L-fucosidase) gene having at least 60% of identity with BLON 2335 gene present in Bifidobacterium longum subsp. infantis ATCC 15697 and/or a glycosyl hydrolase family 29 (GH29, α-L-fucosidase; α-1,3/1,4-L-fucosidase; α-1,2-L-fucosidase) having at least 60% identity with BLON_2336 gene present in Bifidobacterium longum subsp. infantis ATCC 15697.
Furthermore, the specification does not provide adequate support for the invention as claimed as there are no specific examples of an administered composition and variants thereof functioning in the manner the claims require. It is clear the specification does not adequately describe the methods and compositions correlating to the functions as claimed. Applicant must claim their invention by what their specification has adequately described and provides efficacy for.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Written description requirement must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the "written description" inquiry, whatever is now claimed. The Guidelines further state, "[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
An adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
8. Claim 3 is rejected 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.
Claim 3 is rendered vague and indefinite by the use of parenthesis. Parenthesis are viewed in the same manner as ‘such as’, which is exemplary language and is not permitted in a claim. The ambiguity of scope is not clear as the Office does not know clearly what is included and what is to be excluded. As written, it is impossible to determine the metes and bounds of the claimed invention.
9. Claim 12 recites the limitation "wherein the composition comprises 34 wt.% to 85 wt.% of 2’ -FL, 10 wt.% to 40 wt.% of LNT, 4 wt.% to 14 wt.% of DFL and 9 wt.% to 31 wt.% of 3-SL and 6’ -SL combined" in lines 2-4. There is insufficient antecedent basis for this limitation in the claim. Perhaps Applicant intends for claim 12 to depend up claim 11.
10. Claims 4, 8, 9, and 18 are rendered vague and indefinite by the use of the term “utilizes” and the phrase “preferentially utilizes”. It is unclear what is meant by said term/phrase, as it is not explicitly defined in the specification. It appears to be a fermentation step in the specification, however, the claim does not introduce it as an additional step. How does a transitional microorganism ‘utilize’ 3-FL over 2’-FL as it pertains to the methods as claimed? What core features/steps must be maintained? As written, it is impossible to determine the metes and bounds of the claimed invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
11. Claim(s) 3, 4, 8, 9, 11, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newburg et al., WO 2012/158517 A1; Published: 11/22/12 (provided by Applicant on IDS 1/5/24).
Independent claim 8 is drawn to a method of promoting the growth of a Bifidobacterium longum transitional microorganism to modulate the gut microbiota of an infant and/or of a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Independent claim 9 is drawn to a method of promoting or assisting the transition from a milk-based diet to solid food in an infant and/or in a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Independent claim 18 is drawn to a method of promoting the growth of the Bifidobacterium longum transitional microorganism that preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL) to modulate the gut microbiota of an infant and/or of a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Newburg discloses compositions and metabolic activity of the intestinal bacterial community, which can confer a health benefit to the host, achieved by administration of growth promoting sugars (i.e. prebiotics), by administration of live exogenous microorganisms (i.e. , probiotics), or a combination of both. Further, Newburg describes compositions that contain one or more highly purified prebiotic fucosylated oligosaccharides, e.g. , 2'-fucosyllactose (2’-FL), 3-fucosyllactose (3-FL), and lactodifucotetraose (LDFT), in amounts that promote proliferation and residence of endogenous commensal or symbiotic microbes or exogenously administered probiotics in the mammalian gut (meets claim 11). One or a combination of purified human milk oligosaccharides (HMOS) described herein alter microbiota composition in human stools, and stimulate the growth of beneficial/symbiotic bacteria in the human intestine (see page 8; paragraph 2, meets claim 8). As well as maximize the beneficial effect of endogenous commensal microbes or exogenously administered probiotic microorganisms, prebiotic agents (purified oligosaccharides) are administered to stimulate the growth and/or activity of advantageous bacteria in the digestive system. Described herein are prebiotic agents that selectively improve the survival and effectiveness of probiotic microbes. For example, as described in detail below, isolated and/or purified 2'-FL, 3-FL, or LDFT are administered to selectively stimulate the growth of beneficial bacteria (see page 8; paragraph 3, meets claim 18). Bifidobacterium longum ATCC 15697 were tested in the presence of 2'-FL, 3-FL, LDFT and HMOS (see page 17; meets claim 3).
Moreover, Newburg discloses prebiotics, including purified 2’-FL, 3-FL and, LDFT prevent constipation frequently observed in formula-fed infants. Prebiotics stimulate the growth of the beneficial bacteria including common species of bifidobacteria (see page 13). The prebiotics are administered to an infant (see page 14). Further, Newburg discloses that due to the surge in disease in infants at weaning, the composition comprising HMOS of the invention are added to weaning foods, such as solids like mashed riced and bananas (see page 15, 3rd&4th paragraphs; meets claim 9). Lastly, the mean concentrations of 2'-FL, 3-FL, and LDFT in human milk are as follows: 2'-FL = 2.43g/L (±0.26), 3-FL = 0.86g/L (±0.10), and LDFT = 0.43g/L (±0.04). The prebiotics of the invention are administered in any ratio of 2'-FL:3FL:LDFT, e.g. , 1:1:1, 5:2:1, 10:5:1, 1:2:5, 1:5:10, 5:1:2, 10:1:5, 2:1:5, or 5:1:10, or any other ratio suitable to obtain prebiotic effects. Alternatively, 2'-FL and 3-FL are administered together in the following exemplary ratios of 2' -FL:3-FL 1:1, 1:2, 1:5, 1:10, 1:100, 100: 1, 10:1, 5:1, or 2:1 (see pages 3-4; meets claim 4).
12. Claim(s) 3, 8, 9, 11 and 18 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Chow et al., US 2012/0172319 A1; Published: 7/5/12.
Independent claim 8 is drawn to a method of promoting the growth of a Bifidobacterium longum transitional microorganism to modulate the gut microbiota of an infant and/or of a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Independent claim 9 is drawn to a method of promoting or assisting the transition from a milk-based diet to solid food in an infant and/or in a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Independent claim 18 is drawn to a method of promoting the growth of the Bifidobacterium longum transitional microorganism that preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL) to modulate the gut microbiota of an infant and/or of a young child, the method comprising administering to the infant and/or to the young child a composition comprising a Bifidobacterium longum transitional microorganism, wherein the Bifidobacterium longum transitional microorganism is capable of utilizing prebiotic oligosaccharides and wherein the Bifidobacterium longum transitional microorganism preferentially utilizes 3-fucosyllactose (3-FL) over 2’ -fucosyllactose (2’-FL).
Chow disclose methods of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child using nutritional compositions including human milk oligosaccharides. The nutritional compositions including the human milk oligosaccharides are effective in reducing inflammation and the incidence of inflammatory diseases. The nutritional compositions of the present disclosure may, in addition to HMOs (and, optionally, other prebiotic oligosaccharides as described above), comprise one or more probiotics and offers a synergistic benefit, promoting the growth of microbiota of infants (see paragraph 0096). Probiotics for use in the nutritional composition include B. longum infantis ATCC 15697 (see paragraph 0099; meets claim 3). In some embodiments, the nutritional composition includes a probiotic in combination with a first oligosaccharide including fructooligosaccharide and/or a galactooligosaccharide further in combination with a second oligosaccharide including at least one HMO such as 2′FL, 3′FL, 3′SL, 6′SL, and/or LNnT (see paragraph 0101; meets claim 8, 11, 18).
Chow discloses nutritional compositions as described herein can be used to address one or more of the diseases, disorders, or conditions discussed herein, or can be used to provide one or more of the benefits described herein, to preterm infants, infants, toddlers, children, and adults, including pregnant women. The preterm infant, infant, toddler, child, adult and pregnant women utilizing the nutritional compositions described herein may actually have or be afflicted with the disease or condition described, or may be susceptible to, or at risk of, getting the disease or condition (that is, may not actually yet have the disease or condition, but is at elevated risk as compared to the general population for getting it due to certain conditions, family history, etc.) (see paragraph 0143; meets claim 9).
Along with improved growth and maturation of an individual's immune system as described above, the use of the nutritional compositions of the present disclosure may also function to enhance the individual's ability to resist microbial infection and to promote the growth of beneficial microbiota in the gastrointestinal tract of an infant, toddler, child, or adult (see paragraph 0147; meets claim 18).
The method steps as claimed are the same as disclosed in Chow, said method necessarily promotes or assist the transition from a milk-based diet to solid food in an infant and/or in a young child, absent evidence to the contrary.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary B Nickol can be reached at 571-272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 December 10, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645