DETAILED ACTION
Amendments made September 11, 2025 have been entered.
Claims 1-20 remain pending.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). However, the earlier filed foreign applications, EP20211089.6, EP21161030.8, and EP 21171500.8 do not support all of the instantly claimed limitations.
Claims 1-5 and 8 are supported in said applications, and thus have an effective filing date of December 1, 2020.
Claims 6 and 11 do not have support for at least 0.01g 2’FL (claim 6) or at least 0.01g 2’FL (claim 11) in EP20211089.6 or EP21161030.8, but do find support in EP 21171500.8 and thus has an effective filing date of April 30, 2021.
Claims 7, 10, 14, 15, and 18 do not have support for a weight ratio 2’FL to GOS of 0.05:1-2 (claims 7 and 10) or 0.25:1-0.5:1 (claims 15 and 18), or a daily dose of 2’FL of at least 0.1 grams (claim 14) in EP20211089.6, but do find support in EP21161030.8 and thus has an effective filing date of March 5, 2021.
Claims 9, 10, 12, 13, and 16-20 do not have support for the treatment of COVID-19 in EP20211089.6, but do find support in EP21161030.8 and thus has an effective filing date of March 5, 2021.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-4 and 6-20 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joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention has been withdrawn in light of applicant’s amendments and arguments made September 11, 2025. Specifically, the rejection due to the term “increasing” in claims 1 and 9 has been withdrawn in view of the amendments, and the rejection due to the phrase “lower than average” has been withdrawn in light of applicant’s arguments on page 5 of the response which refer to the specification to set clear metes and bounds for the term.
Claim 5 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 5 recites “enhancing the effect of the dietary fibers” and it is unclear as to what would and would not encompass enhanced as no baseline has been set.
Claim Rejections - 35 USC § 102
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, 2 and 4-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ao et al (WO 2018/210807 A1).
Regarding claims 1, 2, 8, 9, and 13, Ao et al (Ao) teaches a method of stimulating the growth, i.e. abundance, of gut bacteria including Faecalibacterium prausnitzii in the gastrointestinal tract of human patients including infants and those over 1 years of age comprising administering an effective amount of a dietary fiber in a nutritional composition (abstract and paragraphs 19, 213-215, and 229). Ao teaches the composition as comprising: proteins, lipids, and carbohydrate components, wherein the fiber components, and thus fiber composition comprises galacto-oligosaccahrides (GOS) and human milk oligosaccharides (HMO) selected from the group including 2’-fucosyllactose (2’FL) (abstract and paragraphs 4, 12, 32, 48, and 50-58). Ao teaches that the composition may improve anxiety, inflammation, and allergies (107, 227, and 229), and thus encompasses administering the composition to a human subject suffering from or being at risk for anxiety, inflammation and allergies as recited in claim 9.
Regarding the dietary fiber composition as consisting essentially of 2’FL and optionally one or more galacto-oligosaccahrides (GOS) as recited in claims 1 and 9, for the purpose of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to comprising.” (MPEP 2111.03). Thus, as Ao teaches of a composition comprising the named components, the teachings of Ao encompass the claimed limitation. Regardless it is noted that Ao teaches the disclosed compositions comprising GOS and a human milk oligosaccharide selected from the group including 2’FL (abstract and paragraphs 12, 50, 54), and that the composition may consist or consist essentially of the listed ingredients (paragraph 48), wherein any optional ingredients may be excluded (paragraph 45), and wherein the carbohydrates include non-fiber sources, such as sucrose, glucose, and fructose (paragraph 160).
Regarding claims 4 and 5, as discussed above, Ao teaches administration of a formula comprising fibers to a patient. Ao further teaches that the method results in better neural development and function which gives way to benefits including healthy sleep patterns (paragraph 52), and thus improved quality and/or continuity of sleep. Furthermore, as Ao teaches the method results in less stress (paragraph 52), less colic, and less pain (paragraph 107), the human subject would have reduced catalyst for waking and the method of Ao would supported improved sleep quality and/or continuity as claimed.
Regarding the daily dosage of 2’FL as at least 0.01 grams as recited in claims 6 and 11, preferably 0.10 grams as recited in claim 14, preferably at least 2.0 grams as recited in claim 19, or at most 40 grams as recited in claim 12, or at most 10 grams as recited in claim 20, Ao teaches the disclosed composition is based on 100kcal per serving (paragraphs 62 and 224), wherein a serving can comprise 10-50% of the recommended daily dose (RDA) of constituents (paragraph 200) and the composition provides for total nutritional support (paragraphs 210 and 233). Thus, to achieve a total nutritional supply, a daily dose at 10% of the RDA would mean the composition was administered at times for a total of 1000kcal, and at 20% of the RDA would mean the composition was administered 5 times for a total of 500kcal. Ao further teaches that the composition has about 0.015g-2.2grams 2’FL per 100kcal, and thus would have a daily dosage within the claimed ranges. For example, when the 100kcal composition was administered 10 times, or 5, a daily dosage would be about 0.15-22grams (daily dose = 10 x 100kcal composition) or 0.075-11g (daily dose = 5 x a 100kcal composition).
Regarding the ratio of 2’FL to GOS as 0.05:1 to 2:1 as recited in claims 7 and 10, preferably from 0.25:1 to 0.5:1 as recited in claims 15 and 18, as Ao claims the human oligosaccharide, which is 2’FS from about 0.01-1g and the probiotic which is the GOS from about 0.1-1.5 grams (paragraphs 12, 50-56, 70, 72, and 73), the teachings of Ao encompass the claimed ranges including a ratio of 0.25:1 as claimed.
Regarding claims 16 and 17, as discussed above Ao teaches that the composition may improve anxiety (229). As treating inflammatory bowel conditions and allergies are optional limitations of claim 9, from which claims 16 and 17 depend, and thus are not required, the limitations of claims 16 and 17 which further limit the optional limitations of allergies and inflammatory bowel conditions are not required, and therefor the claims have been included in the rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ao et al (WO 2018/210807 A1).
Regarding the composition as administered to a human subject with a lower than average abundance of Faecalibacterium prausnitzii prior to administration of the preparation as recited in claim 3, Ao is not specific to the limitation as claimed. However, as Ao teaches a method of stimulating the growth, i.e. increasing the abundance, of gut bacteria including Faecalibacterium prausnitzii in the gastrointestinal tract of human patients including infants (abstract and paragraphs 213, 214, and 229), and that target subjects include formula fed infants because they were known to have a different gut microbiota (paragraph 216), the teachings of Ao encompass or at least make obvious the human subject as a formula fed infant which would have a lower than average abundance of Faecalibacterium prausnitzii compared to healthy infant/a breast feed infant of approximately the same age.
Response to Arguments
Applicant's arguments filed September 11, 2025 regarding the prior art rejections have been fully considered but they are not persuasive. It is noted that the arguments in relation to 112 have been addressed above in the 112 section.
Applicant argues that Ao provides no evidence that the effects listed will occur and that the examples in the reference are not specific to the claimed composition. This argument is not convincing to withdrawn the rejection. First, a reference is not limited to its examples and must be considered for all that it teaches. Second, patents are presumed valid and Ao states the effect of administering the composition, and thus, said effects would be expected. It is unclear as to how applicant can administer the same composition and also claim the same effects and yet say said effects would not have been expected. As discussed above, Ao teaches a method of stimulating the growth, i.e. abundance, of gut bacteria including Faecalibacterium prausnitzii in the gastrointestinal tract of human patients including infants and those over 1 years of age comprising administering an effective amount of a dietary fiber in a nutritional composition (abstract and paragraphs 19, 213-215, and 229).
In request to applicant’s request for an interview in the Introduction of the Remarks page 5, the general, non-specific request for an interview will not be considered at this time. The outstanding issues have been addressed herein.
Conclusion
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 KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792