DETAILED ACTION
Amendments made January 7, 2026 have been entered.
Claims 1-5, 9, and 13-27 are 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.
Specification and Claim Objections
The previous objections to claims 1-5, 9, and 13 and the disclosure have been withdrawn in light of applicant’s amendments made January 7, 2026.
Claim 15 is objected to because of the following informalities:
In step II, there should be a space before “of”.
In step I, “2FL” should be “2’FL” to maintain consistency of claim language.
Appropriate correction is required.
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 previous rejection of claims 1-9 and 13 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention have been withdrawn in light of applicant’s amendments made January 7, 2026.
The rejection of claims 1-9 and 13 under 35 U.S.C. 112, first paragraph, as containing 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in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention has been withdrawn in light of applicant’s remarks and evidence submitted January 7, 2026. It appears the criteria required for 37 CFR 1.801-1.809 has been met.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 depends from claim 1 and recites that the bifidobacteria comprises Bifidobacterium longum subsp infantis, however, this is already required in either option recited in claim 1, and thus, claim 2 fails to further limit the claim from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 5, 9, 13-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Knol et al (WO 2020/089463).
Knol et al (Knol) teaches a nutritional composition for infants or young children in the form of infant or follow on formula (abstract and page 11 lines 12-36), wherein the composition is administered to the child or infant to increase the abundance of Bifidobacteria (page 8 lines 9-15 and pages 12-14, Application). As Knol teaches of the same active steps recited in claim 13, the method of Knol would encompass one which modulates the microbiota as claimed. Knol teaches that the composition comprises: oligosaccharides selected from 2’FL, DFL, LNT, 6’SL, 3SL, 3FL (3’FL), and combinations thereof (page 6 lines 9-21) and one or more probiotics preferably selected from B. animalis and B. longum, more preferably including B. longum spp infantis obtained from an ATCC culture collection (page 10 lines 1-22 and 30-40). Knol exemplifies B. longum spp infantis obtained from an ATCC as ATCC 17930 (Knol Example 3, paragraph 1; note the instant application page 7 states “LMG 11588 is also known as ATCC 17930). Thus, for at least one bifidobacteria in the composition of Knol to be Bifidobacterium longum subsp infantis LMG 11588 would have been encompassed or at least obvious to one of ordinary skill in the art. To use the exemplified form of a disclosed and preferred component would have been obvious and well within the purview of one of ordinary skill in the art.
Regarding the composition as comprising a mixture consisting of 2’FL, lactodifucotetraose or DFL, LNT, 6’SL, and 3SL as recited in claims 1 and 13, and optionally 3’FL as recited in claim 13; or 2’FL, lactodifucotetraose or DFL, LNT, 6’SL, 3SL, and 3’FL as recited in claim 20; or the mixture of HMOs as consisting of 42-71% or 50-70% 2’FL, 14-26% LNT, 5-10%DFL, and 10-28% 6’FL and 3’SL as recited in claims 5 and 15; or the mixture of HMOs as consisting of 27-49% 2’FL, 15-17% LNT, 4-7%DFL, 5-8% 6’FL, 6-14% 3’SL, and 14-35% 3’FL as recited in claims 14 and 25; or the mixture of HMOs as consisting of 20-60% 2’FL, 8-30% LNT, 2-12%DFL, 7-23% 6’FL and 3’SL combined, and 10-40% 3’FL as recited in claims 16 and 21; or the mixture of HMOs as consisting of 26-65% 2’FL, 8-30% LNT, 3-11%DFL, 7-23% 6’FL and 3’SL combined, and 12-38% 3’FL as recited in claims 17 and 22; or the mixture of HMOs as consisting of 25-55% 2’FL, 11-20% LNT, 4-8%DFL, 8-22% 6’FL and 3’SL combined, and 11-37% 3’FL as recited in claims 18 and 23; or the mixture of HMOs as consisting of 32-54% 2’FL, 11-20% LNT, 4-8%DFL, 8-22% 6’FL and 3’SL combined, and 17-31% 3’FL as recited in claims 19 and 24, the claimed limitations of forming a mixture consisting of the named elements are product by process limitations, and thus are considered in which it affects the claimed product. In the instant case, said limitations would impart some degree of 2’FL, DFL, LNT, 6’SL, 3SL, and 3FL into the product. It is noted that as the product comprises the mixture, it can contain additional components with the named elements, or other oligosaccharides and is not limited to the inherent ratios of the recited percentages. As Knol teaches the composition comprises: oligosaccharides selected from 2’FL, DFL, LNT, 6’SL, 3SL, and 3FL (page 6 lines 9-21) to form the composition of Knol with 2’FL, DFL, LNT, 6’SL, 3SL, and 3FL would have been encompassed or at least obvious to one of ordinary skill in the art. The position is further supported as Knol teaches that “it is understood that some non-digestible oligosaccharides and preferably that some mixtures have an even further improved effect. Therefore, the oligosaccharides are selected from the group consisting of fructo-oligosaccharides, galacto-oligosaccharides and mixtures thereof” (page 6 lines 23-29), wherein the fructo-oligosaccharides of Knol are those as claimed (page 6 lines 17-21). The teachings of Knol clearly teach, or at least suggest and make obvious a product with an overlapping composition of fructo-oligosaccharides to that as claimed.
Claims 3-4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Knol et al (WO 2020/089463), further in view of Donnet-Hughes et al (US 2009/0304655).
As discussed above, Knol teaches a nutritional composition for infants or young children comprising: oligosaccharides selected from 2’FL, DFL, LNT, 6’SL, 3SL, 3FL, and combinations thereof (page 6 lines 9-21) and one or more probiotics preferably selected from B. animalis and B. longum, more preferably including B. longum spp infantis obtained from an ATCC culture collection (page 10 lines 1-22 and 30-40).
Knol is not specific to the B. animalis as Bifidobacterium animalis subsp lactis as recited in claim 3, or the CNCM I-3446 strain as recited in claims 4 and 26.
Donnet-Hughes et al (DH) teaches infant formula with probiotics for forming beneficial microbiota and promotion of the maturation of the immune system (abstract and paragraphs 10-16). DH teaches that preferred probiotics include B longum and B animalis, wherein Bifidobacterium animalis subsp lactis CNCM I-3446 strain is particularly preferred (paragraph 33 and claim 7). It would have been obvious for the B. animalis in the infant formula of Knol to be Bifidobacterium animalis subsp lactis CNCM I-3446 strain as it was a particularly preferred strain for infant formulas and forming beneficial microbiota and promotion of the maturation of the immune system as taught by DH.
Response to Arguments
Applicant's arguments filed January 7, 2026 regarding the prior art rejection have been fully considered but they are not persuasive.
Applicant argues that as Knol discloses a plurality of oligosaccharides, the skilled artisan would not have been motivated or able to select the claimed oligosaccharides. This argument is not convincing. First, as stated previously, although the claim recites a composition comprising a prebiotic oligosaccharide mixture consisting of specific oligosaccharides, the step of forming a mixture consisting of the named ingredients is a product by process limitation and thus is considered only as it affects the claimed product. Since the product claimed comprises a probiotic oligosaccharide mixture, other components, such as a second or third oligosaccharide and/or oligosaccharide mixture may be within the claimed product. Thus, the product as claimed is not limited to only the oligosaccharides recited in the mixture, nor is the product limited to those oligosaccharides in the percentages or resulting ratios claimed in the later dependent claims. As Knol teaches the composition comprises: oligosaccharides selected from 2’FL, DFL, LNT, 6’SL, 3SL, and 3FL (page 6 lines 9-21) to form the composition of Knol with 2’FL, DFL, LNT, 6’SL, 3SL, and 3FL would have been encompassed or at least obvious to one of ordinary skill in the art. The position is further supported as Knol teaches that “it is understood… preferably that some mixtures have an even further improved effect. Therefore, the oligosaccharides are selected from the group consisting of fructo-oligosaccharides, galacto-oligosaccharides and mixtures thereof” (page 6 lines 23-29), wherein the fructo-oligosaccharides of Knol are those as claimed (page 6 lines 17-21). The teachings of Knol clearly teach, or at least suggest and make obvious a product with an overlapping composition of fructo-oligosaccharides to that as claimed.
Applicant argues that as Knol discloses a long list of lactic acid producing bacteria it would not have been obvious to use the claimed strain with the claimed oligosaccahrides. This argument is not convincing. As discussed above, the teachings of Knol clearly teach, or at least suggest and make obvious a product with an overlapping oligosaccharide composition to that as claimed. Furthermore, Knol teaches that the composition comprises one or more probiotics preferably selected from B. animalis and B. longum, more preferably including B. longum spp infantis obtained from an ATCC culture collection (page 10 lines 1-22 and 30-40). Knol exemplifies B. longum spp infantis obtained from an ATCC as ATCC 17930 (Knol Example 3, paragraph 1; note the instant application page 7 states “LMG 11588 is also known as ATCC 17930). Thus, for at least one bifidobacteria in the composition of Knol to be Bifidobacterium longum subsp infantis LMG 11588 would have been encompassed or at least obvious to one of ordinary skill in the art. To use the exemplified form of a disclosed and preferred component would have been obvious and well within the purview of one of ordinary skill in the art. The teachings of Knol at least suggest and make obvious a product with an overlapping composition to that as claimed.
Conclusion
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 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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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792