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 with traverse of Group I, claims 30-39 in the reply filed on November 21, 2025 is acknowledged. The traversal is on the ground(s) that the 2-fucosyllactitol was not present in the human milk fraction of Egge, and that 2-fucosyllactitol is not an HMO as understood in the art (Remarks, p. 5, ¶ 4- p. 6, ¶ 5).
This argument has been considered. However, Egge discloses that 2-fucosyllactitol is a peracetylated neutral oligosaccharide for human milk (p. 239, Table II) and Buck states that suitable HMOs in the composition may include neutral oligosaccharides. Thus, one of ordinary skill would have recognized that 2-fucosyllactitol, a neutral oligosaccharide from human milk, can be added in the invention of Buck as an additional HMO. Additionally, the 103 rejection below in view of Morrow and Egge demonstrates that the shared technical feature of the product of claim 30 is not a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 40-48 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected processes, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 21, 2025.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
30-48
Withdrawn claims:
40-48
Previously canceled claims:
1-29
Newly canceled claims:
None
Amended claims:
None
New claims:
None
Claims currently under consideration:
30-39
Currently rejected claims:
30-39
Allowed claims:
None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 36 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 36 recites the limitation “wherein the 2’FL and the 2’FLol are present in the prebiotic solids product in a ratio of 2’FL to 2’FLol of 14.3 to 470.” This renders the claim indefinite because it is unclear if the ratio of 2’FL to 2’FLol is 14.3:470 or 14.3:1 to 470:1. Claim 36 depends on claim 35, which states that the 2’FL is present in an amount of 86.0 to 94.0 wt.%. Claim 35 depends on claim 30, which recites that the 2’FLol is present in an amount of “0.2 to 6.0 wt.%”. Therefore, claim 35 requires that the composition has a ratio of 2’FL to 2’FLol of 14.3:1 to 470:1. Thus, for the purposes of examination, it is presumed that the claim recites “in a ratio of 2’FL to 2’FLol of 14.3:1 to 470:1”.
Claim Rejections - 35 USC § 103
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.
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.
Claims 30-36, 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Morrow (US 2020/0129534 A1) in view of Egge (Egge, Heinz, et al. “Fucose Containing Oligosaccharides from Human Milk”, Archives of Biochemistry and Biophysics, Vol. 224, No. 1, p. 235-253, published July 1 1983)(IDS Reference).
Regarding claim 30, Morrow teaches a 2’fucosyllactose (2′-FL) powder (i.e., solid) product comprising 93% 2’FL and 3% other sugars ([0155]).
Morrow does not teach the composition comprising 0.2 to 6.0 wt.% based on the total weight of the prebiotic solids product of 2’-fucosyllactitol.
However, in the same field of endeavor, Egge teaches an oligosaccharide derived from human milk including the neutral oligosaccharide (i.e., a type of sugar) 2-fucosyllactitol (p. 239, Table II, row 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use 2’-fucosyllactitol (a known oligosaccharide) of Egge as the 3% other sugars in the product taught by Morrow. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another are equivalent and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B). 3% of 2-fucosyllactitol falls within the claimed range of “0.2 to 6.0 wt.%”.
Regarding claim 32-34, Morrow teaches a 2’fucosyllactose (2′-FL) powder (i.e., solid) product comprising 93% 2’FL and 3% other sugars ([0155]).
Morrow does not teach the composition comprising 0.2 to 6.0 wt.% based on the total weight of the prebiotic solids product of 2’-fucosyllactitol.
However, in the same field of endeavor, Egge teaches an oligosaccharide derived from human milk including the neutral oligosaccharide (i.e., a type of sugar) 2-fucosyllactitol (p. 239, Table II, row 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use 2’-fucosyllactitol (a known oligosaccharide) of Egge as the 3% other sugars in the product taught by Morrow. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another are equivalent and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B). 3% of 2-fucosyllactitol falls within the claimed range of “0.5 to 6.0 wt.%” (claim 31), “0.5 to 3.5 wt.% (claim 32), “2.0 to 4.5 wt.%” (claim 33), and “2.0 to 4.0 wt.%” (claim 34).
Regarding claim 35, Morrow teaches 2’fucosyllactose (2′-FL) powder (i.e., solid) product comprising 93% 2’FL ([0155]), which falls within the claimed range of “86.0 to 94.0 wt.%”.
Regarding claim 36, Morrow teaches a 2’fucosyllactose (2′-FL) powder (i.e., solid) product comprising 93% 2’FL and 3% other sugars ([0155]).
Morrow does not teach the composition comprising 0.2 to 6.0 wt.% based on the total weight of the prebiotic solids product of 2’-fucosyllactitol.
However, in the same field of endeavor, Egge teaches an oligosaccharide derived from human milk including the neutral oligosaccharide (i.e., a type of sugar) 2-fucosyllactitol (p. 239, Table II, row 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use 2’-fucosyllactitol (a known oligosaccharide) of Egge as the 3% other sugars in the product taught by Morrow. The claim would have been obvious because one of ordinary skill in the art would have been able to make this simple substitution of one known element for another are equivalent and yield predictable results to one of ordinary skill in the art, see MPEP §2143(B). Thus, the combination of Morrow has a ratio of 2’FL to 2’FLol of 31:1, which falls within the claimed range of “14.3:1 to 470:1”.
Regarding claim 38, Morrow teaches that the 2’FL product is a white powder ([0155]).
Regarding claim 39, Morrow in view of Egge teaches the product of claim 30. Morrow also teaches that the compound may be included in food products or formula ([0044]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Morrow (US 2020/0129534 A1) in view of Egge (Egge, Heinz, et al. “Fucose Containing Oligosaccharides from Human Milk”, Archives of Biochemistry and Biophysics, Vol. 224, No. 1, p. 235-253, published July 1 1983)(IDS Reference) as applied to claim 30 above, and further in view of Viertelhaus (WO 2020/079146 A1)(IDS Reference filed 06/09/2023).
Regarding claim 37, Morrow and Egge do not teach wherein the prebiotic solids product is a crystallized product.
However, in the same field of endeavor of 2’FL supplements, Viertelhaus teaches a crystalline form of 2’FL supplement (p. 4, line 33).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the product of Morrow to be crystalline as taught by Viertelhaus. One of ordinary skill would have been motivated to make this modification because Viertelhaus teaches that crystallization is a cheap and simple method for isolating product from a reaction mixture (p. 2, lines 6-8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached Generally available M-Th 8:00a-5:00p, F 8:00-2:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793