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 .
This office action is in regard to the application filed on June 14, 2022 and in response to Applicant’s Amendments and Arguments/Remarks filed on March 23, 2026.
Status of Application
The amendment filed March 23, 2026 has been entered. Claims 1, 2, 4-6, 9-16, 18, and 20-25 are currently pending in the application. Claim 9 is withdrawn; claims 3, 7, 8, 17, and 19 have been canceled; claims 1, 2, 4, 10, 16, 18, and 22 have been amended; claims 24 and 25 are new. Claims 1, 2, 4-6, 10-16, 18, and 20-25 are hereby examined on the merits.
The previous 112(b) rejections of claims 1, 2, 4-6, 10-18, and 20-23 have been withdrawn.
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 1, 2, 4, 5, 15, 16, 18, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Van Baalen et al. (US PG Pub. 2011/0206743; cited on PTO-892 dated Dec. 20, 2024) in view of Abdullah et al. (“Recent advances in the composition, extraction and food application of plant-derived oleosomes,” Trends in Food Science & Technology; volume 106, December 2020, pp. 322-332; cited on PTO-892 dated June 11, 2025), herein after referred to as Van Baalen and Abdullah.
Regarding claims 1, 5, 18, and 24, Van Baalen discloses a nutritional composition comprising:
enlarged lipid globules (i.e., enlarged oleosomes) having an average globule diameter in the range of 2 to 12 microns [0012]; and
protein, carbohydrates, and vitamins (i.e., at least one nutritional ingredient other than enlarged oleosomes) [0105],
wherein the enlarged lipid globules are from vegetable lipids ([0012]; claim 24), and wherein the nutritional composition comprises 50-100 wt.% vegetable lipids based on total lipids [0080] and wherein the enlarged lipid globules present in the nutritional composition comprise the vegetable lipids ([0015]-[0017]; [0020]) (i.e., the enlarged oleosomes from a vegetable source make up 50-100 wt.% of a lipid content of the nutritional composition).
The globule diameter taught by Van Baalen overlaps with the claimed range of claim 1 of 3.5-12 microns and of claim 24 of 5-12 microns. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Van Baalen does not explicitly state that the oleosomes are isolated. However, the instant specification describes the steps of obtaining isolated oleosomes as being from the seed to the final lipid oleosome (Specification: [0028]-[0032]). Where Van Baalen describes enlarging normal-sized, small lipid globules (i.e., oleosomes), into the enlarged lipid globules, from the globules themselves, and not from an intermediate step in the isolation process (Van Baalen: [0012]), it is presumed and considered that the lipid globules prior to enlargement are isolated oleosomes, and thus, the enlarged oleosomes taught by Van Baalen are enlarged isolated oleosomes, as claimed.
Van Baalen is silent as to that the enlarged isolated oleosomes comprise intrinsic proteins in an amount of from 0.2 to 6.0 wt.%.
Abdullah, in the same field of invention, teaches oleosomes sourced from sunflower seeds comprising 2.5 wt.% intrinsic protein (5.1. Oleosomes as natural emulsions, second paragraph). Abdullah offers the motivation that oleosomes derived from plants are “all natural,” safe in food products (Introduction), advantageous in oleosome-based natural emulsions, beneficial in imitation milk products, and act as natural emulsifiers to stabilize food emulsions (Food applications). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have included the oleosomes of Abdullah as part of the nutritional composition of Van Baalen, thereby arriving at the claimed invention. One would have been motivated to make this modification for the benefit of having an “all natural” product and possessing various advantageous properties.
Regarding claim 2, Van Baalen teaches that the enlarged isolated lipid globules (i.e., oleosomes) are present in an amount of 10-50 wt.% based on dry weight of the nutritional composition [0078], which lies within the claimed range of 1-70 wt.%.
Regarding claims 4 and 22, Van Baalen teaches that the enlarged isolated lipid globules (i.e., oleosomes) are sourced from sunflower oil [0080].
Abdullah also teaches that the oleosomes are sourced from sunflower oil (Table 1; 5.4. Oleosomes as natural emulsifiers).
Regarding claim 15, Van Baalen teaches that the nutritional composition is in powder form [0129].
Regarding claim 16, Van Baalen teaches that the enlarged isolated lipid globules (i.e., oleosomes) are present in an amount of 10-50 wt.% based on dry weight of the nutritional composition [0078], which overlaps with the claimed range of 15-65 wt.%. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Regarding claim 20, Abdullah teaches that the proteins comprise oleosin, caleosin, and stereolosin (Introduction; Fig. 2; 2.2.1 Oleosin; 2.2.2. Caleosin; 2.2.3. Steroleosin).
Regarding claim 21, the nutritional composition taught by Van Baalen does not contain ingredients of animal origin (claim 24).
Regarding claim 23, Van Baalen teaches that the nutritional composition comprises one or more non-nutritional ingredients comprising stabilizing gums [0108], which are considered to be emulsifiers, thereby meeting the instant claim limitation.
Claims 6, 10-14, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Van Baalen et al. (US PG Pub. 2011/0206743; cited on PTO-892 dated Dec. 20, 2024) in view of Abdullah et al. (“Recent advances in the composition, extraction and food application of plant-derived oleosomes,” Trends in Food Science & Technology; volume 106, December 2020, pp. 322-332; cited on PTO-892 dated June 11, 2025), as applied to claims 1 and 24 above, and as evidenced by Alimentarium (“THEORY – Nutritional Information,” alimentarium, 2017; https://www.alimentarium.org/en/node/5632).
Modified Van Baalen teaches the nutritional composition as set forth above with regard to claim 1.
Regarding claims 6, 10, and 25, Van Baalen teaches that the nutritional composition is an infant formula [0012]; and that the infant formula has:
a protein content that provides 5-15% of the total calories [0124],
a carbohydrate content that provides 40-60% of the total calories [0116], and
a lipid content that provides 35-55% of the total calories [0078],
wherein the nutritional composition comprises 50-100 wt.% vegetable lipids based on total lipids [0080] and wherein the enlarged lipid globules present in the nutritional composition comprise the vegetable lipids ([0015]-[0017]; [0020]) (i.e., at least 40% or more of the lipid content by weight is present as enlarged oleosomes).
Van Baalen does not express the protein, carbohydrate, and lipid contents as gram per 100 kcal. However, as evidenced by Alimentarium, 1 g of protein equals 4 kcal, 1 g of carbohydrates equals 4 kcal, and 1 g of fat (i.e., lipid) equals 9 kcal (“Energy Value”). Using this to convert the range of grams claimed in the instant claims, the ranges become 7.2-11.2 kcal protein per 100 kcal, 36-56 kcal carbohydrates per 100 kcal, and 40-54 kcal fat per 100 kcal. Thus, assuming 100 total kcals, the instant claim limitations are equivalent to:
a protein content that provides 7.2-11.2% of the total calories,
a carbohydrate content that provides 36-56% of the total calories, and
a lipid content that provides 40-54% of the total calories.
Therefore, the protein, carbohydrate, and lipid contents taught by Van Baalen encompass and/or overlap with the claimed ranges. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Regarding claims 11 and 13, Van Baalen teaches that the infant formula is in powder form [0129].
Regarding claims 12 and 14, Van Baalen teaches that the infant formula comprises free amino acids [0125] and is thus a hypoallergenic formula.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-7, filed March 23, 2026, with respect to the 112(b) rejections of claims 1, 2, 4-6, 10-18, and 20-23 have been fully considered and are persuasive. Therefore, these rejections have been withdrawn.
Applicant's arguments filed March 23, 2026, with respect to the 103 rejections have been fully considered but they are not persuasive.
Applicant argues that the lipid globules of Van Baalen are not enlarged isolated oleosomes, “as explained previously” (Remarks, p. 7-12).
This argument is not persuasive. As explained above in the rejection, the enlarged lipid globules taught by Van Baalen are considered to be enlarged isolated oleosomes. The instant specification, as cited in the remarks dated August, 27, 2025, defines “oleosomes” as “lipid bodies,” “lipid droplets” among other terms. A “lipid globule” is fundamentally the same as a lipid body or lipid droplet, thus the lipid globules taught by Van Baalen are oleosomes. Furthermore, the lipid globules taught by Van Baalen are both enlarged and isolated as according to the definitions of the instant specification, as the diameter of the lipid globules are enlarged and they are isolated from a single oleosome source. Additionally, regarding the polar lipid coating, the lipid globules taught by Van Baalen are not required to have a polar lipid coating in order to be enlarged, and as such, merely the lipid globules are considered to be the oleosomes as claimed.
Applicant argues that the globule size of Van Baalen is not informative of the average globule size (Remarks, p. 8).
This argument is not persuasive. Van Baalen teaches that the lipid globules have a diameter of “2 to 12 [microns] in an amount of at least 45, more preferably at least 55 volume % based on total lipid” [0035]; 45-55 volume % is close enough to average (50 volume %) that the taught range reads on the claimed range.
Applicant argues that Abdullah does not teach the average globule diameter or enlarged oleosomes and that Abdullah teaches away from the claimed invention (Remarks, p. 8-9).
This argument is not persuasive. Where Van Baalen already teaches enlarged oleosomes overlapping with the claimed size range, Abdullah does not also have to teach this enlargement or size. Abdullah is used only to teach the amount of intrinsic proteins. In any case, where applicant argues that Abdullah teaches away from the claimed invention because Abdullah teaches that oleosomes with a diameter of more than 5 microns is unstable, this argument is not persuasive since 5 microns lies within the claimed range of the diameter of the claimed enlarged oleosomes, and thus cannot teach away.
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these dependent claims are maintained.
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 MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 9:00-6:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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