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 a Request for Continued Examination filed on August 27, 2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 27, 2025 has been entered.
Status of Application
The amendment filed August 27, 2025 has been entered. Claims 1, 2, 4-6, 9-18, and 20-23 are currently pending in the application. Claim 9 is withdrawn; claims 3, 7, 8, and 19 have been canceled; claims 1, 6, 20, and 23 have been amended. Claims 1, 2, 4-6, 10-18, and 20-23 are hereby examined on the merits.
The previous claim objection to claim 23 has been withdrawn in view of applicant’s claim amendments.
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.
Claims 1, 2, 4-6, 10-18, and 20-23 are 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 1 refers to a percentage, “make up 40% or more of a lipid content,” without defining the base unit. The claim limitation is unclear as to whether the percentage is based on weight, volume, molar, etc., and as such, the claim fails to distinctly claim the subject matter of the invention and is therefore rendered indefinite. For the purposes of examination, the claim will be interpreted as percent by weight.
Claim 1 recites “intrinsic proteins,” which renders the claim indefinite as the term “intrinsic protein” is unclear as to the meaning. The specification, at [0022], states that the oleosomes comprise proteins such as “intrinsic proteins” and that “said intrinsic proteins are mostly oleosin…caleosin and stereolosin are minor intrinsic proteins,” but does not actually define what intrinsic proteins are. The term “intrinsic protein” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the claim is rendered indefinite. For the purposes of examination, “intrinsic proteins” will be considered to be any proteins comprised in the enlarged oleosomes.
Claims 2, 4-6, 10-18, and 20-23 are rejected as being dependent on a rejected base claim.
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, 15-18, and 20-23 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, and 18, Van Baalen discloses a nutritional composition comprising:
enlarged lipid globules with a polar lipid coating (i.e., enlarged oleosomes) [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),
wherein the enlarged lipid globules have an average globule diameter in the range of 2 to 12 microns [0012].
Van Baalen is silent as to that the enlarged 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.
Abdullah also teaches that stable sunflower seed oleosomes have a diameter of 0.4-5 microns (5.4. Oleosomes as natural emulsifiers, second paragraph), which overlaps with the claimed range of 2-12 microns, and 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 2, Van Baalen teaches that the enlarged 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 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 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 17, Van Baalen teaches that more than 98 wt.% of the vegetable lipid content of the nutritional composition is present in the lipid globules (i.e., enlarged oleosomes) [0085]. Van Baalen also teaches that the composition comprises 50-100 wt.% vegetable lipids based on total lipids [0080].
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 and 10-14 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 claim 1 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 and 10, 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 pages 9-11, filed August 27, 2025, with respect to the rejections of claims 1, 5, 6, 10-14, 18, 19, and 23 under 35 U.S.C. 103 as being obvious over Banavara et al. in view of Van Baalen et al. and the rejection of claim 20 under 35 U.S.C. 103 as being unpatentable over Banavara et al. in view of Van Baalen et al. as evidenced by Abdullah et al., have been fully considered and are persuasive. Therefore, these rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of a different interpretation of the previously applied reference, Van Baalen et al. Van Baalen has been found to teach the claimed amounts of protein, carbohydrate, and lipid as in instant claims 6 and 10, as well as teaching the limitations of the dependent claims thereof.
Applicant’s arguments, see pages 6-9, filed August 27, 2025, with respect to the rejections of claims 1, 2, 4, 5, 15-18, 21, and 22 under 35 U.S.C. 103 as being obvious over Van Baalen et al. have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of a new application of a previously found prior art reference. Abdullah et al. teaches natural oleosomes derived from sunflower oil and has been found to provide sufficient teaching and motivation to incorporate those oleosomes into the nutritional composition of Van Baalen. The oleosomes taught by Abdullah are an obvious addition to a nutritional composition where lipid globules are already being used, and it is not expected that anything unexpected would occur from the oleosomes’ inclusion.
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
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 8:00-5:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791