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 52-56 in the reply filed on May 12, 2026 is acknowledged. The traversal is on the ground(s) that De Boer is silent regarding microRNA and any preservation thereof. Applicant argued that the Examiner’s assertion that miRNA is inherently present is unsupported (Remarks, p. 3, ¶ 2-5). This is not found persuasive. Although Boer does not explicitly disclose that the composition comprises miRNA present in mammal milk, miRNA would necessarily be present in the composition of Boer as evidenced by Reif. Reif discloses that vesicles from mammalian milk comprise various active miRNAs ([0003], [0012]). Applicant’s assertion that the composition of de Boer would be devoid of miRNA because of harsh processing conditions is unfounded. There is no evidence that the composition of de Boer would have the miRNA removed during processing. Furthermore, because the claims do not recite a minimum amount of miRNA, any residual miRNA remaining after processing, even a miniscule amount, would meet the claimed language.
The requirement is still deemed proper and is therefore made FINAL.
Claims 57-74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 12, 2026.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
52-74
Withdrawn claims:
57-74
Previously canceled claims:
1-51
Newly canceled claims:
None
Amended claims:
None
New claims:
None
Claims currently under consideration:
52-56
Currently rejected claims:
52-56
Allowed claims:
None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 52-54 are objected to because of the following informalities:
Claim 52, line 8, amend “present in present in” to be “present in”;
Claim 53, line 6, amend “prefer-ably” to “preferably”;
Claim 54, line 2, amend “phospho-lipid” to “phospholipid”.
Appropriate correction is required.
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 52-56 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
Claim 52 recites the broad recitation “a composition”, and the claim also recites “preferably in the form of a liquid or in the form of a powder” which is the narrower statement of the range/limitation.
Claim 52 recites the broad recitation “microRNA in mammal milk”, and the claim also recites “preferably present in bovine and/or human milk” which is the narrower statement of the range/limitation.
Claim 53 recites the broad recitation “at most 6,000 CFU/g total solids”, and the claim also recites “even more preferably at most 3000 CFU/g total solids, and most preferably the whey-derived composition contains at most 1000 CFU/g total solids” which is the narrower statement of the range/limitation.
Claim 53 recites the broad recitation “total protein in an amount in the range of 66-78% w/w relative to total solids”, and the claim also recites “more preferably 68-76% w/w, and most preferably 70-76% w/w relative to total solids” which is the narrower statement of the range/limitation.
Claim 53 recites the broad recitation “a total amount of beta-lactoglobulin in the range of 10-45% w/w relative to total protein”, and the claim also recites “more preferably 15-40% w/w, even more preferably 20-40% w/w, and most preferably 25-35% w/w relative to total protein” which is the narrower statement of the range/limitation.
Claim 53 recites the broad recitation “a total amount of alpha-lactalbumin in the range of 0-10% w/w relative to total protein”, and the claim also recites “more preferably 0.1-8% w/w, even more preferably 0.3-5% w/w, and most preferably 0.5-3% w/w relative to total protein” which is the narrower statement of the range/limitation.
Claim 54 recites the broad recitation “at least 50% w/w relative to total phospholipid”, and the claim also recites “more preferably at least 54% w/w, even more preferably at least 56% w/w, and most preferably at least 58% w/w relative to total phospholipid, and/or 50-75% w/w relative to total phospholipid, more preferably 54-73% w/w, even more preferably 56-71% w/w, and most preferably 58-70% w/w, and/or at least 76% w/w relative to total phospholipid, more preferably at least 80% w/w, even more preferably at least 85% w/w, and most preferably at least 90% w/w” which is the narrower statement of the range/limitation.
Claim 55 recites the broad recitation “comprising milk EV”, and the claim also recites “preferably intact milk EV” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the broad limitation for each recitation of a broad to narrow range/limitation will be used.
Claims 53-56 are rejected due to dependency on claim 52.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 52-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more as evidenced by de Boer (Boer, Ruud de. (2014). From Milk By-Products to Milk Ingredients - Upgrading the Cycle - Information Sheets. John Wiley & Sons [accessed online June 16, 2026])(IDS Reference filed 08/29/2024).
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims recite a whey derived composition comprising lipids, phospholipids, ash, lactose, protein, microRNA, and colony forming units. The composition of the claims is the same as that of milk fat globule membrane (MFGM) whey, which is derived from cheese curd (i.e., a naturally occurring product during processing (de Boer, p. 229). Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, the composition of the claims is the same as a naturally occurring MFGM whey. Although a concentrated whey product is obtained during the processing of cheese, there is no patentable distinction between the whey of the claim invention and that of naturally occurring cheese. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claims merely recite the whey composition without any addition ingredients that would provide a distinction between the claimed invention and a naturally occurring whey product. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the claims do not recite any additional components than those found in a naturally occurring whey composition. Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
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 52 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Boer (Boer, Ruud de. (2014). From Milk By-Products to Milk Ingredients - Upgrading the Cycle - Information Sheets. John Wiley & Sons [accessed online June 16, 2026])(IDS Reference filed 08/29/2024) as evidenced by Reif (US 2018/0343882 A1).
Regarding claim 52, Boer teaches of a whey composition comprising (p. 229, col. 1, Table):
16% total lipids (which lies within the claimed range of “10 to 30%”);
7.5% total phospholipids (which lies within the claimed range of “3 to 12%”);
≤ 3% ash (which overlaps with the claimed range of “1-10%”);
≤ 3% lactose (which lies within the claimed range of “at most 10%”);
73% protein (which lies within the claimed range of “65 to 80%”); and
< 10,000/g standard plate count (i.e., colony forming units; which matches the claimed range of “at most 10,000 CFU/g”).
Although Boer does not explicitly disclose that the composition comprises miRNA present in mammal milk, miRNA would necessarily be present in the composition of Boer as evidenced by Reif. Reif discloses that vesicles from mammalian milk comprise various active miRNAs ([0003], [0012]).
With respect to the overlapping ranges, MPEP §2144.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 56, although Boer does not teach the type of miRNA present, the composition would necessarily comprise at least one of the claimed miRNA species as evidenced by Reif. Reif discloses that the miRNA molecules can be let-7a-5p ([0063]).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over Boer (Boer, Ruud de. (2014). From Milk By-Products to Milk Ingredients - Upgrading the Cycle - Information Sheets. John Wiley & Sons [accessed online June 16, 2026])(IDS Reference filed 08/29/2024) as evidenced by Reif (US 2018/0343882 A1), in view of Ely (Ely, Isabel A., et al. “The Effect of Leucine-Enriched β-Lactoglobulin Versus an Isonitrogenous Whey Protein Isolate on Skeletal Muscle Protein Anabolism in Young Healthy Males”, Nutrients, Vol. 17(21), 3410, published 2025 [accessed online June 17, 2026]).
Regarding claim 53, Boer teaches the whey composition comprising:
< 10,000/g standard plate count (i.e., colony forming units; which overlaps with the claimed range of “at most 6,000 CFU/g”); and
73% protein (which lies within the claimed range of “66-78%”).
Because Boer is silent regarding the alpha-lactalbumin content of the whey composition, it logically follows that the composition is devoid of alpha-lactalbumin, which falls within the claimed range of “0-10%”.
Boer does not teach the amount of beta-lactoglobulin in the whey composition. However, in the same field of endeavor, Ely teaches that beta-lactoglobulin accounts for 45-75% of bovine whey proteins (p. 2, ¶ 2), which overlaps with the claimed range of “10-45%”.
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 composition of Boer with the use of beta-lactoglobulin as taught by Ely. One of ordinary skill would have been motivated to make this modification because Ely teaches that beta-lactoglobulin is rich in essential amino acids (p. 2, ¶ 2).
With respect to the overlapping ranges, MPEP §2144.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Claims 54 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Boer (Boer, Ruud de. (2014). From Milk By-Products to Milk Ingredients - Upgrading the Cycle - Information Sheets. John Wiley & Sons [accessed online June 16, 2026])(IDS Reference filed 08/29/2024) as evidenced by Reif (US 2018/0343882 A1), and further evidenced by Hansen (Hansen, Maria, et al. “Bovine milk processing impacts characteristics of extracellular vesicle isolates obtained by size-exclusion chromatography”, International Dairy Journal, Vol. 127, 105212, published September 17, 2021 [accessed online June 17, 2026]).
Regarding claim 54, Boer teaches that the phospholipid profile of the whey composition is 25% phosphatidyl ethanolamine (PE), 25% phosphatidyl choline (PC), 12% phosphatidyl serine (PS), 7% phosphatidyl inositol (PI), and 24% sphingomyelin (SM) (p. 229, col. 1, Table). Although Boer does not disclose that these phospholipids are derived from extracellular vesicles (EV), these phospholipids are inherently found in EV that are necessarily found in milk products as evidenced by Hansen. Hansen discloses that EVs are found in milk (Abstract) and that phospholipids in EV include PI, PE, PS, PC, and SM (p. 4, Table 2). Thus, the composition of Boer comprises 86% EV derived phospholipids, which falls within the claimed range of “at least 50% relative to total phospholipid”.
Regarding claim 55, although Boer does not disclose that the whey composition comprises milk EVs, the composition would necessarily comprise milk EVs as evidenced by Hansen. Hansen discloses that EVs are found in milk (Abstract).
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 M-Th 8:00a-4:00p, F 8:00a-1:00p ET.
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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
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