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 II, claims 17-23 and 26-28 in the reply filed on April 27, 2026 is acknowledged. Applicant argued that groups II and IV-VII are related and not distinct from each other. Applicant stated that Groups IV-VI are directed towards the process of using the product of Group II and cannot be separated from the product under MPEP §806.05(h) (Remarks, p. 9, ¶ 3-6).
This argument has been considered. However, the application has been filed as a national stage application as provided by 37 CFR 1.475. Thus, restriction is based on unity of invention under PCT Rule 13.1. As such, MPEP §806 is irrelevant to the restriction requirement. The Examiner maintains that the groups do not relate to a single general inventive concept because they lack a corresponding special technical feature.
Applicant also argued that restriction between Groups II and VII are improper because Groups II and VII are not distinct. Applicant stated that Group VII requires the composition of Group II and would just be the same field of search (Remarks, p. 10, ¶ 1).
This argument has been considered. However, the application has been filed as a national stage application as provided by 37 CFR 1.475. Thus, restriction is based on unity of invention under PCT Rule 13.1. As such, MPEP §806 is irrelevant to the restriction requirement. The Examiner maintains that the groups do not relate to a single general inventive concept because they lack a corresponding special technical feature.
Applicant further argued that no significant search or examination burden exists between Groups II and IV-VII (remarks, p. 10, ¶ 2).
This argument has been considered. However, establishing a search burden is only required for U.S. restriction practice for applications filed under 35 U.S.C. § 121. The instant application has been filed as a 371 under the PCT. Therefore, the argument that there is no undue search burden is not persuasive due to relying on incorrect restriction provisions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 30-33, 36, 39-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), there being no allowable generic or linking claim.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 April 27, 2026.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
17-23, 26-28, 30-33, 36, 39-56
Withdrawn claims:
30-33, 36, 39-56
Previously canceled claims:
24-25, 34-35, 37-38
Newly canceled claims:
1-16, 29
Amended claims:
17
New claims:
40-56
Claims currently under consideration:
17-23, 26-28
Currently rejected claims:
17-23, 26-28
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 18-21 are objected to because of the following informalities: in claims 18-21, the first instance of “EV” should be “extracellular vesicles (EV)”. Appropriate correction is required.
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 17-23, and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
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, and osteopontin. These are all natural components of bovine and human breast milk. 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 compositions of the claims is the same as naturally occurring bovine or human breast milk. Although a concentrated whey product is obtained during processing of milk, there is no patentable distinction between the whey of the claimed invention and that of a naturally occurring milk. 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 additional ingredients that would provide a distinction between the claimed invention and a naturally occurring whey product from milk. 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 that are found in a naturally occurring whey product. 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 17, 27, and 28 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) in view of Belldegrun (US 2019/0388518 A1).
Regarding claim 17, Boer teaches of a milk fat globule membrane (MFGM) 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%”); and
73% protein (which lies within the claimed range of “65 to 80%”).
Boer does not teach the composition comprising osteopontin in an amount of 0.8-5% w/w relative to total protein.
However, in the same field of endeavor, Belldegrun teaches a formulation for nutritional support (Title) comprising osteopontin in an amount of 0.1% to about 4% of the protein component ([0015]), which overlaps with the claimed range of “0.8-5%”. The composition of Belldegrun also comprises a fat component such as MFGM and phospholipids ([0018]) and a carbohydrate component such as lactose ([0020]).
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 addition of osteopontin in an amount taught by Belldegrun. One of ordinary skill would have been motivated to make this modification because Belldegrun discloses a similar composition to that of Boer and teaches that osteopontin has important immunity-protective properties.
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 27, Boer teaches that the whey concentrate is spray dried (p. 229, col. 1, ¶ 1), which would necessarily result in the composition being a powder.
Regarding claim 28, Boer does not teach that the composition is in the form of a liquid.
However, in the same field of endeavor, Belldegrun teaches that the formulation may be in any form suitable for administration, such as a liquid ([0196]).
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 to be in the form of a liquid. The claim would have been obvious because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Claims 18-21 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) in view of Belldegrun (US 2019/0388518 A1) as 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 claims 18 and 20, 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” (claim 18) and “at least 76%” (claim 20).
Regarding claim 19, 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).
Although Boer does not teach that the phospholipids derived from milk EVs are present in an amount of 50-75% w/w relative to the total phospholipid, one of ordinary skill in the art would have adjusted the amount of phospholipids derived from EVs during routine optimization to arrive at the desired phospholipid profile. MPEP §2144.05(II)(A) states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, the claimed range would be obvious.
Regarding claim 21, 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).
Claims 22, 23, and 26 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) in view of Belldegrun (US 2019/0388518 A1) as evidenced by Reif (US 2018/0343882 A1).
Regarding claim 22, 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]).
Regarding claim 23 and 26, although Boer does not explicitly disclose that the composition comprises the recited miRNA present in mammal milk, the recited miRNA sequences would necessarily be present in the composition of Boer as evidenced by Reif. Reif discloses that the miRNA molecules include let-7a-5p, let-7b-5p (i.e., a let-7b), let-7f-5p (i.e., a let-7f), miR-21-5p, and miR-26a-5p (i.e., a miR-26a)([0063]).
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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