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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/5/2026 has been entered.
Claims 1-11 and 14-21 are pending in this application.
Claims 15-21 stand withdrawn from further consideration as being directed to non-elected subject matter. Claims 1-11 and 14 will presently be examined.
35 U.S.C. 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.
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 1-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over CN 1094682651 in view of Reif et al. (WO 2017/090049; hereinafter, Reif) and O’Connor et al. (WO 01/78530; hereinafter, O’Connor).
CN 109468265 teaches a method of extracting milk exosomes that does not utilize ultracentrifugation; instead, milk sample (e.g., bovine milk) is centrifuged at 2000g and 12,000g, milk protein removed, supernatant passed through a 0.22 µm membrane, and freeze dried to obtain bovine milk exosome powder. See abstract; claims 1-2; paragraphs 9-16, 25-28.
Reif (WO 2017/090049) discloses a composition comprising a milk formula and microvesicles isolated from natural milk such as bovine milk, which include exosomes (claims 1-3; page 4, lines 5-6, 12-13; page 5, lines 9-13; page 9, lines 21-30; page 11, lines 24-27). The exosomes comprise proteins and/or miRNA molecules (claims 7-10; page 4, lines 15-17), including miR-210 and miR-146a (pages 13-16). Lyophilized microvesicles are disclosed (claim 14; page 5, lines 3-4). Exosomes are isolated from skim fraction of milk, wherein milk is fractionated by centrifugation at 5000g, the skim fraction is centrifuged at 12,000g, and then the supernatant is filtered through, for example, 5 or 0.45 µm filters; the exosomes are then pelleted, which can be lyophilized (paragraph bridging pages 10-11; claim 14; page 5, lines 3-4). Example 6 discloses isolated exosomes from cow milk, and miRNAs were detected from isolated exosomes, which indicates intact exosomes (pages 49-50). Example 6 discloses further processing by dehydrating the isolated exosomes and adding to milk formulas in dehydrated form (page 50, lines 7-9). Reif discloses exosomes as having a diameter between 30 and 100 nm. Reif’s milk formula contains sufficient nutritional components such as protein, carbohydrates, and fat to serve as a nutritional source when provided in sufficient quantity (page 10, lines 4-7), which includes milk formula for infants (claim 15). Reif further discloses that miRNA content in various infant-milk formulas is significantly lower than that found in cow or human milk, or in most cases absent (page 18, lines 15-17) and commercial milk formulas lack essential components, which are present in natural milk (page 47, lines 23-29).
O’Connor (WO 01/78530) discloses infant formulas containing docosahexaenoic acid (DHA), arachidonic acid (AA), alpha-linolenic acid (ALA), and linolenic acid (LA). See claim 1. Known infant formulas contain protein, fat, carbohydrates, and other ingredients in liquid or powder form (page 15, Table A; pages 23-25). Dietary fiber such as soy polysaccharide can be added (page 23, line 19). Milk protein can be added (page 24, first paragraph).
CN 109468265 does not explicitly disclose the weight percentage of intact bovine milk-isolated powdered exosomes. However, the process taught by CN 109468265 avoids ultracentrifugation, and the centrifugation step of CN 109468265 is low at 2000g and 12,000g. Further, Reif’s comparably processed Example 6 discloses isolated exosomes from cow milk, and miRNAs were detected from isolated exosomes, which indicates intact exosomes.
It would have been obvious to the ordinary skilled artisan that the powdered bovine exosomes taught by CN 109468265 would have the claimed intact exosome features because all the steps of CN 109468265 would not be expected to damage exosomes. Taken with Reif’s teaching that miRNA content in various infant-milk formulas is significantly lower than that found in cow or human milk, or in most cases absent, it would have been obvious to add the bovine milk-isolated powder exosomes to solid infant formulas.
Claim 3 requires the powdered exosomes to comprise greater amount of miRNA after storage at 37 °C for 3 weeks than fresh milk exosomes after storage at 37 °C for 3 weeks. This claim is quite broad in that “fresh milk exosome” could mean significantly different things depending on the medium that the “fresh milk exosome” is in. Besides, does “fresh milk exosomes” include fresh milk, which would probably spoil in 3 weeks at such refrigerator temperature? For these reasons, it would have been obvious that the bovine milk-isolated powder exosomes taught by CN 109468265 would possess the characteristics recited in instant claim 3.
Claim 7 requires 0.001-10 wt% of bovine milk-isolated exosomes, based on the weight of the nutritional composition. Reif teaches that miRNA content in various infant-milk formulas is significantly lower than that found in cow or human milk, or in most cases absent, so it would have been well within the skill of the ordinary skilled artisan to adjust and optimize the amount of powdered, intact exosomes suggested by the combined teachings of the prior art as an additive to known infant-milk formulas.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references.
For these reasons, all claims must be rejected at this time. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699
1 Machine translation is provided herewith. All references are to the machine translation.