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 without traverse of claims 154-160 in the reply filed on January 8, 2026 is acknowledged.
Claims 161-173 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 8, 2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 154, 157 and 158 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geistlinger et al. (WO 2018/039632).
Regarding claim 154, Geistlinger et al. disclose micelles comprising kappa casein without requiring alpha or beta casein (p. 36/L32-P. 37/L11).
Regarding claim 157, Geistlinger et al. disclose all of the claim limitations as set forth above. Geistlinger et al. disclose the kappa casein protein can be derived from any mammalian species including but not limited to cow, human sheep, goat, buffalo, or camel (i.e., having the amino acid sequence of the cited mammals -p. 11/L16-20).
Regarding claim 158, Geistlinger et al. disclose all of the claim limitations as set forth above. Geistlinger et al. disclose the kappa casein is a recombinant protein (p. 19/L15-17). Geistlinger et al. does not disclose the recombinant protein is required to have native post-translational modifications (see at page 2/L6-12 – in some embodiments the recombinant milk proteins have non-native glycosylation and/or phosphorylation patterns).
Claim Rejections - 35 USC § 103
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 156 and 159 are rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (WO 2018/039632).
Regarding claim 156, Geistlinger et al. disclose all of the claim limitations as set forth above. Geistlinger et al. does not disclose the kappa casein has an amino acid sequence as claimed. However, given Geistlinger et al. disclose kappa casein having the amino acid sequence of cow, human sheep, goat, buffalo, or camel and the ability to form micelles without the presence of alpha or beta casein, inherently the kappa casein must exhibit an amino sequence with at least 80% sequence identity to any one of SEQ ID Nos: 40-60.
Regarding claim 159, Geistlinger et al. disclose all of the claim limitations as set forth above. Geistlinger et al. disclose the micelles comprising kappa casein have an average diameters (i.e., size) ranging from 140 nm to 350 nm (p. 37/L12-28). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP §2144.05 I).
Claims 155 and 160 are rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (WO 2018/039632) in view of Aoki et al. (“Role of Individual Milk Salt Constituents in Cross-linking by Colloidal Calcium Phosphate in Artificial Casein Micelles”, Agric. Biol. Chem., 51(3), (1987), pp. 817-821).
Regarding claims 155 and 160, Geistlinger et al. disclose all of the claim limitations as set forth above. Geistlinger et al. is silent with respect to intra-micellar crosslinking. Moreover, while Geistlinger et al. disclose the micelle formation can be affected by the presence of salt, the reference does not specifically mention a citrate salt, a calcium salt or a phosphate salt.
Aoki et al. teach the formation of artificial casein micelles by combining casein and calcium chloride, dipotassium phosphate and/or tripotassium citrate (p. 817-818/Materials and Methods). Aoki et al. teach that when casein is in the presences of both calcium chloride and dipotassium phosphate casein micelles are formed (p. 820/Discussion). Aoki et al. also teach casein aggregates crosslinked by colloidal calcium phosphate (Abstract, p. 820/Discussion).
Geistlinger et al. and Aoki et al. are combinable because they are concerned with the same field of endeavor, namely formation of artificial casein containing micelles. It would have been obvious to one of ordinary skill in the art to have added calcium chloride and dipotassium phosphate to the kappa casein containing micelles of Geistlinger et al. to promote crosslinking between micelles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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