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 response to the application filed on August 23, 2023. The earliest effective filing date of the application is February 24, 2021.
Priority
The present application is a 371 National Stage Application of PCT/US2022/017607 which has a filing date of February 24, 2022.
Status of Application
The amendment filed December 19, 2025 with the Response to Restriction and Election of Species Requirement has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 5, 7, 10, 11, 13, 17, 20 – 24, 26, 31, 33, 35, 36, 46, 61, and 63
Withdrawn claims: 10, 13, 17, 20 – 24, 26, 31, 33, 35, 46, 61, and 63
Previously cancelled claims: 6, 8, 9, 12, 14 – 16, 18, 19, 25, 27 – 30, 32, 34, 37 – 45, 47 – 60, 62
Currently Amended claims: 1, 7, 11, and 36
Claims currently under consideration: 1 – 5, 7, 11, and 36
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: The previous objection to claim 1 is withdrawn in light of applicant’s amendments. A new objection to claim 7 is presented below.
Withdrawn Rejections: The previous rejection under 35 U.S.C. § 101 of claims 1 – 5, 7, 11, and 36 over human milk is withdrawn in light of applicant’s amendments. The previous rejection under 35 U.S.C. § 102(a)(1) of claims 1 – 4 and 36 over human milk is withdrawn in light of applicant’s amendments.
35 U.S.C. § 112 Rejections: New rejections under 35 U.S.C. § 112(a) of claims 1 – 5, 7, 11, and 36 are presented below. The previous rejections under 35 U.S.C. § 112(b) of claim 7 has been withdrawn in light of applicant’s amendments. A new rejection under 35 U.S.C. § 112(b) of claim 11 is presented below.
35 U.S.C. § 102 Rejections: The previous rejections under 35 U.S.C. § 102 over Pandya of claims 1 – 5, 7, 11, and 36 are adjusted in light of applicant’s amendments and presented below.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “comprising from 1 to 10 recombinant human milk proteins, optionally from 1 to 8, optionally from 1 to 5”. Within the range of 1 to 10 recombinant human milk proteins, the ranges 1 to 8 and 1 to 5 are encompassed. The claim may be rewritten as “The formula of claim 5, comprising from 1 to 10 recombinant human milk proteins.” for succinctness.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 5, 7, 11, and 36 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a recombinant human breast milk protein (human milk protein) expressed in a non-human host cell and comprising a non- native post-translational modification relative to endogenous human milk protein”. There is no support in the instant specification with respect to post-translationally modifying the protein relative to endogenous human milk proteins. One of ordinary skill in the art would not have interpreted the disclosure to include the precisely claimed invention of claim 1 because the specification only refers to “recombinant human milk protein”, and each species of human milk protein (i.e., lactoferrin, serum albumin, etc.) generically. There is no suggestion to modify the proteins, or that the proteins are modified relative to endogenous human milk proteins. There is also no suggestion that the recombinant human milk proteins are “variants” or anything other than endogenous human milk proteins.
Claim 11 recites “wherein the proteins lack non-human post-translational modifications associated with allergenicity of bovine- or plant-derived formulas”. There is no support in the instant specification with respect to post-translational modifications, nor how such modifications are associated with allergenicity. One of ordinary skill in the art would not have interpreted the disclosure to include the precisely claimed invention of claim 11 because the specification only refers to “recombinant human milk protein”, and each species of human milk protein (i.e., lactoferrin, serum albumin, etc.) generically. There is no suggestion to modify the proteins, or that the proteins are modified relative to endogenous human milk proteins. There is also no suggestion that the recombinant human milk proteins are “variants” or anything other than endogenous human milk proteins. Furthermore, “modifications associated with allergenicity” to a given human milk protein are not discussed, or evident to one of ordinary skill in the art, since discussion of any modifications to the generically recited recombinant human milk proteins of the instant specification are absent.
Claim 36 recites “and subsequently processed, purified, or chemically or enzymatically modified such that the resulting protein composition differs structurally or functionally from naturally secreted human milk”. There is no support in the instant specification with respect to how the recombinant milk protein is chemically or enzymatically modified. One of ordinary skill in the art would not have interpreted the disclosure to include the precisely claimed invention of claim 36 because the specification only refers to “recombinant human milk protein”, and each species of human milk protein (i.e., lactoferrin, serum albumin, etc.) generically. There is no suggestion to modify the proteins, or that the proteins are modified relative to endogenous human milk proteins. There is also no suggestion that the recombinant human milk proteins are “variants” or anything other than endogenous human milk proteins.
Claims 2 – 5 and 7 are rejected as dependent on a rejected base claim.
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.
Claim 11 is 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 11 recites “the proteins lack non-human post-translational modifications associated with allergenicity of bovine- or plant-derived formulas” which renders the claim indefinite. The term “associated with allergenicity of bovine- or plant-derived formulas” 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. It is unclear what limitation “associated” is intended to introduce into the claim. For the purpose of examination, any non-human post translational modification is considered to be not associated with allergenicity of bovine- or plant-derived formulas.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 – 5, 7, 11, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pandya et al. (WO 2016029193 A1).
Regarding claims 1, Pandya teaches a composition comprising: κ-casein protein, β-casein protein, one or more lipids (i.e., oils), one or more flavor compounds, one or more sweetening agents, and ash, wherein the composition does not comprise an animal-derived component (Claim 3). Pandya teaches the κ-casein protein and β-casein protein, are human milk proteins (p. 6, lines 6 – 15). Pandya teaches the κ-casein protein and β-casein protein are unglycosylated or has a non-mammalian glycosylation pattern (Claim 3).
With respect to the limitation that the human milk protein “comprises a non- native post-translational modification relative to endogenous human milk protein”, Pandya teaches the term "non-mammalian glycosylation pattern" means one of a difference in one or more location(s) of glycosylation in a protein, and/or a difference in the amount of and/or type of glycosylation at one or more location(s) in a protein produced and post- translational modified in a non-mammalian cell (e.g., a yeast cell, an insect cell, or a bacterial cell) as compared to a reference protein (e.g., the same protein produced and post-translationally modified in a mammalian cell, e.g., a CHO cell, a MEK cell, or a mammalian udder cell – p. 19, lines 6 – 12). Therefore, by stating the κ-casein protein (i.e., a protein that may be found in human milk) and the β-casein protein (i.e., a protein that may be found in human milk) are unglycosylated or has a non-mammalian glycosylation pattern, Pandya is teaching the κ-casein protein (i.e., a protein that may be found in human milk) and the β-casein protein (i.e., a protein that may be found in human milk) comprise a non-native post-translational modification relative to endogenous human milk protein.
With respect to the lack of “animal-derived components” in the composition of Pandya, Pandya teaches the term "mammal-derived component" means a molecule or compound (e.g., a protein, a lipid, or a nucleic acid) obtained from the body of a mammal or a molecule obtained from a fluid or solid produced by a mammal (p. 19, lines 1 – 4). Therefore, the term “animal-derived” is referring to the source of the protein, not what the protein is.
Regarding claim 2, Pandya does not teach the composition comprises non-human animal proteins.
Regarding claim 3, Pandya does not teach the composition comprises plant protein.
Regarding claim 4, Pandya does not teach the composition comprises hydrolyzed milk proteins.
Regarding claims 5 and 7, Pandya teaches the composition comprises κ-casein protein (i.e., milk protein), and β-casein protein (i.e., milk protein – Claim 1). Pandya does not require the composition to comprise additional proteins.
Regarding claim 11, Pandya teaches the composition comprises κ-casein protein (i.e., milk protein), β-casein protein (i.e., milk protein – Claim 1). Pandya teaches the composition may further comprise human serum albumin (Claims 35 and 36). Pandya teaches any milk protein (which includes serum albumin) according to the teachings of Pandya may be unglycosylated or has a non-mammalian glycosylation (p. 18, lines 11 – 17; p. 70, lines 17 – 19). Therefore, Pandya teaches embodiments wherein the serum albumin has the modifications as claimed.
Regarding claim 36, given the κ-casein protein and β-casein protein are unglycosylated or has a non-mammalian glycosylation pattern, they are modified such that they differ structurally from naturally secreted human milk.
Response to Arguments
Applicant's arguments filed December 19, 2025 have been fully considered but they are not persuasive.
Applicant argues the amendments overcome the previous rejection under 35 U.S.C. § 101 because the claims have been amended to recite structural differences that distinguish the composition from natural products (p. 2, paragraph 5).
Applicant’s arguments has been carefully considered and is it persuasive. The rejection under 35 U.S.C. § 101 of claims 1 – 5, 7, 11, and 36 has been withdrawn.
Applicant argues Kim does not anticipate the claims as amended (p. 3, paragraph 4).
Applicant’s arguments has been carefully considered and is it persuasive. The rejection under 35 U.S.C. § 102 over Kim of claims 1 – 4 and 36 has been withdrawn.
Applicant argues Pandya only produces recombinant bovine milk proteins (p. 3, Table, Protein Type and Species Selected).
Applicant’s argument has been carefully considered however the argument is not persuasive. Pandya teaches the κ-casein protein and β-casein protein, are human milk proteins (p. 6, lines 6 – 15).
Applicant argues the serum albumin taught by Pandya is optional (p. 3, paragraph 5).
Applicant’s argument has been carefully considered however the argument is not persuasive. The fact that Pandya teaches optional embodiments which include serum albumin does not exclude the embodiments from being taught by Pandya.
Applicant argues the serum albumin taught by Pandya is not infant-formula-specific (p. 3, paragraph 5).
Applicant’s argument has been carefully considered however the argument is not persuasive. While the teachings of Pandya are not solely tailored for infant formula, Pandya teaches the dairy substitute products may be used in infant formula (p. 78, lines 18 – 21).
Applicant argues the serum albumin taught by Pandya is not structurally modified as claimed (p. 3, paragraph 5).
Applicant’s argument has been carefully considered however the argument is not persuasive. Pandya teaches “milk protein” includes serum albumin (p. 18, lines 11 – 17). Pandya teaches any milk protein according to the teachings of Pandya may be unglycosylated or has a non-mammalian glycosylation (p. 70, lines 17 – 19). Therefore, Pandya teaches embodiments wherein the serum albumin has the modifications as claimed.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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