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 Group I, claims 133-149 in the reply filed on 01/13/2026 is acknowledged. Claims 150-152 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim status
Claims 133-152 filed 01/12/2024 are pending in the application. Claims 133-149 are previously presented. Claims 150-152 are withdrawn without traverse in response to the restriction requirement. Claims 133-149 are hereby examined on the merits.
Claim Objections
Claim 133 is objected to because of the following informalities: “wherein the two casein proteins are from different mammalian species; wherein at least one of the casein proteins is a recombinant protein; and wherein the casein proteins are associated in micellar form” should read “wherein the at least two casein proteins are derived from different mammalian species; wherein at least one of the at least two casein proteins is a recombinant protein; and wherein the at least two casein proteins are associated in micellar form”. Appropriate correction is required.
Claim 134 is objected to because of the following informalities: “are from different mammalian species” should read “are derived from different mammalian species”. Appropriate correction is required.
Claim 142 is objected to because of the following informalities: “wherein the hybrid micelle comprises” should read “wherein the hybrid micelle composition comprises”. 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.
Claim 140 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled an alpha casein with 100% amino acid sequence identity to SEQ ID NO 1-3 and 12-47, or a kappa casein with 100% amino acid sequence identity to SEQ ID NO 48-70, does not reasonably provide enablement for an alpha casein that comprises amino acid sequence having at least 90% but less than 100% identity to SEQ ID NO:1-3 and 12-47, or a kappa casein that comprises amino acid sequence having at least 90% but less than 100% identity to SEQ ID NO:48-70. The specification does not disclose any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Case law holds that applicant’s specification must be “commensurately enabling [regarding the scope of the claims]” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all peptide within the scope of claims 1-15 can be used as claimed and whether claims 1-15 meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988). Upon applying this test to claim 140, it is believed that undue experimentation would be required to make or use an invention commensurate with the full scope of these claims because:
(a) The breadth of the claim, the nature of the invention, the state of the art and the level of predictability in the art: claim 140 recites 62 amino acid sequences each of which has ~200 amino acids, and also recites an amino acid sequence that is at least 90% of the sequences above, generating a substantial amount of variations thus the claim is very broad. Further, the impact of substitution or deletion of an amino acid in casein protein is unpredictable.
(b) The level of one of ordinary skill in the art: a Ph. D or a mater in the food art that is also skilled in molecular biology and protein chemistry.
(c) The quantity of experimentation necessary is great: claim 140 reads on an alpha casein that comprises an amino acid sequence having at least 90% identity to SEQ ID NO:1-3 and 12-47, or a kappa casein that comprises an amino acid sequence having at least 90% identity to SEQ ID NO:48-70. Alpha casein is known to perform very important function in a micelle formed by dairy proteins. Kappa casein is known to perform essential function in stabilizing micelles and be responsible for forming curd in cheesemaking. Given that each of the sequences above has ~200 amino acids, a polypeptide having up to 10% of the amino acids that vary from the aforementioned sequences will encompass a large number of variations. Further, the function of alpha casein in a micellar is determined by its conformation and a single change in an amino acid sequence can alter the conformation thus destroy the functionality of the protein. The function of kappa casein in a micellar is determined by its conserved region and a single change in an amino acid sequence can alter the conformation thus destroy the functionality of the protein. As such, great quantity of experimentation is needed to identify the polypeptides that meet the sequence identity and great quantity of experimentation is needed to test if a polypeptide that meets the sequence identities to SEQ ID NO:1-3 and 12-47 or SEQ ID NO:48-70 could perform the function, and the predictability that if a polypeptide that meets the sequence identity will perform the function recited in claims is low.
(d) The amount of direction provided by the inventor: applicant has not identified which portion of the amino acid sequence in SEQ ID NO:1-3 and 12-47 or SEQ ID NO:48-70 must be preserved in order to preserve the function of an alpha or kappa casein and the quantity of experimentation to determine those portions is great given the unpredictability of protein conformations.
(e) The existence of working examples: there is an absence of working examples concerning an alpha and a kappa casein that are at least 90% but less than 100% of the sequence relative to SEQ ID NO:1-3 and 12-47 SEQ ID NO:48-70, respectively .
In light of the above factors, it is seen that undue experimentation would be necessary to use the invention of claim 140.
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 144 and 146-148 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.
Claim 144 recites a ratio of total alpha casein protein to total kappa casein protein. It is unclear what the ratio is based upon (e.g., weight or molar?). Clarification is required.
Claim 146 recites "a dairy-like product". It is unclear what is encompassed by this limitation. More specifically, the phrase "dairy-like product" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim unascertainable. For the purpose of the examination, the recitation of "a dairy-like product" is interpreted as "a dairy replacement product". Claims 147-148 are rejected for their dependency from claim 146.
Claim 147 recites “dairy-like features selected from the group consisting of texture, melt, stretch, turbidity and appearance”. It is unclear what standard is applied to determine whether texture, melt, stretch, turbidity and appearance is dairy like. Appropriate correction is required.
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.
Claims 133-144 and 146-149 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson WO 2020223700 A1 (cited in the IDS submitted 05/03/2023, hereinafter referred to as Gibson).
Regarding claims 133-139, Gibson teaches a hybrid micelle composition comprising alpha casein (e.g., alpha-S1- casein or alpha-S2-casein, 0059) and kappa casein associated in a micellar form (0006), wherein one or both of the alpha casein and the kappa casein is recombinantly produced (0006; 0008), and wherein the alpha casein and the kappa casein are independently derived from bovine (e.g., cow), ovine (e.g., sheep), caprine (e.g., goat), equine (e.g., horse) or camel (00186; 00188), encompassing the embodiment that the alpha casein and the kappa casein are derived from different mammalian species.
Regarding claims 140, Gibson teaches that the alpha casein is bovine alpha-S1 casein (e.g., Seq ID No. 1 of Gibson, Table 1 and 0022), which matches Seq ID No. 1 of instant application. Gibson also teaches that the kappa casein is bovine kappa casein (e.g., Seq ID No. 27 of Gibson, Table 1, and 0023), which matches Seq ID No. 48 of instant application.
Regarding claim 141, Gibson further teaches that the micellar form may not include beta casein (0006; 0037).
Regarding claim 142, Gibson further teaches that micellar forms includes a full length beta casein (0075; 0099; 0132; Seq ID No. 41 of Gibson; Table 1).
Regarding claims 143, Gibson teaches that the alpha casein is not phosphorylated or is substantially reduced in phosphorylation as compared to native alpha casein (0011), and that kappa casein is not glycosylated or is substantially reduced in glycosylation as compared to native kappa casein (0013).
Regarding claim 144, Gibson teaches that the ratio of alpha casein to kappa casein is about 1:1, 2:1, 3:1, 4:1 or 5 :1 (0020).
Regarding claims 146-148, Gibson teaches a cheese derived from the hybrid micelle composition, wherein the hybrid micelle composition provides a texture that is comparable to that of a cheese made using animal-derived dairy protein (0006; 00174).
Regarding claim 149, Gibson teaches a method of making the hybrid micelle composition, comprising combining the alpha casein and the kappa casein with a salt in a liquid colloid (0067).
Claims 133-144 and 146-149 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pandya US Patent Application Publication No. 2017/0273328 A1 (cited in the IDS submitted 05/03/2023, hereinafter referred to as Pandya).
Regarding claims 133-139, Pandya teaches a hybrid micelle composition comprising alpha casein (e.g., alpha-S1-casein or alpha-S2-casein, 0035) and kappa casein associated in a micellar form (0035; 0068; 0194; 0230), wherein one or both of the alpha casein and the kappa casein is recombinantly produced (0193-0194), and wherein the alpha casein and the kappa casein are independently derived from bovine (e.g., cow), ovine (e.g., sheep), caprine (e.g., goat), equine (e.g., horse) or camel (0123; 0125; 0127; 0057), encompasses the embodiment that the alpha casein and the kappa casein are derived from different mammalian species.
Regarding claims 140, Pandya teaches that the alpha casein is bovine alpha-S1 casein (e.g., Seq ID No. 48 on page 67 of Pandya; 0125), which matches Seq ID No. 1 of instant application. Gibson also teaches that the kappa casein is bovine kappa casein (e.g., Seq ID No. 1 on page 40 of Gibson, 0123), which matches Seq ID No. 48 of instant application.
Regarding claim 141, Pandya teaches that the micellar form comprises one or more of alpha casein (e.g., S1 or S2), beta casein, and kappa casein (0230; 0194; 0068; 0035), encompassing the embodiment that the micellar form may not include beta casein.
Regarding claim 142, Pandya teaches that micellar form includes a full length bovine beta casein (0118; Seq ID No. 28 on page 52-53 of Pandya).
Regarding claims 143, Pandya teaches that the kappa casein is not glycosylated (0021; 0181).
Regarding claim 144, Pandya includes an embodiment teaching that the casein composition comprising 12-15 g/L alpha S1-casein, 3-4 g/L alpha-S2-casein and 2-4 g/L kappa casein (0230), thus the ratio of alpha casein: kappa casein is 3.75:1-9.5:1 (calculated from [12-15 g/L + 3-4 g/L] / 2-4 g/L).
Regarding claims 146-148, Pandya teaches a cheese derived from the hybrid micelle composition, wherein the hybrid micelle composition provides an appearance and texture that are comparable to that of a cheese made using animal-derived dairy protein (0007; 0040-0042; 0108; 0228-0229; 0253).
Regarding claim 149, Pandya teaches a method of making the hybrid micelle composition, comprising combining the alpha casein and the kappa casein with a salt in a liquid which necessarily forms a colloidal suspension because a micelle is present (0198; 0029; 0129).
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.
Claim 145 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claims 133-134 above, and further in view of Katz US 2010/0223682 A1 (hereinafter referred to as Katz).
Regarding claims 145, Gibson as recited above teaches full length recombinant kappa casein derived from cow, sheet or goat, thus being silent regarding a recombinant truncated kappa casein.
Katz in the same field of endeavor teaches a method of reducing allergic reaction associated with kappa casein derived from kosher cow, sheet or goat, the method comprising recombinantly produces kappa protein with amino acid deletion (Abstract; 0009; 0032; 0024; 0104).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Gibson by either substituting the recombinant deleted kappa casein as disclosed by Katz for the kappa casein of Gibson or including the recombinant amino acid deleted kappa casein in the micelle composition for reducing allergic reaction.
Claim 145 is rejected under 35 U.S.C. 103 as being unpatentable over Pandya as applied to claims 133-134 above, and further in view of Katz US 2010/0223682 A1 (hereinafter referred to as Katz).
Regarding claims 145, Pandya as recited above teaches full length recombinant kappa casein derived from cow, sheet or goat, thus being silent regarding a recombinant truncated kappa casein.
Katz in the same field of endeavor teaches a method of reducing allergic reaction associated with kappa casein derived from kosher cow, sheet or goat, the method comprising recombinantly produces kappa protein with amino acid deletion (Abstract; 0009; 0032; 0024; 0104).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Pandya by either substituting the recombinant deleted kappa casein as disclosed by Katz for the kappa casein of Pandya or including the recombinant amino acid deleted kappa casein in the micelle composition for reducing allergic reaction.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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