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 action is in response to the papers filed on 08/18/2026. Claims 1-31 are currently pending as per claims filed on 08/18/2026.
Applicant’s election of Group I, without traverse, of claims 1-15 in the reply filed on 08/18/2026 is acknowledged.
Therefore, claims 16-31 are withdrawn from further consideration
pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no
allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 1-15 are subject to examination to which the following grounds of rejection are applicable. Claim 1 is an independent claim.
Priority
This application is a CON of PCT/JP2022/047331 filed on December 22, 2022. This Application claims benefit of foreign filed applications JAPAN 2021-211122 filed 12/24/2021. Acknowledgment is made of applicant’s claim for foreign
priority under 35 U.S.C. 119 (a)-(d) to JAPAN 2021-211122 filed 12/24/2021.
Filing of certified untranslated copies of the applications JAPAN 2021-211122 filed 12/24/2021 is acknowledged.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C.
119(a)-(d) prior to declaration of an interference, a certified English translation of the
foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being
accorded
Thus, the earliest possible priority for the instant application is 12/24/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/21/2024, 08/05/2024, and 12/03/2025 were filed before the mailing date of the current office action. The submission is in compliance with the provisions of 37 CFR 1.97.
Accordingly, the information disclosure statement is being considered by the
examiner.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 and 12-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “the composition according to claim 1, wherein the a-ketoglutaric acid is a salt of a-ketoglutaric acid” yet claim 1 also recites “wherein the a-ketoglutaric acid is a salt of a-ketoglutaric acid”, thus claim 2 does not further limit claim 1.
Claim 12 recites “the composition according to claim 1, wherein the amino acid source is cysteine.”, yet claim 1 recites “the amino acid source is free L-cysteine anhydrate”, which is a species of the genus of cysteines as recited in claim 12, therefore claim 12 is broader than claim 1.
Claim 13 recites “The composition according to claim 9 (which depends on claim 1), wherein the cysteine is free L- cysteine anhydrate or L-cysteine hydrochloride monohydrate” yet claim 1 recites “the amino acid source is free L-cysteine anhydrate”, thus claim 13 does not further limit claim 1 and 9.
Claim 14 recites “The composition according to claim 9 (which depends on claim 1), wherein the cysteine is free L- cysteine anhydrate” yet claim 1 recites “the amino acid source is free L-cysteine anhydrate”, thus claim 14 does not further limit claim 1 and 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim interpretation
Claim 1, 10, 11, and 13 and 14 recite “free L-cysteine”. The term “free” is interpreted to mean that the cysteine is not engaged in disulfide bonds, and it also denotes the standalone amino acid L‑cysteine, which is a thiol‑containing, non‑essential amino acid.
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(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Von Hagen et al (US 20180223250 A1; as cited in IDS) and as evidenced by Millipore Sigma (downloaded 09/21/2026, pages 1-10).
Regarding claim 1, 2, 4, and 12, Von Hagen teaches a cell culture medium comprising one or more amino acids and carrier components to improve solubility of poorly soluble components and the carrier components can be alpha-Ketoglutaric Acid Disodium salt Dihydrate (para 0012, para 0069, Table 1) and L-cysteine (para 0041,0071; CAS: 52-90-4 recited in Table 1, i.e. free L-cysteine as evidenced by Millipore Sigma (downloaded 09/21/2026, pages 1-10)) and the L-cysteine can be in anhydrate form (Table 1, para 0135), thus Von Hagen teaches a composition for animal cell culture comprising an amino acid source and a-ketoglutaric acid; wherein the a-ketoglutaric acid is a salt of a-ketoglutaric acid (claim 1 and 2), the amino acid source is free L-cysteine anhydrate (claim 1), the composition is a culture medium (claim 4), the amino acid source is cysteine (claim 12). Regarding claim 3, the teachings of Von Hagen anticipate claim 1. Moreover, Von Hagen teaches the invention is directed to a powered cell culture media (para 0087), thus anticipating wherein the composition is a powder.
Regarding claim 5, the teachings of Von Hagen anticipate claim 1 and 4. Moreover, Von Hagen teaches the cell culture medium is a full medium or a feed, thus anticipating wherein the culture medium is a feed medium.
Regarding claim 6-8, the teachings of Von Hagen anticipate claim 1. Moreover, Von Hagen teaches the carrier component can be alpha-Ketoglutaric Acid Disodium salt Dihydrate (para 0012, para 0069, Table 1) which is an alkali metal salt (Sodium Na is an alkali metal) and is a sodium salt of α-ketoglutaric acid (claim 7) and is a disodium α-ketoglutarate (claim 8).
Regarding claim 9, the teachings of Von Hagen anticipate claim 1. Moreover, Von Hagen teaches examples of amino acids included in the cell culture medium are leucine, isoleucine, lysine, methionine, phenylalanine, threonine, tryptophane and valine, thus anticipating wherein the amino acid source is lysine, phenylalanine, or methionine.
Regarding claim 10, the teachings of Von Hagen anticipate claim 1 and 9. Moreover, Von Hagen teaches the carrier components in the cell culture media can be: L-Cysteine and Hydrochloride/Hydrate forms, L-Lysine Monohydrate and hydrochloride forms (para 0018), thus anticipating wherein the composition has a property selected from (1) the cysteine is free L-cysteine or L-cysteine hydrochloride and (5) the lysine is L-lysine hydrochloride.
Regarding claim 11, the teachings of Von Hagen anticipate claim 1 and 9. Moreover, Von Hagen teaches the composition that can comprise L-cysteine (CAS: 52-90-4 recited in Table 1, i.e. free L-cysteine) and the L-cysteine can be in anhydrate form (Table 1, para 0135), L-asparagine monohydrate (Table 1), L-cysteine hydrochloride monohydrate (Table 1), thus anticipating (la) the cysteine is free L-cysteine anhydrate or L-cysteine hydrochloride monohydrate and (3a) the asparagine is free L-asparagine monohydrate.
Regarding claim 13 and 14, the teachings of Von Hagen anticipate claim 1 and 9. Moreover, Von Hagen teaches the cell culture medium can comprise L-cysteine (CAS: 52-90-4 recited in Table 1, i.e. free L-cysteine) and the L-cysteine can be in anhydrate form (Table 1, para 0135), and can be L-Cysteine and Hydrochloride/Hydrate forms (para 0018), thus anticipating wherein the cysteine is free L- cysteine anhydrate (claim 13 and 14) or L-cysteine hydrochloride monohydrate (claim 13).
Regarding claim 15, the teachings of Von Hagen anticipate claim 1. Moreover, Von Hagen teaches that the carrier components (i.e. α-ketoglutaric acid) are present in the cell culture medium with a percentage more than 3% and preferably more than 10% (w/w) of the cell culture medium (para 0131). Von Hagen teaches that that the amount of carrier component in the cell culture medium can depend on the amount of poorly soluble component (i.e. amino acid cysteine as recited in para 0129) and preferably between 1 and 50% of the poorly soluble component are co-lyophilized with 99 to 50% of the carrier component (w/w), which makes a dry cell culture medium (para 0170 and 0138). As an example of the molar ratio of carrier components (i.e. α-ketoglutaric acid) to poorly soluble component (i.e. amino acid cysteine), see the calculation below:
Example calculating density of 3% cysteine:
3 g of cysteine and 97 ml of water for 3% cysteine:
3g/1.5 (g/mL; solid density of cysteine) = 2 mL
97 mL of water + 2 mL cysteine = 99 mL
100g (total mass)/99 mL = 1.01 g/mL
****************
10% α-ketoglutaric acid has a density =1.02 g/mL (
Molar mass α-ketoglutaric acid = 146.098 g/mol
Molarity = (%) x 1.02 x 10)/ 146.098 = 0.7 mol/L for 10% α-ketoglutaric acid ****************
3% cysteine has a density =1.01 g/mL
Molar mass cysteine = 121.15 g/mol
Molarity = (%) x 1.01 x 10)/ 121.15 = 0.25 mol/L for 3% cysteine
0.7/0.25 = 2.8 times more α-ketoglutaric acid than cysteine by molar ratio
Therefore, Von Hagen anticipates wherein amount of the a- ketoglutaric acid is 1 to 20 times more than the amount of the amino acid source in terms of molar ratio.
Conclusion
No claims are allowed.
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/JULIANA IRENE CANDELARIA/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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