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 09/11/2024
Claims 1-20 are pending in the application as set forth in the claim set filed 09/11/2024.
Therefore, claims 1-20 are examined on the merits.
Priority
The present application is a CON of International Application No. PCT/JP2023/012828 filed March 29, 2023.
Applicant’s claim for the benefit of a prior-filed Japanese Application JP2022-056162 filed March 30, 2022 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 Japanese 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 for the non-English application.
Thus, the earliest possible priority for the instant application is March 30, 2022.
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 1, 4, 6, 9, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freeland (WO2022/015518; filed 07-01-2021; IDS Reference filed 07/08/2025).
Regarding claim 1, Freeland teaches a method of manufacturing a dry cell culture media powder comprising a step of mixing the dry ingredients with an aqueous medium (i.e. solvent) and then drying the solution to form a powder (Claim 1). Freeland teaches the powdered media comprises amino acids such as tyrosine and histidine (para. 0052).
Regarding claim 4, Freeland teaches heating the aqueous mixture/paste and putting it in a vacuum while heating (para. 0012, 0053-0054, Claims 2-3).
Regarding claim 6, Freeland teaches the mixed power obtained by claim 1 (Claim 11).
Regarding claim 9, as the powder medium does not add additional limitations to claim 6, Freeland is also interpreted as reading on claim 9’s limitations. Freeland additionally teaches that the powder is a cell culture media powder which is formed into liquid cell culture media (Claim 11-12).
Regarding claim 10, Freeland teaches that the aqueous powder (i.e. dissolved in water) has a pH of 7.0 to about 7.4 (Claim 16).
Regarding claim 12, Freeland teaches that the mixed powder is combined with a buffer or solvent (para. 0013-0014). This is interpreted as adding the powder to a media.
Therefore, the invention is anticipated by Freeland.
Claims 1-3, 6, 9-10, 12, 13, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Von Hagan (US12359164; filed 03-19-2021).
Regarding claim 1, Von Hagan teaches a method of manufacturing a dry powder mixture and improving its solubility by making a mixture of one or more components such as a poorly soluble tyrosine with a carrier component such as histidine for a co-lyophilization process (Claim 1 and 5, Col 2, lines 20-32). The co-lyophilization process is a drying process which produces a mixed powder of the two components (Col 15, Variant 1 & 2).
Regarding claims 2, 3 and 13, Von Hagan teaches that poorly soluable components require heat to dissolve (Col 15, Variant 1 & 2).
Regarding claims 6 and 9, as seen above, Von Hagan teaches the method of claim 1 and the powder produced from it.
Regarding claim 10, Von Hagan teaches dissolving in water and pH components which can be at pH 1-14 (col. 1, lines 40-45; Col. 13, lines 35-38).
Regarding claim 12, Von Hagan teaches the lyophilized powder is mixed with cell culture media components (Col. 12, lines 4-13).
Regarding claim 16 and 20, as seen above, Von Hagan teaches the method of claims 1-3 and the mixed powder produced from it.
Therefore, the invention is anticipated by Von Hagan.
Claims 1, 4, 6, 9, 13-14, 16, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blouin (US4734401).
Regarding claim 1, Blouin teaches a method of manufacturing a dry powder mixture by making a mixture of one or more amino acid components such as tyrosine and histidine and dissolving the amino acids in water at room temperature (Col. 9-10, Claim 1). The mixture is then spray dried to form a powder (Example IV).
Regarding claims 2, 3 and 13, Blouin teaches the dissolution vessel can reach higher temperatures, therefore the solution is heated (Col 5, lines 13-20).
Regarding claims 4, 14 and 18, Blouin teaches spray drying in order to make powdered feed media (Example IV, Col 7, lines 26-46).
Regarding claims 6 and 9, as seen above, Blouin teaches the method of claim 1 and the powder produced from it.
Regarding claim 16 and 20, as seen above, Blouin teaches the method of claims 1-3 and the mixed powder produced from it.
Therefore, the invention is anticipated by Blouin.
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.
Claims 5, 7-8, 11, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Von Hagan (US12359164; filed 03-19-2021) in view of Freeland (WO2022/015518)
Regarding claim 7, 8, and 11, Von Hagan teaches a method of manufacturing a dry powder mixture and improving its solubility by making a mixture of one or more components such as a poorly soluble tyrosine with a carrier component such as histidine for a co-lyophilization process (Claim 1 and 5, Col 2, lines 20-32). The co-lyophilization process is a drying process which produces a mixed powder of the two components (Col 15, Variant 1 & 2). Therefore, a mixed powder of tyrosine and histidine is produced.
However, Von Hagan does not teach a specific pH or dissolution temperature/time in water for the composition.
Freeland teaches a method of manufacturing a dry cell culture media powder comprising a step of mixing the dry ingredients with an aqueous medium (i.e. solvent) and then drying the solution to form a powder (Claim 1). Freeland teaches the powdered media comprises amino acids such as tyrosine and histidine (para. 0052). Therefore, a mixed powder of tyrosine and histidine is produced. Freeland additionally obtains a solution by dissolving the powder in solvents such as water which has a pH which can be pre adjusted to the desired pH level (para. 0034). Additionally, Freeland discloses a powder cell culture media that dissolves rapidly in 2.5 minutes or less based on the concentration of components (para. 0022-0031, 0045). The cell culture media powder is considered “rapidly dissolving” because it can dissolve in a period of time that is significantly shorter than the period of time required for existing powder media products under specified conditions (e.g., the two are dissolved at the same concentrations when a specified amount of material of powder material is dissolved in water) (para. 0033). The pre-adjustment of pH saves time for the user and prevents batch contamination (para. 0033).
Freeland and Von Hagan do not teach the resulting tyrosine content of 0.3 g/L or more, however this would be a routinely optimized parameter which is derived from the mixed ratio of the histidine to the tyrosine is 0.5 to 10 as claimed in claims 5, 15 and 19 to obtain the desired dissolution time and parameters. These are result-effective variables. It would have been obvious to one of ordinary skill in the art that through obtaining a rapidly dissolving media and enhancing the solubility of tyrosine as taught by Freeland, an artisan would routinely optimize parameters to obtain a solution with the claimed parameters and tyrosine content of 0.3 g/L or more.
It is well settled that routine optimization is not patentable, even if it results in significant improvements over the prior art. In support of this position, attention is directed to the decision in In re Aller, Lacey, and Haft, 105 USPQ 233 (CCPA 1955): Normally, it is to be expected that a change in temperature, or in concentration, or in both, would be an unpatentable modification. Under some circumstances, however, changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art. In re Dreyfus, 22 C.C.P.A. (Patents) 830, 73 F.2d 931,24 USPQ 52; In re Waite et al., 35 C.C.P.A. (Patents) 1117, 168 F.2d 104, 77 USPQ 586. Such ranges are termed "critical" ranges, and the applicant has the burden of proving such criticality. In re Swenson et al., 30 C.C.P.A. (Patents) 809, 132 F.2d 1020, 56 USPQ 372; In re Scherl, 33 C.C.P.A. (Patents) 1193, 156 F.2d 72, 70 USPQ 204. However, even though applicant's modification results in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art. In re Sola, 22 C.C.P.A. (Patents) 1313, 77 F.2d 627, 25 USPQ 433; In re Normann et al., 32 C.C.P.A. (Patents) 1248, 150 F.2d 708, 66 USPQ 308; In re Irmscher, 32 C.C.P.A. (Patents) 1259, 150 F.2d 705, 66 USPQ 314. More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Swain et al., 33 C.C.P.A. (Patents) 1250, 156 F.2d 239, 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 69 App. D.C. 217, 99 F.2d 986, 38 USPQ 213; Allen et al. v. Coe, 77 App. D. C. 324, 135 F.2d 11,57 USPQ 136. (Emphasis added). With regards to determining experimental parameters, such as time in culture, the court has held that "[d]iscovery of optimum value of result effective variable in known process is ordinarily within skill of art (In re Boesch and Slaney, 205 USPQ 215 (CCPA 1980)).
The adjustment of particular conventional working conditions (e.g., pH, concentration, temperature) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan having the cited reference before him/her.
Conclusion
No claims are allowed.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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