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 .
DETAILED ACTION
Application status
Claims 1-8 are pending in this application.
Priority
It is acknowledged that the instant application is a CON of PCT/JP2023/015195 filed on 04/14/2023.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application JAPAN JP2022-067537 filed on 04/15/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/14/2024 and 05/28/2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink “http://” and/or other form of browser-executable code on paragraphs [0023] and [0146]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Nagase et al. (WO2019/203368 A1) in view of Fiddes et al. (US Patent No. 5604293) and Stout et al. (“Simple and effective serum-free medium for sustained expansion of bovine satellite cells for cell cultured meat”, bioRxiv, publicly available since 05/29/2021, obtained from the Internet: <<https://www.biorxiv.org/content/10.1101/2021.05.28.446057v1>>), obtained on 09/14/2026).
The instant claims are drawn to a method of producing bovine basic fibroblast growth factor (bbFGF) for production of cultured meat, the method comprising: a step of culturing a coryneform bacterium having a gene construct for secretory expression of bbFGF to obtain a culture product containing bbFGF.
Nagase et al. teach a method of producing human bFGF (hbFGF) comprising culturing Corynebacterium glutamicum having a gene construct, i.e., plasmid pPK6_T_bFGF comprising host-functional promoter + TorA signal peptide + hbFGF coding sequence, for secretory expression of hbFGF (as a fusion protein) to obtain a culture product containing hbFGF, and recovering the secreted hbFGF, without a step of purifying hbFGF, i.e., the secreted hbFGF appears in a clean supernatant thereby omitting a purification step optionally via chromatography (see para [0241]-[0250]).
Nagase et al. do not teach bovine bFGF (bbFGF).
Fiddes et al. teach a method of expressing bbFGF in CHO cells or in E. coli as a fusion with a signal sequence for secretory expression of bbFGF (see Examples 7-10). Fiddes et al. further teach complete DNA sequences encoding both bovine and human bFGFs with complete amino acid sequences (see Fig. 3-4, respectively), and expression vector, i.e., pkT52 vector comprising trc promoter for expression in E.coli.
Stout et al. teach a method of culturing bovine satellite cells (animal cells) in medium containing FGF-2 to expand cells for cultured meat.
It would have been obvious to a person of ordinary skill in the art (POSITA) prior to the effective filing date of the instant application to practice the method taught by Nagase et al. and Stout et al. while swapping the hbFGF with the bbFGF taught by Fiddes et al. A POSITA would have been motivated to practice such method because [1] putting bovine gene into the TorA expression construct taught by Nagase et al. is the obvious species-matched substitution so that secreted bbFGF can be used for culturing bovine satellite cells/myoblasts, which were standard methods for producing cultured meat as taught by Stout et al.; and [2] human and bovine bFGF are highly homologous and functionally interchangeable as mitogens.
A POSITA would have had a reasonable expectation of success to practice such method all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Nagase et al. Fiddes et al. and Stout et al. prior to the filing of the instant application.
For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
Conclusion
Claims 1-8 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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