DETAILED ACTION
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 paper filed 4 February 2026. Claim 14 has been amended. Claims 16 and 26 remain withdrawn. Claims 14, 15, 17, 19-23, and 25 are currently pending and under examination.
This application is a national stage application under 35 U.S.C. § 371 of PCT/EP2018/077878, filed October 12 2018, which claims benefit of European Application No. 17196153.5, filed October 12, 2017.
Withdrawal of Rejections:
The rejection of claims 14, 15, 17, and 19-23 under 35 U.S.C. 103 as being unpatentable over Inui et al., is withdrawn.
Maintained/New Rejections Necessitated by Amendment:
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 14, 15, 17, and 19-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically a genetically modified Corynebacterium glutamicum strain with the capabilities as claimed. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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 25 is rejected under 35 U.S.C. 103 as being unpatentable over Inui et al. (WO 2016/027870, published 25 February 2016 – US 2018/0044688, published 2018, is utilized as a translation and referred to hereafter – Previously presented).
With regard to claim 25, it is noted that the limitations that “an ammonia concentration not exceeding 200 mM” and “wherein the ammonia concentration is based on a sum amount of NH3 and NH4+,” are interpreted to include an ammonia concentration from 0 mM to 200 mM. Further, it is noted that the limitation that the culture medium has “a concentration of ortho-aminobenzoic acid (oAB) of 40 g/l to 80 g/l,” is interpreted to include oAB that is exogenously added, and/or is present as a result that naturally flows from performance of the method as claimed where this concentration of oAB is necessarily produced by Corynebacterium glutamicum in a medium having an ammonia concentration not exceeding 200 mM.
Inui et al. teach a method of cultivating cells of a coryneform bacterium, including Corynebacterium glutamicum, in a reaction medium to produce an organic compound, including anthranilic acid (ortho-aminobenzoic acid (oAB)) (Abs.; Para. 23, sections [15]-[19]; Para. 168-177). The reaction medium utilized for producing the organic compound, including oAB, includes a nitrogen source (Para. 168). The nitrogen source can include an ammonium compound, aqueous ammonia, urea, corn steep liquor, peptone, or amino acids, wherein the nitrogen source can be used singly, or in a mixture of two or more kinds (Para. 173). As Inui et al. expressly teach that the reaction medium contains a nitrogen source, including a single nitrogen source, it would have been obvious to one of ordinary skill in the art to utilize a single, expressly taught nitrogen source including urea, corn steep liquor, peptone, or amino acids, which are alternative nitrogen sources not containing ammonia or ammonium compounds. As such, the reaction medium does not comprise ammonia, and thus has an ammonia concentration of 0 mM, including based on a sum amount of NH3 and NH4+.
Corynebacterium glutamicum is the species indicated by Applicant for use in the method as claimed. As Corynebacterium glutamicum cannot be separated from its inherent capabilities, the Corynebacterium glutamicum utilized in the reaction medium for producing organic compounds including oAB by Inui et al., is necessarily a cell capable of converting a fermentable substrate into oAB in the presence of the fermentable substrate while maintaining its metabolic activity. Further, as the Corynebacterium glutamicum, and reaction medium containing a single nitrogen source including urea, corn steep liquor, peptone, or amino acids cannot be separated from their inherent properties, the Corynebacterium glutamicum in the reaction medium as taught by Inue et al. necessarily provides for the production of a concentration of oAB of 40 g/l to 80 g/l, which is present in the medium.
Response to Arguments
Applicant urges that the rejection of claim 25 is traversed for the same reasons set forth for claim 14. However, these arguments involve limitations newly added to claim 14 not present in claim 25 (e.g. the Corynebacterium glutamicum is genetically modified, and the culture medium has a concentration of oAB of at least 40 g/l). Therefore, Applicant’s arguments presented for claim 14 do not appear to be directly applicable to claim 25.
Conclusion
No claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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