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 .
Applicant’s amendment of claims 1 and 15, in the paper of 7/10/2026, is acknowledged. Applicants' arguments filed on 7/10/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1-18 are still at issue and are present for examination.
Potential Examiner Amendment
Applicants representatives were called on multiple dates (8/28/2026, 8/31/2026 and 9/1/2026) and multiple voice mails left for applicants to discuss amendments to put the claims in condition for allowance. Applicants representative did not return the examiners calls. Applicants are invited to contact the examiner to discuss amendments to the claims to put the claims in conditions for allowance.
Election/Restrictions
Applicant's election without traverse of the invention of Group II, claims 1-10, 12, 15-7, drawn to a CefD polynucleotide and mutant Acremonium chrysogenum microorganism comprising said polynucleotide, in the paper of 12/5/2025, is acknowledged.
Claims 11, 13 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Claim Objections
Claims 1-10, 12, 15, 16 are objected to because of the following informalities:
Claims 1 (claims 2-10, 12 dependent from) recite “gene encoding the polypeptide”. It is suggested this be changed to “gene encoding for the polypeptide”.
Claim 15 (claim 16 dependent from) and 17 recite “polynucleotide encoding a polynucleotide”. It is suggested this be changed to “A polynucleotide encoding for a polypeptide”.
Appropriate correction and/or comment is required.
Claim Rejections - 35 USC § 112
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.
Claim 5 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 5 recites the limitation "the gene coding for" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112
The rejection of claim 8 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 claim(s) contains 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. Is withdrawn based upon applicants statement in the paper ot 7/10/2026.
Closest Prior Art
WO 2004/113508 teach a genetically transformed P. chrysogenum comprising DNA encoding an isopenicillin N epimerase system comprising the cefD-, and cefD2 of A. chrysogenum and DNA encoding an enzyme having DAOC synthase activity, and optionally comprising DNA encoding an enzyme having DAC synthase activity, and further optionally comprising DNA encoding an enzyme having acetyl-CoA:DAC acetyltransferase activity.
WO 98/39459 teach the expression in P. chrysogenum or A. Chrysogenum of the heterologous gene under the control of the fungal promoter was performed by fusing said gene into the correct reading frame wherein said gene includes cefD (isopenicillin N isomerase), cefEF (deacetoxycephalosporin C synthase / hydroxylase), cefG (deacetylcephalosporin C acetyltransferase).
Remarks
No claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
9/10/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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