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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-9, 22 and 23 in the reply filed o 1/12/26 is acknowledged. The traversal is on the ground(s) that there is a special technical feature between the groups when considered in light of the specification. This is not found persuasive because see the restriction requirement mailed on 11/13/25 p4.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-21 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/12/26.
Applicant's election with traverse of the species of a deletion of a region corresponding to amino acids at positions 1-160 of SEQ ID NO 1 and SEQ ID NO 1 in the reply filed on 1/12/26 is acknowledged. The traversal is on the ground(s) that there was no reasons or examples as to patentable distinctness of the species. This is not found persuasive because of the reasons set forth in the restriction mailed on 11/13/25, p5.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3, 5, 6 and 22, are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/12/26.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 10/9/23 has been fully considered except where references have been lined through.
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 4 and 23 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.
Regarding claim 4, the claim requires a deletion of a region corresponding to amino acids at positions 1 to 160 in SEQ ID NO 1. It is unclear if this deletion is supposed to be the entire range of 1-160 or if any single deletion of an amino acid that occurs from position 1-160 would be claimed. Therefore, one of ordinary skill in the arts is unable to determine the metes and bounds of the claim. For examination purposes, any deletion found in positions 1-160 of claimed SEQ ID NO 1 will be considered to meet the claim limitation.
Further regarding claim 4, the claim could be interpreted to have a deletion of the entire 160 amino acids. This would result in a ~79% identity to SEQ ID NO 1. Claim 4 depends on claim 2 which requires a 90% identity to claim 1. It is unclear how both conditions can be satisfied.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 7-9 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ward (WO2018067599A1, of record) and Zhang (The transcription factor ACE3 controls cellulase activities and lactose metabolism via two additional regulators in the fungus Trichoderma reesei." Journal of Biological Chemistry 294.48 (2019): 18435-18450, of record).
Regarding claims 1 and 9, Ward teaches protein production in filamentous fungus (title). Ward teaches the fungus comprise a genetic variant of ACE3 (abstract). Ward teaches that the DNA binding domain of ACE3 may be missing (substantially deleted) (fig1b and [0295]). Ward teaches that the variant polypeptide can comprise more than 50 amino acid deletions (substantially deleted) ([0174]). Therefore, one of ordinary skill in the arts could ensure that the entire DNA binding domain of ACE3 is deleted by experimenting within the inventive confine of Ward. All of the claimed components were known in the arts at the time of filing of instant invention and would be yield nothing more than predictable results with a reasonable expectation of success to one of ordinary skill in the arts. Ward teaches the ACE3 protein can be from Trichoderma reesei (claim 54).
Ward does not explicitly teach that the DNA binding domain is a Zn(II)2Cys6 type.
Zhang teaches ACE3 protein in Trichoderma reesei (title). Zhang teaches that the DNA binding domain is a Zn(II)2Cys6 type (fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the substantially deleted DNA binding domain of Ward is the a Zn(II)2Cys6 type as taught by Zhang. One of ordinary skill in the art would be motivated to do so because Zhang only teaches one DNA binding site in ACE3 and Ward teaches that the DNA binding site of ACE3 is deleted. There would be a reasonable expectation of success as both Zhang and Ward are in the same field of endeavor of DNA binding site in ACE3.
Regarding claim 2, Ward teaches a 100% match to claimed SEQ ID NO 1 (appendix).
Regarding claim 4, Ward teaches a deletion through amino acid 129 (appendix). This overlaps the claimed range and therefore the claimed range is prima facia obvious. Moreover, it would have been obvious in view of Ward for one of ordinary skill in the art to use routine experimentation/optimization to discover the optimum and/or workable ranges of deletion for the DNA binding domain (see MPEP 2144.05, II.)
Regarding claim 7, Ward teaches a variant fungal cell encoding the variant polynucleotide (gene) of the ACE3 protein (claim 1)
Regarding claim 8, Ward teaches the ACE3 gene is under the control of a promoter ([0015]).
Regarding claim 23, Ward teaches the modified fungi is cultured ([0003] and fig 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657