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 .
Claim Status
The amended claim set filed 9 Oct 2025 is acknowledged. Claims 1-19 are currently pending. Of those, claims 1 and 11-12 are currently amended, and no claims are new. Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 13 Mar 2024. Claims 1-12 will be examined on the merits herein.
Response to Amendment
The Applicants’ arguments filed 9 Oct 2025 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 11 Apr 2025 will be referred to as “NFOA.”
The drawings were received on 9 Oct 2025. These drawings are accepted.
Objection(s) and Rejection(s) Withdrawn
The objections to the specification related to the sequence disclosure and title is withdrawn in view of the amended specification.
The objection to the drawings is withdrawn in view of the replacement drawings.
The rejection of claim 12 under 35 U.S.C. 112(b) is withdrawn in view of the claim amendments.
The rejections of claims 11-12 under 35 U.S.C. 112(a) are withdrawn in view of the claim amendments and arguments.
The rejection of claims 1-2, 4, and 6-12 under 35 U.S.C. 102 as being anticipated by Julien et al. are withdrawn in view of the claims and arguments. Specifically, Julien teaches a codon optimized EIZS gene (SEQ ID NO:01), which has a GC content of 56%, which is lower than the claimed GC content of at least 70% (see instant specification [0100], native GC content is 56%). The rejections under 35 U.S.C. 103 that rely on Julien et al. as the primary reference also are withdrawn for the same reasons.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-12 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 1, the claim has been amended to require that “the nucleic acid encoding EIZS has an increase of GC-content of at least about 14%, and fewer, or no, ATA, CTA, TTA, AGA, and GTA codons, when compared to the codons encoding Streptomyces coelicolor epi-isozizaene synthase.” The Remarks (pg. 7) pointed to [0073] to support the limitation. However, the specification does not disclose the nucleic acid sequence of Streptomyces coelicolor epi-isozizaene synthase at [0073] or other locations, nor does it disclose the amounts of all the codons currently claimed. The only disclosure that can be found is “epi-isozizaene synthase from S. coelicolor A3(2) (native GC-content: 56%)” at [0110] and “In the native EIZS gene, TTA (13.5%) and GTA (31.8%) are present at a much higher frequency than that in R. toruloides (0.8% and 4.3%, respectively)” [0111]. Therefore, claim 1 is rejected because it requires a comparison but the application does not provide the standard for that comparison, and claims 2-12 are rejected because they depend from claim 1 and do not obviate this grounds of rejection.
The following amendment would overcome this rejection; however, applicant is free to amend or argue as they wish. This amendment applies the relative limitation of [0073] to the values disclosed in [0110-0111].
Claim 1 (Potential Amendment): A genetically modified Rhodosporidium host cell capable of producing epi-isozizaene comprising a nucleic acid encoding an epi-isozizaene synthase (EIZS), wherein the EIZS comprises an amino acid sequence having at least 70% identity with SEQ ID NO:2, and the nucleic acid encoding EIZS has a GC-content of at least 70%, fewer than 13.5% TTA codons, and fewer than 31.8% GTA codons.
Claim Rejections - 35 USC § 112(a)
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.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 12, the claim has been amended to recite specific components that make up CSM powder. Applicant argues (Remarks pg. 7) that “The specification teaches the CSM powder is "CSM powder 0.79 g/L (Sunrise Science Products, 1001-100, San Diego, CA)" (page 49, paragraph [0139]). CSM powder is a product number 1001-100 from Sunrise Science Products (San Diego, CA). The exact contents of this product is well known and publicly available, as shown in the attachment (submitted herein).” However, the website screenshot attached with this action was not part of the specification as originally filed, nor was it incorporated by reference into the specification as originally filed. Also, applicant has not argued or provided evidence that the website screenshot submitted shows the CSM powder formulation at the time of filing, rather than being evidence of the current CSM powder which may have been modified since the time of filing.
This rejection could be overcome by providing evidence, such as a website capture from before the effective filing date, a declaration, or some other form of evidence, showing that the CSM powder referenced in the specification consists of the same material as listed in the Sunrise Science Products website page supplied by applicants on 9 Oct 2025.
Conclusion
No claims are allowed.
A telephonic interview (see request at Remarks pg. 12) is not permitted because it appears applicant has legal representation but a valid power of attorney has not been filed in the present application. Providing representative information in an Application Data Sheet (ADS) does not constitute a power of attorney. See 37 CFR 1.76(b)(4) and MPEP § 408. For information on appointing a power of attorney, see MPEP § 402.02 et seq.
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 AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
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, Gary Nickol can be reached at (571)272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645