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
Claims 3-5, 7, 18, 19, 23, 24, and 29-31 have been cancelled.
Claims 1, 2, 6, 8-17, 20-22, and 25-28 are pending.
Election/Restrictions
Applicant’s election without traverse of claims 26-28 in the reply filed on 12/16/2025 is acknowledged.
Claims 1, 2, 6, 8-17, 20-22, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
Claims 26-28 are under examination.
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 27 and 28 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 27 recites that the one or more heterologous nucleic acids is positively regulated by the activity of a promoter responsive to the small molecule, wherein the concentration of the small molecule in the growth medium is sufficient to repress the promoter, and wherein the concentration of the small molecule in the culture medium during the culturing is sufficiently low that the promoter is activated. The claim language is confusing and it is unclear if “responsive to” means that the promoter activity is repressed, activated, or induced by the small molecule. It is unclear if a concentration sufficient to repress the promoter means that the concentration of the small molecule is low or high.
Claim 27 recites the limitation "the culture medium" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 is also rejected as it depends from claim 27.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Raetz et al., (WO 2021/022216 A1, effective filing date 08/01/2019) in view of Liang et al. (Newly identified genes contribute to vanillin tolerance in Saccharomyces cerevisiae. Microb Biotechnol. 2021 Mar;14(2):503-516; cited in the IDS filed 09/18/2023).
Under BRI, it is interpreted that a promoter that is repressed by a small molecule meets the limitations of claim 27.
Regarding claim 26, Raetz teaches genetically modified host cells and methods for improved production of vanillin and/or glucovanillin (Abstract). Raetz teaches that the host cell is genetically engineered to comprise one or more heterologous nucleic acids and/or biosynthetic pathway enzymes e.g., for a vanillin or glucovanillin compound (para. [00112]). Raetz teaches that the method for producing vanillin or glucovanillin involves culturing a population of host cells in a medium under conditions suitable for making vanillin or glucovanillin (para. [0009]).
Raetz does not teach that the host cell wherein native GCY1 (glycerol dehydrogenase) activity is modified.
Liang teaches a Saccharomyces cerevisiae strain in which the GCY1 gene was deleted (Table 1; p. 504, Results and Discussion, para. 1).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to engineer the vanillin-producing host cell of Raetz by deleting GCY1 gene, as taught by Liang. One of ordinary skill in the art would have been motivated to do so because Liang teaches that the GCY1 gene of S. cerevisiae encodes an enzyme, Gcy1p, with vanillin-reductase activity, i.e., Gcy1p catalyzes the conversion of vanillin to vanillyl alcohol (p. 505, col. 2, The NADPH-dependent vanillin reductase activity of Gcy1p contributes to vanillin tolerance in S. cerevisiae; Conclusion), while Raetz teaches that the host cell is S. cerevisiae (para. [0075]; para. [00131]). There would have been a reasonable expectation of success that deleting GCY1 in S. cerevisiae would result in an increase in vanillin accumulation, based on the teachings of Liang, as said deletion would decrease the conversion of vanillin to vanillyl alcohol. One of ordinary skill in the art would have had a reasonable expectation of success because Raetz and Liang are in the same field of endeavor of S. cerevisiae vanillin biosynthesis.
Regarding claims 27 and 28, Raetz teaches promoters that are repressed by maltose, i.e., a small molecule, (para. [0067]). Raetz teaches that, in certain embodiments, the vanillin-producing enzymes are repressed by maltose during a growth phase of the cells, and the vanillin-producing enzymes are expressed during an expression phase of the fermentation (para. [0085]). Therefore, it would be obvious to one of ordinary skill in the art to use a maltose-repressible promoter to control expression of the heterologous nucleic acids encoding the vanillin biosynthesis genes, to grow the host cells expressing said genes in maltose-containing growth medium, and to culture and/or ferment said cells in a maltose-free or low maltose-containing culture medium to allow for vanillin biosynthesis enzyme production, based on the teachings of Raetz.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657