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 without traverse of Group 1 (claims 17-34), Species 1: TEFI, Species 2: Saccharomyces, and Species 3: Yarrowia lipolytica is acknowledged.
Claims 35 and 36 are withdrawn from further consideration pursuant to CFR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 April 22, 2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17-23 and 25-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lo, Y.C. et al., (US20210095326A1; published 2021-04-01) as evidenced by Curtin, C.D. De-Novo Assembly and Analysis of the Heterozygous Triploid Genome of the Wine Spoilage Yeast Dekkera bruxellensis AWRI1499.PLoS ONE. 7(3); 2012. pp 1-10 and Roach, M.J. et al., New genome assemblies reveal patterns of domestication and adaptation across Brettanomyces (Dekkera) species. BMC Genomics. 21:194; 2020; pp 1-14.
Regarding claims 17, 18, 19, 20, 21,22,23,25, 26, 27, and 28 Lo, et al., discloses a method of producing siamenoside I (formula I) (page 4, paragraph 0045) and contact with mogroside V (formula (VI) (page 2-3, paragraph 0035) with a recombinant host cell, that is Saccharomyces or Yarrowia lipolytica (claims 25,26, 27,28, and 36), cultured in a medium to promote mogroside conversion (page 2, paragraph 0035) (claim 22) containing a beta-glucosidase (Exg1) nucleotide sequence harvested from Dekkera bruxellensis (also known as Brettanomyces bruxellensis, nomenclature differences are relative to asexual or sexual growth) (page 3-4, paragraph 0039). The genomic sequence for exg1 from a Dekkera bruxellensis strain, under promoter sequence GPD (page 4, paragraph 0039-cont.) (claim 23), transcribes a naturally occurring glucosidase sequence (Uniprot Sequence: tr|A0A871RAA5|A0A871RAA5_DEKBR, as evidenced by Curtin, et al.) with 99.29% sequence identity to SEQ ID NO: 25 and SEQ ID NO: 25 has 100% identity to a naturally occurring glucosidase produced by Brettanomyces bruxellensis, Uniprot Sequence UPI00025C3FF5 as evidenced by Roach et al (claims 18-21). Accordingly, UPI00025C3FF5 and tr|A0A871RAA5|A0A871RAA5_DEKBR share 99.29% sequence identity.
Regarding claim 29, 30, and 31, Lo et al., discloses treating cells with pure methanol, which results in cell stress, pore formation and membrane permeability, cell dehydration and leakage, following by collecting siamenoside I from growth media (page 2, paragraph 0022) for HPLC analysis to quantitate purified siamenoside I, relative to other bioconversion compounds, for chromatographic analysis (page 2, paragraph 0024).
Regarding claim 32, Lo et al., discloses a recombinant host cell fed mogrol precursor and further bioconversion by different yeast cells in Figure 1 (page 1, paragraph 0021 and Sheet 3/Fig.1).
Regarding claim 33, Lo et al., discloses a method for converting monk fruit extract (referred to as LHK in the prior art) using recombinant host cells (page 1, paragraphs 006-007).
Regarding claim 34, Lo et al., discloses recombinant cell growth over time, with LHK and, with or without dextrose, in a growth media, in Figure 2 (Sheet 4).
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.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Lo, Y.C. et al., (US20210095326A1; published 2021-04-01) as evidenced by Curtin, C.D. De-Novo Assembly and Analysis of the Heterozygous Triploid Genome of the Wine Spoilage Yeast Dekkera bruxellensis AWRI1499.PLoS ONE. 7(3); 2012. pp 1-10 and Roach, M.J. et al., New genome assemblies reveal patterns of domestication and adaptation across Brettanomyces (Dekkera) species. BMC Genomics. 21:194; 2020; pp 1-14, and further in view of Nevoigt, E. et al., Engineering of Promoter Replacement Cassettes for Fine-Tuning of Gene Expression in Saccharomyces cerevisiae. Applied and Environmental Microbiology. 2006, pp.5266–5273.
The teachings of Lo et al., are discussed previously.
Lo et al., does teach the promoter GPD.
Lo et al., does not teach the heterologous promoter TEF1.
However, Nevoight et al., teaches the promoter TEF1 upstream of the promoter GPD1 in Saccharomyces cerevisiae.
Therefore, it would have been obvious to one of ordinary skill in the art at the effective date of filing, to have added and/or substituted TEF1 with regards to promoter GPD, if TEF1 improved RNA polymerase binding for transcription efficiency, relative to a gene sequence.
The motivation to use TEF1 in addition to and/or in place of GPD is a result effective modification to improve polymerase efficiency for gene expression and resulting protein production of glucosidase. Therefore, the outcome of a substitution and/or addition of the promoter TEFT1 would be prima facie obvious, and one would expect success since the combined prior art teaches the same host cell(s), gene of interest for glucosidase transcription and expression, under the same promoter(s).
Conclusion
No claims are deemed allowable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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