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 70-84 and 88 are pending. Claims 70-77 and 84 are withdrawn. Claims 78-84 are under examination on their merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive.
Applicant argues against the written description rejection of claims under 35 U.S.C. 112(a) on the grounds that the application as filed provides support for a genus of PatB enzymes that are active on both 3SH and 4MSP substrates and cites Table 2 of Example 4 as evidence (Arguments, paragraphs 2-3 on page 7).
In response, this argument is not persuasive because Table 2 only serves as evidenced that the S. hominis PatB cysteine-thiol lyase catalyzes the production of 3SH and 4MSP during fermentation ([0089] and [0090]). The specification does not disclose any variants at least 80% identical to the S. hominis PatB (SEQ ID NO: 8) or any variants at least 80% identical to SEQ ID NO: 9-14 that are capable of converting non-volatile forms of 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP) to free 3SH and free 4MSP, respectively.
Declaration
The declaration under 37 CFR 1.132 filed 4/13/2026 is sufficient to overcome the rejection of claim 78-84 based upon obviousness. Applicant demonstrates unexpected results: see the Fig. 1 of the declaration and compare to Fig. 3 of Rudden. The person of ordinary skill in the art would not have predicted the PatB enzymes to be capable of converting non-volatile forms of both 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP) to free 3SH and free 4MSP based on the teachings of Rudden.
Claim Rejections - 35 USC § 112
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.
Claims 78-84 are 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 claims 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 78 is drawn to a recombinant yeast comprising a polynucleotide encoding a PatB operably linked to a heterologous promoter, wherein the PatB comprises an amino acid sequence that is at least 80% identical to the amino acid sequence set forth in any one of SEQ ID NOs: 8-14, wherein the PatB is capable of converting non-volatile forms of 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP) to free 3SH and free 4MSP, respectively, in the yeast.
Claim 1 recites a genus of PatB variants 80% identical to the amino acid sequence set forth in any one of SEQ ID NOs: 8-14 that are capable of converting non-volatile forms of 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP) to free 3SH and free 4MSP.
The specification discloses that recombinant yeast expressing S. hominis PatB (SEQ ID NO: 8) are capable of catalyzing the production of free 3SH and 4MSP during fermentation ([0089] and [0090]). No data is presented for recombinant yeast expressing SEQ ID NO: 9-14. The specification does not disclose any variants of SEQ ID NOs: 8-14. These sequences correspond to PatB from S. hominis, S. lugdunensis, S. devriesei, S. petrasii, S. haemolyticus, and B. subtilis, respectively. These sequences range in length from 355 amino acids to 398 amino acids. Thus, variants with at least 80% identity may have up to 80 amino acid substitutions.
Rudden et al. (Sci Rep. 2020 Jul 27;10(1):1250; cited in the Non-Final Action mailed on 8/27/2025) teaches a family of enzymes called cysteine-thiol lyases selective for branched aliphatic thiolalcohol ligands such as the substrate Cys-3M3SH, which is the precursor for the volatile 3M3SH (page 3, “ShPatB is selective for branched aliphatic
thioalcohol ligands” and Figure 1 panel B and caption). 3M3SH stands for 3-methyl-3-
sulfanylhexan-1-ol, which is a synonym for 3-mercapto-3-methyl-1-hexanol or 3-
sulfanyl-1-hexanol. Rudden teaches PatB enzymes from S. hominis, Bacillus subtilis, S. lugdunensis, S. devriesei, S. haemolyticus, and B. subtilis (Figure 3). Rudden teaches S. devriesei PatB has a high catalytic efficiency for 3M3SH (Figure 3). Rudden performs functional analysis of ShPatB active site variants and identifies ligand interacting residues in S. hominis PatB (Figure 5). However, this analysis is performed with respect to Cys-3M3SH rather than the presently claimed substrates 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP). Rudden does not teach the activity of these PatB enzymes for the conversion of the non-volatile forms of 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP) to free 3SH and free 4MSP or any variants of these PatB enzymes with the presently claimed enzymatic functions.
Given the analysis above, the person of ordinary skill in the art would not have recognized that the inventors had possession, as of the effective filing date of the claimed invention, of the claimed genus of PatB variants capable of converting non-volatile forms of both 3-sulfanyl-1-hexanol (3SH) and 4-methyl-4-sulfanylpenten-2-one (4MSP) to free 3SH and free 4MSP, respectively, in the yeast.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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