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
Applicants’ election without traverse of Group II, claims 17-22, 24-27, 48 in the reply filed on 6/2/2026 is acknowledged.
Claims 1-5, 7, 10, 15, 17-22, 24-27, 48 are pending.
Claims 1-5, 7, 10, 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/2/2026.
Claims 17-22, 24-27, 48 have been considered on the merits herein.
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 17-22, 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a genetically altered yeast having a mutation in the MDS3 gene, does not reasonably provide enablement for a genetically altered yeast having any mutation in the MDS3 gene, and specifically one which prevents or reduces the inhibition of flavor production by high carbon dioxide pressure, and which increase the ration of isoamyl acetate (IAAc) to isoamyl alcohol (Alc). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Applicants’ specification teaches that they pinpointed a single SNP variant, T2171C, as being the sole SNP in MDS3 responsible for the increase in the isoamyl acetate (IAAc) to isoamyl alcohol (Alc) ratio by the MDS3Seg.63 allele, and thus the MDS3T2171C (Mds3F724S) super variant of MDS3, specifically increases acetate levels (p. 8, lines 1-13, Ex. 6-9). At ex. 9, applicants state that “We compared the ten MDS3 SNPs between Seg.63 and ER7A in the open reading frame with the sequence of the allele present in the lager yeast JT28325. This revealed three unique missense mutations, C305T (T102M), T2171C (F724S), and A3229G (I1077V) in the superior MDS3Seg63 allele compared to the MDS3 alleles in the JT28325 strain. To identify which (combination) of the SNPs were causative, we performed genome editing of the MDS3 loci in the inferior ER7A strain using CRISPR/Cas9 and linear donor DNA constructs, containing all possible SNP combinations. Strikingly, the only causative SNP variant was T2171C, causing an amino acid change of phenylalanine to serine at position 724 in the Mds3 gene product. Any combination that included the T2171C variant yielded an IAAc/Alc ratio indistinguishable from that obtained after exchange of the entire MDS3 allele from Seg.63 (Fig. 6). Except for a slight increase in the ethyl octanoate level ("apple" descriptor), introduction of the T2171C variant did not affect the production of any other flavor compounds. Hence, we have identified a single SNP, T2171C, in the MDS3 gene, which can generate by itself a highly significant and specific enhancement of the IAAc/Alc ratio in fermentations under high CO₂ pressure”. In a preferred embodiment, the mutation is at least a single substitution of F to S at position 724 of SEQ ID NO: 1…This correlates to a T to C mutation at position 2171 of SEQ ID NO: 2. In an alternative embodiment, the mutation is the introduction of one or more MDS3Seg63 alleles, wherein preferably the MDS3 Seg63allele encodes a MDS3 polypeptide as defined in SEQ ID NO: 3 or a functional variant or homologue thereof. More preferably, the MDS3 Seg63 allele comprises or consists of a nucleic acid sequence as defined in SEQ ID NO: 4 or a functional variant or homologue thereof. The MDS3Seg⁶³ allele may be introduced such that it is operably linked to a suitable regulatory sequence, such as the endogenous MDS3 promoter.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. Regarding undue experimentation, In re Wands, 8 USPQ2d 1400, at 1404 (Fed. Cir. 1988) states:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims (Citations omitted). Regarding the breadth of the claims, the claims include a genetically altered yeast having any mutation in the MDS3 gene; however, the specification teaches that it is only one single mutation point which allows applicant to achieve the claimed invention, and one would have to undergo undue experimentation to determine which mutation would lead to the increase in the isoamyl acetate (IAAc) to isoamyl alcohol (Alc) and prevent or reduce inhibition of flavor production by high carbon dioxide pressure. It is clear that undue experimentation would be required to perform the full scope of the claimed invention.
Thus, applicants’ have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims, broadly including any mutation in the MDS3 gene. The scope of the claim must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1975)). Without sufficient guidance, determination of the mutations encompassed is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Claims 17-22, 24-27, 48 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 119, F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997).
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP 2163.
Furthermore, a “‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Claims 17-22 encompass any mutation within the MDS3 gene; however, the specification does not contain adequate description for the entire scope of mutations encompassed by the claims. Further, as seen above the specification only describes a single point mutation which has the function of claims 18-20.
Claims 21, 22, 24, 25 encompass homologues or functional variants thereof, or a fragment or variant thereof, for which written description has not been provided. The specification does not contain an adequate description for the entire scope of homologues, functional variants thereof, or a fragment or variant thereof, and thus the claims. Applicants exemplify only one single mutation in SEQ ID NO:1, which is seen in SEQ ID NO:3 or 4; however no fragments, variants thereof, homologues or functional derivatives of SEQ ID NO:1, 3 or 4 are provided, and which would retain the claimed function. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 17, 27 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by EP3626838 A1 (IDS).
EP383 teaches genetically altered yeast having a mutation in the MDS3 gene, specifically a P727H alteration in the MDS3 gene (0075).
Regarding claim 27, the yeast may of the Saccharomyces sensu stricto complex. A more preferred yeast is a Saccharomyces cerevisiae yeast, a S. carlsbergensis yeast, a S. pastorianus yeast, a S. eubayanus yeast, and/or a hybrid thereof, preferably a S. cerevisiae yeast (0079).
Thus, the reference anticipates the claimed subject matter.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zacchi et al. (Mol. Cell. Bio, 2010, p. 3695-3720, IDS).
Zacchi teaches genetically altered yeast having a mutation in the MDS3 gene, specifically mutants having a deletion of one copy of the MDS3 gene, for example strain DAY938 (p. 3696, Mat. And Methods section, strains and plasmids, whole page, Table 1).
Thus, the reference anticipates the claimed subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
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