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 1-20 are pending and under examination herein.
The rejection of claims 1-19 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent No. 12,203,111 is withdrawn in light of the terminal disclaimer filed on June 12, 2026.
Priority
This application, filed on 12/5/2024, is a CON of 17/261,454 filed on 1/19/2021, issued as patent 12,203,111; which is a 371 of PCT/US2019/042605 filed on 7/19/2019, which claims benefit of 62/700,679 filed on 7/19/2018.
The effective filing date of the current application is July 19, 2018.
Claim Objections
Claims 1 and 17 are objected to because of the following informalities:
Claim 1 is missing multiple
It is suggested that a conjunction of “and” or “or” is inserted as shown below:
“A recombinant yeast strain of S. cerevisiae comprising:
an exogenous MAL1 gene cluster; and
an exogenous MAL2-8c gene cluster,
wherein the exogenous MAL1 gene cluster comprises a MAL11 gene;
wherein the exogenous MAL1 gene cluster comprises a MAL12 gene and/or a MAL 13 gene;
wherein the exogenous MAL1 gene cluster comprises a sequence having at least 80 percent identity to SEQ ID NO:2; and
wherein the exogenous MAL2-8c gene cluster comprises a sequence having at least 80% identity to SEQ ID NO:3.
Claim 17 is missing multiple conjunctions at the end of lines 2 and 5.
It is suggested that a conjunction of “and” or “or” is inserted as shown below:
“A recombinant yeast strain of S. cerevisiae comprising:
an exogenous MAL1 gene cluster; and
an exogenous MAL2-8c gene,
wherein the exogenous MAL1 gene cluster comprises a sequence having at least 95 percent identity to SEQ ID NO:2; and
wherein the exogenous MAL2-8c gene comprises a sequence having at least 95 percent identity to SEQ ID NO:3.
Appropriate correction is required.
Duplicate Claim
Applicant is advised that should claim 3 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 4 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 5 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites: “A recombinant yeast strain of S. cerevisiae comprising:
an exogenous MAL1 gene cluster;
an exogenous MAL2-8c gene cluster;
wherein the exogenous MAL1 gene cluster comprises a MAL11 gene;
wherein the exogenous MAL1 gene cluster comprises a MAL12 gene and/or a MAL13 gene;
wherein the exogenous MAL1 gene cluster comprises a sequence having at least 80 percent identity to SEQ ID NO:2,
wherein the exogenous MAL2-8c gene cluster comprises a sequence having at least 80 percent identity to SEQ ID NO:3.”
It is unclear whether the S. cerevisiae yeast strain is required to comprise an exogenous MAL1 gene cluster; an exogenous MAL2-8c gene cluster, or both. It is further unclear if the MAL1 gene cluster can comprise alternatives of 1) a MAL11 gene, or 2) a MAL12 gene and/or a MAL 13 gene, or if the MAL1 gene cluster can comprise any combination of a MAL11 gene, MAL12 gene, and a MAL13 gene, making it unclear how many genes comprise the MAL1 gene cluster. It is further unclear which MAL1 gene cluster alternative is required to have at least 80% sequence identity to SEQ ID NO:2: the MAL1 gene cluster comprising a MAL11 gene, or the MAL1 gene cluster comprising a MAL12 gene and/or MAL13 gene.
Claims 2-16 are rejected for depending from rejected claim 1, but failing to remedy the indefiniteness therein.
Claim 17 recites: “A recombinant yeast strain of S. cerevisiae comprising:
an exogenous MAL1 gene cluster;
an exogenous MAL2-8c gene;
wherein the exogenous MAL1 gene cluster comprises a sequence having at least 95 percent identity to SEQID NO:2;
wherein the exogenous MAL2-8c gene comprises a sequence having at least 95 percent identity to SEQ ID NO:3.”
It is unclear whether the S. cerevisiae yeast strain is required to comprise an exogenous MAL1 gene cluster; an exogenous MAL2-8c gene, or both.
Claims 18-20 are rejected for depending from rejected claim 17, but failing to remedy the indefiniteness therein.
Response to Arguments
Applicant argues that independent claim 1 and 17 are amended to recite “a strain of S. cerevisiae” in the preamble and removed the term “and” and uses the term “and/or” with clarity (See Remarks dated 7/27/2026, p.17).
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive. As discussed above, claims 1 and 17 remain unclear as to the required structure of the strain.
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.
Claims 6-12 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
In the amendment filed July 27, 2026, applicant added a new limitation to claims 6-12, which recite new matter that is not supported by the application as filed.
Claims 6-9 are directed to “the strain of claim 1, configured for fermentation of sugars comprising glucose and maltose from a medium containing corn mash with 31.3 percent weight to weight solids treated with a 1 percent weight to weight solution of maltogenic alpha amylase, wherein maltose comprises a weight of no more than 4.64 or 2.86 or 1.88 or 1.05 percent of the total volume after 24 or 36 or 48 or 72 hours of fermentation when present in a medium containing corn mash with 31.3 percent weight to weight solids treated with a 1 percent weight to weight solution of maltogenic alpha amylase”.
Claim 10 is directed to “the strain of claim 1, configured for fermentation to produce ethanol from a medium containing corn mash with 31.3 percent weight to weight solids treated with a 1 percent weight to weight solution of maltogenic alpha amylase; wherein ethanol comprises a weight of at least 8.733 percent of the total volume after no more than 24 hours when present in a fermentation of corn mash with 31.3 percent weight to weight solids treated with a 1 percent weight to weight solution of maltogenic alpha amylase”.
Claims 11-12 are directed to “the strain of claim 1, configured for fermentation to produce ethanol from a medium containing corn mash with 31.3 percent weight to weight solids treated with a 0.07 percent weight to weight solution of glucoamylase; wherein ethanol comprises a weight of at least 4.16 or 10.35 percent of the total volume after no more than 15 or 26 hours when present in fermentation of corn mash with 32.6 percent weight to weight solids treated with 0.07 percent weight to weight glucoamylase”.
Although Applicant points to the original Specification [0090] and FIGURE 5A-5E as support for the new limitation in claims 6-10, and Specification [0092] and FIGURE 7A-7E as support for the new limitation in claims 11-12, the specification does not support the requirements of the new limitation. The specification [0090] supports corn mash containing 31.3 percent solids treated with 1 percent solution of maltogenic alpha amylase SEBStar MA, and finishing fermentation with 1.05 percent (w/v) maltose remaining or 2.45 percent (w/v) maltose at the end of fermentation up until 24 hours when fermentation reached steady state. The specification [0092] supports treating corn mash with 32.6 percent solids treated with 0.07 percent w/w glucoamylase. That does not provide support for the full scope of the limitation “configured for fermentation of sugars comprising glucose and maltose from a medium containing corn mash with 31.3 percent weight to weight solids treated with a 1 percent weight to weight solution of maltogenic alpha amylase” or “configured for fermentation to produce ethanol from a medium containing corn mash with 31.3 percent weight to weight solids treated with a 0.07 percent weight to weight solution of glucoamylase”, which is claiming the strain as “configured for” a function. However, the specification does not provide any structure that identifies what is required for the strain to be “configured for fermentation of sugars comprising glucose and maltose” or “configured for fermentation to produce ethanol”, which encompasses any gene modifications and fermentation conditions in any context. Thus, claims 6-12 contain new matter, and the original specification as filed does not support the amendment filed 7/27/2026 adding the new limitations discussed above, which is not sufficient for showing that applicant was in possession of the subject matter regarded as the invention. For this reason, instant claims 6-12 fail to comply with the written description requirement.
Claims 6-12 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Applicant is referred to MPEP 2163(II)(A)(3)(a)(i and ii), which states that 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. 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 genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
Claim 1 is drawn to a recombinant S. cerevisiae yeast strain comprising an exogenous MAL1 gene cluster comprising a MAL11 gene, a MAL12 gene, and/or a MAL13 gene (and) an exogenous MAL2-8c gene cluster; wherein the exogenous MAL1 gene cluster comprises a sequence having at least 80% homology to SEQ ID NO:2; and the exogenous MAL2-8c gene cluster comprises a sequence having at least 80% homology to SEQ ID NO:3.
Claims 6-9 are drawn to the strain of claim 1, wherein maltose comprises a weight of no more than 1.05%, 1.88%, 2.86% or 4.64% of the total volume after fermentation times of 24 hours, 36 hours, 48 hours or 72 hours when present in a medium containing corn mash with 31.3% weight to weight solids treated with a 1% weight to weight solution of maltogenic alpha amylase.
Claim 10 is drawn to the strain of claim 1, wherein ethanol comprises a weight of at least 8.733% of the total volume after no more than 24 hours when present in fermentation of corn mash with 31.3% weight to weight solids treated with 1% weight to weight solution of maltogenic alpha amylase.
Claims 11-12 are drawn to the strain of claim 1, wherein ethanol comprises a weight of at least 4.16% or 10.35% of the total volume after no more than 15 or 26 hours when present in fermentation of corn mash with 32.6% weight to weight solids treated with 0.07% weight to weight glucoamylase.
The current specification identifies a fermentation using specific yeast strain ER-19-11-4, corn mash containing 31.3% solids treated with 1% solution of maltogenic alpha amylase SEBStar MA, identifying that fermentation finished with 1.05% (w/v) maltose remaining (specification [0090]; FIG. 5C). The current specification describes a third test using corn mash with 32.6% solids treated with 0.07% w/w of Spirizyme Achieve Glucoamylase, which resulted in maltophilic yeast ER-19-11-4 consuming maltose slightly faster and producing more ethanol than an isogenic wild type strain (specification [0092]; FIG. 7E).
The specification does not provide any information relating the starting amount of maltose in the medium relative to the final weight to volume amount of maltose remaining in the medium following fermentation. The specification does not provide any guidance on the rate of maltose conversion of the specific strain of yeast tested, nor provide any guidance on whether the maltose conversion of the recombinant yeast strains is the same across the genus of recombinant S. cerevisiae yeast strains comprising an exogenous MAL1 gene cluster and/or an exogenous MAL2-8c gene cluster. The specification does not provide any guidance on the rate of ethanol production of the specific strain of yeast tested, nor provide any guidance on the variability of ethanol production rates of recombinant yeast strains across the genus of recombinant S. cerevisiae yeast strains comprising an exogenous MAL1 gene cluster comprising at least 80% sequence identity to SEQ ID NO:2 and/or an exogenous MAL2-8c gene cluster comprising at least 80% sequence identity to SEQ ID NO:3.
SEQ ID NO:2 and SEQ ID NO:3 are artificial DNA sequences. The insertion of complement LoxP, TEF promoter, Hygromycin B Resistance, TEF terminator, and complement LoxP sequence distinguishes SEQ ID NO:2 from the naturally occurring MAL1 gene cluster. The insertion of upstream_NLS2, upstream Mal6 ER, and downstream_NLS2 sequences distinguishes SEQ ID NO:3 from the naturally occurring MAL2-8c gene cluster. No prior art sequence having at least 80% sequence identity to SEQ ID NO:2 or SEQ ID NO:3 was identified.
The disclosure of examples containing a single recombinant yeast strain incubated for a single fermentation experiment to produce a single data point of maltose or ethanol is not considered to constitute a representative number of species of the genus of recombinant yeast strains comprising an exogenous MAL1 gene cluster comprising a MAL11 gene, a MAL12 gene, and/or a MAL13 gene and/or an exogenous MAL2-8c gene cluster, wherein the exogenous MAL1 gene cluster comprises a sequence having at least 80% identity to SEQ ID NO:2 and wherein the exogenous MAL2-8c gene cluster comprises a sequence having at least 80% identity to SEQ ID NO:3.
Thus, one of ordinary skill in the art could not conclude that Applicant was in possession of any species of the claimed genus of recombinant yeast strains comprising an exogenous MAL1 gene cluster comprising a MAL11 gene, a MAL12 gene, and/or a MAL13 gene and/or an exogenous MAL2-8c gene cluster, wherein the exogenous MAL1 gene cluster comprises a sequence having at least 80% identity to SEQ ID NO:2 and wherein the exogenous MAL2-8c gene cluster comprises a sequence having at least 80% identity to SEQ ID NO:3. This disclosure does not constitute a representative number of species of the genus in view of the potential breadth and variability of the genus, and so there is a failure to satisfy the written description requirement for the genus.
Response to Arguments
Applicant reproduces the original rejection, and argues that independent claims 1 and 17 have been amended to recite “a strain of S. cerevisiae”, to indicate that the recombinant yeast strain is limited to a single species (See Remarks dated 7/27/2026, p.20 last 2 paragraphs). Applicant argues that independent claims 1 and 17 are structured to recite the single species S. cerevisiae in a range of identity of two of approximately 6000 genetic components, “exogenous MAL1 gene cluster” and “exogenous MAL2-8c gene”, which conveys to one skilled in the art that Applicant was in possession of the single species as claimed by the disclosure of test/experimentation with results of performance and refers to the specification paragraphs [00990]-[0093] and Figures 5A-5E, 6A-6E, 7A-7E and 8A-8E (See Remarks dated 7/27/2027, p.21, 1st paragraph). Applicant argues that dependent claims 6-12 recite the single species S. cerevisiae in a range of identity of two of approximately 6000 genetic components, “exogenous MAL1 gene cluster” and “exogenous MAL2-8c gene”, which conveys to one skilled in the art that Applicant was in possession of the single species as claimed by the disclosure of test/experimentation with results of performance and refers to the specification paragraphs [00990]-[0093] and Figures 5A-5E, 6A-6E, 7A-7E and 8A-8E (See Remarks dated 7/27/2027, p.21, 2nd paragraph). Applicant further argues the specification paragraphs [0090] and [0092] and Figures 5C, 5E and 7E provide support for the claimed subject matter comprising a single species S. cerevisiae recited in Claim 1 and dependent claims 6-12 including guidance as to performance for maltose conversion and for ethanol production (See Remarks dated 7/27/2026, p.22).
Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive. Applicant has narrowed the claim to a recombinant yeast strain of S. cerevisiae. However, the specification does not provide any information relating the starting amount of maltose in the medium relative to the final weight to volume amount of maltose remaining in the medium following fermentation. The specification does not provide any guidance on the rate of maltose conversion, nor any guidance on whether the maltose conversion rate is the same or different across the genus of recombinant S. cerevisiae strains comprising an exogenous MAL1 gene cluster and/or an exogenous MAL2-8c gene cluster. The specification does not provide any guidance on the rate of ethanol production of the specific strain of yeast tested, nor provide any guidance on the variability of ethanol production rates of recombinant yeast strains across the genus of recombinant S. cerevisiae strains comprising an exogenous MAL1 gene cluster comprising at least 80% sequence identity to SEQ ID NO:2 and/or an exogenous MAL2-8c gene cluster comprising at least 80% sequence identity to SEQ ID NO:3.
Conclusion
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 DEEPA MISHRA whose telephone number is (571) 272-6464. The examiner can normally be reached Monday - Friday 9:30am - 3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise W. 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.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/DEEPA MISHRA/Examiner, Art Unit 1657
