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
This application is divisional of 17/341,224, issued as US Patent No. 11,725,213, which is a divisional of 16/378,106, issued as US Patent No. 11,028,402, which is a 371 of PCT/EP2016/071801.
The response filed on December 18, 2025 has been entered.
Election/Restrictions
Applicant elected without traverse of Group I with a species election of (1) S. eubayanus as the host cell and (2) AGT1 of SEQ ID NO:6 as the AGT polypeptide in the reply filed on April 25, 2024 is acknowledged.
Claims 49-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 October 17, 2022.
Status of Claims
Claims 36-37, 39-40, 43, and 49-52 are pending.
Claims 49-52 are withdrawn.
Claims 36-37, 39-40, and 43 are under examination.
Response to Amendments/Arguments
Claim Rejections - 35 USC § 103 –Maintained
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 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.
Claim(s) 36-37, 39-40, and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Solodovnikova (WO 2016/101960 – cited previously on form PTO-892), Bortiri (AU 2015213393 – cited previously on form PTO-892), Jung (US 2016/0340698 – form PTO-1449), and Krogerus (Novel brewing yeast hybrids: creation and application. Appl Microbiol Biotechnol. 2017 Jan;101(1):65-78. Epub 2016 Nov 24 – form PTO-892).
Regarding claim 36, Solodovnikova discloses a yeast cell expressing an AGT1 polypeptide of SEQ ID NO:18 (“Non-Sc AGT1 Hybrid1”), which has 100% sequence identity to the AGT1 polypeptide of SEQ ID NO:6 of the instant application (page 47 line 11 through page 48 line 9, Claim 33, Figure 12A “Non-Sc AGT1 Hybrid1” and see the sequence alignment below). Solodovnikova discloses that the yeast expressing the AGT1 polypeptide can be used in fermentation of sugars to produce alcoholic beverages (abstract, page 1, Table 12a “AGT1” at page 118, and page 120, lines 17-19)
Solodovnikova does not disclose a S. eubayanus comprising a DNA construct comprising a heterologous promoter operably linked to the polynucleotide encoding the AGT1 polypeptide. However, recombinant expression of AGT1 via a promoter in Saccharomyces and expression of genes of interest in S. eubayanus were known in the art, as discussed below.
Regarding claims 36-37, Bortiri discloses a DNA construct comprising a heterologous promoter, such as a yeast promoter, operably linked to a polynucleotide encoding an AGT1 polypeptide ([0071]-[0078] and [0089]-[0090]).
Regarding claims 39-40, Bortiri discloses a Saccharomyces, such as S. cerevisiae, comprising the DNA construct or vector/plasmid comprising said DNA construct ([0078], [0088]-[0092]). Bortiri discloses that recombinant expression of AGT1 enhances the level and/or rate of fermentation of oligosaccharides ([0001A)).
Regarding claims 36, Jung discloses a method of expressing a DNA construct comprising a heterologous promoter linked to a polynucleotide encoding polypeptide of interest in S. eubayanus ([0053], [0055]-[0056]). Jung also discloses increasing activity of a polypeptide of interest by at least 30% compared to the parent cell ([0014]).
Regarding claim 36, Krogerus discloses that cold tolerant S. eubayanus x S. cerevisiae hybrid yeast cells is responsible for global lager beer production and is one of the most important industrial microorganisms (abstract).
Regarding claim 36 and 43, the limitation of having increased maltose/maltotriose transport activity at the plasma membrane compared to a control yeast cell and limitation of S. eubayanus capable of using maltotriose as its sole carbon source are inherent characteristics that necessarily flows from expression of the AGT1 polypeptide of Solodovnikova, which is identical to the AGT1 polypeptide of SEQ ID NO:6 of the instant application, in S. eubayanus. Expression of the AGT1 polypeptide of Solodovnikova in S. eubayanus results in the S. eubayanus to have increased maltose/maltotriose transport activity at the plasma membrane and capable of using maltotriose as its sole carbon source even if the prior art did not discuss or recognize such a property. See MPEP 2112.
Therefore, in combining the teachings of the above references, it would have been obvious to one having ordinary skill in the art before the time the claimed invention was effectively filed to express the AGT1 of Solodovnikova in other yeast strains, such as S. eubayanus, via a plasmid comprising a heterologous promoter linked to the AGT1 polypeptide, as taught by Bortiri, because one of ordinary skill in the art would have been able to carry out such a substitution, and the results were reasonably predictable. One of ordinary skill in the art would have been motivated to do so in order to increase AGT1 activity or maltose/maltotriose transport activity in other yeast strains, such as S. eubayanus, and to control expression of the AGT1 polypeptide with a promoter and recombinantly express and produce AGT1 in S. eubaynus to further enhance fermentation of sugars to alcohol. One having ordinary skill in the art would have been motivated to express the AGT1 of Solodovnikova in S. eubaynus to further enhance alcohol production in S. eubaynus since S. eubaynus is a well-established yeast for alcohol production. One of ordinary skill in the art would have had a reasonable expectation of success since Solodovnikova discloses yeast expressing an AGT1 polypeptide and Solodovnikova discloses that the yeast expressing the AGT1 polypeptide can be used in fermentation of sugars to produce alcoholic beverages, Bortiri discloses recombination expression of AGT1 via a plasmid comprising a heterologous promoter linked to the AGT1 polypeptide in Saccharomyces/S. cerevisiae, and Jung discloses a method of expressing a polypeptide of interest in S. eubayanus. Further, the rationale supporting that the claims would have been obvious is that a particular known technique (expression of polypeptides of interest in S. eubayanus) was recognized as part of the ordinary capabilities of one skilled in the art. Therefore, one of ordinary skill in the art would have been capable of applying this known technique to a known device (expression of AGT1 polypeptide of Solodovnikova) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.
Therefore, the above references render claims 36-37, 39-40, and 43 prima facie obvious.
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
Applicant argues that obviousness cannot be predicated on what is not known at the time an invention is made, even if the inherency of a certain feature is later established (MPEP 2141.03(V)). Applicant argues that it was not known that S. eubayanus lacked maltose/maltotriose transport activity or that this was the sole reason that S. eubayanus could not utilize maltose/maltotriose as its sole carbon source. Applicant argues that Jung and Krogerus are the only two cited references to teach use of S. eubayanus yeast. Jung does not comment on the transport activity of S. eubayanus. Krogerus comments that the ability of multiple S. eubayanus strains to grow on maltotriose had not yet been assessed at the time of publication. Applicant argues that at the time of the invention, the reason for the inability of S. eubayanus strains to grow using maltotriose as the sole carbon source as recited in claim 36 was not known. Thus, Applicant argues that it was not known that the transporters found in the strain of S. eubayanus were unable to support growth on maltotriose. Therefore, it would not be obvious that expressing AGT1 in S. eubayanus would increase maltose/maltriose transport activity and produce strains capable of using maltotriose as the sole carbon source as required by claim 36. Furthermore, since the lack of transport activity in S. eubayanus was unknown, there would be no motivation to express AGT1 in S. eubayanus. Thus, Applicant argues there would be no reason to combine Solodovnikova, Bortiri, Jung, and Krogerus without the understanding provided in the current application.
This is not found persuasive.
MPEP 2144. IV. states that the “reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” MPEP 2145 II states that "Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention…The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious."
In the instant application, the following is what was known in the art before the time the claimed invention was effectively filed: (1) Solodovnikova discloses a yeast cell expressing an AGT1 polypeptide of SEQ ID NO:18 (“Non-Sc AGT1 Hybrid1”), which has 100% sequence identity to the AGT1 polypeptide of SEQ ID NO:6 of the instant application. Solodovnikova discloses that the yeast expressing the AGT1 polypeptide can be used in fermentation of sugars to produce alcoholic beverages. (2) Bortiri discloses a Saccharomyces comprising a DNA construct comprising a heterologous promoter, such as a yeast promoter, operably linked to a polynucleotide encoding an AGT1 polypeptide. Bortiri discloses that recombinant expression of AGT1 enhances the level and/or rate of fermentation of oligosaccharides. (3) Jung discloses a method of expressing a DNA construct comprising a heterologous promoter linked to a polynucleotide encoding polypeptide of interest in S. eubayanus and increasing activity of a polypeptide of interest by at least 30% compared to the parent cell. (4) Krogerus discloses that cold tolerant S. eubayanus x S. cerevisiae hybrid yeast cells is responsible for global lager beer production and is one of the most important industrial microorganisms (abstract). Therefore, in combining the above teachings, one having ordinary skill in the art would have been motivated to express the AGT1 of Solodovnikova in S. eubaynus to further enhance alcohol production in S. eubaynus since S. eubaynus is a well-established yeast for alcohol production.
The latent property of having increased maltose/maltotriose transport activity at the plasma membrane compared to a control yeast cell and limitation of S. eubayanus capable of using maltotriose as its sole carbon source are inherent characteristics that necessarily flows from expression of the AGT1 polypeptide of Solodovnikova, which is identical to the AGT1 polypeptide of SEQ ID NO:6 of the instant application, in S. eubayanus. Expression of the AGT1 polypeptide of Solodovnikova in S. eubayanus results in the S. eubayanus to have increased maltose/maltotriose transport activity at the plasma membrane and capable of using maltotriose as its sole carbon source even if the prior art did not discuss or recognize such a property. See MPEP 2112.
Hence the rejection is maintained.
Conclusion
Claims 36-37, 39-40, 43, and 49-52 are pending.
Claims 49-52 are withdrawn.
Claims 36-37, 39-40, and 43 are rejected.
THIS ACTION IS MADE FINAL. 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 YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YONG D PAK/Primary Examiner, Art Unit 1652
Sequence alignment between AGT1 of SEQ ID NO:6 of the instant application (“Qy”) and AGT1 of Solodovnikova (“Db”).
BDB70555
ID BDB70555 standard; protein; 610 AA.
XX
AC BDB70555;
XX
DT 25-AUG-2016 (first entry)
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DE Hybrid yeast 1 non-Sc allele AGT1 protein, SEQ:18.
XX
KW AGT1 protein; alcohol; beverage; fermentation.
XX
OS Saccharomyces cerevisiae.
OS Saccharomyces pastorianus.
OS Synthetic.
XX
CC PN WO2016101960-A2.
XX
CC PD 30-JUN-2016.
XX
CC PF 22-DEC-2015; 2015WO-DK050413.
XX
PR 23-DEC-2014; 2014DK-00070825.
PR 08-JUN-2015; 2015DK-00070351.
XX
CC PA (CARL-) CARLSBERG BREWERIES AS.
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CC PI Solodovnikova NY, Andersen JF, Garcia Sanchez R, Gojkovic Z;
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DR WPI; 2016-40530E/46.
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CC PT Yeast cell for producing beverage, is capable of utilizing panose as sole
CC PT carbon source, and one or more dipeptides as sole nitrogen source.
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CC PS Claim 32; SEQ ID NO 18; 153pp; English.
XX
CC The present invention relates to a yeast cell useful for producing
CC alcoholic beverages. The invention further claims: (1) a yeast cell with
CC useful genotypes including comprising allelic genes encoding IMA1p/IMAP5p
CC ; and (2) a method for producing a beverage. The yeast cell is capable of
CC utilizing amino acids to a higher degree than both conventional lager
CC yeast and ale yeasts. The present sequence is a Hybrid yeast 1 non-Sc
CC allele AGT1 protein, which is useful for producing alcoholic beverages.
XX
SQ Sequence 610 AA;
Query Match 100.0%; Score 3145; Length 610;
Best Local Similarity 100.0%;
Matches 610; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKNILSLVGRKENTPEDVTANLADTSSTTVMQAKDLVIEDFEERKKNDAFELNHLELTTN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKNILSLVGRKENTPEDVTANLADTSSTTVMQAKDLVIEDFEERKKNDAFELNHLELTTN 60
Qy 61 ATQLSDSDEDKENVIRVAEATDDANEANNEEKSMTLRQALRKYPKAALWSILVSTTLVME 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ATQLSDSDEDKENVIRVAEATDDANEANNEEKSMTLRQALRKYPKAALWSILVSTTLVME 120
Qy 121 GYDTALLSALYALPVFQRKFGTMNAEGSYEITSQWQIGLNMCVLCGEMIGLQITTYMVEF 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GYDTALLSALYALPVFQRKFGTMNAEGSYEITSQWQIGLNMCVLCGEMIGLQITTYMVEF 180
Qy 181 MGNRYTMITALSLLTAYIFILYYCKSLAMIAVGQILSAMPWGCFQSLAVTYASEVCPLAL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 MGNRYTMITALSLLTAYIFILYYCKSLAMIAVGQILSAMPWGCFQSLAVTYASEVCPLAL 240
Qy 241 RYYMTSYSNICWLFGQIFASGIMKNSQENLGNSDLGYKLPFALQWIWPAPLIIGIFFAPE 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 RYYMTSYSNICWLFGQIFASGIMKNSQENLGNSDLGYKLPFALQWIWPAPLIIGIFFAPE 300
Qy 301 SPWWLVRKNKIVEAKKSLNRILSGTVTEKEIQVDITLKQIEMTIEKERLRASKSGSFFSC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 SPWWLVRKNKIVEAKKSLNRILSGTVTEKEIQVDITLKQIEMTIEKERLRASKSGSFFSC 360
Qy 361 FKGVDGRRTRLACLTWVAQNSSGAVLLGYSTYFFERAGMATDKAFTFSLIQYCLGLAGTL 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 FKGVDGRRTRLACLTWVAQNSSGAVLLGYSTYFFERAGMATDKAFTFSLIQYCLGLAGTL 420
Qy 421 GSWVISGRVGRWTILTYGLSFQMVCLFIIGGMGFASGSSASNAAGGLLLALSFFYNAGIG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GSWVISGRVGRWTILTYGLSFQMVCLFIIGGMGFASGSSASNAAGGLLLALSFFYNAGIG 480
Qy 481 AVVYCIVAEIPSAELRTKTIVLARICYNLMAVFNAILTPYMLNVSDWNWGAKTGLYWGGF 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 AVVYCIVAEIPSAELRTKTIVLARICYNLMAVFNAILTPYMLNVSDWNWGAKTGLYWGGF 540
Qy 541 TALTLAWVIIDLPETTGRTFSEINELFSQGVPARKFASTVVDPFGKRGLQNRPQVDNIID 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 TALTLAWVIIDLPETTGRTFSEINELFSQGVPARKFASTVVDPFGKRGLQNRPQVDNIID 600
Qy 601 RFSSASQQAL 610
||||||||||
Db 601 RFSSASQQAL 610