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 .
Application Status
In response to Non-Final Office Action mailed on 08/192025, applicants’ response and amendments dated 02/19/2026 is acknowledged. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.
Thus, amended claims 1-2 and 4-15 are pending in this application, amended claims 1-2, 4-9 and 14-15 is now under consideration for examination, and claims 10-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Maintained-Claim Rejections: 35 USC § 112(a)
The following is a quotation 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.
Written Description
I. Claims 1-2, 4-9 and 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-2, 4-9 and 14-15 of the instant application as interpreted are directed to a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed “industrial yeast strain” wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15).
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.
In the instant case, there is no structure associated with function with regard to the members of the genus of polypeptides and encoding polynucleotides; a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed “industrial yeast strain” wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15).
No information, beyond the characterization of a single species, yeast strain S. cerevisiae 23344c and comprising specific structures of DHA1 transporter proteins encoding AQR1, QDR2 and QDR3 (see Fig. 1-4; Examples 1-4, pages 26-28 of specification), has been provided by the applicants’, which would indicate that they had possession of the claimed members of the genus of polypeptides and encoding polynucleotides; genus of polypeptides and encoding polynucleotides; a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed “industrial yeast strain” wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15).
The genus of “industrial yeast strain” and the genus of polypeptides and the encoding polynucleotides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides is adequately described by the disclosure by characterization of AQR1, QDR2 and QDR3 transporter proteins comprising specific structures SEQ ID NOs: 1, 5, 7, 9 and 11 and encoding polynucleotides, since one could use structural homology to isolate those polypeptides and the encoding polynucleotides recited in the claims. The art clearly teaches the “Practical Limits of Function Prediction”: (a) Devos et al., (Proteins: Structure, Function and Genetics, 2000, Vol. 41: 98-107), teach that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and (iv) conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, page 98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude that “Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, page 105). Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, page 105).
(b) Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340) also highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer (page 309, paragraph 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein’s role fundamentally (page 323, paragraph 1).
(c) Specifically regarding Drug: H+ antiporter family 1 (DHA1) transporter proteins, the following references clearly provide evidence that there are structural and functional variability among DHA1 proteins obtained from the same microorganism or between DHA1 proteins obtained from different sources/microorganisms, including sequence/structure errors: see (i) Machado AMM., M.Sc., thesis, Tecnico LISBOA, 2016, pages 1-115) see Abstract; Fig. 21, page 76; Fig. 22, page 78; section 5 Discussion and conclusions, pages 90-96; and entire document; (ii) Redhu et al., (FEMS Yeast Res., 2016, fow043, pages 1-12) also teach structural and functional variability of DHA1 proteins; see Abstract; Concluding Remarks; and entire document; and (iii) Gaur et al., (BMC Genomics, 2008, vol. 9:579, pages 1-12) teach occurrence of pseudogenes in DHA1 proteins obtained from different yeasts (see Abstract; Discussion and conclusion, col. 1, page 7; and entire document).
As stated above, no information beyond the characterization of a single species, yeast strain S. cerevisiae 23344c and comprising specific structures of DHA1 transporter proteins encoding AQR1, QDR2 and QDR3 (see Fig. 1-4; Examples 1-4, pages 26-28 of specification), has been provided by the applicants’, which would indicate that they had possession of the claimed genus of polypeptides and the encoding polynucleotides. As the claimed genera of polypeptides and encoding polynucleotides in a genus cellular context/yeasts having widely variable structure and associated function, since minor changes in structure may result in changes affecting function and no additional information (species/variant/mutant) correlating structure with function has been provided. Furthermore, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features” (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895).
Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Applicants are referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Applicants’ have traversed the above written-description rejection with the arguments following claim amendments (see pages 5-6 of Applicants’ REMARKS dated 02/19/2026).
Applicants’ argue “…Specifically, amended claim 1 now specifies that the one or more membrane transporters of the DHA1 family are selected from the group consisting of AQR1, QDR1, QDR2, QDR3, TPO1, TPO2, TPO3, TPO4, FLR1, YHK8, DTR1, HOL1 or homologues thereof. The specification provides detailed descriptions of each transporter, including their systematic names and corresponding SEQ ID NOs (1-24). For example, the specification describes AQR1 (Systematic name: YNL065W) as corresponding to SEQ ID NOs: 1 and 2, QDR1 (Systematic name: YIL120W) as corresponding to SEQ ID NOs: 3 and 4, QDR2 (Systematic name: YIL121W) as corresponding to SEQ ID NOs: 5 and 6, and so forth for each of the twelve recited transporters.
Furthermore, the specification describes working examples demonstrating possession of the claimed yeast strain. Examples 1-4 describe yeast strains with modifications to these specific transporters and their functional effects. Example 1 describes a yeast strain with aqrl, qdr2, qdr1, and tpo4 deletions. Example 2 describes a yeast strain with aqrl, qdr3, qdr2, qdr1, dtrl, holl, and tpol deletions. Example 3 describes yeast strains with aqr1, qdr3, and qdr2 deletions. Example 4 describes an industrial yeast strain (Ethanol Red) with qdr1, qdr2, and qdr3 deletions. These examples demonstrate that Applicant was in possession of the claimed yeast strain at the time of filing.”
Reply: Applicants' arguments have been considered but are found to be non-persuasive for reasons made of record in the Office-action dated 08/19/2025 and additionally for the following reasons. The disclosure of the specification is still insufficient evidence of possession or to enable the claimed “industrial yeast strain” and method of use to its full scope or evidence of possession. Contrary to applicants arguments, claims as written encompass and reads on many “industrial yeast strains” and the prior art clearly provides evidence that there are significant genotypic and phenotypic differences among various “industrial yeast strains” resulting in significant differences in metabolic pathways, substrate utilization and ethanol production; see Kong et al., (FEMS Yeast Res., 2018, Vol. 18, foy001, pages 1-11), see Abstract; Fig. 1, page 4; Fig. 2, page 5; and entire document.
Additionally, post-filing references clearly provide evidence that there are significant differences even in a given specific yeast strain, as to the activity of DHA1 transporter proteins and down regulation of said DHA1 transporter proteins and their ability to inhibit Lactobacillus species varies widely. (i) Kapetanakis1 et al., (Front. Microbiol., 2021, Vol. 12, article 752742, pages 1-12) provide evidence that only a triple mutant of DHA1 transporter proteins in a specific strain Ethanol Red resulted in reduced ability to sustain the growth of lactic acid bacterium; see Abstract; Fig. 2, page 5; Fig. 5, page 9; and entire document; and (ii) similarly, Kapetanakis2 et al., (Nature, Scientific Reports, 2023, Vol. 13:4986, pages 1-9); also provide evidence that only a triple mutant of DHA1 transporter proteins in a specific strain Ethanol Red resulted in reduced ability to sustain the growth of lactic acid bacterium; Abstract; Fig. 2, page 4; Fig. 3, page 5; and entire document.
Therefore, the scope of the instant claims are broad despite the guidance of the art and specification, the claims remain not commensurate with evidence of possession or in scope with the enabled invention. Hence, claims are reading on significant numbers of inoperative embodiments would render claims non-enabled/lack of written-description, when the specification does not clearly identify the operative embodiments or evidence of possession and undue experimentation is involved in determining those that are operative.” Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); MPEP 2164.08(b).
The specification does not provide support for the full scope and breadth of the claims, thus examiner continues to hold the position the experimentation left to those skilled in the art is unnecessarily, and improperly extensive and undue.
Furthermore, the MPEP states the following: “A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one of skilled in the art to immediately envisage the product claimed from the disclosed species. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed.Cir. 1996). A “laundry list” disclosure of every possible structures as disclosed in prior art/wild-type polypeptide sequences/commercial sources/protein data bank(s) structures does not constitute a written description of every species in a genus, because it would not “reasonably lead” those skilled in the art to any particular species; In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
MPEP 2163.II.A.2. (a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”;
“The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility”, [u]nless and until a process is refined and developed to this point-where specific benefit exists in currently available form-there is insufficient justification for permitting an applicant to engross what may prove to be a broad field”, and “a patent is not a hunting license”,[i]t is not a reward for the search, but compensation for its successful conclusion.”
There are no examples provided to encompass the numerous characteristics of the “industrial yeast strains” claimed. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals applicants’ hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of structures in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Maintained-Enablement
II. Claims 1-2, 4-9 and 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, because the specification is enabling for characterization of a single species, yeast strain S. cerevisiae 23344c and comprising specific structures of DHA1 transporter proteins encoding AQR1, QDR2 and QDR3 (see Fig. 1-4; Examples 1-4, pages 26-28 of specification). However, specification does not reasonably provide enablement for a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (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 claim(s).
Claims 1-2, 4-9 and 14-15 are so broad as to encompass: a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15). The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of polypeptides and encoding polynucleotides broadly encompassed by the claims. Since the amino acid sequence of a protein encoded by a polynucleotide determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires a knowledge of and guidance with regard to which amino acids in the protein's sequence and the respective codons in its polynucleotide, if any, are tolerant of modification and which are conserved (i.e., expectedly intolerant to modification), and detailed knowledge of the ways in which the encoded proteins' structure relates to its function. However, in this case the disclosure is limited to the characterization of a single species, yeast strain S. cerevisiae 23344c and comprising specific structures of DHA1 transporter proteins encoding AQR1, QDR2 and QDR3 (see Fig. 1-4; Examples 1-4, pages 26-28 of specification). It would require undue experimentation of the skilled artisan to make and use the claimed polypeptides and the encoding polynucleotides encompassing a genus of structures i.e., a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15). The specification provides no guidance with regard to the making of variants and mutants or with regard to other uses as claimed in the instant claims. In view of the great breadth of the claims, amount of experimentation required to make and use the claimed polypeptides, the lack of guidance, working examples, and unpredictability of the art in predicting function from a polypeptide primary structure (for example, see Whisstock et al., Prediction of protein function from protein sequence and structure. Q Rev Biophys. 2003, Aug. 36 (3): 307-340), the claimed invention would require undue experimentation. Furthermore, neither the specification nor the prior art provides guidance regarding method for eliminating, or preventing contamination of lactic acid bacteria in yeast cultures. As such, the specification fails to teach one of ordinary skill how to use the full scope of the polypeptides and the encoding polynucleotides encompassed by these claims.
The specification does not support the broad scope of the claims which encompass: a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15), method of making and method of use, as claimed in claims 1-2, 4-9 and 14-15, because the specification does not establish: (A) a rational and predictable scheme for identifying a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11; and a method for eliminating, or preventing contamination of lactic acid bacteria in yeast cultures and with an expectation of obtaining the desired biological function; (B) defined core regions/motifs involved in the desired biologic activity of encoded polypeptides; (C) the tertiary structure of the molecule and folding patterns that are essential for the desired activity and tolerance to modifications; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful.
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 polypeptides and encoding polynucleotides with an enormous number of modifications. 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 polypeptides having the desired biological characteristics 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).
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5).
415 F.3d at 1316, 75 USPQ2d at 1329. See also In re Hyatt, 211 F.3d 1367, 1372,54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969) (Claim 9 was directed to a process of analyzing data generated by mass spectrographic analysis of a gas. The process comprised selecting the data to be analyzed by subjecting the data to a mathematical manipulation. The examiner made rejections under 35 U.S.C. 101 and 102. In the 35 U.S.C. 102 rejection, the examiner explained that the claim was anticipated by a mental process augmented by pencil and paper markings. The court agreed that the claim was not limited to using a machine to carry out the process since the claim did not explicitly set forth the machine. The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) (The court held that the PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the “PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.”). The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach.
Applicants’ have traversed the above enablement rejection with the following arguments (see pages 6-7 of Applicants’ REMARKS dated 02/19/2026).
Applicants’ argue “…In addition, as also referred to above in the written description section. Examples 1-4 provide experimental data for yeast strains in which these transporters are modified. Example 1 describes a yeast strain with aqr1, qdr2, qdr1, and tpo4 deletions and demonstrates reduced L. fermentum growth when cocultivated with this strain. Example 1. Example 2 describes a yeast strain with aqrl, qdr3, qdr2, qdr1, dtrl, holl, and tpol deletions and demonstrates reduced L. fermentum growth.. Example 3 describes yeast strains with aqrl, qdr3, and qdr2 deletions and demonstrates reduced L. fermentum propagation. Example 4 describes an industrial yeast strain (Ethanol Red) with qdr1, qdr2, and qdr3 deletions and demonstrates reduced L. fermentum growth. *
Reply: Applicants' arguments have been considered but are found to be non-persuasive for the following reasons. Applicants’ arguments filed on 02/19/2026 for the traversal of enablement rejection is on similar lines to the arguments presented for traversing the written-description, said arguments have been fully considered but they are not persuasive. Examiner continues to maintain the rejection for reasons stated on record, supporting evidence and arguments presented above in maintaining the written-description rejection also applies to enablement rejection.
Maintained-Claim Rejections: 35 USC § 102 (AIA )
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.
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 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.
I. Claims 1-2 and 4-9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Dundon et al., (US 9,249,420 B2).
Claims 1-2 and 4-9 as interpreted are directed to a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed “industrial yeast strain” wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11.
I. Dundon et al., (US 9,249,420 B2) discloses yeast strains comprising deletion/genetic modification of DHA1 transporter proteins, said transporter proteins includes transporter proteins encoding AQR1, QDR2 and QDR3, including structural information of said transporter proteins and the encoding polynucleotides, wherein the reference polypeptides having 100% sequence identities to SEQ ID NO: 1 & 5 of the instant invention and the encoding reference polynucleotides having 100% sequence identities to SEQ ID NO: 2 & 6 of the instant invention (see provided sequence alignments). Applicants are directed to the following sections in Dundon et al., (US 9,249,420 B2: Abstract; Fig. 1 & 4, col. 6, lines 5-32; col. 2, lines 59-67 to col. 3, lines 1-6; col. 4, lines 44-63; Example 2, Table 2, cols. 31-32; and entire document. Therefore, the disclosure of Dundon et al., (US 9,249,420 B2) anticipate the instant claims 1-2 and 4-9 as written/interpreted.
II. Claims 1-2 and 4-9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Simon et al., (US 10,017,804 B2).
Simon et al., (US 10,017,804 B2) also disclose discloses yeast strains comprising deletion/genetic modification of endogenous transporter proteins, said endogenous transporter proteins includes transporter proteins encoding AQR1, QDR2 and QDR3, including structural in formation of said transporter proteins and the encoding polynucleotides, wherein the reference polypeptides having 100% sequence identities to SEQ ID NO: 1, 5, 9 & 11 of the instant invention and the encoding polynucleotides (see provided sequence alignments). Applicants are directed to the following sections in Abstract; col. 8, lines 5-20; inactivating endogenous transporters, col. 36, lines 58-67 to col. 38, lines 1-31; hosts/yeasts, col. 40, lines 14-67 to col. 42, lines 1-13; Example 5, disruption of endogenous genes includes AQR1, QDR2 and QDR3, col. 54, TABLE 15; and entire document. Therefore, the disclosure of Simon et al., (US 10,017,804 B2) anticipate the instant claims 1-2 and 4-9 as written/interpreted.
Applicants’ have traversed the above 35 USC § 102 with the following arguments: (see page 7 of Applicants’ REMARKS dated 02/19/2026).
Applicants’ argue: “…Applicant respectfully traverses these rejections for at least the following reasons. Claim 1 has been amended, it has been specified that the yeast strain is an industrial yeast strain. None of Dundon or Simon teach or disclose an industrial yeast strain. Claim1 and the claims dependent thereon are thus novel over the cited art and withdrawal of the rejection is respectfully submitted.”
Reply: Applicants' arguments have been considered but are found to be non-persuasive for the following reasons. Examiner continues to maintain the rejection for reasons stated on record (dated 08/19/2025) and additionally for the following reasons.. Contrary to applicants’ arguments structure and function are inseparable, the yeast strains of Dundon et al., (US 9,249,420 B2) and Simon et al., (US 10,017,804 B2) are Saccharomyces cerevisiae and “industrial yeast strains” includes Saccharomyces cerevisiae; and examiner holds the position that claims 1-2 and 4-9 are directed to a product, and said references meet all the limitations of claims 1-2 and 4-9.
Examiner holds the position that claims of the instant application as written reads on the ‘same components’/genetically modified Saccharomyces cerevisiae i.e., endogenous transporter proteins, said endogenous transporter proteins includes transporter proteins encoding AQR1, QDR2 and QDR3, including structural in formation of said transporter proteins and the encoding polynucleotides, wherein the reference polypeptides having 100% sequence identities to SEQ ID NO: 1, 5, 9 & 11 of the instant invention and the encoding polynucleotides of the cited prior art and there are no ‘component(s) or manipulative differences’ of the instant claims as written and the cited prior art. Hence, the cited prior art product and the method of prior art inherently discloses the claimed product and method for the following reasons; components and properties are inseparable. The claimed product/components of the instant application claims the identical components and identical manipulative steps as that of the cited prior art i.e., (i) same genetically modified microorganism/yeast “industrial yeast” comprising the same endogenous transporter proteins, said endogenous transporter proteins includes transporter proteins encoding AQR1, QDR2 and QDR3, including structural in formation of said transporter proteins and the encoding polynucleotides, wherein the reference polypeptides having 100% sequence identities to SEQ ID NO: 1, 5, 9 & 11 of the instant invention and the encoding polynucleotides and (ii) the “same manipulative steps” of claims of the instant invention. Examiner reiterates that if the structure is the same, then the function is also same, as structure and function are inseparable, although, the cited prior art may not have recognized the inherent property, examiner finds support in the following sections of MPEP.
2112 [R-3] Requirements of Rejection Based on Inherency; Burden of Proof The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (, X7Fed. Cir. 1983).
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DIS-COVERY OF A NEW PROPERTY
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). >In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Id.< See also MPEP § 2112.01 with regard to inherency and product-by-process claims and MPEP § 2141.02 with regard to inherency and rejections under 35 U.S.C. 103.
II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004)(“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999) (“If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics.”); Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1348-49 (Fed. Cir. 1999) (“Because sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known.”)>; SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound “inherently” anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound “inherently results in at least trace amounts of” the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate).
III. A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.
Examiner would like to apply similar lines of argument as per MPEP Chapter 2100-Patentability, that applicants’ discovery of an inherent property of previously disclosed prior art product does not make the applicants’ invention novel and hence the rejected claims are fully anticipated by the cited prior art. As per the MPEP 2131 [R-1], each and every element of rejected claims are found either expressly or inherently described in above cited prior art.
Maintained-Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
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 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.
Claims 1-2, 4-9 and 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Dundon et al., (US 9,249,420 B2) or Simon et al., (US 10,017,804 B2) as applied to claims 1-2 and 4-9 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Velasco et al., (Eukaryotic Cell., 2004, Vol. 3(6): 1492-1503, in IDS), Lucic et al., (New Phytologist, 2008, Vol. 180: 343-364), Challinor et al., (Nature, 1954, Vol. 174(4436): 877-878, in IDS) and Ponomarova et al., (Cell Systems., 2017, Vol. 5: 345-357, in IDS).
Claims 1-2, 4-9 and 14-15 as interpreted are directed to a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11 (as in claims 1-2 and 4-9); and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15).
The disclosure of Dundon et al., or Simon et al., as applied to claims 1-2 and 4-9 is described above in 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above. However, Dundon et al., or Simon et al., does not teach a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species (as in claims 14-15).
Additionally regarding claims 1-2 and 4-9, Velasco et al., (Eukaryotic Cell., 2004, Vol. 3(6): 1492-1503, in IDS), disclose the structural and information of DHA1 transporter AQR1 and QDR3 is involved in amino acid excretion/transport into the culture medium and deletion of AQR1 and QDR3 impacted/resulted in reduced/lowered concentration of amino acids into the culture medium (see Abstract; TABLE 1-2, pages 1493-1494; TABLE 3, page 1495; col. 2, page 1497; Fig. 5, page 1498; Discussion, col. 1, page 1501; and entire document); and
Lucic et al., (New Phytologist, 2008, Vol. 180: 343-364) also teach DHA1 transporter AQR1 and QDR3 is involved in amino acid excretion/transport into the culture medium (see col. 1, page 354; and entire document).
Regarding claims 14-15, multiple lines of evidence teaches Lactobacillus growth in co-cultures with yeast/Saccharomyces requires amino acid in culture medium and depletion of amino acids in defined culture medium or deletion of DHA1 transporters AQR1 and QDR3 in yeast/Saccharomyces reduced or impacted the growth of Lactobacillus.
Challinor et al., (Nature, 1954, Vol. 174(4436): 877-878, in IDS) provide evidence regarding interrelationships between a yeast/Saccharomyces and a bacterium/Lactobacillus; said reference provides evidence that bacterium/Lactobacillus fails to grow in defined medium lacking nicotinic acid or thiamine or amino acids but is able to grow when cultured in the presence of yeast and suggest that the amino acids produced and excreted by yeast into the culture medium supports growth of bacterium/Lactobacillus.
Ponomarova et al., (Cell Systems., 2017, Vol. 5: 345-357, in IDS) provide teaching, suggestion and motivation that yeast creates a niche for symbiotic bacteria/Lactobacillus wherein said symbiotic bacteria/Lactobacillus utilizes the amino acids excreted by yeasts into the culture medium and deletion of amino acid transporters reduced/impacted the growth of symbiotic bacteria/Lactobacillus (see Abstract; Fig. 4A, page 360; Table S5; and entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate a genetically modified yeast wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained and said transporters of the DHA1 family are involved in the transport/secretion of amino acid into culture medium as suggested by Velasco et al., and Lucic et al., and the teachings of Challinor et al., and Ponomarova et al., provide evidence that yeast creates a niche for symbiotic bacteria/Lactobacillus, wherein said symbiotic bacteria/Lactobacillus utilizes the amino acids excreted by yeasts into the culture medium and deletion of amino acid transporters reduced/impacted the growth of symbiotic bacteria/Lactobacillus and a skilled artisan would realize yeast employed in the production of industrial products of interest significance and to delete transporters of the DHA1 family transporters and advantageously inhibit unwanted growth of bacteria/Lactobacillus that could potentially utilize and divert nutrients and other growth factors required for the optimal growth and metabolic activity of yeasts, and a skilled artisan will be motivated to modify the teachings of primary references Dundon et al., or Simon et al., and employ the disclosed yeast strains in said references for the production of industrial products of interest significance and as claimed in the method of claims 14-15 of the instant invention. A person of ordinary skill in the art is motivated to make such change, because deletion of DHA1 transporters AQR1 and QDR3 in yeast/Saccharomyces reduced or impacted the growth of Lactobacillus and a skilled artisan would realize such a modification would be useful to increase the production of fermentation products of interest. One of ordinary skill in the art has a reasonable expectation of success yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, because the molecular biology techniques required to construct yeast of interest are well known in the art and disclosed in the cited references and method of use is also suggested in the cited references. Therefore, the inventions as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings of Dundon et al., or Simon et al., Velasco et al., and Lucic et al., Challinor et al., and Ponomarova et al., also provide the structural and functional elements of the instant invention and the method of use (Teaching, Suggestion and Motivation).
Given this extensive teaching in prior art (Dundon et al., or Simon et al., Velasco et al., and Lucic et al., Challinor et al., and Ponomarova et al.,) a genus of structures of undefined and unlimited structures including variants, mutants and homologs in the claimed yeast strain wherein activity of one or more membrane transporters of the DHA1 family is reduced relative to a wild type strain or to a parental strain from which it is obtained, said genera of DHA1 proteins comprising any polypeptide or an amino acid sequence with at least 60% sequence identity to the amino acid sequences SEQ ID NOs: 1, 5, 7, 9 and 11; and a method for eliminating, reducing or preventing contamination of lactic acid bacteria in yeast cultures, the method comprising culturing a yeast strain, wherein the lactic acid bacteria comprise a Lactobacillus species, as taught by the instant invention and as claimed in claims 1-2, 4-9 and 14-15 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Hence, claims 1-2, 4-9 and 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Dundon et al., (US 9,249,420 B2) or Simon et al., (US 10,017,804 B2) as applied to claims 1-2 and 4-9 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Velasco et al., (Eukaryotic Cell., 2004, Vol. 3(6): 1492-1503, in IDS), Lucic et al., New Phytologist, 2008, Vol. 180: 343-364), Challinor et al., (Nature, 1954, Vol. 174(4436): 877-878, in IDS) and Ponomarova et al., (Cell Systems., 2017, Vol. 5: 345-357, in IDS).
Applicants’ have traversed the above 35 USC § 103 rejection with the following arguments: see pages 7-9 of Applicants’ REMARKS dated 02/19/2026)
Applicants’ argue: “…The Examiner's motivation to combine appears to rely on the Applicant's own disclosure as a roadmap, which constitutes impermissible hindsight. A person of ordinary skill in the art would not have been motivated to combine the cited references to arrive at the claimed yeast strain because: (a) the primary references teach transporter modifications for unrelated purposes (isobutanol production and steviol glycoside production, respectively); (b) Ponomarova et al. characterizes yeast-LAB interaction as beneficial symbiosis rather than as contamination to be prevented; and (c) there is no teaching, suggestion, or motivation in the prior art to use DHA1 transporter modifications specifically to prevent LAB contamination.”
Reply: Applicants' arguments have been considered but are found to be non-persuasive for the following reasons. Examiner continues to maintain the rejection for reasons stated on record (dated 08/19/2025) and additionally for the following reasons.
Contrary to applicants’ arguments claims examiner has provided arguments for teaching, suggestion and motivation in the body of rejection above and the support in the cited references.
In response to applicants’ argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicants’ disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Therefore, examiner continues to take the position that each and every element of the instant invention is taught in the combination of cited references and that the combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the genetically modified “industrial yeast strain” and a method of use as claimed herein and the method of use of claimed composition and the claimed benefits are very much expected and predictable.
Summary of Pending Issues
The following is a summary of issues pending in the instant application
Claims 1-2, 4-9 and 14-15 are rejected under 35 U.S.C. 112(a) for written-description and enablement.
I. Claims 1-2 and 4-9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Dundon et al., (US 9,249,420 B2); and II. Claims 1-2 and 4-9 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Simon et al., (US 10,017,804 B2).
Claims 1-2, 4-9 and 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Dundon et al., (US 9,249,420 B2) or Simon et al., (US 10,017,804 B2) as applied to claims 1-2 and 4-9 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Velasco et al., (Eukaryotic Cell., 2004, Vol. 3(6): 1492-1503, in IDS), Lucic et al., (New Phytologist, 2008, Vol. 180: 343-364), Challinor et al., (Nature, 1954, Vol. 174(4436): 877-878, in IDS) and Ponomarova et al., (Cell Systems., 2017, Vol. 5: 345-357, in IDS).
Conclusion
None of the claims are allowable. Claims 1-2, 4-9 and 14-15 are rejected for the reasons identified in the Rejections and Summary sections of this Office Action. Applicants’ must respond to the rejections in each of the sections in this Office Action to be fully responsive for prosecution.
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 extension fee 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.
Regarding filing an After Final amendment, Applicants are directed to MPEP 714.13, which states:
II. ENTRY NOT A MATTER OF RIGHT
It should be kept in mind that applicant cannot, as a matter of right, amend any finally rejected claims, add new claims after a final rejection (see 37 CFR 1.116) or reinstate previously canceled claims. Except where an amendment merely cancels claims, adopts examiner suggestions, removes issues for appeal, or in some other way requires ONLY A CURSORY REVIEW by the examiner (e.g., typographical errors), compliance with the requirement of a showing under 37 CFR 1.116(b)(3) is expected in all amendments after final rejection. An affidavit or other evidence filed after a final rejection, but before or on the same date of filing an appeal, may be entered upon a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier presented in compliance with 37 CFR 1.116(e). See 37 CFR 41.33 and MPEP § 1206 for information on affidavit or other evidence filed after appeal. (Examiner's emphasis) If more than a cursory review is required, Applicants are referred to CFR §1.114.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652