The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I, claims 1-2, 7, 11-13, 15-19, to SEQ ID NO: 3, SEQ ID NO: 7, in the reply filed on September 28, 2026, is acknowledged.
Claims 3-6, 8-10, 14, 20-22, 25-35, 38-49 are canceled. Claims 23-24, 36-37 are withdrawn. Claims 1-2, 7, 11-13, 15-19, to SEQ ID NO: 3, SEQ ID NO: 7, are under consideration.
Priority: This application is a 371 of PCT/IB2023/053276, filed March 31, 2023, which claims benefit of provisional applications 63/326564, filed April 1, 2022, and 63/386394, filed December 7, 2022.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 7, 11-13, 15-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is drawn to a recombinant eukaryotic host cell capable of expressing a heterologous mature polypeptide in an intracellular form. The claim is confusing because it is not clear whether the limitations and/or components recited after “wherein” are comprised in the host cell or part of the host cell. The term “capable” and the limitations that follow appear to be describing a property and/or characteristic of the host cell and the wherein clause limitations are characteristics of the polypeptide to be expressed and are results to be achieved by the host cell. Therefore, for examination and prior art purposes, the claim is still drawn to a recombinant eukaryotic host cell, regardless of its intended uses and/or functions.
Claims 2, 7, 11-13, 15-19 are included in this rejection because they are dependent on claim 1 and fail to cure its defects.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 7, 11-13, 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Argyros et al. (WO 2018167670, cited as US 20220127564 on IDS 09.20.24; previously cited). As noted above, for examination and prior art purposes, since it is not clear whether the limitations after “wherein” are features that are part of the host cell, instant claim 1 and its dependent claims are interpreted as a recombinant eukaryotic host cell that is able to express a heterologous mature polypeptide in an intracellular form, regardless of the characteristics of the polypeptide to be expressed.
Argyros et al. teach recombinant yeast host cells expressing cell-associated heterologous proteins (at least abstract, p. 1-7, 10-24). Therefore, Argyros et al. can be deemed to anticipate instant claims 1-2.
Regarding instant claims 7, 11-13, Argyros et al. teach the heterologous protein is a maltogenic alpha-amylase (at least p. 2-3, 15). Regarding instant claims 15-16, Argyros et al. teach the maltogenic alpha-amylase having the amino acid sequence of SEQ ID NO: 108 (p. 45), which has 99.5% and 99.3% sequence identity with instant SEQ ID NO: 3 and 7, respectively.
Regarding instant claims 17-18, Argyros et al. teach the recombinant yeast host cell is from the genus Saccharomyces sp (at least p. 2, 5, 13).
Regarding instant claim 19, Argyros et al. teach a process for making a cell-associated heterologous protein from a recombinant yeast host cell, comprising propagating the recombinant yeast host cell in a medium placed in a vessel according to a baker’s yeast production method so as to allow the expression of the cell-associated heterologous protein (at least p. 1-2, 5-6, 10-11, 33-41).
Claims 1-2, 7, 11-13, 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oeser et al. (WO 2020058915, cited as US 11891641 on IDS 09.20.24). Oeser et al. teach recombinant yeast host cells capable of expressing a higher amount per cell of a heterologous protein (at least abstract, p. 1-4, 5-13). Therefore, Oeser et al. can be deemed to anticipate instant claims 1-2.
Regarding instant claims 7, 11-13, Oeser et al. teach the heterologous protein is a maltogenic alpha-amylase (at least p. 3-5, 10-11). Regarding instant claims 15-16, Oeser et al. teach the maltogenic alpha-amylase having the amino acid sequence of SEQ ID NO: 3 (p. 11), which has 99.5% and 99.3% sequence identity with instant SEQ ID NO: 3 and 7, respectively.
Regarding instant claim 19, Oeser et al. teach a process for making a cell-associated heterologous protein from a recombinant yeast host cell, comprising culturing (i.e. propagating) the recombinant yeast host cell to allow the expression of the heterologous protein (at least p. 4, 33-34, 35-36).
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656
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