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 .
Applicant response to restriction requirement filed 12/22/25 is acknowledged.
Claims 2-3 are canceled.
Applicant elected Group II (drawn to a recombinant cell comprising a DNA encoding an alpha1-2 fucosyltransferase and a DNA encoding an alpha1,3-fucosyltransferase, DNA encoding a lactose transporter for production of fucosylated oligosaccharides wherein said cell is modified to reduce expression of an L-fucose mutarotase).
In view of applicant’s amendment to the claims, restriction of Groups I-VII is hereby withdrawn. Claims 1, 4-14, 17-20 are hereby rejoined.
Claims 15-16 remain withdrawn as drawn to non-elected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-14, 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 and its dependent claims 4-14, 17-20) is directed to a genus of recombinant cells comprising a genera of genes (polynucleotides) from any source of species encoding α1-2-fucosyltransferase, α1-3-fucosyltransferase, sugar pyrophosphorylase polypeptide, a lactose transporter polypeptide, and an L-fucose transporter polypeptide wherein the recombinant cell is modified to eliminate or reduce expression of a genus of polynucleotides encoding an L-fucose mutarotase from any source or species) and a genus of polynucleotides encoding a β-galactosidase (from any source or species), wherein said genus of cells, a generic method of use said generic recombinant cells and said genera of polynucleotides are inadequately described in the disclosure in terms of structure.
The specification fails to teach which sources or species of the above-mentioned polynucleotides are likely to be operational in the genus of recombinant cells claimed to produce difucosylated oligosaccharides. Given the breadth of the genera of polynucleotides claimed it is likely that many of said polynucleotides will not be proper for production of difucosylated polysaccharides in the recombinant host cell chosen. Therefore, many unrelated sources of said polynucleotides are embraced within the scope of instant claims. All applicant provides is a single species for each of the above-mentioned polynucleotides (see fkp (representing the genus of genes encoding sugar pyrophosphorylase polypeptides, LacY (representing the genus of genes encoding lactose transporter polypeptides), FucP (representing the genus of L-fucose transporter polypeptides), FucU ( representing the genus of polynucleotides encoding L-fucose mutarotase) and lacZ (representing a genus of polynucleotides encoding beta-galactosidase, which is totally inadequate to fully describe the genera of polynucleotides claimed.
In claims 4-14, respectively some more structural information is provided regarding one polynucleotide at the time, ignoring the source and species of all other above-mentioned polynucleotides, rendering said claim subject to 112 first rejection. Regarding the genus of recombinant cells, which can be prokaryotes and eukaryotes including mammalian, insect, vertebrate, plant, etc., applicant has provided some examples in pages 13-14 of the specification however, said cells are only bacterial and fungal cells (two species), which is totally inadequate to fully describe the genus of recombinant cells utilized.
Therefore, based on the information provided in the specification, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention before the effective filing of this application.
Since the genus of recombinant cells is inadequately described, a method of use of said genus (claims 17-20) is also inadequately described.
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 18-20 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. In claim 18, lines 2-3 (and its dependent claims 19-20), the phrase “any one of claim 1” does not make sense.
Claims 19-20 are merely rejected for depending from base claim 18.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4-14, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jennewein et al., “Jennewein” (US2020/0181665, 6/2020, cited in the IDS). Jennewein tecahs about methods for producing fucosylated oligosaccharides utilizing said fucosyltransferases, both α1-2-fucosyltransferase, α1-3-fucosyltransferase (see abstract and [0070]) and functional fragments thereof (see [0097]).
In [0044] of Jennewein, “functional fragments” are disclosed to be truncated polypeptides (see instant claim 5) as compared to the naturally occurring fucosyltransferase, and which fragments are capable of possessing the same fucosyltransferase activity as the naturally occurring polypeptide said fragment originates from.
In [0008], Jennewein recites that for producing 2′-fucosyllactose (2′-FL), the α-1,2-fucosyltransferases WbgL from E. coli O126 and FucT2 from Helicobacter pylori may be used (see instant claim 4and 6), wherein said WbgL gene is capable of synthesizing lactodifucotetraose (LDFT) (see instant claims 4 and 19)
In [0107], according to said publication, in some embodiments, the genetically engineered cell has also been genetically engineered such that a gene encoding a bifunctional fucosekinase/L-fucose-1-phosphate-guanyltransferase (Fkp), preferably a gene encoding the bifunctional fucosekinase/L-fucose-1-phosphate-guanyltransferase (Fkp) from Bacteroides fragilis (acc. no. AY849806), which is capable of converting L-fucose into GDP-fucose, is expressed (see instant claim 8).
In [0169], genomic integration of heterologous genes including LacZ is mentioned (see instant claim 9).
In [0109] Jennewein discloses that in an additional and/or alternative embodiment, the genetically engineered cell has also been genetically engineered to possess an increased import of exogenous L-fucose across its cell membrane. Preferably, the genetically engineered cell has also been genetically engineered to express or overexpress—as compared to the progenitor cell before being genetically engineered—one nucleotide sequence selected from the group consisting of nucleotide sequences encoding the major facilitator transporter FucP from E. coli. MG1655 ( see instant claim 10).
In [0115], According to said publication, the genetically engineered cell has also been genetically modified to lack a functional LacZ or to comprise a functional LacZ gene whose expression is tightly regulated and which is not expressed during the fermentation process for producing the fucosylated oligosaccharide (see instant claim 14).
In [0039] Jennewein teaches that the genetically engineered cell is a prokaryotic cell or a eukaryotic cell. Appropriate cells include yeast cells, bacteria, archaebacteria, fungal cells (such as Pichia pastoris, see [0041]), insect cells, plant cells and animal cells, including mammalian cells (such as human cells and cell lines). Said fungal cells inherently have no FucU gene (see instant claim 12).
Even though said reference does not explicitly teach a recombinant cell comprising all genes with expression levels claimed, given the teachings of Jennewein and the level of knowledge in the prior art before the effective filing of this application, one of ordinary skill in the art depending on the desired difucosylated product, can reasonably envision introducing various combinations of said genes mentioned above to be incorporated into the desired host cell to produce such product.
Regarding instant claim 20, depending on the desired oligosaccharide, optimization of expression levels of said fucosyltransferases for difucosylation are well within the skill of one of ordinary skill in the art before the effective filing of this application and cannot be considered to be a contribution over the prior art.
Therefore, it is believed that the teachings of Jennewein as whole render this invention obvious.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651