DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The response filed June 3, 2026, has been received and entered.
Claims 1-7 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 2 and 3, and the species SEQ ID NO: 2 for (a) and lacto-N-tetraose (LNT) for (b), in the reply filed on June 3, 2026, is acknowledged.
Claims 1 and 4-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 2 and 3 are examined on the merits.
Notice Re: Prior Art Available Under Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 102
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 2 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugita (Journal of Agricultural and Food Chemistry. 2022. 70: 5106-5114. Published April 15, 2022), as evidenced by Result 1 of SEQ ID NO: 2 search in the A_Geneseq Database (Sequence available on December 18, 2001. Search performed on June 12, 2026).
Sugita discloses deleting potential endogenous LNT II (lacto-N-triose II) transporter genes from the genome of a strain of E. coli W3110S (page 5111, left column, last paragraph; strain described as a strain from E. coli W3110S in page 5111, left column, second paragraph). In particular, Sugita discloses disrupting the ydeA gene in the genome of strain TAYΔJ (page 5111, right column, first paragraph). The TAYΔJ strain is constructed from E. coli W3110S in order to produce lacto-N-tetraose (LNT) (page 5111, left column, second paragraph). For the TAYΔJ strain in which the ydeA gene is deleted, the LNT production was increased as compared to the control (the TAYΔJ strain) (Figure 4 on page 5111). LNT is the elected species of an oligosaccharide having a lacto-N-triose II (LNTII) skeleton of instant claim 3. As such, Sugita discloses a microorganism having an inactivated activity of a protein (the protein expressed by the ydeA gene) and improved productivity of an oligosaccharide having a LNTII skeleton (LNT) as compared with a parent strain (the TAYΔJ strain), meeting limitations of instant claims 2 and 3.
Sugita also refers to the E. coli W3110S strain as E. coli W3110 (page 5109, left column, last paragraph; page 5111, right column, paragraph below Figure 4). As evidenced by Result 1 of SEQ ID NO: 2 search in the A_Geneseq Database, the amino acid sequence of ydeA of E. coli W3110 has 100% sequence similarity with the claimed SEQ ID NO: 2. See the second KW line (referring to ydeA), second-to-last KW line (referring to Escherichia coli W3110), and the query match of the evidence. Furthermore, the instant specification recognizes SEQ ID NO: 2 as the amino acid sequence of ydeA derived from E. coli W3110 (page 44, paragraph [0235]). Therefore, the TAYΔJ strain in which the ydeA gene is deleted of Sugita is directed to a microorganism having inactivated activity of a protein according to [1] ‘a protein consisting of the amino acid sequence represented by SEQ ID NO: 2.’ As such, Sugita anticipates instant claims 2 and 3.
Claim Rejections - 35 USC § 103
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.
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Jennewein (US 2018/0305724. Listed on IDS filed 6/21/24), as evidenced by Result 1 of SEQ ID NO: 2 search in the PIR Database (Sequence available on September 10, 1999. Search performed on April 7, 2026. Cited on PTO-892 mailed 4/10/26).
Jennewein discloses a method for the production of a desired oligosaccharide by a genetically modified microbial host cell, comprising providing a genetically modified microbial host cell that comprises at least one recombinant glycosyltransferase and has the expression or activity of at least one endogenous sugar export protein modified such, that the expression or activity of the sugar export protein is decreased or inactivated as compared to a genetically unmodified host cell, so that the transport of a desired oligosaccharide is increased as compared to a genetically unmodified host cell (paragraph [0017]). The invention of Jennewein makes it possible to produce a desired oligosaccharide in large amounts obtainable from the medium (paragraph [0016]). This is directed to improving productivity of the desired oligosaccharide as compared with the unmodified host cell (directed to a parent strain).
In a preferred embodiment of the host cell, the desired oligosaccharide is lacto-N-tetraose, and the host cell has deleted, disrupted or inactivated at least one nucleic acid sequence coding for an exporter protein that is able to export lacto-N-triose II outside the host cell (paragraph [0048]). It is preferred that the protein enabling the export of lacto-N-tetraose is selected from a group that includes YdeA of E. coli MG1655 (paragraph [0049]). See also claim 24 of Jennewein which recites a genetically modified microbial host cell for the production of lacto-N-tetraose as the desired oligosaccharide, comprising the deletion, disruption, or inactivation of at least one endogenous nucleic acid sequence coding for an exporter protein that exports precursors (in this case, the precursor is lacto-N-triose II) of the desired oligosaccharide outside the host cell, wherein the protein enabling the export of lacto-N-tetraose is optionally selected from a group that includes YdeA of E. coli MG1655.
Lacto-N-tetraose is the elected species for an oligosaccharide having a lacto-N-triose II (LNTII) skeleton of instant claim 3. Therefore, the embodiment of Jennewein of a genetically modified microbial host cell for producing lacto-N-tetraose as the desired oligosaccharide is directed to a microorganism having improved productivity of an oligosaccharide having an LNTII skeleton (lacto-N-tetraose) as compared with a parent strain, meeting a limitation of the claimed invention.
As evidenced by Result 1 of SEQ ID NO: 2 search in the PIR Database, the amino acid sequence of the protein ydeA of E. coli strain K-12, substrain MG1655 has 100% similarity with the claimed SEQ ID NO: 2. Therefore, the YdeA of E. coli MG1655 taught by Jennewein is directed to a ‘protein consisting of the amino acid sequence represented by SEQ ID NO: 2’ of instant claim 2. Though Jennewein recognizes that the protein enabling the export of lacto-N-tetraose is preferably a YdeA of E. coli MG1655 (paragraph [0049]), Jennewein does not expressly disclose that YdeA of E. coli MG1655 is the at least one endogenous sugar export protein that is modified such that its expression or activity of the sugar export protein is decreased or inactivated as compared to a genetically unmodified host cell. However, Jennewein discloses that preferred microorganisms as the host cell include Escherichia coli which have the advantage that it can be grown easily and inexpensively in laboratory settings, and has been intensively investigated for over many years (paragraph [00060]). Given this preference, before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the host cell that is being genetically modified according to Jennewein (the embodiment in which the desired oligosaccharide is lacto-N-tetraose) with E. coli MG1655. It would have been a matter of simple substitution of the host cell that is preferably E. coli with another for the predictable result of producing lacto-N-tetraose. In doing so, then YdeA of E. coli MG1655 is the endogenous sugar export protein modified such, that the expression or activity of the sugar export protein is decreased or inactivated as compared to a genetically unmodified host cell for the production of lacto-N-tetraose. Therefore, instant claims 2 and 3 are rendered obvious.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
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