DETAILED ACTION
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 .
Response to Amendment
The amendment received on 01/04/2024 is acknowledged. Claims 1-2, 4-6, 8, and 10 have been amended. Claims 11-17 have been added. Claims 3, 7, and 9 have been cancelled.
Claim Objections
Claim 1, 2, 11-12, 15, 17 are objected to because of the following informalities:
Regarding claim 1, The terms lacZ, galactosidase, E461A, E537, wasJ, FucK, fucI FucT and fkp all lack articles such as “a” “an” and “the”.
Regarding claim 2, the term codon lacks an article. E.g. “a” or “the”.
Regarding claim 11, the limitation states the gene has a GenBank accession number; however the limitation should state that the gene has “a sequence comprising/consisting of the sequence of GenBank…”.
Regarding claim 12 and the limitation “are integrated into separate or same back bone plasmid”, these terms lack articles.
Regarding claim 15, the terms LB, SOB, SOC, 2XYT, TB and SB are abbreviations which have not been introduced. These terms should be given their full name.
Regarding claim 17, the term IPTG is an abbreviation which should be introduced using its full name.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “Use” claims do not claims a process, machine, manufacture or composition, see MPEP 2173.05(q).
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, 4-6, 8 and 10-17 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.
Regarding claim 1 and claims dependent thereon, Claim 1 recites the language “lacZ gene is completely inactivated, but does not affect exogenous protein expression of the genetically engineered bacteria, wherein β- galactosidase encoded by lacZ gene has E461A and/or E537A mutations compared with β- galactosidase encoded by wild-type lacZ gene” as currently worded it is unclear what applicant is claiming as applicant claims the gene has been completely inactivated; however, then also claims limitations involving the gene product encoded by the gene. It appears applicant is claiming that the gene product does not have activity but that it is expressed. Amending the claim to recite that would provide clarity, such as “the engineered bacteria has a mutation in the lacZ gene selected from the group consisting of E461A, E537A and a combination thereof, and expresses a β-galactosidase with no detectable activity”.
Regarding claim 2 and the limitation “wherein codon for amino acid A is GCG”, it is unclear what applicant is claiming as this is one of the codons for alanine in E. coli. It is not clear as currently worded if this claim further limits the claim from which it depends. It is unclear if applicant is claiming all A codons are GCG or if a specific codon is. The lack of an article for the term “codon” further makes it unclear what this limitation should be interpreted as. From the claim prior to amendment, it appears that the limitation may be referring to the mutated residue. If this is the intent, amendment to the following claim language would provide clarity “wherein the alanine residue of the E461A and/or E537A mutation is encoded by a GCG codon”.
Regarding claim 5 and the limitation “wherein the E. coli is E.coli DH5a(XDE3), E.coli BL21 (XDE3), E.coli BL21 Star (DE3), or E. coli JM109 (XDE3)”, It is unclear what applicant is claiming as these strains do not have the modifications claimed. It is unclear if this limitation further narrows the claim form which it depends as it cannot be determined what is being claimed. If applicant is claiming that the modifications present in claim 1 were done to the strains claimed, then using wording like the following would add clarity “The genetically engineered bacteria according to claim 1, where in the engineered bacteria was made by making the modifications to a strain selected from the group consisting of….”.
Regarding claim 8 and claims dependent thereon and the limitation “the genetically engineered bacteria according to claim 1 is adopted, L-fucus and lactose are added in fermentation medium for fermentation to obtain the 2’-fucosyllactose” It is unclear what applicant is claiming and what method steps are being claimed. It is unclear what the term “adopted” refers to. It is unclear what steps are performed to adopt the bacteria. It is further unclear exactly when the L-fucose and lactose are added to the medium and how the product is obtained. It may be the limitation was not clearly translated into regular English or language for US practice. If applicant is claiming the bacteria is adapted to a set of conditions, amending the claims to describe the steps of adaptation would provide clarity. Further using active steps to describe the formation of the product would add clarity. For example:
“A method for preparing 2’fucosyllactose comprising: Culturing the genetically engineered bacteria according to claim 1…” followed by steps by which the strain is cultured. And then if the sugars are later added adding active steps such as “adding L-fucose and lactose to the fermentation medium comprising the adapted bacteria and fermenting the medium to form 2’-fucosyllactose” would make the claim clearer.
Regarding claim 10 and the limitation “Use of the genetically engineered bacteria according to claim 1 in the production of 2’-fucosyllactose”, it is unclear what applicant is claiming as it is not one of the for statutory classes of invention and the claims does not have a transitional phrase such as comprising followed by one or more elements. It is unclear if any method steps or structure are being claimed.
Regarding claim 11, the claims states that the genes have certain Genbank Accession numbers. However, Genbank entries such as those recited contain multiple types of information and it is unclear which information is limiting with respect to the claimed bacteria. Moreover, sequence information within Genbank entries are subject to revision, making it unclear what sequence is being claimed. To the extent Applicant wishes to limit the claims to a specific sequence, the claims should be amended to expressly recite the sequence along with a suitable SEQ ID NO.
Regarding claims 14 and the limitation “wherein the medium is E. coli conventional medium”, it is unclear what applicant is claiming as there is no specific medium which is called “conventional medium”. While there are some common media in the field of microbiology, such as those abbreviated in claim 15, it is unclear which media would be considered “conventional”.
Regarding claim 17, and the limitation “wherein when the genetically engineered bacteria are cultured to OD6oo=0.5~1.0, preferably 0.6~0.8, a final concentration of 0.1-0.3 mM IPTG, such as 0.1 mM IPTG, 5 g/L L-fucose, and 10 g /L lactose are added.” It is unclear what applicant is claiming as applicant lists a series of limitations; however, it is unclear what they are limiting, what active steps are being claimed and how they limit the claim. See also above the rejection of claim 8. Listing active steps in claim 8 and providing futher limitations would likely add clarity for example. For example active steps like “culturing the bacteria to an OD600 =0.5-1.0; adding IPTG to a final concentration of 0.1 mM…” would provide clarity.
Regarding claim 17 the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 17, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Conclusion
No claim is allowed.
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/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657