The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11 are pending and under consideration.
Priority: This application is a 371 of PCT/KR2021/018486, filed December 7, 2021, which claims benefit of foreign application KR 10-2020-0169583, filed December 7, 2020. A copy of the foreign priority document has been received in the instant application and is not in the English language.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraph 0051 (of the application publication). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 1-11 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 recites a recombinant microorganism “having enhanced ability to produce spider silk protein”. It is not clear what is considered an “enhanced” ability. The recited phrase is open ended and has an undeterminable scope. Further clarification and/or correction is requested.
Claim 5 is dependent on claim 3. The additional genes “pstI” and “pck” recited in claim 5 do not appear to be recited in claim 3. Further clarification and/or correction is requested.
Claims 2-4, 6-11 are included in this rejection because they are dependent on the above claim(s) 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, 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noh et al. (2017 Cell Systems 5: 418-426). Instant claim 1 appears to be a product-by-process claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself.” MPEP 2113. For prior art purposes, instant claim 1 has been interpreted as directed to a recombinant microorganism having inhibited expression of eno gene. The additional limitations of the recombinant microorganism “having enhanced ability to produce spider silk protein” is an intended use of the recombinant microorganism and has not been accorded patentable weight. MPEP 2111.02.
Noh et al. teach transforming an E. coli cell with plasmids constructed to generate a synthetic small RNA (sRNA) to knockdown a target gene, where the target gene is the eno gene (at least p. 420-421, also Fig. 2). Therefore, Noh et al. can be deemed to anticipate instant claims 1-2, 8.
Regarding instant claim 7, Noh et al. teach synthetic sRNAs are composed of two modules: an mRNA-binding module and an Hfq-binding module (p. 419). Noh et al. teach the synthetic sRNA comprises a Hfq-binding sRNA SgrS that retains the high capacity of the original SgrS, to repress the target gene (p. 419). Therefore, Noh et al. can be deemed to teach that the synthetic sRNA for repressing the eno gene comprises the recited Hfq binding site derived from SgrS and a region forming a complementary bond with an mRNA of the eno gene.
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.
Claims 1-2, 3-4, 5, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Noh et al. (2017 Cell Systems 5: 418-426). The teachings of Noh et al. over at least instant claims 1-2, 7-8 are noted above.
As noted above, Noh et al. disclose transforming an E. coli cell with plasmids constructed to generate a synthetic small RNA (sRNA) to knockdown a target gene (at least p. 420-421, also Fig. 2). Noh et al. disclose various target genes for knockdown, including the eno gene and ackA gene (at least p. 420).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further include a plasmid for generating a synthetic sRNA to knockdown an additional gene ackA into the E. coli cell having inhibited expression of the eno gene noted above in Noh et al. (instant claims 3-4). The motivation to do so is given by Noh et al., which disclose a synthetic sRNA-based knockdown strategy for production of a target substance of interest in E. coli (p. 418, 421). One of ordinary skill would have a reasonable expectation of success because the prior art Noh et al. disclose E. coli having inhibited eno expression and E. coli having inhibited ackA expression both successfully produced the target substance of interest. Therefore, the combination of the two inhibited genes would be obvious because it would have the same purpose for enhancing production of the target substance of interest production.
Regarding instant claim 5, Noh et al. also disclose synthetic sRNA to knockdown the target gene pck (p. 420-421, also Fig. 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further include a plasmid for generating a synthetic sRNA to knockdown an additional gene pck into the E. coli cell having inhibited expression of the eno gene noted above in Noh et al. (instant claim 5). The motivation to do so is given by Noh et al., which disclose a synthetic sRNA-based knockdown strategy for production of a target substance of interest in E. coli (p. 418, 421). One of ordinary skill would have a reasonable expectation of success because the prior art Noh et al. disclose E. coli having inhibited eno expression and E. coli having inhibited pck expression both successfully produced the target substance of interest. Therefore, the combination of the two inhibited genes would be obvious because it would have the same purpose for enhancing production of the target substance of interest production.
Claims 1-5, 6, 7-8, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Noh et al. (2017 Cell Systems 5: 418-426) in view of Xia et al. (2010 PNAS 107(32): 14059-14063; IDS 06.10.23). The teachings of Noh et al. over instant claims 1-5, 7-8 are noted above.
As noted above, Noh et al. disclose introducing synthetic sRNA-based to knockdown target genes to engineer E. coli for efficient production of a target substance of interest (p. 420-421, also Fig. 2, 424-425). Noh et al. do not teach a target substance of interest being silk protein.
Xia et al. disclose spider dragline silk is a remarkably strong fiber that makes it attractive for numerous applications (p. 14059). Xia et al. disclose that native-sized recombinant spider silk protein expressed and produced in a metabolically engineered E. coli results in a strong fiber (p. 14059-14060). Xia et al. disclose the recombinant spider silk protein expression construct comprises silk protein monomer (p. 14060, Fig. 1), where the monomer sequence has 100% sequence identity with the amino acid sequence of instant SEQ ID NO: 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the recombinant spider silk expression construct of Xia et al. for the target substance of interest into the engineered E. coli having a knocked down eno gene of Noh et al. or alternatively, incorporate the engineered E. coli having a knocked down eno gene of Noh et al. for the metabolically engineered E. coli utilized in Xia et al. for expression of recombinant spider silk protein, to thereby at the claimed microorganism having inhibited eno expression and a gene encoding a recombinant silk protein having the amino acid sequence of instant SEQ ID NO: 1 (instant claims 6, 9). The motivation to do so is given by the prior art, which disclose metabolically engineered E. coli cells can be transformed to express products of interest, including spider silk proteins. One of ordinary skill would have a reasonable expectation of success E. coli is a well-known host cell and can be adapted for expression of known recombinant proteins.
Regarding instant claims 10-11, Xia et al. disclose a process for culturing the metabolically engineered E. coli to produce recombinant spider silk protein and recovering the recombinant spider silk protein (p. 14060), where the recovered spider silk protein is precipitated with a salt (p. 14061). Therefore, it would be obvious that a metabolically engineered E. coli having a knocked down eno gene of Noh et al. utilized in Xia et al. for expression of recombinant spider silk protein can be cultured to produce recombinant spider silk protein and recovering the recombinant spider silk protein by a salt precipitation step. One of ordinary skill would have a reasonable expectation of success because metabolically engineered E. coli are still host cells capable of being adapted for expressing known recombinant proteins.
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656