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 .
Claims 1-20 are pending and are under examination.
The information disclosure statements filed 3/27/24 and 10/2/25 have been considered and initialed copies are enclosed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-9, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. KR20200051375A 5-13-2020 cited in IDS.
Claim 1: Lee et al disclose an Escherichia coli (E. coli) that produces 3-hydroxypropionic acid (3-HP), transformed with a gene encoding adenosyltransferase inserted (integrated) into the genomic DNA with at least one copy number. See claim 1, paragraph 33, 35 and 38.
Claim 2: Lee et al disclose the E. coli further comprises a gene encoding glycerol dehydratase, a gene encoding, aldehyde dehydrogenase and a gene encoding glycerol dehydratase reactivase. See paragraph 39, 52 and the claims.
Claim 6, 9, : Lee et al disclose that the 3-HP producing ability is increased as compared to in the same microorganism that has not been transformed with a gene encoding adenosyl transferase – thus it can be concluded that the 3-HP producing ability is increased in proportion to the copy number of the 3 -HP producing genes introduced into the genome of the E. coli. See claims.
Claim 7-8, 13-14: Lee et al disclose a composition comprising the E. coli bacterium. See paragraph 45.
Claim 7-8 and 13-14 recites the intended uses of the composition for determining 3 HP producing ability by confirming the 3-HP production by the E. coli bacterium is proportional to the copy number of the 3-HP producing gene inserted into the genomic DNA of the E. coli bacterium. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim(s) 1-3, 5-10, 12-16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jo et al. US 2023/0348942 11/22/2023 cited in IDS.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Jo et al disclose an Escherichia coli bacterium having 3-hydroxypropionic acid producing capability, in which a foreign gene encoding at least one protein selected from the group consisting of glycerol dehydratase, aldehyde dehydrogenase, glycerol dehydratase reactivating enzyme GdrAB and adenosyltransferase is inserted into the E. coli genomic DNA (chromosomally) with at least one copy number. See paragraphs 8-16, 22-32, 35-40, 45-56, 62.
Jo et al disclose the E. coli has the gene yqhD, glpk, ldha, ack-pta and/or gldA is deleted.
Jo et al disclose the 3-HP producing gene is inserted into genomic DNA by RNA-guided nuclease e.g. Cas9 which is the CRISPR-CAS9 (paragraph 62):
Jo et al disclose the E. coli having the 3-HP producing ability has the 3-HP producing ability increased in proportion to the copy number of the 3-HP producing gene. See paragraph 61.
Jo et al disclose a composition comprising the E. coli expressing the 3-HP producing gene. See paragraph 18.
The intended uses of the composition for determining 3 HP producing ability by confirming the 3-HP production by the E. coli bacterium is proportional to the copy number of the 3-HP producing gene inserted into the genomic DNA of the E. coli bacterium. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 3-5, 10-11, 12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over anticipated by Lee et al. KR20200051375A 5-13-2020 cited in IDS in view of in view of Ho et al KR20140094364 7-30-2014 cited in IDS and Frendewey et al. US 2016/0145646 5/26/2016 cited in IDS
Claim 1: Lee et al disclose an Escherichia coli (E. coli) that produces 3-hydroxypropionic acid (3-HP), transformed with a gene encoding adenosyltransferase inserted (integrated) into the genomic DNA with at least one copy number. See claim 1, paragraph 33, 35 and 38. Lee et al disclose the E. coli further comprises a gene encoding glycerol dehydratase, a gene encoding, aldehyde dehydrogenase and a gene encoding glycerol dehydratase reactivase. See paragraph 39, 52 and the claims.
Lee et al disclose a composition comprising the E. coli bacterium. See paragraph 45. The intended uses of the composition for determining 3 HP producing ability by confirming the 3-HP production by the E. coli bacterium is proportional to the copy number of the 3-HP producing gene inserted into the genomic DNA of the E. coli bacterium. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Lee et al does not disclose that the yqhD, glpK or gldA gene is deleted in the E. coli. Lee et al does not disclose the 3-HP producing gene is inserted where the 3-HP producing gene is inserted wherein the yqhD, glpK or gldA gene is deleted and does not disclose the 3-HP producing gene is inserted into the genomic DNA in the E. coli.
by CRISPR-Cas9 system.
Ho et al disclose in order to prevent the 1,3-propanediol dehydrogenase (yqhD) from becoming active, the gene encoding it may be partially disrupted or all of the genes removed so that its function is lost. Ho et al disclose that the glycerol kinase (glpK) and glycerol dehydrogenase (gldA) genes involved in glycerol metabolism were disrupted using lambda red recombinase method to obtain HP and in addition, to inhibit the production of 1,3-PDO (propanediol), another metabolite that can be produced from 3-hydroxypropionaldehyde (3-HPA), the precursor of 3-HP. Propanediol dehydrogenase (1,3-propanediol dehydrogenase, yqhD) genes were disrupted in the same manner. Ho et al also disclose that yqhD, glpK or gldA gene is deleted in the E. coli. See paragraphs 1-4 and 26.
Frendewey et al disclose a method for inserting a gene within a cell using CRISPR-Cas9 system. See abstract and paragraphs 5-6, 17 and 119. Frendewey et al disclose biallelic gene modifications which comprises simultaneous deletion of a nucleic acid sequence withing the cell and replacement with an exogenous nucleic aicd sequence. Frendewey et al disclose that nucleic acid inserts include segments of DNA to be integrated at genomic target loci. Integration of a nucleic acid insert at a target locus can result in addition of a nucleic acid sequence of interest to the target locus, deletion of a nucleic acid sequence of interest at the target locus, and/or replacement of a nucleic acid sequence of interest at the target locus (i.e., deletion and insertion) and that this process can be accomplished using the CRISPR/Cas9 system. See paragraph 103, 151, 185 and 196-198.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the E. coli of Lee et al by deleting the yqhD, glpK or gldA gene as taught by Ho et al using the gene deletion and replacement method using CRISPR/Cas9 taught by Frendewey et al wherein the 3-HP producing gene replaces the deleted yqhD, glpK or gldA gene, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Ho et al disclose that deletion of yqhD, glpK or gldA gene in the E. coli helps to increase 3-HP production and Lee et al teaches that the 3-HP producing gene is inserted into the E. coli genome and Frendewey et al disclose that the CRISPR-Cas9 system can be used to simultaneously delete a gene and replace with an exogenous nucleic acid into the genome of a cell.
Claim(s) 1, 3-5, 10-11, 12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jo et al. US 2023/0348942 11/22/2023 in view of Frendewey et al. US 2016/0145646 5/26/2016 cited in IDS.
Jo et al disclose an Escherichia coli bacterium having 3-hydroxypropionic acid producing capability, in which a foreign gene encoding at least one protein selected from the group consisting of glycerol dehydratase, aldehyde dehydrogenase, glycerol dehydratase reactivating enzyme GdrAB and adenosyltransferase is inserted into the E. coli genomic DNA (chromosomally) with at least one copy number. See paragraphs 8-16, 22-32, 35-40, 45-56, 62.
Jo et al disclose the E. coli has the gene yqhD, glpk, ldha, ack-pta and/or gldA is deleted.
Jo et al disclose the 3-HP producing gene is inserted into genomic DNA by RNA-guided nuclease e.g. Cas9 which is the CRISPR-CAS9 (paragraph 62):
Jo et al disclose the E. coli having the 3-HP producing ability has the 3-HP producing ability increased in proportion to the copy number of the 3-HP producing gene. See paragraph 61.
Jo et al disclose a composition comprising the E. coli expressing the 3-HP producing gene. See paragraph 18.
The intended uses of the composition for determining 3 HP producing ability by confirming the 3-HP production by the E. coli bacterium is proportional to the copy number of the 3-HP producing gene inserted into the genomic DNA of the E. coli bacterium is recited. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Jo et al does not disclose the 3-HP producing gene is inserted where the 3-HP producing gene is inserted wherein the yqhD, glpk, ldha, ack-pta and/or gldA gene is deleted.
Frendewey et al disclose a method for inserting a gene within a cell using CRISPR-Cas9 system. See abstract and paragraphs 5-6, 17 and 119. Frendewey et al disclose biallelic gene modifications which comprises simultaneous deletion of a nucleic acid sequence withing the cell and replacement with an exogenous nucleic aicd sequence. Frendewey et al disclose that nucleic acid inserts include segments of DNA to be integrated at genomic target loci. Integration of a nucleic acid insert at a target locus can result in addition of a nucleic acid sequence of interest to the target locus, deletion of a nucleic acid sequence of interest at the target locus, and/or replacement of a nucleic acid sequence of interest at the target locus (i.e., deletion and insertion) and that this process can be accomplished using the CRISPR/Cas9 system. See paragraph 103, 151, 185 and 196-198.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the E. coli of Jo et al by deleting the yqhD, glpk, ldha, ack-pta and/or gldA gene using the gene deletion and replacement method by CRISPR/Cas9 taught by Frendewey et al wherein the 3-HP producing gene replaces the deleted yqhD, glpk, ldha, ack-pta and/or gldA gene, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Jo et al disclose that deletion of yqhD, glpk, ldha, ack-pta and/or gldA gene in the E. coli helps to increase 3-HP production and that the 3-HP producing gene is inserted into the E. coli genome and Frendewey et al disclose that the CRISPR-Cas9 system can be used to simultaneously delete a gene and replace with an exogenous nucleic acid into the genome of a cell.
Duplicate Claims
Applicant is advised that should claims 7-8 be found allowable, claims 13-14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Status of Claims
Claims 1-20 are rejected.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645