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 .
Priority
This application claims benefit of priority to foreign application CN202111171829.4 filed 10/08/2021 and is also a 371 of PCT/CN2021/135643 filed 12/06/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, an English translation of the foreign patent documents was not provided. Therefore, for the purposes of applying prior art, the effective filing date of the claimed invention is the filing date of the PCT, 12/06/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 04/05/2024 and 01/16/2026 have been acknowledged and considered.
Drawings
The Drawings filed 04/05/2024 are accepted by the Examiner.
Claim Status
Claims 1-17 and 29-31 are currently pending and under examination.
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.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically Bacillus licheniformis BN11 deposited in the China Center for Type Culture Collection on 01/08/2016 as CCTCC NO: M2016026. Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials. It appears this deposit was not made under the Budapest Treaty. Additionally, Applicant has not provided an assurance statement.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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 3-6, 8, 10-11 and 16 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 3 recites “a D-lactate dehydrogenase gene ldhTi” in lines 3, 5 and 6 of the claim. It appears ldhTi is a specific D-lactate dehydrogenase gene because D-lactate dehydrogenase genes are generally referred to as ldhA or ldhD, however, one of ordinary skill in the art would not be reasonably apprised of which specific D-lactate dehydrogenase gene ldhTi is as it is not a well known gene nor does the instant Specification delineate which D-lactate dehydrogenase gene ldhTi is. Thus, claim 3 and all claims dependent upon claim 3 are indefinite. For the purposes of compact prosecution, ldhTi is being interpreted as any D-lactate dehydrogenase gene.
Claims 3-5 and 11 recite “a sequence of the … as shown in SEQ ID NO,” it is unclear what ‘as shown in’ is intended to mean. It is unclear if ‘as shown in’ means a sequence similar to the particular SEQ ID NO, the exact sequence of the SEQ ID NO, a small portion of the SEQ ID NO or even a longer sequence that includes other nucleic acids. Thus, the scope of the claim is unascertainable because the metes and bounds of “as shown in SEQ ID NO” are unclear, rendering claims 3-5 and 11, and all claims dependent on said claims, indefinite. It is suggested to amend each claim to recite “the sequence of the … is SEQ ID NO”
Regarding claims 3 and 5-6, the term “preferably” 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).
Claim 10 recites “wherein the promoter is Pals” in line 2 of the claim. It appears Pals is a specific promoter, however, one of ordinary skill in the art would not be reasonably apprised of which specific promoter Pals is as it is not a well-known promoter nor does the instant Specification delineate what a Pals promoter is. Thus, claim 10 is indefinite.
Regarding claim 16, the phrase “or a derivative thereof” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by “or a derivative thereof”), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). Additionally, it is noted the instant Specification does not define what a ‘derivative’ is, only provides two examples of what the derivative could be while also indicating the derivative is “not limited to” to the two examples given (Specification, Page 24, Paragraph 1). Thus, the scope of the claim is unascertainable because the metes and bounds of ‘or a derivative thereof’ are unclear, rendering claim 16 indefinite.
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.
(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.
Claims 1-2, 4-5, 12-17 and 29-31 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Jaitzig et al. (US 10837034 B2, 11/17/2020) (IDS Reference of 01/16/2026) as evidenced by Zalma et al. (Science Progress, 2021).
Regarding claims 1-2 and 5, Jaitzig et al. disclose a recombinant microorganism for the fermentative production of alanine (See entire document, Abstract). More specifically, a process for the fermentative production of alanine, pyruvate, succinate, aspartate, malate, lactate, valine and/or leucine, preferably succinate or alanine, more preferably alanine, most preferably L-alanine, comprising the steps of growing the microorganism according to the invention as defined in a fermenter and recovering the product (Column 25, Lines 27-39). Jaitzig et al. disclose the recombinant microorganism of the invention comprises:
introduced, increased or enhanced activity and/or expression of an asd or a gdhA gene encoding an aspartate-beta-semialdehyde dehydrogenase or a glutamate dehydrogenase, additionally having at least two, more preferably at least three, even more preferably at least four, even more preferably at least five, most preferably all of the features selected from the group of:
(a) a reduced, repressed or deleted activity and/or expression of a pflB gene encoding a pyruvate formate lyase I and
(b) a reduced, repressed or deleted activity and/or expression of a adhE gene encoding a bifunctional acetaldehyde-CoA dehydrogenase/iron-dependent alcohol dehydrogenase/pyruvate-formate lyase deactivase) and
(c) a reduced, repressed or deleted activity and/or expression of a IdhA gene encoding a NAD-dependent fermentative D-lactate dehydrogenase and
(d) a reduced, repressed or deleted activity and/or expression of a pta gene encoding a phosphate acetyltransferase and/or a reduced, repressed or deleted activity and/or expression of an ackA gene encoding an acetate kinase A and propionate kinase 2 and
(e) a reduced, repressed or deleted activity and/or expression of a frdA gene encoding a fumarate reductase and
(f) an introduced, increased or enhanced activity and/or expression of an alaD gene encoding an alanine dehydrogenase,
(g) a reduced, repressed or deleted activity and/or expression of a dadX gene encoding an alanine racemase
wherein the reduction, repression, deletion, introduction, increase or enhancement of the activity and/or expression of a gene is determined compared to a respective reference microorganism (Column 5, Lines 57-67 – Column 6, Lines 1-24).
Jaitzig et al. further disclose the alaD gene is from Geobacillus stearothermophilus (Column 6, Line 35), reading on a GSald gene. The fermentations are carried out in a temperature range from about 10°C to about 60°C (Column 18, Lines 50-52). It is noted Jaitzig et al. do not explicitly state the alaD gene from G. stearothermophilus is thermostable at 42°C to 55°C, however, it would be expected, absent evidence to the contrary, the alaD gene would be thermostable at all temperatures utilized for fermenting the recombinant microorganism, being 10°C to about 60°C, fully encompassing 42°C to 55°C. Thus, the alaD gene from G. stearothermophilus disclosed by Jaitzig et al. reads on a GSald gene thermostable at 42°C to 55°C.
Jaitzig et al. go on to state the recombinant microorganism of the invention may comprise further genetic modifications, such as mutations, knock-outs or enhanced or introduced enzyme activities that further improve yield and/or productivity of alanine, pyruvate, succinate, aspartate, malate, lactate, valine and/or leucine (Column 6, Lines 39-43).
Thus, Jaitzig et al. disclose a method of producing L-alanine or pyruvate, reading on a pyruvate synthesis pathway, via fermenting a recombinant microorganism wherein that microorganism has deleted activity and/or expression of a dadX gene encoding an alanine racemase and an introduced GSald gene thermostable at 42°C to 55°C, anticipating instant claims 1 and 5. Jaitzig et al. anticipate instant claim 2 insofar as disclosing the fermentative process can produce lactate, reading on a lactate synthesis pathway, and (C) reduced, repressed or deleted activity and/or expression of a ldhA gene encoding a NAD-dependent fermentative D-lactate dehydrogenase reads on inactivating or deleting a lactate dehydrogenase gene.
Regarding claim 4, see 112b above. Jaitzig et al. disclose the alaD gene comprises the nucleic acid sequence of SEQ ID NO: 1 or a sequence with at least 80% sequence identity to SEQ ID NO:1 (Column 10, Lines 31-40). SEQ ID NO:1 of Jaitzig et al. shares 72.1% sequence identity and 82.6% local similarity to instant SEQ ID NO:1., reading on a sequence of the GSald gene as shown in SEQ ID NO:1. A sequence alignment is provided below wherein Qy represents instant SEQ ID NO:1 and Db represents SEQ ID NO:1 disclosed by Jaitzig et al.
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Regarding claims 12 and 29, Jaitzig et al. disclose the fermentations are carried out in a temperature range from about 10°C to about 60°C (Column 18, Lines 50-52).
Regarding claims 13 and 30, Jaitzig et al. disclose species of the genus Bacillus can be utilized, including B. subtilis, B. lichenformis and B. amyloliquefaciens (Column 4, Lines 25-30). B. subtilis, B. lichenformis and B. amyloliquefaciens are all thermophilic strains, as evidenced by Zalma et al. Zalma et al. disclose multiple species of Bacillus that are thermophilic strains, including B. subtilis, B. lichenformis and B. amyloliquefaciens (Table 1 of Zalma et al.).
Regarding claim 14, Jaitzig et al. disclose the microorganism can be Bacillus (Claim 19 of Jaitzig et al.).
Regarding claims 15 and 31, Jaitzig et al. disclose species of the genus Bacillus can be utilized, including , B. lichenformis, B. coagulans and B. stearothermophilus (Column 4, Lines 25-29).
Regarding claim 16, see 112b above. As discussed above regarding claim 15, Jaitzig et al. disclose the utilized bacterial strain is B. lichenformis. As it is unclear exactly what ‘a derivative’ is, the disclosure of Jaitzig et al. of B. lichenformis reads on a derivative of B. lichenformis ATCC 14580.
Regarding claim 17, see 112b above. It is noted the only identifying information given by the instant Specification about B. lichenformis BN11 deposited as CCTCC NO: M2016026 is that it is a lactate-producing strain constructed from ATCC 14580 (Specification, Page 31, Paragraph 3). It is further noted a deposit number is simply an identifier, it does not distinguish the deposited strain from any other B. lichenformis strain absent a sequence or other definable characteristics. Thus, the B. lichenformis disclosed by Jaitzig et al. reads on B. lichenformis BN11 as Jaitzig et al. disclose a product of fermentation is lactate (Column 25, Lines 27-39) and the only characteristic given of B. lichenformis BN11 is that it can produce lactate.
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.
Claims 1-7, 9, 12-17 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jaitzig et al. (US 10837034 B2, 11/17/2020) (IDS Reference of 01/16/2026) as evidenced by Zalma et al. (Science Progress, 2021) in view of Yamamoto et al. (Applied and Environmental Microbiology, 2012) (IDS Reference of 04/05/2024).
The teachings of Jaitzig et al. are discussed above.
Regarding claim 3, see 112b above. As discussed above regarding claim 2, Jaitzig et al. disclose the fermentative process can produce lactate, reading on a lactate synthesis pathway, and (C) reduced, repressed or deleted activity and/or expression of a ldhA gene encoding a NAD-dependent fermentative D-lactate dehydrogenase, reading on deleting a D-lactate dehydrogenase gene. The gene being a D-lactate dehydrogenase indicates the strain possesses a D-lactate synthesis pathway.
Jaitzig et al. do not disclose the original strain posses a lactate dehydrogenase gene and a D-lactate dehydrogenase gene or inactivating or deleting both genes.
However, Yamamoto et al. disclose an engineered strain for producing alanine (See entire document, Abstract). Yamamoto et al. further disclose one of the engineered strains has an ldhA gene deletion to minimize the formation of major by-products (Page 4451, Right Column, Results, Paragraph 1). ldgA promotes the formation of lactate, a by-product, from pyruvate instead of the desired product, alanine, from pyruvate (Figure 1 of Yamamoto et al.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have deleted all lactate dehydrogenase genes in the original strain of Jaitzig et al., including D-lactate dehydrogenase, to minimize the formation of major by-products, like lactate and D-lactate, as taught by Yamamoto et al. motivated by the desire to promote the formation of the desired product, alanine.
Regarding claims 6 and 7, Jaitzig et al. do not disclose step S200, inserting a copy of a 6-Phosphofructokinase gene pfk and a copy of a pyruvate kinase gene pyk.
However, Yamamoto et al. disclose the overexpression of genes encoding glycolytic enzymes enhances glucose metabolism and alanine production (Title). More specifically, Yamamoto et al. disclose chromosomal integration of pyruvate kinase-encoding pyk and phosphofructokinase-encoding pfk into a strain, creating a recombinant strain called GLY2 (Abstract). Strain GLY2 improved the rate of alanine formation by 20% compared to a strain without the pyk and pfk genes (Abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have inserted a copy of a pfk gene and a pyk gene into the recombinant microorganism of Jaitzig et al. motivated by the desire to create a microorganism that can effectively produce alanine because Jaitzig et al. specifically state the recombinant microorganism can include further enzyme introductions that improve the yield of alanine and the introduction of a pfk gene introduces 6-phosphofructokinase and the introduction of a pyk gene introduces a pyruvate kinase, both enzymes, that improve the yield of alanine as taught by Yamamoto et al.
Regarding claim 9, Jaitzig et al. disclose the nucleic acid sequence to be expressed recombinantly is positioned behind the sequence acting as a promoter so that the two sequences are linked covalently to each other (Column 28, Lines 56-59). The expression construct, comprising the linked promoter and nucleic acid sequence to be expressed, can be inserted into the genome, for example, by transformation (Column 29, Lines 12-16).
Jaitzig et al. do not specifically disclose inserting a pfk and pyk gene (step S200) and a GSald gene (step S300) by adding a copy of the genes to the chromosome and ligating a promoter upstream from the promoter.
However, as discussed immediately above, it would have been obvious to have inserted a copy of a pfk gene and a pyk gene into the recombinant microorganism of Jaitzig et al. motivated by the desire to create a microorganism that can effectively produce alanine because Jaitzig et al. specifically state the recombinant microorganism can include further enzyme introductions that improve the yield of alanine and the introduction of a pfk gene introduces 6-phosphofructokinase and the introduction of a pyk gene introduces a pyruvate kinase, both enzymes, that improve the yield of alanine as taught by Yamamoto et al.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have inserted a copy of each gene into the genome, reading on a chromosome, and ligated a promoter upstream of the nucleic acid sequence encoding the genes because Jaitzig et al. specifically disclose the linked promoter and nucleic acid sequence to expressed can be inserted into the genome.
Claims 1-9, 12-17 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jaitzig et al. (US 10837034 B2, 11/17/2020) (IDS Reference of 01/16/2026) as evidenced by Zalma et al. (Science Progress, 2021) in view of Yamamoto et al. (Applied and Environmental Microbiology, 2012) (IDS Reference of 04/05/2024) and further in view of Zhang et al. (Applied Genetics and Molecular Biotechnology, 09/15/2007) (IDS Reference of 01/16/2026).
Regarding claim 8, as discussed above regarding claim 3, Jaitzig et al. disclose (C) reduced, repressed or deleted activity and/or expression of a ldhA gene encoding a NAD-dependent fermentative D-lactate dehydrogenase, reading on deleting a D-lactate dehydrogenase gene. Additionally, as discussed above regarding claim 1, Jaitzig et al. disclose deleted activity and/or expression of a dadX gene encoding an alanine racemase, reading on alr2, and an introduced GSald gene.
Neither Jaitzig et al. nor Yamamoto et al. disclose knocking out both alanine racemase genes, alr1 and alr2.
However, Zhang et al. disclose a genetically engineered strain to produce L-alanine (See entire document, Abstract). Zhang et al. further disclose there are two distinct alanine racemase genes, alr and dadX, which are responsible for the conversion between L-alanine and D-alanine (Page 363, Right Column, Last Paragraph). Zhang et al. further disclose deleting the dadX gene to increase the purity of L-alanine (Page 364, Left Column, Paragraph 1). The gene for alanine racemase 1 is alr1 and the gene for alanine racemase 2, or alr2, is dadX (Figure 1 of Zhang et al.).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to knock out all alanine racemase genes, including alr1 and dadX, in the recombinant microorganism of Jaitzig et al. motivated by the desire to promote the formation of L-alanine because Zhang et al. teach the alanine racemase genes are responsible for the conversion of L-alanine to D-alanine.
Claims 1-2, 4-5, 10-17 and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Jaitzig et al. (US 10837034 B2, 11/17/2020) (IDS Reference of 01/16/2026) as evidenced by Zalma et al. (Science Progress, 2021) in view of Xu et al. (US 20190040425 A1, 02/07/2019).
Regarding claims 10-11, Jaitzig et al. do not disclose the promoter is Pals or the promoter is a sequence of SEQ ID NO:2.
However, Xu et al. disclose a method for producing D-lactic acid through fermentation at high temperatures which can reduce the production cost (See entire document, Abstract). Xu et al. further disclose the use of a promoter, Pals (Paragraph [0036]), which is encoded by SEQ ID NO: 69 (Paragraph [0162]). The Pals promoter disclosed by Xu et al. shares 100% sequence identity to instant SEQ ID NO:2. An alignment is provided below wherein Qy is instant SEQ ID NO:2 and Db is SEQ ID NO:69 disclosed by Xu et al.
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Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the Pals promoter disclosed by Xu et al. in the method of Jaitzig et al. because the method does not require a specific promoter and the Pals promoter was a known and effective promoter as taught by Xu et al. for use in engineered strains motivated by the desire to create an effective expression construct.
Regarding claim 17, Jaitzig et al. do not explicitly disclose the original strain is B. licheniformis BN11 deposited in the China Center for Type Culture Collection on 01/08/2016 as CCTCC NO: M2016026.
However, Xu et al. disclose the gene engineering strain is B. licheniformis BN11 with preservation number CCTCC NO: M2016026 preserved in the China Center for Type Culture Collection on 01/08/2016.
Thus, it would have been obvious to one of ordinary skill in the art to utilize B. licheniformis BN11 as the original strain in the recombinant organism of Jaitzig et al. because Jaitzig et al. disclose B. licheniformis is a strain usable in their method and B. licheniformis BN11 was a known and effective strain for genetic engineering as taught by Xu et al. motivated by the desire to create a recombinant microorganism that can effectively create the desired product.
Conclusion
Claims 1-17 and 29-31 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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