DETAILED ACTION
Claim Rejections - 35 USC § 112-2nd paragraph
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 1-21 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.
Claims 1-7 and 9-21 are vague and indefinite because it the mere recitation of a name to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the nucleic acid of the gene coding for the protein having the function of an L-arginine:glycine aminidontransferase, the genes coding for the enzymes in claims 5, 11, 14, 18, etc., which would allow for one to identify the gene without ambiguity. The claims also do not make it clear that these are heterologous genes and/or that the microorganism is a host cell. The arginine exporter is only identified by ‘name’. The mere recitation of a name does not adequately define the claimed gene. Further, the claims are unclear if this is a host cell or a mutated wild-type cell. A “microorganism” encompasses a virus, bacterium, fungus, etc. The metes and bounds of the claim are unclear. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claims 1-21 are vague and indefinite as they relate to a microorganism having a "decreased activity", "attenuated", "overexpress", "inactivated" of a given protein encompasses any cell that at a given time and circumstances of the cell cycle shows a different expression level of it. Moreover, a comparison with a wild type microorganism is vague and not definitive since the term "wild type microorganism" is not defined in scope and the claim lack the technical features needed for a comparison "at the same status of the cell cycle." While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Written Description
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.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to, for example:
1. (Currently Amended): A microorganism having an increased ability to provide L-arginine compared with the ability of the wildtype microorganism, and comprising; at least one gene coding for a protein having the function of an L-arginine/glycine amidinotransferase and having a decreased activity of a protein having the function of an arginine exporter compared with the activity of the respective protein in the wildtype microorganism at the same status of the cell cycle.
8. (Currently Amended): The microorganism of any of the preceding claims claim 1, wherein the protein having the function of an L-arginine:glycine amidinotransferase comprises an amino acid sequence which is at least 70% identical to the amino acid sequence according to SEQ ID NO: 13.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed microorganisms such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
The claims allow for any microorganism, any gene from any microorganism of any structure as long as it has the function of L-arginine:gylycine having a decreased activity of a protein that functions as an arginine exporter. This allows for many different microorganisms with vastly different proteins from many different sources.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described. With respect to the genes of the microorganisms and the proteins they encode, Devos et al., (Proteins: Structure, Function and Genetics, 2000, Vol. 41: 98-107), teach that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, page 98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude that "Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, and page 105). Further, Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340,) also highlight the difficulties associated with "Prediction of protein function from protein sequence and structure": "To reason from sequence and structure to function is to step onto much shakier ground", closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, to reason from sequence and structure to function is to step onto much shakier ground, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein's role fundamentally (page 323, paragraph 1). C. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function);
Because the art is unpredictable, in accordance with the Written Description Guidelines, the recitation of "a sequence at least 70% identical to one of SEQ ID No: 13” with any changes (and any combination of changes) or the recitation just that the protein comprises SEQ ID NO: 13 is not adequate. The scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
There are no drawings or structural formulas disclosed of any of thesefragments or variants of the claimed polynucleotides. There is no teaching in thespecification regarding which 30% of the structure can be varied and still produce a polypeptide which has at least two of the recited enzymatic activities. Although the disclosure of SEQ ID NO: 13 combined with the knowledge in the art, may put one in possession of peptides that are at least 70% identical to SEQ ID NO: 13, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those peptides would have the required functional activities. Based on the lack of knowledge and predictability in the art, those of ordinary skill in the art would not conclude that the applicant was in possession of theclaimed genus of modified microorganisms and the heterologous genes contained within them.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
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 –
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) 1-7 and 9, 11, 13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (ACS SYNTHETIC BIOLOGY, vol. 9, no. 8, July 23, 2020, pages 2066-2075, provided by Applicants).
Zhang et al discloses Escherichia coli strain C24 carrying a plasmid expressing L- arginine:glycine amidinotransferase (AGAT) from Amycolatopsis kentuckyensis (AkAGAT) and glutamine synthase from Corynebacterium glutamicum (CgglnA); carbamoyl phosphate synthase II operon (carAB) under a constitutive heterologous promoter; a plasmid overexpressing argFI (ornithine carbamoyltranferase), argG and argH. The strain produces an increased amount of both guanidino acetic acid (GAA) as precursor of creatine (see introduction) and arginine (see Fig 5). The AGAT from Moorea producens is also tested (see Fig. 1). It should be noted that the drafting of claims 1, 2, 6, in so far it relates to a microorganism having a "decreased activity", "attenuated", "overexpress", "inactivated" of a given protein encompasses any cell that at a given time and circumstances of the cell cycle shows a different expression level of it.
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.
Claim(s) 12, 14 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (ACS SYNTHETIC BIOLOGY, vol. 9, no. 8, July 23, 2020, pages 2066-2075, provided by Applicants) in view of Lubitz et al (APPLIED MICROBIOLOGY AND BIOTECHNOLOGY, SPRINGER BERLIN HEIDELBERG, BERLIN/HEIDELBERG, vol. 100, no. 19, June 27, 2016, pages 8465-8474; provided by Applicants) and Ginsey et al (MICROBIAL CELL FACTORIES,, vol. 14, no. 1, March 7, 2015, pages 1-11, provided by Applicants).
The teachings of Zhang et al are set forth above.
Lubitz teaches that L-arginine is a semi-essential amino acid with application in cosmetic, pharmaceutical, and food industries. Metabolic engineering strategies have been applied for overproduction of L-arginine by Corynebacterium glutamicum. LysE was the only known L-arginine exporter of this bacterium. However, an l-arginine-producing strain carrying a deletion of lysE still accumulated about 10 mM l-arginine in the growth medium. Overexpression of the putative putrescine and cadaverine export permease gene cgmA was shown to compensate for the lack of lysE with regard to l-arginine export. Moreover, plasmid-borne overexpression of cgmA rescued the toxic effect caused by feeding of the dipeptide Arg-Ala to lysE-deficient C. glutamicum and argO-deficient Escherichia coli strains. Deletion of the repressor gene cgmR improved l-arginine titers by 5 %. Production of l-lysine and l-citrulline was not affected by cgmA overexpression. Taken together, CgmA may function as an export system not only for the diamine putrescine and cadaverine but also for l-arginine. The major export system for l-lysine and l-arginine LysE may also play a role in l-citrulline export since production of l-citrulline was reduced when lysE was deleted and improved by 45 % when lysE was overproduced. See abstract. Lubitz discloses ArgR, lysG and LysE deficient C. glutamicum strains ARG2deltaLysEG, ARG2deltacmgR-deltaLysEG ARG2deltacmgO-deltaLysEG and ARG2deltacmgOp-deltaLysEG (see table 1). Strain ARG2deltacmgOp deltaLysE results in an increased production of arginine ( Fig 1).
Ginsey aims to improve arginine production in Escherichia coli by metabolic engineering and to establish a fermentation process in 1-L bioreactor scale to evaluate the different mutants. Ginsey discloses E. coli mutants having ArgR gene deleted that result in enhanced arginine production. In this study, E. coli was successfully engineered for enhanced arginine production. The ∆adiA, ∆speC, ∆speF, ∆argR, ∆argA mutant with high gene copy number of argA214 and argO produced 11.64 g/L of arginine in batch fermentation, thereby demonstrated the potential of E. coli as an industrial producer of arginine. Ginsey teaches E.coli also possesses machineries for the export of some amino acids, including arginine. The arginine export pump ArgO, encoded by the argO gene, is transcriptionally regulated by ArgP . The latter is responsive to intracellular arginine levels and activates the transcription of argO accordingly. Ginsey teaches that arginine production was significantly increased by overexpression of either argP or argO. In the Conclusion, Ginsey reports the development E. coli strains overproducing arginine, by targeting genes regulating repression of arginine biosynthesis and competing degradation pathways in addition to amplification of genes for N-acetylglutamate formation and arginine export. The two final strains obtained (SJB009 and SJB010) had the highest arginine yield (1.18 and 0.44 g arg/g glc, respectively) and productivity (0.24 and 0.29 g arg/L/h, respectively) and will be used for further genetic improvement and/or process optimization.
The difference with Zhang lies in the arginine exporter. The problem to be solved can be seen as the provision of a further mutation involved in the production of arginine. the solution is the deletion of a transcriptional activator of the arginine exporter and this is disclosed in Lubitz et al. and Ginsey. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to delete the activator of the arginine exporter as taught by Lubitz since it was another means to increase the amount L-arginine in the modified bacterial cell and Ginsey also discloses E. coli mutants having ArgR gene deleted that result in enhanced arginine production.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,312,622. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a microorganism with at least one heterologous gene coding for a protein having a function of L-arginine:glycine amidinotranfersase (instant claim 1), and additionally carbamoyl transferase (instant claim 5). Patent claim 7 recites that the microorganism has increased ability to produce L-arginine (instant claim 1). Patent claim 8 recites that the ArgR gene is attenuated compared to wild-type (instant claim 1 and 2). Methods of fermentation of GAA with the same method steps are also disclosed. Accordingly, the scope of the two sets of claims is not patentably distinct.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,065,677. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a microorganism with at least one heterologous gene coding for a protein having a function of L-arginine:glycine amidinotranfersase (instant claim 1), and additionally carbamoyl transferase (instant claim 5; patent claim 6). Patent claim 3 recites that the microorganism has increased ability to produce L-arginine (instant claim 1). Patent claim 12 recites that the ArgR gene is attenuated compared to wild-type (instant claim 1 and 2). Methods of fermentation of GAA with the same method steps are also disclosed. Accordingly, the scope of the two sets of claims is not patentably distinct.
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,065,677. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a microorganism with at least one heterologous gene coding for a protein having a function of L-arginine:glycine amidinotranfersase (instant claim 1), and additionally carbamoyl transferase (instant claim 5; patent claim 4). Patent claim 3 recites that the microorganism has increased ability to produce L-arginine (instant claim 1). Patent claim 12 recites that the ArgR gene is attenuated compared to wild-type (instant claim 1 and 2). Methods of fermentation of GAA with the same method steps are also disclosed. Accordingly, the scope of the two sets of claims is not patentably distinct
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,999,982. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a microorganism with at least one heterologous gene coding for a protein having a function of L-arginine:glycine amidinotranfersase (instant claim 1), and additionally carbamoyl transferase (instant claim 5; patent claim 7). Patent claim 6 recites that the microorganism has increased ability to produce L-arginine (instant claim 1). Patent claim 13 recites that the ArgR gene is attenuated compared to wild-type (instant claim 1 and 2). Methods of fermentation of GAA with the same method steps are also disclosed. Accordingly, the scope of the two sets of claims is not patentably distinct.
Claims 1-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4-23 of copending Application No. 18/869,988 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims recite a microorganism with at least one heterologous gene coding for a protein having a function of L-arginine:glycine amidinotranfersase (instant claim 1), and additionally carbamoyl transferase (instant claim 5; co-pending claim 7). Co-pending claim 12 recites that the microorganism has increased ability to produce L-arginine (instant claim 1). Co-pending claim 11 recites that the ArgR gene is attenuated compared to wild-type (instant claim 1 and 2). Methods of fermentation of GAA with the same method steps are also disclosed. Accordingly, the scope of the two sets of claims is not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 3/11/26