DETAILED ACTION
Acknowledgment and entry of the Amendment submitted on 6/12/26 is made.
Claims 1-6, 8, 10 and 12-23 are currently pending.
The prior art rejections under 35 USC 102 and 103 have been withdrawn pursuant to the amendment to the claims.
Allowable Subject Matter
New claims 22 and 23 are allowed.
Claim 8 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-6, 10 and 12-21 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 1-6, 10, 12-21 are vague and indefinite because 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’, as well as the numerous other proteins/genes in the dependent claims. The mere recitation of a name does not adequately define the claimed gene. 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 one to identify what is being claimed. Appropriate clarification and/or correction is required.
Response to Applicants’ arguments:
Applicants argue:
Claim 1 is believed to be sufficiently definite. It was amended to describe a heterologous gene coding for a protein having the function of an L-arginine:glycine amidinotransferase. It was also amended to recite that a gene of the microorganism coding for a protein having the function of an arginine exporter is inactivated or deleted. Further, the microorganism was specified, and the cell cycle language was deleted.
This has been fully and carefully considered but is not deemed persuasive. The claims still do not provide any structure for this gene or protein, or for the numerous other genes and proteins recited in the dependent claims. There are many recitations that specify proteins and genes by function rather than specific names (for example, L-arginine ), such as " L-ornithine : at least one gene encoding proteins having the function of glycine amidinotransferase", "proteins having the function of arginine exporter", "enzymatic activity having the function of carbamoyl phosphate synthase", "at least one or more genes encoding enzymes of L-arginine and guanidinoacetate N-n methyltransferase biosynthetic pathways", and "genes encoding enzymes having the activity of ArgR, argF/argF2, argH, etc. However, it cannot be said that the specific proteins and genes having the function in a certain microorganism have been described to the extent that they can be naturally understood for patent protection purposes. The metes and bounds of the claim cannot be readily understood. The mere recitation of a name does not adequately define the claimed gene. 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 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 1-6,10 and 12-21 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:
(Currently Amended): A microorganism having an increased ability to provide L-arginine compared with the ability of the wildtype microorganism, comprising: at least one heterologous gene coding for a protein having the function of an L- arginine:glycine amidinotransferase wherein a gene of the microorganism coding for a protein having the function of an arginine exporter is inactivated or deleted. wherein the microorganism belongs to the genus Corynebacterium, to the family Enterobacteriaceae or to the genus Pseudomonas.
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);
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. 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
Response to Applicants’ arguments:
Applicants argue:
Regarding claim 1, a person having ordinary skill in the art can readily understand the meaning and scope of a heterologous gene coding for a protein having the function of an L-arginine:glycine amidinotransferase, without specifying the specific protein. Examples of such genes that are suitable are provided in the present specification and are known in the literature. See the present specification at page 4, lines 16- 31, and page 6, lines 7-32.
This has been fully and carefully considered but is not deemed persuasive.
In the claims, there are many recitations that specify proteins and genes by function rather than specific names (for example, L-arginine ), such as " L-ornithine : at least one gene encoding proteins having the function of glycine amidinotransferase", "proteins having the function of arginine exporter", "enzymatic activity having the function of carbamoyl phosphate synthase", "at least one or more genes encoding enzymes of L-arginine and guanidinoacetate N-n methyltransferase biosynthetic pathways", and "genes encoding enzymes having the activity of ArgR, argF/argF2, argH, etc. However, it cannot be said that the specific proteins and genes having the function in a certain microorganism have been clarified to the extent that they can be naturally understood from the common technical knowledge in the art at the time the invention was made. Then, even if it can be predicted to some extent from the identity of the protein or gene sequence, it is common technical knowledge at the time of filing the present application that whether or not the function is actually preserved cannot be known unless the activity is confirmed by experiments. On the other hand, only specific proteins and genes such as MpAGAT are used in the detailed description of the invention of the present application. Thus, it is an excessive trial and error for a person skilled in the art to identify a protein or gene actually having the function specified in the claims from a large number of genes possessed by the microorganism. In addition, the disclosure of the invention in the instant specification cannot be extended or generalized to those using proteins or genes whose specific names are not specified, and the inventions according to the claims are beyond the scope described so that a person skilled in the art can understand that the problems described in the detailed description of the invention (providing "microorganisms transformed to enable the production of guanidinoacetic acid (GAA), and a method for producing GAA by fermentation using such microorganisms" and "a method for producing creatine by fermentation": paragraph [0001]) can be solved. In addition, it cannot be said that a person skilled in the art can uniquely understand which protein or gene is specifically included and which protein or gene is not specifically included in the protein or gene specified by the function, and the outer edge of the invention is unclear. Therefore, the detailed description of the invention of this application is not clearly and sufficiently described to the extent that a person skilled in the art could implement the inventions according to the above-mentioned claims. In addition, the inventions according to the above-mentioned claims are not described in the detailed description of the invention. In addition, the inventions according to the above-mentioned claims are unclear.
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 1-6, 10 and 12-21 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 1-6, 10 and 12-21 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 1-6,10 and 12-21 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 1-6,10 and 12-21 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.
Response to Applicants’ arguments:
Applicants argue:
None of the reference patents or patent application claims discloses or suggests the feature wherein a gene of the microorganism coding for a protein having the function of an arginine exporter is inactivated or deleted. Therefore, these claims do not render the present claims obvious.
These arguments have been fully and carefully considered but are not deemed persuasive. Each of the cited reference patents and patent application do teach “a gene of the microorganism coding for a protein having the function of an arginine exporter is inactivated or deleted.” In US Patent No. 11,999,982, see claim 13. In US Patent No. 12,312,622, see claim 8. In US Patent No. 12,065,677, see claim 12. In reference application no. 18/869,988, see claim 11.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 8/24/26
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