DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on November 26, 2025, have been received and entered.
Claim Disposition
3. Claim 7 has been cancelled. Claims 1-6 and 8-13 are pending and are under examination.
Specification Objection
4. The specification is objected to for the following informalities:
The specification is objected to because the priority information is missing from page 1.
Appropriate correction required.
Claim Objection
5. Claims 1-6 and 8-13 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “provide the specific microorganism having the enhanced activity”. It is also suggested that claim 1 is amended to incorporate claims 2 and 4 so that it is clear how the enhancement is achieved and what is modified. The dependent claims hereto are also included.
For clarity it is suggested that claim 2 is amended to provide the specific modifications that results in the enhancement (i.e. what modification is introduced). The dependent claims hereto are also included.
For clarity and consistency it is suggested that claim 9 is amended to recite, “of” instead of ‘according to’. The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claim 11 is amended to recite, “….43 of [[a]] the nucleotide sequence [[as]] set forth in SEQ ID NO:1”.
For clarity it is suggested that claim 13 is amended to recite, “….SEQ ID NOs: 3 to 5”. See also claim 6 wherein the sequence notation is improper.
Appropriate correction is required.
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.
6. Claims 1-6 and 8-13 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) contain 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 claimed invention is directed to an isolated microorganism of the genus Corynebacterium having enhanced activity that produces an L-branched chain amino acid, however, the claimed invention is broad and not adequately described. It encompasses a large variable genus of microorganisms and genes that could potentially assist with the production of said amino acids. There are no indicia in claim 1 about how the activity recited is enhanced. It is noted that claim 2 provides a modification introduced via a gene expression regulatory sequence, however said gene is not provided and this information does not limit claim 1 which is overly broad. It is noted that claims 4-5 provides a structure, however, is not limited to a specific organism and does not limit claim 1 as no structure-function correlation is made in claim 1. It is also noted that claim 8 provides the specific organism, however claim 1 needs to stand on its own. It is well established in the art that several different genes can encode the same protein and the claimed invention encompasses a large variable genus of foreign genes.
The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. The claimed invention is overly broad and encompasses large variable genus of genes, organisms and modifications (see claim 1). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of structures, modifications and organisms, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the fusion protein that encompasses mutants and fragments with no asserted activity.
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.
7. Claim(s) 1-2 and 8-10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (Scientific Reports 2018, of record in the application).
Zhang discloses Corynebacterium glutamicum grown in the presence of L-valine at a high level of production and utilized transcriptomics and proteomics. Zhang teach that the key genes involved in the biosynthesis of L-valine among others were up regulated in VWB-1 which together made prominent contributions in improving carbon flow. Furthermore, it is disclosed that the upregulation of the branched chain amino acid transporter genes promoted the L-valine secretion capability of VWB-1. Moreover, pyruvate accumulation was achieved through the weakening of the L-lactate, acetate and L-alanine pathways (see abstract and entire document). Therefore, the limitations of the claims are met by the reference.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejection will not be discussed herein as applicant’s comments are moot. Note that the rejections of record under 112 first paragraph and 102 remains but have been altered based on amendments made to the claims such as the cancellation of claim 7.
Regarding the 112, first paragraph applicant state that the claims have been amended and point to the disclosure in the specification as well as made assertions that one of skill in the art would know the missing information pointed out in the claims. This argument is not persuasive, firstly, the claimed invention in claim 1 remains broad and directed to a large genus not adequately described. The recitation of Corynebacterium without the species did not obviate this ground of rejection. Applicant has not demonstrated possession of the entire genus. The 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993). Thus for all these reasons the rejection remains.
Applicant traverses that art rejection stating that the cited reference does not teach the claimed invention. The invention is overly broad and thus the rejection remains relevant. The fact that the same organism and species is taught by the art and there is nothing in claim 1 to indicate a specific modification to achieve enhanced, this can be construed as inherent. Therefore, the rejection remains meritorious (specific embodiments need to be cited to obviate this ground of rejection as suggested above).
Conclusion
9. No claims are presently allowable.
10. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652