DETAILED CORRESPONDENCE
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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 7, 2025, has been entered.
Claim Disposition
3. Claims 22-25 have been added. Claims 1-10, 12, 15 and 17 have been cancelled. Claims 11, 13-14, 16 and 18-25 are pending and are under examination.
Claim Objection
4. Claims 20, 22-23 and 25 are objected to because of the following informalities:
For clarity it is suggested that claims 20, 22-23 and 25 are amended to add the transitional phrase, “and” between the two ‘wherein’ clause ( for example, “….wherein the microorganism further……; and wherein the carbohydrate…”).
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.
5. Claims 11, 13-14, 16 and 18-25 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 claimed invention as amended is directed to a method for increasing nutritional value of a microorganism in a food or feed composition, comprising introducing into the microorganism a genetic modification that increases the expression of an endogenous gene encoding a protein having an elevated ratio of a preselected amino acid relative to the total amino acid content of the protein, of at least 1.4 compared to the ratio of the preselected amino acid relative to the total amino acid content of all proteins produced by the microorganism, wherein the preselected amino acid confers a nutritional benefit to the food or feed composition compared to an otherwise identical food or feed composition comprising an otherwise identical microorganism (Saccharomyces sp.), …wherein the microorganism is lysine. The claimed invention is not adequately described because the method does not define what nutritional value is increased in the microorganism, what genetic modification is introduced, what endogenous gene, what protein has the elevated ratio and there’s no reference ratio for the comparison (see claim 11). It is noted that claim 13 recites that the genetic modification is an introduced expression cassette with an additional copy of the endogenous gene. Further, claim 14 indicates that the modification is a promoter of the endogenous gene to increase expression of the endogenous gene, which is not identified nor is the increase quantified. The invention provides what is referenced as an elevated ratio, however, there is no baseline provided to demonstrate the ‘elevation’ or increase. Claim 11 needs to stand on its own and the claimed invention is not adequately described.
The specification at paragraphs [0007, 0015, 0017 and 0025] and claims 11,13-14,16 and 18-25 all disclose and recite “confers/conferring a nutritional benefit to the food/feed” which is very broad and not descriptive. It is understood that nutritional benefit can mean improvement, or just simply adding micronutrients or other components such as adding vitamins, pro/pre-biotics, and phytochemicals. The instant claims recite pre-selected amino acids confers a nutritional benefit to the food/feed, however, the claims do not recite what genetic modification aligns with the amino acid or value/benefit, thus not adequately described.
The claimed invention is not adequately described because it encompasses a large variable genus of genes, proteins and genetic modifications that could modify expression of an endogenous gene that encodes a protein having an elevated ratio of pre-selected amino acids. No structure-function correlation is made for the gene and its expression product. Although, claim 11 recites Saccharomyces sp., claim 11 is not limited to that and that yeast category is also broad, and although lysine is identified as the amino acid no specific protein is claimed or the gene that is endogenous or exogenous.
The invention as claimed recites the introduction of an additional copy of an endogenous gene, however, this limitation is not defined, the same is true for the recited ‘stronger promoter’. The limitation of a modification is also not adequately described as no specific negative or positive regulators are provided. The claimed invention is directed to an endogenous gene being manipulated, however, claim 19 has a negative proviso of not comprising an exogenous gene, which means claim 11 encompasses several which is not adequately described. Further, claim 20 is directed to an exogenous gene encoding a carbohydrate processing enzyme and/or other polypeptides, which are not adequately described since no specific gene is provided.
No structure-function relationship is established for the gene and expression product, no wild type is provided for comparison, no specific host cell is identified, and the method does not define specific mutations/modification. There are no indicia in the claimed limitations regarding the structure of the exogenous gene. The claimed invention does not inform an ordinary skilled worker of the metes and bounds.
The claimed invention requires a product that is not adequately described because there is no structure-function correlation provided for the broad variable genus of genes and expression products encompassed in the claims. 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, 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.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejections of record under 112, first paragraph and 102 remain but have been altered based on amendments made to claims.
With regard to the 112, first paragraph rejection, applicant traverses the rejection by stating that claim 11 has been amended and it recites the genetic modification to the organism increases the expression of an endogenous gene; and the microorganism and the preselected amino acid are provided. This argument is not persuasive because the amendments did not address all the issues raised. The claimed invention as set forth in claim 11 recites, “introducing into the microorganism a genetic modification that increase the expression of an endogenous gene encoding a protein having an elevated ratio of a preselected amino acid…”, the amino acid is provided as being lysine, however, the modification is not provided, just the resulting effect, nor the gene or the expression product thereof. The art recognizes that several different genes can encode the same protein and applicant in the method needs to inform the ordinary skilled worker what steps were taken in the method. What specific modification was introduced into the organism to result in an elevated ratio and what specific gene expression was increased. The claimed invention set forth in claim 11 is overly broad and encompasses a large variable genus of genes, proteins and modifications that are not adequately described. Applicant also points to the specification. It is noted what is disclosed in the specification, however, the limitations of the specification cannot be imported into the claims. It is also noted that dependent claims recite the missing information in claim 11, however, claim 11 needs to stand on its own. Also note the large genus encompassed in claim 20 (any exogenous gene and alteration, although a laundry list of enzymes are provided). Therefore, the rejection of record remains because the claimed invention is not adequately described.
Conclusion
7. No claims are presently allowable.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652