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. The Amendment filed on July 2, 2026, has been received and entered.
Claim Disposition
3. Claims 1-10, 12-15 and 17-20 have been cancelled. Claims 11, 16 and 21-25 are pending and are 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.
4. Claims 11, 16 and 21-25 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 a Saccharomyces cerevisiae an expression cassette comprising an additional copy of an endogenous gene or a strong promoter operably linked to an endogenous gene, wherein the endogenous gene encodes a protein…….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 endogenous gene, what protein has the elevated ratio and there’s no reference ratio for the comparison (see claim 11). It is noted that dependent claims recites that the undefined gene is introduced into an expression cassette with an additional copy of the endogenous gene; as well as additional genes from several pathways, among other modifications. Further, claimed invention 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 promoters to modify expression of an endogenous gene that encodes a protein having an elevated ratio of the pre-selected amino acid lysine. No structure-function correlation is made for the gene and its expression product. The method needs to identify what specific endogenous gene has an additional copy in the expression cassette and what protein is expressed that has the elevated ratio of lysine of 1.4. An ordinary skilled worker is invited to explore all the possibility since the method does not define critical parameters. Will the method work with any endogenous gene and any strong promoter and any protein expressed. Although, the vast majority of proteins contain at least one lysine residue, there are some specific proteins completely devoid of lysine (lysine is common but not universal). The art recognizes that there are hundreds of proteins with long stretches completely missing lysine (lysine deserts). Thus the claimed invention needs to be adequately described. Although lysine is identified as the amino acid no specific protein is claimed or the gene that is endogenous. The claimed invention also encompasses additional modifications such as alteration in pathways claimed in claims 22-25 which are not adequately described.
The invention as claimed recites the introduction of an additional copy of an endogenous gene and further alterations, however, this limitation is not defined, the same is true for the recited ‘stronger promoter’. No structure-function relationship is established for the gene and expression product, and no wild type is provided for comparison. There are no indicia in the claimed limitations regarding the structure of the endogenous 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
5. 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 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 organism etc. 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 cassette with an endogenous gene that encodes a protein with elevated levels of lysing, however, the gene and the product and strong promoter are not provided, just the resulting effect. 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. Applicant opines that the application provides examples of lysine-rich proteins having the features described, however none is recited in the claims (the limitations of the specification cannot be read into the claim). The claimed invention set forth in claim 11 is overly broad and encompasses a large variable genus of genes, proteins and promoter 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. Therefore, the rejection of record remains because the claimed invention is not adequately described.
Conclusion
6. No claims are presently allowable.
7. 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
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