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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 23, 2026, has been entered.
Claim Disposition
3. Claims 3-4, 8-9, 12-13, 15 and 26 have been cancelled. Claims 28-29 have been added. Claims 1-2, 5-7, 10-11, 14, 17, 18-25 and 27-29 are pending and are under examination.
Claim objection
4. Claims 1-2, 5-7, 10-11, 14, 17, 18-25 and 27-29 are objected to for the following informalities:
For clarity it is suggested that claim 1 is amended to add a transitional phase between the last two ‘wherein’ clause (such as ‘and’ or ‘or’). It is suggested that claim 1 is amended to delete, “further” in front of “…wherein the yeast cell belongs to a genus…”. Claim 1 should be amended to delete “and” after, ‘…..carbon chain length of 12….’. For clarity claim 1 should be amended to read, “….E8, E10-dodecadien-1-01, and [[further]] wherein the yeast cell belongs to….”. For clarity it is suggested that claim 1 is amended to recite “….at least 90% sequence identity to SEQ ID NO: 2 [[thereto]]….”. The dependent claims hereto are also included. See also claim 14 with similar language.
For clarity and precision of claim language it is suggested that claim 2 is amended to read, “The yeast cell of claim 1, [[…..wherein the at least one desaturase is at least two desaturases, and]] wherein the other desaturase in (b) is selected ….”.
For clarity it is suggested that claims 6 and 7 are amended to spell out the acronyms.
For clarity it is suggested that claim 28 is amended to recite “…..sequence identity….”.
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 1-2, 5-7, 10-11, 14, 17, 18-25 and 27-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 yeast cell that produces E8,E10-dodecadienyl coenzyme A, said yeast cell expressing at least one heterologous desaturase that introduces one or more double bonds in a fatty acyl-CoA having a carbon chain length of 12, thereby converting said fatty acyl-CoA to a desaturated fatty acyl-CoA, wherein at least part of said desaturated fatty acyl-CoA is E8,E10-dodecadienyl coenzyme A… ….” (see claim 1 in its entirety) and a method of using the yeast to do the same (see claim 14). The claimed invention lacks adequate written description for a yeast that produces the coenzyme A and expresses the heterologous desaturase or a functional variant thereof..”. Furthermore, the amended claimed invention recites a Markush of genus for the yeast cell and it is not clear if any or all yeast cells in these large genus can produce the desired results (note that claim 1 has large genus of organisms, however, claim 14 provides no genus and is generically and broadly drawn to any yeast). Moreover, the claimed invention encompasses a large variable genus of “functional variants thereof having at least 90% sequence identity any of the recited structures of the enzymes (no correlation is made between structure and function). Further, the yeast cell is recited as having two separate heterologous enzymes and it is not defined if they are introduced with the same gene or multiple genes or a construct.
The claimed invention is not adequately described with respect to the all that is encompassed in claim 7 (i.e. comprising a mutation of one or more genes encoding an elongate and resulting in a partial or total loss of elongase activity), see also the method of claim 14 (which are very broad). The scope of the claims far exceeds the disclosure in the specification. Therefore, the claimed invention is not adequately described and encompasses a large variable genus of products.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. 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 products or cells, 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).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Response to Arguments
6. Applicant’s arguments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection of record under 112 first paragraph remains and is amended to reflect changes made to the claims.
Applicant traverses the rejection under 112 first paragraph stating that the invention is adequately described, and the claims have been amended. Applicant also state that the specification have two very different yeast species Yarrowia lipolytica and Saccharomyces cerevisiae and that they can be considered as a representative of yeast as a whole. This argument is not persuasive when the method of claim 14 is not limited to any specific yeast and claim 1 recites a large genus with Candida, Cryptococcus, lipomyces, Rhodotorula, Trichosporon etc. Applicant opines that genetic tools exist that allow for engineering of the other yeast genera recited in amended claim 1. It is further stated that the other yeast genera are all known to naturally produce unsaturated fatty acids. This argument is not persuasive since the claims encompass any functional variant and not just the recited Cpo_CORQ for example. The specific structure is undisclosed and the specific species of the organism. Applicant has not demonstrated possession of he entire genus encompassed in the claims.
The claimed invention remains drawn to a large genus of enzymes, large genus of cells and does not adequately describe the activity claimed for the cell. Applicant points to S. cerevisiae and Y. lipolytica and the respective examples, however, the claimed invention is not limited to these and is directed to a large variable genus that is not demonstrated as within possession of the inventor and not commensurate in scope with the disclosure. Further the recited at least 90% is vast in terms of the amount of variability. Applicant argues that the claims are directed to a specific core structure, however, this argument is not persuasive since the structure includes mutations throughout as set forth in the claims and encompassed in the language “variant thereof”. Thus, for all these reasons the rejection remains.
Conclusion
7. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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