DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
2. The Amendment filed on January 26, 2026, has been received and entered.
Claim Disposition
3. Claims 2 and 6 have been cancelled. Claims 1, 3-5 and 7-15 are pending. Claims 1, 3-5 and 7-8 are under examination. Claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim objection
4. Claim 4 is objected to for the following informalities:
For clarity it is suggested that claim 4 is amended to spell out “PUFA”.
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, 3-5 and 7-8 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 method for producing a microbial oil comprising genetically modifying a labyrinthulid by disrupting and/or silencing a gene or by transforming another gene in addition to the disrupting and /or gene silencing of the gene… (see claim 1 in its entirety). The claimed invention is not adequately described with respect to the genes (no correlation is made between structure and function).
The claimed invention encompasses a broad variable genus of genes and transformed host cells that are not adequately described. The claimed invention requires disrupting/silencing a gene or additionally adding another gene and there are no indicia as to what genes are involved and it is noted that the claim recites that the gene can by a polyketide gene, fatty acid desaturase gene or fatty acid elongase gene, however this still does not put the expressed gene in the position of the applicant. Therefore, the claimed invention is not adequately described and encompasses a large variable genus of products. Note that the specification at paragraph [0004] discloses
that “the present invention relates to a method for transforming stramenopile whereby genes of stramenopile are disrupted and/or expression thereof is inhibited by genetic engineering. Particularly, the invention relates to a transformation method for disrupting genes associated with fatty acid biosynthesis and/or inhibiting expression thereof, a method for modifying the fatty acid composition of a stramenopile, a method for highly accumulating fatty acids in a stramenopile, a stramenopile having an enhanced unsaturated fatty acid content, a method for producing unsaturated fatty acid from the unsaturated fatty acid content-enhanced stramenopile, a microbial oil comprising the fatty acid obtained from microorganisms belonging to stramenopile, especially from the class Labyrinthulomycetes, and a method of producing the microbial …..”. The ordinary skilled worker does not get a glimpse of the structure of the genes, which is a large variable genus.
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, 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
6. Claim(s) 1 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Weaver et al. (WO2006/044646, 2006, of record in US 13/877225 parent application).
Claim 1 is directed to a method for genetically modifying a labyrinthulid (belongs to the genus of Schizochytrium) by disrupting and/or silencing a gene (which is OrfA), to produce microbial oil. Weaver et al. teach that their inventors have also created knockouts of Orf A, Orf B, and Orf C in Schizochytrium (see Example 4). The knockout strategy relies on the homologous recombination that has been demonstrated to occur in Schizochytrium” (page 88, last paragraph) and “genes encoding the Schizochytrium [polyunsaturated fatty acids] PUFA [polyketide synthase] PKS enzyme complex can be selectively inactivated (knocked out)” (Example 4, page 122). Therefore, the limitations of the claims are met by the reference.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that new rejections have been instituted for the reasons set forth above.
Conclusion
8. 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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