DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to claims 1-2, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 in the reply filed on 11/26/2025 is acknowledged.
Status of Claims
Claims 1-2, 8, 15, 21, 29-30, 32, 42, 47, 50, 52, 55 and 57-62 are pending.
Claims 57-62 are withdrawn as drawn to an unelected invention.
Claims 1-2, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities: in Line 34 of Page 57 there appears to be a typographical error. The specification reads “DHA201.1 contains”, however in the line immediately before this there is a subsection title “Design of DHA2015.1” and nowhere else in this section is DHA201.1 recited. As such it appears that “DHA201.1” should read “DHA2015.1”.
Appropriate correction is required.
Claim Objections
Claims 1-2, 8, 15, 21, 29-30, 32, 42, 47 and 55 are objected to because of the following informalities: each of these claims recites a/the “recombinant plant, part thereof or plant cell”. This language is awkward and while it is clear from the context of the claim that the plant cell is a recombinant plant cell the language could be changed to improve syntax. The office suggests changing the existing language to “recombinant plant, a part thereof or a recombinant plant cell” would improve syntax and promote clarity.
Appropriate correction is requested.
Claim 47 is objected to because of the following informalities: the claim recites “LC-PUFAs”. This appears to be an abbreviation of long chain polyunsaturated fatty acids and therefore the first time this is recited in the claim, the full name should be written out followed by the abbreviation in parenthesis and the abbreviation alone can be used thereafter.
Claim Rejections - 35 USC § 112 (Indefiniteness)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 1 and 21, the recitation of “an enzyme involved in the synthesis of very long chain fatty acids (VLCFAs)” renders the claim indefinite. This is because it is not clear what involved means in this context and as such the scope of enzymes involved in the synthesis of VLCFAs is unclear. For example under a narrow interpretation the enzymes involved in the synthesis of VLCFAs are those enzymes which catalyze specific reactions which produce these fatty acids which figure 1 of Bach presents as a condensing enzyme, 3-keto-acyl-CoA reductase, 2-hydroxy-acyl-CoA dehydratase and 2,3-trans-enoyl reductase (Bach, Comptes rendus biologies 333.4 2010). In contrast a broad interpretation of enzymes involved in the synthesis of very long chain fatty acids could include any enzyme involved in fatty acid metabolism or catabolism as these enzymes effect the concentration and availability of precursors and substrates required for the synthesis of very long chain fatty acids. As such the use of the term “involved” when describing enzymes related to the synthesis of very long chain fatty acids introduces at least two distinct scopes of the claims and renders claims 1 and 21 indefinite. All dependent claims are included for failing to limit claim scope to definite subject matter.
In claim 1, the recitation of “at least one nucleic acid sequence encoding a ∆6-elongase, a ∆5-desaturase and a ∆6-desaturase” renders the claim indefinite. This is because the language introduces more than one distinct scope of the invention. For example, a more narrow scope of the claim is limited to one or more nucleic acids which each encode all three of a ∆6-elongase, a ∆5-desaturase and a ∆6-desaturase. A more broad scope of the claim is drawn to one or more nucleic acids which in combination encode a ∆6-elongase, a ∆5-desaturase and a ∆6-desaturase. These scopes differ in that the more narrow one limits the claims to nucleic acids which encode all three enzymes while the more broad requires only that all three genes must be encoded on the nucleic acids but that there may be three distinct nucleic acids each encoding one enzyme.
These differences arise because in the more narrow interpretation “at least one” is interpreted to mean at least one nucleic acid encodes all three enzymes while in the more broad interpretation “at least one” is interpreted to mean that ethe three enzymes are encoded on at least one nucleic acid but may be encoded separately on more than one nucleic acid.
As such the phrase is not just broad but indefinite because the precise scope imparted on the claims by this recitation is not clear.
Claim 8 which limits the enzymes to those from specific sources highlights the above analysis. In this claim the three enzymes are derived from different organisms which indicates that they are encoded by different nucleic acids, however in order to facilitate efficient transformation there would have been motivation to fuse each enzyme to the other creating a single nucleic acid encoding all three enzymes.
Further, claim 29 which depends on claim 1 recites “The recombinant plant, part thereof or plant cell of claim 1, wherein the nucleic acid sequences are each operably linked to a regulatory sequence”. This indicates that there are multiple nucleic acid sequence which each encode one gene. Should this not be the intended scope of claim 1, claim 29 should be amended to recite “the at least one nucleic acid sequence” in order to prevent a lack of antecedent basis for the term “the nucleic acid sequences”.
As such claim 1 is rejected as indefinite and all dependent claims are also rejected as depending on an indefinite claim and failing to limit the scope of the claims to definite subject matter.
In claim 1, the recitation of “has reduced expression or activity of a gene encoding an enzyme” renders the claim indefinite because reduced is a term of degree and without a reference to judge the expression or activity against it is not possible to known if a recombinant plant comprised reduced expression of a gene encoding an enzyme. As such claim 1 is rejected as indefinite and all dependent claims are similarly rejected for depending on an independent claim and failing to limit the claim scope to definite subject matter.
In claim 8, the use of the phrase “is derived from” to describe the relationship between enzymes and organisms renders the claim indefinite. This is because the use of the term “derived” in this context imparts at least two distinct scopes to the claims. A first scope interprets derived from to mean that the enzymes are the exact enzymes from the specific organism. The second scope interprets derived from to mean that the enzymes started as the enzymes from those specific organisms but that changes have occurred or been made to those enzymes such that a new or modified enzyme derived from the enzyme of the specific organism has been produced and that is what is claimed.
This demonstrates that the use of “is derived from” in this context introduces at least two different distinct scopes of the claims and as such claim 8 is rejected as indefinite.
In claim 32, the description of the seed oil is indefinite.
First the claim states that “wherein the seed oil is characterized by increased EPA and/or DHA” but there is no reference state with which to compare EPA and DHA levels and without a reference it is not possible to know if EPA or DHA levels are increased and therefore the scope imparted by this phrase is unclear and this phrase renders the claim indefinite.
Second, the claim states that “wherein the seed oil is characterized by increased EPA and/or DHA, wherein EPA constitutes at least 5% (mole%) of the total fatty acid content of said oil, and wherein DHA constitutes at least 5% (mole%) of the total fatty acid content of said oil”. This is indefinite because the claim states the EPA and/or DHA level is increased but the claim follows that by stating that both EPA and DHA levels are at least 5% of the total fatty acid content. It is not clear if both EPA and DHA levels must both be above 5% regardless of whether it is EPA, DHA or both that are increased or if instead if it is just EPA that is increased and that oils with DHA levels below 5% are included within the scope of this claim. Therefore, the claim scope imparted by this phrase is unclear and this phrase renders the claim indefinite.
Third, in the eight line the claim recites “and/or”. Earlier, the claim states that the seed oil is characterized by increased EPA and/or DHA, that EPQA constitutes at least 5% of total fatty acid content of said oil, and wherein DHA constitutes at least 5% of the total fatty acid content of said oil, and wherein the seed oil has a gondoic acid content of 10% or less of the total fatty acid content of the seed oil.
Given the language of the claim it is not clear if the limitation found after “and/or” is an alternative to only the gondoic acid content limitation or if instead the limitation after “and/or” is an alternative to all of the earlier limitations.
As such this phrase introduces more than one scope of the claim and renders the claim indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Usher, Scientific reports 7.1 (2017) in view of Ozseyhan, Plant Physiology and Biochemistry 123 (2018): 1-7.
With respect to claim 1, Usher teaches recombinant Camelina sativa plants comprising expression constructs made up of exogenous promoters and terminators operably linked to Physcomitrella patens ∆6-elongase, Thraustochytrium sp. ∆5-desaturase and Ostreococcus tauri ∆6-desaturase (Usher, Page 1, Abstract; Usher, Page 3, Figure 1B, DHA5_33_13 Vector Map). Further, Usher teaches that these enzymes are responsible for catalyzing the ETA-EPA, RPA-DPA and DPA-DHA reactions, respectively, which convert the stearidonic acid produced from α-linolenic acid into EPA and DHA (Usher, Page 3, Figure 1a). Finally, Usher provides motivation to produce EPA and DHA in plants stating that these fatty acids are important in human nutrition and aquaculture and further that these have a proven role in reducing human risk of cardiovascular disease (Usher, Page 1, Abstract; Usher, Page 1, Last Paragraph, First Sentence). Usher continues noting that farmed fish appear to contain significantly less EPA and DHA than they did ten years ago and suggests that using plants to produce these compounds would represent a potentially more sustainable and less environmentally-intrusive production route for these compounds (Usher, Page 1, Last Paragraph).
With respect to claim 8, Usher teaches all of the limitations of claim 1 taught above, see above.
With respect to claim 15, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches that the expression constructs include a ω3-desaturase (Usher, Page 3, Figure 1B Legend).
With respect to claim 21, Usher teaches all of the limitations of claim 1 taught above, see above.
With respect to claim 29, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches that the Physcomitrella patens ∆6-elongase gene is operably linked to the unknown seed protein seed-specific promoter, the Thraustochytrium sp. ∆5-desaturase gene is operably linked to the Conlinin 1 promoter and the Ostreococcus tauri ∆6-desaturase is operably linked to the sucrose binding protein 1800 promoter (Usher, Page 3, Figure 1B Legend).
With respect to claim 30, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches that in the field trial that the transgenic Camelina plants, once established were treated with a grass specific herbicide (Usher, Page 2, Last Paragraph). This herbicide did not kill the Camelina plants, therefore compared to grass species which possess a susceptible allele conferring herbicide susceptibility to this herbicide, the Camelina plants comprise a nucleic acid which confers resistance to this herbicide. Even though this is an endogenous allele which is not explicitly described as being a resistance allele to grass specific herbicide, the language of the claim is clear: “resistance to at least one herbicide” as the resistance of the Camelina plants to the grass specific herbicide as such it is clear that the Camelina plants of Usher possess as an inherent characteristic a nucleic acid sequence which encodes resistance to this herbicide, even if the nucleic acid sequence in Camelina is the nucleic acid which makes up a chromosome which lacks the gene targeted in grass species.
With respect to claim 32, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches the recombinant plants comprise increased EPA percentages including 16.2 and 17.2 percent of total fatty acids as mol% for plants comprising ∆6-elongase, a ∆5-desaturase and a ∆6-desaturase genes (Usher, Page 4, Figure 2C and Figure 2D; Usher, Page 3, Figure 1B).
With respect to claim 42, Usher teaches all of the limitations of claim 1, see above.
With respect to claim 47, Usher teaches all of the limitations of claim 1 taught above, see above. Further, Usher teaches growing the recombinant plants and obtaining fatty acids from the seeds of transgenic plants which comprised the expression construct as confirmed by detecting the DsRed selectable marker(Usher, Page 10, Paragraphs 2-3; Usher, Page 10, Paragraph 5). Further, Usher teaches that when plants were transformed omega-3 fatty acid concentration was increased, see Usher, page 7, Last Paragraph for an example.
With respect to claims 50 and 52, Usher teaches all of the limitations of claim 47 taught above, see above. Further, Usher teaches that in the transformed Camelina plants that TAG levels were increased compared to wild type plants, these increased TAG species include C56:8-56:11 and 58:8-58:12 (Usher, Page 7, Figure 5a)
With respect to claim 55, Usher teaches all of the limitations of claim 1, see above. Further, Usher teaches growing the recombinant plants and obtaining fatty acids from the seeds of transgenic plants which comprised the expression construct as confirmed by detecting the DsRed selectable marker which demonstrates expression of the transformed sequences (Usher, Page 10, Paragraphs 2-3; Usher, Page 10, Paragraph 5).
With respect to claims 1, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 Usher does not explicitly teach recombinant plants having reduced expression or activity of a gene encoding an enzyme involved in the synthesis of very long chain fatty acids (VLCFAs).
With respect to claims 1, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 Ozseyhan teaches that Camelina sativa is a re-emerging low input oilseed crop that has great potential but that this crop should be modified to produce optimized fatty acid composition and that this plant produces significant amounts of very long chain fatty acids that may not be desirable (Ozseyhan, Page 1, Abstract). As a solution to this problem Ozseyhan teaches homozygous knockout mutants of the FAE1 genes in Camelina using CRISPR technology. In these plants VLCFAs were reduced to less than 2% of total fatty acids compared to over 22% in wild type seeds. Correspondingly Ozseyhan found that in these mutant plants that 18 carbon fatty acids were concomitantly increased, including α-linolenic acid (18:3) (Ozseyhan, Page 1, Abstract; Ozseyhan, Page 6, Column 1, First Paragraph). Finally, Ozseyhan teaches that FAE1 elongates oleic, acid a precursor to α-linolenic acid (18:3), into 20:1 or 22:1 (Ozseyhan, Page 2, Column 1, First Complete Paragraph).
At the time of filing it would have been obvious to modify the plants and methods of Usher by generating a mutant FAE1 gene in these plants. This would have been obvious because the method of Usher is drawn to Camelina sativa plants having elevated levels of EPA and DHA, two fatty acids which are produced from the 18 carbon α-linolenic acid precursor, while Ozseyhan is also drawn to Camelina sativa plants having improved oil characteristics. Specifically, Ozseyhan teaches that fae1 mutant plants have decreased levels of VLCFAs which are undesirable and increased levels of 18 carbon fatty acids including α-linolenic acid. As such it would have been obvious to generate fae1 mutants in the transgenic plants of Usher in order to decrease undesirable VLCFAs and to increase the pool of α-linolenic acid in these plants.
This would have been motivating to the ordinary artisan because as taught by Ozseyhan VLCFAs are undesirable and as taught by Usher α-linolenic acid is the precursor to EPA and DHA biosynthesis. Therefore, generating fae1 mutants in the transgenic plants of Usher would reduce the content of undesirable fatty acids and allow for the production of higher levels of EPA and DHA by increasing the concentration of the precursor that the enzymes that where transformed into these plants use to produce EPA and DHA. Additionally, Usher makes clear that producing EPA and DHA in plants represents a potentially more sustainable and less environmentally-intrusive production route for these compounds which have significant heart health benefits for humans.
Claims 1, 8, 15, 21, 29-30, 32, 42, 47, 50, 52 and 55 are rejected as obvious under Usher in view of Ozseyhan.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Usher as evidenced by Gomez-Cano, CamRegBase: a gene regulation database for the biofuel crop, Camelina sativa, 2020 Dec 11 in view of Ozseyhan.
With respect to claim 2, Usher and Ozseyhan collectively teach all of the limitations of claim 1, see above.
With respect to claim 2, Usher and Ozseyhan do not explicitly teach the Camelina sativa cell further comprising a nucleic acid sequence encoding a phytoene synthase gene.
With respect to claim 2, Gomez-Cano provides evidence that Camelina sativa possesses a gene Csa13g019990.1 which is the Camelina ortholog of Arabidopsis thaliana phytoene synthase. Therefore, Gomez-Cano provides evidence that possessing a nucleic acid encoding a phytoene synthase gene is an intrinsic characteristic of Camelina sativa cells.
In light of this evidence it is clear that Usher as evidenced by Gomez-Cano in view of Ozseyhan collectively teach all of the limitations of claim 2.
Double Patenting
Non-statutory double patenting rejections of the instant claims would have been made given the claims presented in US 10,881,631 B2 which was patented January 5, 2021 and shares and instant applicant and inventors with the instant application, however instant claim 1 requires the recombinant plants, parts thereof or plant cell to have the three enzymes and also reduced expression of a gene encoding an enzyme involved in the synthesis of very long chain fatty acids, while the reference patent does not require this limitation.
Conclusion
No examined claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663