Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s amendment filed February 25, 2025. Claims 38-56 are pending. Claims 45 and 47-56 are withdrawn. Claims 38-44 and 46 are examined to the extent of the elected species (soluble protein content in claims 38, 39 and 42; down-regulating TAG lipase in claim 40; and admixing the transgenic progeny plant with one other food ingredient to produce a feedstuff in claim 46). Applicant inquired as to why claims 45 and 47-53 are withdrawn. In the restriction requirement filed May 22, 2025, Applicant was required to elect one species from claims 45-53. Applicant elected the species of claim 46, admixing the transgenic progeny plant with one other food ingredient to produce a feedstuff (see p. 3 of Applicant’s response filed July 22, 2025). Accordingly, the non-elected species (claims 45 and 47-53) are withdrawn. They may be rejoined when allowability is indicated.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Information Disclosure Statement (IDS)
2. Citations in Applicant’s IDS submitted July 22, 2025 have not been considered. 37 CFR 1.98(b) requires that each US patent, each US patent application, each foreign patent and each foreign patent application be listed by inventor / applicant, patent number / patent application number, and issue date / publication date. For each foreign patent and each foreign patent application, the country or office which issued patent or published the application must also be included. For each publication, the publisher, author, title, relevant pages, date and place of publication must be identified. Even though 37 CFR 1.98(d) states that submission of a copy of each reference is not required if it was previously cited by or submitted to the Office in a prior application, Applicant failed to cite the references in the format required under 37 CFR 1.98(b). A listing of the IDS, Form 892 and examination reports from a foreign patent office containing citations of the references submitted in another application is not sufficient to comply with the requirements. See also MPEP 609.
If Applicant wishes for the references cited in a previous application to be considered, a new IDS listing each reference in the proper citation format must be submitted.
Applicant traverses that MPEP 609.02 states that the examiner of the continuing application will consider information which has been considered by the Office in the parent application.
Applicant’s IDS filed July 22, 2025 has been considered. A signed copy is attached. References not in proper citation format have been lined through.
Specification
3. The disclosure is objected to because of the following:
The Title is not descriptive of the claimed invention. It is suggested the title be amended to “Processes for increasing triacylglycerol in a plant”.
Appropriate correction is required.
Claim Objections
4. Claims 38-44 and 46 are objected to because of the following:
In claim 38(i), “each comprise” should be amended to “each comprises” for grammatical correctness. Applicant traverses that “each” refers to a plurality of plants or parts thereof. Applicant’s traversal is unpersuasive because “each” is singular. Of interest, “a plurality” is also singular, and “of candidate transgenic plants” is a prepositional phrase.
In claim 40, in the last “wherein” clause, “that” should be inserted before “directs”. It should be noted that the last “wherein” clause does not apply to the elected (a) embodiment of claim 40 and is redundant if referring to the exogeneous polynucleotides of claim 38.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
5. Claims 38-44 and 46 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 claim 38, there is no nexus between steps (i) and (ii). Step (i) recites obtaining plants having two exogenous polynucleotides. Step (ii) recites measuring triacylglycerol (TAG) content in a plant part. It is unclear whether step (ii) measures preexisting TAG content in the plant part, or the TAG is a product of the “obtaining” step of (i). How are step (i) and step (ii) related? Is there a reaction between the transcription factor and the fatty acid acyltransferase that affects TAG content?
In claim 38, there is no nexus between steps (ii) and (iii). Step (ii) recites measuring TAG content in a plant part. Step (iii) recites measuring the soluble protein content in a plant part. Is the plant part of (ii) the same as the plant part of (iii), or are they independent of each other? Is the soluble protein content in step (iii) somehow related to the TAG content of step (ii) or to the “obtaining” step of (i)?
In claims 38, 39 and 42, it is unclear how soluble protein content is defined. Additionally, what is the protein soluble in—water, oil, or some other medium? It is further unclear whether (a) the soluble protein content is pre-existing in the plant, as plants contain soluble proteins, (b) the soluble protein refers to the proteins expressed by the two exogenous polynucleotides, or (a) the soluble protein is different from those of (a) and (b). Applicant traverses that p. 84, lns. 14-22, provides the definition, and the protein is soluble in water or other aqueous solution. Applicant’s traversal is unpersuasive because the specification states that ““soluble protein content” or variations thereof refers to the amount of soluble protein in the plant or part thereof.” This is not an adequate definition because the term in question, i.e., soluble, is in the definition itself. Moreover, examples from the specification do not provide a definition, and limitations from the specification are not read into the claims. The definition does not indicate that the protein is soluble in water or other aqueous solution. “[I]t is the language itself of the claims which must particularly point out and distinctly claim the subject matter which the applicant regards as his invention, without limitations imported from the specification. … Limitations in the specification not included in the claims may not be relied upon to impart patentability to an otherwise unpatentable claim.” In re Lundberg, 244 F.2d 543, __, 113 USPQ 530, 534 (CCPA 1957). It is suggested Applicant recites the method provided on p. 84, lns. 16-20, to measure soluble protein content.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
6. Claims 38-44 and 46 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses RNAi silencing of an endogenous Sugar Dependent 1 (SDP1) lipase gene in transgenic Nicotiana tabacum expressing WRI1, DGAT1 and oleosin polypeptides significantly increased the TAG (triacylglycerols) oil content in senescing leaves (Ex. 2). The specification further discloses expressing LEC2 transcription factor under the control of an Arabidopsis thaliana SAG12 senescence-specific promoter increased TAG levels in vegetative N. tabacum tissues (Ex. 3). Example 4 discloses 1) plants over-expressing WRI1, DGAT and oleosin polypeptides (HO plants) produced increased TAG compared to WT (Table 7); 2) plants expressing the RNAi SDP1 lipase silencing construct and WRI1, DGAT and oleosin polypeptides from two T-DNAs (hereafter “SDP1 plants”) produced increased TAG and soluble protein content compared to WT (Table 9); and 3) plants over-expressing LEC2, WRI1, DGAT and oleosin polypeptides from two T-DNAs (hereafter “LEC2 plants”) also produced increased TAG and soluble protein content compared to WT (Table 9). HO plants have a higher leaf protein content than WT plants at 69 days (Table 8). SDP1 and LEC2 leaves have a 59% and 34% reduction in total dietary fiber content, respectively, when compared to wild-type (p. 207-208). The capacity for photosynthesis was increased in the transgenic HO plants (p. 208).
The claimed invention lacks adequate written description for the following reasons. Claim 38 recites expression of two sequences: (1) a transcription factor that increases the expression of one or more glycolytic and/or fatty acid biosynthetic gene, and (2) a sequence encoding a fatty acid acyltransferase. Claim 38 states that expression of these two sequences would produce a plant having increased triacylglycerol (TAG) and increased soluble protein content. There is no disclosure as to which transcription factor expressed by the first exogenous polynucleotide would promote expression of the second exogenous polynucleotide to produce the desired phenotype. Moreover, none of the working examples discloses any such two sequences for producing the increased soluble protein content. Only the constructs indicated as LEC2 (LEC2 + WRI1 + DGAR + oleosin) and SDP1 (RNAi SDP1 + WRI1 + DGAR + oleosin) produced the increased TAG content and soluble protein content (Table 9). Thus, at least four sequences are required to produce the claimed phenotypes. One skilled in the art cannot predict which two sequences would produce the claimed phenotypes from the disclosure of the four. Accordingly, the claimed invention lacks adequate written description. Dependent claims 39 and 41 merely recite plant features of the plant produced by the claimed method. Dependent claims 42, 43, 44 and 46 merely describe progeny plants of the plant produced by the claimed method. These dependent claims do not address the written description issues set forth above.
Additionally, there is no disclosure as to what soluble protein content is being measured for in claims 38, 39 and 42. Because a plant contains numerous soluble proteins, and two proteins are expressed from the two exogenous polynucleotides, it is unclear whether the plant is being measured for pre-existing soluble proteins in the plant, the two proteins expressed from the two exogenous polynucleotides, or a different, undisclosed soluble protein. The soluble protein is not identified by structure or function, and there is no disclosure as to what medium the protein is soluble in. Accordingly, the soluble protein content lacks adequate written description.
In claim 40, the additional limitation of “a genetic modification which down-regulates endogenous production and/or activity of a TAG lipase in the transgenic plant” is not adequately described. The scope of the claim encompasses targeting other genes that affect TAG lipase production and/or activity, either directly or indirectly. However, no such gene is disclosed. Moreover, an RNAi of an SDP1 gene is not representative of the genus of TAG lipases in the plant to be targeted. RNAi is not representative of the genus of genetic modifications, and SDP1 is not representative of the genus of TAG lipases.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, at least four genes are disclosed to produce a plant having the recited phenotypes. However, none of these four genes and their structures are recited in the claims. No structure and function relationship is disclosed for any sequence. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics of at least the four embodiments utilized in the claimed method, the specification does not provide adequate written description of the claimed invention.
Applicant’s Traversals
Applicant traverses primarily the following. (1) Claim 38 is an assay method and does not require an increase in TAG and soluble protein content. (2) The specification defines soluble protein content on p. 84, lns. 14-22, and the protein is soluble in water or other aqueous solution.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), claim 38(i) requires that the two exogenous polynucleotides are expressed in the transgenic plants, and 38(iv) recites the step of selecting a transgenic plant having the phenotypes of increased TAG content and increased soluble protein content. The claimed method steps are not the same as the assay method steps in the claims of US Pat. No. 5837479 (hereafter ‘479). In ‘479, the expressed prostaglandin H synthase-2 (PGHS-2) is contacted with a compound in the presence of arachidonic acid, and if the compound converts the arachidonic acid to its prostaglandin metabolite, then the compound is said to inhibit PGHS-2. No other compound is required. In contrast, in the instant claims, none of the proteins required to produce the claimed phenotypes of increased TAG and increased soluble protein is recited. None of the steps requires contacting any two or more proteins to produce a metabolite or secondary compound. “[A] transcription factor polypeptide that increases expression of one or more glycolytic and/or fatty acid biosynthetic genes” and “a fatty acid acyltransferase” are not representative of the four polynucleotides required to produce the claimed phenotypes. None of the claims recites RNAi SDP1+ WRI1+DGAT+oleosin or LEC2+WRI1+DGAT+oleosin for producing the claimed phenotypes. In fact, WRI1+DGAT+oleosin alone (which is also not recited), does not produce the claimed phenotypes.
With regard to traversal (2), the specification states that ““soluble protein content” or variations thereof refers to the amount of soluble protein in the plant or part thereof.” This is not an adequate definition because the term in question, i.e., soluble, is in the definition itself. Moreover, examples from the specification do not provide a definition, and limitations from the specification are not read into the claims. The definition does not indicate that the protein is soluble in water or other aqueous solution. “[I]t is the language itself of the claims which must particularly point out and distinctly claim the subject matter which the applicant regards as his invention, without limitations imported from the specification. … Limitations in the specification not included in the claims may not be relied upon to impart patentability to an otherwise unpatentable claim.” In re Lundberg, 244 F.2d 543, __, 113 USPQ 530, 534 (CCPA 1957). It is suggested Applicant recites the method provided on p. 84, lns. 16-20, to measure soluble protein content.
Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 102
7. Claims 38-44 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vanhercke et al. (US 20130247451 (previously cited)).
Vanhercke teaches a process for selecting a transgenic plant or part thereof with a desired phenotype comprising
(i) obtaining plants or parts thereof each comprising a) a first exogenous polynucleotide which encodes a transcription factor polypeptide that increases the expression of one or more glycolytic and/or fatty acid biosynthetic genes, operably linked to a promoter, and b) a second exogenous polynucleotide which encodes a DGAT or DGAT1, which are fatty acid acyltransferases, operably linked to a promoter,
(ii) measuring the TAG content in the plurality of parts,
(iii) measuring the plurality of parts for soluble protein content, and
(iv) selecting a plant or part thereof comprising an increased TAG content and an increased soluble protein content in the plant part ([0129], [0217], [0037], [0438], [1249], [0100], claim 3). The transcription factors of Vanhercke are WRI1 and LEC2. It is unclear how “soluble protein content” is defined, as discussed in the 35 USC 112(b) rejection above, however, the oleosin of Vanhercke is an amphipathic protein which has both hydrophilic and hydrophobic ends [1036]. Furthermore, Vanhercke teaches measuring the oil and/or protein content of the seed ([0129], [1249]). With regard to claim 39, the increased total soluble protein content in the selected plant or part thereof appears to be at least 10% on a relative basis, because Vanhercke teaches the claimed method steps utilizing the same materials. With regard to claim 40, Vanhercke teaches the inclusion of an RNA molecule which inhibits expression of a CGi58 lipase or SUGAR-DEPENDENT1 triacylglycerol lipase (SDP1) [0189], which is a TAG lipase [1045]. With regard to claim 41, Vanhercke teaches the selected plant or part thereof comprising a total non-polar lipid content of at least 10% w/w dry weight (claim 1). With regard to claims 42 and 43, Vanhercke further teaches 3rd and 4th generation progeny plants [1110]. With regard to claim 44, Vanhercke teaches leaves, stems and seeds [1184]. With regard to claim 46, Vanhercke teaches admixing the transgenic progeny plants or parts thereof with at least one other feed ingredient to produce a feedstuff [0473].
Accordingly, the claimed invention is anticipated by the prior art.
Applicant’s Traversals
Applicant traverses primarily the following. (1) one skilled in the art would understand that step (iii) recites measuring the total amount of protein in water or other aqueous solution. (2) Vanhercke does not describe the step of measuring the total amount of soluble protein in a plant or part thereof or any of the other parameters in claim 38 (iii).
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), Applicant is arguing limitations not present in the claims. None of the claims recites measuring the total amount of protein in water or other aqueous solution. With regard to traversal (2), as stated in the 35 USC 112(b) above, it is unclear what soluble protein constitutes. Moreover, paragraphs [0129] and [1249] of Vanhercke teach measuring oil and/or protein content of the plant seed. Accordingly, the rejection is maintained.
Conclusion
8. No claim is allowed.
9. Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached on M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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