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 .
Status of Claims
Claims 1, 2, 5 and 7-14 are pending and examined. Claims 3, 4 and 6 have been cancelled.
The objections to claims 1 and 4 are withdrawn in light of the amendments.
The rejection of claim 3 under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention is withdrawn in light the cancellation thereto.
The rejection of claims 1-5 and 7-14 under 35 U.S.C. 103 as being unpatentable over Jobling (2015, Science Advances, 1:1-9) is withdrawn in light of Applicant’s amendments: Jobling does not teach or reasonably suggest the particular mutation as claimed.
However, Applicant should note that the arguments with respect to unexpected results are not commensurate in scope with what is claimed. Namely, claim 1 is not directed to any particular DP3:DP4 ratio but to an “altered” (1,3,1-4)-β-glucan content.
Specification
The objection to the disclosure for containing an embedded hyperlink and/or other form of browser-executable code is withdrawn in light of the amendments.
Rejections - 35 USC § 112
The following is a quotation 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.
Claims 1, 2, 5 and 7-14 REMAIN rejected under 35 U.S.C. 112(a), first paragraph, because the specification, while being enabling for replacing Tyr787 with a His residue in SEQ ID NO: 15 to change DP3:DP4 ratio to about 1:24 in a barley plant, does not reasonably provide enablement for expressing the genus of nucleic acids in the broad genus of plant species as claimed to predictably obtain the phenotypes as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the claims are broadly drawn to a cereal plant having an altered (1,3,1-4)-β-glucan content compared to wildtype that carries a mutation in the CslF6 gene and encodes a mutated protein and wherein said mutated protein comprises a substitution of an amino acid sequence in a switch motif of the protein that comprises SEQ ID NO: 14, wherein tyrosine is substituted with a histidine, wherein the (1,3,1-4)-β-glucan content results in a ratio of DP3:DP4 of 1:2.5 to 1:32, wherein the (1,3,1-4)-β-linkage formation decreases, a composition comprising said plant, a food or drink product or food additive comprising said plant and a method to improve bowel or cardiovascular health comprising administering said plant to a person in need thereof
Meanwhile, the specification teaches the barley CslF6 gene was amplified and mutated using mutagenesis primers to produce four variants having no detectable reduction in protein activity (p. 23, ¶ 1; see also p. 32, penultimate ¶). Replacing Tyr787 in barley Cslf6 with a His residue or where the entire switch motif is replaced with that of CesAs dramatically reduced (1,3)-β-glucosyl linkages in synthesized glucan (p. 32, last ¶).
The specification teaches that a CslF6-Y787H point mutant and switch-motif swapped constructs synthesize a predominantly (1,4)-linked β-glucan (i.e., cellulose), with only a negligible fraction of (1,3)-β-glucan glucosyl units. The apparent ratio of (1,3)- to (1,4)-linkages drops from 1:2 for the wild-type enzyme to about 1:24 and 1:32 for the single residue and switch motif-swapped constructs, respectively. The specification teaches these mutants appear to synthesize polysaccharides with DPs close to 100 (p. 33, ¶ 1).
Here, the claims fail to recite the particular nucleic acid structure of the CslF6 gene or the corresponding amino acid sequences of the protein encoded by said gene that may be mutated. Thus, the claims encompass an infinite number of CslF6 nucleic and amino acid structures.
Additionally, the specification fails to provide the requisite guidance to predictably make and use these mutated structures, and further fails to provide working examples for predictably making and using these mutated structures as broadly claimed.
These teachings and working examples are critical in light of the state of the art, which teaches that not all CSLF6 will predictably increase or decrease (1,3,1-4)-β-glucan content. For example, Jobling et al (Pub. No. US 2016/0251670 A1) teach that barley CSFL6 does not predictably increase BG content, and that various CSLF6 genes expressed in tobacco do not predictably increase BG content (e.g., see p. 51, Table 8 and 11; see also p. 52, Table 12).
In fact, CslF genes are found only in monocotyledons to regulate directly or indirectly the abundance and fine structure of beta-glucans in the grain and due to the complex biosynthetic mechanism, in order to provide an efficient and correct synthesis of beta-glucans one or more additional proteins interacting with CslF and CslH enzymes are probably required (Marcotuli et al, 2018, Scientific Reports, 8: 1-9; p. 1, last ¶; see also p. 2, ¶ 3).
Therefore, in light of the breadth of the claims, the lack of guidance and working examples in the specification and the state of the art which teaches that altering (1,3,1-4)-β-glucan levels can be unpredictable, the skilled practitioner would turn to undue trial and error experimentation for making the plants and practicing the methods as claimed. As such, and, in the absence of further guidance, undue experimentation will become the burden of the practitioner.
Response to Arguments
Applicant traverses the rejection of the claims because the claims have been narrowed to a specific embodiment (Applicant reply dated 20 July 2026, p. 7, ¶ 3).
As an initial matter, the Office did not intend to imply amendments to the claims would satisfy the enablement requirement if they were limited to a particular mutation in SEQ ID NO: 15. This is clear in the body of the rejection which provides the claims fail to recite the particular nucleic acid structure of the CslF6 gene or the corresponding amino acid sequences of the protein encoded by said gene that may be mutated, and that the claims encompass an infinite number of CslF6 nucleic and amino acid structures (e.g., see Office action dated 20 April 2026, p. 5, last ¶).
Or see page 6, ¶ 3 and 4, of the Office action dated 20 April 2026 which addresses the state of the art: Jobling teaches that barley CSFL6 does not predictably increase BG content, and that various CSLF6 genes expressed in tobacco do not predictably increase BG content (e.g., see p. 51, Table 8 and 11; see also p. 52, Table 12).
Furthermore, the rejection statement indicated that enabled subject matter would arguably include a barley plant as opposed to any cereal plant as encompassed by claim 1 and those claims that depend therefrom which are not limited to barley plants.
Therefore, in light of the breadth of the claims, the lack of guidance and working examples in the specification and the state of the art which teaches that altering (1,3,1-4)-β-glucan levels can be unpredictable, the skilled practitioner would turn to undue trial and error experimentation for making the plants and practicing the methods as claimed. As such, and, in the absence of further guidance, undue experimentation will become the burden of the practitioner.
Claims 1, 2, 5 and 7-14 REMAIN are rejected under 35 U.S.C. 112(a), 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, at the time the application was filed, had possession of the claimed invention.
Instant claims 1, 2, 5 and 7-14 are broadly drawn to a cereal plant having an altered (1,3,1-4)-β-glucan content compared to wildtype that carries a mutation in the CslF6 gene and encodes a mutated protein and wherein said mutated protein comprises a substitution of an amino acid sequence in a switch motif of the protein that comprises SEQ ID NO: 14, wherein tyrosine is substituted with a histidine, wherein the (1,3,1-4)-β-glucan content results in a ratio of DP3:DP4 of 1:2.5 to 1:32, wherein the (1,3,1-4)-β-linkage formation decreases, a composition comprising said plant, a food or drink product or food additive comprising said plant and a method to improve bowel or cardiovascular health comprising administering said plant to a person in need thereof
Meanwhile, the specification describes the barley CslF6 gene was amplified and mutated using mutagenesis primers to produce four variants having no detectable reduction in protein activity (p. 23, ¶ 1; see also p. 32, penultimate ¶). Replacing Tyr787 in barley Cslf6 with a His residue or where the entire switch motif is replaced with that of CesAs dramatically reduced (1,3)-β-glucosyl linkages in synthesized glucan (p. 32, last ¶).
The specification describes that a CslF6-Y787H point mutant and switch-motif swapped constructs synthesize a predominantly (1,4)-linked β-glucan (i.e., cellulose), with only a negligible fraction of (1,3)-β-glucan glucosyl units. The apparent ratio of (1,3)- to (1,4)-linkages drops from 1:2 for the wild-type enzyme to about 1:24 and 1:32 for the single residue and switch motif-swapped constructs, respectively. The specification teaches these mutants appear to synthesize polysaccharides with DPs close to 100 (p. 33, ¶ 1).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing 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 invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the claims fail to recite the particular nucleic acid structure of the CslF6 gene or the corresponding amino acid sequences of the protein encoded by said gene that may be mutated. Thus, the claims encompass an infinite number of CslF6 nucleic and amino acid structures.
Additionally, the specification fails to describe a representative number of species from the vast genus of CslF6 genes and polypeptides as claimed, and further fails to describe the structures within said genes and polypeptides that when mutated confer the traits and properties as claimed.
These descriptions are critical in light of the state of the art, which describes that not all CSLF6 does not predictably increase or decrease (1,3,1-4)-β-glucan content. For example, Jobling et al (Pub. No. US 2016/0251670 A1) describe that barley CSFL6 does not predictably increase BG content, and that various CSLF6 genes expressed in tobacco do not predictably increase BG content (e.g., see p. 51, Table 8 and 11; see also p. 52, Table 12).
In fact, CslF genes are found only in monocotyledons to regulate directly or indirectly the abundance and fine structure of beta-glucans in the grain and that due to the complex biosynthetic mechanism, in order to provide an efficient and correct synthesis of beta-glucans one or more additional proteins interacting with CslF and CslH enzymes are probably required (Marcotouli et al, p. 1, last ¶; see also p. 2, ¶ 3).
Therefore, in light of the state of the art and without a further description of a representative number of species of plants expressing the nucleic acids as claimed, Applicant has failed to sufficiently describe plants with the phenotypes as claimed or methods of using said plants.
Given the lack of written description in the specification with regard to the plants as broadly claimed, it is not clear that Applicant was in possession of the invention at the time this application was filed.
Response to Arguments
Applicant traverses the rejection of the claims as they have been amended to embodiments found to be enabled and described (Applicant reply dated 20 July 2026, p. 8, penultimate ¶).
This argument is not persuasive because the Office did not indicate that amendments to the claims would obviated the rejection of the claims for failing to comply with the written description requirement.
As noted above, the claims fail to recite the particular nucleic acid structure of the CslF6 gene or the corresponding amino acid sequences of the protein encoded by said gene that may be mutated. Thus, the claims encompass an infinite number of CslF6 nucleic and amino acid structures.
Additionally, the specification fails to either describe a representative number of species from the vast genus of CslF6 genes and polypeptides as claimed, and further fails to describe the structures within said genes and polypeptides that when mutated confer the traits and properties as claimed.
The absence of the description is compounded by the state of the art which describes barley CSFL6 does not predictably increase BG content, and that various CSLF6 genes expressed in tobacco do not predictably increase BG content.
Therefore, in light of the state of the art and without a further description of a representative number of species of plants expressing the nucleic acids as claimed, Applicant has failed to sufficiently describe plants with the phenotypes as claimed or methods of using said plants.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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