DETAILED ACTION
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 .
Claims Status
The Office acknowledges the receipt of Applicant’s amendment filed 06/10/2026. Claims 1, 6, 13-14, 16-17, 20-21, 23-24, 30-31, 33, 35-36 and 40-41 are pending. Claims 33 and 35-36 are withdrawn. Claims 1, 6, 13-14, 16-17, 20-25, 30-31 and 40-41 are examined in the instant application.
All previous rejections not set forth below have been withdrawn.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.
Claim Objections
Claims 1, 6, 13-14, 16-17, 20-25, 30-31 and 40-41 are objected to because of the following:
In claims 1, 13, and 20, the recitation of “wheat plant comprising the nucleic acid molecule” should be amended to “wheat plant expressing the nucleic acid molecule” because “expressing”, rather than “comprising”, results in the stem rust resistance.
In claim 6, “with” should be deleted.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 13-14, 16-17 and 30-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) do not fall within at least one of the four categories of patent eligible subject matter because the encompasses a product of nature.
In regard to claim 13, the plant or seed comprising a heterologous polynucleotide construct comprising SEQ ID NO:14 or a nucleotide sequence encoding SEQ ID NO:15 is indistinguishable from a naturally occurring Aegilops sharonensis plant or seed. SEQ ID NO: 14 encoding SEQ ID NO:15 was obtained from Ae. sharonensis.
In regard to claim 14, the promoter is indistinguishable from a naturally occurring Ae. sharonensis promoter operably linked to the nucleotide sequence.
In regard to claim 16, Ae. sharonensis is wheat.
In regard to claim 17, because Ae. sharonensis comprises SEQ ID NO: 14 or a sequence encoding SEQ ID NO: 15, Ae. sharonensis is inherently resistant to Puccinia graminis f. sp. tritici.
In regard to claim 30, a wheat seed naturally falls to the ground and grows into a wheat plant, which is the same as Applicant’s “planting” and “growing” steps. These steps fulfill the claimed method of limiting wheat stem rust in agricultural crop production.
In regard to claim 31, Applicant’s “harvesting” step is indistinguishable from birds picking or collecting at least one seed from the naturally-occurring wheat plant.
Applicant’s Traversals
Applicant traverses primarily that Applicants are their own lexicographers, and “heterologous” refers to a sequence that originates from a foreign species or is modified from its native form by human intervention.
Reply to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. While a heterologous polynucleotide construct may be from another source or may be modified by human intervention, the claims do not recite a structure, such as a heterologous promoter, that would allow one skilled in the art to distinguish a heterologous construct from one that is not from another source or is not modified by human intervention. That is, a plant/seed comprising stably incorporated in its genome a heterologous polynucleotide construct is indistinguishable from a wheat plant/seed comprising a naturally occurring gene. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(a) Written Description
Claims 1, 6, 13-14, 16-17, 20-25, 30-31 and 40-41 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 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.
Applicant’s disclosure is as follows.
Applicant identified stem rust resistance gene Sr62 from Ae. sharonensis accession 1644 that confers fungal resistance P. graminis f. sp. tritici (pp. 40-44, Example 2). SEQ ID NO:14 is the genomic Sr62 gene sequence; SEQ ID NO:15 is the protein encoded by the Sr62 gene. SEQ ID NO:16 is the cDNA of the Sr62 gene. SEQ ID NO:17 is the nucleotide sequence of the transcript of Sr62. Table 2 identified Sr62 disease susceptible mutants.
95% sequence identity to a sequence encoding SEQ ID NO:15 for conferring the stem rust resistance phenotype lacks adequate written description. While one skilled in the art can generate a population of sequences having 95% sequence identity to a sequence encoding SEQ ID NO:15, it is unpredictable which sequence(s) withing said population would have the claimed phenotype. Table 2 shows that a single nucleotide change in an Sr62 gene can result in a susceptible plant. There is no known or disclosed structure – function relationship between a particular sequence structure and the stem rust resistance phenotype. Accordingly, 95% sequence identity to a sequence encoding SEQ ID NO:15 for conferring stem rust resistance to a wheat plant lacks adequate written description.
Additionally, 95% sequence identity to a sequence encoding SEQ ID NO:15 encompasses Sr62 gene sequences from sources other than A. sharonensis, whereby their structure and identity are not disclosed, so long as they share at least 95% sequence identity to a sequence encoding SEQ ID NO:15. The claims encompass mutants and allelic variants of a sequence encoding SEQ ID NO:15 and thus imply that structural variants exist in nature, yet no structural variant has been disclosed. The implication is there is a gene and a protein other than that disclosed which exists in nature, but the structure thereof is not known. The disclosure of SEQ ID NO:15 isolated from Ae. sharonensis is not representative of Sr62 sequences from other sources for conferring resistance to stem rust to a wheat plant. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine such mutants and allelic variants of a sequence encoding SEQ ID NO:15, or other Sr62 sequences, from another Ae. sharonensis, a plant other than Ae. sharonensis, or an organism, absent further guidance. Applicant failed to disclose a representative number of species within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111.
Applicant’s Traversals
Applicant traverses primarily the following: (1) The claims have been amended to recite a sequence encoding an amino acid sequence having at least 95% sequence identity to SEQ ID NO:15. (2) MPEP §2163 states that written description requirement may be satisfied through disclosure of function and minimal structure where there is a well-established correlation between structure and function. (3) A person of ordinary skill would consider any experimentation that might be required to make and use the variant nucleotide sequences as routine experimentation.
Reply to Applicant’s Traversals
Applicant’s traversals Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), 95% sequence identity to a sequence encoding SEQ ID NO:15 lacks adequate written description for the reasons set forth above. With regard to traversal (2), no established or disclosed structure – function relationship is shown for sequences having 95% sequence identity to SEQ ID NO:15 and stem rust resistance phenotype, or functional activity that results in the stem rust resistance phenotype. With regard to traversal (3), Applicant is arguing enablement rather than written description. One skilled in the art cannot predict which sequence(s) within the 95% sequence identity population to SEQ ID NO:15 would confer the stem rust resistance phenotype in a wheat plant. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(a) Enablement
Claims 1, 6, 13-14, 16-17, 20-25, 30-31 and 40-41 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons. The nature of the invention is an Sr62 gene sequence encoding SEQ ID NO:15 for conferring stem rust resistance to a wheat plant. The scope of 95% sequence identity to a nucleotide sequence encoding SEQ ID NO:15 encompasses any mutation including insertions, deletions, substitutions and any combination thereof in any region of a sequence encoding SEQ ID NO:15, so long as said mutation retains the stem rust resistance phenotype. Table 2 shows that a single nucleotide change in an Sr62 gene can result in a susceptible plant. Neither the state of the prior art nor Applicant’s disclosure teaches which region(s) of a sequence encoding SEQ ID NO:15 are essential for retaining the stem rust resistance phenotype. From the disclosure in Table 2 one skilled in the art cannot readily identify operable or inoperable embodiments without resorting to random trial and error requiring undue experimentation. It is not known whether mutations resulting in a different amino acid or in a different position of SEQ ID NO:15 would produce a resistant or susceptible phenotype. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Applicant’s Traversals
Applicant traverses primarily the following: (1) The claims have been amended to recite a nucleotide sequence encoding an amino acid sequence having at least 95% sequence identity to SEQ ID NO:15. (2) One skilled in the art having knowledge of the Sr62 nucleotide sequence would have been able to use known tools to make and use the claimed invention without undue experimentation.
Reply to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), 95% sequence identity is not fully enabled for the reasons set forth above. With regard to traversal (2), while one skilled in the art can readily make mutations to a sequence, further guidance is needed as to what mutation(s) in which region(s) of a sequence encoding SEQ ID NO:15 would not render the plant susceptible to stem rust disease. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 102
Claims 13, 14, 16, 17, 30 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Theor. Appl. Genet., 2017, 130:1207-1222 (Applicant’s IDS)).
With regard to claim 13, Yu teaches a stem rust resistant progeny seed/plant produced by crossing stem rust resistant donor Ae. sharonensis parent with stem rust susceptible Ae. sharonensis parent (Abstract). The specification states that the gene conferring the stem rust resistant phenotype of Yu (accession 1644) is identical to Applicant’s gene (Example 2). Thus, the stem rust resistant progeny seed/plant inherently has the same sequence as Applicant’s SEQ ID NO: 14 encoding SEQ ID NO:15. Due to Mendelian genetics, the progeny plant/seed from the cross comprises stably incorporated in its genome a heterologous polynucleotide construct comprising the sequence inherited from the donor parent.
With regard to claim 14, the heterologous polynucleotide construct from the donor parent inherently comprises a promoter operably linked for the expression of the nucleotide sequence in a plant to produce the stem rust resistant phenotype.
With regard to claim 16, Ae. sharonensis is wheat.
With regard to claim 17, because the progeny plant/seed has the gene sequence from the stem rust resistant donor parent, said progeny plant/seed comprises enhanced resistance to wheat stem rust caused by P. graminis f. sp. tritici (p. 1207, “Introduction”, first sentence).
With regard to claims 30 and 31, Yu teaches planting the progeny wheat seed, growing a wheat plant under conditions favorable for the growth and development of the wheat plant, and harvesting at least one seed from the wheat plant, thereby limiting wheat stem rust in agricultural crop production (“Materials and methods”).
Accordingly, the claimed invention is anticipated by the prior art.
Applicant’s Traversals
Applicant traverses primarily the following: (1) Applicants are their own lexicographers, and “heterologous” refers to a sequence that originates from a foreign species or is modified from its native form by human intervention. (2) The Examiner fails to state the accession numbers of the sequences for Sr-1644-1Sh that are allegedly disclosed in Yu and/or provide nucleotide or amino acid sequences of Sr62, i.e., SEQ ID Nos. 14-17.
Reply to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. With regard to traversal (1), the donor parent provides the “heterologous” polynucleotide construct to the progeny plant/seed. With regard to traversal (2), because Applicant’s source for the sequence conferring the stem rust resistance is from Yu per Applicant’s admission (p. 40, lns.9-10), the sequence of Yu must by necessity be the same as Applicant’s SEQ ID NO:14 encoding SEQ ID NO:15. Sometimes the limitation, in fact, does not even impose an additional requirement on the claimed invention, i.e., does not narrow the claim, but is a property necessarily present due to other aspects of the claimed invention. See In re Kubin, 561 F.3d 1351, 1357 (Fed.Cir.2009); Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012). Similarly, precedent provides that “mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art.” In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981). In this instance, the mere recitation of a structure (a SEQ ID NO. for the Sr62 gene) inherently possessed by the prior art does not distinguish a claim drawn to the structure from the prior art. Accordingly, the rejection is maintained.
Conclusion
No claim is allowed.
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.
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/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663
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