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 .
Claim Status
1. Claims 1-2, 4, 12, 15, and 58 are pending and examined to the extent of the elected species of SEQ ID NO:13 and SEQ ID NO:17.
Claims 20-21, 23, 26-27, 35-36, 40, 44-45, 47, and 59-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 04, 2026.
Claims 3, 5-11, 13-14, 16-19, 22, 24-25, 28-34, 37-39, 41-43, 46, and 48-57 are cancelled.
Restrictions/Elections
2. The Office acknowledges receipt of Applicant’s restriction election filed May 04, 2026. Applicant elects Group I, claims 1-2, 4, 12, 15, 58, and 60-61, drawn to a what plant comprising a genetic modification in at least one Amy1 gene on chromosome 6B, with traverse. Applicant further elects the combination of the species of Amy1-6B-1 (SEQ ID NO:13) and Amy1-6B-2 (SEQ ID NO:17), with traverse.
In the remarks dated 05/04/2026, Applicant argues primarily that the claims have been amended to recite “a genetic modification in at least one Amy1 gene on chromosome 6B selected from Amy1-6B-1, Amy1-6B-2, Amy1-6B-3, Amy1-6B-4, and Amy1-6B-5 […] wherein the genetic modification is an introduced mutation selected from a deletion mutation, an insertion mutation, a substitution mutation, a splice-site mutation, a premature translation termination mutation, a nonsense mutation, and a frameshift mutation” and that the claims have also been amended to recite a grain weight that is about the same or increased relative to wild-type wheat grain (p. 12). Applicant further argues that these amendments distinguish the claims from the cited prior art because the wheat line disclosed in the cited art “is ditelosomic, lacking the full long-arm of chromosome 6B and is thus not an ‘introduced mutation selected from a deletion mutation, an insertion mutation, a substitution mutation, a splice-site mutation, a premature translation termination mutation, a nonsense mutation, and a frameshift mutation’” (p. 13). Applicant also argues that the grain weight of the wheat disclosed by Mrva did not have a weight that is about the same or increased relative to wild-type wheat grain (p. 13).
Applicant’s arguments have been carefully considered but are not persuasive for the following reasons.
First, the amended recitation of “a genetic modification in at least one Amy1 gene on chromosome 6B selected from Amy1-6B-1, Amy1-6B-2, Amy1-6B-3, Amy1-6B-4, and Amy1-6B-5 […] wherein the genetic modification is an introduced mutation selected from a deletion mutation, an insertion mutation, a substitution mutation, a splice-site mutation, a premature translation termination mutation, a nonsense mutation, and a frameshift mutation” does not distinguish the recited modification from the modification disclosed by Mrva. The recitation and definition, as provided by the instant specification, of a “genetic modification” is broad and refers to any modification to an Amy1 gene that leads to a reduction in the expression of an Amy1 gene on chromosome 6B[0164]. The definition explicitly provides that the plant may be either transgenic or nontransgenic. Because the amended claim does not limit the modification to exclusively Amy1-6B-1, Amy1-6B-2, Amy1-6B-3, Amy1-6B-4, and Amy1-6B-5 and Applicant’s definition of a genetic modification encompasses both transgenic and nontransgenic plants, the amended claim is interpreted to encompass any recombinant or nonrecombinant wheat plant having any mutation wherein said mutation leads to a reduction in the expression of an Amy1 gene on chromosome 6B. Mrva discloses the regulation of high pI α-amylase synthesis in wheat by genes located on chromosome 6B (Title; Asbtract) and a ditelosomic derivative of the wheat cultivar Chinese spring (Cs dit 6BS) which lacks the long arm of chromosome 6B (Abstract). Because the long arm of chromosome 6B has been deleted, the wheat plants disclosed by Mrva comprise a deletion mutation in which each of Amy1-6B-1, Amy1-6B-2, Amy1-6B-3, Amy1-6B-4, and Amy1-6B-5 have been deleted and the expression of each gene reduced relative to a wildtype plant.
Second, Applicant’s argument that Mrva fails to anticipate the amended limitation regarding a wheat grain that has a grain weight that is about the same or increased relative to wild-type wheat grain is not persuasive because the claimed invention encompasses the plant of the prior art, the plant of the prior art would necessarily have all the properties set forth in the claims. Furthermore, the claims do not recite or require a specific grain weight and the recitation of a grain weight “about the same” as that of a wild-type wheat grain encompasses grain weighing up to 10% less than a wild-type wheat grain (see Applicant’s definition of “about” at paragraph [0144]). One of ordinary skill in the art would reasonably interpret a grain weight that is 10% less than that of a wild-type wheat grain as “generally smaller” than a wild-type wheat grain. Accordingly, in teaching grains that are “generally smaller and slightly shriveled”, Mrva teaches grains that are about the same or reduced relative to a wild-type wheat grain. If the instant invention requires a change in grain weight that is distinct from the “generally smaller and slightly shriveled” grain disclosed by Mrva, it is suggested the claims be amended to distinguish the claimed invention from the plants disclosed in the prior art.
For the reasons above, Applicant’s argument is not considered persuasive.
Newly submitted claims 59-61 are withdrawn as being directed to the non-elected species of Amy1-6B-3, Amy1-6B-4, and/or Amy1-6B-5.
The requirement is deemed proper and is made FINAL.
However, method claims may be rejoined in accordance with In re Ochiai when allowability is indicated.
Priority
3. The instant Application is a 371 of Internation Application No. PCT/AU2022/050917 filed August 18, 2022. The Office acknowledges receipt of Applicant’s foreign priority document Application No. AU2021902585 filed August 18, 2021.
Information Disclosure Statement
4. No Information Disclosure Statement (IDS) has been received for consideration by the Office.
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
6. Claims 1-2, 4, 12, 15, and 58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mrva et al. (Euphytica. 1999; 109:17–23 (previously cited)).
Mrva discloses the regulation of high isoelectric point (high pI) α-amylase synthesis in wheat by genes located on chromosome 6B (Title; Asbtract) and a ditelosomic derivative of the wheat cultivar Chinese spring (Cs dit 6BS) which lacks the long arm of chromosome 6B (Abstract). The recitation and definition, as provided by the instant specification, of a “genetic modification” is broad and refers to any modification to an Amy1 gene that leads to a reduction in the expression of an Amy1 gene on chromosome 6B[0164]. Because the long arm of chromosome 6B has been deleted, the wheat plants disclosed by Mrva comprise a deletion mutation in which each of Amy1-6B-1, Amy1-6B-2, Amy1-6B-3, Amy1-6B-4, and Amy1-6B-5 have been deleted and wherein the expression of each gene and the level and/or activity of the polypeptides encoded therein are reduced relative to a wildtype plant.
Therefore, with regard to claim 1, Mrva teaches a wheat plant comprising a genetic modification in at least one Amy1 gene on chromosome 6B selected from Amy1-6B-1, Amy1-6B-2, Amy1-6B-3, Amy1-6B-4, and Amy1-6B-5 (Abstract), wherein the genetic modification leads to reduced expression of the at least one Amy1 gene on chromosome 6B relative to a wild-type wheat plant (Abstract; pp. 17-18, “Introduction”; p. 22, first paragraph), wherein grain from the plant is characterized by a reduced level or activity, or both, of alpha-amylase 1 (Amy1) polypeptides relative to wild-type wheat grain (Abstract; p. 19, “Total α-amylase activity in GA3-treated de-embryonated grains and germinated grains of CS and CS dit 6BS”; Figure 1; Figure 2), wherein grain from the plant has a grain weight that is about the same or increased relative to wild-type wheat grain (p. 22, fifth paragraph), and wherein the genetic modification is an introduced mutation selected from a deletion mutation, an insertion mutation, a substitution mutation, a splice-site mutation, a premature translation termination mutation, a nonsense mutation, and a frameshift mutation (Abstract; p. 22, first paragraph).
Instant claim 1 does not recite or require a specific grain weight and the recitation of a grain weight “about the same” as that of a wild-type wheat grain encompasses grain weights up to 10% less than that of a wild-type wheat grain (see Applicant’s definition of “about” at paragraph [0144]). Because the claimed invention encompasses the plant of the prior art (i.e., a wheat plant comprising a mutation resulting in reduced expression of an Amy1 gene on chromosome 6B), the plant of the prior art would necessarily have all the properties set forth in the claims. Furthermore, the Examiner interprets a grain weight that is 10% less than that of a wild-type wheat grain as “generally smaller” than a wild-type wheat grain. Accordingly, in teaching grains that are “generally smaller and slightly shriveled”, Mrva teaches grains having a grain weight that is about the same or reduced relative to a wild-type wheat grain. If the instant invention requires a change in grain weight that is distinct from the “generally smaller and slightly shriveled” grain disclosed by Mrva, it is suggested the claims be amended to distinguish the claimed invention from the plants disclosed in the prior art.
Regarding claim 2, in addition to the teachings discussed above, the plant disclosed by Mrva is further characterized by reduced total alpha-amylase activity relative to a control level (Abstract; p. 19, “Total α-amylase activity in GA3-treated de-embryonated grains and germinated grains of CS and CS dit 6BS”); reduced expression of AMY1 polypeptides or peptides in the grain relative to a control level (Abstract; pp. 17-18, “Introduction”; p. 22, first paragraph); and has reduced susceptibility to late-maturity alpha-amylase (LMA) relative to wild-type wheat grain (Abstract; pp. 17-18, “Introduction”; p. 22, third, fourth, and fifth paragraphs).
Regarding claim 4, in addition to the teachings discussed above, the plant disclosed by Mrva is further characterized by reduced expression of at least two, at least three, or at least four Amy1 genes on chromosome 6B; reduced expression of all five Amy1 genes on chromosome 6B; reduced expression of the at least one Amyl gene to an undetectable level; reduced expression of at least one Amyl gene on chromosome 6B via gene silencing; the genetic modification is a deletion mutation, which deletes all or a part of at least one Amy1 gene on chromosome 6B; and the genetic modification is a deletion mutation which is a deletion of about 1-30 base pairs (Abstract; pp. 17-18, “Introduction”; p. 19, “Total α-amylase activity in GA3-treated de-embryonated grains and germinated grains of CS and CS dit 6BS”; p. 22, first paragraph).
Regarding claim 12, in addition to the teachings discussed above, the plant disclosed by Mrva is further characterized by a total alpha-amylase activity of about 1% to about 50% of the total alpha-amylase activity of grain from a wild-type wheat plant grown under the same conditions (p. 19, “Total α-amylase activity in GA3-treated de-embryonated grains and germinated grains of CS and CS dit 6BS”; Figure 1; Figure 2).
Regarding claim 15, in addition to the teachings discussed above, Mrva discloses that the grain of the plant comprising the mutation in the Amy1 genes (i.e., CS dit 6BS) is characterized by a content of low isoelectric point (low pI) alpha-amylase enzymes that is increased relative to wild-type wheat grain (Table 1; Figure 4). Mrva discloses that intact-germinated lines of the plant comprising the mutation in the Amy1 genes (i.e., CS dit 6BS) demonstrated increased low pI alpha-amylase content at 2, 3, and 4 days relative to intact-germinated lines of CS wheat (i.e., the wild-type strain).
With regard to claim 58, the teachings of Mrva are as discussed above. The CS dit 6BS wheat plant disclosed by Mrva comprises a deletion of the long arm of chromosome 6B. Therefore, Mrva teaches a wheat plant wherein the wheat plant comprises a genetic modification in each of Amy1-6B-1 and Amy1-6B-2.
Accordingly, the claimed invention is anticipated by the prior art.
Conclusion
7. No claim is allowed.
Examiner’s Contact Information
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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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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/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663 /Amjad Abraham/SPE, Art Unit 1663
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