Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 50-61 are pending and examined. Claims 1-49 have been cancelled.
Examiner’s Comment
The previous Office action dated 01 September 2026 was withdrawn as noted in the communication dated 17 September 2026. The current Office action is now issued in light of Applicant’s request for suspension and pursuant to the request for continued examination under 37 CFR 1.114 dated 18 June 2026.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 June 2026 has been entered.
Claim Interpretation
The claims are interpreted to encompass plants where if one SBEIIa gene comprises a point mutation then the other SBEIIa gene may not comprise a point mutation and must comprise a different mutation, for example, a deletion mutation (see Applicant reply dated 18 June 2026, p. 9, last ¶; see p. 10, penultimate ¶). In any event and regardless of how the grain is mutated, it must not comprise any detectable SBEIIa protein.
Claim Rejections - 35 USC § 112
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 50-57 and 59-61 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.
Claims 50 and 61 recite the limitation “about” which the specification fails to define and is a subject term. Therefore, the metes and bounds of the claim are indefinite because it is not clear what actual germination percentage is encompassed by the claims.
Claims 51-57 and 59-60 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 50-59 REMAIN rejected, and claims 60 and 61 are NOW 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.
Claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% resistant starch (RS), a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The specification describes that HIB-generated triple null mutant seed are affected in germination whereas plants with five null alleles were normal and fertile and could reach up to 67% amylose content (p. 97, ¶ 0361; p. 98, ¶ 0365). The specification also describes generating triple null mutants with point mutations and deletion mutations (p. 107, Example 11; see p. 111, ¶ 0403). Triple mutants demonstrated a range of amylose contents with some showing considerable sterility (p. 113, ¶ 0410; see ¶ 0411).
The specification prophetically describes that crosses with durum wheat plants were carried out to introduce mutations and produce high amylose wheat (p. 127, ¶ 0454).
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 specification fails to describe, in fact, a single species from the vast genus of durum wheat grain comprising a null point mutation at any possible nucleotide position in the SBEIIa gene and further comprising a null deletion of any size in the other SBEIIa gene and wherein said grain comprises the traits as claimed.
Therefore, to satisfy the written description requirement the instant application must adequately describe the starting material in order to practice the methods and/or processes as claimed. For example, See University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CA FC 2004).
Here, the starting material encompasses a vast genus of plants. Thus, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) (Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed.
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation."
Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See MPEP 2163(II)(A)(3)(a)(ii).
Here, a description of a representative number of species is critical as the specification describes that different combinations of mutations give different amylose contents and can lead to considerable sterility (e.g., see instant specification p. 113, ¶ 0410; see ¶ 0411).
Additionally, the specification fails to describe how mutating the same gene with different point and deletion mutations predictably leads to an amylose content of 50% and up to an amount as great as 90%. This description is critical because one would recognize that if SBEIIa protein is undetectable in the grain that a particular amylose content would result and not a broad range as claimed.
Thus, skilled practitioner would not be of the opinion that Applicant possesses the vast genus of grain as claimed, and given the lack of written description in the specification with regard to the grain 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 because the only evidence provided to support the rejection is Applicant’s own specification which is not relevant because the cited paragraphs pertain to results in hexaploid wheat and not tetraploid wheat (Applicant reply dated 18 June 2026, p. 7, ¶ 1).
This argument is not persuasive because on the one hand Applicant argues that results from hexaploid wheat are not relevant but then on the other hand argues that results from hexaploid wheat are relevant (e.g., see Applicant reply dated 18 June 2026, p. 7, last ¶).
Namely, Applicant wishes the Office to accept that the prophetic example of introducing SBEIIa null genes from hexaploid wheat into tetraploid wheat will yield the traits as claimed but at the same time urges the Office to ignore results observed in hexaploid wheat plants.
Here, one would extrapolate results from tetraploid wheat to hexaploid wheat because the SBEIIa genes have the same exact function in both types of wheat. Thus, if one of skill in the art understands that abolishing SBEIIa protein in hexaploid wheat increases amylose content then the skilled artisan would certainly expect the same to occur in tetraploid durum wheat.
Moreover, Applicant’s argument is not persuasive because the specification fails to describe, in fact, the amylose content or germination rate of grain from durum wheat as claimed, and only indicates that crosses have been made to produce the grain as claimed.
Applicant asserts the specification provides an actual reduction to practice of the claimed invention and that mutant genes from the hexaploid plant would readily transfer to the tetraploid plant (Applicant reply dated 18 June 2026, p. 7, last ¶).
This argument is not persuasive and contradictory because it is not clear how one can expect the phenotypes observed in hexaploid wheat to be transferred to tetraploid wheat but then at the same time not be able to predict the phenotypes in tetraploid wheat based on the phenotypes observed in hexaploid wheat.
Moreover, Applicant’s argument is not persuasive because the specification fails to describe, in fact, the amylose content or germination rate of grain from durum wheat as claimed, and only indicates that crosses have been made to produce the grain as claimed.
Applicant traverses the rejection of the claims because methods for making mutations in wheat plants are described and known in the art (Applicant reply dated 18 June 2026, p. 7, last ¶ bridging p. 8; see also p. 8, ¶ 2).
This argument is unpersuasive because it does not address whether the specification has described, in fact, the broad genus of null alleles as claimed that confer the equally broad genus of traits as claimed.
Regarding Sestili, the issue is not whether one can make the grain as claimed. In fact, Sestili supports the rejection of the claims in light of the prior art as set forth infra in the instant Office action because one would have a reasonable expectation of success in making the grain as claimed (i.e., a grain where SBEIIa protein is undetectable).
Thus, Sestili does not address the issue of whether the skilled artisan would be of the opinion that Applicant possesses each and every species of grain as encompassed by the claims where any point mutation and a deletion of any size can be made where the resulting grain has an amylose content anywhere from 50% to as much as 90%.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, under pre-AIA 35 U.S.C. 102(e) as being anticipated by Regina et al (Patent No. US 8,115,087) or in the alternative are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Regina et al (Patent No. US 8,115,087).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The broadest reasonable interpretation of the claims is that the only structural requirement of the grain is that it comprise combinations of naturally occurring or induced null point or deletion mutations. In light of this interpretation, all other characteristics of the grain are considered functional and result from the structure conferred by the aforementioned mutations.
Regina et al claim wheat grain comprising starch and null mutations of two SBEIIa gene with amylose greater than 30%, wherein the grain is from durum wheat, products produced therefrom and processes for making said grain by crossing two plants each comprising null mutations in the SBEIIa gene to obtain progeny (i.e., grain capable of germinating) with at least 30% amylose (claims 1, 2, 4, 10, 12-14, 18, 20, 22-24, 26, 27, 29, 30, 33 and 34). Western blot analysis is used to detect protein levels (col. 11, ¶ 2).
Mutations to the SBEIIa gene in the A and B genomes may be null and made by using point mutations or deletion mutations such that two identical null alleles of the SBEIIa-A and SBEIIa-B gene comprise either said mutations (col. 18, ¶ 1; see col. 25, last ¶ bridging all of col. 26; see also Example 10). Thus, it is clear that “null mutations” as recited in the claims encompass both point and deletion mutations.
Applicant should note the Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product.
In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Here, the crosses as indicated noted supra are species of plants producing grain that is encompassed by the genus of SBEIIa null mutants of the instant claims and thus also yield the amylose content and germination rate as instantly claimed.
Therefore, because the grain of Regina et al has null mutations of two SBEIIa genes and undetectable levels of SBEIIa protein, durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles is anticipated by Regina et al.
In the alternative and at the time of filling of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify durum grain that has two identical null mutations in SBEIIa genes as taught by Regina et al by instead making a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene because the types of mutations are functionally equivalent in so far as they yield grain with undetectable levels of SBEIIa protein.
Namely, when looking at the totality of the teachings of Regina et al one would readily appreciate that point mutations and deletion mutations could be combined rather than just using point mutations because the same result occurs: lack of SBEIIa gene expression which leads to an increase in amylose content and in turn an increase in RS, the benefits of which are addressed above.
One would have a reasonable expectation of success in arriving at the grain as claimed because all that is required of the grain is that it comprise two identical null alleles of the SBEIIa-A and B gene, and because Regina et al provides the methodology to do so.
One would also have a reasonable expectation of success in arriving at the grain as claimed because when SBEIIa gene expression is eliminated amylose content is increased (e.g., see Table 8; see also Table 10).
Response to Arguments
Applicant traverses the rejection of the claims arguing that the instant claims exclude from their scope wheat grain where each of the SBEIIa-A gene and SBEIIa-B genes may comprise point mutations and that the reference fails to disclose grain where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 15).
Applicant’s argument is not persuasive because Regina specifically claims wheat grain comprising two null mutations in the SBEIIa gene wherein one of the mutations is a deletion mutation and wherein SBEIIa activity is reduced meaning that it may be completely undetectable. Regarding the other mutation, it is understood the limitation “null” encompass point mutations. Therefore, the grain of claim 1 in Regina anticipates the instantly claimed grain.
Applicant’s argument is also not persuasive because nowhere does the reply rebut the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of Regina.
Here, one has a reasonable expectation of success in arriving at the grain as claimed because all one needs to do, for example, is follow the claims and suggestions of Regina to cross one durum plant comprising identical null point mutations in one SBEIIa gene with another durum plant comprising different identical null mutations in the other SBEIIa gene.
One is motivated to do so because Regina teaches that abolishing SBEIIa activity leads to an increase in RS which is desirable because of the health benefits associated with RS in products produced from wheat.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 50, 51, 53-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Slade et al (Patent No. US 10,563,217 B2).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 50, 51 and 53-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The broadest reasonable interpretation of the claims is that the only structural requirement of the grain is that it comprise combinations of naturally occurring or induced null point or deletion mutations. In light of this interpretation, all other characteristics of the grain are considered functional and result from the structure conferred by the aforementioned mutations.
Slade et al claim a wheat plant or seed comprising splice junction mutation in the SBEIIa allele of the A genome and a second SBEIIa allele having a severe mutation and wherein the amylose content is increased, a flour or a food product comprising a cell of said wheat plant and wherein the plant produces seeds that germinate such that it is fertile (see claims 24-27). Mutations in the A and B genomes may be combined (col. 27, last ¶). Severe mutations are those having deleterious effects on protein function (col. 55, ¶ 4).
Slade et al teach the invention is directed to human induced non transgenic mutations at one or more of the SBEII genes of wheat to produce products exhibiting increased amylose and RS content (see Abstract).
The invention contemplates using point mutations or short deletions of about 1 to 30 nucleotides to the SBEIIa gene to inhibit production of SBEIIa protein or produce a SBEIIa protein with no activity (i.e., the protein is undetectable and null), that the SBEIIb gene may also be mutated, and that tetraploid Durum wheat plants may be used (col. 7, ¶ 2; see col. 15 and 19; see col. 20, ¶ 6; see also col. 21, last ¶; see col. 24, ¶ 2).
Slade et al teach, in fact, that Kronos Durum wheat was EMS mutagenized to produce plants comprising a stop mutation in the SBEIIa gene of the A genome and a splice mutation in the SBEIIb gene of the B genome, or plants comprising a stop mutation and a missense mutation the SBEIIa gene of the A and B genome, respectively, had 49% amylose and increased RS having health benefits (col. 53, last ¶; col. 61, ¶ 1; see also col. 1).
Slade et al also teach triple homozygous Express wheat plants with a stop mutation in each of the SBEIIa genes wherein the amylose content of the seed was increased to between 50-60% (col. 61).
Thus, while Slade et al reasonably teach, suggest and provide motivation for making Durum wheat grain wherein SBEIIa protein is undetectable with a reasonable expectation of success, the issue is whether one would have made said grain that comprises a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene.
Therefore, at the time of filling of the instant invention it would have been prima facie obvious to modify durum grain that has two identical null mutations in SBEIIa genes as taught by Slade et al by instead making a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene because the types of mutations are functionally equivalent in so far as they produce undetectable levels of SBEIIa protein.
Namely, when looking at the totality of the teachings of Slade et al one would readily appreciate that point mutations and deletion mutations could be combined rather than just using point mutations because the same result occurs: lack of SBEIIa gene expression which leads to an increase in amylose content and in turn an increase in RS, the benefits of which are addressed above.
One would have a reasonable expectation of success in arriving at the grain as claimed because all that is required of the grain is that it comprise two identical null alleles of the SBEIIa-A and B gene, and because Slade et al provides detailed methodology to do so.
One would also have a reasonable expectation of success in arriving at the grain as claimed because Slade, in fact, teaches that SBEIIa mutations lead to increased amylose content of greater than 50% and because Slade teaches that any level of increased amylose content is desirable (e.g., see col. 30, ¶ 4; see also col. 61, ¶ 1 and 2).
Response to Arguments
Applicant traverses the rejection of the claims arguing that the instant claims exclude from their scope wheat grain where each of the SBEIIa-A gene and SBEIIa-B genes may comprise point mutations and because the reference fails to disclose grain where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations. Applicant references Patent Interference 106,094 to support this claim interpretation (Applicant reply dated 18 June 2026, p. 9, last ¶ spanning p. 10).
As an initial matter, it is noted that the decision in ‘094 does not pertain to whether one would find it prima facie obvious to arrive at the instant invention. While the decision in ‘094 addresses what may be claimed in Slade, it does not address whatsoever the teachings, suggestions and motivation provided in Slade with respect to whether it is obvious to produce grain from durum wheat wherein SBEIIa is undetectable.
Therefore, Applicant’s repeated argument that the decision in ‘094 implies that Slade is directed to plants only comprising point mutations and not combinations of a point mutation in one SBEIIa gene and a different mutation in the other SBEIIa gene that is not a point mutation is immaterial in determining whether the instant invention is obvious is in light of Slade or any other prior art of record.
Applicant’s argument is unpersuasive because nowhere does the reply rebut the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of Slade.
Here, one has a reasonable expectation of success in arriving at the grain as claimed because all one needs to do, for example, is follow the suggestions of Slade to cross one durum plant comprising identical null point mutations in one SBEIIa gene with another durum plant comprising different identical null mutations in the other SBEIIa gene.
One is motivated to do so because Slade teaches that abolishing SBEIIa activity leads to an increase in RS which is desirable because of the health benefits associated with RS in products produced from wheat.
Claim(s) 50, 51 and 53-59 REMAIN rejected, and claims 60 and 61 are NOW under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Slade et al (Patent No. US 11,649,464 B2).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 50, 51 and 53-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The broadest reasonable interpretation of the claims is that the only structural requirement of the grain is that it comprise combinations of naturally occurring or induced null point or deletion mutations. In light of this interpretation, all other characteristics of the grain are considered functional and result from the structure conferred by the aforementioned mutations.
Slade claim a process for producing a milled product, comprising: (i) providing wheat grain (Triticum durum) comprising an embryo and starch, wherein the embryo comprises two SBEIIa genes, wherein both alleles of the SBEIIa-A gene are identical and both alleles of the SBEIIa-B gene are identical, and wherein (a) the SBEIIa-A gene has a severe mutation that is a short deletion and the SBEIIa-B gene has a severe mutation that is a short deletion; (b) SBEIIa enzyme activity is reduced or eliminated in the wheat grain; (c) the wheat grain has an increased amylose content compared to the amylose content of wild type wheat grain; and (d) the wheat grain is capable of germinating, and (ii) milling the grain to produce a milled grain product, and wherein the grain is non-transgenic, wherein the grain has at least 4% RS and wherein the deletion is 1 to 10 nucleotides in length (see claims 1-9).
Slade et al teaches, in fact, that Kronos Durum wheat was EMS mutagenized to produce plants comprising a stop mutation in the SBEIIa gene of the A genome and a splice mutation in the SBEIIb gene of the B genome, or plants comprising a stop mutation and a missense mutation the SBEIIa gene of the A and B genome, respectively had 49% amylose and increased RS (col. 53, last ¶; col. 61, ¶ 1; see also col. 1).
Slade et al also teach triple homozygous Express wheat plants with a stop mutation in each of the SBEIIa genes wherein the amylose content of the seed was increased to between 50-60% (col. 61).
Slade et al teaches the invention is directed to human induced non transgenic mutations at one or more of the SBEII genes of wheat to produce products exhibiting increased amylose and RS content (see Abstract).
The invention contemplates using point mutations or short deletions of about 1 to 30 nucleotides to the SBEIIa gene to inhibit production of the protein (i.e., the protein is undetectable), that the SBEIIb gene may also be mutated, and that tetraploid Durum wheat plants may be used (col. 7, ¶ 2; see col. 15 and 19; see col. 20, ¶ 6; see also col. 21, last ¶; see col. 24, ¶ 2).
Thus, while Slade et al reasonably teach, suggest and provide motivation for making Durum wheat grain wherein SBEIIa protein is undetectable with a reasonable expectation of success, the issue is whether one would have made said grain that comprises a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene.
Therefore, at the time of filling of the instant invention it would have been prima facie obvious to modify durum grain that has two identical null mutations in each of the SBEIIa genes as taught by Slade et al by instead making a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene because the types of mutations are functionally equivalent in so far as undetectable levels of SBEIIa protein are obtained.
Namely, when looking at the totality of the teachings of Slade et al one would readily appreciate that point mutations and deletion mutations could be combined rather than just using point mutations because the same result occurs: lack of SBEIIa gene expression which leads to an increase in amylose content and in turn an increase in RS, the benefits of which are addressed above.
One would have a reasonable expectation of success in arriving at the grain as claimed because all that is required of the grain is that it comprise two identical null alleles of the SBEIIa-A and B gene, and because Slade et al provides the methodology to do so.
One would also have a reasonable expectation of success in arriving at the grain as claimed because Slade, in fact, teaches that SBEIIa mutations lead to increased amylose content of greater than 50% and because Slade teaches that any level of increased amylose content is desirable (e.g., see col. 30, ¶ 4; see also col. 61, ¶ 1 and 2).
Response to Arguments
Applicant traverses the rejection of the claims arguing that the instant claims exclude from their scope wheat grain where each of the SBEIIa-A gene and SBEIIa-B genes may comprise point mutations and that the reference fails to disclose grain where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations. Applicant references Patent Interference 106,094 to support this claim interpretation (Applicant reply dated 18 June 2026, p. 11, penultimate ¶ spanning p. 12).
However, this argument is not persuasive because nowhere has Applicant rebutted the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of Slade.
Here, one has a reasonable expectation of success in arriving at the grain as claimed because all one needs to do, for example, is follow the suggestions of Slade to cross one durum plant comprising identical null point mutations in one SBEIIa gene with another durum plant comprising different identical null mutations in the other SBEIIa gene.
One is motivated to do so because Slade teaches that abolishing SBEIIa activity leads to an increase in RS which is desirable because of the health benefits associated with RS in products produced from wheat.
Claim(s) 50, 51 and 53-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Slade et al (Patent No. US 12,319,920 B2).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 50, 51 and 53-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The broadest reasonable interpretation of the claims is that the only structural requirement of the grain is that it comprise combinations of naturally occurring or induced null point or deletion mutations. In light of this interpretation, all other characteristics of the grain are considered functional and result from the structure conferred by the aforementioned mutations.
Slade et al claim durum flour comprising one or more homozygous mutations in both SBEIIa alleles of each SBEIIa gene of the A and B genome, purified starch from said flour, food comprising said flour and a method of making wheat grain comprising obtaining a durum plant comprising said mutations wherein the plant produces grain that germinates and the grain has increased amylose content (claims 1-9).
Slade et al teach, in fact, that Kronos Durum wheat was EMS mutagenized to produce plants comprising a stop mutation in the SBEIIa gene of the A genome and a splice mutation in the SBEIIb gene of the B genome, or plants comprising a stop mutation and a missense mutation the SBEIIa gene of the A and B genome, respectively had 49% amylose and increased RS (col. 61, ¶ 1 and 2).
Slade et al also teach triple homozygous Express wheat plants with a stop mutation in each of the SBEIIa genes wherein the amylose content of the seed was increased to between 50-60% (col. 61).
Slade et al teach the invention is directed to human induced non transgenic mutations at one or more of the SBEII genes of wheat to produce products exhibiting increased amylose and RS content (see Abstract).
The invention contemplates using point mutations or short deletions of about 1 to 30 nucleotides to the SBEIIa gene to inhibit production of the protein (i.e., the protein is undetectable), that the SBEIIb gene may also be mutated, and that tetraploid Durum wheat plants may be used (col. 7, ¶ 2; see col. 9; see col. 20, ¶ 6; see also col. 21, penultimate ¶; see col. 24, ¶ 1).
Thus, while Slade et al reasonably teach, suggest and provide motivation for making Durum wheat grain wherein SBEIIa protein is undetectable with a reasonable expectation of success, the issue is whether one would have made said grain that comprises a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene.
Therefore, at the time of filling of the instant invention it would have been prima facie obvious to modify durum grain that has two identical null mutations in SBEIIa genes as taught by Slade et al by instead making a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene because the types of mutations are functionally equivalent in so far as undetectable levels of SBEIIa protein are obtained in grain.
Namely, when looking at the totality of the teachings of Slade et al one would readily appreciate that point mutations and deletion mutations could be combined rather than just using point mutations because the same result occurs: lack of SBEIIa gene expression which leads to an increase in amylose content and in turn an increase in RS, the benefits of which are addressed above.
One would have a reasonable expectation of success in arriving at the grain as claimed because all that is required of the grain is that it comprise two identical null alleles of the SBEIIa-A and B gene, and because Slade et al provides the methodology to do so.
One would also have a reasonable expectation of success in arriving at the grain as claimed because Slade, in fact, teaches that SBEIIa mutations lead to increased amylose content of greater than 50% and because Slade teaches that any level of increased amylose content is desirable (e.g., see col. 30, ¶ 1; see also col. 61, ¶ 1 and 2).
Response to Arguments
Applicant traverses the rejection of the claims arguing that the instant claims exclude from their scope wheat grain where each of the SBEIIa-A gene and SBEIIa-B genes may comprise point mutations and that the reference fails to disclose grain where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations. Applicant references Patent Interference 106,094 to support this claim interpretation (Applicant reply dated 18 June 2026, p. 13, ¶ 2 spanning p. 14).
However, this argument is not persuasive because nowhere has Applicant rebutted the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of Slade.
Here, one has a reasonable expectation of success in arriving at the grain as claimed because all one needs to do, for example, is follow the suggestions of Slade to cross one durum plant comprising identical null point mutations in one SBEIIa gene with another durum plant comprising different identical null mutations in the other SBEIIa gene.
One is motivated to do so because Slade teaches that abolishing SBEIIa activity leads to an increase in RS which is desirable because of the health benefits associated with RS in products produced from wheat.
Claim(s) 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Regina et al (Patent No. US 7,812,221 B2).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The broadest reasonable interpretation of the claims is that the only structural requirement of the grain is that it comprise combinations of naturally occurring or induced null point or deletion mutations. In light of this interpretation, all other characteristics of the grain are considered functional and result from the structure conferred by the aforementioned mutations.
Regina et al claim a wheat grain comprising wheat endosperm having starch and DNA which encodes a double-stranded RNA molecule comprising nucleotides in a sequence which corresponds to a sequence of at least 30 contiguous nucleotides of an exon of the SBEIIa gene which inhibits expression of SBEIIa, wherein the proportion of amylose of the starch of the wheat endosperm is at least 40% (w/w), a process of producing said grain and wherein the protein is undetectable as determined by Western blot analysis, and products produced from said grain (see claims 1, 3, 13-15 and 17).
Alternatively, Regina et al disclose durum plants which are SBEIIa double null A and B mutants can be generated with high amylose content (col. 50 beginning at line 40). Mutations may be point mutations or deletion mutations (col. 7, ¶ 1 and last ¶; see also col. 15; see col. 18, penultimate ¶; see also col. 26 and 27; see also Example 10).
Therefore, at the time of filling of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to modify the durum grain as claimed by Regina by instead making a point mutation in one SBEIIa gene and a different mutation, for example, a deletion mutation in the other SBEIIa gene because gene silencing and mutating genes are functionally equivalent in so far as they lead to undetectable levels of SBEIIa protein as required by the instant claims.
Namely, when looking at the totality of the teachings of Regina et al one would readily appreciate that point mutations and deletion mutations could be combined rather using double stranded RNA because the same result occurs: lack of SBEIIa gene expression which leads to an increase in amylose content and in turn an increase in RS, the benefits of which are addressed above.
One would have a reasonable expectation of success in arriving at the grain as claimed because all that is required of the grain is that it comprise two identical null alleles of the SBEIIa-A and B gene, and because Regina et al provides the methodology to do so.
One would also have a reasonable expectation of success in doing so because when SBEIIa gene expression is eliminated amylose content is increased (e.g., see Table 8; see also Table 10).
Response to Arguments
Applicant traverses the rejection because Regina only discloses plants as null and does not teach plants comprising the mutations as claimed and that the examiner has not provided a rationale based on the teachings of Regina why a POSA would be led to produce grain as claimed (Applicant reply dated 18 June 2026, p. 16).
This argument is not persuasive because (1) it fails to address why it would not have been prima facie obvious to arrive at the grain as claimed; and (2) the Office specifically provided a rationale in the Office action dated 18 March 2026 (e.g., see p. 34, penultimate and last ¶).
To reiterate, one of ordinary skill in the art is motivated to make a grain completely lacking SBEIIa protein (i.e., where the protein is undetectable) because to do so increases amylose content and in turn increases RS content which is associated with various health benefits.
One may obtain this grain through the use of RNAi as claimed in Regina or by using point mutations or deletion mutations as taught and suggested in ‘221.
Claims 50 and 52 REMAIN rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Slade et al (Patent No. US 10,563,217 B2) and Slade et al (Patent No. US 12,319,920 also referred to herein as ‘920) in view of Urban et al (2007, Bio-Rad Laboratories, Inc., Bulletin 5576:1-6).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Instant claims 50 and 52 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, and wherein the protein is undetectable by Western blot analysis.
Slade et al claim a wheat plant or seed comprising splice junction mutation in the SBEIIa allele of the A genome and a second SBEIIa allele having a severe mutation and wherein the amylose content is increased, and flour or a food product comprising a cell of said wheat plant and wherein the plant produces seeds that germinate (see claims 24-27). Mutations in the A and B genomes may be combined (col. 27, last ¶). Severe mutations are those having deleterious effects on protein function (col. 55, ¶ 4).
Slade et al teach the invention is directed to human induced non transgenic mutations at one or more of the SBEII gene of wheat to produce products exhibiting increased amylose and resistant starch content (see Abstract).
The invention contemplates using point mutations or short deletions of about 1 to 30 nucleotides to the SBEIIa gene to inhibit production of the protein (i.e., the protein is undetectable), that the SBEIIb gene may also be mutated, and that tetraploid Durum wheat plants may be used (col. 7, ¶ 2; see col. 15 and 19; see col. 20, ¶ 6; see also col. 21, last ¶; see col. 24, ¶ 2).
Slade et al teach, in fact, that Kronos Durum wheat was EMS mutagenized to produce plants comprising a stop mutation in the SBEIIa gene of the A genome and a splice mutation in the SBEIIb gene of the B genome, or plants comprising a stop mutation and a missense mutation the SBEIIa gene of the A and B genome, respectively (col. 53, last ¶; col. 61, ¶ 1).
Slade et al also teach triple homozygous Express wheat plants with a stop mutation in each of the SBEIIa genes wherein the amylose content of the seed was increased to between 50-60% (col. 61).
Meanwhile, Slade et al ‘920 claim durum flour comprising one or more homozygous mutations in both SBEIIa alleles of each SBEIIa gene of the A and B genome, purified starch from said flour, food comprising said flour and a method of making wheat grain comprising obtaining a durum plant comprising said mutations wherein the plant produces grain that germinates and the grain has increased amylose content (claims 1-9).
Thus, while Slade et al and Slade et al ‘920 reasonably teaches, suggests and provides motivation for making the grain as claimed with a reasonable expectation of success, the issue is whether one would have used Western blot assay to determine protein levels.
Therefore, at the time of the instant invention it would have been prima facie obvious to one of ordinary skill in the art, and with a reasonable expectation of success, to determine SBEIIa protein levels in durum wheat using the Western blot assay because it was a well-known and readily available methodology (e.g. see Urban et al; entire document).
Response to Arguments
Applicant traverses the rejection of the claims ‘217 is not prior art (Applicant reply dated 18 June 2026, p. 17, section I).
First, it should be noted the current rejection explains why it would be obvious to use Western blot analysis as encompassed by claim 52. Applicant has failed to rebut this particular aspect of the rejection and instead returns to argue what is or is not taught by ‘217 and ‘920.
Moreover, this argument is not persuasive because (1) Applicant chooses to question whether ‘217 is prior art but has not done so for the rejection of other claims under pre-AIA 35 U.S.C. 102(e) as being anticipated and under pre-AIA 35 U.S.C. 103(a) for being obvious; and (2) ‘217 need not specifically disclose limitations as claimed because the claims are not rejected for being anticipated.
With regard to the specific teachings of both ‘217 and ‘920 (e.g., see Applicant reply dated 18 June 2026, p. 17, section II) it is again noted that each provide clear teachings and suggestions to obtain grain with undetectable levels of SBEIIa protein. One is motivated to do so because it is known that decreasing SBEIIa expression leads to increased amylose content, the importance of which is discussed above.
In other words, the specific types of mutations are immaterial so long as SBEIIa protein is undetectable in the wheat grain.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sestilli et al (2010, BMC Plant Biology, 10:1-12) in view of Uauy et al (2009, BMC Plant Bio., 9:1-14) and Regina et al (Patent No. US 7,812,221 B2) and Slade et al (Patent No. US 10,563,217 B2, also referred to as ‘217) and in further view of Dong et al (2009, Plant Genome, 2:39-47) and Slade et al (2005, Nature Biotechnology, 23:75-81) and Urban et al (2007, Bio-Rad Laboratories, Inc., Bulletin 5576:1-6).
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
Sestilli et al teach that amylose content can be increased in durum wheat through silencing of SBEIIa genes (see Abstract). RNAi lines lacked expression of SBEIIa genes and was undetectable (see Figure 1; see also p. 6, col. 2, ¶ 2). Amylose content reached upwards of 75% of the starch content while there was no significant difference observed in grain yield between transformed and control lines (p. 6, col. 2, last ¶; see also p. 7, col. 1, ¶ 1).
Sestilli et al teach that to obtain a null phenotype it is usually necessary to generate double or triple null mutants by crossing single null phenotypes (p. 6, col. 1, last ¶). Sestilli et al teach that high amylose foods are of interest because they have increased amounts of RS which has been shown to have beneficial health effects on human health (p. 2, col. 1, last ¶).
Thus, while Sestilli et al reasonably teach, suggest and provide motivation for producing wheat grain with undetectable SBEIIa protein and an amylose content of greater than 50% with a reasonable expectation of success, the issue is whether one would have made null point and deletion mutations in each SBEIIa gene, respectively, rather than use RNAi.
To this point, Uauy et al teach a reverse genetics approach through the combination of ethyl methane sulphonate (EMS)-mediated mutagenesis and TILLING may be used to screen different genetic backgrounds allowing for the construction of cultivar mutant allele specific libraries (p. 2, col. 2 ¶ 1 and 2). These specific mutant alleles may be used in traditional breeding programs since the technology is non-transgenic and mutations are stably inherited (p. 2, col. 2, ¶ 2).
In particular, Uauy et al teach an EMS-mutagenized durum wheat breeding line (p. 3, col. 1), characterization of the obtained TILLING libraries by screening for SBEIIa in each of the different wheat genomes (p. 3, col. 1, ¶ 2; see also p. 5, Table 1). Splice junction mutations, premature stop codons (i.e., null mutations), and several missense mutations were identified in the SBE genes (p. 3, col. 2, last par, bridging p. 5; see also Table 3). Germination rates of about 50-60% were obtained (p. 3, col. 1, ¶ 1).
Uauy et al teach that the SBEIIa gene is an important target with commercial application as mutants have a high amylose phenotype and that TILLING has various benefits in comparison to the use of RNAi to inhibit expression of genes of interest (p. 7, col. 2, ¶ 1; see also p. 2, col. 1, last ¶ bridging col. 2).
Similarly, Regina et al disclose durum plants which are SBEIIa double null A and B mutants can be generated with high amylose content, the importance of which is noted supra (col. 50 beginning at line 40).
Slade et al ‘217 claim a wheat plant or seed comprising splice junction mutation in the SBEIIa allele of the A genome and a second SBEIIa allele having a severe mutation and wherein the amylose content is increased, and flour or a food product comprising a cell of said wheat plant and wherein the plant produces seeds that germinate (see claims 24-27). Mutations in the A and B genomes may be combined (col. 27, last ¶). Severe mutations are those having deleterious effects on protein function (col. 55, ¶ 4).
Slade et al ‘217 teach the invention is directed to human induced non transgenic mutations at one or more of the SBEII gene of wheat to produce products exhibiting increased amylose and resistant starch content (see Abstract), that the invention contemplates using point mutations or short deletions of about 1 to 30 nucleotides to the SBEIIa gene to inhibit production of the protein (i.e., the protein is undetectable), and that tetraploid Durum wheat plants may be used (col. 7, ¶ 2; see col. 15 and 19; see col. 20, ¶ 6; see also col. 21, last ¶; see col. 24, ¶ 2).
Meanwhile, Dong et al teach that it was known in the art that EMS concentrations can alter germination rates in wheat, and that germination rates of greater than 70% can be obtained (p. 41, col. 2, ¶ 2).
Like Dong et al, Slade et al teach that for efficient TILLING, mutagenesis of the target population must produce a mutation frequency that is conducive to high-throughput screening but is below a threshold that causes widespread sterility and lethality, and that most mutated plants appeared no different than wild-type plants (p. 76, col. 1, ¶ 1).
Urban et al teach that Western blot methodologies were well-known and routine in the art for the detection or proteins (see entire document).
Therefore, at the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed with null point and deletion mutations as opposed to using RNAi because Uauy et al teaches that mutagenesis is preferable to RNAi in order to avoid making transgenic plants. In this way high amylose foods would be produced with increased amounts of RS which has been shown to have beneficial health effects on human health.
One would have a reasonable expectation of success in obtaining the amylose content as claimed because Sestilli et al teach that knocking out SBEIIa, which is analogous to making null SBEIIa genes, yields an amylose content upwards of 75% of the starch content
One would have a reasonable expectation of success in producing grain having a germination rate of greater than 70% because each of Uauy et al, Slade et al and Dong et al recognize that EMS concentrations affect germination rate, and that if the proper concentrations are used then a germination of greater than 70% can be obtained. This is obvious to do as one of ordinary skill in the art would want germination rates of as close to 100% as possible.
With respect to claims 50 and 53, it would have been prima facie obvious to one of ordinary skill in the art to make combinations of deletions and point mutations as claimed because to do so is also a design choice between functional equivalents which Slade et al ‘217 clearly teaches and which Regina et al recognizes: both point mutations and deletion mutations of at least part of the gene may be used to abolish SBEIIa function (e.g., see col. 15, ¶ 2). In fact, Regina et al specifically teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability (col. 26, last ¶).
It is noted that the equivalency must be recognized in the prior art, and cannot be based on applicant’s disclosure or the mere fact that the components at issue are functional or mechanical equivalents. In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958). See MPEP 2144.06
Factors that will support a conclusion that the prior art element is an equivalent are: (1) the prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co. , 208 F.3d 1352, 54 USPQ2d 1308 (Fed. Cir. 2000); or (2) a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. Caterpillar Inc. v. Deere & Co. , 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); or (3) there are insubstantial differences between the prior art element and the corresponding element disclosed in the specification. IMS Technology, Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1436, 54 USPQ2d 1129, 1138 (Fed. Cir. 2000). See MPEP 2183.
Here, using a combination of deletion mutations and null point mutations as opposed to point mutations satisfy all three criteria outlined above: point mutations and deletion mutations both abolish SBEIIa activity, one would have recognized that either method would abolish activity, and there is no difference between using one versus the other (e.g., see Regina et al).
Response to Arguments
Applicant traverses the rejection of the claims because the instant application is the first to teach that one of the null mutations in the SBEIIa null wheat grain should be a point mutation to avoid germination issues (Applicant reply dated 18 June 2026, p. 20, last ¶).
This argument is not persuasive because the issue is not whether one has a reasonable expectation of success in producing grain with the germination rate as claimed but whether one has a reasonable expectation of success in making grain that
comprises a point mutation in one SBEIIa gene and where the other SBEIIa gene does not comprise a point mutation and must comprise a different mutation, for example, a deletion mutation.
Furthermore, Applicant appears to imply that this particular result is unexpected as this this the first time germination issues are avoided. If Applicant’s argument is accepted then the argument is not commensurate in scope with what is claimed. Namely, even if the issue was whether one has a reasonable expectation of success in producing grain with the germination rate as claimed, the claims are not directed to any particular point mutation in an SBEIIa gene that would avoid alleged germination issues.
Applicant argues the teachings of Uauy and Slade and Dong are generic and do not inform one regarding germination issues caused by specific mutations in specific genes (Applicant reply dated 18 June 2026, p. 21, ¶ 1).
This argument is not persuasive because the instant claims are not drawn to any specific mutation in the structure of any particular gene. Rather, the claims are broadly drawn to generic mutations that may occur in a nucleic acid position of the gene.
Moreover, Dong specifically provides one with a reasonable expectation of success when introducing point mutations in wheat: germination rates of greater than 70% can be obtained when using EMS mutagenesis (p. 41, col. 2, ¶ 2).
Applicant argues none of the references teach grain where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 21, ¶ 2).
However, this argument is not persuasive because nowhere has Applicant rebutted the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of the art as addressed supra.
Here, one has a reasonable expectation of success in arriving at the grain as claimed because all one needs to do, for example, modify the method of Sestilli for producing grain with undetectable levels of SBEIIa by instead making combinations of point mutations and deletion mutations, for example, as taught and suggested by Regina and ‘217. One does this because Uauy teaches mutated alleles are preferable to transgenic gene silencing.
One is motivated to do so because that prior art recognizes that abolishing SBEIIa activity leads to an increase in RS which is desirable because of the health benefits associated with RS in products produced from wheat.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees.
A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 13-15 and 17 of U.S. Patent No. US 7,812,221 B2 (referred to herein as ‘221) in view of US Patent No. US 11,649,464 B2 (referred to herein as ‘464). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘221 claims a wheat grain comprising wheat endosperm having starch and DNA which encodes a double-stranded RNA molecule comprising nucleotides in a sequence which corresponds to a sequence of at least 30 contiguous nucleotides of an exon of the SBEIIa gene which inhibits expression of SBEIIa, wherein the proportion of amylose of the starch of the wheat endosperm is at least 40% (w/w), a process of producing said grain and wherein the protein is undetectable as determined by Western blot analysis, and products produced from said grain (see claims 1, 3, 13-15 and 17).
‘464 claims a process for producing a milled product, comprising: (i) providing wheat grain (Triticum durum) comprising an embryo and starch, wherein the embryo comprises two starch branching enzyme IIa (SBEIIa) genes, wherein both alleles of the SBEIIa-A gene are identical and both alleles of the SBEIIa-B gene are identical, and wherein (a) the SBEIIa-A gene has a severe mutation that is a short deletion and the SBEIIa-B gene has a severe mutation that is a short deletion; (b) SBEIIa enzyme activity is reduced or eliminated in the wheat grain; (c) the wheat grain has an increased amylose content compared to the amylose content of wild type wheat grain; and (d) the wheat grain is capable of germinating, and (ii) milling the grain to produce a milled grain product, and wherein the grain is non-transgenic, wherein the grain has at least 4% RS and wherein the deletion is 1 to 10 nucleotides in length (see claims 1-9).
Therefore, at the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed with a reasonable expectation of success because ‘221 teaches the elimination of SBEIIa to increase amylose content while ‘464 provides another specific and functionally equivalent alternative manner in which to do so.
Response to Arguments
Applicant traverses the rejection because the art does not teach grain where either two identical null alleles of the SBEIIa-A gene or two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 21, penultimate ¶).
However, this argument is not persuasive because nowhere has Applicant rebutted the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of ‘221 in view of ‘464.
Here, one is motivated to, and has a reasonable expectation of success in, arriving at the grain as claimed because all one needs to do is modify the methods of ‘221 in view of ‘464 to eliminate SBEIIa protein in order to increase amylose content.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 10, 12-14, 18, 20, 22-24, 26, 27, 29, 30, 33 and 34 of US Patent No. US 8,115,087 (referred to herein as ‘087) in view of Patent No. US 11,649,464 B2 (referred to herein as ‘464). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘087 claims wheat grain comprising starch and null mutations of two SBEIIa gene with amylose greater than 30%, wherein the grain is from durum wheat, products produced therefrom and processes for making said grain by crossing two plants each comprising null mutations in the SBEIIa gene to obtain progeny (i.e., grain capable of germinating) with at least 30% amylose (claims 1, 2, 4, 10, 12-14, 18, 20, 22-24, 26, 27, 29, 30, 33 and 34). Western blot analysis is used to detect protein levels (col. 11, ¶ 2). Null mutations include point mutations (col. 18, ¶ 1; see col. 25, last ¶ bridging all of col. 26; see also Example 10).
‘464 claims a process for producing a milled product, comprising: (i) providing wheat grain (Triticum durum) comprising an embryo and starch, wherein the embryo comprises two starch branching enzyme IIa (SBEIIa) genes, wherein both alleles of the SBEIIa-A gene are identical and both alleles of the SBEIIa-B gene are identical, and wherein (a) the SBEIIa-A gene has a severe mutation that is a short deletion and the SBEIIa-B gene has a severe mutation that is a short deletion; (b) SBEIIa enzyme activity is reduced or eliminated in the wheat grain; (c) the wheat grain has an increased amylose content compared to the amylose content of wild type wheat grain; and (d) the wheat grain is capable of germinating, and (ii) milling the grain to produce a milled grain product, and wherein the grain is non-transgenic, wherein the grain has at least 4% RS and wherein the deletion is 1 to 10 nucleotides in length (see claims 1-9).
Therefore, at the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed with a reasonable expectation of success because ‘087 the claims encompass a null point mutation in SBEIIa that that mutagenesis may be used to eliminate SBEIIa gene expression while ‘464 provides an additional and specific functionally equivalent means to do so.
Response to Arguments
Applicant traverse the rejection of the claims because the art does not teach grain where either two identical null alleles of the SBEIIa-A gene or two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 22, ¶ 1).
However, this argument is not persuasive because nowhere has Applicant rebutted the argument that it would have been prima facie obvious to arrive at the instant claims based on the teachings of ‘087 in view of ‘464.
Here, one is motivated to, and has a reasonable expectation of success in, arriving at the grain as claimed because all one needs to do is modify the methods of ‘087 in view of ‘464 to eliminate SBEIIa protein in order to increase amylose content.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7 of U.S. Patent No. 7,700,139 B2 (referred to herein as ‘139) in view of US Patent No. US 8,115,087 (referred to herein as ‘087) and Patent No. US 11,649,464 B2 (referred to herein as ‘464). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘139 claims a method for decreasing pH of bowel contents by providing grain from a durum wheat plant with at least 40% amylose content and comprising a reduced level of SBEIIa enzyme or protein wherein said grain comprises a mutation in the SBEIIa gene and the starch of said grain comprises 2% RS wherein (see claims 1-3 and 7).
‘087 claims wheat grain comprising starch and null mutations of two SBEIIa gene with amylose greater than 30%, wherein the grain is from durum wheat, products produced therefrom and processes for making said grain by crossing two plants each comprising null mutations in the SBEIIa gene to obtain progeny (i.e., grain capable of germinating) with at least 30% amylose (claims 1, 2, 4, 10, 12-14, 18, 20, 22-24, 26, 27, 29, 30, 33 and 34). Western blot analysis is used to detect protein levels (col. 11, ¶ 2).
‘464 claims a process for producing a milled product, comprising: (i) providing wheat grain (Triticum durum) comprising an embryo and starch, wherein the embryo comprises two starch branching enzyme IIa (SBEIIa) genes, wherein both alleles of the SBEIIa-A gene are identical and both alleles of the SBEIIa-B gene are identical, and wherein (a) the SBEIIa-A gene has a severe mutation that is a short deletion and the SBEIIa-B gene has a severe mutation that is a short deletion; (b) SBEIIa enzyme activity is reduced or eliminated in the wheat grain; (c) the wheat grain has an increased amylose content compared to the amylose content of wild type wheat grain; and (d) the wheat grain is capable of germinating, and (ii) milling the grain to produce a milled grain product, and wherein the grain is non-transgenic, wherein the grain has at least 4% RS and wherein the deletion is 1 to 10 nucleotides in length (see claims 1-9).
Therefore, at the time the invention was made, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘139 teaches the product as claimed for various treatments, because ‘087 recognizes that that mutagenesis may also be used to make this product and thus avoids making transgenic plants, and because ‘464 discloses that deletions as opposed to null point mutations may also be used.
Response to Arguments
Applicant traverse the rejection of the claims because if a teaching needed to arrive at the claimed invention is entirely absent from each of the references then the claimed invention cannot be obvious, and that the references fail to teach the grain as claimed (Applicant reply dated 18 June 2026, p. 22, last ¶).
The former argument is not persuasive because assuming arguendo that it is valid then Applicant would have presented this particular argument with respect ‘087 and ‘464 in the rejections as set forth supra.
Even so, Applicant’s argument is not persuasive because ‘139 claims grain that is indistinguishable from the grain of claim 1: it has a reduced level of SBEIIa activity which encompasses grain from durum wheat having undetectable levels of SBEIIa. ‘139 claims that this may be made with point mutations.
Thus, when ‘139 is viewed in light of ‘087 one of ordinary skill in the art would appreciate that the grain of ‘139 could be made using combinations of null point and deletion mutations. One is motivated to do so because amylose content is increased in addition to RS content, the importance of which is discussed above.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,737,482 B2 (referred to herein as ‘482) in view of Uauy et al (2009, BMC Plant Bio., 9:1-14). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘482 claims wheat grain of Triticum aestivum comprising an embryo and starch, wherein (a) the embryo is homozygous for null alleles of three starch branching enzyme IIa (SBEIIa) genes, wherein said SBEIIa genes are an SBEIIa-A gene, an SBEIIa-B gene, and an SBEIIa-D gene, wherein the homozygous null alleles of at least one of the SBEIIa-A gene, the SBEIIa-B gene, and the SBEIIa-D gene comprise a null point mutation or a deletion of 1-30 basepairs, and (b) SBEIIa protein is undetectable in the wheat grain; (c) the starch comprises amylose such that the grain has an amylose content of between 50% and 90% (w/w) as a proportion of the extractable starch of the grain; and (d) the wheat grain has a germination rate of about 70% to about 100% relative to the germination rate of a wild-type wheat grain and a process of making said grain (see claims 1-9).
Uauy et al teach an EMS-mutagenized durum wheat breeding line (p. 3, col. 1), characterization of the obtained TILLING libraries by screening for SBEIIa in each of the different wheat genomes (p. 3, col. 1, ¶ 2; see also p. 5, Table 1). Splice junction mutations, premature stop codons (i.e., null mutations), and several missense mutations were identified in the SBE genes (p. 3, col. 2, last par, bridging p. 5; see also Table 3). Germination rates of about 50-60% were obtained (p. 3, col. 1, ¶ 1).
Uauy et al teach that the SBEIIa gene is an important target with commercial application as mutants have a high amylose phenotype and that TILLING has various benefits in comparison to the use of RNAi to inhibit expression of genes of interest (p. 7, col. 2, ¶ 1; see also p. 2, col. 1, last ¶ bridging col. 2).
Therefore, at the time of filing of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘482 claims the same point and deletions mutations as claimed but in hexaploid wheat while Uauy et al clearly recognize that these mutations are applicable to tetraploid wheat for increasing amylose and RS content.
Response to Arguments
Applicant traverses the rejection of the claims because ‘482 does not relate to durum wheat where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 23, ¶ 3).
This argument is not persuasive because the issue is whether one would have found it obvious to arrive at the grain as claimed based on the teachings of ‘482 in view of Uauy.
Here, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘482 claims the same point and deletions mutations as claimed but in hexaploid wheat while Uauy et al clearly recognize that these mutations are applicable to tetraploid wheat for increasing amylose and RS content.
One would be motivated to do so because SBEIIa protein would be undetectable leading to increased amylose and RS content, the importance of which is discussed supra.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,798,957 B2 (referred to herein as ‘957) in view of Uauy et al (2009, BMC Plant Bio., 9:1-14). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘957 claims a process for producing a milled product or starch, comprising the steps of (i) obtaining wheat grain of Triticum aestivum comprising an embryo and starch, wherein the embryo: is homozygous for null alleles of three starch branching enzyme IIa (SBEIIa) genes, wherein said SBEIIa genes are an SBEIIa-A gene, an SBEIIa-B gene, and an SBEIIa-D gene, wherein the homozygous null alleles of at least one of the SBEIIa-A gene, the SBEIIa-B gene, and the SBEIIa-D gene have a null point mutation, wherein (a) SBEIIa protein is undetectable in the wheat grain; (b) the starch comprises amylose such that the grain has an amylose content of between 67% and 90% (w/w) as a proportion of the extractable starch of the grain; and (c) the wheat grain has a germination rate of about 70% to about 100% relative to the germination rate of a wild-type wheat grain, and (ii) milling the grain, thereby producing the milled product, wherein the mutations are null deletions deleting at least part of the SBEIIa gene (see claims 1-11).
Uauy et al teach an EMS-mutagenized durum wheat breeding line (p. 3, col. 1), characterization of the obtained TILLING libraries by screening for SBEIIa in each of the different wheat genomes (p. 3, col. 1, ¶ 2; see also p. 5, Table 1). Splice junction mutations, premature stop codons (i.e., null mutations), and several missense mutations were identified in the SBE genes (p. 3, col. 2, last par, bridging p. 5; see also Table 3). Germination rates of about 50-60% were obtained (p. 3, col. 1, ¶ 1).
Uauy et al teach that the SBEIIa gene is an important target with commercial application as mutants have a high amylose phenotype and that TILLING has various benefits in comparison to the use of RNAi to inhibit expression of genes of interest (p. 7, col. 2, ¶ 1; see also p. 2, col. 1, last ¶ bridging col. 2).
Therefore, at the time of filing of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘957 claims the same mutations in hexaploid wheat while Uauy et al clearly recognize that these mutations are applicable to tetraploid wheat to increase amylose and RS content.
Response to Arguments
Applicant traverses the rejection of the claims because ‘957 does not relate to durum wheat where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 23, last ¶).
This argument is not persuasive because the issue is whether one would have found it obvious to arrive at the grain as claimed based on the teachings of ‘957 in view of Uauy.
Here, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘957 claims the same point and deletions mutations as claimed but in hexaploid wheat while Uauy et al clearly recognize that these mutations are applicable to tetraploid wheat for increasing amylose and RS content.
One would be motivated to do so because SBEIIa protein would be undetectable leading to increased amylose and RS content, the importance of which is discussed supra.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,357,722 B2 (referred to herein as ‘722) in view of Uauy et al (2009, BMC Plant Bio., 9:1-14). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘722 claims a process for producing a milled product, comprising the steps of (i) obtaining wheat grain (Triticum aestivum) comprising an embryo and starch, wherein the embryo comprises two identical null alleles of an SBEIIa-A gene, two identical null alleles of an SBEIIa-B gene and two identical null alleles of an SBEIIa-D gene, wherein either the two identical null alleles of the SBEIIa-A gene, or of the SBEIIa-B gene or of the SBEIIa-D gene are point mutations, wherein SBEIIa protein is undetectable in the wheat grain, and wherein (a) the starch comprises amylose such that the grain has an amylase content of between 50% and 90% (w/w) as a proportion of the extractable starch of the grain; and (b) the wheat grain has a germination rate of about 70% to about 100% relative to the germination rate of a wild-type wheat grain, and (ii) milling the grain, thereby producing the milled product (see claims 1-3).
Uauy et al teach an EMS-mutagenized durum wheat breeding line (p. 3, col. 1), characterization of the obtained TILLING libraries by screening for SBEIIa in each of the different wheat genomes (p. 3, col. 1, ¶ 2; see also p. 5, Table 1). Splice junction mutations, premature stop codons (i.e., null mutations), and several missense mutations were identified in the SBE genes (p. 3, col. 2, last par, bridging p. 5; see also Table 3). Germination rates of about 50-60% were obtained (p. 3, col. 1, ¶ 1).
Uauy et al teach that the SBEIIa gene is an important target with commercial application as mutants have a high amylose phenotype and that TILLING has various benefits in comparison to the use of RNAi to inhibit expression of genes of interest (p. 7, col. 2, ¶ 1; see also p. 2, col. 1, last ¶ bridging col. 2).
Therefore, at the time of filing of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘722 claims the same mutations in hexaploid wheat while Uauy et al clearly recognize that these mutations are applicable to tetraploid wheat.
Response to Arguments
Applicant traverses the rejection of the claims because ‘722 does not relate to durum wheat where either of the two identical null alleles of the SBEIIa-A gene or the two identical null alleles of the SBEIIa-B gene comprise point mutations (Applicant reply dated 18 June 2026, p. 24, penultimate ¶).
This argument is not persuasive because the issue is whether one would have found it obvious to arrive at the grain as claimed based on the teachings of ‘722 in view of Uauy.
Here, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because ‘722 claims the same point mutations but in hexaploid wheat and where SBEIIa protein is undetectable, because null mutations encompass deletion mutations, and because Uauy et al clearly recognize that these mutations are applicable to tetraploid wheat for increasing amylose and RS content.
One would be motivated to do so because SBEIIa protein would be undetectable leading to increased amylose and RS content, the importance of which is discussed supra.
Claims 50-59 REMAIN rejected, and claims 60 and 61 are NOW rejected, on the ground of nonstatutory double patenting as being unpatentable over claims 48-62 of serial no. 18/808,516 (referred to herein as ‘516). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 50-61 are drawn to durum wheat comprising an embryo and starch wherein the embryo comprises two identical null alleles of an SBEIIa-A and SBEIIa-B gene wherein either of said identical null alleles comprises a point mutation and the SBEIIa protein is undetectable and the amylose content is between 50% and 90% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid, wherein the protein is undetectable by Western blot analysis, wherein the grain comprises a deletion mutation in the A genome which deletes at least a part of the SBEIIa-A gene or wherein the grain comprises a deletion mutation in the B genome which deletes at least a part of the SBEIIa-B gene, wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘516 claims durum wheat grain comprising an embryo and starch, wherein (a) the embryo is homozygous for a loss of function mutation in each of two starch branching enzyme (SBEIIa) genes, wherein said SBEIIa genes are an-A gene and an SBEIla-B gene, and wherein the loss of function mutation in at least one of the SBElla genes is a point mutation or a deletion of 1-20 base-pairs;(b) the grain has a germination rate of between 70% and 100% relative to the germination rate of wild-type wheat grain; and (c) the starch comprises amylose such that the grain has an increased amylose content as a proportion of the starch in the grain relative to wild-type wheat grain (see claims 48-62).
Therefore, at the time of filing of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the grain as claimed and with a reasonable expectation of success because each of the grains comprise the same mutations.
Conclusion
No claim is allowed.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
