Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 48-62 are pending and examined. Claims 1-47 have been cancelled.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 62 is objected to for the following reason: part (b) recites the limitation “a gene”. However, the claims are not directed to a gene but rather an SBEIIa gene. It is suggested that consistent limitations be used throughout the claim.
Appropriate action is advised.
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 48-62 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% resistant starch (RS), a plant that produces said grain where the plant is fertile, wholemeal or flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
The specification prophetically describes that crosses with durum wheat plants were carried out to introduce mutations and produce high amylose wheat (p. 115, last ¶).
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 mutations at any possible nucleotide position in the SBEIIa gene and also comprising the characteristics as claimed.
This description is especially critical in light of the fact that the instant specification describes that it was allegedly unexpected that hexaploid wheat grain had starch with greater than 40% amylose (p. 87, last ¶).
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. 91; see also Table 18).
Regarding claim 61, is it noted that the claim recites “obtaining” a durum wheat plant with various mutations meaning the claim encompasses merely isolating a durum plant with mutations rather than introducing mutations into a durum plant.
Here, and aside from describing that wheat may be mutated, the specification fails to describe obtaining/isolating a durum plant with the mutations as claims.
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.
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 –
(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) 48-62 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by, or in the alternative is/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.
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
Regina et al claim wheat grain comprising starch and null mutations of two SBEIIa genes with amylose greater than 30%, wherein the null mutations are on the A and B genomes, wherein the grain is from durum wheat, wherein the grain further comprises a reduced level of SBEIIb protein, 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 and thus fertile) with at least 30% amylose (claims 1, 2, 4, 7, 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 may be point mutations or deletion mutations (col. 18, ¶ 1; see also col. 25, last ¶ bridging col. 26). Amylose content may be measured using the iodine binding assay (see Example 1; see also claim 1). The starch comprises an elevated level of resistant starch (see col. 17, ¶ 4; see also col. 30, ¶ 1 and 2).
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). In fact, Regina et al specifically teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability and that they should be localized to the gene of interest, namely, SBEIIa (col. 26, ¶ 1 and 2).
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 grain from the plants as disclosed supra are species encompassed by the genus of SBEIIa point and deletion mutants of the instant claims and thus also yield the amylose content and germination rate as instantly claimed.
Therefore, 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 two identical point mutations and the SBEIIa protein and the amylose content is at least 50% and the grain has germination rate of about 70% to 100%, wherein the grain is free of any exogenous nucleic acid 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, prior to the 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 because Regina et al explicitly suggest to do so (e.g., col. 50, lines 30-47).
In particular, one would have found it obvious to make deletions of 1-30 base pairs or deletions that delete at least part of the gene because Regina et al teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability and that they should be localized to the gene of interest, namely, SBEIIa (col. 26, penultimate and last ¶).
One would have a reasonable expectation of success in doing so because grain lacking SBEIIa protein has unaltered grain weight and increased amylose content (col. 38 beginning at line 35; see col. 39; see Table 8).
Claim(s) 48-62 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by, or in the alternative is/are 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.
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
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). In fact, Regina et al specifically teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability and that they should be localized to the gene of interest, namely, SBEIIa (col. 26, penultimate and last ¶).
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 grain from the plants as disclosed supra are species encompassed by the genus of SBEIIa point and deletion mutants of the instant claims and thus also yield the amylose content and germination rate as instantly claimed.
Therefore, 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 two identical point 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 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, prior to the 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 because Regina et al explicitly suggest to do so (col. 50, lines 30-47).
In particular, one would have found it obvious to make deletions of 1-30 base pairs or deletions that delete at least part of the gene because Regina et al teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability and that they should be localized to the gene of interest, namely, SBEIIa (col. 26, penultimate and last ¶).
One would have a reasonable expectation of success in doing so because grain lacking SBEIIa protein has unaltered grain weight and increased amylose content (col. 38 beginning at line 33; see col. 39; see Table 8).
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 50-58 is/are 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 8,115,087 B2) and in further view of Dong et al (2009, Plant Genome, 2:39-47) and Slade et al (2005, Nature Biotechnology, 23:75-81).
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 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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 that lacks SBEIIa expression, the issue is whether one would have made null point or deletion mutations leading to an amylose content of greater than 50% and a germination rate of between 70% and 100% relative to wild-type grain.
To this point, Uauy et al teach a reverse genetics approach through the combination of ethyl methane sulphonate (EMS)-mediated mutagenesis and TILLING 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 and characterization of 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). In fact, Regina et al specifically teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability and that they should be localized to the gene of interest, namely, SBEIIa (col. 26, penultimate and last ¶).
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).
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 or deletion mutations of 1-30 base pairs 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.
In particular, one would have found it obvious to make deletions of 1-30 base pairs or deletions that delete at least part of the gene because Regina et al teaches that large deletions are not preferred as they may adversely impact vigor and commercial viability and that they should be localized to the gene of interest, namely, SBEIIa (col. 26, penultimate and last ¶).
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.
Or see Regina et al, which teaches grain lacking SBEIIa protein has unaltered grain weight and increased amylose content (col. 38 beginning at line 33; see col. 39; see Table 8).
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.
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 48-62 are 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). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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).
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 which is analogous to using loss of function null mutations as instantly claimed.
Claims 48-62 are 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). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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, 10-14, 18, 20, 22-24, 26, 27, 29, 30, 33 and 34). Western blot analysis is used to detect protein levels (col. 11, ¶ 2).
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 recognizes that that mutagenesis may be used to eliminate SBEIIa gene expression and because null alleles as claimed in ‘087 encompass loss of function point mutations as instantly claimed.
Claims 48-62 are 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. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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).
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 while ‘087 also teaches that that mutagenesis can be used to make SBEIIa null alleles in grain for end use products with increased amylose content.
Claims 48-62 are 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:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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 mutations in hexaploid wheat while Uauy et al teaches that these mutations are applicable to tetraploid wheat such that one would readily appreciate the benefits of making the durum wheat as claimed as opposed to hexaploid wheat.
Claims 48-62 are 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:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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 teaches that these mutations are applicable to tetraploid wheat such that one would easily recognize the benefits of making the durum wheat as claimed as opposed to hexaploid wheat.
Claims 48-62 are 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:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or 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 teaches that these mutations are applicable to tetraploid wheat such that one would easily recognize the benefits of making the durum wheat as claimed as opposed to hexaploid wheat.
Claims 48-62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-62 of serial no. 18/456,986 (Pub. No. US 2024/0122218 A1, referred to herein as ‘986). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 48-62 are drawn to durum wheat comprising an embryo and starch wherein the embryo is homozygous for a loss of function mutation in each of SBEIIa-A and SBEIIa-B gene and at least one of the mutations is a point mutation or a deletion of 1-30 base pairs and the amylose content is at least 50% (w/w) of the starch content and the grain has germination rate of between 70% to 100%, wherein the grain is free of any exogenous nucleic acid wherein the starch comprises 2% RS, a plant that produces said grain where the plant is fertile, wholemeal or flour produced from said grain and a process of producing said plant by crossing two plants comprising said null alleles.
‘986 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