Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are pending. Claims 1-38, 40, 41, 43, 46-49, 52, 56 and 58-63 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.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (e.g., Figure 3) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 39, 42-45, 50, 51, 53-55, 57 and 64-66 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claims 39, 42-45, 50, 51, 53-55, 57 and 64-66 are broadly drawn to a barley plant producing grain comprising 50ppm or less hordeins, methods of producing said grain or products therefrom, a method of identifying an allele of a barley D hordein gene encoding a truncated D hordein and a method of avoiding or reducing the incidence or severity of coeliac’s disease in a subject comprising orally administering said product.
Meanwhile, the specification describes that Hor2-lys3a double mutant barley line “G1” (i.e., as disclosed by Tanner et al, see section 7 infra) was crossed with the publicly available line R118 (i.e., as described by Brennan et al, see section 8 infra) to make triple null lines (p. 60, Example 7). This line, designated ULG3.0, comprised the hordein content as claimed (see Table 6) and possessed good grain yield (p. 61, ¶1).
However, because seed size was poor (p. 61, ¶1), seed derived from two subsequent crosses (i.e., lines designated UGL3.2) were made to obtain the desired seed weight and thickness in addition to the aforementioned hordein content (Example 8).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
Here, the claims are directed to an exhaustive genus of barley plants: the plants need not comprise any mutation whatsoever so long as the plant produces grain comprising less than 50ppm hordeins. However, the specification fails to describe a representative number of species from this broad genus of plants with grain comprising the hordein levels, seed size and seed weight as claimed.
In fact, the skilled artisan need not look further than Applicant’s own disclosure: it is particular mutations in particular genetic backgrounds that are required to obtain plants with grain comprising the hordein content, seed size and weight as claimed.
This description is also critical in light of the art, which describes that single or double null plants lacking B, C or D hordeins do not predictably comprise the traits as claimed.
For example, hordein double null lines comprise hordein levels that are above 50ppm and lack the seed characteristics as claimed (e.g., see Tanner et al, 2016, Plant Biotech, 14:1139-1150; see Abstract; see also Figures 3 and 4; see Table 4). In fact, only sixth generation triple null plants yielded plants with the traits as claimed (see Figure 4).
Moreover, it also known that the genotype of barley influences the hordein content: the proportions of the different hordein fractions present in mature grain depend on the cultivar and growth conditions (Simic et al, 2007, Cereal Research and Communications, 35, 1487-1496: see p. 1488, ¶1). Or see Molina-Cano et al, which describe that different cultivars have different hordein contents and that even the same cultivar can have different hordein contents across different environments (2001, Journal of Cereal Science, 34: 285-294; see Abstract; see also Table and Figures 3-6).
The art also describes that expression of the Hor loci in normal genotypes appears to be under complex controls, that different factors affect the expression of Hor 1 relative to Hor 2, that lys 3a has a differential effect on the expression of the Hor loci, and that increases in D hordein may represent compensatory effects arising from the depression of synthesis of other hordeins (Kreis et al, 1984, Biochemical Genetics, 22:231-255; p. 252, ¶ 1).
Or see Hansen et al, which describes that decreases in C hordeins leads to an increase in D hordeins (2007, Journal of Experimental Botany, 58:3987-3995; see Abstract; see Figure 1 and Table 3).
Therefore, absent a description of a representative number of species from the genus of barley plants which produce grain comprising about 50ppm or less hordeins, the lack of a description with respect to the particular mutations and their corresponding effects on hordein levels, and the state of the art which describes that genotypes and environment play a role in hordein content while the mechanism by which hordein content is controlled is complex and unknown, the skilled practitioner would not be of the opinion that Applicant possess the plants and method as broadly claimed.
Claim Rejections - 35 USC § 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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tanner et al (Pub. No. US 2011/0135784 A1) in view of Brennan et al (1998, Journal of Cereal Science, 28:291-299) and Howard et al (1996, J. Cereal Sci., 24:47-53) and in further view of Sykorova et al (2009, Czech J. Food Sci., 27:249-258).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are drawn to a barley plant producing grain comprising 50ppm or less hordeins, a method of producing said barley, beer or flour or malt produced from said plant, obtaining a sample from said plant to identity an allele of the D hordein gene encoding a truncated protein, and wherein the average weight of the grain is at least 35mg.
Tanner et al claim a method of producing a food product from barley grain wherein the grain comprises 25% or less (i.e., 0%) the level of hordeins compared to grain from wild type barley or that comprises less than about 0.4% (i.e., 0%) hordeins or less than 200 ppm (i.e., 0 ppm) hordeins wherein the grain comprises 25% or less the level of B, C and D hordeins wherein the plant is homozygous at one or more loci for a genetic variation that reduces at least one hordein, flour comprising less than 1 ppm hordeins or grain comprising about 25% or less hordeins, a method of reducing the incidence of CD by orally administering said grain or flour and a method of identifying barley grain suitable for treating CD (see claims 1, 2, 11, 15, 34, 58, 59, 61, 68, 73, 77 and 79).
Tanner et al teach that B, C and D hordeins are encoded by the Hor2, Hor1 and Hor3 loci, respectively, and that they induce undesirable inflammatory responses in subjects with CD (p. 2, ¶0010).
Tanner et al teach that the barley plant is homozygous for at least one, two or three or more loci for a genetic variation that deletes most or all of the B-hordein encoding genes at the Hor2 locus and at the Lys3 locus which results in reduced levels of at least one, two or three hordein classes of the B, C and D classes (p. 2, ¶ 0022).
This grain can be made by crossing Riso 56 (comprising the hor2 mutation and reduced B hordeins) and Riso 1508 (comprising lys3 mutations for reduced B and C hordeins), respectively (p. 3, ¶0049 and 0050; see also p. 22, ¶0249; see p. 24, ¶0264 for the plant of this cross referred to as G1).
Tanner et al teach that mutations of the aforementioned hordeins can be produced by chemical mutagenesis, and that mutants in one hordein can be crossed with a second mutant to combine mutations (p. 19, ¶0228). The grain from said plants has an average weight of at least 2.4 grams (p. 2, ¶0017).
Tanner et al teach that Riso 56 includes a deletion of DNA from the Hor2 locus encoding B hordeins while the lys6i mutation has decreased levels of D hordeins (p. 21, ¶0245 and 0246). Tanner et al also teaches that the Riso 1508 barley comprising the lys3a mutant gene was found to have no C hordeins and reduced D and B hordeins (see also instant specification p. 43, ¶1; see p. 21, ¶0247).
Tanner et al teach, in fact, the crossing of Riso 1508 (i.e., having reduced B and C hordeins) and Riso 56 (i.e., having a deletion of the Hor2 locus encoding B hordeins) yielding plants double null for each gene (p. 22, ¶0251 and ¶0256) and having reduced toxicity (p. 26, ¶0297). Hordein levels were as low as 5% of the wild-type level (p. 23, ¶0263; see also Table 3). Any reduction in seed size was due to genetic background and not reduced hordein level (p. 27, ¶ 0299). Backcrossing may be used for different traits (p. 16, ¶ 0198).
The barley produced by the teachings of Tanner et al have most of the hordein production abolished and can be used to produce malt and beer or whiskey having less than 1 ppm hordeins (p. 3, ¶0029 and ¶0031), and is directed to methods for producing food or malt-based beverages comprising less than 75 ppm hordeins (p. 3, ¶0035 and 0047).
Thus, because Tanner et al teach, suggest and provide motivation for producing barley plants with grain comprising 50ppm or less hordeins, the issue is whether one would have a reasonable expectation of success in doing so.
Addressing this issue, Brennan et al teach that Hor 3 null lines of barley were known in the art to lack D hordein (see Abstract; see also Table 1; see also instant specification p. 58, ¶1). Null lines in which the hor 3 locus has been lost or silenced due to mutation provides an ideal opportunity to explore the relationship between D hordein and malting performance as they can be crossed with cultivars to produce isogenic pairs in which the D hordein gene is silent (p. 292, col. 1, ¶ 1).
Meanwhile, Howard et al teach that the amount of D hordein in grain offers an accurate guide to malting quality, and that lower D hordein content correlates with increased malt extract and quality (see Abstract; see p. 52, col. 1, ¶1; see p. 51, Fig. 3). In other words, Howard et al teach that D-hordein is undesirable.
Sykorova et al teach that a criteria for malting barley is that at least 85% of the barley grain should be retained on 2.5mm sieves (p. 250, col. 1, ¶ 2).
Therefore, prior to the effective filing date of the instant invention, it would have been prima facie obvious to arrive at barley plant producing grain comprising about 50ppm or less hordeins as Tanner et al specifically suggests doing so by making grain that lacks B, C and D hordeins with the purpose of making end products with reduced toxicity.
One would have a reasonable expectation of success in doing so because it was known in the art that B and C hordeins alone can account for up to 100% of the hordein content (e.g., see Howard et al p. 48, col. 1: B and C hordeins account for 70-80% and 10-20% of the hordein fraction), and it was also known that grain exists completely lacking D hordeins (e.g., see Brennan et al). Therefore, one would reasonably conclude that hordeins can be completely eliminated from barley grain to yield end products that are not toxic.
One would have found it obvious to identify an allele of the D hordein gene encoding a truncated protein because it was known that this allele could be used to predict malting quality. One would have found it obvious to arrive at analyzing the particular residue as claimed because it is merely a design choice.
Namely, if one knows that a hor3 null allele is a predictor of malting quality, then it is immaterial as to which particular position produces a truncated hordein so long as the gene is not expressed and/or the protein is non-functional.
It also would have been obvious to arrive at the grain size as claimed because it was known that that a criteria for malting barley is that at least 85% of the barley grain should be retained on 2.5mm sieves, and that the seed size is not affected by mutations in hordein genes.
Thus, if one did not obtain appropriate seed size for processing as recognized in the art, one would merely backcross the grain comprising less than 50ppm hordein with different genetic backgrounds until the acceptable seed size was obtained.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9, 10 and 13-17 of U.S. Patent No. 10,849,345 B2 (referred to herein as ‘345). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a barley plant producing grain comprising 50ppm or less hordeins, methods of producing said grain from said plant, methods of producing products from said plants, products produced therefrom, a method of identifying an allele of a barley D hordein from said plant and a method of reducing the incidence of CD by administering a producing from said plant.
Meanwhile, ‘345 claims a method of producing a food or malt-based beverage ingredient, or a food or a malt-based beverage, from barley grain comprising 50 ppm or less hordeins, the method comprising: (i) processing barley grain comprising 50 ppm or less hordeins to produce malt, wort, flour or wholemeal, and/or (ii) mixing barley grain comprising 50 ppm or less hordeins, or malt, wort, flour or wholemeal produced from said grain, with at least one other food or beverage ingredient, wherein: a) the barley grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the barley grain is homozygous for a genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Hor3 locus of barley which results in the grain lacking D-hordein, and c) the barley grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Lys3 locus which results in the grain lacking C-hordeins, thereby producing the food or malt-based beverage ingredient, or food or malt-based beverage, wherein the grain, malt, wort, flour or wholemeal comprises 20 ppm or less hordeins, wherein the average weight of the grain is at least 35 mg, wherein at least 80% of the grain do not pass through a 2.8 mm sieve, wherein the genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein is a null allele of the gene encoding D-hordein which comprises a stop codon, splice site mutation, frame-shift mutation, insertion, deletion or encoding a truncated D-hordein, or wherein most or all of the D-hordein encoding gene has been deleted, products produced therefrom, barley grain comprising about 50 ppm or less hordeins, or a barley plant which produces grain comprising about 50 ppm or less hordeins, wherein: a) the grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the grain is homozygous for a genetic variation at the Hor3 locus which results in the grain lacking D-hordeins, and c) the grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, and a method of producing barley grain comprising about 50 ppm or less hordeins, the method comprising; a) growing said barley plant, and b) harvesting the grain of the barley plant
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to arrive that the plant, grain products and methods as claimed because ‘345 specifically claims methods to arrive at the plant as claimed having a genetic variation at the Hor3 locus and lacking D hordeins in addition to teaching species that are encompassed by the genus of plants as claimed.
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 6 of U.S. Patent No. 8,642,846 B2 (referred to herein as ‘846) in view of U.S. Patent No. 10,849,345 B2 (referred to herein as ‘345). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a barley plant producing grain comprising 50ppm or less hordeins, methods of producing said grain from said plant and for identifying an allele of a D hordein gene encoding a truncated protein, methods of producing products from said plants, products produced therefrom, and a method of reducing the incidence of CD by administering a producing from said plant.
Meanwhile, ‘846 claims a method of producing a food, the method comprising mixing barley grain or flour produced from said grain, with at least one other food ingredient thereby producing the food, wherein the grain or flour produced from said grain comprises about 25% or less of the level of total hordeins when compared to grain from a corresponding wild-type barley plant or flour produced in the same manner from grain from a corresponding wild-type barley plant, wherein the grain i) comprises about 15% or less of the level of total hordeins when compared to grain of the corresponding wild-type barley plant, ii) has an average weight (100 grain weight) of at least 2.4 g, iii) has an average weight (100 grain weight) of about 2.4 g to about 6 g, iv) has a starch content which is at least 50% (w/w), v) has a starch content which is about 50% to about 70% (w/w), or vi) is from a plant which is homozygous at one or more loci for a genetic variation(s) which results in reduced levels of at least one hordein when compared to a corresponding wild-type barley plant, wherein the coeliac toxicity of flour produced from the grain is i) less than 50% of flour produced from grain of a corresponding wild-type barley plant, ii) less than 25% of flour produced from grain of a corresponding wild-type barley plant, or iii) about 10% of flour produced from grain of a corresponding wild-type barley plant wherein the method further comprises producing flour from the grain and wherein the food is leavened or unleavened breads, pasta, noodles, breakfast cereals, snack foods, cakes, pastries or foods containing flour-based sauces.
‘345 claims a method of producing a food or malt-based beverage ingredient, or a food or a malt-based beverage, from barley grain comprising 50 ppm or less hordeins, the method comprising: (i) processing barley grain comprising 50 ppm or less hordeins to produce malt, wort, flour or wholemeal, and/or (ii) mixing barley grain comprising 50 ppm or less hordeins, or malt, wort, flour or wholemeal produced from said grain, with at least one other food or beverage ingredient, wherein: a) the barley grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the barley grain is homozygous for a genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Hor3 locus of barley which results in the grain lacking D-hordein, and c) the barley grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Lys3 locus which results in the grain lacking C-hordeins, thereby producing the food or malt-based beverage ingredient, or food or malt-based beverage, wherein the grain, malt, wort, flour or wholemeal comprises 20 ppm or less hordeins, wherein the average weight of the grain is at least 35 mg, wherein at least 80% of the grain do not pass through a 2.8 mm sieve, wherein the genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein is a null allele of the gene encoding D-hordein which comprises a stop codon, splice site mutation, frame-shift mutation, insertion, deletion or encoding a truncated D-hordein, or wherein most or all of the D-hordein encoding gene has been deleted, products produced therefrom, barley grain comprising about 50 ppm or less hordeins, or a barley plant which produces grain comprising about 50 ppm or less hordeins, wherein: a) the grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the grain is homozygous for a genetic variation at the Hor3 locus which results in the grain lacking D-hordeins, and c) the grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, and a method of producing barley grain comprising about 50 ppm or less hordeins, the method comprising; a) growing said barley plant, and b) harvesting the grain of the barley plant.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the plants, products and methods as claimed because ‘846 claims methods requiring the use of a barley plant comprising the features as instantly claimed (i.e., grain lacking hordeins) and because ‘345 claims methods that require identifying truncated D hordein protein.
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8, 10, 11, 14 and 16 of U.S. Patent No. 9,133,427 B2 (referred to herein as ‘427) in view of U.S. Patent No. 10,849,345 B2 (referred to herein as ‘345). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a barley plant producing grain comprising 50ppm or less hordeins, methods of producing said grain from said plant, methods of producing products from said plants, products produced therefrom, a method of identifying an allele of a barley D hordein from said plant and a method of reducing the incidence of CD by administering a producing from said plant.
Meanwhile, ’427 claims a process of making a malt-based beverage, the process comprising obtaining malt from barley grain which is homozygous for at least one genetic modification which results in 25% or less of the level of total hordeins when compared to a corresponding wild-type barley grain, mixing the malt with at least one other beverage ingredient to make a mixture, and processing the mixture to produce the malt-based beverage, wherein the malt produced from said grain comprises about 25% or less of the level of total hordeins when compared to malt produced in the same manner from corresponding wild-type barley grain.
‘345 claims a method of producing a food or malt-based beverage ingredient, or a food or a malt-based beverage, from barley grain comprising 50 ppm or less hordeins, the method comprising: (i) processing barley grain comprising 50 ppm or less hordeins to produce malt, wort, flour or wholemeal, and/or (ii) mixing barley grain comprising 50 ppm or less hordeins, or malt, wort, flour or wholemeal produced from said grain, with at least one other food or beverage ingredient, wherein: a) the barley grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the barley grain is homozygous for a genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Hor3 locus of barley which results in the grain lacking D-hordein, and c) the barley grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Lys3 locus which results in the grain lacking C-hordeins, thereby producing the food or malt-based beverage ingredient, or food or malt-based beverage, wherein the grain, malt, wort, flour or wholemeal comprises 20 ppm or less hordeins, wherein the average weight of the grain is at least 35 mg, wherein at least 80% of the grain do not pass through a 2.8 mm sieve, wherein the genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein is a null allele of the gene encoding D-hordein which comprises a stop codon, splice site mutation, frame-shift mutation, insertion, deletion or encoding a truncated D-hordein, or wherein most or all of the D-hordein encoding gene has been deleted, products produced therefrom, barley grain comprising about 50 ppm or less hordeins, or a barley plant which produces grain comprising about 50 ppm or less hordeins, wherein: a) the grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the grain is homozygous for a genetic variation at the Hor3 locus which results in the grain lacking D-hordeins, and c) the grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, and a method of producing barley grain comprising about 50 ppm or less hordeins, the method comprising; a) growing said barley plant, and b) harvesting the grain of the barley plant.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the plants, products and methods as claimed because ‘427 claims methods requiring the use of a barley plant comprising the features as instantly claimed (i.e., grain lacking hordeins) and because ‘345 claims methods that require identifying truncated D hordein protein.
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 8, 9, 10, 11, 12, 13 and 14 of U.S. Patent No. 10,501,712 B2 (referred to herein as ‘712) in view of U.S. Patent No. 10,849,345 B2 (referred to herein as ‘345). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a barley plant producing grain comprising 50ppm or less hordeins, methods of producing said grain from said plant, methods of producing products from said plants, products produced therefrom, a method of identifying an allele of a barley D hordein from said plant and a method of reducing the incidence of CD by administering a producing from said plant.
Meanwhile, ‘712 claims a malt-based beverage, comprising one or more barley grain proteins, produced from malt obtained from barley grain homozygous for at least two genetic variations which result in 25% or less of the level of total hordeins when compared to a corresponding wild-type barley grain, wherein the at least two genetic variations comprise: (a) a deletion of most or all of the B-hordein encoding genes at the Hor2 locus of barley and (b) a mutation in a Lys3 gene whereby the barley grain comprising the mutation comprises 25% or less of the level of C-hordein when compared to the corresponding wild-type barley grain, wherein the malt-based beverage comprises 25% or less of the level of total hordeins relative to a malt-based beverage produced in the same manner from malt obtained from corresponding wild-type barley grain and wherein the beverage has less than 1ppm hordeins.
‘345 claims a method of producing a food or malt-based beverage ingredient, or a food or a malt-based beverage, from barley grain comprising 50 ppm or less hordeins, the method comprising: (i) processing barley grain comprising 50 ppm or less hordeins to produce malt, wort, flour or wholemeal, and/or (ii) mixing barley grain comprising 50 ppm or less hordeins, or malt, wort, flour or wholemeal produced from said grain, with at least one other food or beverage ingredient, wherein: a) the barley grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the barley grain is homozygous for a genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Hor3 locus of barley which results in the grain lacking D-hordein, and c) the barley grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Lys3 locus which results in the grain lacking C-hordeins, thereby producing the food or malt-based beverage ingredient, or food or malt-based beverage, wherein the grain, malt, wort, flour or wholemeal comprises 20 ppm or less hordeins, wherein the average weight of the grain is at least 35 mg, wherein at least 80% of the grain do not pass through a 2.8 mm sieve, wherein the genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein is a null allele of the gene encoding D-hordein which comprises a stop codon, splice site mutation, frame-shift mutation, insertion, deletion or encoding a truncated D-hordein, or wherein most or all of the D-hordein encoding gene has been deleted, products produced therefrom, barley grain comprising about 50 ppm or less hordeins, or a barley plant which produces grain comprising about 50 ppm or less hordeins, wherein: a) the grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the grain is homozygous for a genetic variation at the Hor3 locus which results in the grain lacking D-hordeins, and c) the grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, and a method of producing barley grain comprising about 50 ppm or less hordeins, the method comprising; a) growing said barley plant, and b) harvesting the grain of the barley plant.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the plants, products and methods as claimed because ‘712 claims products that requiring making a barley plant comprising the features as instantly claimed (i.e., grain lacking hordeins) and because ‘345 claims methods that require identifying truncated D hordein protein.
Claims 39, 42, 44-45, 50, 51, 53-55, 57 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 5, 14, 15 and 17 of U.S. Patent No. 11,326,134 B2 (referred to herein as ‘134) in view of U.S. Patent No. 10,849,345 B2 (referred to herein as ‘345). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a barley plant producing grain comprising 50ppm or less hordeins, methods of producing said grain from said plant, methods of producing products from said plants, products produced therefrom, a method of identifying an allele of a barley D hordein from said plant and a method of reducing the incidence of CD by administering a producing from said plant.
Meanwhile, ‘134 claims a barley plant which produces barley grain comprising about 25% or less of the level of total hordeins when compared to grain from a corresponding wild-type barley plant, wherein the barley grain is homozygous for: (a) a deletion of most or all of the B-hordein encoding genes at the Hor2 locus of barley and (b) a mutation in a Lys3 gene whereby the barley grain comprising the mutation comprises 25% or less of the level of C-hordein when compared to the corresponding wild-type barley grain wherein the barley grain comprises about 15% or less of the level of total hordeins when compared to grain from a corresponding wild-type barley plant, wherein the barley grain comprises about 5% or less of the level of hordeins when compared to grain from a corresponding wild-type barley plant, barley grain of said plant and a method of producing barley grain comprising growing said plant and a method of producing a product from said grain.
‘345 claims a method of producing a food or malt-based beverage ingredient, or a food or a malt-based beverage, from barley grain comprising 50 ppm or less hordeins, the method comprising: (i) processing barley grain comprising 50 ppm or less hordeins to produce malt, wort, flour or wholemeal, and/or (ii) mixing barley grain comprising 50 ppm or less hordeins, or malt, wort, flour or wholemeal produced from said grain, with at least one other food or beverage ingredient, wherein: a) the barley grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the barley grain is homozygous for a genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Hor3 locus of barley which results in the grain lacking D-hordein, and c) the barley grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, or wherein the malt, wort, flour or wholemeal produced from said grain comprises DNA which comprises the genetic variation at the Lys3 locus which results in the grain lacking C-hordeins, thereby producing the food or malt-based beverage ingredient, or food or malt-based beverage, wherein the grain, malt, wort, flour or wholemeal comprises 20 ppm or less hordeins, wherein the average weight of the grain is at least 35 mg, wherein at least 80% of the grain do not pass through a 2.8 mm sieve, wherein the genetic variation at the Hor3 locus of barley which results in the grain lacking D-Hordein is a null allele of the gene encoding D-hordein which comprises a stop codon, splice site mutation, frame-shift mutation, insertion, deletion or encoding a truncated D-hordein, or wherein most or all of the D-hordein encoding gene has been deleted, products produced therefrom, barley grain comprising about 50 ppm or less hordeins, or a barley plant which produces grain comprising about 50 ppm or less hordeins, wherein: a) the grain is homozygous for a genetic variation of the Hor2 locus where most or all of the B-hordein encoding genes in the Hor2 locus have been deleted relative to the Hor2 locus of wild-type barley grain, b) the grain is homozygous for a genetic variation at the Hor3 locus which results in the grain lacking D-hordeins, and c) the grain is homozygous for a genetic variation at the Lys3 locus of barley which results in the grain lacking C-hordeins, and a method of producing barley grain comprising about 50 ppm or less hordeins, the method comprising; a) growing said barley plant, and b) harvesting the grain of the barley plant.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive at the plants, products and methods as claimed because ‘134 claims a species of barley plant that is encompassed by the genus of plants comprising the features as instantly claimed (i.e., grain lacking hordeins) and because ‘345 claims methods that require identifying truncated D hordein protein.
Conclusion
No claim is allowed.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662