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 .
Status of Claims
Claims 27 and 36-52 are pending. Claims 1-26 and 28-35 have been cancelled.
The rejection of claims 27 and 35-46 27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendments.
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 27 and 36-46 REMAIN rejected, and claims 47-52 are NOW rejected, under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 27 and 36-52 are drawn to a processes for producing a wheat plant that produces grain comprising homozygous null mutations in each of the SSIIa-A, B and D genes by crossing two parental plants comprising said mutations, screening for plants comprising the mutations and selecting for plants which are fertile and comprise an amylose content between 54% and 66% and no SSIIa activity, wherein the grain comprises a starch content between 30% and 70% of the grain weight, wherein the starch is increased in the proportion of chain lengths of DP 7-10 an decreased in the proportion of chain lengths DP 11-24, where at least 50% of the fructan content is of DP 3-12 and is increased between 2 and 10-fold, wherein the BG is increased 1 or 2% on an absolute basis or between 2 and 7 fold relative to wild type or is between 1 and 4% of the grain weight wherein the AX or cellulose content is increased by between 1 and 5% on an absolute basis and wherein the germination rate is greater than 70%, and wherein the grain comprises at least 2% RS, and wherein the process further comprises backcrossing the plant with non-mutated plants
The specification describes that prior art wheat cultivars already known in the art and comprising single null mutations in SSIIa were obtained and used in crosses to generate SSIIa triple null plants (p. 82, ¶ 0350; see also p. 95, ¶ 0389). These triple nulls were also used in crosses with different genetic backgrounds to generate additional SSIIa triple null plants (p. 96). The specification refers to wild-type plants as “ABD” whereas triple null mutants are referred to as “abd” (p. 97, ¶. 0394).
The specification describes that the average grain weight in the mutants was 25mg to 36mg, an amylose content of 36-64%, a starch content ranging from 30-70%, a BG content from 1.3-3.3%, a fructan content ranging from 3.1-10.8%, an AX content from 6.7-8.8%, a cellulose content from 2.6-4.6% and RS ranging from 1-3.8% (p. 97, ¶. 0395; p. 98, ¶. 0399 and 0401, p. 99, ¶. 0402 and 0404; p. 100, ¶. 0406 and 0407; p. 101, ¶. 0409; see also p. 103, Table 6).
The specification alleges that instant invention pertains to the discovery that the genetic background of SSIIa mutations had an effect on grain compositions parameters (p. 101, ¶. 0410). The specification also describes additional SSIIa mutants (e.g., p. 119, Table 9), and that these results are purportedly unexpected based on the fact that prior art SSIIa triple null plants comprise an amylose content of less than 45% (p. 14, ¶. 0143).
The specification describes that the level of SSIIa mRNA in triple null plants from Konik-Rose et al was about 8% of the level relative to wild-type (p. 121, ¶. 0451). The specification describes that protein was not detected (p. 122, ¶. 0454 and 0456).
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 adequately describe a representative number of species from the broad genus of wheat plants producing grain comprising mutations from the crosses as claimed, which encompass mutations at any nucleotide position in the SSIIa gene of the A, B and D genome in any genetic background of T. aestivum and which predictably yield grain with the amylose content as claimed. The specification fails to even describe, in fact, that amylose content can reach up to 66% as claimed (see Table 6 describing that the highest content is 64%).
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 comprising mutations that are used in crosses. 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, Applicant admits that the state of the art is unpredictable with respect SSIIa mutations and the resulting amylose content as claimed (see Applicant reply dated 26 March 2025, p. 22, ¶ 2 and 3; see also p. 23, ¶ 1 and 3), while the specification fails to describe the common attributes or features possessed by the members of the genus in view of the species disclosed and which confer the specific amylose content range of 54%-66%.
Applicant’s own specification reinforces this unpredictability and lack of description: the specification describes that the average grain weight in the mutants was 25mg to 36mg, an amylose content of 36-64%, a starch content ranging from 30-70%, a BG content from 1.3-3.3%, a fructan content ranging from 3.1-10.8%, an AX content from 6.7-8.8%, a cellulose content from 2.6-4.6% and RS ranging from 1-3.8% (p. 97, ¶. 0395; p. 98, ¶. 0399 and 0401, p. 99, ¶. 0402 and 0404; p. 100, ¶. 0406 and 0407; p. 101, ¶. 0409; see also p. 103, Table 6).
Moreover, the claims encompass wheat plants from any possible genetic background yet the specification makes clear that instant invention pertains to the discovery that the genetic background of SSIIa mutations had an effect on grain compositions parameters (p. 101, ¶. 0410), while grain from the same genetic background comprising triple null mutations fails to reach the amylose content in the processes as claimed (e.g., see Table 6 of the instant specification; see also Applicant reply dated 13 May 2022, p. 10, penultimate and last ¶; see also p. 11, ¶ 1; see p. 11, ¶ 2: SSIIa triple null mutations do not necessarily result in the amylose content as claimed).
A description of a representative number of species is also critical because the art describes that the difference in amylose content between two types of triple nulls could be the result of either using different genetic backgrounds or different analytical methods for amylose determination (Konik-Rose et al, p. 1063, col. 1, last ¶. bridging col. 2; p. 1057, Table 1).
Furthermore, the art describes, and the specification reinforces what is described in the art: triple null mutations in wheat grain do not necessarily yield grain with an amylose content of greater than 45% (e.g., see Konik-Rose et al, p. 1054, col. 1, penultimate ¶.; see also Yamamori et al, 2000, Theor Appl Genet, 101:21-29; see Abstract; see also p. 24, Table 2; see instant specification p. 14, ¶. 0143).
Similarly, if the claimed amylose content is a property purported to previously never been achieved in triple null plants of the prior art and has been done for the first time in an unpredictable art (e.g., see Applicant reply dated 18 November 2022, p. 13, ¶ 1; see also Applicant reply dated 26 March 2025, p. 23; see also p. 24, last ¶), then the claims must recite limitations in the process to yield a plant with grain possessing the claimed amylose content as there are no differences between the process as claimed and the processes in the prior art. The claimed process and that as described in the art fail to produce grain with any structural difference between the claimed plant and the prior art plant.
The specification does not distinguish and/or describe the processes and/or structure of the grain that confers the claimed amylose content from the structure of grain lacking the amylose content as claimed: both grain types are SSIIa triple nulls. In other words, if the plant of the instant invention is capable of reaching amylose contents above what is described in the art, then the claims must recite the particular structures of the grain and/or processes that yield grain with the traits as claimed and which are distinguishable from the art.
Thus, skilled practitioner would not be of the opinion that Applicant possesses the processes as claimed to identify the exhaustive genus of plants producing grain as claimed since the specification has failed to describe whether it is particular mutations, the genetic background, or a combination of both that are required in order to obtain the grain as claimed.
Therefore, in light of the instant disclosure and the state of the art, the skilled practitioner would not be of the opinion that Applicant possesses the genus of grain from any genetic background from which there are over 100 varieties (e.g., see Final 2019/20 WQA Wheat Variety Master List) and which comprises the genus of mutations as broadly claimed.
Given the lack of written description in the specification with regard to the processes and production of mutated grain as broadly claimed, it is not clear that Applicant was in possession of the invention at the time this application was filed.
Response to Arguments
Applicant traverses the rejection of the claims because the claims are directed to a method of identifying members of a genus and not the members of the genus per se (Applicant reply dated 06 October 2026, p. 10, ¶ 1).
This argument is not persuasive based on Applicant’s own arguments. Namely, Applicant goes to great lengths to rebut the rejection of the claims as obvious over the art because one would not have a reasonable expectation of success in arriving at the instantly claimed products (e.g., see p. 14, section I of Applicant reply dated 06 October 2025), but here argues the claims are not directed to products. Thus, it is clear that Applicant considers the claims to be directed to members of a genus, namely products.
Applicant traverses the rejection because the claims are analogous to assay methods for “selecting” or “identifying” that the Rochester court explicitly noted were adequately described (Applicant reply dated 06 October 2025, p. 10, section II).
Applicant specifically asserts on page 11:
In University of Rochester v. G.D. Searle & Co., the court explicitly acknowledged that the claims of U.S. Patent No. 5,837,479, directed to assays for identifying compounds that selectively inhibit prostaglandin H synthase-2 (PGHS-2) were supported by the specification, despite also finding that the specification failed to describe a single compound that had such inhibitory activity. 358 F.3d 916, 928 (2004) ("The only claims that appear to be supported by the specification are claims to assay methods but those claims were already issued in the '479 patent").
Applicant’s argument is not persuasive and misleading. Applicant cites to a ‘479 patent which is not the patent at issue in Rochester. The citation in Rochester to which Applicant cites does not hold that the methods of ’850 were adequately described in the specification but that the claims of ‘479 appear to be supported.
Thus, the court does not conclude that the claims in ‘850 satisfy the requirements of the written description requirement. In fact, Rochester holds that the ‘850 patent of University of Rochester is invalid for failing to adequately describe method claims because it has failed to describe the compound used in the method.
Even if one were to arguendo accept Applicant’s position that the claim is a process for “identifying” a wheat plant, one must still identify plants comprising mutations that yield the traits as claimed. As discussed above, the specification fails to adequately describe this as triple null SSIIa grain consistently yields grain with amylose contents of well below the claimed content of 54%.
Moreover, this argument has been previously addressed in prior Office actions including the most recent dated 05 May 2025: the nature of the invention and the claims as whole is not that it is merely a “screening” process or a process to “identify” grain with particular characteristics.
Applicant apparently wishes the Office to ignore the plain language of the claims which reads “A process for identifying a wheat plant that produces grain”. In fact, steps (i)-(iii) are all directed to a process for producing a product that is a wheat plant that produces grain with certain characteristics. Emphasis added.
Applicant even reiterates this position by stating that the specification describes and experimentally shows the unexpected finding that SSIIa triple null wheat grain having an amylose content of between 54% and 66% can be produced (Applicant reply dated 06 October 2025, p. 12, ¶ 1).
Here, the invention encompasses a process for producing a wheat plant with grain comprising specific mutations to SSIIa genes and as such requires knowledge of the structures and properties of the mutants that predictably yield the alleged unexpected property of the claimed amylose content.
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).
Rochester also attempts to distinguish Fiers, Lilly, and Enzo by suggesting that the holdings in those cases were limited to composition of matter claims, whereas the '850 patent is directed to a method. We agree with the district court that that is “a semantic distinction without a difference.” Univ. of Rochester, 249 F. Supp. 2d at 228.
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. As the district court observed, “[t]he claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment.”
This is precisely the issue at hand: one of skill in the art cannot distinguish prior art grain which also SSII triple null, or crosses using single and double null mutants to produce said triple null plants, from the plants of the instant invention made by the crosses as claimed.
In other words, it does not matter whether the claims are drawn to products/compounds or methods/processes or methods of “using” a product versus methods of “identifying” a product.
This is because the specification does not distinguish and/or describe the differences between the processes to obtain the structure of the grain, or the structure of the grain, that confers the claimed amylose content and the structure of grain which fails to achieve the amylose content as claimed: both grain types are SSIIa triple nulls.
If the plant of the instant invention is capable of reaching amylose contents above what is described in the art, then the claims must reflect the structure that confer the function/phenotype of higher amylose content or the processes to obtain grain comprising said structures and corresponding function/amylose phenotype.
Here, the specification fails to make a distinction between the triple null grain as claimed and that which is in the prior art, and further fails to describe the particular process and/or structure of the grain conferring the function of having increased amylose content.
Applicant argues the claims adequately define the level of amylose because one measures amylose content using the iodine binding assay so that is does not matter if different assays yield different amylose contents (Applicant reply dated 06 October 2025, p. 12, section III).
This argument is not persuasive and immaterial: Applicant’s own specification describes that SSIIa triple null grain routinely falls well short of the claimed amylose content (e.g., see Table 6).
Applicant argues the claimed process is different from the process in the prior art because claim 27 is directed to selecting a fertile wheat plant (Applicant reply dated 06 October 2025, p. 13, section IV). Applicant’s argument is not persuasive. The claims are not directed to selecting a fertile plant.
Claim Rejections - 35 USC § 103
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.
Claim(s) 27 and 36-46 REMAIN rejected, and claims 47-52 are NOW rejected, under 35 U.S.C. 103 as being unpatentable over Giroux (Pub. No. US 2017/0006815 A1 with an effective filing date of 09 July 2015) in view of Konik-Rose et al (2007, Theor Appl Genet, 115:1053-1065) and Morell et al (1998, Electrophoresis, 19:2603-2611).
Claims 27 and 36-52 are drawn to a processes for identifying a wheat plant that produces grain comprising homozygous null mutations in each of the SSIIa-A, B and D genes by crossing two parental plants comprising said mutations, screening for plants comprising the mutations and selecting for plants which are fertile and comprise an amylose content between 54% and 66% and no SSIIa activity, wherein the grain comprises a starch content between 30% and 70% of the grain weight, wherein the starch is increased in the proportion of chain lengths of DP 7-10 an decreased in the proportion of chain lengths DP 11-24, where at least 50% of the fructan content is of DP 3-12 and is increased between 2 and 10-fold, wherein the BG is increased 1 or 2% on an absolute basis or between 2 and 7 fold relative to wild type or is between 1 and 4% of the grain weight wherein the AX or cellulose content is increased by between 1 and 5% on an absolute basis and wherein the germination rate is greater than 70%, and wherein the grain comprises at least 2% RS, and wherein the process further comprises backcrossing the plant with non-mutated plants.
As discussed in section 5 of the instant Office action supra, the claims encompass a broad genus of grain produced from wheat plants comprising mutations at any nucleotide position in the SSIIa gene of the A, B and D genome in any genetic background of T. aestivum.
Importantly, the art teaches it was known that starch consists of amylose and amylopectin, the latter of which is produced by enzymes such as SSIIa. Mutating the gene is known to increase amylose content (see Giroux, p. 15, ¶ 0207 and 0213; see instant specification p. 4, ¶ 0012: SSIIa participates in amylopectin synthesis).
Therefore, because the claims merely require that grain identified be SSIIa triple null from any genetic background, and because it is known that a lack of SSIIa increases amylose content, it necessarily follows that any prior art disclosing SSIIa triple null grain would be a species of the genus of grain as claimed and is structurally indistinguishable from the grain produced by the instant method.
In turn, because there is no structural difference, the prior art grain would also comprise any and all traits as the grain as claimed, such as being fertile and comprising the amylose content as claimed or the chain length distribution could be determined by FACE, a well-known method as used in the art (e.g., see Morell et al).
Giroux teaches screening and selecting for wheat SSIIa triple null mutants with an average starch content of 51.5%, while the grain in the row showing line 102 reached an amylose content of up to 56.7% (e.g., see p. 33, Table 5; p. 31, ¶. 0392). Amylose content can be measured by an iodine binding assay, and double nulls completely lacking SSIIa protein comprise an amylose content of 53% as determined by iodine staining (p. 8, ¶ 0131; see also p.35, ¶ 0410).
Giroux teaches the production of SSIIa triple null plants and the crossing of said plant with other SSIIa mutants, and that the mutations may be premature translation stop codons (p. 33, par. 0397; p. 32, Table 2). Starch is produced from said grain (p. 32, par. 0394).
Giroux teaches that SSIIa mutant grain is expected to have increased RS as compared to controls and may be greater than 2% (p. 37, ¶. 0433; p. 27, ¶. 0331 and 0332; p. 26, ¶. 0322 and 0323). Flour products may be produced from the triple null mutant (p. 5, ¶. 0079).
Giroux teaches that amylose content can be increased anywhere from 1% to 100% compared to that of wildtype and that there is in an interest in high amylose food because they have higher fractions of RS (p. 23, ¶. 0300; p. 17, ¶. 0225; see also p. 5, ¶. 0081). Even small increases in amylose can impact end product quality: higher amylose contents lead to firmer noodles after cooking which is preferable (p. 17, ¶. 0225 and 0226; see also p. 16, ¶. 0223 and 0224).
Thus, because the grain as disclosed by Giroux has the identical structure to the grain as claimed (i.e., it is triple null for the SSIIa gene), the issue is whether the plants as taught by Giroux would be expected to produce grain having all of the characteristics and/or traits of the grain as recited in instant claims.
Here, one would have found it prima facie obvious to select the SSIIa triple null wheat grain with the amylose content as claimed prior to the effective filing date of the instant invention because Giroux teaches, in fact, grain that is SSIIa triple null, that increasing amylose content increases RS content, and that grain with high amylose contents are desirable.
For example, one would screen for an amylose content of 54% to 66% because grain comprising 80% amylose showed significant improvements in bowl health indices (p. 16, ¶ 0217), and because said grain would have elevated RS content, the importance of which is discussed above.
Alternatively, one would be motivated to select and identify plants having an amylose content of 54 to 66% because even small increases in amylose can impact end product quality: higher amylose contents lead to firmer noodles after cooking which is preferable (p. 17, ¶. 0225 and 0226; see also p. 16, ¶. 0223 and 0224). By selecting and identifying plants one could harvest seed to produce additional generations of plants having this properties without having to cross plants comprising the mutations or making mutagenized plants again.
Here, the particular range of amylose is not of great importance so long as one obtains grain yielding end products with desirable cooking properties. Namely, one would continually screen SSIIa triple null plants until the desired end product is achieved.
Applicant was previously made aware that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected ).
In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." See MPEP 716.02
Here, the allegedly unexpected/nonobvious range of amylose contents is not a marked improvement over the prior art as it is not a difference in kind but one of degree: one of ordinary skill in the art would appreciate that incremental increases in amylose content do not yield products with marked or different in kind improvements but rather products that have different degrees of subjective qualities (e.g., firm versus firmer noodles).
One would have a reasonable expectation of success in arriving at the triple null grain with all of the traits as claimed because it comprises mutations that are encompassed by the genus of triple null mutations of the grain as instantly claimed, because it was well known in the art that other plant species producing grain comprising SSIIa mutations can yield up to 80% amylose content (e.g., see instant specification p. 4, ¶ 0013; see also Giroux ¶ 0217), because Giroux specifically teaches that is desirable to obtain grain with any number of different amylose contents, because triple null grain reached an amylose content of up to 56.7% and because an amylose content of 53.3% was obtained in SSIIa double null mutants as determined by the iodine staining assay (see line M175 in Table 9).
Thus, one would screen through the various grains comprising the triple null mutations until grain with greater than 54% amylose is obtained and which has desirable end product qualities.
Moreover, one would have a reasonable expectation of success in obtaining the instantly claimed amylose range because the art recognized that amylose content can also be affected by different genetic backgrounds or different analytical methods for determining amylose content (see Konik-Rose et al p. 1063, col. 1, last ¶).
Thus, one would merely cross the plants as taught by Giroux with plants of other genetic backgrounds until the desired amylose content is screened for and achieved to produce noodles having the desired firmness.
Response to Arguments
Applicant traverses the rejection of the claims because the Howitt Declaration asserts tetraploid and hexaploid wheat grain are known in the art to differ in both gene expression and phenotype, as discussed, for example, in Islam et al. (2003), at p. 555 (Applicant reply dated 06 October 2025, p. 15, ¶ 2; see also Howitt Declaration dated 26 March 2025 referred to herein as “Howitt Declaration”, section 16).
However, this argument is not persuasive because a general allegation that hexaploid and tetraploid wheat can differ in how “various genes” are expressed and regulated based on interactions among their genomes does not address one’s expectation with respect to how SSIIa genes are expressed in tetraploid versus hexaploid wheat.
Here, there is a reasonable expectation of success because it is known in the art that starch consists of amylose and amylopectin, the latter of which is produced by enzymes such as SSIIa. Mutating the gene is known to increase amylose content (see Giroux, p. 15, ¶ 0207 and 0213; see instant specification p. 4, ¶ 0012: SSIIa participates in amylopectin synthesis).
Thus, because one knows the function of SSIIa, because other plants comprising SSIIa mutations can yield grain with up to 80% amylose content (e.g., see instant specification p. 4, ¶ 0013; see also Giroux ¶ 0217), because Giroux specifically teaches that is desirable to obtain grain with any number of different amylose contents, because triple null grain reached an amylose content of up to 56.7% and because an amylose content of 53.3% was obtained in the same SSIIa genes of tetraploid null mutants as determined by the iodine staining assay (see line M175 in Table 9), one would reasonably expect that making triple mutants would also have the ability to produce triple null grain with the claimed amylose content.
Applicant argues that Dr. Howitt explained how various efforts to produce SSIIa triple null hexaploid wheat grain in different genetic backgrounds with elevated levels of amylose prior to the July 5, 2016 filing of the subject application all failed to achieve an amylose content of 54% to 66% including in Yamamori which achieved an amylose content of only about 38% of the total starch content, Konik-Rose which failed to reach an amylose content of 54% to 66% and produced SSIIa triple null wheat grain with an average amylose content achieved of only 44% of total starch (Applicant reply dated 06 October 2025, p. 15, ¶ 3 and 4; see also Howitt Declaration 17, 18 and 21). Thus, Applicant appears to argue the claims are non-obvious based on the secondary consideration of long-felt need and failure of others.
However, this argument is not persuasive because while factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue.
While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962) (expert opinion that an application meets the requirements of 35 U.S.C. 112 is not entitled to any weight; however, facts supporting a basis for deciding that the specification complies with 35 U.S.C. 112 are entitled to some weight); In re Lindell, 385 F.2d 453, 155 USPQ 521 (CCPA 1967) (Although an affiant’s or declarant’s opinion on the ultimate legal issue is not evidence in the case, "some weight ought to be given to a persuasively supported statement of one skilled in the art on what was not obvious to him." 385 F.2d at 456, 155 USPQ at 524 (emphasis in original)). See MPEP 716.04.
Here, Applicant’s draws generalized conclusions with respect to obviousness vis-à-vis arguing long-felt need and failure of others without establishing and/or providing factual evidence that the need to produce amylose contents in the specific range of 54% to 66% was a persistent need that was recognized by those of ordinary skill in the art.
Applicant argues that there was no understanding in the art regarding the extent to which genetic background may influence amylose content of SSII triple null wheat grain, or whether an amylose content of 54% to 66% was possible in SSIIa triple null wheat grain (Applicant reply dated 06 October 2025, p. 15, last ¶).
This argument is unpersuasive and has been addressed supra: generalized conclusions with respect to obviousness vis-à-vis arguing long-felt need and failure of others without establishing and/or providing factual evidence that the need to produce amylose contents in the specific range of 54% to 66% was a persistent need that was recognized by those of ordinary skill in the art.
Moreover, this argument is not found to be persuasive as it is not commensurate in scope with what is claimed. Namely, if one would understand that the variety of genetic backgrounds of SSIIa triple null wheat grain of the prior art is unable to reach 54% to 66% amylose content, then a one of ordinary skill in the art would also appreciate that these same species/genetic backgrounds are encompassed by the genus of plants of the invention since the claims are not directed to any particular genetic background but rather encompass all genetic backgrounds.
In fact, Applicant’s argument supports the position of the Office that the claims are properly rejected for failing to comply with the written description requirement: if there was no understanding in the art regarding the extent to which genetic background may influence amylose content of SSII triple null wheat grain, or whether an amylose content of 54% to 66% was possible in SSIIa triple null wheat grain then the instant claims encompass subject matter that is not described in the specification.
Applicant argues that a POSA would understand that one cannot predict or form expectations regarding the amylose content of SSIIa triple null wheat grain based on the amylose content of SSIIa null barley grain (Applicant reply dated 06 October 2025, p. 16, ¶ 1; see also Howitt Declaration 22).
Applicant’s argument is not persuasive as it is merely conclusory and does not provide any factual reasoning as to why one would not have a reasonable expectation of success. For example, Applicant has failed to explain why one would not reasonably expect to see increased amylose contents as claimed even when a different plant species, such as barley completely lacking SSIIa activity, also has increased amylose content.
The fact that an outcome may not be predicted does not speak to whether one does or does not have a reasonable expectation of success in obtaining said outcome. In other words, whether one of ordinary skill in the art is uncertain that a result can be obtained does not address whether one would reasonably expect said result to occur.
Moreover, by merely dismissing the prior art without an appropriate explanation, Applicant appears to suggest if prior art fails to teach triple null grain with the claimed amylose content then no other prior art may be used to conclude whether one would have a reasonable expectation of success in producing triple null grain with the amylose content as claimed.
However, conclusive proof of efficacy is not required to show a reasonable expectation of success. Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). See MPEP 2143.02 (I).
Namely, oobviousness does not require absolute predictability, but some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). See MPEP 2143.02 (II).
Here, and as outlined above, one would have a reasonable expectation of success in producing a wheat plant the produces grain comprising the triple null mutations and attributes as claimed because the prior art expressly suggests doing so, because reducing SSIIa expression decreases amylopectin synthesis thereby increasing amylose content, because it was well known in the art that other grain plants comprising SSIIa mutations can yield up to 80% amylose content (e.g., see instant specification p. 4, ¶ 0013; see also Giroux ¶ 0217), because Giroux specifically teaches that is desirable to obtain grain with any number of different amylose contents, and because an amylose content of 53.3% was obtained in SSIIa double null mutants as determined by the iodine staining assay (see line M175 in Table 9).
Applicant argues the rejection relies on hindsight reconstruction based on knowledge of from the subject application (Applicant reply dated 06 October 2025, p. 16, section II).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Here, Applicant’s opinion as to a legal conclusion is not entitled to any weight as the entire premise of the rejection stems from the prior art and not from Applicant’s specification whatsoever.
Applicant argues one would not have a reasonable expectation of success in producing the grain as claimed with the features as recited in new claims 47-52 (Applicant reply dated 06 October 2025, p. 17, section III).
This argument is not persuasive and has been addressed previously: because the claims merely require identifying grain that is SSIIa triple null from any genetic background, and because it is known that a lack of SSIIa increases amylose content, it necessarily follows that any prior art disclosing SSIIa triple null grain would be a species of the genus of grain as claimed and is structurally indistinguishable from the grain produced by the instant method.
In turn, because there is no structural difference, the prior art grain would also comprise any and all traits as the grain as claimed, such as being fertile and comprising the amylose content as claimed.
Claim(s) 27 and 36-46 REMAIN rejected, and claims 47-52 are NOW rejected, under 35 U.S.C. 103 as being unpatentable over Jenkins et al (Pub. No. US 2011/0281818 A1) and Konik-Rose et al (2007, Theor Appl Genet, 115:1053-1065) and as evidenced by Giroux (Pub. No. US 2017/0006815 A1 with an effective filing date of 09 July 2015) and Yamamori et al (2006, Australian Journal of Agricultural Research, 57. 531-535).
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 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 27 and 36-52 are drawn to a processes for identifying a wheat plant that produces grain comprising homozygous null mutations in each of the SSIIa-A, B and D genes by crossing two parental plants comprising said mutations, screening for plants comprising the mutations and selecting for plants which are fertile and comprise an amylose content between 54% and 66% and no SSIIa activity, wherein the grain comprises a starch content between 30% and 70% of the grain weight, wherein the starch is increased in the proportion of chain lengths of DP 7-10 an decreased in the proportion of chain lengths DP 11-24, where at least 50% of the fructan content is of DP 3-12 and is increased between 2 and 10-fold, wherein the BG is increased 1 or 2% on an absolute basis or between 2 and 7 fold relative to wild type or is between 1 and 4% of the grain weight wherein the AX or cellulose content is increased by between 1 and 5% on an absolute basis and wherein the germination rate is greater than 70%, and wherein the grain comprises at least 2% RS, and wherein the process further comprises backcrossing the plant with non-mutated plants.
Jenkins et al teaches exemplary wheat plants B29 GES 2003 and B63 GES 2003 that are SSIIa mutants in all three genomes, namely, triple nulls (p. 29, ¶. 00246 and Table 5). Therefore, Jenkins et al disclose wheat grain comprising mutations in each SSIIa gene such that the grain is homozygous for a mutation in its SSIIa-A, B and D gene that are null mutations.
This wheat grain was obtained by crossing a parental SSIIa null (SGP-1 null plant) with plants of cultivar Sunco, which is the same genetic background used in crosses as disclosed in the instant specification (p. 29, ¶. 00246; see instant specification p. 96, Example 4)
Jenkins et al teaches that total sugars were extracted from 100mg dry weight wholemeal for SSIIa triple null mutants in the A, B and D genome and the corresponding wild-type and analyzed for fructan content (p. 29, ¶. 0245).
The results indicated that said triple null mutants contained increased fructan levels relative to wild-type under all growing conditions, for example, by 2-3 fold in the B63 line, indicating that an SSIIa mutation increased fructan content in wheat, for example, as in instant claim 38 (p. 29, ¶ 00246).
The increased level of fructan is preferably at least 3x or at least 10x that of a control plant prior to introduction of the mutations, and the percentage fructan of grain by weight is at least 5% (p. 3, ¶. 0030).
This is accomplished in cereal plants such as wheat or Triticum aestivum by reducing the level of SSII, which is synonymous with SSIIa (p. 2, ¶. 0016 and 0023-0024; see also p. 20, ¶. 0166). The level of SSIIa may be reduced by mutating the SSIIa gene and screening for said mutants (p. 3, par. 0028; p. 10, par. 0092).
Jenkins et al teaches that SSIIa mutations can be made by deletions, insertions or substitutions, and can be introduced by mutagens or by crossing of two parental plants (p. 10, ¶. 0090; see also p. 17 and ¶ 0144). Jenkins et al disclose screening for said grain (p. 3, ¶. 0038). Starch may be isolated from said grain (p. 20, ¶. 0171).
Jenkins et al teaches that a suitable number of backcrosses can be performed to cross out any undesirable genetic background, and that the desired genetic background can include grain with altered amylose to amylopectin ratios (p. 17, ¶. 0143; see also p. 20, ¶. 0169 and 0170).
Jenkins et al teaches food products such as flour including fructan with a degree of polymerization from about 3 to about 12 obtained from grain with reduced SSIIa activity relative to an unmodified control, and that the food product comprises a food ingredient at a level of at least 10% on a dry weight basis wherein the food ingredient is said grain (p. 3, ¶. 0026; see also p. 20, ¶. 0168-0175). Starch can also be isolated from the grain (p. 20, ¶. 0171). FACE may be used to determine chain length distribution (¶ 0193)
Jenkins et al teaches a method for ameliorating one or more symptoms of a condition associated with low levels of dietary fructan in a subject in need thereof, for example, diabetes or heart disease, by providing to a subject grain comprising homozygous null mutations in the SSIIa gene (p. 4, ¶ 0041-0042).
Jenkins et al teaches the need for efficient production of fructan from plant sources at low cost whereby said fructan product is obtained in a method comprising obtained or producing a cereal plant or grain or flour that comprises at least 3% fructan as a percentage of the cereal grain weight and processing said grain to produce the product, and that the starch content should be at least 30% or more as a percentage of the total grain weight (p. 2, ¶. 0011 and 0020-0021). The need is due to the beneficial properties of dietary fructan (p. 1, ¶. 0009).
Konik-Rose et al teaches the crossing of a wheat plant which lacks functional SSIIa genes on each genome with an Australian what cultivar Sunco to yield eight possible genotypes, one of which has homozygous null mutations in each of the SSIIa-A, B and D genomes (see Abstract; see also p. 1055, col. 1). Thus, Konik-Rose et al disclose making a triple null in the same manner as disclosed in the instant specification (e.g., 96, ¶. 0391).
Konik-Rose et al teaches that triple null lines showed an increase in amylose content to 44% and a starch content of 47% (p. 1063, col. 1, last ¶. bridging col. 2; p. 1057, Table 1). This is of interest because starches with elevated amylose contents provide RS with positive impacts on bowel health (p. 1054, col. 1, last ¶. bridging col. 2).
Konik-Rose et al teaches that the difference in amylose contents between two types of triple null SSIIa lines could be result of using either different genetic backgrounds or different analytical methods for amylose determination (p. 1063, col. 1, last ¶).
Giroux teaches wheat SSIIa triple null mutants with an average starch content of 51.5% (e.g., see p. 33, Table 5) while Yamamori et al discloses that SSIIa triple null grain has up to 3.64 RS (p. 532, Table 1). High amylose is known to correlate with increased RS (p. 531, col. 2, last ¶.). Giroux also discloses processing of wheat grain (e.g., see p. 21, ¶. 0270-0276). An amylose content of 53.3% was obtained in SSIIa double null mutants as determined by the iodine staining assay (see Giroux: line M175 in Table 9).
Giroux teaches that amylose content can be increased anywhere from 1% to 100% compared to that of wildtype and that there is in an interest in high amylose food because they have higher fractions of RS (p. 23, ¶. 0300; p. 17, ¶. 0225; see also p. 5, ¶. 0081). Even small increases in amylose can impact end product quality: higher amylose contents lead to firmer noodles after cooking which is preferable (p. 17, ¶. 0225 and 0226; see also p. 16, ¶. 0223 and 0224).
In the instant matter, the claims encompass a genus of mutations: mutations may be in any position in the SSIIa-A, B or D gene, and the grain may comprise three homozygous null mutations. This is precisely what the art teaches, and is therefore structurally indistinguishable from the grain as instantly claimed.
Thus, because the grain as disclosed by Jenkins has the identical structure to the grain as claimed (i.e., it is triple null for the SSIIa gene), the issue is whether the plants as taught by Jenkins would be expected to produce grain having all of the characteristics and/or traits of the grain as recited in instant claims.
Here, and prior to the effective filing date of the instant invention, one would have found it prima facie obvious to select the SSIIa triple null fertile wheat grain with the amylose content as claimed because Jenkins teaches method for ameliorating one or more symptoms of a condition associated with low levels of dietary fructan in a subject in need thereof, for example, diabetes or heart disease, by providing to a subject grain comprising homozygous null mutations in the SSIIa gene and wherein the fructan content, in fact, increased by 2-3 fold in the mutant grain.
One would also be motivated to do so because grain comprising 80% amylose showed significant improvements in bowl health indices (see Giroux, p. 16, ¶ 0217), and because said grain would have elevated RS content, the importance of which is discussed above.
Alternatively, one would be motivated to select fertile plants having the fructan content as claimed and an amylose content of 54 to 66% because even small increases in amylose can impact end product quality: higher amylose contents lead to firmer noodles after cooking which is preferable (see Giroux, p. 17, ¶. 0225 and 0226; see also p. 16, ¶. 0223 and 0224). By selecting fertile plants one could harvest seed to produce additional generations of plants having this properties without having to cross plants comprising the mutations or making mutagenized plants again.
Here, the particular range of amylose is not of great importance so long as one obtains grain yielding end products with desirable cooking properties. Namely, one would continually screen SSIIa triple null plants until the desired end product is achieved.
It is also noted that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected ).
In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." See MPEP 716.02
Here, the allegedly unexpected/nonobvious range of amylose contents is not a marked improvement over the prior art as it is not a difference in kind but one of degree: one of ordinary skill in the art would understand that increases in amylose content do not yield products with marked improvements but rather products that have particular and subjective qualities (e.g., firm versus firmer noodles).
One would have a reasonable expectation of success in arriving at the triple null grain with all of the traits as claimed because it comprises mutations that are encompassed by the genus of triple null mutations of the grain as instantly claimed, because it was well known in the art that other plant species producing grain comprising SSIIa mutations can yield up to 80% amylose content (e.g., see instant specification p. 4, ¶ 0013; see also Giroux ¶ 0217), because Jenkins teaches triple null mutants produce the fructan content as claimed, because Giroux specifically teaches that is desirable to obtain grain with any number of different amylose contents, because triple null grain reached an amylose content of up to 56.7% and because an amylose content of 53.3% was obtained in SSIIa double null mutants as determined by the iodine staining assay (see line M175 in Table 9).
Thus, one would screen through the various grains comprising the triple null mutations until grain with greater than 54% amylose is obtained and which has desirable end product qualities.
Moreover, one would have a reasonable expectation of success in obtaining the instantly claimed amylose range because the art recognized that amylose content can also be affected by different genetic backgrounds or different analytical methods for determining amylose content (see Konik-Rose et al p. 1063, col. 1, last ¶).
Thus, one would merely cross the plants as taught by Giroux with plants of other genetic backgrounds until the desired amylose content is achieved to produce noodles having the desired firmness.
In this way, one would screen either screen plants until an amylose content of greater than 54% is obtained, or conversely, one would cross the triple null mutant plant with different genetic backgrounds which are known to affect amylose content to yield a plant with an amylose content of greater than 54%.
One would be motivated to do because as discussed above, this grain would have elevated RS content which is known to have beneficial health properties and because by finely tuning the amylose content one can produce noodles with a desired firmness.
Response to Arguments
Applicant traverses the rejection of the claims asserting that tetraploid and hexaploid wheat are differ in gene expression and phenotype, that it was not known in the art that SSIIa triple null hexaploid wheat grain with different genetic backgrounds could reach an amylose content of 54% to 66% as measured by iodine binding assay and that efforts to produce SSIIa triple null hexaploid wheat grain with elevated levels of amylose prior to the July 5, 2016 filing of the subject application all failed to achieve an amylose content of 54% to 66% such that one would not have a reasonable expectation of success in arriving at the grain as claimed (Applicant reply dated 06 October 2025, p. 18, penultimate ¶, p. 19, ¶ 1; see also Howitt Declaration ¶ 32-34 and 37).
However, this argument is not persuasive because while factual evidence is preferable to opinion testimony, such testimony is entitled to consideration and some weight so long as the opinion is not on the ultimate legal conclusion at issue.
While an opinion as to a legal conclusion is not entitled to any weight, the underlying basis for the opinion may be persuasive. In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962) (expert opinion that an application meets the requirements of 35 U.S.C. 112 is not entitled to any weight; however, facts supporting a basis for deciding that the specification complies with 35 U.S.C. 112 are entitled to some weight); In re Lindell, 385 F.2d 453, 155 USPQ 521 (CCPA 1967) (Although an affiant’s or declarant’s opinion on the ultimate legal issue is not evidence in the case, "some weight ought to be given to a persuasively supported statement of one skilled in the art on what was not obvious to him." 385 F.2d at 456, 155 USPQ at 524 (emphasis in original)). See MPEP 716.04.
Here, Applicant’s draws generalized conclusions with respect to obviousness vis-à-vis arguing long-felt need and failure of others without establishing and/or providing factual evidence that the need to produce amylose contents in the specific range of 54% to 66% was a persistent need that was recognized by those of ordinary skill in the art.
Also, and as addressed above, a general allegation that hexaploid and tetraploid wheat can differ in how “various genes” are expressed and regulated based on interactions among their genomes does not address one’s expectation with respect to how SSIIa genes are expressed in tetraploid versus hexaploid wheat.
Here, there is a reasonable expectation of success because it is known in the art that starch consists of amylose and amylopectin, the latter of which is produced by enzymes such as SSIIa. Mutating the gene is known to increase amylose content (see Giroux, p. 15, ¶ 0207 and 0213; see instant specification p. 4, ¶ 0012: SSIIa participates in amylopectin synthesis).
Applicant argues that based on the difference in amylose content between the SSIIa null barley grain and SSIIa triple null wheat grain described in the prior art, a POSA would understand that one cannot predict or form expectations regarding the amylose content of SSIIa triple null wheat grain based on the amylose content of SSIIa null barley grain (Applicant reply dated 06 October 2025, p. 19, ¶ 2; see also Howitt Declaration ¶ 38).
Applicant’s argument is not persuasive as it is merely conclusory and does not provide any factual reasoning as to why one would not have a reasonable expectation of success. For example, Applicant has failed to explain why one would not reasonably expect to see increased amylose contents as claimed even when a different plant species, such as barley completely lacking SSIIa activity, has increased amylose content.
Moreover, the fact that an outcome may be unpredictable/unknown does not speak to whether one does or does not have a reasonable expectation of success in obtaining said outcome. In other words, whether one of ordinary skill in the art does not know for certain that a result can be obtained does not address whether one would reasonably expect said result to occur.
Additionally, by merely dismissing the prior art without an appropriate explanation, Applicant appears to suggest if prior art fails to conclusively teach triple null grain with the claimed amylose content then no other prior art may be used to conclude whether one would have a reasonable expectation of success in producing triple null grain with the amylose content as claimed.
However, conclusive proof of efficacy is not required to show a reasonable expectation of success. Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")). See MPEP 2143.02 (I).
Namely, oobviousness does not require absolute predictability, but some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). See MPEP 2143.02 (II).
Here, and as outlined above, one would have a reasonable expectation of success in producing a wheat plant the produces grain comprising the triple null mutations and attributes as claimed because the prior art expressly suggests doing so, because reducing SSIIa expression decreases amylopectin synthesis thereby increasing amylose content, because it was well known in the art that other grain plants comprising SSIIa mutations can yield up to 80% amylose content (e.g., see instant specification p. 4, ¶ 0013; see also Giroux ¶ 0217), because Giroux specifically teaches that is desirable to obtain grain with any number of different amylose contents, because triple null grain reached an amylose content of up to 56.7% and because an amylose content of 53.3% was obtained in SSIIa double null mutants as determined by the iodine staining assay (see line M175 in Table 9).
Applicant argues the rejection relies on hindsight reconstruction based on knowledge of from the subject application (Applicant reply dated 06 October 2025, p. 19, section II; Howitt Declaration ¶ 39).
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Here, Applicant’s opinion as to a legal conclusion is not entitled to any weight as the entire premise of the rejection stems from the prior art and not from Applicant’s specification whatsoever.
Applicant argues that one would not have a reasonable expectation of success in selecting a fertile plant (Applicant reply dated 06 October 2025, p. 20, last ¶). This argument is not persuasive as the claims are not directed to selecting a fertile plant.
Applicant argues one would not have a reasonable expectation of success in producing the grain as claimed with the features as recited in new claims 47-52 (Applicant reply dated 06 October 2025, p. 17, section III).
This argument is not persuasive and has been addressed previously: because the claims merely require that grain produced by the process be SSIIa triple null from any genetic background, and because it is known that a lack of SSIIa increases amylose content, it necessarily follows that any prior art disclosing SSIIa triple null grain would be a species of the genus of grain as claimed and is structurally indistinguishable from the grain produced by the instant method.
In turn, because there is no structural difference, the prior art grain would also comprise any and all traits as the grain as claimed, such as being fertile and comprising the amylose content as claimed.
Moreover, this argument is not persuasive because the reasonable expectation of success arises from the fact that Jenkins teaches the fructan content as claimed was obtained in SSIIa triple nulls, it was well known in the art that other plants comprising SSIIa mutations can yield up to 80% amylose content (e.g., see instant specification p. 4, ¶ 0013; see also Giroux ¶ 0217), because Giroux specifically teaches that is desirable to obtain grain with any number of different amylose contents, because triple null grain reached an amylose content of up to 56.7% and because an amylose content of 53.3% was obtained in SSIIa double null mutants as determined by the iodine staining assay (see line M175 in Table 9).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662