DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination under 37 CFR § 1.114
A request for continued examination under 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR § 1.114, and the fee set forth in 37 CFR § 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR § 1.114.
Applicant’s submission filed on December 30, 2025 has been entered.
Claims
The amendments submitted on December 30, 2025 have been entered.
Claims 1-2 and 4-20 are examined in this Office action.
Claim Rejections - 35 USC § 103
Claims 1-2 and 4-20 are rejected under 35 U.S.C. § 103(a) as being unpatentable over in view of CAO (Cao et al., United States Patent Application Publication No. 2021/10022303 A1, published January 28, 2021) in view of SUI (Sui et al., 2018, Photosynthetic Characteristics of a Super High Yield Cultivar of Winter Wheat During Late Growth Period, 2010, Agricultural Sciences in China 9(3): 346-354).
The claims are drawn to a method of breeding wheat cultivars, which comprises 1) screening or preparing a breeding material according to a breeding objective; wherein traits of the breeding objective comprise yield greater than or equal to 10% of that of Lumai 14, 2) configuring a hybrid combination for the breeding material according to the breeding objective, and conducting hybridization to obtain an early-generation material, and 3) conducting selfing on the early-generation material for not less than five generations, and selecting new wheat cultivars meeting the objectives, which comprise yield greater than or equal to 5% of that of Lumai 14; wherein the selecting comprises selecting a strain with a visual vigor and a grain-to-leaf ratio greater than or equal to 5% of those of Lumai 14; wherein the selecting comprises selecting a strain with a gelatinization peak viscosity greater than or equal to 5% higher than of Lumai 14; wherein the process of the selecting comprises selecting a strain with moderate resistance and higher resistance to two or more local diseases through composite identification; which comprises one or more of natural diseases in the field, planting of infected lines or inoculation of infected strains in the field, and molecular marker-assisted selection.
In Example 1 at pages 12-17 (paragraphs 0090-00115), the instant Specification describes the breeding of a wheat cultivar Jimai 22 with high yield, multiple disease resistance and stress resistance, and wide applicability; which cultivar was produced in accord with the methods of the instant invention.
In Example 2 at pages 17-20 (paragraphs 00116-00136), the instant Specification describes the breeding of a high-quality noodle wheat cultivar Jimai 19; which cultivar was produced in accord with the methods of the instant invention.
In Example 4 at page 22 (paragraphs 00151-00154), the instant Specification describes the breeding of a super strong gluten wheat Jimai 954072; which cultivar was produced in accord with the methods of the instant invention.
The instant disclosure further states that “[a] series of new wheat varieties such as Jimai 229, Jimai 44, and Shannong 20 were successively derived from the 954072, which provided abundant high-quality resources for the genetic improvement of wheat in China” (page 22, paragraph 00154).
CAO teaches an inferior-eliminating and superior-selecting breeding method for synergistically improving wheat yield and quality (i.e., a method of breeding wheat cultivars) (entire document; see Title, Abstract, for example).
CAO teaches a method for breeding target wheat varieties with improved yield and quality, which combines the advantages of pedigree method and hybrid method, and provides a method for selection of all generations using molecular marker in combination with phenotype identification, and for selection of each generation according to different standards. The parents have clear backgrounds before combination and the selection process is simple and easy to operate, with clear goal, especially for those with no breeding experiences, it is easy to master and provides technical support for the rapid breeding of new varieties of high-quality and high-yield wheat. (Abstract; paragraph 0050).
CAO teaches that wheat is a conventional self-pollinated crop. The pedigree method, hybrid method, derivative system method, single seed descend method and double haploid method are commonly used in the selection of hybrid progeny. In China, the pedigree
method is the most widely used method (paragraph 0005).
CAO teaches and claims a method for breeding target wheat varieties with improved yield and quality, which comprises the steps of: selecting parental combinations that meet the following criterion from multiple parental combinations as multiple candidate parental combinations that contain at least one high-quality related protein; hybridizing the multiple candidate parental combinations respectively to obtain F0 and F1 hybrids; selecting a plant whose the yield per plant is greater than that of a high-quality control variety or greater than or equal to that of a high-yield control variety; and collecting seeds of the selected F1 plants.
CAO teaches and claims the method wherein, the high-yield control is a high-yield regional trial control variety in a local wheat area; or, the high-quality control is a high-quality regional trial control variety in a local wheat area (claim 4 of CAO).
CAO also teaches breeding and selection methods that include investigation of winter freezing injury, disease resistance, quality identification, yield detection, field traits, TGW identification, and molecular marker detection (Examples).
CAO teaches in detail the use of molecular marker detection, including primers and amplification conditions (paragraphs 0052, 0075-0077; Table 1; Figure 2 and accompanying text).
CAO teaches wheat cultivar Jimai 22 as a high-yield regional trial control variety of the local wheat area, and teaches the production and use of Jimai 22 according to the methods of the invention (paragraphs 0026, 0092-0094, 0100, 0122-0123, 0161, 0189). The yield per plant of Jimai 22 was 12.8 g (paragraph 0094). Therefore, the instant disclosure parallels the teachings of CAO, and teaches methods that result in the production of the Jimai 22 wheat cultivar previously taught by CAO.
CAO teaches wheat cultivar Jimai 19 as a high-yield regional trial control variety of the local wheat area, and teaches the production and use of Jimai 19 according to the methods of the invention (paragraphs 0052-0053, 0062, 0065, 0069, 0075-0077). Furthermore, Jimai 19 is sold by Shandong Luyan Agricultural Co., Ltd. (paragraph 0062). Therefore, the instant disclosure parallels the teachings of CAO, and teaches methods that result in the production of the Jimai 19 wheat cultivar previously taught by CAO.
CAO teaches wheat cultivar Jimai 954072 (previously described in a 2003 publication by Jinchuan et al.; reference not provided) as a high-protein cultivar, and teaches the production and use of Jimai 954072 according to the methods of the invention (paragraphs 0051-0053, 0061, 0065, 0069, 0071, 0073, 0075). CAO teaches the extraction and analysis of glutenins from Jimai 950472 (paragraphs 0069, 0071). Therefore, the instant disclosure parallels the teachings of CAO, and teaches methods that result in the production of the Jimai 954072 wheat cultivar previously taught by CAO.
CAO teaches and claims wheat populations derived from the combination of Ji 954072 and Jimai 19, with plant-to-row yields of at least 12.51 kg (paragraphs 0046, 0065, 0079, 0177, 0182; claim 9 of CAO). The F5 plot populations derived from the combination of Ji 954072 and Jimai 19 met the chosen criteria with respect to plot yield, as greater than the high-quality control or greater than or equal to the high-yield control, and these were the selected F5 plot (i.e., five generations) (paragraphs 0175-0177).
CAO teaches the detection of the new wheat cultivar Jimai 44 (paragraphs 0188-0189). The grain protein content of Jimai 44 was 15.4%, dough stabilization time was 41.8 min, maximum extension resistance was 800BU, which met the standard of national high-quality strong gluten wheat (paragraph 00189). Jimai 44 participated in the first year of regional trial in Shandong province, and the unified quality test results showed that the grain protein content was 14.7%, the dough stability time was 39.5 min, which met the standard of national high-quality strong gluten wheat. Compared with the control variety Jimai 22, its yield was increased by 2.3%. Its comprehensive characteristics were excellent, with very high promotion value. Molecular marker and SDS-PAGE detections showed that it contained 1, 7+8, and 5+10 subunits (FIG. 7) (Id.). Therefore, the instant disclosure parallels the teachings of CAO, and teaches methods that result in the production of the Jimai 44 wheat cultivar previously taught by CAO.
Throughout the disclosure, CAO extensively teaches crosses and F1 plot populations derived from the combination of Ji 954072 and various other wheat lines (Jimai 14, Jimai 17, Jimai 19). It is noted that, paralleling the teachings of CAO, the instant disclosure also teaches that “[a] series of new wheat varieties such as Jimai 229, Jimai 44, and Shannong 20 were successively derived from the 954072, which provided abundant high-quality resources for the genetic improvement of wheat in China” (instant Example 4, paragraph 00154).
CAO teaches and claims (claim 1 of CAO; paragraphs 0010-0017) a method of breeding target wheat varieties, which comprises hybridizing parental combinations to obtain F0-F5 hybrids and plants.
CAO teaches breeding and identification of wheat plants for disease resistance, including powdery mildew (i.e., natural disease in the field) (paragraphs 0139; 0150-0153).
CAO teaches the detection of wheat plants (Jimai 44) with string lodging resistance (i.e., stress resistance).
CAO teaches and claims molecular marker-assisted selection (Abstract; paragraphs 0184-0189; claims 3 and 7 of CAO).
CAO teaches obtaining F2 generation by plot sowing and breading the selected F2 plot, including selection for winter freezing injury less than grade 4; plots with yield greater than that of a high-quality control variety or greater than or equal to that of a high-yield control variety, plots with TGW [Thousand-Grain Weight, one of the major yield-contributing traits routinely used as a selection criterion by plant breeders] (paragraphs 0096-0102).
CAO teaches obtaining and selecting of F3 generation plants for single plants for properties including: (1) single plants containing high quality- associated protein; (2) single plants with no less than 5 tiller-earing, stick or square ears, flag leaves raised (with an angle between the flag leaves of 10-30 degrees), powdery mildew less than grade 4, stripe rust less than grade 4, and plant height of 70-85 cm; (3) the protein content of single plant grains was greater than or equal to 13% (paragraphs 0129-0102).
CAO teaches obtaining and selecting of F4 generation plants for properties including: (1) winter freezing injury less than or equal to grade 3; (2) both grade of powdery mildew and grade of stripe rust were less than 4; (3) plant height of 75-80 cm; (4) plant-to-rows with TGW greater than or equal to 38 g; (5) the peak time of the mixograph in the mixing characteristics identification of plant-to-row single plants was not less than 2 minutes, and the 8-minute band width was not less than 10% (paragraphs 0142-0161).
CAO teaches obtaining and selecting of F5 generation plants for properties including: (1) winter freezing injury of grade 3; (2) number of ears per mu of 440,000; (3) a lodging grade of 2 (paragraphs 0162-0187).
CAO does not explicitly teach every single step of the instant claims, as CAO does not explicitly teach comparison of traits relative to Lumai 14 (as control cultivar). However, such compositions and methods practiced with them would have been prima facie obvious to a person having ordinary skilled in the art at the time the application was filed for the following reasons.
SUI teaches the mechanism of high yield of winter wheat in the field, and teaches the photosynthetic characteristics of a super high yield cultivar of winter wheat during late growth period (entire document; see Title, Abstract, for example). For example, to study the photosynthetic characteristics of photosystem II (PSII) and xanthophylls cycle is beneficial to reveal the mechanism of high yield, which can provide physiological reference for breeding (i.e., breeding objective) (Introduction).
SUI teaches that super high yield wheat is a new cultivar, which is a comprehensive, efficient use of soil, fertilizer, water, heat, gas capacity and high input, high output and high efficiency characteristics of varieties (page 347, left col.).
SUI teaches direct comparison of a super high yield wheat cultivar called Weimai 8 with the wheat cultivar Lumai 14 as control (Abstract; Materials and Methods section; see also page 352, and the excerpted table below). Before maturity, ear per unit area of the experimental plot was measured, mature wheat of the experimental plot was harvested to calculate the yield of two varieties and sampled to test yield components of the grain number per ear and the weight per 1 000 kernels (page 348, left col., first paragraph). The yield (kg ha-1) of the wheat cultivar Weimai 8 is approximately 24.27% greater than that of Lumai 14 (i.e., greater than or equal to 10%).
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SUI teaches and compares the changes of chlorophyll content of flag leaf, second leaf and third leaf of Weimai 8 and Lumai 14 at late growth period (Fig. 2, page 349). SUI teaches and compares the yield and yield components of Weimai 8 and Lumai 14, with the yield of Weimai 8 being 24.3% higher than that of Lumai 14 (section bridging pages 349-350).
SUI teaches that photosynthetic and electron transport capacity of PSII reaction center are parameters that could be used as indicators for breeding or selecting winter wheat with high yield in the field. Super wheat cultivar Weimai 8 could absorb more light energy by later senescence of leaves, had higher photosynthetic capacity to make use of more lights in photochemistry reaction and could decrease energy dissipation, which might be associated with the super high yield of the wheat cultivar. This deduction was proved by the higher yield of Weimai 8 relative to Lumai 14 (Table 1). These parameters could be used as indicators for breeding or selecting winter wheat with high yield in the field. (page 352, CONCLUSION section).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine and to modify the teachings of CAO and SUI, to screen and select individual wheat plants in a breeding program, and to compare these with the control wheat Lumai 14; thus arriving at the Applicant’s invention, with a reasonable expectation of success, and without any surprising results. Obviously, one of ordinary skill in the art would have been motivated to do so for the purpose of breeding for improvement of wheat yield and quality (as taught by both CAO and SUI). As evidenced above, the instant application parallels the teachings of CAO with the descriptions of methods of breeding at least the wheat cultivars Jimai 22, Jimai 19, Ji 954072, and Jimai 44.
Even though CAO and SUI do not explicitly teach every single recited step of all of the instant claims (for example, selecting a strain with a visual (spring) vigor and a grain-to-leaf ratio greater than or equal to 5% those of Lumai 14; selecting a strain with a gelatinization peak viscosity greater than or equal to 5% higher than that of Lumai 14; selecting a cultivar with yield and a water and fertilizer use efficiency greater than or equal to 5% better than those of a local control cultivar; selecting a strain with a more stable yield and better stress resistance in a heading stage, and a better leaf function and a higher stem quality in a grouting stage; conducting off-site selection and identification and selecting a strain with traits better than those of Lumai 14), these are considered design choice and mere routine optimization of the compositions and methods, which would be obvious toa person having ordinary skill in the art. They are taught by the cited references and by the state of the art of breeding wheat cultivars in general. One of ordinary skill in the art would have been motivated to do so because desirable phenotypic traits are associated with the economically important products from wheat and are one of the main reasons farmers grow wheat.
The screening or preparing a breeding material according to a breeding objective, configuring a hybrid combination for the breeding material according to the breeding objective, conducting selfing on the early-generation material for not less than five generations, selecting high-yield and high-quality new wheat cultivars with desired starch (amylose, amylopectin) content, gluten content, sedimentation value, sensory noodle properties, improved fertilizer utilization, stress resistance, and disease resistance, are design choice and mere routine optimization of the compositions and methods taught by the cited references and by the state of the art of breeding wheat cultivars in general, absent evidence to the contrary.
Response to Applicant’s arguments:
Applicant’s arguments in the response submitted on December 30, 2025 have been carefully considered but they were not found to be persuasive. Applicant argues that “CAO lacks any teaching on water-fertile efficiency, drought resistance, etc.”, and that “CAO teaches quality-first screening via molecular markers but never suggests subsequently subjecting the same limited population to drought/water limited selection”. Applicant contends that a person of ordinary skill in the art would have had no reasonable expectation that the CAO’s scheme would succeed in any trait combinations”. Applicant contends that SUI is silent on any stress-resistance trait or no how to breed lines that simultaneously perform Lumai 14 in yield, quality, and water-use efficiency (Remarks, last two paragraphs of page 1).
The Examiner disagrees with Applicant’s characterization of the prior art, and of the state of the art in general, vis-à-vis the instant claims.
As described above, the instant application parallels the teachings of CAO with the descriptions of methods of breeding at least the identical, previously described (by CAO) wheat cultivars Jimai 22, Jimai 19, Ji 954072, and Jimai 44.
The main issue in the present obviousness analysis is whether there was any reason based on prior art teachings that would have motivated one of ordinary skill in the art to modify and to combine the teachings of CAO, for comparison of agriculturally relevant traits of the taught wheat cultivars (including wheat cultivars Jimai 22, Jimai 19, Ji 954072, and Jimai 44) with a control wheat Lumai 14, as taught by SUI. The answer to this question is obviously yes. It is in this context that the combined teachings of the cited references precisely teach, suggest, and provide motivation for the instantly claimed compositions and methods.
Contrary to Applicant’s arguments, the instant claims are directed to methods of breeding wheat cultivars with traits of the breeding objective comprising one or more of: gluten strength, yield, water and fertilizer efficiency, disease resistance, stress resistance, a waxy property, and resistant starch. The combination of the cited prior art references, together with the general state of the art, teaches and makes obvious the instantly claimed invention of breeding wheat cultivars with traits of the breeding objective comprising one or more of: gluten strength, yield, water and fertilizer efficiency, disease resistance, stress resistance, a waxy property, and resistant starch.
Further contrary to Applicant’s arguments, SUI teaches that a super high yield wheat is a new cultivar, which is a comprehensive, efficient use of soil, fertilizer, water, heat, gas capacity and high input, high output and high efficiency characteristics of varieties. CAO teaches obtaining and selecting F1, F2 ,F3, F4, and F5 generation plants, using a plurality of diverse selection criteria that are deemed favorable in breeding. Again, in contrast to Applicant’s arguments, the instant claims are not merely directed to just drought/water limited selection.
In response to Applicant’s arguments against the cited references individually, these are not persuasive, because they are attacks on the CAO and SUI references individually rather than considering the combined teachings as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant is reminded that the burden is on Applicant to establish results that are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness. See MPEP § 716.02(b).
It is also important to note that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant is also reminded that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skilled in the art would have arrived at the Applicant’s invention by combining the teachings of the cited art as discussed above.
Summary
No claim is allowed.
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BRATISLAV STANKOVIC, JD, PhD
Supervisory Patent Examiner
Art Units 1661 & 1662
/BRATISLAV STANKOVIC/SPE, Art Units 1661 & 1662
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