DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Formal Matters
Applicant’s remarks and amendments filed on 13 April 2026 are acknowledged and have been fully considered. Claims 25, 30, 33, 35, and 37-52 are pending. Claims 25, 30, 33, 35, and 37-52 are under consideration in the instant office action. Claims 1-24, 26-29, 32, 34, and 36 are canceled. Applicant amended claims 25, 35, 38, and 43 by adding a similar functional or intended use limitation. Applicant’s claim amendments and arguments did not overcome the rejections under 35 USC set forth in the previous office action for reasons set forth in the previous office action and herein below.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Rejections Maintained
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 25, 30, 33, 35, and 37-52 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith et al. (WO2004/071195, previously cited) in view of Madsen et al. (US 2010/0267554, previously cited), Goswami et al. (WO99/04027, previously cited cited), and Balachander et al. (WO2010/141892, previously cited).
Applicants’ claims
Applicants claim a dry coated seed composition, method for making dry coated seeds and method of extending shelf life of seeds or seedlings.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Smith et al. teach methods and compositions used to promote seed germination, emergence, healthy root development, plant growth, disease resistance, maturity and ultimately increase tuber crop yield in agricultural commodities. The present invention also relates to seeds and seed pieces treated with the compositions and methods of the present invention. The compositions of the invention contain a polysaccharide and/or protein (see abstract). A method of increasing crop yield comprising administering a composition comprising a polysaccharide on a seed or seed piece of said crop or to a soil in which said crop is cultivated (see claim 1). The method of claim 1, 2 or 3, wherein said polysaccharide is present in an amount of 0.1-99.9% by weight of the dry weight of the total composition (see claim 12). A seed composition comprising a crop seed and coating, said coating comprising a polysaccharide (see claim 18). The composition of claim 18, wherein the crop seed is a potato piece (see claim 19). The composition of claim 18, wherein the crop seed is a grain (see claim 20). The composition of claim 20, wherein the grain is barley (see claim 21). The composition of claim 18, wherein the polysaccharide is selected from the group consisting of a cellulosic derivative, starch or a starch derivative, pectin, carrageenan, an exudate gum polysaccharide, polysaccharide derived from seed gum and alginates (see claim 22). The composition of claim 22, wherein the polysaccharide may be derived from seed gum is guar gum or locust bean gum (see claim 26). The composition of claim 18, wherein said composition further comprises limestone (see claim 27). The composition of claim 18, wherein said composition further comprises a drying agent (see claim 28). The composition 28, wherein the drying agent is fir bark (see claim 29). It is also an object of this invention to provide a coated seed or seed piece (e.g. potato) which exhibits increased germination, uniform and early emergence, healthy root mass development, disease resistance, and increased crop yield (paragraph 0010). In one embodiment, the present invention provides a method of increasing tuber crop yield. In another embodiment, the present invention provides a method for accelerating tuber crop emergence and maturity. In a further embodiment, the invention provides a seed (e.g. potato) composition comprising a crop seed and a coating composition (paragraph 0011) The polysaccharides used in the present invention are, in particular, hydrocolloid polysaccharides derived from plant, animal or microbial sources. Polysaccharides useful in the present invention include, but are not limited to, cellulosic derivatives such as carboxymethylcellulose, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, etc., starches and derivatives including, but not limited to, com starch, tapioca starch, potato starch, rice starch, wheat starch, and modified versions thereof such as pregelatinized starch, oxidized starch, ethylated starch, starch dextrins, maltodextrin, etc. Additional polysaccharides useful in the present invention include, but are not limited to, pectin, polysaccharides derived from seaweed such as agar, alginates, carrageenan, and fucellaran, exudate gum polysaccharides such as gum arabic, gum ghatti, gum karaya, and gum tragacanth, seed gums such as guar gum and locust bean gum, polysaccharides derived from microbial fermentation such as xanthan gum and gellan gum, and nitrogen containing polysaccharides such as chitosan. Polysaccharides of the type described herein produced by transgenic organisms can also be useful in the present invention. Preferred polysaccharides for use in the invention are guar gum, starch dextrins, pectin, gum arabic, celluloses, carrageenan, alginates and mixtures thereof (see paragraph 0014). In one embodiment of the invention, the seed/tuber is contacted with a composition (coating composition) comprising an effective amount of a composition composed of 1-50% A and 50-99% B as a dry powder mix. Part A is comprised of a peptide (or protein) alone or a polysaccharide alone or a combination of the peptide and polysaccharide in a ratio ranging from 99.9% peptide: 0.1% polysaccharide to '0.1% protein: 99.9% polysaccharide that is blended. Part B is comprised of additives that promote stability and functionality of the final product (paragraph 0012). Part B comprises additives that promote the stability and functionality of the final product. Preferred additives include but are not limited to solubilizing agents such as glycol, propylene glycol, or other low molecular weight alcohols; surfactancts such as alkylpolyglucosides, fatty alcohols, fatty acids, or alkylbenzenesulfonates and dispersants; emulsifiers such as lecithin or sorbitan monooleate; pH control agents such as mineral acids and their salts, organic acids and their salts, bases, both organic and inorganic; buffers such as phosphates, acetates and carbonates; anti-microbial compounds such as BHT, methyl or propylparaben, benzoic acid, sorbic acid, propionic acid and their salts; chelataing agents such as EDTA, MEA or TEA; thickeners such as glycerol; drying agents such as fir bark and other such additives generally known or apparent to those skilled in the art (paragraph 0016). The composition can be effectively used to treat seeds or seed pieces by direct application to the seeds or seed pieces before planting (paragraph 0020). The compositions can be admixed with inert agents, bulking agents, or diluent materials in order to uniformly distribute the composition onto the seed piece surface. Materials which can be used in the present invention include, but are not limited to clay, talc, limestone, quick lime, silica, hydrated silica, bentonite, salts of organic acids, organic acids, surfactants, dispersants, emulsifiers, solvents, ash, composted materials, tree bark, and mixtures thereof. When admixing these materials care should be taken to insure that the appropriate amount of dry powder mix is distributed uniformly onto the seed piece (paragraph 0021). Similarly, other functional ingredients may be added to the complex to simplify distribution of these ingredients onto the seed piece. When admixing these materials care should be taken to insure that the appropriate amount of the composition is distributed uniformly onto the seed piece (see paragraph 0022). When the composition is dissolved in aqueous or organic solution, additives may be added to the solution to promote stability of the components. Additives include, but are not limited to, solubilizing agents such as glycol, propylene glycol, or other low molecular weight alcohols; surfactants such as alkylpolyglucosides, fatty alcohols, fatty acids, or alkylbenzenesulfonates and dispersants; emulsifiers such as lecithin or sorbitan monooleate; pH control agents such as mineral acids and their salts, organic acids and their salts, bases, both organic and inorganic; buffers such as phosphates, acetates and carbonates; anti-microbial compounds such as BHT, methyl or propylparaben, benzoic acid, sorbic acid, propionic acid and their salts; chelating agents such as EDTA, MEA or TEA; and other such additives generally known or apparent to those skilled in the art (paragraph 0023). The composition can be effectively used to treat soils, plant seeds or seed pieces either by direct application to the seed or seed piece before planting or, alternatively, the composition may be added during the planting process along with the seeds or seed pieces (paragraph 0024). The present invention can be used to enhance the germination, emergence, root mass development, disease resistance, photosynthetic rate, plant growth, and crop yield of a variety of agricultural commodities including but not limited to: vegetables, such as asparagus, beans, beets, broccoli, brussels sprouts, cabbage, carrots, cauliflower, celery, chayote, com, cucumbers, eggplant, kohlrabi, okra, onions, garlic, parsnips, peas, peppers, potatoes, pumpkins, radishes, rutabagas, squash, turnips, lettuce, kale, collards, spinach, sweet potato, sugar beets, etc.; fruits, such as apples, apricots, avocados, bananas, cherries, coconuts, dates, grapes, guava, lychee, mangoes, melons, nectarines, papaya, peaches, pears, persimmons, pineapples, plantains, plums, pomegranates, prunes, stone fruit, strawberries, tomatoes, blueberries, raspberries, blackberries, and citrus fruits, such as grapefruit, oranges, lemons, limes, Clementines and tangerines (paragraph 0027). Smith et al. for instance teach PM-PG: 0.25% zein (which the examiner notes is binder); 2.75% guar gum (polysaccharide); 30% limestone (which the examiner notes is an active); 67% fir bark. Smith et al. teach a natural guar gum so it is clearly unmodified or underivatized.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Smith et al. do not teach agglomeration of the seeds in a grouping of fifty or more individual seeds together. This deficiency is cured by the teachings of Madsen et al.
Madsen et al. teach innovative methods and techniques for improving seedling germination and plant establishment within wildland and forested ecosystems, cultivated systems, urbanized areas, and areas impacted by wildfire. The invention comprises novel seed coating methods for applying wetting agents (or surfactants), tackifiers, and other beneficial soil and plant amendments, to single seeds or agglomerates composed of pellets containing multiple seeds. The invention can be used to: 1) ameliorate soil water repellency for increasing soil moisture availability; 2) bind seeds to the soil surface in order to prevent loss from wind and water erosion; 3) provide seedlings necessary leverage required for root penetration; 4) improve seedling emergence, by having several cotyledons associated with an agglomerate collectively generate sufficient force to penetrate the soil surface, with particular utility for seedlings impaired by a soil physical crust; and 5) minimize impacts from disturbance by increasing seedling stability (see abstract). The invention also contemplates agglomerates, which are two or more seeds that have been coated into a single agglomerate. Some advantages of using an agglomerate include: multiple seeds are delivered to a site, and the agglomerate also carries wetting agents and other amendments (plant or soil amendments) so that land with a hydrophobic layer can be treated. In one aspect and embodiment of the invention, the wetting agents are amphipilic and contain hydrophobe portions and hydrophile portions. The hydrophobe portions of the wetting agent allow the wetting agent to be attracted to the hydrophobic soil, and the hydrophile portions of the wetting agent facilitate the accumulation of water around the wetting agent (paragraph 0022).
Smith et al. and Madsen et al. do not teach the average molecular weight of the guar gum. This deficiency is cured by the teachings of Goswami et al.
Goswami et al. teach a polygalactomannan products, particularly guar gum products, of greatly reduced molecular weight and viscosity in aqueous solutions thereof, are produced by direct enzymatic depolymerization of polygalactomannan splits (see abstract). Goswami et al. teach a process for the production of low viscosity, low molecular weight galactomannan products by enzymatic reaction on guar splits. More particularly, this invention relates to an improved process for providing free-flowing guar gum powder of low viscosity and low molecular weight by the action of a galactomannan depolymerizing enzyme directly on guar splits. Among the various gum products used as thickeners in the food, pharmaceutical, coatings, mining, oil field, paint, textile, paper and personal care products industries, the most significant has been guar gum. Also guar gum has been recognized as a highly beneficial source of dietary fiber with beneficial effects on serum lipid levels, gastrointestinal travel time and glucose tolerance (see page 1). Guar gum is derived from the seed of the guar plant, Cvamopsis tetraσonolobus . a pod-bearing nitrogen-fixing legume. Guar gum is a source of polygalactomannan which is a polysaccharide composed primarily of galactose and mannose units. Guar gum is primarily a galactomannan which is essentially a straight chain of D-mannose with single membered D-galactose branches. The mannose units are linked in a l-4-3-glycosidic linkage with galactose branching occurring by means of a 1-6-linkage on approximately alternate mannose units. Thus, the ratio of galactose to mannose in guar polymer is about 1 to 2 (see page 1). During processing, the coat of the guar gum seed and the germ portions are generally removed by heating and mechanical separation, such as by milling, to provide guar splits having a particle size range of generally from about 4 to 20 mesh, U.S. Standard Sieve Series. The endosperm, comprising approximately 40% of the seed and being the galactomannan source, is then hydrated, ground and dried by various processes to produce a guar gum powder having a particle size of generally about 100 mesh or less, useful as a thickening agent. The final milled endosperm, used commercially as guar gum, generally contains about 5-15% moisture, 4-7% protein, less than 7% insoluble residue and about 1.0% ash (see pages 1-2). While such guar gum powders have found good success as thickening agents in the various aforementioned industries, its use in the food and pharmaceutical industries has met with rather limited success. At least one of the reasons for its limited success in the food and pharmaceutical industries derives from the fact that it provides a highly viscous solution when hydrated in cold water. Guar gum generally has a molecular weight of about 2,000,000 and the viscosity of a 1% solution will generally range from about 2000 to as high as 8000 cps (see page 2). While such guar gum powders have found good success as thickening agents in the various aforementioned industries, its use in the food and pharmaceutical industries has met with rather limited success. At least one of the reasons for its limited success in the food and pharmaceutical industries derives from the fact that it provides a highly viscous solution when hydrated in cold water. Guar gum generally has a molecular weight of about 2,000,000 and the viscosity of a 1% solution will generally range from about 2000 to as high as 8000 cps (see page 2). In accordance with the present invention, it has been discovered that polygalactomannans from guar gum can be depolymerized to provide a polygalactomannan product of low molecular weight and aqueous solutions thereof of greatly reduced viscosity in a process wherein there is a direct reaction of depolymerizing enzyme on guar splits. While the process has been discovered in connection with polygalactomannans from guar gum, it is also applicable to producing depolymerized polygalactomannans from other seed gum sources of polygalactomannans, such as, for example, locust bean, honey locust, tara and flame tree gum and the like. While the process of this invention is applicable to polygalactomannans from any suitable seed gum, for purposes of illustration, it will be described in connection with guar gum (see page 4). In accordance with the process of this invention, a galactomannan depolymerizing enzyme is employed to act directly on guar splits to depolyerize the polygalactomannan in the guar splits thereby producing a low molecular guar product capable of producing an aqueous solution thereof of greatly reduced viscosity (see page 4). The ability of galactomannase depolymerizing enzyme to react directly on guar splits to produce the product of low molecular weight, greatly reduced viscosity in aqueous solution and relatively unchanged ash content is quite surprising. It was considered necessary to first hydrate the polysaccharide of the endosperm and then reduce it to a fine powder to provide sufficient surface area of polygalactomannan for the depolymerization enzyme to be able to work effectively on the polysaccharide. It is further surprising that the reaction of the polygalactomannan depolymerizing enzyme on the guar splits does not require any increased level of enzyme despite the lower surface area of the guar splits compared to the powdered guar gums previously subjected to enzymatic reaction (see pages 4-5). The depolymerization process of this invention enables one to provide a guar gum product of significantly reduced molecular weight. The molecular weight can be reduced significantly, even up to about 99%, e.g. from about 2,000,000 for guar splits down to about 20,000, generally to a molecular weight of from about 20,000 to 1,000,000, for the depolymerized product. The depolymerization process of this invention also enables one to provide a guar gum product having a greatly reduced viscosity in aqueous solution, e.g. reduced to a viscosity of about 2,000 cps or less, and could even be reduced to a viscosity of about the viscosity of water, i.e. to a viscosity of about 1 cp or less for a 1% aqueous solution measured at room temperature (see page 5). The products of this invention can be employed in any use where guar gum of reduced molecular weight and viscosity are desired, particularly in oil field, personal care, food and pharmaceutical uses. In food applications, these products could be used as a source of dietary fiber, products for the reduction of blood cholesterol and products for controlling glucose absorption (see page 7).
Smith et al. and Madsen et al., and Goswami et al. do not teach wherein the dry seed coating composition is of uniform size with a diameter ranging from 300 micrometers to 4 millimeters as recited in claims 35, 46, and 50-51. This deficiency is cured by the teachings of Balachander et al.
Balachander et al. teach compositions for delivering agricultural active ingredients, for example for coating seeds. The active ingredient is associated with a crystalline carrier, for example a crystalline polymer. Optionally, the composition includes an amphiphilic additive, which influences the characteristics of the crystalline polymer and the delivery will of the active ingredient (see abstract). The CYC carriers used in the present invention are useful in compositions for agricultural and agricultural applications. The compositions can, for example, contain (in addition to the CYC carrier) any of the numerous bioactive materials which are known to be useful in agricultural and agricultural applications. Such bioactive materials include, but are not limited to, fertilizers, pesticides, insecticides, herbicides and fungicides. Specific examples of bioactive materials include Thiram, Fludioxaonil, Captan, Rival, and Apron and insecticides such as imidacloprid, chlothianidin, dinotefuran and thiomethoxam (see pages 10-11). The release compositions of the invention can be used to treat a wide variety of substrates, including for example seeds and soil. The release compositions of the invention can include other polymeric carriers (see page 11). Agricultural compositions can optionally also have one or more of the following features.
(a) The composition can contain a compound containing a long chain n-alkyl component which will "self assemble" with the biodegradable CYC polymer or other CYC carrier. Such components include for example fatty acids, fatty alcohols, modified PEG'S, n-alkylamine ethoxylates, and derivatives of a polyhydroxy compound, e.g. sorbitol, which have been obtained by esterifying, alkylating or otherwise modifying the compound with a suitable compound containing an n-alkyl group containing at least 14, preferably 18-30 or 18-22 carbon atoms, for example a carboxylic acid or acid derivative or alcohol containing such an n-alkyl group.
(b) The composition can contain, in addition to the CYC biodegradable polymer or other CYC carrier, one or more other synthetic or naturally occurring biodegradable polymers, e.g. PLGA, poly(ethylene oxide), polypropylene oxide, polyvinyl alcohol), polyurethane, collagen, gelatin, chitosan or sugar, and/or one or more other polymers which are not biodegradable, e.g. the SCC polymers already known for use as a oil thickeners.
(c) The composition can contain additives, which may be inorganic or organic, e.g. kaolin, talc, magnesium trisilicate, and various derivatives of cellulose. Agricultural compositions of the invention can be of any type, including those disclosed in the patents and patent applications incorporated by reference herein (see page 12).
Another form is a dispersion, an emulsion or a suspension in which particles comprising the release material and the CYC carrier are uniformly distributed in an aqueous medium.
In some embodiments, the release composition comprises a colloidal dispersion of particles having a size of 1 nm to 0.5 mm. Such a dispersion can be produced by mixing or sonication or homogenization of an aqueous mixture of the release material and polymer matrix in the presence of a surfactant. The release material and/or the CYC carrier may be dissolved in a solvent which evaporates during the sonication or homogenization process. This process can lead to microparticles having a size of from 0.1 to 1000 microns. These colloidal and emulsion mixtures may be suitable for a variety of applications. The release material may influence the processing conditions. For example, some release materials are likely to be adversely affected by conventional emulsification used for microsphere production (see page 19). In one method for making compositions comprising a CYC carrier and a release material, the CYC carrier is melted, and the release material is mixed with the CYC carrier, the mixing being carried out at a temperature which is above the To, usually above the Tp, of the CYC carrier. During such mixing, other desired ingredients, e.g. fillers, excipients, dyes, colorings, flavors, disintegrators, stabilizers, can be added. The mixing can optionally be carried out in the presence of another material which is liquid at the mixing temperature and which is not a CYC carrier. This method can result in a uniform mixture which can, if desired, be suspended above the melting point of the mixture in a non-solvent, thus producing, upon cooling, solidification of the release composition as particles. The particles can be washed and filtered, and, for example, suspended in a liquid carrier. In another embodiment, in which no solvent is preferably used, the molten mixture, or the solidified mass obtained by cooling the molten mixture, can be processed into desired shapes, e.g. into rods, ovals, and tablets, using known procedures. In another embodiment, the CYC carrier and the release material are mixed into a homogeneous solution in a suitable solvent, the solution evaporated to dryness, followed by milling of the resulting solids of the required particle size (see page 20). An agricultural composition according to claim 1 wherein the agricultural material is a fungicide, pesticide, insecticide, fertilizer or plant hormone (see claim 2). An agricultural composition according to claim 1 which is in the form of a coating on a seed (see claim 3).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art at the time the present invention was made to modify the teachings of Smith et al. wherein agglomeration being a grouping of fifty or more individual seeds together because Madsen et al. teach innovative methods and techniques for improving seedling germination and plant establishment within wildland and forested ecosystems, cultivated systems, urbanized areas, and areas impacted by wildfire. The invention comprises novel seed coating methods for applying wetting agents (or surfactants), tackifiers, and other beneficial soil and plant amendments, to single seeds or agglomerates composed of pellets containing multiple seeds. The invention can be used to: 1) ameliorate soil water repellency for increasing soil moisture availability; 2) bind seeds to the soil surface in order to prevent loss from wind and water erosion; 3) provide seedlings necessary leverage required for root penetration; 4) improve seedling emergence, by having several cotyledons associated with an agglomerate collectively generate sufficient force to penetrate the soil surface, with particular utility for seedlings impaired by a soil physical crust; and 5) minimize impacts from disturbance by increasing seedling stability (see abstract). One of ordinary skill in the art would have been motivated to do so because Madsen et al. teach the invention also contemplates agglomerates, which are two or more seeds that have been coated into a single agglomerate. Some advantages of using an agglomerate include: multiple seeds are delivered to a site, and the agglomerate also carries wetting agents and other amendments (plant or soil amendments) so that land with a hydrophobic layer can be treated. In one aspect and embodiment of the invention, the wetting agents are amphipilic and contain hydrophobe portions and hydrophile portions. The hydrophobe portions of the wetting agent allow the wetting agent to be attracted to the hydrophobic soil, and the hydrophile portions of the wetting agent facilitate the accumulation of water around the wetting agent (paragraph 0022). One of ordinary skill in the art would have had a reasonable chance of success in combining the teachings of Smith et al. and Madsen et al. because all of the references are drawn to compositions for coating seeds. As the examiner previously indicated any property limitation would necessarily be there as the combination teachings of Smith et al. and Madsen et al. met the claimed structure. With regard to the number of seeds or seedlings to be coated where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, generally differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is within the purview of the skilled artisan to optimize the number of seeds and seedlings to be coated.
It would have been prima facie obvious to a person of ordinary skill in the art at the time the present invention was made to modify the teachings of Smith et al. and Madsen et al. by utilizing the guar gum with average molecular weights as recited because Goswami et al. teach a polygalactomannan products, particularly guar gum products, of greatly reduced molecular weight and viscosity in aqueous solutions thereof, are produced by direct enzymatic depolymerization of polygalactomannan splits (see abstract). Goswami et al. teach a process for the production of low viscosity, low molecular weight galactomannan products by enzymatic reaction on guar splits. More particularly, this invention relates to an improved process for providing free-flowing guar gum powder of low viscosity and low molecular weight by the action of a galactomannan depolymerizing enzyme directly on guar splits. Among the various gum products used as thickeners in the food, pharmaceutical, coatings, mining, oil field, paint, textile, paper and personal care products industries, the most significant has been guar gum. Also guar gum has been recognized as a highly beneficial source of dietary fiber with beneficial effects on serum lipid levels, gastrointestinal travel time and glucose tolerance (see page 1). Guar gum is derived from the seed of the guar plant, Cvamopsis tetraσonolobus . a pod-bearing nitrogen-fixing legume. Guar gum is a source of polygalactomannan which is a polysaccharide composed primarily of galactose and mannose units. Guar gum is primarily a galactomannan which is essentially a straight chain of D-mannose with single membered D-galactose branches. The mannose units are linked in a l-4-3-glycosidic linkage with galactose branching occurring by means of a 1-6-linkage on approximately alternate mannose units. Thus, the ratio of galactose to mannose in guar polymer is about 1 to 2 (see page 1). During processing, the coat of the guar gum seed and the germ portions are generally removed by heating and mechanical separation, such as by milling, to provide guar splits having a particle size range of generally from about 4 to 20 mesh, U.S. Standard Sieve Series. The endosperm, comprising approximately 40% of the seed and being the galactomannan source, is then hydrated, ground and dried by various processes to produce a guar gum powder having a particle size of generally about 100 mesh or less, useful as a thickening agent. The final milled endosperm, used commercially as guar gum, generally contains about 5-15% moisture, 4-7% protein, less than 7% insoluble residue and about 1.0% ash (see pages 1-2). One of ordinary skill in the art would have been motivated to utilize guar gum with lower average molecular weights because Goswami et al. teach that while such guar gum powders have found good success as thickening agents in the various aforementioned industries, its use in the food and pharmaceutical industries has met with rather limited success. At least one of the reasons for its limited success in the food and pharmaceutical industries derives from the fact that it provides a highly viscous solution when hydrated in cold water. Guar gum generally has a molecular weight of about 2,000,000 and the viscosity of a 1% solution will generally range from about 2000 to as high as 8000 cps (see page 2). In accordance with the present invention, it has been discovered that polygalactomannans from guar gum can be depolymerized to provide a polygalactomannan product of low molecular weight and aqueous solutions thereof of greatly reduced viscosity in a process wherein there is a direct reaction of depolymerizing enzyme on guar splits. While the process has been discovered in connection with polygalactomannans from guar gum, it is also applicable to producing depolymerized polygalactomannans from other seed gum sources of polygalactomannans, such as, for example, locust bean, honey locust, tara and flame tree gum and the like. While the process of this invention is applicable to polygalactomannans from any suitable seed gum, for purposes of illustration, it will be described in connection with guar gum (see page 4). In accordance with the process of this invention, a galactomannan depolymerizing enzyme is employed to act directly on guar splits to depolyerize the polygalactomannan in the guar splits thereby producing a low molecular guar product capable of producing an aqueous solution thereof of greatly reduced viscosity (see page 4). The ability of galactomannase depolymerizing enzyme to react directly on guar splits to produce the product of low molecular weight, greatly reduced viscosity in aqueous solution and relatively unchanged ash content is quite surprising. It was considered necessary to first hydrate the polysaccharide of the endosperm and then reduce it to a fine powder to provide sufficient surface area of polygalactomannan for the depolymerization enzyme to be able to work effectively on the polysaccharide. It is further surprising that the reaction of the polygalactomannan depolymerizing enzyme on the guar splits does not require any increased level of enzyme despite the lower surface area of the guar splits compared to the powdered guar gums previously subjected to enzymatic reaction (see pages 4-5). The depolymerization process of this invention enables one to provide a guar gum product of significantly reduced molecular weight. The molecular weight can be reduced significantly, even up to about 99%, e.g. from about 2,000,000 for guar splits down to about 20,000, generally to a molecular weight of from about 20,000 to 1,000,000, for the depolymerized product. The depolymerization process of this invention also enables one to provide a guar gum product having a greatly reduced viscosity in aqueous solution, e.g. reduced to a viscosity of about 2,000 cps or less, and could even be reduced to a viscosity of about the viscosity of water, i.e. to a viscosity of about 1 cp or less for a 1% aqueous solution measured at room temperature (see page 5). The products of this invention can be employed in any use where guar gum of reduced molecular weight and viscosity are desired, particularly in oil field, personal care, food and pharmaceutical uses. In food applications, these products could be used as a source of dietary fiber, products for the reduction of blood cholesterol and products for controlling glucose absorption (see page 7). Furthermore, when the claimed ranges of average molecular weight of guar gum “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, generally differences in concentration or molecular weight will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is within the purview of the skilled artisan to optimize the molecular weight of the polymer. One of ordinary skill in the art would have had a reasonable chance of expectation of success in combining Smith et al. and Madsen et al., and Goswami et al. because both references teach a coating composition.
It would have been prima facie obvious to a person of ordinary skill in the art at the time the present invention was made to modify the teachings of Smith et al., Madsen et al., and Goswami et al. by including coating composition with average particle sizes as recited in claims 35, 46, 50-51 because Balachander et al. teach compositions for delivering agricultural active ingredients, for example for coating seeds. The active ingredient is associated with a crystalline carrier, for example a crystalline polymer. Optionally, the composition includes an amphiphilic additive, which influences the characteristics of the crystalline polymer and the delivery will of the active ingredient (see abstract). The CYC carriers used in the present invention are useful in compositions for agricultural and agricultural applications. The compositions can, for example, contain (in addition to the CYC carrier) any of the numerous bioactive materials which are known to be useful in agricultural and agricultural applications. Such bioactive materials include, but are not limited to, fertilizers, pesticides, insecticides, herbicides and fungicides. Specific examples of bioactive materials include Thiram, Fludioxaonil, Captan, Rival, and Apron and insecticides such as imidacloprid, chlothianidin, dinotefuran and thiomethoxam (see pages 10-11). The release compositions of the invention can be used to treat a wide variety of substrates, including for example seeds and soil. The release compositions of the invention can include other polymeric carriers (see page 11). Agricultural compositions can optionally also have one or more of the following features. (a) The composition can contain a compound containing a long chain n-alkyl component which will "self assemble" with the biodegradable CYC polymer or other CYC carrier. Such components include for example fatty acids, fatty alcohols, modified PEG'S, n-alkylamine ethoxylates, and derivatives of a polyhydroxy compound, e.g. sorbitol, which have been obtained by esterifying, alkylating or otherwise modifying the compound with a suitable compound containing an n-alkyl group containing at least 14, preferably 18-30 or 18-22 carbon atoms, for example a carboxylic acid or acid derivative or alcohol containing such an n-alkyl group. (b) The composition can contain, in addition to the CYC biodegradable polymer or other CYC carrier, one or more other synthetic or naturally occurring biodegradable polymers, e.g. PLGA, poly(ethylene oxide), polypropylene oxide, polyvinyl alcohol), polyurethane, collagen, gelatin, chitosan or sugar, and/or one or more other polymers which are not biodegradable, e.g. the SCC polymers already known for use as a oil thickeners. (c) The composition can contain additives, which may be inorganic or organic, e.g. kaolin, talc, magnesium trisilicate, and various derivatives of cellulose. Agricultural compositions of the invention can be of any type, including those disclosed in the patents and patent applications incorporated by reference herein (see page 12). Another form is a dispersion, an emulsion or a suspension in which particles comprising the release material and the CYC carrier are uniformly distributed in an aqueous medium. One of ordinary skill in the art would have been motivated to do so because Balachander et al. teach that in some embodiments, the release composition comprises a colloidal dispersion of particles having a size of 1 nm to 0.5 mm. Such a dispersion can be produced by mixing or sonication or homogenization of an aqueous mixture of the release material and polymer matrix in the presence of a surfactant. The release material and/or the CYC carrier may be dissolved in a solvent which evaporates during the sonication or homogenization process. This process can lead to microparticles having a size of from 0.1 to 1000 microns. These colloidal and emulsion mixtures may be suitable for a variety of applications. The release material may influence the processing conditions. For example, some release materials are likely to be adversely affected by conventional emulsification used for microsphere production (see page 19). In one method for making compositions comprising a CYC carrier and a release material, the CYC carrier is melted, and the release material is mixed with the CYC carrier, the mixing being carried out at a temperature which is above the To, usually above the Tp, of the CYC carrier. During such mixing, other desired ingredients, e.g. fillers, excipients, dyes, colorings, flavors, disintegrators, stabilizers, can be added. The mixing can optionally be carried out in the presence of another material which is liquid at the mixing temperature and which is not a CYC carrier. This method can result in a uniform mixture which can, if desired, be suspended above the melting point of the mixture in a non-solvent, thus producing, upon cooling, solidification of the release composition as particles. The particles can be washed and filtered, and, for example, suspended in a liquid carrier. In another embodiment, in which no solvent is preferably used, the molten mixture, or the solidified mass obtained by cooling the molten mixture, can be processed into desired shapes, e.g. into rods, ovals, and tablets, using known procedures. In another embodiment, the CYC carrier and the release material are mixed into a homogeneous solution in a suitable solvent, the solution evaporated to dryness, followed by milling of the resulting solids of the required particle size (see page 20). An agricultural composition according to claim 1 wherein the agricultural material is a fungicide, pesticide, insecticide, fertilizer or plant hormone (see claim 2). An agricultural composition according to claim 1 which is in the form of a coating on a seed (see claim 3). The examiner notes that Balachander et al. particles composition is used for coating seeds. Furthermore, when the claimed ranges of average diameter of the composition “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, generally differences in concentration or molecular weight will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). It is within the purview of the skilled artisan to optimize the particle size of the coating composition. One of ordinary skill in the art would have had a reasonable chance of expectation of success in combining Smith et al., Madsen et al., Goswami et al., and Balachander et al. because all of the references teach a coating composition.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 13 April 2026 have been fully considered but they are not persuasive.
Applicant argues independent claims 25, 35, 38 and 43 are amended to recite that upon placement of the dry coated seed composition in soil, the underivatized guars promote wetting of the soil surrounding the dry coated seed compositions. These aspects are not taught or suggested by the prior art. Smith does not teach or suggest wetting or wetting agents nor wetting in association with underivatized guars. Rather, Smith's guars are mentioned among several different polysaccharide additives across different classes of compounds and are taught to promote stability and functionality of the final product (dry powder mix). Additionally, Smith teaches that their invention can be used to enhance germination, emergence, root mass development, disease resistance, photosynthetic rate, plant growth, and crop yield of a variety of agricultural commodities. See Smith para. [0028]. The final product of Smith may be applied to soil, but there is no teaching about wetting the soil, particularly with the guar, nor any recognition that the guar or any of Smith's polysaccharides, may be capable of wetting the soil through water absorption or water retention. As such, a person of ordinary skill in the art would not have reasonably expected for specifically the underivatized guar to act as a wetting agent for the instantly claimed dry coating seed compositions. Additionally, Madsen, while cited for teaching wetting agents in single seeds and agglomerates to treat hydrophobic soil (or increase moisture in nonhydrophobic soils), also does not suggest that guars are suitable wetting agents. Applicant further argues the newly cited Goswami and Balachander also do not teach the newly amended intended use limitations.
The above assertions are not found persuasive because first the examiner reminds Applicant that the claims are drawn to a composition of matter not a method of use. The intended functions are the result of the innate or inherent property of the composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The examiner also reminds Applicant that the rejection was made based on the combination teachings of the references. In response to applicant's arguments against the references individually, 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). The combination teachings of the references do meet the inclusion of guar gum and a proper motivation was provided to combine the references. Smith et al. clearly teach the inclusion of guar gum in the composition. Smith et al. teach methods and compositions used to promote seed germination, emergence, healthy root development, plant growth, disease resistance, maturity and ultimately increase tuber crop yield in agricultural commodities. The present invention also relates to seeds and seed pieces treated with the compositions and methods of the present invention. The compositions of the invention contain a polysaccharide and/or protein (see abstract). A method of increasing crop yield comprising administering a composition comprising a polysaccharide on a seed or seed piece of said crop or to a soil in which said crop is cultivated (see claim 1). The method of claim 1, 2 or 3, wherein said polysaccharide is present in an amount of 0.1-99.9% by weight of the dry weight of the total composition (see claim 12). A seed composition comprising a crop seed and coating, said coating comprising a polysaccharide (see claim 18). The composition of claim 18, wherein the crop seed is a potato piece (see claim 19). The composition of claim 18, wherein the crop seed is a grain (see claim 20). The composition of claim 20, wherein the grain is barley (see claim 21). The composition of claim 18, wherein the polysaccharide is selected from the group consisting of a cellulosic derivative, starch or a starch derivative, pectin, carrageenan, an exudate gum polysaccharide, polysaccharide derived from seed gum and alginates (see claim 22). The composition of claim 22, wherein the polysaccharide may be derived from seed gum is guar gum or locust bean gum (see claim 26). The composition of claim 18, wherein said composition further comprises limestone (see claim 27). The composition of claim 18, wherein said composition further comprises a drying agent (see claim 28). The composition 28, wherein the drying agent is fir bark (see claim 29). It is also an object of this invention to provide a coated seed or seed piece (e.g. potato) which exhibits increased germination, uniform and early emergence, healthy root mass development, disease resistance, and increased crop yield (paragraph 0010). In one embodiment, the present invention provides a method of increasing tuber crop yield. In another embodiment, the present invention provides a method for accelerating tuber crop emergence and maturity. In a further embodiment, the invention provides a seed (e.g. potato) composition comprising a crop seed and a coating composition (paragraph 0011) The polysaccharides used in the present invention are, in particular, hydrocolloid polysaccharides derived from plant, animal or microbial sources. Polysaccharides useful in the present invention include, but are not limited to, cellulosic derivatives such as carboxymethylcellulose, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, etc., starches and derivatives including, but not limited to, com starch, tapioca starch, potato starch, rice starch, wheat starch, and modified versions thereof such as pregelatinized starch, oxidized starch, ethylated starch, starch dextrins, maltodextrin, etc. Additional polysaccharides useful in the present invention include, but are not limited to, pectin, polysaccharides derived from seaweed such as agar, alginates, carrageenan, and fucellaran, exudate gum polysaccharides such as gum arabic, gum ghatti, gum karaya, and gum tragacanth, seed gums such as guar gum and locust bean gum, polysaccharides derived from microbial fermentation such as xanthan gum and gellan gum, and nitrogen containing polysaccharides such as chitosan. Polysaccharides of the type described herein produced by transgenic organisms can also be useful in the present invention. Preferred polysaccharides for use in the invention are guar gum, starch dextrins, pectin, gum arabic, celluloses, carrageenan, alginates and mixtures thereof (see paragraph 0014). In one embodiment of the invention, the seed/tuber is contacted with a composition (coating composition) comprising an effective amount of a composition composed of 1-50% A and 50-99% B as a dry powder mix. Part A is comprised of a peptide (or protein) alone or a polysaccharide alone or a combination of the peptide and polysaccharide in a ratio ranging from 99.9% peptide: 0.1% polysaccharide to '0.1% protein: 99.9% polysaccharide that is blended. Part B is comprised of additives that promote stability and functionality of the final product (paragraph 0012). Part B comprises additives that promote the stability and functionality of the final product. Preferred additives include but are not limited to solubilizing agents such as glycol, propylene glycol, or other low molecular weight alcohols; surfactancts such as alkylpolyglucosides, fatty alcohols, fatty acids, or alkylbenzenesulfonates and dispersants; emulsifiers such as lecithin or sorbitan monooleate; pH control agents such as mineral acids and their salts, organic acids and their salts, bases, both organic and inorganic; buffers such as phosphates, acetates and carbonates; anti-microbial compounds such as BHT, methyl or propylparaben, benzoic acid, sorbic acid, propionic acid and their salts; chelataing agents such as EDTA, MEA or TEA; thickeners such as glycerol; drying agents such as fir bark and other such additives generally known or apparent to those skilled in the art (paragraph 0016). The composition can be effectively used to treat seeds or seed pieces by direct application to the seeds or seed pieces before planting (paragraph 0020). The compositions can be admixed with inert agents, bulking agents, or diluent materials in order to uniformly distribute the composition onto the seed piece surface. Materials which can be used in the present invention include, but are not limited to clay, talc, limestone, quick lime, silica, hydrated silica, bentonite, salts of organic acids, organic acids, surfactants, dispersants, emulsifiers, solvents, ash, composted materials, tree bark, and mixtures thereof. When admixing these materials care should be taken to insure that the appropriate amount of dry powder mix is distributed uniformly onto the seed piece (paragraph 0021). Similarly, other functional ingredients may be added to the complex to simplify distribution of these ingredients onto the seed piece. When admixing these materials care should be taken to insure that the appropriate amount of the composition is distributed uniformly onto the seed piece (see paragraph 0022). When the composition is dissolved in aqueous or organic solution, additives may be added to the solution to promote stability of the components. Additives include, but are not limited to, solubilizing agents such as glycol, propylene glycol, or other low molecular weight alcohols; surfactants such as alkylpolyglucosides, fatty alcohols, fatty acids, or alkylbenzenesulfonates and dispersants; emulsifiers such as lecithin or sorbitan monooleate; pH control agents such as mineral acids and their salts, organic acids and their salts, bases, both organic and inorganic; buffers such as phosphates, acetates and carbonates; anti-microbial compounds such as BHT, methyl or propylparaben, benzoic acid, sorbic acid, propionic acid and their salts; chelating agents such as EDTA, MEA or TEA; and other such additives generally known or apparent to those skilled in the art (paragraph 0023). The composition can be effectively used to treat soils, plant seeds or seed pieces either by direct application to the seed or seed piece before planting or, alternatively, the composition may be added during the planting process along with the seeds or seed pieces (paragraph 0024). The present invention can be used to enhance the germination, emergence, root mass development, disease resistance, photosynthetic rate, plant growth, and crop yield of a variety of agricultural commodities including but not limited to: vegetables, such as asparagus, beans, beets, broccoli, brussels sprouts, cabbage, carrots, cauliflower, celery, chayote, com, cucumbers, eggplant, kohlrabi, okra, onions, garlic, parsnips, peas, peppers, potatoes, pumpkins, radishes, rutabagas, squash, turnips, lettuce, kale, collards, spinach, sweet potato, sugar beets, etc.; fruits, such as apples, apricots, avocados, bananas, cherries, coconuts, dates, grapes, guava, lychee, mangoes, melons, nectarines, papaya, peaches, pears, persimmons, pineapples, plantains, plums, pomegranates, prunes, stone fruit, strawberries, tomatoes, blueberries, raspberries, blackberries, and citrus fruits, such as grapefruit, oranges, lemons, limes, Clementines and tangerines (paragraph 0027). Smith et al. for instance teach PM-PG: 0.25% zein (which the examiner notes is binder); 2.75% guar gum (polysaccharide); 30% limestone (which the examiner notes is an active); 67% fir bark. Smith et al. teach a natural guar gum so it is clearly unmodified or underivatized. The newly amended limitation recited in the claims is an innate or inherent property of the guar gum as a compound or a composition and its properties are inseparable absent evidence to the contrary.
Applicant clearly asserted that the newly recited functional property is caused by the undervatized guar gum. Smith et al. met the inclusion of underivatized guar gum as shown above. In the instant case, the examiner makes the position that regarding the newly recited functional properties, inherency renders the claimed functional properties obvious since the limitation is "necessarily present”.
Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195 . Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531 , 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511 -96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 , 1369 (Fed. Cir. 2012) (relying on inherency where the claims recited "a property that is necessarily present" in the prior art). "If . . . the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient" to render the function inherent. Oelrich, 666 F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d 212 , 214 , 26 C.C.P.A. 937 , 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939)). On appeal, Persion contends that the district court erred in applying the inherency doctrine in its obviousness analysis because Devane does not teach administering its hydrocodone-only formulation to patients with mild or moderate hepatic impairment. Thus, Persion asserts, "'the natural result flowing from the operation as taught' in Devane cannot be the claimed [pharmacokinetic] values for [hepatically impaired] patients." Appellant's Br. 37 (quoting Oelrich, 666 F.2d at 581 ); Reply Br. 19. To the extent Persion contends that inherency can only satisfy a claim limitation when all other limitations are taught in a single reference, that position is contrary to our prior recognition that "inherency may supply a missing claim limitation in an obviousness analysis" where the limitation at issue is "the natural result of the combination of prior art elements." PAR, 773 F.3d at 1194-1195 (emphasis added, internal quotations omitted). Here, the district court specifically found that Devane, together with Jain, the state of the prior art at the time of invention, and the Vicodin and Lortab labels, taught the combination of elements that inherently result in the claimed pharmacokinetic parameters. The district court found that a person of ordinary skill in the art would have been motivated, with reasonable expectation of success, to administer an unadjusted dose of the Devane formulation to hepatically impaired patients. There was also no dispute that the Devane formulation, which was identical to the Zohydro ER formulation described in the patents in suit, necessarily exhibited the claimed parameters under these conditions. Pernix, 323 F. Supp. 3d at 607 , 610 . In this context, the district court did not err by finding that the pharmacokinetic limitations of the asserted claims were inherent and added no patentable weight to the pharmacokinetic claims.
Conclusion
No claims are 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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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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