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 .
Formal Matters
This office action is issued in response to the claim set filed on April 23, 2024. Claims 21-40 are pending. Claims 21-40 are under consideration in the instant office action. Claims 1-20 are canceled.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in AUSTRALIA 2021902391 on August 03, 2021. It is noted, however, that applicant has not filed a certified copy of the AUSTRALIA 2021902391 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDSs) submitted on November 01, 2024, July 21, 2025, and November 06, 2025 are noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the information disclosure statement. Signed copies are attached herein.
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “STABILISED COMPOSITIONS”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not describe the main purpose of the invention. It is generically applicable to any stabilized compositions. Applicant must reflect their invention in brief in the title with respect to the main active ingredient specifically regarding the halocarbon. Furthermore, the term “STABILISED” should be written as “STABILIZED”. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21, 28, and 38 are rejected 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.
The term “substantially” in claim 21 line 14, is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase “substantially stable ”does not provide a clear standard by which one of ordinary skill in the art could determine whether a given composition falls within or outside the scope of the claim. The claim fails to specify what degree of change, period of time, storage or use conditions, or measurement method constitutes “substantially stable”. Without objective boundaries or a defined reference condition, the metes and bounds of the claim cannot be determined with reasonable certainty.
In claim 28, the clause “wherein the edible composition comprises stabilized halocarbon in rumen of the ruminant and is a slow-release solid composition.” is vague and ambiguous because it fails to clearly define the physical state or location of the claimed composition. It is unclear whether the claim intends to define the composition as administered (before ingestion) or the composition as it exists inside the rumen after ingestion and possible transformation (e.g., swelling, dissolution, release of the halocarbon. As written, the limitation mixes a structural limitation (“is a slow-release solid composition”) with a functional or situational limitation (“comprises the stabilized halocarbon in rumen of the ruminant”) in a way that renders the claim’s scope uncertain.
In claim 38, the clause “further comprising spray drying the encapsulated combined halocarbon and stabilizing agent.” is vague and ambiguous because one of ordinary skill in the art cannot ascertain the meaning of “the encapsulated combined” in the phrase. It is unclear whether the claim intends to define by reciting “further comprising spray drying the encapsulated halocarbon and stabilizing agent”. As written, the limitation mixes a two verbs “encapsulated” and ‘combined” rendering the claim’s scope uncertain.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21-25, 28-33, 36-38, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balouch et al. (Mol. Syst. Des. Eng., 2021, 6, 368, published on February 08, 2021).
Balouch et al. disclose liposomal formulations can be advantageous in many scenarios such as targeted delivery to reduce the systemic toxicity of highly potent active pharmaceutical ingredients (APIs), to increase drug bioavailability by prolonging systemic circulation, to protect labile APIs from degradation in the gastrointestinal tract, or to improve skin permeation in dermal delivery. However, not all APIs are suitable for encapsulation in liposomes. Some of the issues are too high permeability of the API across the lipid bilayer, which may lead to premature leakage, too low permeability, which may hinder the drug release process, or too strong membrane affinity, which may reduce the overall efficacy of drug release from liposomes. Since the most reliable way to test API encapsulation and release from liposomes so far has been experimental, an in silico model capable of predicting API transport across the lipid bilayer might accelerate formulation development. In this work, we demonstrate a new in silico approach to compute the temperature-dependent permeability of a set of compounds across the bilayer of virtual liposomes constructed by molecular dynamics simulation. To validate this approach, we have conducted a series of experiments confirming the model predictions using a homologous series of fluorescent dyes. Based on the performance of individual molecules, we have defined a set of selection criteria for identifying compatible APIs for stable encapsulation and thermally controlled release from liposomes (see abstract). In order to test this set of rules, a total of 56 toxic compounds from the DrugBank database were chosen, and their log K_lip/wat and log Perm values were computed. The substances had a broad category of chemical actions, including the potentially harmful or deadly effect on living organisms. Since toxicity means bioactivity, such substances – even though harmful on their own – are potential candidates for applications in human or veterinary medicine, disinfection, crop protection, etc. Encapsulation into liposomes followed by controlled release could be a way how to apply such substances safely at the appropriate dose. After applying the classification criteria (Fig. 6A) to all 56 evaluated molecules, the following groups were obtained: 27 substances were suitable for membrane-bound liposome encapsulation due to their high partition coefficient (yellow dots in Fig. 6B): anacetrapib, amitraz, dalcetrapib, chlorotoxin I-131, calyculin A, deltamethrin, cyfluthrin, cypermethrin, altretamine, bempedoicacid, cerivastatin, benfluorex, coumaphos, atorvastatin, acifluorfen, bisphenol A, benzyl benzoate, clofibrate, 1,2-dichlorobenzene, ciprofibrate, crotamiton, bromoform, bezafibrate, 9H-carbazole, dantron and chlorambucil (see page 378). The bromoform meets the requirements of (i)-(iv) in claims 21, 31, and 36. Model of a membrane mixture containing premixed 1,2-dipalmitoyl-snglycero-3-phosphocholine (DPPC) : 1,2-dipalmitoyl-sn-glycero-3-phosphoglycerol (DPPG): cholesterol (Chol) at a molar ratio of 75 : 10 : 15 was created using an in-house script with a total number of 128 lipids (64 lipids per leaflet) (the examiner notes that these agents meet the requirement of a stabilizing agent listed in claim 25) (see page 369). With regard to the limitation of claim 23 reciting “wherein the stabilizing agent reduces volatility of the stabilized halocarbon compound in the edible composition as compared to the volatility of an isolated halocarbon.” and also the pharmacokinetic and stability limitations recited in claims 28-29, and 32-33, since Balouch et al. disclose the same stabilizing agents the same as those recited in claim 25, the stabilizing agents of Balouch et al. inherently reduces volatility of the stabilized halocarbon compound in the edible composition as compared to the volatility of an isolated halocarbon. Balouch et al. disclose identical structure as the claimed structures of claim 21 and 31. Therefore, the pharmacokinetic and storage stability data would be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."). Liposomes were prepared using the Bangham method. Briefly: 10 mg of lipid and cholesterol mixture was dissolved in 2 mL of chloroform : methanol mixture (2 : 1) in a 25 mL round flask. The mixture was evaporated in a rotary evaporator at a constant temperature of 55 °C and gradually lowering pressure from atmospheric to 150 mbar. The dried lipids formed a film around the flask. The sample was then kept under vacuum for at least 12 hours. For further rehydration, 2 mL of a hydration phosphate buffer solution containing the substance to be encapsulated was added to the flask (the compounds and their concentrations are listed in Table 1). The flask's content was then heated and stirred using a vortex shaker until no visible lipid film pieces were present on the flask walls. 1 mL of the obtained lipid suspension was then transferred to a liposome extrusion device (Avanti Polar Lipids), heated to 69 °C and extruded through a porous membrane with 800 nm pores 21 times to decrease and unify the size of the formed liposomes. The size distribution of the prepared liposomes was measured using the Malvern Zetasizer. The liposomes were also visualized using transmission electron microscopy (TEM, Jeol JEM-1010, acceleration voltage 80 kV) (page 370-371). Balouch et al. disclose the properties of liposomes can be tailored to specific delivery and release mechanisms. Among the most critical parameters affecting the storage stability and the final application properties of liposomes are the bilayer composition, lamellarity and size. These parameters can be influenced by the liposome preparation method, which typically involves the dissolution of lipids in an organic solvent and subsequent dispersion into aqueous media with or without relying on membrane permeation of the encapsulated solute. The solute permeation mechanism at the point of use can include spontaneous loss of lipid bilayer integrity upon interaction with living cells or an externally triggered event such as local hyperthermia. Depending on its composition, the lipid bilayer has a phase transition temperature at which it changes from a highly ordered into a disordered state where it becomes significantly more permeable for the encapsulated solutes. This transition between states is usually reversible, and can be triggered by incorporated magnetic nanoparticles stimulated by an external magnetic field. This offers interesting possibilities for customized controlled release scenarios, e.g. in theranostics (page 369). The most promising substance identified by the in silico model from a sample of 56 entries in the DrugBank database (cycloserine) was encapsulated into liposomes as described in section 2.2. The stability of liposomes at storage temperature and the ability to release the substance above the lipid bilayer's phase transition temperature was demonstrated by measuring the proliferation of bacteria E.coli using the resazurin assay. The bacteria suspension was grown overnight in LB media at 37 °C, shaken at 200 rpm. The inoculate was diluted to the appropriate cell density (OD = 0.06) and seeded on 96-well plates. The assay composed of a row of samples exposed to liposomes before release, liposomes after heat release (60 °C for 30 minutes), liposomes after membrane disruption by TRITON® as a positive control, and a row of bacteria with an added antibiotic (50 μg mL−1 kanamycin) as a further positive control. Each well was filled with 100 μl of the sample (liposomes loaded with 10 mg mL−1 cycloserine, repeatedly diluted and centrifugated). Then, 20 μl of diluted bacterial suspension was added into all wells and mixed thoroughly. Samples after release and antibiotics were performed in triplicates. Sample before the release in duplicates of both samples, which were later used for release. After overnight incubation at 37 °C, 20 μL resazurin was added to all wells and incubated at 37 °C for another 4 h. Colour changes were observed. Fluorescence measurements were performed in a spectrofluorometer (Infinite 200 PRO, Tecan Austria) at 560 nm excitation and 590 nm emission wavelength. Bacteria without any antibiotics were used as a negative control (pages 371-372).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Funda et al. (WO2021/116395, with an effective filing date of December 11, 2020) in view of TEMİZ et al. (Selcuk J Agr Food Sci, (2018) 32 (3), 624-631).
Applicant Claims
Applicant claims an edible composition for reducing or inhibiting methanogenesis in a ruminant, the edible composition comprising (a) a stabilized halocarbon and (b) either an emulsion, a micelle, or a liposome, with other requirements listed along with a method for reducing or inhibiting methanogenesis in ruminant and a method of manufacturing an edible composition. Dependent claims thereof recite other features that further limit each of the independent claims.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Funda et al. teach a slow-release delivery composition for rumen methane inhibitors, characterized in that the composition consists of (a) a solid core comprising gluten, a non-enzymatically browned bypass protein and a rumen methane inhibitor, and (b) at least one coating over the core (see claim 1). Rumen methane inhibitors such as e.g. 3-nitrooxypropanol, allicin and bromoform and have been reported to significantly reducing the methane production in ruminants. As the current product forms, however, instantly release the active into the aqueous rumen fluid, they have to be dosed in regular time intervals to obtain effective methane reduction. Such a dosage regime is however not feasible for grazing animals (see page 1). It has now been found that when a non-enzymatically browned bypass protein is added to the solid core of a delivery composition consisting of a coated solid core comprising gluten and a rumen methane inhibitor, a significantly improved long-term methane reduction is achieved. Said delivery composition is furthermore obtainable in an efficient and economical way and exhibits a favourable tablet hardness. Thus, in a first embodiment the present invention relates to a slow-release delivery composition for rumen methane inhibitors consisting of (a) a solid core comprising gluten, a non-enzymatically browned bypass protein and a rumen methane inhibitor, and (b) at least one coating over the core (see pages 1-2). The term ‘rumen methane inhibitor’ as used herein relates to all compounds suitable to reduce the methane emissions in ruminants. Suitable methane inhibitors according to the present invention include garlic extracts, allicin, chloroform, bromoform, nitrate, nitroethane, lauric acid, lauricidin, marine algae such as the Hawaiian micro-algae Chaetoceros and compounds of formula (I),
PNG
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159
382
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formula (I) wherein n is an integer from 2 to 46
R1 is H, Ci-Cealkyl, phenyl, -OH, -NH2, -CN, -COOH, -0(C=0)R8, -NHC(=0)R8, SO2NHR8, or -ONO2, and R8 is Ci-C6alkyl, phenyl, pyridyl such as preferably 2-pyridyl with the proviso that when n is > 3 the hydrocarbon chain may be interrupted by -O- and/ or -NH-. Particularly suitable rumen methane inhibitors to be supplemented by the slow-release delivery composition according to the present invention are liquid (i.e. liquid at ambient temperature (i.e. 22°C) (see page 4). The amount of the rumen methane inhibitor in the solid core according to the present invention is advantageously at least 0.01 wt.-%. Preferably, however, the amount is selected in the range from 0.01 to 25 wt.-%, more preferably in the range from 0.05 to 25 wt.-%, most preferably in the range from 0.075 to 20 wt.-%, based on the total weight of the solid core. Further particular suitable ranges are selected in the range from 1 to 25 wt.-%, from 5 to 25 wt.-%, from 1 to 20 wt.-% and from 5 to 20 wt.-%, based on the total weight of the solid core (see page 5). Suitable coatings according to the present invention encompass waxes, fats, oils or cellulose derivatives without being limited thereto (see page 5). Particularly suitable waxes to be used as coating in the context of the present invention are natural waxes (i.e. plant or animal derived) which are typically esters of fatty acids and long chain alcohols as well as synthetic waxes, which are generally long-chain hydrocarbons. Particularly suitable fats to be used as coating in the context of the present invention are fats which are soluble in organic solvents but largely insoluble in water such as hydrogenated fats (or saturated fats) which are generally triesters of glycerol and fatty acids. Suitable fats can have natural or synthetic origin. It is possible to hydrogenate a (poly)unsaturated fat to obtain a hydrogenated (saturated) fat. Particularly suitable cellulose derivatives to be used as coating in the context of the present invention are ethylcellulose, methylcellulose, hydroxypropyl methylcellulose (Hypromellose), hydroxyethylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, sodium carboxymethylcellulose, carboxylmethylcellulose, carboxymethyl- sulfoethylcellulose and hydroxypropyl methylcellulose acetate succinate. Particularly preferred coatings according to the present invention are glycerine monostearate, carnauba wax, candelilla wax, sugarcane wax, shellac (also referred to as shellac wax, shellac ammonium salt or shellac ammonium solution), palmitic acid, stearic acid hydrogenated cottonseed oil, hydrogenated palm oil and hydrogenated rapeseed oil as well as mixtures thereof. The coating (total amount) is generally applied in amounts from 1 to 50 wt.-%, based on the total weight of the solid core, more preferably in the range from 5 to 30 wt.-%, most preferably in the range of 5 to 25 wt.-% (see page 6 in entirety). It is well understood that the at least one rumen methane inhibitors can be incorporated into the solid core as such or, in particular if the rumen methane inhibitor is liquid, in the form of a powderous formulation, i.e. after having been absorbed onto a suitable carrier. Thus, in another embodiment, the present invention relates to a slow-release delivery composition wherein the rumen methane inhibitor, preferably the liquid rumen methane inhibitor is incorporated into the solid core in the form of a powderous formulation comprising the rumen methane inhibitor and a carrier. In a particularly preferred embodiment, the present invention relates to a slow-release delivery composition according to the present invention wherein the compound of formula (1) is incorporated into the solid core in the form of a powderous formulation comprising the compound of formula (I) and a carrier. The term carrier as used herein refers to any carrier material suitable to absorb the rumen methane inhibitors such as in particular the compound of formula (1) to be supplemented to animals (including humans). Particular suitable carriers are silica, sepiolite, zeolite, maltodextrin, limestone, cyclodextrin, diatomaceous earth, wheat as well as mixtures thereof. Particularly preferred in all embodiments is the use of silica (silicone dioxide) as carrier, most preferably of precipitated silica. Even more advantageously, in all embodiments of the present invention, said powderous formulation consists essentially of a compound of formula (l), an edible diluent and a carrier. The term edible diluent as used herein refers to any edible liquid, solvent or oil which is suitable to dilute the compound of formula (I) before absorption onto the carrier and remains adsorbed on the carrier as well. Particularly suitable edible diluents are propylene glycol, corn oil, rapeseed oil, sunflower oil, middle chain triglyceride (MCT) and glycerol as well as mixtures thereof. The most preferred edible diluent in all embodiments of the present invention is propylene glycol (see page 8 in its entirety). Particularly preferred compressed tablets according to the present invention also exhibit a tablet hardness after coating selected in the range of 75 to 175 N, more preferably in the range of 80 to 150 N, most preferably in the range of 80 to 125 N as such tablets are particularly well accepted by the respective animals while still being sufficiently stable to be processed, handled and administered to the ruminants. Further preferred ranges are 75 to 140 N, 75 to 130 N, 80 to 140 N and 80 to 130 N. The most preferred hardness acceptability range by the animals is in the range from 75 to 130 N, i.e. also in the range from 80 to 125 N (page 13)
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.012)
Funda et al. is silent with respect to the incorporation of either an emulsion, a micelle, or a liposome and the encapsulation process steps recited in claim 36. These deficiencies are cured by the teachings of TEMİZ et al.
TEMİZ et al. teach encapsulation is a technology based on coating an active compound with one or more coating material and keeping it in the capsule. Encapsulation is a system can be used for increased stability and bioavailability, protecting the form and controlled secretion to target tissues of bioactive compounds. Coating materials are can be ranged as starch, analogs of starch, proteins, gums, lipids or their mixtures. Encapsulation is a technology based on coating an active compound with one or more coating material and keeping it in the capsule. Encapsulation is a system can be used for increased stability and bioavailability, protecting the form and controlled secretion to target tissues of bioactive compounds. Coating materials are can be ranged as starch, analogs of starch, proteins, gums, lipids or their mixtures (abstract). Liposomes are preferred as encapsulating materials in microencapsulation technology (see page 626 under section other coating materials). Liposomes are colloidal particle structures formed by bilayer lipid layers encapsulating liquid fields, and containing membrane systems (Fang & Bhandar 2010). Liposomes are biocompatible materials, have many important advantages such as being able to hold the water-soluble active ingredients in the hydrophilic center, to hold the water-insoluble hydrophobic ingredients on the membrane, to be resistant to environmental effects without side effects, to have the action of bioactive compounds in the cell and even in the cellular compartments at a high level. They also have desirable biological activities such that their size can be made desirable by various processes (Torchilin 2005). In addition to the above methods, nowadays air suspension coating, rotary suspension separation, water removal by centrifugation, phase separation and molecular complex formation methods are also used (see page 627 under liposomal dispensing). TEMİZ et al. also teach the proteins are very good coating materials for microencapsulation processes due to their functional properties. Especially they have a high positive effect on the binding of flavor components (Landy et al.1995). The diversity within the chemical groups is an important advantage of having water-soluble and insoluble groups together, having the properties such as interacting with each other and with a wide variety of substances, large molecular weights, a flexibility of molecular chains, as well as technological properties such as solubility, viscosity, emulsification, film formation. During emulsion formation, protein molecules absorb rapidly between the newly formed oil and water phase (Madene 2006). Protein-based coating materials which possess physicochemical and functional properties were in the Amfifik to encapsulate hydrophobic material. Generally, gelatin, whey proteins, casein, caseinates are preferred as a coating material in microencapsulation process (Gharsallaoui et al. 2007).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious before the effective filing date of the instant application to modify the teachings of Funda et al. by incorporating or utilizing a liposome or an emulsion in the composition and follow the steps recited in claim 36 to prepare the liposomes and emulsions because TEMİZ et al. teach encapsulation is a technology based on coating an active compound with one or more coating material and keeping it in the capsule. Encapsulation is a system can be used for increased stability and bioavailability, protecting the form and controlled secretion to target tissues of bioactive compounds. Coating materials are can be ranged as starch, analogs of starch, proteins, gums, lipids or their mixtures. Encapsulation is a technology based on coating an active compound with one or more coating material and keeping it in the capsule. Encapsulation is a system can be used for increased stability and bioavailability, protecting the form and controlled secretion to target tissues of bioactive compounds. Coating materials are can be ranged as starch, analogs of starch, proteins, gums, lipids or their mixtures (abstract). One of ordinary skill in the art would have been motivated to incorporate liposomes because TEMİZ et al. teach liposomes are preferred as encapsulating materials in microencapsulation technology (see page 626 under section other coating materials). Liposomes are colloidal particle structures formed by bilayer lipid layers encapsulating liquid fields, and containing membrane systems (Fang & Bhandar 2010). Liposomes are biocompatible materials, have many important advantages such as being able to hold the water-soluble active ingredients in the hydrophilic center, to hold the water-insoluble hydrophobic ingredients on the membrane, to be resistant to environmental effects without side effects, to have the action of bioactive compounds in the cell and even in the cellular compartments at a high level. They also have desirable biological activities such that their size can be made desirable by various processes (Torchilin 2005). In addition to the above methods, nowadays air suspension coating, rotary suspension separation, water removal by centrifugation, phase separation and molecular complex formation methods are also used (see page 627 under liposomal dispensing). One of ordinary skill in the art would have been motivated to incorporate or utilize emulsions because TEMİZ et al. also teach the proteins are very good coating materials for microencapsulation processes due to their functional properties. Especially they have a high positive effect on the binding of flavor components (Landy et al.1995). The diversity within the chemical groups is an important advantage of having water-soluble and insoluble groups together, having the properties such as interacting with each other and with a wide variety of substances, large molecular weights, a flexibility of molecular chains, as well as technological properties such as solubility, viscosity, emulsification, film formation. During emulsion formation, protein molecules absorb rapidly between the newly formed oil and water phase (Madene 2006). Protein-based coating materials which possess physicochemical and functional properties were in the Amfifik to encapsulate hydrophobic material. Generally, gelatin, whey proteins, casein, caseinates are preferred as a coating material in microencapsulation process (Gharsallaoui et al. 2007) (see page 626 under section proteins). Furthermore, in the case where the claimed ranges for the amounts and concentrations of active agent and other ingredients “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 amounts of active agents and ingredients. The skilled artisan would have had a reasonable expectation of success in combining the teachings of Funda et al. and TEMİZ et al. because both references teach encapsulation of volatile liquid active agents.
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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619