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 .
Priority
This application is a Division of U.S. Application No. 17/258,540 filed on 01/07/2021 and now Abandoned, which is a national stage entry of PCT/KR2018/014704 filed on 11/27/2018. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in REPUBLIC OF KOREA (10-2018-0080798) on 07/11/2018 under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/258,540, filed on 01/07/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for improving a muscle function, enhancing a motor performance of a subject in need thereof, and treating a muscle disease selected from muscular atrophy, muscular dystrophy, myasthenia, muscle degeneration, and sarcopenia, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient, does not reasonably provide enablement for a method for preventing and treating any muscle disease in a subject in need thereof, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing hydrangenol as an active ingredient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The specification does not provide sufficient information to support the claimed invention of treating any muscle disease comprising the administration of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The instant invention pertains to a method for preventing and treating any muscle disease, improving a muscle function, or enhancing a motor performance of a subject in need thereof, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol can be used to treat and prevent any muscle disease known in the art which includes a large number of diseases. Thus the cited claims are deemed very broad since these claims read on treating and preventing any muscle disease comprising the administration of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol, which includes numerous diseases involving muscles.
State of the Art: The state of the art as provided by Barohn (Muscle Diseases, Medicina, 2007) teaches that diseases of skeletal muscle, termed myopathies, are disorders in which there is a primary structural or functional impairment of muscle. Disorders of muscles can be categorized into hereditary and acquired myopathies (page 2). Hereditary myopathies include Muscular dystrophies, Congenital myopathies, Myotonias and channelopathies, Metabolic myopathies, and Mitochondrial myopathies (page 2). Acquired myopathies include Inflammatory myopathies, Endocrine myopathies, Myopathies associated with systemic illness, and Drug-induced/toxic myopathies (page 2). Muscular dystrophies include numerous disease with multiple causes (pages 11-12). Congenital and metabolic myopathies which are distinct from dystrophies also include numerous diseases with multiple causes (pages 22-24). Thus the state of the art recognizes that muscle diseases constitute a large variety of both acquired and hereditary disorders that can affect muscle structure, metabolism, or the function of the muscle channel. Thus muscle diseases include many disorders having distinct etiologies. Prior to the effective filing date of the claimed invention, Jang et al. (WO 2019/004797) teaches that a hydrangea extract may be useful in the treatment of muscle-weakness related diseases such as sarcopenia by promoting differentiation of muscle stem (see claims 1-14). Jang et al. provides preliminary data suggesting that the extract may be useful in the treatment of muscle-weakness related diseases such as sarcopenia, muscular atrophy, and muscular dystrophy, however, there is no data administering the extract to any human patient which demonstrates effective treatment of any disease. Thus prior to the effective filing date of the claimed invention, the use of a hydrangea extract in the treatment of muscle disease was highly speculative and moreover, there was no evidence that the extract would be effective in the treatment of any known muscle disorder. Thus, the state of the art fails to provide sufficient evidence in support of the broad treatment of any muscle disease comprising the administration of hydrangenol or a hydrangea extract containing the hydrangenol as recited in the instant claims.
Predictability/Unpredictability in the Art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses treating and preventing any muscle disease, which include a great number of diseases with different etiologies. Thus, the skilled artisan would view that the treatment of all disorders/diseases encompassed by the claims, by administering hydrangenol or a hydrangea extract containing the hydrangenol, is highly unpredictable.
Moreover, one of skill in the art would recognize that it is highly unpredictable in regard to therapeutic effects, side effects and toxicity generated by administering hydrangenol or a hydrangea extract containing the hydrangenol for treating all disorders/diseases encompassed by the claims.
Guidance of the Specification/Working Examples: In the instant specification, Applicant demonstrates that hydrangenol or a hydrangea extract containing the hydrangenol changes expression of genes involved in muscle mass and muscle cell differentiation (pages 11-15). Applicant further demonstrates that hydrangenol or a hydrangea extract containing the hydrangenol changes expression of proteins involved in muscle diseases (page 15). Applicant further demonstrates that hydrangenol or a hydrangea extract containing the hydrangenol increase the amount of ATP in cells which demonstrates enhancement of motor performance (page 16). However, there is no data administering hydrangenol or a hydrangea extract containing the hydrangenol to any patient for the treatment or prevention of any muscle disease. Thus there is no actual evidence presented which demonstrates that the data presented in the instant specification will lead to any practical significance in the treatment of any muscle disease. Thus, the specification fails to provide sufficient evidence in support of the broad treatment or prevention of any muscle disease comprising the administration of hydrangenol or a hydrangea extract containing the hydrangenol as recited in the instant claims.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to determine that the hydrangenol or a hydrangea extract containing the hydrangenol can be used to treat any muscle disease. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A method for preventing and treating any muscle disease in a subject in need thereof, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing hydrangenol as an active ingredient is not enabled by the instant specification.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for improving a muscle function, enhancing a motor performance of a subject in need thereof, and treating a muscle disease selected from muscular atrophy, muscular dystrophy, myasthenia, muscle degeneration, and sarcopenia, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient, does not reasonably provide enablement for preventing a muscle disease selected from muscular atrophy, muscular dystrophy, myasthenia, muscle degeneration, and sarcopenia or any other muscle disease, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The specification does not provide sufficient information to support the claimed invention of preventing any muscle disease comprising the administration of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The instant invention pertains to a method for preventing and treating any muscle disease, improving a muscle function, or enhancing a motor performance of a subject in need thereof, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol can be used to treat and prevent any muscle disease known in the art which includes a large number of diseases. Thus the cited claims are deemed very broad since these claims read on treating and preventing any muscle disease comprising the administration of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol, which includes numerous diseases involving muscles.
State of the Art: While the state of the art is relatively high with respect to treating muscle diseases including treating symptoms of muscle diseases, the state of the art with regard to prevention of muscle disease is underdeveloped. The state of the art as provided by Barohn (Muscle Diseases, Medicina, 2007) teaches that diseases of skeletal muscle, termed myopathies, are disorders in which there is a primary structural or functional impairment of muscle. Disorders of muscles can be categorized into hereditary and acquired myopathies (page 2). Hereditary myopathies include Muscular dystrophies, Congenital myopathies, Myotonias and channelopathies, Metabolic myopathies, and Mitochondrial myopathies (page 2). Acquired myopathies include Inflammatory myopathies, Endocrine myopathies, Myopathies associated with systemic illness, and Drug-induced/toxic myopathies (page 2). Muscular dystrophies include numerous disease with multiple causes (pages 11-12). Congenital and metabolic myopathies which are distinct from dystrophies also include numerous diseases with multiple causes (pages 22-24). Thus the state of the art recognizes that muscle diseases constitute a large variety of both acquired and hereditary disorders that can affect muscle structure, metabolism, or the function of the muscle channel. Thus muscle diseases include many disorders having distinct etiologies. Thus, it is highly unlikely that muscle diseases can be prevented since they are hereditary disorders and moreover are acquired for many different reasons. Prior to the effective filing date of the claimed invention, Jang et al. (WO 2019/004797) teaches that a hydrangea extract may be useful in the treatment of muscle-weakness related diseases such as sarcopenia by promoting differentiation of muscle stem (see claims 1-14). Jang et al. provides preliminary data suggesting that the extract may be useful in the treatment of muscle-weakness related diseases such as sarcopenia, muscular atrophy, and muscular dystrophy, however, there is no data administering the extract to any human patient which demonstrates effective treatment or prevention of any disease. Thus prior to the effective filing date of the claimed invention, the use of a hydrangea extract in the prevention of muscle diseases was highly speculative and moreover, there was no evidence that the extract would be effective in the prevention of any known muscle disorder. Thus, the state of the art fails to provide sufficient evidence in support of the broad prevention of muscular atrophy, muscular dystrophy, myasthenia, muscle degeneration, and sarcopenia or any other muscle disease comprising the administration of hydrangenol or a hydrangea extract containing the hydrangenol as recited in the instant claims.
Predictability/Unpredictability in the Art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses preventing muscle diseases, which include a great number of diseases with different etiologies. Thus, the skilled artisan would view that the prevention of all disorders/diseases encompassed by the claims, by administering hydrangenol or a hydrangea extract containing the hydrangenol, is highly unpredictable.
Guidance of the Specification/Working Examples: In the instant specification, Applicant demonstrates that hydrangenol or a hydrangea extract containing the hydrangenol changes expression of genes involved in muscle mass and muscle cell differentiation (pages 11-15). Applicant further demonstrates that hydrangenol or a hydrangea extract containing the hydrangenol changes expression of proteins involved in muscle diseases (page 15). Applicant further demonstrates that hydrangenol or a hydrangea extract containing the hydrangenol increase the amount of ATP in cells which demonstrates enhancement of motor performance (page 16). However, there is no data administering hydrangenol or a hydrangea extract containing the hydrangenol to any patient for the treatment or prevention of any muscle disease. Thus there is no actual evidence presented which demonstrates that the data presented in the instant specification will lead to any practical significance in the treatment or prevention of any muscle disease. Thus, the specification fails to provide sufficient evidence to support the broad treatment or prevention of any muscle disease comprising the administration of hydrangenol or a hydrangea extract containing the hydrangenol as recited in the instant claims.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to determine if hydrangenol or a hydrangea extract containing the hydrangenol can prevent a muscle disease. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A method for preventing a muscle disease selected from muscular atrophy, muscular dystrophy, myasthenia, muscle degeneration, and sarcopenia or any other muscle disease, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient. is not enabled by the instant specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jang et al. WO 2019/004797 (filing date of 06/29/2018) (English Translation provided) as evidenced by Akada et al. (Yakugaku Zasshi (1979), 99(6), 683-7).
Claims 1-5 and 7-8 of the instant application claim a method for improving a muscle function, enhancing a motor performance of a subject in need thereof, and preventing and treating a muscle disease selected from muscular atrophy, muscular dystrophy, myasthenia, muscle degeneration, and sarcopenia, comprising administering to the subject an effective amount of a composition comprising hydrangenol or a hydrangea extract containing the hydrangenol as an active ingredient wherein hydrangenol has the following structure
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Jang et al. teaches compositions for preventing or treating muscular weakness-related diseases (title). Jang et al. teaches a composition for promoting differentiation of muscle stem cells into muscle cells, a pharmaceutical composition for preventing or treating muscular weakness-related diseases, and a health functional food composition for improving exercise performance, which comprise Lithospermum erythrorhizon extract, Hydrangea macrophylla tea extract, or a mixture thereof as active ingredients (abstract). Jang et al. teaches that Lithospermum erythrorhizon extract, Hydrangea macrophylla tea extract or a mixture thereof has the effect of promoting differentiation into myotube cells, preventing or treating obese sarcopenia, and producing a health functional food for improving exercise performance (abstract).
Jang et al. teaches that skeletal muscle is an organ occupying the largest part in the human body, occupies 40 to 50% of the total weight, and plays an important role in various metabolic functions in the body, including energy homeostasis and heat generation. Jang et al. teaches that the muscle of the person begins to decrease by 1% or more in the year after 40 years, and decreases to a level of 50% of the maximum muscle mass when the human muscle is 80 years, so that the muscle loss of the elderly is recognized as the most important cause of lowering the overall physical function. See paragraph [6] of translation.
Jang et al. teaches that they have attempted to develop a pharmaceutical composition capable of preventing or treating muscle weakness-related diseases and as a result, it was found that the Lithospermum erythrorhizon extract and the Hydrangea serrata Serin var. thumbergii Sugimoto extract effectively inhibited muscle loss induced by palmitic acid in myotube cells, and thus it was identified that the Lithospermum erythrorhizon extract and the Hydrangea serrata Serin var. Thunb. extract can be usefully used for the prevention or treatment of muscular weakness-related diseases. See paragraph [15] of translation.
Jang et al. teaches the term "muscle weakness-related disease" as used herein refers to all diseases in which muscle tissue or myoblasts are reduced or lost. The muscular weakness-related disease may be sarcopenia, muscular atrophy, muscle dystrophy, or heart atrophy, but is not limited thereto. Sarcopenia refers to a decrease in progressive skeletal muscle mass according to aging, and refers to a state in which a decrease in muscle strength is directly caused, and as a result, various physical functions may be reduced and disorder may be caused. Types of muscle atrophy include amyotrophic lateral sclerosis (ALS) and spinal progressive muscular atrophy (SPMA). The muscle atrophy refers to a disease in which a gradual muscular atrophy and a muscle weakness are exhibited, and refers to a degenerative muscle disease characterized by the necrosis of muscle fibers in a pathological condition. See paragraphs [48]-[53] of translation.
Jang et al. teaches that the pharmaceutical composition may be administered to mammals, including humans, in various routes, for example, oral, skin, venous, muscle, subcutaneous, and the like, and preferably orally administered. See paragraph [62] of translation.
Jang et al. teaches that an aspect of the invention relates to a health functional food composition for enhancing exercise performance, comprising the extract as an active ingredient. The term "enhancing exercise performance" refers to strengthening of body performance, strengthening of maximum endurance, increasing muscle mass, strengthening muscle recovery, reducing muscle fatigue, or a complex effect thereof. See paragraphs [65]-[71] of translation.
Example 2 of Jang et al. specifically demonstrates the sarcopenia improvement effect of hydrangea macrophylla extract. Jang et al. teaches that leaves of dried Hydrangea serrata Serin var. thumbergii Sugimoto were immersed in 20-fold weight 70 (v/v) % ethanol. The immersed Hydrangea tea was extracted overnight in a shaking incubator at room temperature, the reaction mixture was filtered, and the supernatant was freeze-dried to prepare a Hydrangea macrophylla extract. Thus Jang et al. teaches that the composition contains 100% of the hydrangea extract. See paragraphs [152]-[168] of translation.
Claims 6-14 of Jang et al. specifically claim a pharmaceutical composition for preventing or treating muscle weakness-related diseases, comprising, as an active ingredient, a Lithospermum erythrorhizon extract, a Hydrangea serrata Serin var. thimbergii Sugimoto extract, or a mixture thereof, wherein the muscle weakness-related disease is sarcopenia, muscular atrophy, muscle dystrophy, or heart atrophy.
Thus the cited claims of the instant application are anticipated since Jang et al. specifically teaches a method for improving a muscle function, enhancing a motor performance of a subject in need thereof, and preventing and treating a muscle disease selected from muscular atrophy, muscular dystrophy, and sarcopenia, comprising administering to the subject an effective amount of a hydrangea extract as an active ingredient. The Hydrangea serrata extract of Jang et al. contains hydrangenol as evidenced by Akada et al. which teaches that hydrangenol is extracted from Hydrangea serrata (see abstract). Thus Jang et al. inherently teaches treating a muscle disease comprising the administration of a composition comprising hydrangenol or a hydrangea extract containing hydrangenol as an active ingredient as claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. WO 2019/004797 (filing date of 06/29/2018) (English Translation provided) as evidenced by Akada et al. (Yakugaku Zasshi (1979), 99(6), 683-7) as applied to claims 1-5 and 7-8 above and further in view of Yang et al. WO 2019/088720 (Provided on IDS) (Machine English Translation Provided).
Claim 6 of the instant application claims the composition has at least one dosage form selected from the group consisting of toner, essence, nourishing cream, moisturizing cream, spot, gel, lotion, ointment, patch, and aerosol, wherein the composition is for cutaneous application.
Jang et al. as evidenced by Akada et al. is as set forth above.
Jang et al. as evidenced by Akada et al. does not specifically teaches a dosage form such as a cream for cutaneous application.
However, Jang et al. teaches that the pharmaceutical composition may be administered to mammals, including humans, in various routes, for example, oral, skin, venous, muscle, subcutaneous, and the like, and preferably orally administered. See paragraph [62] of translation. Thus the invention of Jang et al. contemplates administration to the skin such as cutaneous application.
Yang et al. teaches a composition containing a Hydrangea macrophylla extract which includes high amounts of hydrangenol ([1] and [10]-[11]). Yang et al. teaches that the composition is a cosmetic composition containing a hydrangea extract that has more than 8% of hydrangenol [41]. Yang et al. teaches that the cosmetic composition may include 0.1 to 20% by weight, preferably 1 to 10% by weight based on the total weight of the composition of the hydrangea extract which contains hydrangenol [48]. Yang et al. teaches that the hydrangea extract may be prepared using an alcohol or a mixture of ethanol and water [50]-[51]. Yang et al. teaches that the cometic composition may be in the form of skin lotion, skin toner, cream, essence, etc. [54]. Yang et al. specifically teaches preparation of a hydrangea extract using methanol or 70% ethanol solution [57]-[58]. Yang et al. further teaches a cosmetic composition comprising 5% of the hydrangenol containing extract [80]-[87].
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Jang et al. which teaches that the pharmaceutical composition comprising a hydrangea extract may be administered to mammals, including humans, in various routes, for example, oral, skin, venous, muscle, subcutaneous, and the like, with the teachings of Yang et al. which teaches a cometic composition in the form of skin lotion, skin toner, cream, essence, etc. comprising a hydrangea extract. Thus an ordinary skilled artisan would have been motivated to use the topical formulation of Yang et al. for the method of treating muscle weakness-related diseases as taught in Jang et al. since Jang et al. teaches the composition may be administered to the skin. Thus administration of a hydrangea extract in the form of a cream, toner, essence and the like for the treatment of muscle weakness-related diseases is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-8 are rejected. No claims are allowed.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
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