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 .
DETAILED ACTION
Claims 1-7 are pending. Claims 1-7 are examined on the merits.
Specification/Abstract Objections
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the Abstract has two paragraphs instead one paragraph.
Claim Rejections –35 USC § 103
The following is a quotation of 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 through 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.
Claims 1-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Asaka et al (US 8182845 B2), in view of Li et al (CN 110841023 A).
Asaka et al teach a method of treating a disease selected from the group consisting of myocardial infarction, heart failure, Alzheimer's disease and chronic obstructive pulmonary disease in a subject in need thereof, the method comprising administering an effective amount of Rikkunshi-to to the subject to treat the disease and promote production of ghrelin, wherein said Rikkunshi-to comprises 3.0 to 4.0 weight parts of Atractylodes Lancea or Atractylodes, 2.0 to 4.0 weight parts of ginseng radix (thus the claimed component), 3.0 to 4.0 weight parts of pinelliae tuber (thus the claimed Pinellia tuber), 3.0 to 4.0 weight parts of Poria Sclerotium, 2.0 weight part of zizyphi fructus (thus the claimed component), 2.0 to 4.0 weight parts of aurantii nobilis pericarpium, 1.0 to 1.5 weight parts of Glycyrrhiza radix (thus the claimed component), and 0.5 to 2.0 weight parts of zingiberis rhizome (thus the claimed Zingiberis rhizome) (see claim 1); Asaka et al teach the method of claim 1, wherein the disease is Alzheimer's disease (thus the necessary mechanism of treating Alzheimer's disease, thus exhibits the effect of reducing amyloid beta, thus claim 5 is met) (see claim 5). Asaka et al teach the extract of Rikkunshi-to can be prepared according to classical methods in which a mixture of the crude drugs mixed at the compounding ratio mentioned above is extracted with 5 to 20 volumes of an appropriate aqueous solvent followed by solid-liquid separation. Examples of the preferred aqueous solvent are water, ethanol and aqueous solution of acetic acid. The extraction method can be hot or cold extraction. In particular, extraction conducted at 90 to 100.degree. C. using water (thus claim 4 is met) as the solvent is preferred (col 3, lines 29-37). Asaka et al teach the present invention relates to a novel pharmaceutical such as ghrelin production promoter comprising "Rikkunshi-to" (a kind of kampo medicine) (thus claims 6 and 7 are met) as the active ingredient (col 1, lines 13-15). Asaka et al teach formulations for oral use include solid ones such as powder (thus a food, thus claim 6 is met), granules, tablets and capsules, and liquid ones such as suspensions, emulsions, syrups, and elixirs; and pharmaceutical carriers may be used in accordance with the administration routes and formulations (thus col 3, lines 54-58).
Asaka et al do not teach the incorporation of Scutellariae radix and Coptidis rhizome into the composition; neither do Asaka et al teach treating late onset Alzheimer’s disease, or the Alzheimer’s disease caused by ApoE4 gene mutation.
Li et al teach the invention relates to a pharmaceutical composition for treating Alzheimer disease and belongs to the field of traditional Chinese medicine The pharmaceutical composition is prepared from, by weight, 8-12 parts of radix scutellariae (thus the claimed Scutellariae radix), 6-10 parts of rhizoma coptidis (thus the claimed Coptidis rhizome), 10-20 parts of cortex phellodendri, 8-12 parts of fructus gardeniae, 6-12 parts of tortoise-plastron glue, 10-20 parts of fructus alpiniae oxyphyllae and 8-16 parts of wine-processed rhubarb (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition of Li et al containing Scutellariae radix and Coptidis rhizome into the composition of Asaka et al since Li et al teach a method of treating Alzheimer disease containing Scutellariae radix and Coptidis rhizome, etc. Since both of references teach a method of treating Alzheimer disease, one of the ordinary skill in the art would have been motivated to combine the teachings of the references together so as to enhance the efficacy the composition.
It would also have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to treat either early or late onset Alzheimer’s disease or Alzheimer’s disease caused by any reason since Asaka et al and Li et al teach a method of treating Alzheimer's disease using the claimed composition.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Applicant is noted that if Applicant argues about any unexpected result, the scope of the claim has to commensurate with the unexpected result, if any particular ratio or amount of the components was used to achieve the unexpected result, those ratio or amount needs to the present in the claims.
Conclusion
No claim is allowed.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655