DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 08/25/2023 has been entered. Claims 1-5 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/KR2021/014493 10/18/2021 and claims foreign priority of KOREA, REPUBLIC OF 10-2021-0026545 02/26/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
Three information disclosure statements (IDS) filed on 08/25/2023, 10/20/2024, and 03/19/2025 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, insert the missing phrase “in need thereof” immediately after the recitation “in a patient” (line 2) because there is no evidence that any patient requires such treatment. Appropriate correction is required.
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.
(I) Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (KR 1020080107922, published on 12/11/2008, hereinafter referred to as Song ‘922, also provided in IDS and the 42-page FOR filed on 08/25/2023).
With regard to structural limitations “a method comprising administering a pharmaceutical composition comprising eleutheroside B (also known as syringin) or a pharmaceutically acceptable salt thereof as an active ingredient to a patient having neuroinflammatory disease (or Alzheimer’s disease)” (claims 1 and 3):
Song ‘922 disclosed study of mistletoe extract in in vivo animal experiment, in case of causing the toxicity in the nerve cell using the Alzheimer disease model due to the memory power damaged model due to scopolamine and beta amyloid. More preferably, the active compound syringin is obtained using the chromatography from the mistletoe extract (page 8/42, right col., para. 3; page 12/42, right col., para. 2). The memory power damaged model induced to scopolamine: The mistletoe extract at 200 mg/kg was orally administered to rats administered with scopolamine at 0.5 mg/kg to the abdominal cavity to cause the memory power damage or with saline solution. The memory power damaged model induced to the beta amyloid: the beta amyloid (ß-amyloid, Sigma, USA) was injected into the ventriculus lateralis (lateral ventricle) at 5 μI (15 nmole) for 2 weeks. The mistletoe extract was orally administered at 200 mg/kg or the saline solution was administered after the Alzheimer induction. In case of the result of performance the experiment, the rats administered with scopolamine (SC) to the abdominal cavity were nearly unable to searching for the platform in the training period. The time to search for the platform during the experiment period to 4th day is remarkably reduced in case of the rat (SC + Mistletoe). The time to search for the platform during the experiment period to 6th day is remarkably reduced in case of the rat (Aß + Mistletoe) in comparison with the saline control (page 17/42, right col., para. 2-9; page 18/42, right col., para. 1 to 2; page 19/42, right col., para. 4-8; page 20/42, right col., para. 1 to 2).
Thus, these teachings of Song ‘922 anticipate Applicant’s claims 1-5 and would also achieve the intended results or consequence after administering, including “activates neurites in neural stem cells and promotes differentiation of brain neurons”, “enhances a secretion of anti-inflammatory cytokines and inhibits a secretion of pro-inflammatory cytokines in astrocytes or microglia”, and “inhibits neuroinflammation of CA1 region of hippocampus induced by activity of microglia or astrocytes”, required by claims 2, 4, and 5.
(II) Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Redox Biology 36 (2020) 101672, Available online 10 August 2020, hereinafter referred to as Wang ‘2020, also provided in IDS and the 19-page NPL filed on 08/25/2023).
With regard to structural limitations “a method comprising administering a pharmaceutical composition comprising eleutheroside B (also known as syringin) or a pharmaceutically acceptable salt thereof as an active ingredient to a patient having neuroinflammatory disease (or Alzheimer’s disease)” (claims 1 and 3):
Wang ‘2020 disclosed that treatment with an antioxidant, syringin, could ameliorate Alzheimer’s disease (AD)-related pathologic and behavioural impairments in in the amyloid precursor protein (APP)/presenilin 1 (PS1) mouse brain. Syringin, 4-[(1E)-3-hydroxyprop-1-en-1-yl]-2,6-dimethoxyphenyl β-D-glucopyranoside], also known as eleutheroside B. The APP/PS1 (B6C3-Tg [APPswe, PSEN1dE9] 85Dbo/Mmjax) double transgenic mice used as the AD animal model in the present study. Four-month-old male APP/PS1 mice and age-matched WT mice were randomly divided into three groups: the control
group treated with vehicle (150 μL), composed of 5% ethanol, 15% polyethylene glycol (PEG400) and 15% 1,2-propanediol in deionized water, and the syringin-administered groups treated with vehicle and
syringin at doses of 20 and 60 mg/kg body weight. The mice were treated with vehicle or syringin by oral gavage once a day for five months (page 1, Abstract; page 2, left col., para. 3; right col., para. 1).
Thus, these teachings of Wang ‘2020 anticipate Applicant’s claims 1-5 and would also achieve the intended results or consequence after administering, including “activates neurites in neural stem cells and promotes differentiation of brain neurons”, “enhances a secretion of anti-inflammatory cytokines and inhibits a secretion of pro-inflammatory cytokines in astrocytes or microglia”, and “inhibits neuroinflammation of CA1 region of hippocampus induced by activity of microglia or astrocytes”, required by claims 2, 4, and 5.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691