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 43-69 are pending. Claims 43-69 are examined on the merits.
Claim Objections
Claims 44, 45, 52-54, and 58-69 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
(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 43, 46, 47, 51, 55, and 56 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Asmawati et al (Asmawati et al, Antidiabetic activity of aqueous extract of Leptospermum flavescens in alloxan induced diabetic rats. Sains Malaysiana (2014), Volume 43, Number 9, pp.1295-1304) (see IDS filed on 3/28/24).
Asmawati et al teach Leptospermum flavescens (thus the same as the claimed Leptospermum polygalifolium), commonly known as 'Gelam bukit' has been used by the Malays as traditional plants in Malaysia for antidiabetic treatment. However, at this moment there is no scientific evidence and data available to validate such claim. In the present study, the aqueous extract of leaves and stems were studied for its antidiabetic activity. The total phenols and flavonoids were determined and correlated with antidiabetic activity. The detection of aqueous leaves extract with LCMS/MS showed the presence of flavonoids aromadendrin glucoside, kaempferol rhamnoside, quercetin rhamnoside and vindoline. The extract has significantly inhibited glycogen phosphorylase at 85% with IC50=0.18 mg/mL. In the alloxan induced diabetic rats showed that extract at 500 mg/kg decreased significantly fasting plasma glucose level by 61.9% (p<0.001) on the 20th day as compared to diabetic control. The treatment with Leptospermum flavescens at 500 mg/kg showed that it decreased the total cholesterol and triglycerides but restored the HDL level. The high antidiabetic activity was correlated with high total phenol at 1.57±0.01 GAE/g and total flavonoids at 1.41±0.01 mg QE/g. Thus, the high antidiabetic activity of the aqueous leaves (thus the claimed polar solvent is water, thus claim 43 is met) extract attributed due to the presence of aromadendron glucoside, kaempferol rhamnoside, quercetin rhamnoside and vindoline (thus the claimed components in claim 46) in aqueous extract of Leptospermum flavescens (see Abstract).
Asmawati et al teach the male Sprad Dawley rats weighing 120 -150 g were used for the study (page 1297, 1st paragraph, 2nd paragraph).
Asmawati et al teach the animals were divided into seven groups, each consisting of six rats (thus a subject in need thereof, since everyone is in need of preventing lung cancer, it reads on everyone who is being administered with the claimed water extract of Leptospermum polygalifolium, thus claim 43 is met). Group IV and Group V diabetic rats administered leaves aqueous extract 200 mg/kg (thus 30 g for a rat weight 150 g, thus meets the requirement on page 19, 3rd paragraph of the spec), and 500 mg/kg respectively (page 1297, 2nd column, 1st paragraph) for 20 days, thus oral administration (see acute toxicity study for “fed” on page 1297, 1st column, 2nd paragraph) thus claim 47 is met, thus a food composition, thus claim 51 is met; thus a vehicle, thus a wetting agent, thus claim 55 is met; thus once daily, thus claim 56 is met).
Asmawati et al teach the powdered sample of leaves, stems and roots were
extracted with 100 mL of water. Then the mixture was incubated in water bath 40°C for 2 h. After the incubation the mixture was filtered and the water extract was dried in the freeze drier (page 1296, 1st paragraph, 2nd paragraph from the bottom).
Therefore, the reference is deemed to anticipate the instant claim above.
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 43, 46-51, and 55-57 are rejected under 35 U.S.C. 103(a) as being unpatentable over Asmawati et al as applied to claims 43, 46, 47, 51, 55, and 56 above.
The teachings of Asmawati et al are set forth above and applied as before.
The teachings of Asmawati et al do not specifically teach a form of powder, encapsulated form, an additional agent for treating hyperglycermia, or a treatment duration of one month.
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 use powdered form since after the water extract was dried in the freeze drier, most likely it is a powdered form.
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 add an additional agent for treating hyperglycermia, since Asmawati et al teach Leptospermum flavescens for antidiabetic treatment, one of ordinary skill in the art would have been motivated to include an additional agent for treating hyperglycermia in order to achieve additive or synergistic effect.
It would further have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to adjust treatment duration according to the diabetic condition or the dosage of the treatment, either 20 days or a month, determining an appropriate treatment duration is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
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 use the form of capsule in clinical study for human since tablet, capsule, and powder are mostly used forms for human oral administration.
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.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655