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
Applicant’s amendment in the reply filed on 4/15/26 is acknowledged, with the cancellation of Claims 43-69; and the additional newly added Claims 70-71. Claims 43-71 are pending. Any rejection that is not reiterated is hereby withdrawn.
Claim Objections
Claims 52-54 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, 48, 55, and 70 are newly rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Navanesan et al (Navanesan et al, Leptospermum flavescens Constituent-LF1 Causes Cell Death through the Induction of Cell Cycle Arrest and Apoptosis in Human Lung Carcinoma Cells. PloS one, (2015) Vol. 10, No. 8, pp. e0135995).
This is a new rejection necessitated by the Applicant’s amendment filed on 4/15/26.
Navanesan et al teach Leptospermum flavescens (thus the same as the claimed Leptospermum polygalifolium) Sm. (Myrtaceae), locally known as 'Senna makki' is a smallish tree that is widespread and recorded to naturally occur in the montane regions above 900 m a.s.l from Burma to Australia. Although the species is recorded to be used traditionally to treat various ailments, there is limited data on biological and chemical investigations of L. flavescens. The aim of the present study was to investigate and understand the ability of L. flavescens in inducing cell death in lung cancer cells. The cytotoxic potentials of the extraction yields (methanol (thus a polar solvent extract), hexane, ethyl acetate and water extracts (thus a polar solvent extract, since the claimed solvent was used to extract the claimed plant material, the components in claim 46 is necessarily contained in the extract, thus claim 46 is met, thus a wetting agent, thus claim 55 is met) as wells as a semi pure fraction, LF1) were evaluated against two human non-small cell lung carcinoma cell lines (A549 and NCI-H1299) (thus a method of treating lung cancer in a subject in need thereof, thus claim 43 is met) using the MTT assay. LF1 showed the greatest cytotoxic effect against both cell lines with IC50 values of 7.12 ± 0.07 and 9.62 ± 0.50 μg/ml respectively. LF1 treated cells showed a sub-G1 region in the cell cycle analysis and also caused the presence of apoptotic morphologies in cells stained with acridine orange and ethidium bromide. Treatment with LF1 manifested an apoptotic population in cells that were evaluated using the Annexin V/ propidium iodide assay. Increasing dosage of LF1 caused a rise in the presence of activated caspase-3 enzymes in treated cells. Blockage of cell cycle progression was also observed in LF1-treated cells. These findings suggest that LF1 induces apoptosis and cell cycle arrest in treated lung cancer cells. Further studies are being conducted to isolate and identify the active compound as well to better understand the mechanism involved in inducing cell death (see Abstract).
Navanesan et al teach a semi-pure fraction (LF1; approx. 12.6 g) which was a white powder (thus claim 48 is met) with slight greenish tinge was precipitated during methanol extraction, and was included in the current study together with the crude methanol and frac tionated (hexane, ethyl acetate and water) extracts.
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, 55-57, and 70 are newly rejected under 35 U.S.C. 103(a) as being unpatentable over Navanesan et al as applied to claims 43, 46, 48, 50, and 70 above.
This is a new rejection necessitated by the Applicant’s amendment filed on 4/15/26.
The teachings of Navanesan et al are set forth above and applied as before.
The teachings of Navanesan et al do not specifically teach encapsulated form, a food composition, oral administration, an additional agent such as a chemotherapeutic agent, or a treatment frequency, or 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 add an additional agent such as a chemotherapeutic agent since Navanesan et al teach Leptospermum flavescens for lung carcinoma treatment, one of ordinary skill in the art would have been motivated to include an additional agent for treating lung carcinoma in order to achieve additive or synergistic effect.
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 adjust treatment frequency or duration according to the lung cancer condition or the dosage of the treatment, either 20 days or a month, determining an appropriate treatment frequency or duration is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
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 use the form of capsule in clinical study for human since tablet, capsule, and powder are mostly used forms for human oral administration or as a food 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’s arguments have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Navanesan et al.
Conclusion
Claims 44, 45, 58-69, and 71 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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 8:30 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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