1. Third Party Submission under Art 37 CFR 1.99
TKDL third party submission under Art 37 CFR 1.99 brought to the notice of examination division the prior art references on the use of Myristica fragrans (Jatiphal) for the treatment of Freckle, Chloasma/Melasma/Melanoderma, Skin Marks, Mothers mark/Naevus and as Rubefacient and Complexion enhancer from the books –Bhavaprakasa by Bhavamisra (Ayurveda, Exhibit 1), Bharata Bhaisajya Ratnakara (Ayurveda, Exhibit 2 & 4), Khazaain-al-Advia, Vol II by Mohammad Najmul Ghani Khan (Unani, Exhibit 3 & 5), Khazaain-al-Advia, Vol I by Mohammad Najmul Ghani Khan (Unani, Exhibit 6), Al-Qaanoon-fil-Tibb, Vol. II by Abu Ali Ibn-e-Sina (Unani, Exhibit 7) and Gadanigrahah by Sodhala (Ayurveda, Exhibit 8).
2. Relevant Extract of USPTO Examination Report
USPTO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report are reproduced below:
“Applicant argues that the BhavamiSra Bhavaprakasa reference does not specifically disclose the macelignan and does not disclose that the macelignan compound is useful for inhibiting melanin production. In response to applicant’s arguments against the reference individually, one cannot show nonobviousness by attacking reference individually where the rejections are based on combinations of reference.
As taught by Hwang et all., Macelignan is clearly present in Myristica fragrans (i.e. nutmeg) which is used in the formulation taught by BhavamiSra Bhavaprakasa reference.
Claim 9 is rejected under 35 U.S.C, 103 (a) as being unpatentable over BhavamiSra; Bhavaprakasa (Edited & translated by Brahmasankara Misra, Part-II: Chaukhamba Sanskrit Sansthan, Varanasi, Edn. 7th, 2000. [Time of origin 16th century], pg 589; Formulation Id: RG/2838A; Formulation Name: Jatiphalalepah; Publication (Prior art): pg No. 03; English Translation including Terminology Conversion (TKDL Extract): pg No.04-05 – Cited on IDS) in view of Hwang et al. (KR 1020050073027 A). It is noted that US 2009/0192217 A1 is used as the English language equivalent of the KR publication for citation purposes.
The formulation Jatiphalalepah is a therapeutic single compound formulation consisting of the useful parts of the nutmeg tree Myristica fragrans Houtt, wherein the ingredients are made into a fine power and mixed with liquid to form a paste. The paste is locally applied, such as to the face, for the treatment of freckles and cholasma/melasma/melanoderma (i.e. abnormal darkening of the skin caused by excess melanin).”
Full examination report can be referred at US2040118346.pdf
3. Outcomes of Third Party Submission & Examination Report
As the outcome of TKDL third party and other documents cited in examination report, the examiner decided to reject the claim 9 on 24.12.2012 under 35 U.S.C 103 (a) and applicant amended the claims on 24.06.2013. Examiner again rejected the claim 9 on 27.03.2014.