1. Third Party Observations under Section 27 of the Australian Patent Act of 1990.

TKDL third party submission under Section 27 of the Australian  Patent Act of 1990 brought to the notice of examination division the prior art references on the use of Rheum palmatum as Cardio-tonic and for the treatment of Weakness of heart, Palpitation and Cancer from the books – Kitaab-al-Haawi-fil-Tibb by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani, Exhibit 1), Kitaab-al-Haawi-fil-Tibb by Abu Bakr Mohammad.Bin Zakariyya Al-Razi (Unani, Exhibit 2), Qaraabaadeen Najm-al-Ghani by Mohammad Najmul Ghani Khan (Unani, Exhibit 3) and Ikseer Azam by Mohammad Azam Khan (Unani, Exhibit 4).

2. Relevant Extract of IP Australia Examination report

IP Australia Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at para 2 are reproduced below:

“The invention defined in claims 1-12, 15-20, 23-28, 31-46, 59-62  is not novel (and does not involve an inventive step) when compared with the following prior art documents that disclose all the essential features of the invention claimed:

NOTE: The following documents D5-D8 were cited by a third party under Section 27 of the Australian Patent Act of 1990 on 21 January 2011 with a letter written on 10 January 2011. A copy of these documents and translation had been forwarded to the applicant on 22 February 2011.

D5:      Kitaab-al-Haawi-fil-Tibb, Vol. XX by Abu Bakr Mohammad. Bin Zakariyya Al-Razi (9th century AD), Dayerah-al-Ma’aarif Usmania, Hyderabad, (first Edition) 1967 Ad, Pg 525 Relevant to claims: 1-12, 17-20, 25-28, 33-46, 59-62

D6:      Kitaab-al-Haawi-fil-Tibb, Vol. XX by Abu Bakr Mohammad. Bin Zakariyya Al-Razi (9th century AD), Dayerah-al-Ma’aarif Usmania, Hyderabad, (first Edition) 1958 Ad, Pg 38 Relevant to claims: 1-12, 17-20, 25-28, 33-46, 59-62

D7:      Qaraabaadeen Najm-al-Ghani by Mohammad Najmul ghani Khan (20th century AD), Munshi Nawal Kishor, Lucknow, (Second Edition) 1928 Ad, Pg 456 Relevant to claims: 1-12, 15-20, 23-28, 31-46, 59-62

D8:      Ikseer Azam, Vol, IV by Mohammad Azam Khan (19th Century AD), Matba Nizami, Kanpur, 1872 AD, Pg 324 Relevant to claims: 1-12, 15-20, 23-28, 31-46, 59-62

D5       discloses a formulation containing Rheum Palmatum as a single ingredient used for the treatment of weakness of heart through oral administration.

D6       discloses a formulation containing Rheum Palmatum as a single ingredient used for the treatment of palpitation through oral administration.

D7       discloses a formulation containing Rheum Palmatum along with one other ingredient used as cardio-tonic through oral administration.

D8       discloses a formulation containing Rheum Palmatum along with one other ingredient used for the treatment of cancer through oral administration.

NOTE: The claims include expressions such as compositions that modulate or methods of modulating the expression of genes under control of an estrogen or TNF response element, which do not limit the scope of the claims. For example, claims 1 and 62 define a composition “that modulates the expression of a gene under control of an estrogen response element….” This place limits the scope of this claim to the extent that the composition must be suitable, but not limited, to such as use. The claims are, therefore, considered to be directed to the compositions per se. Therefore, a citation only needs to disclose a composition comprising a compound this (see above), claims 1 and 62 are not novel. Furthermore, claim 9 defines a method of “modulating the expression of a gene under control of an estrogen response element comprising administering…a composition comprising one or more compounds obtained form…Rheum palamatum…” Claim 40 defines a method very similar to claim 9 except that the gene is under control of a TNF response element instead of an estrogen response element. Dependent claims 11-16 further define the method to include the treatment or prophylaxis of a variety of conditions or disease. However, D5, D6, D7 and D8 each disclose methods of treating the same conditions (menopausal symptoms or cancer) with the same composition (comprising extracts of Rheum palmatum) as defined in the claims.”

Full examination report can be referred at 2008296078.pdf

3. Outcomes of Third Party Observations & Examination Report.

On the basis of TKDL third party and other documents cited in examination report, Examination of the application is under progress and reply from the applicant M/s BioNovo, Inc., 5858 Horton Street Suite 375 Emeryville CA 94608 United States of America is still awaited.