1. Third Party Observations under article 115 of EPC

TKDL third party submission under Article 115 EPC brought to the notice of examination division the prior art references on the use of Zizyphus jujuba, Nelumbo nucifera(Lotus), Portulaca oleracea(Common Purslane), Cinnamomum zeylanicum(Cinnamon) and Malva sylvestris for the treatment of Cystitis / Urethritis  from the books – I'laaj-al-Amraaz by Mohd. Shareef Khan(Unani, Exhibit 1),  Bhaisajya Ratnavali by Govinda Dasa (Ayurveda, Exhibit 2), Quaraabaadeen Quaadri by Mohd. Akbar Arzani (Unani, Exhibit 3), Nighanturatnakarah(Ayurveda, Exhibit 4), I'laaj-al-Amraaz by Mohd. Shareef Khan (Unani, Exhibit 5) and Bharata Bhaisajya Ratnakara (Ayurveda, Exhibit 6).

2. Relevant Extract of EPO Examination report

EPO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report at para 1 are reproduced below:

“With letter dated 28/05/2010 observation of a third party (art: 115 EPC) has been filed and communicated to the applicant (rule 114(2) EPC).

TKDL MH1/2650: Julaab Bara-e-Warm-e-Masaanah Haar, Knowledge since 200 Years (=Exhibit 1; = D15) discloses a composition for the treatment of cystitis comprising Zizyphus jujuba. Hence, in the light of D15 the subject-matter of claims 1-3, 9-12 and 16 is not novel. The subject-matter of claims 4-8 and 13-15 although novel cannot be considered inventive since the contribution of cranberry, or of a calcineurin enzyme activator or of the urine pH stabilizer to the pharmacologic activity of the composition is questionable and there is nothing in the application demonstrating an additional unexpected effect.

TKDL AK/2204: Vrhadgoksuradyavalehah, Knowledge since 200 Years (=Exhibit 2; = D16) discloses a composition for the treatment of cystitis and urethritis comprising Nelumbo nucifera, and Cinnamomum ceylanicum.  Hence, in the light of D16 the subject-matter of claims 1-3, 9-12 and 16 is not novel. The subject-matter of claims 4-8 and 13-15 although novel cannot be considered inventive since the contribution of cranberry, or of a calcineurin enzyme activator or of the urine pH stabilizer to the pharmacologic activity of the composition is questionable and there is nothing in the application demonstrating an additional unexpected effect.

TKDL MH5/1994: Safoof Bara.e.warm-e-Masanah, Knowledge since 200 Hears (=Exhibit3; = D17) discloses a composition for the treatment of cystitis and urethritis comprising Malva Sylvestris and Portulaca oleracea. Hence, in the light of D17 the subject-matter of claims 1-5, 7,9-14 and 16 is not novel. The subject-matter of claims 6,8 and 15 although novel cannot be considered inventive since the contribution of the urine pH stabilizer to the pharmacologic activity of the composition is questionable and there is nothing in the application demonstrating an additional unexpected effect.

TKDL RG/5556: Brhadgoksuradyavalehah, Knowledge since 200 Years (=Exhibit 4; = D18) discloses a composition for the treatment of cystitis and urethritis comprising Nelumbo nucifera, and Cinnamomum ceylanicum.  Hence, in the light of D18 the subject-matter of claims 1-3, 9-12 and 16 is not novel. The subject-matter of claims 4-8 and 13-15 although novel cannot be considered inventive since the contribution of cranberry, or of a calcineurin enzyme activator or of the urine pH stabilizer to the pharmacologic activity of the composition is questionable and there is nothing in the application demonstrating an additional unexpected effect.

TKDL RS/2134: Vrhadgoksuradyavalehah, Knowledge since 200 Years (=Exhibit 2; = D19) discloses a composition for the treatment of cystitis and urethritis comprising Nelumbo nucifera, and Cinnamomum ceylanicum.  Hence, in the light of D19 the subject-matter of claims 1-3, 9-12 and 16 is not novel. The subject-matter of claims 4-8 and 13-15 although novel cannot be considered inventive since the contribution of cranberry, or of a calcineurin enzyme activator or of the urine pH stabilizer to the pharmacologic activity of the composition is questionable and there is nothing in the application demonstrating an additional unexpected effect.”

3. Outcomes of Third Party Observations & Examination Report.

As the outcome of TKDL third party and other documents cited in examination report, Applicant M/s CHIH-HSIUNG LIN, Taiwan, Province of China, decided to amend the claims on 27.04.11. The examination of the application is under progress.

The Applicant originally claimed the usefulness of a composition comprising Zizyphus jujuba, Malva sylvestris, Opuntia Streptacantha, Cinnamomi Cortex, Hippophae rhamnoides, Panax ginseng, Eriobotrya japonica, Citrus depressa Hayata, Nelumbo nucifera, Mosla chinensis, Fructus schisandrae, Dalbergia odorfera, Smilax glabra, kale , Lonicera japonica Thunb., Cordeceps sinensis, Sophorae Radix, Hippophae rhamnoides, Flos Lonicerae, Pulsatillae Radix, extract of the dried leaf of Camellia sinensis (L.) C. Kuntze, Ganoderma lucidum, Gynostemma pentaphyllum, Cynara Scolymus L, Thyme, Fructus Schisandrae, Prunellae spica, Lophatheri spica, Coptis Chinensis Franchet, Dandelion (Taraxacum officinale F. Weber ex Wiggers), Portulacae Herba, Gardeniae Fructus, Sophora subprostrata Radix, Houttuynia cordata Thurn, Forsythia suspense (Thurn) Vahl, Smilax glabra and Coptis groenlandica Salisb and their extracts for treating urethritis or cystitis to be novel. TKDL submitted its prior art evidences stating the usefulness of Zizyphus (Zizyphus jujube), Lotus (Nelumbo nucifera), Common Purslane (Portulacae Herba/Portulaca oleracea), Cinnamon (Cinnamomum zeylanicum) and Common mallow (Malva sylvestris) for the treatment of Cystitis / Urethritis. Based on the TKDL evidences and Examiner’s report the Applicant amended the claims by removing all the plants where prior arts existing in TKDL.