Ref: Examiner(s) Comments in the Examination Report Dated: 02.03.2015 on TKDL Submission Dated: 05.07.2012 in the context of Patent Application No. 09832680.4 (EP2393503) at EPO

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 Terminalia arjuna (Arjuna), Commiphora wightii (Guggulu), Inula recemosa and Hippophae rhamnoides (seabuckthorn) for the treatment of Diseases of heart, Obesity, Angina pectoris, Palpitation, Diabetes mellitus and as cardio-tonic from the books – Bharata Bhaisajya Ratnakara (Ayurveda, Exhibit 1), Rasayoga Sagara (Ayurveda, Exhibit 2), Astanga Samgraha by Vagbhatta (Ayurveda, Exhibit 3), Bhavaprakasa by Bhavamisra (Ayurveda, Exhibit 4), Brhat Nighantau Ratnakara (Saligramanighantubhusanam) (Ayurveda, Exhibit 5), Vangasena by Vangasena (Ayurveda, Exhibit 6), Rasaratnasamuccayah by Vagbhagttah (Ayurveda, Exhibit 7) and Rasatantrasarah Evam Siddhaprayogasamgrahah (Ayurveda, Exhibit 8).

2. Relevant Extract of EPO Examination report

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

“It is noted that the compositions of D1 and D5 are directed to the same use, and in the field of phytotherapy, it is a common approach to combine ingredients, especially if it is known that they have the same therapeutic effect. Furthermore, an additive effect can then be expected and would not justify the acknowledgement of inventive step.

The late filed data, comparative examples over what is disclosed in D1 and what can be expected from a combination of D1 and D4, shows that only in a few parameter a statistically significant improvement of the composition with four ingredients (i.e. Test formulation No. II) with the composition of D1 (i.e. Test formulation No. I). With respect to HDL-c level, LDL-c level, triglycerides, adiponectine, and endothelin-1, there is no statistically significant difference.

An additive effect is however what the skilled man would expect from combining D1 and D4, also taking into consideration the description where the four ingredients are randomly combined. What is shown in the late filed evidence is plausible, but also in line what the skilled man would expect from combining D1 and D4.

In order to acknowledged inventive step, a synergistic effect, beyond what could be expected from combining ingredients and obtaining an obvious additive effect, would need to be shown.”

Full examination report can be referred at EP2393503-II.pdf

3. Outcomes of Third Party Observations & Examination Report.

As the outcome of TKDL third party and other documents cited in examination report, the examination is under process and reply is still awaited from the Applicant Anurag Sharma / INDIA.