1. Relevant Extract of CGPDTM Examination report

Based on search conducted in TKDL database the Examiner concluded:

“Subject matter does not constitute an invention u/s 2(1)(j). Claims are not novel and lack inventive step in view of the following formulations disclosed in TKDL database.”

S.No. Formulation-
1. BA3/465 Hab Deedan
2. BA3/478 Hab Barg-e- Neeb
3. BA4/1745 Nuskha Dawa
4. BA4/1745A Habb Musaffi-e-khoon
5. BA4/1754 Nuskha Naqoo
6. MA3/122 Habb-e- Surkhbada
7. MA3/160 Habb-e- Musaffi-e-khoon Ba Nuskha Khaas
8. MH1/2352 Hab Bara-e- Ishaal-e- Atfaal
9. MH1/2352A Hab Barae Ishaal-e- Atfaal – A
10. NA4/1027 Khesanda Surkhbada
11. NA4/4068 Hab Barae Deedaan Deegar Qawitar
12. NA4/4083 Habb-e- Bawaaseer Khooni

Based on examiner’s reports and applicants arguments’ the controller made the following decision:

“The application was examined u/s 12 and 13 of the Patents Act, 1970 and first examination report (FER) was issued on 11/02/2011. The main technical objection raised were as follows
-that the claims do not constitute an invention u/s 2(1)(j) as the claims lack inventive step;
-that the claims fall u/s 3(p) in view of TKDL documents.”

Second examination report along with hearing notice was issued to the applicant on 9/11/2012. The main technical objection raised in SER were as follows -
-that the claims do not constitute an invention u/s 2(1)(j) as the claims lack inventive step in view of cited TKDL documents;
-that the claims fall u/s 3(p) in view of TKDL documents;

Applicant’s arguments have been carefully considered but are not deemed persuasive.
Applicant argues that the cited TKDL references do not teach combination of standardized plant parts in certain ratio and process parameters.

“I refer to ‘Guidelines for processing of patent applications relating to Traditional Knowledge and Biological materials’.

(“Guiding Principle 4: Discovering the Optimum or Workable Ranges of Traditionally known ingredients by Routine experimentation is not inventive.)

“I observe that although the cited references do not specifically teach adding the ingredients in the amounts claimed by the applicant, however the references does teach the ingredients Maghz-e-Nimkoli, Rasaut and Chaksu as a composition to treat skin disorders. This reasonable expectation of success would motivate an artisan of ordinary skill to use the said plant parts for reaching at the claimed composition.”

Further the clinical results furnished by the applicant shows that by the use of the claimed composition the patients got complete relief from all symptoms. I observe that the said clinical studies do confirm the activity of the claimed composition (which is also indicated in the cited TKDL documents) but do not show any enhanced efficacy or unexpected surprising results.

In absence of any inventive feature in the claims, the said claimed composition is considered to be aggregation of known properties of traditionally known components. Therefore, the said claims fall u/s 3(p) of the Patents Act, 1970.

“I observe that the process steps as claimed in claim 2 are routine experimentation steps and are general state of art for a skilled artisan who would be motivated to use the same for reaching at the claimed composition in view of the cited TKDL documents. Therefore, claim 2 lack inventive step and does not constitute an invention u/s 2(1)(j) of the Patents Act, 1970.”

In view of the above said, it is inferred that the amended claims 1 and 2 lack inventive step and therefore do not constitute an invention u/s 2(1) (j) of the Patents Act, 1970. Also the said claims fall u/s 3(e) and u/s 3(p) of the Patents Act, 1970.

The application is refused for grant of patent.

Full examination report can be referred at 1576_DEL_2006.pdf

3. Outcomes of Examination Report

As the outcome of TKDL references and other documents cited in examination reports, Controller, CGPDTM decided to refuse the Application 1576/DEL/2006 for grant of patent on 27-Dec-12.