Ref: Examiner(s) Comments in the Examination Report Dated: 25.08.2011 on TKDL Submission Dated: 23.05.2011 in the context of Patent Application No. 12/674,113 (20110097424) at USPTO

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 Pongamia pinnata (Karanja), Lawsonia alba (henna), Datura innoxia (desert thorn apple) and Cocos nucifera (coconut), for the treatment of ulcer/wound from the books – Ayurvedic  Formulary of India - Part II, Govt. of India, Ministry of Health & Family Welfare, (Ayurveda, Exhibit 1), Din Abdullah Ibn Al- Baitar; Al-Jaam'e-li-Mufradaat-al-Advia-wal-Aghzia, Vol. I by Ziya Al (Unani, Exhibit 2), Muheet-e-Azam Vol. IV by Mohammad Azam Khan  (Unani, Exhibit 3), Kaamil-al-Sena'ah, Part  II by Ali Ibn-e-Abbaas Majoosi; (Unani, Exhibit 4), Qaraabaadeen Qaadri by  Mohammad Akbar Arzani; (Unani, Exhibit 5), Al-Qaanoon-fil-Tibb, Vol. V by Abu Ali Ibn-e-Sina; (Unani, Exhibit 6, 7, 8)  and Kitaab-al-Haawi-fil-Tibb vol IV by Abu Bakr Mohammad.Bin Zakariyya Al-Razi; (Unani, Exhibit 9 &10)

2. Relevant Extract of USPTO Examination Report

USPTO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report are reproduced below:
“Claim 1-6 are rejected under 35 U.S.C. 103(a) being unpatentable over Agasthiyar (Agathiyar vaithya vallanthi 600, Pub&Ed Deenadhayalu muthaliar, Chennain (1924).

This reference teaches a composition which comprises extracts of Pongamia pinnata and Lawsonia alba. This composition is formulated as an oil for topical treatment of ulcers and wounds.

            This reference does not specifically teach adding the ingredients in the percentages claimed by applicant. The amount of specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller,220 F.2d 454,456,105 USPQ 233,235 (CCPA 1955). The reference teaches that each of the claimed ingredients is an active ingredient. An artisan of ordinary skill would routinely modify the amount of pharmaceutically active ingredients based on the patient’s age, weight, gender, and condition. Therefore, an artisan would have been motivated to modify the amount of each ingredient in  the combination in order to formulate a product that best achieves the desired results set forth in the reference. Thus, absent some demonstration of unexpected results form the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.

            The reference also does not specifically teach formulating the composition into an ointment or a cream. However, as discussed above, the reference does teach using the compositing topically. Ointments and creams are well known topical compositions. Thus, an artisan of ordinary skill would be motivated to formulate the composition taught by the reference into these known forms.”

Full examination report can be referred at 20110097424.pdf

3. Outcomes of Third Party Submission & Examination Report

As the outcome of TKDL third party and other documents cited in examination report, the Applicant, Apptec Inc,C/o Bregen TechnicaL ConsultantS L.L.C., NJ, US, decided to amend the claims on 19. 12.12. The application is Rejected finally on 20.04.2012.

Analysis of amendment of claims

The Applicant originally claimed the usefulness of a formulation comprising at least two of the following: an extract of Pongamia pinnata (in the range of 2 to 20%), an extract of lawsonia alba (in the range of 5 to 15%), an extract of Dhatura alba (in the range of 2 to 20%) and an extract of of Cocos nucifera (in the range of 20 to 60%) for the management of chronic ulcer, diabetes ulcer, and the management of bleeding in cuts and wounds. TKDL submitted its prior art evidences stating the usefulness of Karanj (Pongamia pinnata), Heena (lawsonia alba), Datura (Dhatura alba) and Coconut (Cocos nucifera) for the treatment of Ulcer and Non healing ulcer.. Based on the TKDL evidences and Examiner’s report the Applicant amended the claims by making all the four plants i.e. Pongamia pinnata (in the range of 2 to 20%), an extract of lawsonia alba (in the range of 5 to 15%), an extract of Dhatura alba (in the range of 2 to 20%) and an extract of Cocos nucifera (in the range of 20 to 60%) compulsory in the formulation.