JUDGMENT

Prathiba M. Singh, J.

Brief Facts

1.  This is an appeal under Section 117A of the Patents Act, 1970 (hereinafter `the Act') challenging order dated 31st August, 2021, issued by the ld. Assistant Controller of Patents and Designs (hereinafter `Controller'). By the impugned order, the Appellant's patent application bearing number 201717000025 titled `Methods of Increasing Tonic Inhibition and Treating Secondary Insomnia' (hereinafter `subject patent') has been refused under Section 15 of the Act. The Bibliographic details of the subject patent application are set out below:

APPLICATION NUMBER 201717000025APPLICATION TYPE PCT NATIONAL PHASE APPLICATIONDATE OF FILING02/01/2017APPLICANT NAMEOVID THERAPEUTICS INC.TITLE OF INVENTIONMETHODS OF INCREASING TONIC INHIBITION AND TREATING SECONDARY INSOMNIAFIELD OF INVENTIONPHARMACEUTICALSADDITIONAL-EMAIL (As Per Record)knk@kankrishme.comPCT INTERNATIONAL APPLICATION NUMBER PCT/US2015/034018PCT INTERNATIONAL FILING DATE 03/06/2015PRIORITY DATE 06/06/2014REQUEST FOR EXAMINATION DATE 18/05/2018PUBLICATION DATE (U/S 11A) 07/04/2017REPLY TO FER DATE 13/02/2020

2. The Appellant filed the present application as a National Phase Application, before the Indian Patent Office on 2nd January, 2017. The said application arose out of the PCT application dated 3rd June 2015, bearing number PCT/US2015/034018. The said application claimed priority from a US Patent Application, with a priority date of 6th June, 2014.

3. The Appellant filed the request for examination of the subject patent application on 18th May, 2018. In response to the request for examination, a First Examination Report (FER) with a statement of objections was issued on 16th August, 2019 by the Controller. The objections raised were of lack of novelty, lack of inventive step and non- patentability under Section 3 (i) and Section 3 (e) of the Act. As per the FER, Claims 1-28 of the subject patent application were directed towards a method of treatment and fell within the scope of non-patentability under Section 3(i) of the Act. Further, it was stated that the claimed composition as per Claims 1, 4-8 and 18-28 were obtained by a mere admixture resulting only in an aggregation of the properties of the components without any synergistic effect, thereby attracting the objection under Section 3(e) of the Act. In addition, the ground of insufficiency of disclosure and definitiveness in the Claims, in violation of the requirements under Sections 10(4)(c) & 10(5) of the Act, were also raised by the Controller in the FER.

4. To substantiate the objection of lack of novelty the Controller relied on the prior art document being D1 which discloses the effect of Gaboxadol in a model of Angelman syndrome, anticipating Claims 1-28 of the subject patent application. For the purpose of lack of inventive step, prior arts D2- D5 were cited by the Controller. The details of the said prior art documents cited by the Controller are as under:

(i) D1-Decreased Tonic Inhibition in Cerebellar Granule Cells Causes Motor Dysfunction in a Mouse Model of Angelman Syndrome by K. Egawa et. al. with publication date 5th December, 2012;

(ii) D2- JP2012501301 A, titled `Pharmaceutical composition comprising gaboxadol and PAT1 inhibitor or OAT inhibitor', with publication date 19th January, 2012;

(iii) D3-US2005/0137222 A1, titled `Treatment of Insomnia in Humans' with publication date 23rd June, 2005;

(iv) D4-WO2009/056146, titled `Pharmaceutical Composition Comprising Gaboxadol and an Inhibitor of PATL or Oat' with publication date 7th May, 2009;

(v) D5- US2011/0046090 A1 titled `Modulation of Neurogenesis with Gaba Agents and Gaba Analogs' with publication date 24th February, 2011.

5. A response dated 13th February, 2020 was filed to the said FER by which the Appellant amended the Claims of the subject patent to Claims 1- 20, and limited the present invention to `a composition'. It is the stand of the Appellant that by the said amendments the Appellant had clarified th

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