An in vitro analytical method that does not perform diagnosis directly on a living human or animal body is not excluded from patentability under Section 3(i) of the Patents Act, 1970, and authorities must independently evaluate all claims in a patent application.

O R D E R

1. This appeal is filed by the Appellant under Section 117A of the Patents Act, 1970 (‘1970 Act’) laying a challenge to order dated 15.04.2024 passed by the Respondent, whereby the patent application of the Appellant has been refused under Section 15 of the 1970 Act on the ground that claims 1-6 are not patentable under Section 3(i) of the 1970 Act.

2. To the extent necessary, facts of the case are that US Priority Application No. 61/595,050 was filed on 21.02.2012 and PCT International Application No. PCT/EE2013/000001 was filed on 21.02.2013. Indian Patent Application No. 7173/DELNP/2014 was filed as National Phase Application on 26.08.2014 out of PCT International Application by MC PROFESSIONAL OU, EIKJE, Natalja and SKREBOVA, Irina, as co-applicants. Voluntary amendment of description and claims of instant application was filed on 13.04.2018 on Form-13. First Examination Report (FER) was issued on 26.02.2021, wherein Respondent raised objections related to lack of inventive step, lack of patentability etc., under Sections 2(1)(ja), 3(d), 3(i) and 3(k), to which reply was filed on 26.08.2021 along with amended set of claims. After hearing was concluded, Appellant filed post-hearing written submissions on 15.10.2023 along with amended set of claims. However, vide impugned order dated 15.04.2024, Respondent refused the grant of patent.

3. Learned counsel for the Appellant submits that Appellant is a Norwegian national with research experience of several years in the fields of dermatology, venereology, physiology, clinical physics, radiology, tomography, medical instrumentation, physiological biophysics and specializes in discovering and developing new approaches to cure skin cancer. Her research is focused on understanding the mechanisms behind carcinogenesis. Present invention relates to ‘An in vitro method of comparative spectral pattern analysis of nucleic acids and proteins molecules sequentially expressed in benign, premalignant and malignant tumourous tissues for characterizing multistage epidermal carcinogenesis model and indicating the grade of neoplastic activity in cells on a biopsied skin tissue sample by FTIR microspectroscopy’ (claims 1-6) and ‘an FTIR microspectrometer’ (claims 7-10) and ‘a combination group of nucleic acids and proteins molecules with characteristic spectral parameters and with characteristic intra- and inter-molecular expression of DNA, RNA and proteins’ (claims 11-16). It is urged that the present application provides an optical method for characterization of carcinogenesis in skin tumourous tissues based on FTIR microspectroscopy and more specifically, it provides an analytical method for simultaneous observation and further characterization of intramolecular and intermolecular interactions for nucleic acids and proteins commonly and specifically expressed in an IR spectrum of pathology, with respect to understanding molecular, cellular and tissue changes occurring during skin carcinogenesis.

4. Learned counsel inter alia raises two broad grounds challenging the impugned order. It is urged that a total of 16 claims were made by the Appellant and while there were no objections raised against claims 7-16, the entire set of claims have been rejected in toto on the ground that claims 1-6 are not patentable under Section 3(i). Assuming for the sake of argument, there was an objection qua claims 1-6, Respondent ought to have passed an order granting claims 7 to 16, which admittedly, do not fall within the purview of Section 3(i) and this is a sufficient ground for setting aside the impugned order and remanding the matter.

5. With regard to rejection of claims 1-6 un