Controller must follow sequential five-step test and consider written submissions when determining lack of inventive step.

The Appellants filed Indian Patent Application No. 201917035558 titled "Means and Methods for Oral Protein Delivery," seeking to protect a dried formulation of recombinant yeast culture medium for therapeutic use.

The Controller issued a First Examination Report (FER) raising objections under Sections 2(1)(ja) and 3(c), (d), (e), and (i) of the Patents Act, 1970.

Despite the Appellants filing detailed responses and post-hearing written submissions distinguishing eight prior art documents (D1–D8) and disclosing the biological material's origin as "van Belgium," the Respondent refused the application via an order dated 28.03.2025.

The refusal was based on lack of inventive step, non-disclosure of biological source, and the "vague" nature of product-by-process claims lacking SEQ ID numbers.

1. Whether the impugned order was non-speaking and failed to consider the Appellants' written submissions in violation of the principles of natural justice.

2. Whether the Controller followed the mandatory five-step test for determining "inventive step" and "obviousness" under Section 2(1)(ja).

3. Whether the Controller erred in holding that the product-by-process claims were insufficiently defined/vague under Section 10.

4. Whether there was a failure to disclose the geographical origin of biological material under Section 10(4)(ii)(D).

The court applied Section 2(1)(ja) regarding "inventive step" and Section 10(4) and (5) concerning the sufficiency of disclosure and the scope of claims.

It relied on the precedent in Boehringer Ingelheim Vetmedica GMBH v. Controller of Patents, emphasizing that a failure to consider a party's technical justifications in written submissions warrants a remand.

It further followed the mandatory five-step sequential test for "obviousness" established in F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd. and reaffirmed in Tapas Chatterjee v. Assistant Controller of Patents and Designs, which requires identifying the "person skilled in the art" and the specific differences between the prior art and the invention.

The Court found the impugned order to be a "verbatim reproduction" of the hearing notice, lacking independent analysis of the Appellants' technical arguments.

Regarding Section 10(4)(ii)(D), the Court noted a "perverse" finding by the Controller, as the Appellants had twice disclosed the origin as Belgium, yet the Controller treated it as a non-disclosure.

On the issue of inventive step, the Court observed that the Respondent failed to identify the "person skilled in the art" or explain why such a person would combine D1–D8 to arrive at the specific filtration and drying process of the invention.

The Court highlighted that the Controller ignored the "unexpected technical effect" of the Pichia-derived formulation being superior to plant-derived systems.

The Court criticized the Controller for summarily dismissing product-by-process claims as "vague" without addressing the legal necessity of such claims when a product cannot be described by structure alone.

The Court quashed the order dated 28.03.2025 and remanded the matter to the Respondent for reconsideration, directing a fresh hearing and a reasoned speaking order within four months.