Failure to evaluate amended claims significantly altering patent scope constitutes a glaring error necessitating fresh adjudication on remand.

The Appellant filed a patent application (No. 201617000758) on January 8, 2016, titled “SC-β CELLS AND COMPOSITIONS AND METHODS FOR GENERATING THE SAME”

Following the issuance of a First Examination Report (FER) and a subsequent hearing on August 6, 2021, the Appellant filed written submissions and a set of amended claims on August 21, 2021

The original claims primarily related to a "composition comprising a non-native pancreatic β cell" along with carriers and diluents

However, the amended claims shifted the focus to the "non-native pancreatic β cell" itself

On August 25, 2022, the Respondent (Controller) issued the Impugned Order refusing the grant of the patent under Sections 3(j), 3(e), 10(4), and 10(5) of the Patents Act, 1970

The Appellant challenged this order on the grounds that the Controller failed to consider the amended claims and incorrectly applied statutory exclusions

1. Whether the Controller committed a procedural error by refusing the patent application based on the original claims while ignoring the amended claims submitted post-hearing

2. Whether the claimed "non-native pancreatic β cells" constitute non-patentable subject matter under Section 3(j) as "parts of animals" or whether they are patentable as man-made, non-naturally occurring constructs

3. Whether the application met the requirements of sufficiency of disclosure and definitiveness under Sections 10(4) and 10(5)

The court primarily applied Section 15 of the Patents Act, 1970, which governs the Controller's power to refuse or require amendments to applications

It examined Section 3(j), which excludes plants and animals (in whole or part) from patentability, and Section 3(e), regarding mere discoveries of known substances

The court further relied on the procedural requirements of Sections 10(4) and 10(5) regarding the clarity and scope of claims

The court applied the precedent from Jitendra Kohli v. The Controller of Patents, which establishes that failure to consider amended claims during the adjudication process constitutes a "glaring error"

It also followed Akebia Therapeutics INC v. The Controller of Patents and Designs, holding that when the nature of a claim changes (e.g., from composition to cell), the Controller must address the substance of the amended claims

The Court observed that while the Controller’s order mentioned the "Alternative set of Claims" filed by the Appellant, it did not actually evaluate them

Instead, the Controller’s findings on non-patentability (Section 3(j) and 3(e)) and lack of definitiveness (Section 10(4) and 10(5)) were predicated entirely on the original "composition" claims

The Court highlighted that the amended claims significantly altered the scope of the invention by claiming the "non-native pancreatic β cell" directly rather than a pharmaceutical composition

Consequently, the technical objections regarding missing disclosure of carriers or synergy in a composition were rendered moot or required a completely different analysis in light of the amended subject matter

The Court reasoned that a refusal order cannot stand if it ignores the actual claims the applicant seeks to patent at the time of the decision, as this violates the principles of natural justice and the statutory scheme of the Patents Act

The Court held that the failure to consider the amended claims was a procedural impropriety that necessitated a remand

The matter was remanded to the Controller for fresh consideration specifically in light of the amended claims filed on August 21, 2021

The Controller was directed to pass a detailed order within six months after providing the Appellant with an opportunity for a hearing

The Court clarified that it did not express any opinion on the merits of patentability under Section 3(j) or other sections, leaving those questions to be decided de novo by the Controller