In University of North Texas & Anr. vs Assistant Controller of Patents and Designs [C.A.(COMM.IPD-PAT) 32/2025], the Delhi High Court set aside the refusal of patent application number 202117006438, entitled “Technologies for Rapid Detection and Quantitation of Volatile Organic Compounds (VOCs) Using Breath Samples” and remanded the matter for fresh consideration. The Court held that the impugned order suffered from serious deficiencies, including failure to apply the settled obviousness framework laid down in Agriboard International LLC v. Controller and F. Hoffmann-La Roche Ltd. vs Cipla Ltd. as reiterated in Tapas Chatterjee vs Controller, inadequate examination of sufficiency and clarity objections under Section 10(4) and 10(5), and mechanical invocation of Section 3(i) without analysing whether the claimed invention actually constituted a “diagnostic method”.

The subject patent application related to breathalyser systems and methods for rapid detection and quantitation of volatile organic compounds (VOCs) using breath samples for identifying cannabinoids and other substances in field conditions. The invention sought to overcome limitations in conventional analytical techniques such as gas chromatography coupled with mass spectrometry (GC/MS), which require laboratory analysis and involve significant detection time. According to the Appellants, the claimed invention enabled rapid and accurate on-site detection through the use of a THz spectrometer, heating elements, and a molecule collector within a sampling chamber.

The application was refused on grounds of lack of inventive step under Section 2(1)(ja), non-patentability under Section 3(i), insufficiency of disclosure and lack of clarity and conciseness under Section 10(4) and 10(5). The Appellants challenged the refusal principally on the basis that the Controller had failed to conduct the legally mandated inventive step analysis, demonstrated non-application of mind and issued a cryptic and non-speaking order.

The Court noted that in Tapas Chatterjee, the Division Bench had clarified that the five-step obviousness framework laid down in F. Hoffmann-La Roche must be followed sequentially while assessing inventive step. Examining the impugned order, the Court found that the Controller had failed at the very threshold to identify the person skilled in the art (PSITA), which itself vitiated the inventive step analysis. The Court further observed that even the inventive concept embodied in the invention had not been properly identified, and the Controller had incorrectly incorporated the technical features of the claimed invention in the impugned order.

The Court found that while the Controller had referred to the similarities and differences in prior art documents D1 and D2, there was no substantive analysis as to how the claimed invention would have been obvious to a PSITA. The impugned order merely concluded that the use of a heating element and THz spectrometer did not amount to a technical advancement over prior art systems employing SERS or nanoparticle-based sensors. The Court held that such conclusions were unsupported by analytical reasoning and failed to explain how the specific differentiating features identified by the Appellants were either disclosed in or rendered obvious by the cited prior art documents.

The Court noted that the Appellants had specifically argued that D1 relied on Surface Enhanced Raman Spectroscopy (SERS), whereas D2 employed nanoparticle-based sensing mechanisms, and neither disclosed nor suggested the claimed THz spectroscopy-based system. Despite these detailed submissions, the Controller had failed to analyse these distinctions.

The Court observed that the inventive step analysis bordered on a hindsight approach, which had been expressly condemned in F. Hoffmann. Relying also on Agriboard International LLC vs Deputy Controller of Patents and Designs, the Court reiterated that inventive step determinations must necessarily involve examination of: (i) the invention disclosed in prior art; (ii) the invention disclosed in the application; and (iii) the manner in which the subject invention would be obvious to a PSITA. The absence of this exercise rendered the refusal unsustainable.

On the objection under Section 10(4) and 10(5), the Court similarly found the reasoning in the impugned order inadequate. The Controller had objected that the “molecule collector” and “heating element” lacked sufficient structural and functional disclosure. However, the Court noted that the Appellants had specifically referred to paragraphs of the specification along with figures to explain the structure, material composition, and operation of the molecule collector and heating mechanism. The specification expressly disclosed that the heating element could apply voltage to the molecule collector, thereby heating the sampling chamber and enabling release of VOCs. The Court found that these explanations had not been addressed in the impugned order.

In this context, the Court relied on the Bombay High Court’s decision in JFE Steel Corporation vs Controller of Patents & Designs, where it had been held that refusal orders based solely on insufficiency without independent analysis of substantive patentability requirements i.e. novelty and inventive step, are unsustainable. The Court observed that the Controller had failed to indicate what additional disclosure was allegedly necessary or why the existing disclosure was insufficient for a PSITA to perform the invention.

The Court also found merit in the Appellants’ challenge to the Section 3(i) objection. The Controller had characterised claim 14 as a “diagnostic method” because it involved analysing breath samples for VOC detection. In support of this objection, the Controller relied upon a figure from the specification, titled “graph illustrating observed VOCs for a breath sample of a person suffering from seasonal allergies”, as well as a paragraph from the specification, which referred to the need for improved detection of “synthetic opioid overdoses” in civilians and military personnel. On this basis, the Controller concluded that identifying a drug overdose constituted a medical diagnosis requiring immediate therapeutic intervention.

The Court held that this conclusion had been reached without analysing the claims and applying any test for determining whether the claimed invention actually fell within the ambit of a diagnostic method. The Court noted the Appellants’ reliance on the Madras High Court’s decision in Chinese University of Hong Kong v. Assistant Controller of Patents & Designs, wherein it was held that diagnosis in the context of Section 3(i) pertains to identifying the existence or nature of a disease or disorder or medical condition and/or the site, extent, severity or other aspects thereof. The Court noted that the present invention was directed towards detection and quantification of cannabinoids in breath samples. Accordingly, the Court held that the Controller had mechanically invoked Section 3(i) without undertaking the necessary analysis.

In view of the above, the Court set aside the impugned order and remanded the matter to the patent Office for fresh consideration.