Here is a detailed legal journal-style article based on University of North Texas & Anr. v. Assistant Controller of Patents and Designs, C.A.(COMM.IPD-PAT) 32/2025, decided on 12 May 2026 by the Delhi High Court.
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Delhi High Court Sets Aside Patent Refusal for Breath Analysis Technology: University of North Texas Case Explained
Inventive Step, Diagnostic Method and Sufficiency of Disclosure in Patent Law: Delhi High Court's Landmark Ruling
Can Breath Analysis Technology Be Patented? Delhi High Court Clarifies Section 3(i) of Patents Act
University of North Texas v. Assistant Controller of Patents: Detailed Analysis of Delhi High Court Patent Decision
Delhi High Court Reiterates Five-Step Test for Inventive Step in Patent Examination
Patent Office Must Pass Reasoned Orders: Delhi High Court Remands Breathalyser Patent Application
Section 3(i) Diagnostic Method Exception Explained Through University of North Texas Patent Case
Delhi High Court on Inventive Step, Sufficiency of Disclosure and Patentability of Breath Sample Analysis Technology
University of North Texas & Anr. v. Assistant Controller of Patents and Designs: Delhi High Court Reaffirms the Need for Proper Analysis of Inventive Step, Sufficiency of Disclosure and Diagnostic Method Exclusions
Introduction
The judgment delivered by the Delhi High Court in University of North Texas & Anr. v. Assistant Controller of Patents and Designs is another important addition to the growing body of Indian patent jurisprudence dealing with inventive step, patentability of diagnostic technologies, sufficiency of disclosure and the obligation of Patent Controllers to pass reasoned orders. The case arose from the refusal of a patent application relating to technologies for rapid detection and quantitation of volatile organic compounds (VOCs) through breath samples. The invention was intended to facilitate quick identification of substances such as cannabinoids and other compounds from a person's breath, particularly for use in field conditions by law-enforcement agencies.
The Court was called upon to determine whether the Patent Office had correctly applied the legal principles governing inventive step under Section 2(1)(ja) of the Patents Act, 1970, sufficiency of disclosure under Section 10(4), and the exclusion of diagnostic methods under Section 3(i). Justice Jyoti Singh ultimately concluded that the refusal order suffered from significant legal deficiencies because the Controller failed to properly analyse the applicant's submissions and did not apply the settled judicial tests governing patent examination. Consequently, the matter was remanded for fresh consideration.
Factual and Procedural Background
The appellants, University of North Texas and another applicant, filed a Patent Cooperation Treaty (PCT) application bearing No. PCT/IB2019/056456 claiming priority from US Patent Application No. 62/712,941 dated 31 July 2018. The corresponding Indian National Phase Application No. 202117006438 was filed before the Indian Patent Office on 16 February 2021 for an invention titled “Technologies for Rapid Detection and Quantitation of Volatile Organic Compounds (VOCs) Using Breath Samples.”
The Request for Examination was filed on 4 July 2022. The First Examination Report (FER) was issued on 18 April 2023 raising objections under Section 2(1)(ja) for lack of inventive step, Section 3(i) for non-patentability, and Sections 10(4) and 10(5) relating to clarity, conciseness and sufficiency of disclosure. The applicants responded to the FER on 25 September 2023 and amended the claims. A hearing was conducted on 21 October 2024, followed by written submissions on 5 November 2024. Ultimately, the Assistant Controller refused the application by order dated 31 January 2025.
The invention related to breathalyser technology capable of rapidly identifying cannabinoids and other volatile organic compounds through breath samples. The applicants explained that conventional testing methods relied on blood, urine or oral fluid samples analysed using gas chromatography coupled with mass spectrometry. These methods required laboratory testing and often consumed considerable time. The claimed invention sought to overcome these limitations by providing a portable and efficient system capable of real-time field analysis.
According to the applicants, the technology could be particularly useful for law-enforcement agencies attempting to identify drivers under the influence of marijuana and other substances. Existing technologies such as liquid chromatography coupled with mass spectrometry (LC/MS), high-field asymmetric waveform ion mobility (FAIMS) and spectroscopy-based systems suffered from various drawbacks including delayed analysis, inadequate sensitivity or limited field usability. The invention aimed to address these shortcomings through the use of a molecule collector, heating element and Terahertz (THz) spectrometer.
The Dispute Before the Court
The principal dispute before the Court concerned the validity of the refusal order passed by the Patent Office.
The applicants argued that the Controller had incorrectly concluded that the invention lacked inventive step over prior art documents D1 and D2. They submitted that neither D1 nor D2 disclosed the essential features of the invention, particularly the use of a THz spectrometer comprising an excitation source and detector operating in the specific manner claimed. They further argued that the Controller had failed to apply the well-established legal tests governing obviousness and inventive step.
The applicants also challenged the findings relating to insufficiency of disclosure and lack of clarity. According to them, the complete specification adequately described the structure and operation of the molecule collector, heating element and THz spectrometer. The refusal order allegedly ignored detailed explanations already provided in response to the FER.
Another important dispute concerned Section 3(i) of the Patents Act. The Controller had held that the invention amounted to a diagnostic method and was therefore excluded from patentability. The applicants argued that the invention merely analysed breath samples to detect substances and did not diagnose any disease, disorder or medical condition.
The Patent Office, on the other hand, defended the refusal order by asserting that D1 and D2 disclosed similar systems for collecting, conditioning and analysing breath samples. It argued that replacing existing sensing technologies with a THz spectrometer was merely a routine substitution and did not constitute a technical advance. The Controller also maintained that the claims lacked adequate disclosure and fell within the scope of diagnostic methods excluded under Section 3(i).
Reasoning and Analysis of the Judge
Justice Jyoti Singh began by examining the settled legal principles governing inventive step. The Court noted that the law relating to inventive step had been comprehensively explained in earlier judicial precedents and that Controllers are required to apply these principles systematically while assessing patentability.
A major deficiency identified by the Court was the Controller's failure to apply the five-step obviousness test formulated by the Division Bench of the Delhi High Court in F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., 2015 SCC OnLine Del 13619. According to this test, the Controller must identify the person skilled in the art, identify the inventive concept embodied in the patent, ascertain common general knowledge, identify differences between prior art and the invention, and finally determine whether those differences would have been obvious to a skilled person while avoiding hindsight analysis.
The Court observed that the Controller had not even completed the first step of identifying the person skilled in the art. This failure itself was sufficient to undermine the validity of the refusal order. The Court further noted that the Controller had incorrectly identified the inventive concept and failed to meaningfully analyse the distinctions highlighted by the applicants.
The Court reproduced extensive portions of the applicants' response to the FER demonstrating how D1 relied upon Surface Enhanced Raman Spectroscopy (SERS), whereas the claimed invention employed a THz spectrometer with an excitation source and detector operating in a fundamentally different manner. Likewise, D2 used a nanoparticle-based sensing mechanism and did not disclose the claimed THz spectroscopy arrangement. Despite these detailed submissions, the Controller merely concluded that the invention lacked inventive step because both systems involved breath sample analysis. Justice Singh found this reasoning wholly inadequate.
The Court held that there was no meaningful discussion regarding how a person skilled in the art would move from D1 or D2 to the claimed invention. Merely stating that certain elements were similar did not satisfy the statutory requirement of analysing inventive step. Such reasoning effectively amounted to hindsight reconstruction, a practice repeatedly condemned in patent jurisprudence.
Discussion of Earlier Judgments
The Court relied significantly upon Agriboard International LLC v. Deputy Controller of Patents and Designs, 2022 SCC OnLine Del 940. In that case, the Delhi High Court had held that while determining inventive step, the Controller must analyse three essential elements: the invention disclosed in prior art, the invention disclosed in the patent application and the manner in which the claimed invention would be obvious to a skilled person. The Court reiterated that failure to conduct this exercise renders a refusal order legally unsustainable.
The Court also relied on F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., 2015 SCC OnLine Del 13619, where the Division Bench elaborated the structured five-step approach for evaluating obviousness and warned against hindsight analysis.
Another important precedent discussed was Tapas Chatterjee v. Assistant Controller of Patents and Designs and Another, 2025 SCC OnLine Del 6369. The Division Bench had clarified that the five-step test must be applied sequentially and systematically. The Court found that this requirement had not been followed by the Controller in the present case.
The Court further referred to Best Agrolife Limited v. Deputy Controller of Patents and Another, 2022 SCC OnLine Del 1982 and Otsuka Pharmaceutical Co. Ltd. v. Controller of Patents, 2022 SCC OnLine Del 4982, both of which emphasized the necessity of passing reasoned and speaking orders in patent matters.
On the issue of sufficiency of disclosure, the Court relied upon the Bombay High Court decision in JFE Steel Corporation v. Controller of Patents & Designs, 2026:BHC-OS:4866. That judgment held that a patent application cannot be rejected without proper analysis of substantive patentability requirements and that mere assertions regarding insufficiency of disclosure are inadequate.
Regarding Section 3(i), the Court referred to Chinese University of Hong Kong and Another v. Assistant Controller of Patents & Designs, 2023 SCC OnLine Mad 6372. The Madras High Court had explained that a diagnostic method ordinarily involves identifying the existence or non-existence of a disease, disorder or medical condition. Justice Singh found that the Controller had not examined whether the present invention actually performed such a diagnostic function.
Analysis of the Court's Findings on Section 10(4)
The Court was particularly critical of the Controller's treatment of the objections relating to sufficiency of disclosure. The Controller had alleged that the specification did not adequately explain the material composition of the molecule collector or the functioning of the heating element.
However, the Court observed that the applicants had specifically pointed to paragraphs [0027] and [0028] of the specification and Figures 1 and 2 explaining these features. The applicants had also demonstrated how the heating element functioned through application of voltage to the molecule collector. Yet the Controller neither discussed these explanations nor identified what additional disclosure was allegedly required. Justice Singh therefore found the reasoning incomplete and legally inadequate.
Analysis of the Court's Findings on Section 3(i)
The Court also found serious flaws in the Controller's conclusion that the invention was a diagnostic method. The Controller had simply assumed that analysing breath samples for VOCs amounted to diagnosis.
Justice Singh held that the Controller had failed to analyse the claims and had not applied any recognised legal test to determine whether the invention actually diagnosed a disease or medical condition. The invention was directed toward detecting cannabinoids and other substances in breath samples, particularly for determining intoxication. The Court noted that the specification nowhere claimed diagnosis of a disease or disorder. Consequently, the Section 3(i) objection required fresh consideration.
Final Decision of the Court
After examining the matter in detail, the Delhi High Court held that the refusal order dated 31 January 2025 could not be sustained. The Court found that the Controller had failed to apply the settled legal tests relating to inventive step, had not properly analysed the applicants' submissions concerning sufficiency of disclosure and had incorrectly addressed the objection under Section 3(i).
Accordingly, the impugned order was quashed and set aside. The matter was remanded to the Assistant Controller for fresh consideration of Patent Application No. 202117006438. The Court directed that a fresh hearing be granted and that the response to the FER and written submissions be duly considered. A fresh reasoned decision was directed to be issued within four months. The Court expressly clarified that it had not expressed any opinion on the ultimate merits of the patent application.
Point of Law Settled
This judgment reinforces that while assessing inventive step under Section 2(1)(ja), Patent Controllers must rigorously apply the judicially recognised five-step test and cannot reject patent applications through conclusory observations. The decision further establishes that prior art analysis must be detailed and reasoned, and hindsight reconstruction of inventions is impermissible.
The judgment also emphasizes that objections relating to sufficiency of disclosure under Section 10(4) require meaningful examination of the specification and cannot be sustained without identifying what additional disclosure is actually necessary.
Finally, the Court reaffirmed that an invention does not become a diagnostic method under Section 3(i) merely because it analyses biological samples. The Controller must determine whether the claimed invention actually diagnoses a disease, disorder or medical condition before invoking the statutory exclusion.
Case Details
Title: University of North Texas & Anr. Vs. Assistant Controller of Patents and Designs
Date of Decision: 12 May 2026
Case Number: C.A.(COMM.IPD-PAT) 32/2025
Neutral Citation: 2026:DHC:____ (Neutral citation not available in the uploaded copy)
Court: High Court of Delhi
Hon'ble Judge: Justice Jyoti Singh
Headnote
The Delhi High Court set aside the refusal of a patent application relating to rapid detection and quantitation of volatile organic compounds using breath samples. The Court held that the Patent Office failed to apply the settled five-step test for determining inventive step and did not properly analyse the differences between the claimed invention and prior art references. The Court further held that objections concerning insufficiency of disclosure and diagnostic method exclusion under Sections 10(4) and 3(i) respectively had not been adequately examined. The refusal order was quashed and the matter remanded for fresh consideration with directions to pass a detailed, reasoned and speaking order.
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Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Disclaimer: Readers are advised not to treat this as substitute for legal advise as it may contain errors in perception, interpretation, and presentation.
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