The patent application filed by University of North Texas for “Technologies for Rapid Detection and Quantitation of Volatile Organic Compounds (VOCs) Using Breath Samples” was refused by the Patent Office on the grounds that the claimed invention lacked inventive step, clarity and conciseness, suffered from insufficient disclosure under Section 10(4), and was non-patentable under Section 3(i) of the Patents Act, 1970. University of North Texas preferred an appeal in University of North Texas & Anr. vs Assistant Controller of Patents and Designs [C.A.(COMM.IPD-PAT) 32/2025], before the Delhi High Court, contending that the application had been refused by a cryptic, non-speaking and unreasoned order, and without following the five-step test enunciated by the Court in F. Hoffmann and Tapas Chatterjee.
The appellant also contended that the respondent Controller had failed to properly assess inventive step or apply the settled obviousness test. The appellant further argued that the finding on the applicability of Section 3(i) was based on an inadequate analysis of whether the claimed invention was a diagnostic method. The Court agreed that the respondent had neither analysed the claims nor applied any test to assess whether the claimed invention fell within the ambit of “diagnostic method” so as to be categorised as non-patentable under Section 3(i) of the Patents Act, 1970.
The Subject Invention
The appellant submitted that the present invention relates to breath analyser systems and devices designed to facilitate quantitative analysis of tetrahydrocannabinol (THC) and other substances using breath samples. Existing techniques require collection of samples and their transportation to a laboratory for further analysis. These techniques also have long analysis times, with most analyses taking more than 15 minutes to detect cannabinoids. The claimed invention presents a technologically advanced solution for facilitating detection of cannabinoids and other substances in breath samples in the field. Such systems can be used by law enforcement agencies to rapidly and accurately identify and detect marijuana in drivers on the road.
Appellant’s Case
On Non-Applicability of Section 3(i)
According to the appellant, the present invention was wrongly categorised by the respondent Controller as a diagnostic method. The appellant placed reliance on the Madras High Court’s ruling in The Chinese University of Hong Kong vs Assistant Controller of Patents & Designs, wherein it was clarified that diagnosis, in the context of Section 3(i), concerns identifying the existence or nature of a disease, disorder or medical condition, including the extent, severity or other aspects thereof. The appellant contended that the respondent Controller had neither analysed the claims nor applied any test to assess whether the claimed invention fell within the ambit of “diagnostic method” so as to be categorised as non-patentable under Section 3(i). The appellant pointed out that nowhere in the complete specification was there any discussion about the existence of any disease or disorder, let alone a method for diagnosis. The subject application was instead targeted towards the detection of cannabinoids in the breath sample of a person suspected of driving under the influence of marijuana.
On Inventive Step Analysis
The appellant submitted that the respondent Controller had referred to the differences between D1 and the claimed invention but, without any proper comparison or analysis, directly reached the conclusion that Claim 1 lacked inventive step. The impugned order observed as follows:
“The system described in Claim 1 lacks inventive steps over D1 as it also involves collecting a breath sample, conditioning it, and detecting VOCs using a sensor. The use of a heating element and a THz spectrometer does not provide a technical advance over the SERS-based detection system described in D1.”
According to the appellant, this conclusion was drawn without following the five-step test for inventive step determination as mandated in F. Hoffmann and Tapas Chatterjee. The appellant argued that the application had been refused by a cryptic, non-speaking and unreasoned order. The appellant further submitted that the respondent Controller had failed to identify the person skilled in the art and had also failed to determine whether the differences between the cited documents and the claimed invention constituted steps which would have been obvious to an ordinary person skilled in the art, while ruling out a hindsight approach.
Respondent Controller’s Reply
The respondent Controller maintained that the subject application was prosecuted in accordance with the provisions of the Patents Act, 1970, and that a speaking and detailed order was passed after considering the submissions of the appellant. According to the respondent, the claimed invention lacked inventive step in view of prior arts D1 and D2. D1 disclosed a system for collecting, conditioning and detecting analytes, including drugs, from breath using a spectroscopic sensor, namely SERS. The respondent argued that mere substitution of SERS with a THz spectrometer or addition of a heating element, both being standard and known components, did not provide any technical advancement.
The respondent also asserted that the use of a heating element and a THz spectrometer could not constitute a technical advancement over the nanoparticle-based detection system described in D2. Referring to Figure 6 and the specification, the respondent argued that the claimed invention was a diagnostic method, as identifying a drug overdose is a critical medical diagnosis required for immediate therapeutic intervention. The respondent further defended the objection of insufficiency of disclosure under Section 10(4), asserting that precise reasoning had been provided regarding the lack of structural definition for critical claim elements.
Court’s Analysis and Findings
On Not Following the “Hoffmann Test”
The Court perused the impugned order and found that, without following the five-step analysis, the respondent Controller had concluded that the independent claims did not demonstrate a technical advance, as the use of a heating element and a THz spectrometer was not a non-obvious improvement over existing technology. On comparison of independent Claim 1 with cited prior art D2, which disclosed a system for sensing analytes in a fluid, including breath, using a nanoparticle-based sensor, the respondent concluded that the claimed invention did not demonstrate a technical advance or a non-obvious improvement over existing technology.
The Court cited the ruling in Agriboard, wherein it was held that while adjudicating an application for lack of inventive step, it is imperative to consider three elements: the invention disclosed in the prior art, the invention disclosed in the application under consideration, and the manner in which the subject invention would be obvious to a person skilled in the art. The Court pointed out that, in the present case, there was not even a bare minimum discussion in the impugned order on these three elements and their impact on the determination of inventive step.
The Court agreed with the appellant that, without such analysis, rejection of the patent application under Section 2(1)(ja) would be contrary to the provision itself and would essentially border on a hindsight approach, which has been seriously condemned by the Division Bench in F. Hoffmann. The Court also noted that the appellants had rightly flagged and highlighted what, in their perception, were material and stark differences between the claims of the claimed invention and prior arts D1 and D2 during prosecution and hearing. However, the respondent Controller failed to analyse these submissions.
The Court also pointed out that the respondent Controller was unable to contest the point raised by the appellant that the key technical features had been wrongly incorporated and construed in the impugned order, which made a difference to the ultimate conclusion. Since this point could not be effectively contested even before the Court, the Court held that the matter required fresh consideration.
On the Ground of Insufficiency Under Section 10(4)
On the aspect of Section 10(4), the Court found merit in the contention of the appellants that the respondent Controller had not dealt with the objection in the manner required by law. This finding was based on the fact that the respondent Controller had not considered the submissions and explanations given by the appellants in response to the First Examination Report and in the written submissions filed in support of their claim of sufficiency of disclosure. According to the Court, the impugned order did not even mention or discuss what further disclosure was required from the appellants.
The Court noted that the respondent Controller had merely stated in the impugned order that the material composition, structure and mechanism of adhesion to VOCs were not explicitly explained when the phrase “molecule collector” was used, and that similar observations were made in respect of the “heating element”. However, the impugned order did not analyse the appellant’s explanation that these aspects were disclosed through the specification and Figure 1. After reading the complete specification and the figures, the Court found no ambiguity in the claim or lack of sufficient disclosure.
On the Applicability of Section 3(i)
The Court held that the appellants had rightly contended that the respondent had neither analysed the claims nor applied any test to assess whether the claimed invention fell within the ambit of “diagnostic method” so as to be categorised as non-patentable under Section 3(i) of the Patents Act, 1970. The Court found that the claimed invention had been wrongly categorised as a diagnostic method by the respondent. The Court relied on the Madras High Court ruling in The Chinese University of Hong Kong and Anr vs Assistant Controller of Patents & Designs [2023 SCC OnLine Mad 6372], wherein it was held that:
‘23. The odd one out, as indicated above, is ‘diagnostic’. Diagnosis, in the context of medical science, is a method of identifying the existence or non-existence of a disease or disorder or condition and/or the site, extent, severity or other aspects thereof…’
The Court noted that nowhere in the complete specification was there any discussion about the existence of any disease or disorder, let alone a method for diagnosis. The subject application was targeted towards the detection of cannabinoids in the breath sample of a person suspected of driving under the influence of marijuana. The Court also pointed out that the “Summary” of the complete specification provided that the application claimed systems, apparatuses and methods for improved on-site quantification of cannabinoids and other substances from breath samples. The Court held that the fallacies brought forth by the appellants in the impugned order on this issue also warranted remand of the matter for fresh consideration by the respondent.
Decision of the Court
The Court set aside the refusal order and remanded the matter for fresh consideration. The matter was remanded to the respondent Controller for fresh consideration of the subject patent application. The Controller was directed to pass a detailed, speaking and reasoned order after conducting a fresh hearing and after considering all submissions made by the appellant.
Conclusion
The Court rightly held that the respondent Controller had neither analysed the claims nor applied any test to assess whether the claimed invention fell within the ambit of “diagnostic method” so as to be categorised as non-patentable under Section 3(i). The Court also agreed with the appellant that the impugned order was unreasoned and non-speaking, and that the five-step test laid down in F. Hoffmann and reiterated in Tapas Chatterjee had not been followed. The ruling reiterates that refusal of a patent application must be supported by proper reasoning, analysis of the claims, consideration of the applicant’s submissions and application of the settled tests for patentability.
Author: DPS Parmar