University Of North Texas & Anr. vs Assistant Controlelr Of Patents And Designs

$~3
* IN THE HIGH COURT OF DELHI AT NEW DELHI
th
% Date of Decision: 12 May, 2026
+ C.A.(COMM.IPD-PAT) 32/2025
UNIVERSITY OF NORTH TEXAS & ANR. .....Appellants
Through: Ms. Vaishali Joshi, Mr. Vineet
Rohilla and Mr. Ankush Verma, Advocates.

versus

ASSISTANT CONTROLELR OF PATENTS AND DESIGNS
.....Respondent
Through: Ms. Nidhi Raman, CGSC with Mr.
Arnav Mittal and Ms. Nikita Singh, Advocates.
CORAM:
HON'BLE MS. JUSTICE JYOTI SINGH
JUDGEMENT
JYOTI SINGH, J. (ORAL)

1. This appeal is filed on behalf of the Appellants under Section 117A(2)
of the Patents Act, 1970 (‘1970 Act’) laying a challenge to impugned order
dated 31.01.2025 as also for a direction to the Respondent to grant patent in
respect of Indian Patent Application No. 202117006438.
2. For the sake of completeness, necessary facts as pleaded in the appeal
are that subject application was filed on 29.07.2019 as a National Phase
Application of PCT having PCT International Application No.
PCT/IB2019/056456 claiming priority from US Patent Application No.
62/712,941 dated 31.07.2018. Subject application was filed before Indian
Patent Office (‘IPO’) on 16.02.2021 for grant of patent for invention titled
‘TECHNOLOGIES FOR RAPID DETECTION AND QUANTITATION
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OF VOLATILE ORGANIC COMPOUNDS (VOCS) USING BREATH
SAMPLES’ and was allotted Indian Patent Application No. 202117006438.
Request for Examination was filed by the Appellants on 04.07.2022 and
First Examination Report (‘FER’) was issued on 18.04.2023 raising
objections under Section 2(1)(ja) for lack of inventive step, non-patentability
under Section 3(i), lack of clarity and conciseness and sufficiency of
disclosure under Section 10(4) and (5) of 1970 Act. Detailed response was
filed by the Appellants to the FER on 25.09.2023 with amended claims 1-19.
Hearing was concluded on 21.10.2024, whereafter Appellants filed written
submissions on 05.11.2024 along with amended claims 1-19. By order dated
31.01.2025, Respondent refused the subject application on the grounds that
the claimed invention lacks inventive step, clarity and conciseness and there
is insufficient disclosure as also that the invention was non-patentable under
Section 3(i) of 1970 Act.
3. Learned counsel for the Appellants submits that present invention
relates to breathalyser systems and devices designed to facilitate quantitative
analysis of Tetrahydrocannabinol (THC) and other substances in the field
using breath samples (para [0002] of the complete specifications). With rise
in the consumption of marijuana due to legalization in some States, it has
become necessary to properly quantitate ∆-9- THC, such that an accurate and
rapid determination of whether a person is under the influence of marijuana
can be achieved. Three cannabinoid compounds are currently analysed to
determine cannabinoid concentrations in the blood: ∆-9- THC, 11- hydroxy-
tetrahydocannabinol (11-0H-THC) and carboxy-tetrahydrocannabinol
(THC-COOH). Currently, techniques for determining the presence of drugs,
such as cannabinoids, require analysis via blood plasma, urine or oral fluid
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samples. Most analytical techniques use gas chromatography coupled to
mass spectrometry (GS/MS). This presents a problem of having to collect a
sample and bring it back to the lab for further analysis. These techniques
have a long analysis time, with most analyses taking more than 15 minutes
to detect cannabinoids. Furthermore, detecting ∆-9- THC using GC/MS can
also introduce another problem because the ionization source is electron
ionization (EI).
4. It is stated that currently three types of breathalysers are being used by
local law enforcement officers in the field i.e., liquid chromatography
coupled to mass spectrometry (LC/MS), high-field asymmetric waveform
ion mobility (FAIMS) and liquid chromatography coupled to spectroscopy.
Existing methodologies highlight various drawbacks. LC/MS is useful for
quantitation but cannot be used in the field and requires several minutes to
analyse the sample before the cannabinoids can be seen. In other cases inter
alia either the required resolution or peak capacity to determine the
concentration of ∆-9- THC is lacking or the time required to analyse a
sample is in the range of 8-15 minutes. Present invention is technologically
advanced with several features inter alia facilitating detection of
cannabinoids and other substances in breath samples in the field and such
systems can be used by lawful enforcement agencies to rapidly and
accurately identify and detect marijuana in drivers on road.
5. It is urged that Section 2(1)(ja) of 1970 Act defines ‘inventive step’ as
a feature of invention that involves technical advancement as compared to
existing knowledge or having economic significance or both and requires
that the claimed invention should not be obvious to a person skilled in the
art. In the decision in Agriboard International LLC v. Deputy Controller of
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Patents and Designs, 2022 SCC OnLine Del 940 , this Court has given a
framework for assessing an inventive step in view of cited documents and
directed that the Controller must consider three elements: (a) invention
disclosed in the prior art; (b) invention disclosed in the application under
consideration; and (c) manner in which subject invention would be obvious
to a person skilled in the art. However, without any analysis on the three
elements, Respondent has arrived at a conclusion that the claimed invention
lacks inventive step. Division Benches of this Court in F. Hoffmann-La
Roche Ltd. & Anr. v. Cipla Ltd., 2015 SCC OnLine Del 13619 has laid
down a five-step test to determine obviousness/lack of inventive step and
also held that while conducting an enquiry into obviousness, hindsight
approach is impermissible and legal conclusion must be reached on the basis
of facts gleaned from the prior art and should not include knowledge
gleaned from patent disclosure. This position of law was reiterated in and
Tapas Chatterjee v. Assistant Controller of Patents and Designs and
Another, 2025 SCC OnLine Del 6369. It is urged that the teachings in prior
art documents have to be considered as a whole and teachings away from
patent claim are treated as non-obvious. To enquire into obviousness, two-
fold enquiry is required to be conducted i.e., motivation to select and
motivation to modify. None of these steps have been followed by the
Respondent before arriving at the impugned decision and on this ground, the
order deserves to be set aside.
6. It is argued that Respondent failed to appreciate the technical aspect
of present invention and although an attempt was made to identify the key
technical features, the identification was as follows, which was incorrect:-

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“ Key technical features:
o A system for analyzing a breath sample
o A sampling chamber
o
An inlet coupled to the sampling chamber
o
A molecule collector disposed within the sampling chamber”
7. Had the Respondent correctly identified the technical features in
claim 1 of claimed invention as also differentiating features with the prior
arts, as pointed out by the Appellants in response to FER and written
submissions, the decision would have been otherwise. Respondent has
clearly failed to identify the person skilled in the art, which is a failure to
follow Step-1 of F. Hoffmann (supra) and has also failed to decide whether
the differences pointed out in the cited documents and claimed invention,
constituted steps which would have been obvious to the ordinary person
skilled in the art and rule out a hindsight approach. On internal page 24 of
the impugned order, Respondent has referred to the differences between D1
and claimed invention but without any comparison and analysis, Respondent
has directly reached the conclusion at page 26 that claim 1 lacks inventive
step, 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.”

8. The conclusion is thus cryptic and unreasoned on as to how the use of
a heating element and a THz spectrometer does not provide a technical
advancement over the SERS-based detection system described in D1, when
both the features are not disclosed in D1. The only similarity that exists
between the two is that both analyse breath samples, which was not enough
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to refuse the application. Detailed submissions were filed to show how the
teachings of D1 cannot be obvious to a person skilled in the art to lead to the
claimed invention but none of these points have been considered and the
only reasoning given is that fundamental elements of the system are similar
in the prior art. Similarly, with respect to D2, Respondent has failed to point
out relevant disclosure or analysis and has simply jumped to a conclusion
that the system described in claim 1 lacks inventive step over D2 as it also
involves collecting a breath sample, conditioning it and detecting VOCs
using a sensor and mere use of heating element and a THz spectrometer is
not a technical advance. This Court in 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 has highlighted the importance and mandate of passing
reasoned and speaking orders but contrary thereto, the application has been
refused by a cryptic, non-speaking and unreasoned order as also without
following the five-step test in F. Hoffmann (supra) and Tapas Chatterjee
(supra).
9. It is argued that Appellants filed a detailed response to the FER on
25.09.2023 bringing forth the stark differences between D1 and D2,
however, these have not been considered in the impugned order. Respondent
has also erred in refusing the application on ground of lack of clarity and
sufficient disclosure overlooking that the disclosure provided in the
complete specification fully and particularly describes the present invention
and its method. Illustratively, Respondent has observed that the material
composition, structure and mechanism of adhesion to VOCs are not
explicitly explained when the phrase ‘molecule collector’ is used. In a
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similar vein, the ‘heating element’ is referred to but its precise configuration
and interaction with the molecule collector is not explained. Paragraphs
[0027] and [0028] along with Figure 1 and 2 of the complete specifications
of the subject application clearly describe the structure and material
composition of the ‘molecule collector’ and further, the term ‘heating
element’ can be clearly visualized from paragraph [0028] with Figure 1 of
complete specification, which states that ‘the sampling device 110 may also
include or be coupled to a heating element 118 configured to introduce
heath within the sampling chamber 110. For example, the heating element
118 may include a power source coupled to the molecule collector 116 and
configured to apply a voltage to the molecule collector 116. Applying
voltage to the molecule collector 116 may heat up the molecule collector,
thereby introducing heat within the sampling chamber 110’. It is thus clear
that the heating element is getting heated by application of voltage which
increases the temperature of sampling chamber and heats the molecule
collector. A complete chain of interaction between heating element and
molecule chamber has been described in the complete specification, which
has not been considered by the Respondent.
10. It is argued that the order suffers from several other errors such as in
internal page 27 of the order Respondent has observed that although the
analysis device that consists of THz spectrometer is detailed, it is unclear
how the excitation source and detector work and the claims do not explain
how the detector detects target VOCs based on excitation characteristics or
how the excitation signal is introduced. The observation completely glosses
over paragraph [0032] of the complete specification which describes
working of the spectroscope and line 18 whereof states that ‘In an aspect,
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the excitation source 320 may be a THz laser device and the excitation
signal 324 may be a THz laser signal. In aspects, the one or more
characteristics associated with the excitation of at least the portion of the
VOCs may include at least one of the absorbance characteristics and a
fluorescent emission characteristic, which may be utilized to identify the one
or more target VOCs present within the breath sample 102, as described in
more detail below. In an aspect, the THz spectrometer components (e.g., the
excitation source 320 and the detector 322) may operate under control of, or
in coordination with, a computing device, such as a computing device that
includes the one or more processors 122, the memory 130, and the one or
more I/O devices 126’. Therefore, the description clearly and sufficiently
discloses the functioning of the analysis device.
11. As for the objection of non-patentability under Section 3(i) of 1970
Act, it is argued that Respondent has neither analysed the claims nor applied
any test for making an assessment whether claimed invention falls within the
ambit of ‘diagnostic method’. The entire purpose of subject invention is
analysis of breath samples to detect certain VOCs and ‘Summary’ in the
complete specifications brings forth that present application claims systems
and apparatuses and the methods providing techniques for improved on-site
quantification of cannabinoids and other substances from breath samples are
disclosed (paragraph [0009] of the complete specifications). The preamble
to claim 14, which the Respondent has explicitly objected under Section
3(i), clearly states ‘A method for analysing a breath sample, the method
comprising: ....’ . There is no discussion in the specification about existence
of any disease or disorder let alone claiming a method for diagnosis and
impugned order is a result of non-application of mind by the Respondent.
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12. Ms. Nidhi Raman, learned CGSC arguing for the Respondent submits
that subject application was prosecuted in accordance with provisions of
1970 Act and is a speaking and detailed order and conclusions have been
arrived at after carefully considering the specifications and claims of the
claimed invention, FER, hearing submissions, both oral and written and
other records. The claimed invention lacks inventive step in view of prior
arts D1-D2. D1 discloses a system for collecting, conditioning and detecting
analytes (drugs) from breath using a spectroscopic sensor (SERS). Mere
substitution of SERS with THz spectrometer or addition of heating element,
which are standard and known components, does not provide technical
advancement. Similarly, D2 discloses a system for sensing analytes in breath
using a nanoparticle sensor and fundamentally mirrors the claimed invention
i.e., collecting breath, conditioning it and detecting VOCs. Respondent has
reasoned that use of heating element and THz spectrometer cannot be a
technical advancement over nanoparticle-based detection system described
in D2.
13. It is further argued that Appellants’ challenge to objection under
Section 2(1)(ja) of 1970 Act is primarily based on the assertion that D2 does
not disclose a heating element for releasing analytes. The assertion is
factually incorrect and inconsistent with their own admission during
prosecution that ‘Also, D2 at paragraph [0285] discloses: ‘…An
embodiment that aids in increasing sensitivity is shown in FIG. 53… Once
the analyte is captured, it is ‘flushed out’ from the concentrator via some
mechanism such as a heater 421’. Once the heating element is removed as a
differentiator, the only difference is use of THz spectrometer in subject
application and nanoparticle-based sensor in D2 or SERS sensor in D1. THz
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spectroscopy is already a known technique and replacement of one sensor
with another is a routine optimization. Hence, there is no technical
advancement in the claimed invention.
14. It is urged that the argument of the Appellants that the invention is not
a diagnostic method is untenable. Figure 6 of subject application is titled
‘graph illustrating observed VOCs for a breath sample of a person suffering
from seasonal allergies’ and paragraph [0008] highlights the need for
improved detection of ‘synthetic opioid overdoses’ in civilians and military
personnel. Identifying a drug overdose is a critical medical diagnosis
required for immediate therapeutic intervention.
15. On insufficiency of disclosure under Section 10(4) of 1970 Act, Ms.
Raman urges that Respondent has provided precise reasoning regarding lack
of structural definition for critical claim elements. The order notes that while
specification mentions the collector ‘can cling’ to VOCs, it is not explained
what materials, configurations or mechanisms are used to accomplish this
and moreover, the nature and extent of innovation is difficult to comprehend
due to unclear wordings in the claim, more particularly, claim 1. Similarly,
there is lack of clarity and detail for heating element where precise
configuration and interaction with the molecule collector is not explained.
Many such issues have been raised in the order and it cannot be argued by
the Appellants that the impugned order is non-speaking or suffers from non-
application of mind.
16. Heard learned counsels for the parties and examined their
submissions.
17. The subject application relates to techniques for rapid detection and
quantitation of volatile organic compounds (VOCs) using breath samples. In
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the FER, objections were raised under Section 2(1)(ja) for lack of inventive
step, non-patentability under Section 3(i), lack of clarity and conciseness
and sufficiency of disclosure under Section 10(4) and (5) of 1970 Act.
Responding to the objections in the FER, Appellants amended the claims
deleting claim 20 and resultantly, claims 1-19 were under consideration for
grant of patent.
18. The first contention of the Appellants is that the impugned order is
unreasoned and non-speaking and the five-step test laid down in F.
Hoffmann (supra) and reiterated in Tapas Chatterjee (supra) was not
followed by the Respondent. For sake of reference, the five steps are as
follows:-
Step No. 1 - To identify an ordinary person skilled in the art;
Step No. 2 - To identify the inventive concept embodied in the patent;
Step No. 3 - To impute to a normal skilled but unimaginative ordinary
person skilled in the art what was common general knowledge in
the art at the priority date;
Step No. 4 - To identify the differences, if any, between the matter
cited and the alleged invention and ascertain whether the differences
are ordinary application of law or involve various different steps
requiring multiple, theoretical and practical applications; and
Step No. 5 - To decide whether those differences, viewed in the
knowledge of alleged invention, constituted steps which would have
been obvious to the ordinary person skilled in the art and rule out
hindsight approach.
19. In Tapas Chatterjee (supra) , Division Bench held that the five steps
have to be followed sequentially while examining the aspect of obviousness
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and existence of inventive step. In the present case, Respondent has not
followed the first step of identifying an ordinary person skilled in the art and
this is enough to vitiate the impugned order. In fact, Appellants have pointed
out that even the second step of identifying the inventive concept embodied
in the invention has also not been followed and a grave error has occurred in
identifying the key features, noted above. Insofar as Steps 3-5 are
concerned, while the impugned order makes a reference to similarities and
differences in the prior arts D1 and D2 and the claimed invention, there is no
analysis on whether the differences brought forth by the Appellants between
the cited prior arts and the claimed invention would constitute steps which
would have been obvious to an ordinary person skilled in the art so as to rule
out hindsight approach. Impugned order reflects that at internal pages 24 and
25, Respondent has referred to D1 and D2 but without carrying out further
exercise as required in law, reached a conclusion that since D1 discloses a
system for collecting a sample from exhaled breath and detecting the
presence of analytes such as drugs substances and the system described in
claim 1 also involves collecting a breath sample, conditioning it and
detecting VOCs using a sensor, mere use of heating element and THz
spectrometer does not constitute technical advancement. In response to the
FER, Appellants had brought forth how cited portions of D1 and D2,
individually or in combination, failed to disclose each and every element of
amended claim. For sake of reference, relevant paragraphs are extracted
hereunder:-
“We respectfully submit that the cited portions of D1 and D2, individually
or in combination, fail to disclose each and every element of amended
claim 1. For example, the cited portions of D1 and D2 do not disclose “an
analysis device comprising a Terahertz (THz) spectrometer that includes
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an excitation source and a detector, wherein the analysis device is
configured to: introduce, via the excitation source, an excitation signal
within the sampling chamber subsequent to the release of at the least a
portion of the VOCs from the molecule collector; identify, via the detector,
one or more target VOCs from among the VOCs present in the sampling
chamber subsequent to release of at least the portion of the VOCs from the
molecule collector, wherein the one or more target VOCs are identified
based on one or more characteristics associated with excitation of at least
the portion of the VOCs released from the molecule collector in response
to the excitation signal; and generate an output representative of the one
or more target VOCs,” as recited in amended claim 1.
In the FER, the Office indicates that “D1 discloses systems and methods
for collecting a sample from exhaled breath of a subject, and for detecting
the presence or determining the quantitative amount of analytes in the
breath sample. The analytes are for instance drug substances in the
exhaled breath. More particularly, the invention relates to such portable
systems using Surface Enhanced Raman spectroscopy in a sensor for
detecting the analytes from the exhaled breath (see para[0001]).” Thus,
the cited portions of D1 specifically indicate that the invention uses
Surface Enhanced Raman spectroscopy, not Terahertz (THz) spectroscopy.
D1 is silent regarding an analysis device that includes a THz spectrometer
including an excitation source and a detector. Therefore, D1 does not
disclose “an analysis device comprising a Terahertz (THz) spectrometer
that includes an excitation source and a detector, wherein the analysis
device is configured to: introduce, via the excitation source, an excitation
signal within the sampling chamber subsequent to the release of at the
least a portion of the VOCs from the molecule collector; identify, via the
detector, one or more target VOCs from among the VOCs present in the
sampling chamber subsequent to release of at least the portion of the
VOCs from the molecule collector, wherein the one or more target VOCs
are identified based on one or more characteristics associated with
excitation of at least the portion of the VOCs released from the molecule
collector in response to the excitation signal; and generate an output
representative of the one or more target VOCs,” as recited in amended
claim 1.

In the FER, the Office indicates that “D2 discloses apparatus comprises a
fluid collecting device configured to receive a sample of breath; a
conditioning device coupled to the fluid collecting device and configured
to receive the sample of breath and condition the sample with respect to at
least one of temperature, flow rate, pressure, humidity, and concentration;
and a sensing device coupled to the conditioning device and configured to
receive the conditioned sample, wherein the sensing device includes a
nanoparticle-based sensor and further whereby the analyte interacts with
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the sensing device to cause a change that is sensed by the sensing device
and wherein the change comprises information useful in characterizing the
analyte. Preferably, the apparatus is hand-held and characterizing the
analyte is useful for health monitoring (see abstract).” Thus, the cited
portions of D2 specifically indicate that characterization of an analyte is
based on a change associated with analyte interaction with a
nanoparticle-based sensor. D2 is silent regarding an analysis device that
includes a THz spectrometer including an excitation source and a
detector. Therefore, D2 also does not disclose “an analysis device
comprising a Terahertz (THz) spectrometer that includes an excitation
source and a detector, wherein the analysis device is configured to:
introduce, via the excitation source, an excitation signal within the
sampling chamber subsequent to the release of at the least a portion of the
VOCs from the molecule collector; identify, via the detector, one or more
target VOCs from among the VOCs present in the sampling chamber
subsequent to release of at least the portion of the VOCs from the molecule
collector, wherein the one or more target VOCs are identified based on
one or more characteristics associated with excitation of at least the
portion of the VOCs released from the molecule collector in response to
the excitation signal; and generate an output representative of the one or
more target VOCs,” as recited in amended claim 1.
Consequently, the cited portions of D1-D2, individually or in combination,
fail to disclose, teach, or suggest at least the above-cited features of
amended claim 1. Hence, amended claim 1 has inventive step in view of
D1-D2. Amended claim 14 recites similar features and has inventive step
in view of D1-D2 for similar reasons. Amended claims 2-13 and 15-19
depend from amended claims 1 and 14, respectively, and have inventive
step at least by virtue of depending from independent claims having
inventive step.
At least for the above reasons, we respectfully submit that the amended
claims 1-19 constitute an invention as defined under Section 2(1)(j) of the
Patents Act, 1970 (“the Act”).
In view of the above, reconsideration and withdrawal of this objection is
respectfully requested.”

20. None of these points have been mentioned leave alone analyzation by
the Respondent and similar is the position on comparison of independent
claim 1 on cited prior art D2, which discloses a system for sensing analytes
in a fluid including breath, using a nanoparticle-based sensor. All that is
stated in the order is that independent claims do not demonstrate a technical
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advance inasmuch as use of a heating element and a THz spectrometer is not
a non-obvious improvement over existing technologies. In Agriboard
(supra) , this Court held that while adjudicating the subject application for
lack of inventive step, it is imperative to consider three elements: (a)
invention disclosed in the prior art; (b) invention disclosed in the application
under consideration; and (c) manner in which subject invention would be
obvious to a person skilled in the art. There is not even a bare minimum
discussion in the impugned order on the three elements and their impact on
determination of inventive step. As rightly flagged by the Appellants,
without such analysis, rejection of the patent application under Section
2(1)(ja) of 1970 Act is contrary to the provision itself and essentially borders
on hindsight approach, which has been seriously condemned by the Division
Bench in F. Hoffmann (supra) . Pertinently, Appellants had 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 but
none have been analysed and allegedly, even the key technical features have
been wrongly incorporated in the impugned order and construed, making a
difference to the ultimate conclusion. Even today, Respondent is unable to
contest this point and therefore, the matter does require a fresh
consideration.
21. On the aspect of Section 10(4) of 1970 Act, both parties have made
rival submissions but Court finds merit in the contention of the Appellants
that Respondent has not dealt with the objection in the manner required by
law. The Bombay High Court in JFE Steel Corporation v. The Controller
of Patents & Designs, 2026:BHC-OS:4866 held that “Having gone through
the Impugned Order, I find merit in the aforesaid submission. A plain
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reading of the order makes it clear that the rejection is founded entirely on
an alleged failure to meet the requirement of sufficiency of disclosure under
Section 10 of the Patents Act, 1970. The Order does not contain any
independent analysis or reasoning on the substantive statutory requirements
of patentability, namely novelty and inventive step. Thus, in the absence of
any findings on the aspect of lack of novelty or inventive step, the Impugned
Order would have to be set aside.” It is stated in the impugned order that
material composition, structure and mechanism of adhesion to VOCs are not
explicitly explained when the phrase ‘molecule collector’ is used and in a
similar vein, ‘heating element’ is referred, but its precise configuration and
interaction with molecule collector is not explained. Illustratively,
Appellants submitted that the complete specification sufficiently discloses
the claimed invention. The impugned order does not even mention or
discuss as to what more disclosure was required by the Appellants. It is also
argued that paragraphs [0027] and [0028] along with Figures 1 and 2 of
complete specification clearly describe the structure and material
composition of molecule collector and the term ‘heating element’ is not just
self-explanatory but can be clearly visualised from reading of paragraph
[0028] with Figure 1 of complete specification, which states that ‘the
sampling device 110 may also include or be coupled to a heating element
118 configured to introduce heath within the sampling chamber 110. For
example, the heating element 118 may include a power source coupled to
the molecule collector 116 and configured to apply a voltage to the molecule
collector 116. Applying voltage to the molecule collector 116 may heat up
the molecule collector, thereby introducing heat within the sampling
chamber 110’ and hence, there is no ambiguity in the claim or lack of
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sufficient disclosure. Similar submissions were brought forth with respect to
other objections under Section 10(4) and were explained by the Appellants
but there is no analysis in the impugned order.
22. On the aspect of non-patentability under Section 3(i) of 1970 Act,
Respondent has observed that the technique outlined in claim 14 is a
diagnostic method since it focuses on a diagnostic procedure for examining
breath samples to identify and measure VOCs. This conclusion has been
drawn glossing over the explanation given by the Respondent to support the
plea that the claimed invention has been wrongly categorized as a
‘diagnostic method’. Appellants relied on the judgment of the Madras High
Court in the Chinese University of Hong Kong and Another v. Assistant
Controller of Patents & Designs, 2023 SCC OnLine Mad 6372, where the
Court observed 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 ... ’ and
pointed out that nowhere in the complete specification is there a discussion
about existing of any disease or disorder let alone a method for diagnosis
and that the subject application is targeted towards detection of cannabinoids
in breath sample of a person who is suspected to be driving under the
influence of marijuana (DUIM). The ‘Summary’ of the complete
specifications provides that the present application claims systems,
apparatuses and methods providing techniques for improved on-site
quantification of cannabinoids and other substances from breath samples. In
fact, the Preamble to claim 14 clearly states ‘A method for analysing a
breath sample, the method comprising:….’ . Appellants rightly contend that
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Signing Date:20.05.2026
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Respondent has neither analysed the claims nor applied any test for making
an assessment whether the claimed invention falls within the ambit of
‘diagnostic method’ so as to be categorized the claimed invention non-
patentable under Section 3(i) of 1970 Act. In my considered view, the
fallacies brought forth by the Appellants in the impugned order warrant
remand of the matter for fresh consideration by the Respondent.
23. For all the aforesaid reasons, impugned order dated 31.01.2025 is
quashed and set aside, without expressing any opinion on the merits of the
case and is remanded to the Respondent for considering Indian Patent
Application bearing No. 202117006438, afresh. The decision will be taken
within a period of four months from today, after granting opportunity of
hearing to the Appellants as also considering response to the FER and
written submissions filed by the Appellants. Needless to state, the order will
be a detailed, speaking and a reasoned order and the decision will be taken
uninfluenced by the observations in this order or the impugned order.
24. Appeal is partially allowed in the aforesaid terms and disposed of.


JYOTI SINGH, J
MAY 12, 2026/ RW
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Digitally Signed
By:SAHIL SHARMA
Signing Date:20.05.2026
20:16:35
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