BEFORE THE DEPUTY CONTROLLER OF PATENTS

THE PATENT OFFICE, CHENNAI

THE PATENTS ACT, 1970 (AS AMENDED)

&
THE PATENTS RULES, 2003 (AS AMENDED)

In the matter of an application for

Patent bearing number 201617029499
Filed on 30/08/2016

SECTION 15 & 43(1)

Applicants PHILIP MORRIS PRODUCTS S.A.

Address of Service LEX ORBIS CONSULTING PVT. LTD, 709/710 Tolstoy House,
15 17 Tolstoy Marg, New Delhi 110001, Inida.
E-mail: manisha@lexorbis.com, mail@lexorbis.com

Present during the hearing proceedings U/S 14

1. Mr. Patel Narayanlal Virendra Bhai [INPA 3017], Patent agent for the Applicant.
2. Mr. Vignesh G, Coordinator – Engineering, IPO Chennai.

DECISION

1. The application (201617029499) was filed by PHILIP MORRIS PRODUCTS S.A.,

(hereinafter referred to as the "applicant") on30/08/2016 with a title “FLAVOURED
NICOTINE POWDER INHALER”. The application was published on 27/01/2017and request
for expedited examination (Form 18) was filed on 24/03/2018. The application was examined
and First Examination Report (FER) was issued on 20/04/2020. The applicant submitted reply to
FER on 08/10/2020with the amended claims.

201617029499 Page 1
2. For the sake of understanding the invention, relevant portions of the inventions are reproduced
here with
Field of Invention
This disclosure relates to flavoured nicotine powder inhalers, where the flavoured
nicotine powder is delivered at low air flow rates.
Summary of the Invention
The present disclosure provides flavoured nicotine powder inhalers for inhaling dry
powder nicotine and flavourant. The flavoured nicotine powder inhalers include a body
extending between a mouthpiece portion and a distal end portion. An airflow channel extends
between the mouthpiece portion and a distal end portion and a nicotine powder receptacle.
The dose of nicotine powder can be inhaled into lungs of a user at an inhalation rate of
less than about 5 L/min or less than about 2 L/min which mimics the inhalation flow rate utilized
for a conventional smoking regime. The flavourant is delivered to the mouth of the user
simultaneously as the nicotine particles are inhaled.
Suitable flavours and aromas include, but are not limited to, any natural or synthetic
flavour or aroma, such as tobacco, smoke, menthol, mint (such as peppermint and spearmint),
chocolate, licorice, citrus and other fruit flavours, gamma octalactone, vanillin, ethyl vanillin,
breath freshener flavours, spice flavours such as cinnamon, methyl salicylate, linalool, bergamot
oil, geranium oil, lemon oil, and ginger oil, and the like.
The Applicant has developed a flavoured nicotine powder inhaler that can deliver the
flavoured nicotine powder at low air flow rates within conventional smoking regime inhalation
or air flow rates and provide a metered dose of flavoured nicotine and an optional simultaneous
delivery of a second active ingredient.
3. This office has examined the original claims and issued a First examination report to the
applicants with mainly following objections (Gist only reproduced here with for reference) along
with the other objections.
List of documents cited:
a) EP2399637A1published on 28/12/2011 (hereinafter referred to as "D1")
b) US7089934B2published on 15/08/2006(hereinafter referred to as "D2")
c) US20110220106A1published on 15/09/2011 (hereinafter referred to as "D3")

201617029499 Page 2
 • Subject matter of claims 1-13 does not constitute an invention as it lack in inventive step
under section 2(1)j(a) of the Patent Act 1970 as amended in view of documents
D1:EP2399637A1, D2:US7089934B2 and D3:US20110220106A1 as these documents all
together teaches the subject matter of the present claims.
• Non-patentability: Since it causes serious prejudice to human life or health and to the
environment, it is non-patentable under 3(b) of Indian Patents Act.
• Sufficiency of disclosure: Applicant is reminded of the proper language and format for an
abstract of the disclosure. The abstract should be in narrative form and generally limited to a
single paragraph on a separate sheet within the range of 50 to 150 words.
• Claim 14 is a mere use claim and do not involve any technical features to be considered as
novel and inventive. The use of the above mentioned claim is an inherent industrial
applicability of the preceding claims i.e. of the application in view of description disclosure
and doesn’t require separate recitation as claims.
• Claims 1-13 are not clear in respect of the inventive step. Inventive step should be
pinpointed clearly in the principal claim incorporating all the constructional features
described therein and should be characterized.

4. Applicants replied to the FER and applicants have amended the claims. This office has the prime
facie duty to check whether amended claims are within the Purview of Section 59(1) of the
Patents Act.
In reply to the FER, applicants submitted that originally filed claims 1 to 14 were pending
at the time of receiving FER. Claim 1 has been amended to bring out the novelty of the
invention. New Claim 11 and 12 are amended to bring out clarity of invention. Further applicants
submitted that no new subject matter has been added by way of amendments.
For the sake of clarity, amended claims and Applicant response in line with cited
documents (D1 – D3) is reproduced here with
1. A nicotine powder inhaler (10) comprising:
a body extending between a mouthpiece portion (12) and a distal end portion
(14);
an airflow channel (13, 15, 15A, 15B, 5C) extending between the mouthpiece
portion (12) and the distal end portion (14);

201617029499 Page 3
 a nicotine powder receptacle (30, 32, 33) disposed along the airflow channel (13,
15, 15A, 15B, 5C) and comprising a dose of nicotine powder and a dose of
flavourant, wherein the nicotine powder comprises nicotine salt; and
a swirl generator element constructed to induce rotational movement in the
airflow,
wherein the dose of nicotine powder can be inhaled into lungs of a user at an
inhalation rate of less than about 5 L/min.
2. The nicotine powder inhaler (10) as claimed in claim 1, wherein the dose of flavorant
comprises powdered flavourant.
3. The nicotine powder inhaler (10) as claimed in claim 1, wherein the dose of flavorant
comprises liquid flavourant.
4. The nicotine powder inhaler (10) as claimed in claim 1, wherein the nicotine powder
receptacle (30, 32, 33) is configured to receive a capsule (20) containing nicotine powder
comprising nicotine salt.
5. The nicotine powder inhaler(10) as claimed in claim 4, wherein the capsule (20) contains
the dose of flavorant comprises powdered flavourant.
6. The nicotine powder inhaler (10) as claimed in claim 1, wherein the dose of flavorant
comprises a crushable capsule that can be ruptured by a user to release flavourant.
7. The nicotine powder inhaler (10) as claimed in claim 1, wherein the nicotine powder
inhaler (10) comprises a filter element upstream of the nicotine powder receptacle (100).
8. The nicotine powder inhaler (10) as claimed in claim 7, wherein the dose of flavorant is a
thread impregnated with menthol.
9. The nicotine powder inhaler (10) as claimed in claim 1, wherein the nicotine powder
inhaler (10) comprises dose of a second active agent.
10. A method of inhaling flavoured nicotine into lungs of a user comprising: inhaling air
through the flavoured nicotine power inhaler (10) as claimed in claim 1 at a flow rate of
less than about 2 L/min to deliver flavoured powder nicotine into lungs of a user.
11. The nicotine powder inhaler as claimed in claim 1, wherein the dose of flavourant is
selected from tobacco, smoke, menthol, mint, chocolate, licorice, citrus and other fruit
flavours, gamma octalactone, vanillin, ethyl vanillin, breath freshener flavours,

201617029499 Page 4
 cinnamon, methyl salicylate, linalool, bergamot oil, geranium oil, lemon oil, and ginger
oil.
12. The nicotine powder inhaler as claimed in claim 1, wherein the dose of flavourant
comprises menthol.

Applicant's response to cited documents

D1 does not disclose a nicotine powder inhaler comprising a nicotine powder receptacle
with a dose of nicotine powder. Instead, D1 discloses in paragraph [0009] of the specification
that a smokeless cigarette and not a nicotine powder inhaler. D1 teaches that by inhaling air
through the smokeless cigarette, the user inhales tobacco flavoured air. Even if that air contained
some amount of nicotine, there is no suggestion in D1 of providing a device for inhaling nicotine
powder.
It is submitted that D2 is aimed at solving an entirely different problem from that of the
present invention. The present invention is aimed at providing an inhaler for nicotine powder
such that the dose of nicotine powder can be inhaled into lungs of a user at a lower inhalation
rate, the document D2 is aimed at providing a drug delivery system to minimize the pulmonary
deposition of materials having undesirable or unknown pulmonary toxicology and allow only
those which are approved for oral delivery.
D3 discloses a mouthpiece which is axially engageable with the inhaler through a
delivery needle. The medication delivery needle penetrates the medication containers when the
inhaler is actuated and has an opening for passing exterior air and medication from interior
spaces of the containers to mouthpiece. However, D3 fails to disclose an inhaler that comprises a
nicotine powder receptacle comprising a dose of nicotine powder and a dose of flavourant; and a
swirl generator element constructed to induce rotational movement in the airflow, wherein the
dose of nicotine powder can be inhaled into lungs of a user at an inhalation rate of less than
about 5 L/min.
In view of the above submission, the Applicant submits that the cited documents D1-D3,
either alone or on being mosaicked, fail to suggest the features of the independent claim 1 of the
present invention.
Applicant's response to other objections
Applicant submits that the present invention actually focuses on reducing the harmful
effect of smoking, instead of causing serious prejudice to human, animal or plant life. Moreover,

201617029499 Page 5
 the Indian Patent Office (IPO) has continuously been allowing patents for similar technical fields
and applications. There are numerous patents granted by the IPO relating to smoking articles,
smoking compositions, wrapper material enwrapping a tobacco smoking material, and traditional
cigarettes. Such patents are still being allowed by the IPO.
The Applicant hereby submits a copy of revised abstract in the above prescribed format.
Particularly, the revised abstract is well within the prescribed word limit and presents a short
summary communicating the essence of the invention.
The Applicant submits that claim 14 (amended and renumbered claim 10) is a dependent
claim dependent on the principal claim 1. The independent claim 1 is related to a nicotine
powder inhaler while claim 14 recites a method of inhaling nicotine into the lungs of a user.

5. In view of the amendments, this office has checked whether the

Following four conditions to be satisfied for passing amendments in accordance with Section
59(1) of the Patents Act.
a) The amendment can only be through a disclaimer, correction and explanation.
b) No amendment shall be allowed except for the incorporation of fact.
c) Amendment, the effect of which would be that of the specification as amended would
claim or describe the matter not in substance disclosed or shown in the specification
before the amendment, shall not be allowed.
d) The amendment, the effect of which would be that any claim as amended would not fall
wholly within the scope of a claim of the specification before the amendment, shall not be
allowed.
With the given explanation and support of the amended claims, I was satisfied that conditions
prescribed in accordance with Section 59(1) had been met and decided to allow the amendments
carried out in the claims.

6. After considering the reply filed in response to the FER by the applicant and the report of the
examiner's view on the reply, it was observed that the said patent application was not in order for
grant. Keeping in view the provisions of the Patents Act, 1970 (as amended) and to provide
natural justice to the applicant, hearings were offered to the applicant.

201617029499 Page 6
7. This office issued a hearing notice under Section 14 and the Hearing was fixed on 11/09/2023 at
1.00 pm with the following objections.
Invention u/s 2(1)(ja)
The present Invention is very much marginal improvement from the cited documents,
therefore the person skilled in the art will come to the conclusion of the present invention, While
combining D1To D3. Hence lacks Inventive step.
Claims 1-10 are not clear in respect of the inventive step. Inventive step should be pinpointed
clearly in the principal claim incorporating all the constructional features described therein and
should be characterized. Claims should be drafted in a strategic way such that it should cover
main inventive feature in first/Principle claim along with other features in a single sentence,
preferably with a word ‘characterized’ separating inventive feature from the rest i.e. features
known in combination from prior art being placed in preamble and the inventive and new feature
in the characterising part.
Since it causes serious prejudice to human life or health and to the environment, it is non-
patentable under 3(b) of Indian Patents Act.
Scope of claim 12 is redundant in view of claim 11 and hence the same must be deleted.

8. The hearing was attended by the learned agent of the applicant. The applicant has substantiated
the oral arguments with the written submissions on 22/09/2023.

9. My Analysis
Lack of Inventive Step under Section 2(1)(ja) of the Act in the light of the prior art
documents referenced as D1-D3
D1 teaches that by inhaling air through the smokeless cigarette, the user inhales tobacco-
flavored air. Even if that air contained some amount of nicotine, there is no suggestion of
providing a device for inhaling nicotine powder. D1 teaches that the tobacco shreds or grains of
the filler must have a particle size of between 0.212 mm and 2.0 mm. D1 further teaches that this
particle size is important for achieving the desired ventilation resistance of between 40-80
mmAq.
D2 particularly discloses a method and a system for delivery of multiple doses of a
therapeutic agent in multi particulates form which minimizes the need for inert pharmaceutical
excipients and protects the active ingredient from contamination and moisture, wherein the
201617029499 Page 7
dosing is adjustable based on the needs of an individual patient. In contrast, the present invention
refers to a nicotine powder inhaler which makes possible to enable a delivery of flavoured
nicotine powder to a user’s lungs without compromising with the inhalation rates/air-flow rates
along with the size and configuration of the nicotine powder inhaler.
D3 discloses a multiple dose medication inhaler for concurrently delivering multiple
doses of medications, which includes: (i) a medication container chamber for receiving a
plurality of medication containers and an air passage connecting the medication container
chamber with external air, (ii) a mouthpiece axially engageable with the inhaler body and having
a mouthpiece chamber for communication with a patient’s respiratory system, and (iii) a hollow
medication delivery needle communicating with the mouthpiece chamber, wherein the
medication delivery needle penetrates the medication containers when the inhaler is actuated and
has at least one opening for passing exterior air and medication from interior spaces of the
medication containers and through the needle to mouthpiece.
Thus, none of the prior art discloses below-mentioned features of the flavoured nicotine
powder inhaler according to present invention.
• a nicotine powder receptacle (30, 32, 33) disposed along the airflow channel(13,
15, 15A, 15B, 5C) and comprising a dose of nicotine powder and a dose of
flavourant, wherein the nicotine powder comprises nicotine salt; and
• a swirl generator element constructed to induce rotational movement in the
airflow,
• wherein the dose of nicotine powder can be inhaled into lungs of a user at an
inhalation rate of less than about 5 L/min”, as recited by the independent claim 1.
Therefore, from the above discussion, the office concludes that, w.r.t the prior art
disclosure, it is not obvious and routine experimentation for a person skilled in the art; and
inventive step for the claims 1-11 is acknowledged.

Claimed subject matter is not an Invention under the Act in relation to section 3(b).

However without prejudice, to the observation given under Section 2(1)(ja), the
following observation under Section 3(b) is been given:
Office Objection: Since the present subject matter causes serious prejudice to human life or
health and to the environment, it is non-patentable under 3(b) of Indian Patents Act.

201617029499 Page 8
For better clarifications, I have referred the following documents.
1) Chakma, J.K., Dhaliwal, R.S., Mehrotra, R. and Writing Committee, 2019. White paper
on electronic nicotine delivery system. The Indian Journal of Medical Research, 149(5),
pp. 574–583 (hereinafter referred to as "A1").
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6702703/pdf/IJMR-149-574.pdf
2) Media report on (Electronic Nicotine Delivery System (ENDS) by Indian Council of
Medical Research (hereinafter referred to as "A2").
https://main.icmr.nic.in/sites/default/files/ICMR_NEWS_ENDS.pdf
3) Government of India, Ministry of Health & Family Welfare order no. F.No.-P-
16012/19/2017-TC dated 28/08/2018(hereinafter referred to as "A3").
https://ntcp.mohfw.gov.in/assets/document/CIRCULAR-ADVISORY/Advisory-on-
Electronic-Nicotine-Delivery-Systems-(ENDS)-and-the-like-devices-which-enable-
nicotine-delivery.pdf
4) Government of India, Ministry of Home Affairs order no. F.No. 24013/50/Misc./2019-
CSR.III dated 07/10/2019 (hereinafter referred to as "A4").
https://www.mha.gov.in/sites/default/files/CSDiv_ecigerete_12122019.pdf
5) World Health Organization(WHO) report on the global tobacco epidemic
2021(hereinafter referred to as "A5").
https://iris.who.int/bitstream/handle/10665/343287/9789240032095-eng.pdf?sequence=1
6) The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export,
Transport, Sale, Distribution, Storage and Advertisement) Act, 2019 (No. 42 of 2019)
dated 05/12/2019 (hereinafter referred to as "A6").
https://ntcp.mohfw.gov.in/assets/document/The-Prohibition-of-Electronic-Cigarettes-
Production-Manufacture-Import-Export-Transport-Sale-Distribution-Storage-and-
Advertisement)-Act-2019.pdf
7) Government of India, Ministry of Commerce and Industry notification no. 20/2015-2020
dated 26/09/2019 (hereinafter referred to as "A7").
https://content.dgft.gov.in/Website/Notification%20No.%2020%20dated%2026.09.2019
%20in%20E.pdf
8) Government of India, Ministry of Commerce and Industry notification no. 22/2015-2020
dated 30/09/2019 (hereinafter referred to as "A8").

201617029499 Page 9
 https://content.dgft.gov.in/Website/Noti%2022%20dated%2030.09.2019%20Eng_0.pdf
9) Government of India, Ministry of Health & Family Welfare report on Economic Burden
of Tobacco Related Diseases in India (hereinafter referred to as "A9").
https://nhm.gov.in/NTCP/Surveys-Reports-
Publications/Economic_Burden_of_Tobacco_Related_Diseases_in_India-Report.pdf

Applicant Argument 1:
The applicant has argued that, the present invention actually focuses on reducing the
harmful effect of smoking, instead of actually causing serious prejudice to human, animal or
plant life. The Applicant herewith emphasizes that the Nicotine oral inhalation is used to help
people stop smoking and the Nicotine oral inhalation should be used together with a smoking
cessation program. The Nicotine inhalation is in a class of medications called smoking cessation
aids which works by providing nicotine (without using tobacco) to the body to decrease the
withdrawal symptoms experienced when smoking is stopped and to reduce the urge to smoke.

Observations under Indian Government Policies and Guidelines

It is pertinent to refer to relevant portions of Document “A1” which are reproduced as below:
… Nicotine is considered as one of the most addictive substances. The rapidity at
which it is introduced into the body, age of first exposure and the dosage administered all
add to determine the potential risk of a person being addicted to it throughout life. The
various flavours and attractive designs also add to the allure of these products to the
young population[Page 1, Line 14 – 17].
Electronic nicotine delivery systems (ENDS) as a tobacco cessation aid: Myths and
reality
… There is very limited evidence regarding the impact of ENDS on tobacco
smoking cessation, reduction in cigarette use or adverse health effects. The International
Association for the Study of Lung Cancer does not recommend the use of e-cigarettes for
treating nicotine dependence even in cancer patients, due to the absence of sufficient
evidence on their efficacy and safety. The Indian Medical Association considered ENDS
as an unhealthy and disguised form of tobacco addiction, with serious long-term health
effects and unfit to be used for tobacco cessation [Page 3, Line 13 – 17].
Marketing and promotion

201617029499 Page 10
 … They are being marketed as safer alternatives to conventional cigarettes or
harm reduction products, in a glamorous manner, so as to make them attractive under
the guise of being less harmful. These techniques are aimed at targeting the youth and
children. Some of their advertisements also suggest that these products can be used for
bypassing the smoke-free rules.
It is also noteworthy that major tobacco companies have purchased or developed
ENDS products, with the dual commercial intent of expanding their range of tobacco
products while touting their ability to offer a product that they claim reduces harm from
the cigarettes. Cigarette smokers who may have otherwise given up the habit are thereby
retained as nicotine-addicted customers, while those who may have never attempted to
experiment with cigarettes are drawn into the nicotine addiction web [Page 3, Line 20 –
28].
Indian perspective
In India, use of nicotine as an ingredient in any food item is prohibited under the
Food Safety and Standards (Prohibition and Restrictions on Sales) Regulation, 2011 of
the Food Safety and Standards Act, 2006. Nicotine and nicotine sulphate are listed as
hazardous chemicals under the Environment (Protection) Act, 1986 and in the
Manufacture, Storage and Import of Hazardous Chemical Rules, 1989. There are other
laws and regulations which are also applicable to ENDS [Page 3, Line 40 – 44].
Tobacco consumption, especially cigarette smoking, has shown a decline in India
in recent years, in response to several tobacco control measures. The marketing of a
product-like ENDS, with unproven benefit and high potential harm from addiction and
health risks, is unwarranted as a tobacco control measure. The risk of youth addiction is
high as borne out by international experience and in Indian media reports. The adverse
population-level health impact will outweigh any presumed benefit to individual cigarette
smokers [Page 3, Line 1 – 5].

It is evident from ICMR White Paper on Electronic Nicotine Delivery System (A1), the
argument that products like e-cigarettes, electronic nicotine delivery system, and nicotine
inhalation system are not helpful to the smokers to reduce and/or quit the tobacco consumption.
Furthermore, it also highlighted that “Young person’s using products like ENDS are more likely
to use regular cigarettes later. ENDS use increases the likelihood to experiment with regular

201617029499 Page 11
tobacco products, increases intention to cigarette smoking and also increases the risk of dual use,
due to lack of awareness about the harmful effects of ENDS. The risk of youth addiction is high
as borne out by international experience and in Indian media reports”.

It is pertinent to refer to relevant portions of Document “A2” which are reproduced as below:
ICMR calls for ban on e-cigarettes (May 31, 2019/The Hindu Business Line)
… The paper has rejected the argument that e-cigarettes could help smokers quit
tobacco consumption. “While such benefits have not been firmly established, there is also
evidence that there is risk of people continuing to use both them as well as tobacco
products. In addition, these devices could encourage non-smokers to get addicted to
tobacco,” it said [Page 5, Line 33 – 37].
White Paper On Electronic Nicotine Delivery System (ENDS) Released At ICMR Hqrs
May 31, 2019/The Express Healthcare
… Nicotine is considered as one of the most addictive substances and the rapidity
at which it is introduced into the body, age of first exposure and the dosage administered
all add to determine the potential risk of a person being addicted to it throughout
life[Page 6, Line 12 – 15].
E-cigarettes cause as much harm as smoking say doctors on World Tobacco Day May 31,
2019/The New Indian Express
… “It is myth that e-cigarettes are better. While there’s no specific data on how
the e-cigarettes are selling in the country, they are especially popular with the young
generation,” Dr Randeep Guleria, Director, AIIMS, said[Page 7, Line 41 – 43].
ICMR warns: E-cigarettes can lead to public health disaster May 31, 2019/Drug Today
Medical Times
… Prof. Ravi Mehrotra, Director, ICMR-National Institute of Cancer Prevention
and Research, said, “Smokeless tobacco use still remains a public health concern beyond
the Southeast Asia Region and requires a comprehensive approach to deal with the
various challenges to its control.” He stated, “ENDS or e-cigarettes are not the only
products which have been marketed as an alternative to regular tobacco smoking. There
are other devices already available in the market which are also used without any known
safety and efficacy of these products as tobacco cessation aid.” [Page 12, Line 18 – 25].

201617029499 Page 12
 Experts call for full e-cigarette ban June 1, 2019/The Telegraph
… “They’re traps that could perpetuate nicotine dependence — they push non-
smokers towards nicotine addiction and smokers into dual use,” said K. Srinath Reddy, a
senior cardiologist and president of the Public Health Foundation of India who chaired
the 12-member expert panel that produced the white paper [Page 13, Line 27 – 31].

It is evident from Media report on (Electronic Nicotine Delivery System (ENDS) (A2),
the argument that the degree to which, if at all, the products like ENDS or e-cigarettes benefit as
tobacco cessation aides is not firmly established, evidence suggests that there is a risk of dual use
to some extent and initiation to tobacco addiction to non-smokers. Hence, on the balance these
products have a net negative impact on public health.”

Response to Applicant Argument 1:

Based on the above reasoning, cited documents A1 and A2 clearly describes
“tobacco lobbies have been claiming that electronic cigarettes are less harmful than
cigarettes and should therefore be acceptable as a viable alternative to reduce tobacco
smoking. Many public health experts believe the claim is a misleading one”. The applicant
argument on “by providing nicotine (without using tobacco) to the body to decrease the
withdrawal symptoms experienced when smoking is stopped and to reduce the urge to
smoke” is completely myth and there is no proved evidence in it. So the Argument 1 is not
valid and the present invention is subject to causes serious prejudice to human life or
health and to the environment.

Applicant Argument 2:
The applicant has argued that, the Indian Patent Office (IPO) has continuously been
allowing patents for similar technical fields and applications. There are numerous patents granted
by the IPO relating to smoking articles, smoking compositions, wrapper material enwrapping a
tobacco smoking material (including nicotine), and traditional cigarettes.

Response to Applicant Argument 2:

The granting of Patents U/S 15 is relied on discretionary power of the respective
controller. The controller can perform the technical analysis and observe whether the
requirements are met by the applicant as per the Patent Act and Patent Rules and decide the case

201617029499 Page 13
based on the merit. The controller never looks in to the similar cases whether it is granted or not
and nowhere in the Patent Act or guidelines suggest that to do so. Moreover, the present
application dealt with flavoured nicotine powder inhalers for inhaling dry powder nicotine and
flavourant which causes serious prejudice to human health as per the ICMR studies and
guidelines. So the Argument 2 is not acceptable.

Applicant Argument 3:
The applicant has argued that, it appears to the Applicant that the Controller may be influenced
by the recent ban on e-cigarettes by the Indian Government. However, the present application is
not focused on e-cigarettes and is primarily focused on a nicotine powder inhaler, which cannot
be considered similar to e-cigarettes, the dry powder inhaler of the present application has been
fabricated only for pharmaceutical uses.

Observations under Indian Government Policies and Guidelines

It is pertinent to refer to relevant portions of Document “A3” which are reproduced as below:
Advisory on Electronic Nicotine Delivery Systems (ENDS) including e- Cigarettes, Heat-
Not-burn devices, Vape, e-Sheesha, e-Nicotine Flavoured Hookah, and the like products
… Also, nicotine may function as a "tumour promoter" and seems to be involved
in the biology of malignant diseases. Foetal and adolescent nicotine exposure may have
long-term consequences for brain development, potentially leading to learning and
anxiety disorders. A number of metals - including lead, chromium, and nickel, and
chemicals like formaldehyde have been found in aerosols of some ENDS, with
concentrations equal to or greater than traditional cigarettes, under normal experimental
conditions of use[Page 1, Line 14 – 20].
And whereas, nicotine is prohibited for use as an ingredient in any food item
under the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulation,
2011 of the Food Safety and Standards Act, 2006[Page 2, Line 1 – 3];
And whereas, both Nicotine and Nicotine Sulphate are listed as hazardous
chemicals in the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989
made under the Environment (Protection) Act, 1986[Page 2, Line 4 – 6];

201617029499 Page 14
 And whereas, nicotine is also listed as an insecticide in the Schedule of
Insecticides under the Insecticide Act 1968, and subsequently its use as a pesticide is also
highly restricted by Government of India[Page 2, Line 7 – 9];
The Ministry of Health & Family Welfare, Government of India conducted a
Roundtable discussion on Electronic Nicotine Delivery Systems (ENDS) in 2014, wherein
eminent doctors, specialists, scientists and officers of Health and Drug departments
concluded that available scientific evidences indicate that the ENDS and similar
technologies that encourage tobacco use, are hazardous for an active as well as passive
users and have an adverse impact on public health. The State Governments of Punjab
[Vide Circular dated 5.9.131; Karnataka [Vide Circular dated 15thJune, 2016]; Mizoram
[Vide Circular dated 8thJune 2016], Kerala [Vide Order dated 1stAugust, 2016]; Jammu
& Kashmir [vide Circular dated 24thJuly, 20171; Uttar Pradesh [Vide Order dated
14thNovember, 2017]; Bihar [Vide Order dated 28thNovember, 2017] have prohibited the
manufacture, distribution, import and sale of Electronic Nicotine Delivery Systems
(ENDS)[Page 3, Line 1 – 4];
Now therefore, it is evident that Electronic Nicotine Delivery Systems (ENDS)
including e- Cigarettes, Heat-Not-Burn devices, Vape, e-Sheesha, e-Nicotine Flavoured
Hookah, and the like devices or products available by whatsoever name, that enable
nicotine delivery or its use, are a great health risk to public at large, especially to
children, adolescents, pregnant women and women of reproductive age. It is also evident
that ENDS are not approved as NRT's under the Drugs and Cosmetics Act and Rules
made there under [Page 3, Line 10 – 15].

It is pertinent to refer to relevant portions of Document “A4” which are reproduced as below:
E-cigarettes includes all forms of Electronic Nicotine Delivery Systems, Heat Not
Burn Products, e-Hookah and the like devices, by whatever name called and whatever
shape, size or form it may have, but does not include any product licensed under the
Drugs and Cosmetics Act, 1940.
Production, manufacture, import, export, transport, sale, distribution, storage
and advertisement of electronic-cigarettes or any parts or components thereof such as

201617029499 Page 15
 refill pods, atomisers, cartridges etc, is prohibited. Online sale and advertisement have
also been prohibited.

It is evident from Advisory on Electronic Nicotine Delivery Systems (ENDS)

including e- Cigarettes, Heat-Not-burn devices, Vape, e-Sheesha, e-Nicotine Flavoured
Hookah, and the like products (A3) and The Prohibition of Electronic Cigarettes
(production, manufacture, import, export, transport, sale, distribution, storage and
advertisement) Ordinance, 2019 (A4) the ban by the Indian Government is not only
focused on e-cigarettes, it clearly says E-cigarettes includes all forms of Electronic
Nicotine Delivery Systems, Heat Not Burn Products, e-Hookah and the like devices, by
whatever name called and whatever shape, size or form it may have, but does not include
any product licensed under the Drugs and Cosmetics Act, 1940.

Response to Applicant Argument 3:

Based on the above reasoning, cited documents A3 and A4 clearly describes “nicotine
may function as a "tumour promoter", nicotine is prohibited for use as an ingredient in any food
item, nicotine and nicotine sulphate are listed as hazardous chemicals in the Manufacture,
Storage and Import and nicotine is also listed as an insecticide”. Document A4 also states that
production, manufacture, import, export, transport, sale, distribution, storage and advertisement
of electronic-cigarettes includes all forms of Electronic Nicotine Delivery Systems, Heat Not
Burn Products, e-Hookah and the like devices, by whatever name called and whatever shape,
size or form it may have or any parts or components thereof such as refill pods, atomisers,
cartridges etc, is prohibited.
The applicant argument on the present application is not focused on e-cigarettes and is
primarily focused on a nicotine powder inhaler is not allowable under the Indian Government
policies and guidelines.
Moreover, the applicant argued that the present application has been fabricated only for
pharmaceutical uses, but nowhere in the originally filed complete specification (dated
30/08/2016) and amended complete specification (dated 08/10/2020) describes the present
invention is fabricated only for pharmaceutical or medical purposes. So this argument is baseless
and not allowable.

201617029499 Page 16
 Hence, the Argument 3 is not allowable and the present invention is subject to
causes serious prejudice to human life or health and to the environment.

Applicant Argument 4:
Nevertheless, the Applicant would like to invite the attention of the Controller to Article 4quater
of the Paris Convention. Article 4quater of the Paris Convention states that the grant of a patent
shall not be refused, and a patent shall not be invalidated on the ground that the sale of the
patented product or of a product obtained by means of a patented process is subject to restrictions
or limitations resulting from the domestic law.
Similarly, Article 27 of the TRIPS agreement states that members may exclude from
patentability inventions, the prevention within their territory of the commercial exploitation of
which is necessary to protect order public or morality, including to protect human, animal, or
plant life or health or to avoid serious prejudice to the environment, provided that such exclusion
is not made merely because the exploitation is prohibited by their law. It is clear from the plain
reading of Article 27 that a patent application cannot be refused merely for the reason that the
exploitation of the associated product or process is prohibited by the local law.

Observations
It is pertinent to refer to relevant portions of Article 4quater of the Paris Convention which are
reproduced as below:
The grant of a patent shall not be refused and a patent shall not be invalidated on
the ground that the sale of the patented product or of a product obtained by means of a
patented process (c) is subject to restrictions or limitations (d) resulting from the
domestic law[Page 65, Line 2 – 5].
… The provision was proposed for the following reasons. It sometimes happens
that an invention leads to the manufacture of a product which does not conform to the
requirements of the national law of a country as to, for example, security or quality. In
other cases the manufacture or sale of such product is restricted, because the State
concerned has granted a monopoly or an exclusive concession for such manufacture or
sale to an organization of public or private law. It would, however, be unjust to refuse or
invalidate patents concerning such inventions. In cases of the first category, the invention
may show that the requirements of the law prohibiting the sale of certain products are

201617029499 Page 17
 obsolete, in which case the law may be modified or repealed, which will then allow the
application of the invention. In the second case, a patent is justified since the holder of
the monopoly may obtain a contractual or a compulsory license for the exploitation of the
invention. The provision under examination therefore prescribes that patents may not be
refused or invalidated in such cases [Page 65, Line 8 – 23].

It is pertinent to refer to relevant portions of Article 27 of the TRIPS agreement which are
reproduced as below:
Members may exclude from patentability inventions, the prevention within their
territory of the commercial exploitation of which is necessary to protect order public or
morality, including to protect human, animal or plant life or health or to avoid serious
prejudice to the environment, provided that such exclusion is not made merely because
the exploitation is prohibited by their law [Page 1, Line 20 – 24].

It is pertinent to refer to relevant portions of Document “A5” which are reproduced as below:
Dr Tedros Adhanom Ghebreyesus, Director-General, WHO, said,
The WHO report on the global tobacco epidemic 2021: addressing new and
emerging products highlights how these products are promoted aggressively as “safer”
or “smoke-free” alternatives to conventional cigarettes. Although their full risks remain
unknown, the impact of nicotine delivery devices is clear [Page 15, Column 2].
While framing these products as a contribution to global tobacco control, the
tobacco and related industries employ the same old marketing tactics to promote new
tools to hook children on nicotine and circumvent tobacco legislation. At the same time,
they continue to fight measures and legislation designed to protect people from the many
harms of tobacco across the globe [Page 15, Column 2].
Michael R. Bloomberg, WHO Global Ambassador for Non-communicable Diseases and
Injuries Founder, Bloomberg Philanthropies, said
And as cigarette sales have fallen, tobacco companies have been aggressively
marketing new products – like e-cigarettes and heated-tobacco products – and lobbying
governments to limit their regulation. Their goal is simple: to hook another generation on
nicotine [Page 17, Column 2].
Dr Adriana Blanco Marquizo, Head of the WHO FCTC Secretariat, said

201617029499 Page 18
 Finally, new challenges lie ahead. Electronic nicotine delivery systems – also
known as e-cigarettes – and novel tobacco products are promoted as healthier
alternatives to smoking by their manufacturers (mainly the tobacco industry) and their
supporters. Until independent research shows the real risk profile of these products,
governments should be cautious. Science-based evidence, not marketing, should guide
their actions [Page 19, Column 2].
This is the first time that the WHO report on the global tobacco epidemic has
included data on electronic nicotine delivery systems (ENDS), and it reveals that a total
of 111 countries regulate ENDS in some way. Thirty two of these countries (covering 2.4
billion people) ban the sale of ENDS, and the other 79 countries have adopted one or
more legislative measures to regulate ENDS, covering 3.2 billion people[Page 21,
Column 2].
Article 5.2 of the WHO FCTC obliges Parties to implement effective measures
aimed at preventing and reducing tobacco consumption, nicotine addiction and exposure
to tobacco smoke, and decision FCTC/COP7(9) invites Parties to consider applying
regulatory measures (such as those referred to in document FCTC/ COP/7/11) to
prohibit or restrict the manufacture, import, distribution, presentation, sale and use of
ENDS, as appropriate to their national laws and public health objectives [Page 31,
Column 1].
ENDS are harmful. For example, nicotine can have deleterious impacts on brain
development, leading to long-term consequences for children and adolescents in
particular (15). ENDS are marketed in thousands of flavours, which can increase the
palatability of the product and help them be targeted specifically at children and young
adults [Page 31, Column 2].
Nicotine also poses health risks to children, adolescents and pregnant women.
The consumption of nicotine in children and adolescents has deleterious impacts on brain
development, leading to long-term consequences for brain development and potentially
leading to learning and anxiety disorders (56–58). Nicotine exposure in pregnant women
can have similar consequences for the brain development of the fetus (59, 60) [Page 36,
Column 3].

201617029499 Page 19
 Nicotine is so addictive that a quarter of teenagers can become dependent upon it
after smoking just three or four cigarettes, and after smoking five packs, nearly 60% are
dependent (202). Most people who use tobacco regularly do so because they are addicted
to nicotine. This means they can therefore benefit greatly from a range of effective
tobacco cessation interventions. Without cessation assistance, only around 4% of
attempts to quit tobacco are successful (203) [Page 68, Column 2].
The focus of this report, addressing new and emerging products, charts a new
threat to tobacco control. ENDS are increasingly available in many countries along with
other novel products like heated tobacco products and nicotine pouches. As they emerge
and rapidly evolve, these products can be difficult to characterize and therefore bring
with them many regulatory challenges. At the same time, the tobacco and related
industries behind these newer products pedal misinformation campaigns, marketing them
as “clean”, “smoke-free” or “safer”, and claim they are effective cessation aids. By
doing so, these industries attempt to appear part of the solution to the tobacco epidemic,
as opposed to instigators and perpetrators of the epidemic. These industries also target
children and adolescents by using marketing strategies and thousands of flavours that
make ENDS and other nicotine and tobacco products appealing. When children use
ENDS, or even try them, they are more than twice as likely to use conventional cigarettes.
The tobacco industry gains new customers [Page 108, Column 3].

The Article 4quater of the Paris Convention and Article 27 of the TRIPS
agreement providing guidelines to make decisions on the patentable invention without
prejudice to the applicant natural justice. But the present invention dealt with nicotine
inhalation, as per WHO report (A5) Nicotine is so addictive, can have deleterious impacts
on brain development and also poses health risks to children, adolescents and pregnant
women. The Document A5 further adds that the new novel nicotine products are
promoted aggressively as “safer” or “smoke-free” alternatives to conventional cigarettes
which cause serious prejudice to human health.

Response to Applicant Argument 4:

The referred Article 4quater of the Paris Convention states that the grant of a patent shall
not be refused and a patent shall not be invalidated on the ground that the requirements of the
national law of a country as to, for example, security or quality.
201617029499 Page 20
 The referred Article 27 of the TRIPS agreement states that the patentability exclusion is
not made merely because the exploitation is prohibited by their law.
Based on the above reasoning, both the referred articles providing natural justice to the
applicant on patentable inventions even when the law on particular jurisdiction is against the
invention. But the present invention dealt with nicotine inhalation. The cited documents A5
clearly describes Nicotine is so addictive and consumption of nicotine in children and
adolescents has deleterious impacts on brain development. The products like e-cigarettes,
electronic nicotine delivery system, and nicotine inhalation system are banned not only in Indian
Jurisdictions, as per the WHO report (A5), a total of 111 countries regulate ENDS in some way.
Thirty-two of these countries (covering 2.4 billion people) ban the sale of ENDS, and the other
79 countries have adopted one or more legislative measures to regulate ENDS.
Moreover, the reasons to put patentability objections on the “flavoured nicotine powder
inhaler (present invention)” is not only because of it violating the national law, it also causes
serious prejudice to human health and life. That’s why 32 countries completely ban the nicotine
inhalation devices.
Furthermore, the applicant referring the Article 4quater of the Paris Convention and
Article 27 of the TRIPS agreement and seeking for exclusion from the contradicting the national
law for the present invention (nicotine inhalation device) is not appropriate, even WHO also
recommending guidelines to ban production, manufacture, import, export, transport, sale,
distribution, storage and advertisement of these kind of inventions.
The applicant argument on citing the Article 4quater of the Paris Convention and Article
27 of the TRIPS agreement to remove the objections U/S 3(b) of the Patent Act 1970 for nicotine
inhalation device is against the public morality and not acceptable.
Hence, the Argument 4 is not acceptable and the present invention is subject to
causes serious prejudice to human life or health and to the environment.

Applicant Argument 5:
Further, the Applicant submits that if the patent applications relating to the inhalation of nicotine
formulations are refused, for example, on the grounds of Section 3(b), such inventions will then
be publicly available for use by anybody. Therefore, it would not be practically possible to
regularize the use of such inventions considering the wide outreach of the inventions in the

201617029499 Page 21
public. Rather, by allowing the application, the rights of the invention belong to the Applicant
only and it would be possible for the Indian Government to regulate the intended use, if required.

Observations under Indian Government Policies and Guidelines

It is pertinent to refer to relevant portions of Document “A6” which are reproduced as below:
This Act may be called the Prohibition of Electronic Cigarettes (Production,
Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement)
Act, 2019 [Page 1].
(d) "electronic cigarette" means an electronic device that heats a substance, with
or without nicotine and flavours, to create an aerosol for inhalation and include sall
forms of Electronic Nicotine Delivery Systems, Heat Not Burn Products, e-Hookah and
the like devices, by whatever name called and whatever shape, size or form it may have,
but does not include any product licensed under the Drugs and Cosmetics Act, 1940
[Page 2].
4. On and from the date of commencement of this Act, no person shall, directly or
indirectly, - (i) produce or manufacture or import or export or transport or sell or
distribute electronic cigarettes, whether as a complete product or any part thereof; and
(ii) advertise electronic cigarettes or take part in any advertisement that directly or
indirectly promotes the use of electronic cigarettes [Page 3].
5. On and from the date of commencement of this Act, no person, being the owner
or occupier or having the control or use of any place shall, knowingly permit it to be used
for storage of any stock of electronic cigarettes [Page 3]:
7. Whoever contravenes the provisions of section 4, shall be punishable with
imprisonment for a term which may extend to one year or with fine which may extend to
one lakh rupees, or with both, and, for the second or subsequent offence, with
imprisonment for a term which may extend to three years and with fine which may extend
to five lakh rupees [Page 4].
8. Whoever contravenes the provisions of section 5, shall be punishable with
imprisonment for a term which may extend to six months or with fine which may extend to
fifty thousand rupees or with both [Page 4].

It is pertinent to refer to relevant portions of Document “A7” which are reproduced as below:

201617029499 Page 22
 Import of electronic cigarettes (e-cigarettes) or any parts or components thereof
such as refill pods, atomisers, cartridges etc, including all forms of Electronic Nicotine
Delivery Systems, Heat Not Burn Products, e - Hookah and the like devices by whatever
name and shape, size or form it may have, but does not include any product licenced
under the Drugs and Cosmetics Act, 1940, under HS Code: 8543 is Prohibited in
accordance with the Prohibition of Electronic Cigarettes (Production, Manufacture,
Import, Exports, Transport, Sale, Distribution, Storage and Advertisement) Ordinance,
2019.

It is pertinent to refer to relevant portions of Document “A8” which are reproduced as below:
Export of Electronic Cigarettes (E-Cigarettes) including all forms of Electronic
Nicotine Delivery Systems, Heat not burn products, e-hookah and the like devices, by
whatever name called and whatever shape, size or form it may have, but not including
any product licensed under the Drugs and Cosmetics Act, 1940 or any parts or
components thereof such as refill pods, atomisers, cartridges etc under Chapter 85 ITC
(HS) code 8543 is prohibited in accordance with the Prohibition of Electronic Cigarettes
(Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and
Advertisement) Ordinance 2019.

The Prohibition of Electronic Cigarettes (Production, Manufacture, Import,

Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019 (A6),
Amendment in import policy electronic cigarettes (A7) and Amendment in Export Policy
of Electronic Cigarettes (A8) providing the complete guidelines to prohibit the
Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and
Advertisement of Electronic Cigarettes like products in Indian Jurisdictions. Also,
document A6 further emphasis on punishments those who contravenes the Prohibition of
Electronic Cigarettes.

Response to Applicant Argument 5:

Based on the above reasoning, cited documents A6, A7 and A8 clearly describes
Government of India has passed Act on the prohibition of electronic cigarettes like devices
production, manufacture, import, export, transport, sale, distribution, storage and advertisement.
Also proving guidelines on punishments those who contravenes the Act.

201617029499 Page 23
 The applicant argument on the inhalation of nicotine formulations are refused, for
example, on the grounds of Section 3(b), such inventions will then be publicly available for use
by anybody is phantasy as per the Indian Government Act on the prohibition of electronic
cigarettes.
If the applicant is really concerned about the human life or health and to the environment,
herewith advised to, not to invent the inventions related to products like e-cigarettes, electronic
nicotine delivery system, and nicotine inhalation systems.
Moreover, the applicant argued that by allowing the application, the rights of the
invention belong to the Applicant only and it would be possible for the Indian Government to
regulate the intended use, if required. From this statement the applicant is asking exclusive right
to prevent third parties, who do not have his consent, from the act of making, using, offering for
sale, selling or importing (as per the Section 48 of Patent Act 1970) for electronic cigarettes like
devices. But the applicant should aware that the making, using, offering for sale, selling or
importing electronic cigarettes like devices are already banned in Indian Jurisdiction and which
is punishable offence too as per the Government of India Act on the prohibition of electronic
cigarettes.
Hence, the Argument 5 is not acceptable and the present invention is subject to
causes serious prejudice to human life or health and to the environment.

Applicant Argument 6:
In addition, the Applicant submits that Government policies keep changing over time. Therefore,
the possibility of revocation of this ban in the future cannot be negated. In case this ban is
revoked by the Indian Government in the future, the refusal of the application at this stage will
incur an irreparable loss to the Applicant. Moreover, such rejection would be in direct
contradiction with the principle of natural justice, more so, if the ban is revoked in the future.

Observations
It is pertinent to refer to relevant portions of Document “A9” which are reproduced as below:
The total economic costs attributable to tobacco use from all diseases in India in
the year 2011 for persons aged 35-69 amounted to Rs. 1,04,500 crores (US$ 22.4
billion), of which 16% was direct cost and 84% was indirect cost [Page 12, Line 2 – 4].

201617029499 Page 24
 Direct medical costs of hospital care and treatment of tobacco attributable
diseases amounted to Rs. 16,800 crore (US$ 3.6 billion), and associated indirect
morbidity cost amounted to Rs. 14,700 crore (US$ 3.1 billion). The cost from premature
mortality was Rs. 73,000 crores (US$ 15.6 billion) [Page 12, Line 5 – 8].
Males contributed 91 % of the total economic burden while females accounted for
the rest. However, the contribution from females was much higher (29%) for smokeless
tobacco. If one considers only the direct medical costs, the female share in costs
attributable to smokeless tobacco increases substantially (66%). The huge difference in
premature mortality costs between males and females is on account of lower annual
average earnings and the lower present value of lifetime earnings for females in India
compared to their male counterparts [Page 12, Line 9 – 15].
Cardiovascular diseases (CVDs) shared the highest burden (Rs. 3,600 crores) of
direct medical and indirect morbidity costs on account of tobacco use, followed by
respiratory diseases (Rs. 2,800 crores), tuberculosis (Rs. 2,300 crores) and cancers
(Rs.1,400 crores) [Page 12, Line 16 – 19].

[Reference: Report on Economic Burden of Tobacco Related Diseases in India (A9)]

201617029499 Page 25
 [Reference: Report on Economic Burden of Tobacco Related Diseases in India (A9)]

The Report on Economic Burden of Tobacco Related Diseases in India (A9)

providing the complete study on economic burden of diseases attributable to tobacco use
in India and across the states using the latest available evidence and estimated the direct
and indirect costs from all diseases caused due to tobacco use and specifically respiratory
diseases, tuberculosis, cardiovascular diseases and cancers.

Response to Applicant Argument 6:

Based on the above reasoning, cited document A9 clearly details the evidence on the
economic burden of diseases attributable to tobacco use at the national and sub-national levels in
India, and the cost of diseases attributable to tobacco use at the sub-national level. It also
estimated the cost of premature mortality at the all-India level thereby quantifying the losses in
productivity due to premature deaths.

201617029499 Page 26
 The applicant argued that, in case this ban is revoked by the Indian Government in the
future, the refusal of the application at this stage will incur an irreparable loss to the Applicant.
Moreover, such rejection would be in direct contradiction with the principle of natural justice,
more so, if the ban is revoked in the future.
It is evident from the cited document A9, the total cost of tobacco-attributable diseases is
substantial and in excess of public expenditure to GDP ratio in India. In 2011-12, the public
expenditure to GDP ratio was 1.04% whereas the cost to GDP ratio was 1.16%. The economic
costs from tobacco attributable diseases is more than 5 times higher than the excise tax revenue
from tobacco in India in 2011. Awareness on the hazards of tobacco use and the consequent
social, health, environment and economic burden must be generated and tobacco related
information must be communicated in local languages to draw public attention to the colossal
burden of the epidemic.
The applicant, try to understand the social, health, environment and economic burden on
the Government to control tobacco and nicotine consumption in order to protect the human life
or health and to the environment. The regulations and restrictions implied on the products like e-
cigarettes, electronic nicotine delivery system, and nicotine inhalation systems is to minimize the
social, health, environment and economic burden of the tobacco-attributable diseases. So, the
context of the objection is not only relied on the prohibition Act and Government policies,
it also relied on protecting human life and health and achieves the long term vision of
tobacco free country.

Hence, the Argument 6 is not allowable and the present invention is subject to
causes serious prejudice to human life or health and to the environment.

Applicant Argument 7:
The Applicant submits that the technical aspect of inhalation of the nicotine formulations,
strictly, from the perspective of patenting should be kept separate from the Government policies.
Anyway, the ban supersedes the patent rights and therefore, the grant of a patent application
would not allow the Applicant to perform any activity which is banned.

Observations
For the sake of brevity, the provision of the Section 83 of Patent Act 1970 is recited here

201617029499 Page 27
 Without prejudice to the other provisions contained in this Act, in exercising the powers
conferred by this Chapter, regard shall be had to the following general considerations,
namely;—
a. that patents are granted to encourage inventions and to secure that the
inventions are worked in India on a commercial scale and to the fullest extent
that is reasonably practicable without undue delay;
b. that they are not granted merely to enable patentees to enjoy a monopoly for the
importation of the patented article;
c. that the protection and enforcement of patent rights contribute to the promotion
of technological innovation and to the transfer and dissemination of technology,
to the mutual advantage of producers and users of technological knowledge and
in a manner conducive to social and economic welfare, and to a balance of
rights and obligations;
d. that patents granted do not impede protection of public health and nutrition and
should act as instrument to promote public interest specially in sectors of vital
importance for socio-economic and technological development of India;
e. that patents granted do not in any way prohibit Central Government in taking
measures to protect public health;
f. that the patent right is not abused by the patentee or person deriving title or
interest on patent from the patentee, and the patentee or a person deriving title
or interest on patent from the patentee does not resort to practices which
unreasonably restrain trade or adversely affect the international transfer of
technology; and
g. that patents are granted to make the benefit of the patented invention available
at reasonably affordable prices to the public.

The general principles relied on the granting patents is to, the patented inventions
are worked in India on a commercial scale and to the fullest without undue delay at the
same time the Central Government needs to ensure the public health, if the patented
inventions are contrary to public order or morality the Central Government has all rights
to prohibit those inventions.

201617029499 Page 28
Response to Applicant Argument 7:
The applicant argued that, the ban supersedes the patent rights and therefore, the grant of
a patent application would not allow the Applicant to perform any activity which is banned.
Based on the above reasoning, Section 83 of Patent Act 1970 is clearly indicates that
granting patents is to give access to be worked in India on a commercial scale, but if the present
invention (nicotine inhalation system) is provided with access to be worked in India then it
prohibit the central government to protect the public health. This causes serious prejudice to
human, animal or plant life or health or to the environment.
Hence, the Argument 7 is not allowable and the present invention is subject to
causes serious prejudice to human life or health and to the environment.

From the above arguments it is established that the present application which
causes serious prejudice to human health and is not allowed as per Section 3(b) of Patents
Act 1970. Therefore, the subject matter of claims 1 – 11 does not meets the requirements of
Patent Act 1970 and is not allowable under Section 3(b) of The Patents Act 1970.

Scope

Office Objection: Scope of claim 12 is redundant in view of claim 11 and hence the same must
be deleted.
The applicant submitted that the claim 12 has now been deleted in accordance with the
direction of the Controller
Therefore, from the above discussion, the office concludes that, w.r.t the claim
amendments, the scope objections are removed.

201617029499 Page 29
 ORDER
The arguments and the written submission of the Ld. Agent of the Applicant have been
carefully considered. However, without prejudice, the hearing submissions have attempted to
address the objections on inventive step and scope, yet the substantive requirement of the Patents
Act, 1970 i.e. Section 3(b) is not found complied with. Hence, in view of the above and unmet
requirements, this instant application is not found in order for grant.
In view of the above facts, and under the provisions of the Patens Act such as Section
3(b), under the purview of the same, refuses to proceed further with this application (application
no. 201617029499 dated 30/08/2016) for the patent right as the objection is still pending and
hence, the same is refused under Section 15 of The Patents Act, 1970 (as amended).

Dated on 19th day of October 2023.

Sd/-
M.RAM JAWAHAR
(Deputy Controller of Patents and Designs)

Copy to:
LEX ORBIS CONSULTING PVT. LTD, 709/710 Tolstoy House,
15 17 Tolstoy Marg, New Delhi 110001, Inida.
E-mail: manisha@lexorbis.com, mail@lexorbis.com

201617029499 Page 30