RK Gupta, Head,

1
IGNOU September 11, 2005
PROTECTING AN INVENTION
RK Gupta, Head, Intellectual Property Management
Division Council of Scientific Industrial
Research India guptark04_at_yahoo.com
2
CRITERIA FOR PATENT PROTECTION

• NOVELTY (WORLDWIDE BASIS)
• NON-OBVIOUSNESS
• UTILITY

3

• EXPLAINING THE EXPRESSION
• NATIONAL PATENT
• OR
• WORLD PATENT

4

• WHAT IS A PATENT SPECIFICATION?

5
DIFFERENCE BETWEEN A PUBLICATION AND A PATENT

• SCOPE
• DISCLOSURE
• BEST MODE
• CRITERIA OF PATENTABILITY

6
DISCLOSURE

• WHEN (Before or after Publication)
• WHERE Routes (PCT/SINGLE FILINGS)
• WHAT - look at what is not patentable

7
Costs associated with the disclosure

• Disclosure - How much
• Disclosure more
• Disclosure - less
• Disclosure bad
• Disclosure - timing

8
DISCLOSURE

• Understanding the readers of your patent.

9
UNDERSTANDING DISCLOSURE

• TECHNO-LEGAL-BUSINESS NATURE OF THE DISCLOSURE
• REQUIRES TECHNO-LEGAL-BUSINESS SKILLS FOR DRAFTING

10
Structure of A Patent Document

• Title of the invention
• Abstract
• Field of the invention
• Background of the invention
• Prior art discussion
• Objects of the invention
• Summary of the invention
• Detailed description of the invention
• Examples
• Advantages
• Claims

11
Understanding the Prior Art
12

• Searching the Prior Art

13
FINDING THE INVENTION

• 1. INVENTORSS BRIEF
• 2.OBJECTIVES OF THE INVENTION
• 3. Component parts/process /method/product
  /application details about the invention
• A. What component parts/process steps/product
  characteristics make up the invention?
• B. What component parts/process steps, if any,
  are new?
• C. How are the component parts connected?What are
  the process steps involved?
• D. Is there any new function achieved/NEW STEP
  INVOLVED?
• E. What variations in the method/ reaction
  conditions/reactants/structure possible?
• F. Which part of the invention is most critical
  and took longest to develop? Why?
• 4. Purpose and function of the invention
• A.What does the invention do and its utility
• B.Are there other ways to do what the invention
  does?

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FINDING THE INVENTION

• 5. Establishing the Problems.
• How were these problems addressed IN THE
  PRIOR ART?
• 6. Competition
• A.What inventions in the prior art competes with
  the invention?
• B.What are the advantages of the invention over
  the known art?
• C.How are these advantages achieved?
• D.What features of the invention would be more
  vulnerable?
• E.Does the invention improve upon a prior
  product/process? If so,what products/processes
  and in what ways?
• F.Provide a full description of prior
  product/PROCESSES to cite as prior art.

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FINDING THE INVENTION

• A.whether the invention developed has commercial
  potential or similar product/process already in
  the market
• B.Is it possible to introduce the product in the
  market immediately? If so, when, and under what
  circumstances?
• C.What advantages and features help sell the
  product?
• D.How are these advantages and features achieved?
• E. What is the life of the product?
• 8. What is the AVERAGE skill in this art?
• Who else is working in the area?

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FINDING THE INVENTION

• 9.Best mode contemplated by the inventor
• - Has the inventor thought about a best mode
  of practicing the invention?
• - If a best mode has been contemplated, is it
  fully disclosed?

17
BIOLOGICAL MATERIAL

• Use of Bilogical Material
• MTAs
• Depositions
• Availability

18
DRAFTING PATENT SPECIFICATION

• PROBLEM SOLVING APPROACH

19
Drafting Claims

• Every patentable invention represents a novel,
  nonobvious improvement over what existed before
  it. Thus, rarely does study of a claim of a
  particular prior art patent shed much light on
  how to draft a claim for a new invention. Indeed,
  the patent claim for a new invention must
  represent something different from what the prior
  art claim represents.
• Avoid revising an existing Claims set to draft a
  new application. One need to start from scratch
  in his own way to remain in control of all the
  countless subtleties.

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CLAIM TYPE

• INDEPENDENT TYPE
• DEPENDENT TYPE
• WHY MORE FALLBACK SITUATIONS

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Claim Elements

• All claims include
• - a preamble - A brief description about the
  invention (Dont add any limitations to the
  preamble).
• - a transitional phrase, (comprising, consisting
  essentially of and consisting) and
• - a body.

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CLAIMS TYPE

• Product Type Claims directed to a Product
  (compound/apparatus/composition/formulation)
• Process/Method/Application/USE Type
• Claims directed to a process (new or improved)
• Claims directed to a method (new or improved)
• Claims directed to an application (method of
  using/new use)
• HOW TO GO About
• -   METHOD/PROCESS CLAIM ( FUNCTIONAL LANGUAGE/
  recite stepwise)
• -   APPARATUS/DEVICE CLAIM - recite in terms of
  structural elements or means plus function
  language
•      (USE So that / WHEREIN / WHEREBY CLAUSES
  FOR FUNCTIONAL LANGUAGE)
• Use both formats whenever possible

23
INDIA

• SECTION 10
•   This section deals with the contents of the
  specifications and other documents/mode/sample to
  be providedwith the specifications.
•   SECTION 10 (1)
•   Every specification, whether provisional or
  complete, shall describe the invention and shall
  begin with a title sufficiently indicating the
  subject-matter to which the invention relates.
•  10.1 The provisional specification/complete
  specification shall be submitted in form2. It
  shall have a title clearly indicating the
  invention and the description. The description
  should start with a statement of, as to what
  subject the invention relates to, the background
  art if available, and the object of the
  invention. This should be followed by the details
  of the invention which are available to the
  applicant at the time of filing the
  provisional/complete specification. The
  description can be accompanied with drawings (see
  section 10 (2).
•  

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INDIA

• The Complete specification shall be submitted in
  Form 2. It will have a title clearly indicating
  the invention and description as specified in
  (10.1) and further specified in Section 10(4).
• SECTION 10 (4) Every Complete specification
  shall
• (a) fully and particularly describe the invention
  and its operation or use and the method by which
  it is to be performed
• (b) disclose the best method of performing the
  invention which is known to the applicant and for
  which he is entitled to claim protection and
• (c) end with a claim or claims defining the scope
  of the invention for which protection is claimed.
• The description should fully and particularly
  describe the invention, by clearly distinguishing
  it from the prior art if available. If the
  applicant is not aware of any prior art such a
  statement may be given. The description should
  include a statement of invention before giving
  the details of the invention and how to perform
  it. This should be sufficient for an average
  person skilled in the art to perform the
  invention. This can include examples/drawings or
  both. The complete specification should end with
  a claim or claims. The purpose of the claims is
  to define the scope of the invention and gives
  the exclusive right to the patentee for the term
  of a patent.
•  

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UNITY OF INVENTION
26
INDIA

• SECTION 10 (5)
• The claim or claims of a complete specification
  shall relate to a single invention, shall be
  clear and succinct and shall be fairly based on
  the matter disclosed in the specification and
  shall.
• 10.5 The claims should relate to an single
  inventive concept.
• 10.5(1) The purpose of claims is to limit the
  scope of the invention rather than enhance it,
  and should be made so as to clearly distinguish
  the invention from the existing state of art, if
  any, and clearly define the boundary of the
  invention.

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PRECAUTIONS

• Figures/black white/color photographs should be
  numbered
• Various parts of an apparatus over device must be
  numbered
• Units used must be internationally acceptable
• Trademarks used must describe product details
• Expressions used must be explained wherever
  necessary
• In each example reaction conditions as given
  should be specific
• No parameter ranges should be given in a specific
  example
• Best mode must be described

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PRECAUTIONS

• Trade secret information should not be use
• Incase of biological material deposit details
  must be given(deposit number date of deposit
  and place of deposit)
• Sufficient number of working example with varying
  parameters should be given
• Starting materials used must be available
• Cross-reference to another pending application
  must be given
• Nucleotide sequences should be prepared using
  patentln software downloadable from USPTO/EPO
  site
• Incase of compositions/formulations various
  components must add up to 100
• Ratios of various components should be given
  within ranges in the claims
• Structure of a new compound need to be properly
  checked
• Examples with comparative data/examples should be
  titled as comparative data/example to avoid
  confusion with the working examples

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STRATEGY IN WRITING A PATENT

• Adopt a business approach
• Differentiate with existing products
• Highlight Advantages
• Lab to Market
• Current level of development
• Replacement of existing product
• Product Life Cycle

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What is claimed is (US Patent No.
5,955,084)Process for the simultaneous
production of artemisnin and essential oil from
the plant artemisia annua

• 1. A process for the simultaneous production of
  essential oil and artemisinin from the Artemisia
  annua, said process comprising (i) drying and
  powdering an A. annua plant part to produce a
  dried and powdered plant or plant part, (ii)
  extracting the powdered plant or plant part of A.
  annua with hexane to produce a hexane extract and
  a residual Marc. (iii) reducing the hexane
  extract to 5-20 of its original volume under
  vacuum, (iv) partitioning the resultant
  concentrated hexane extract between hexane and
  acetonitrile water mixture to produce a hexane
  phase and an aqueous acetonitrile phase, (v)
  evaporating the hexane phase to dryness to obtain
  a hexane residue,

31
Contd.

• (vi) hydrodistilling the hexane residue and
  residual Marc to yield essential oil, (vii)
  removing water from the aqueous acetonitrile
  phase to produce an acetonitrile phase, (viii)
  extracting the acetonitrile phase with a
  hexane-benzene mixture to obtain a hexane-benzene
  extract and a residual acetonitrile phase, (ix)
  removing the hexane-benzene solvent to yield a
  residue (x) dissolving the residue in
  chloroform (xi) extracting the chloroform
  solution with a base, (xii) neutralizing the
  aqueous basic solution, (xiv) extracting the
  neutralized aqueous solution with chloroform,

32
Contd.

• (xiv) evaporating the chloroform and
  crystallizing the extracted hexane-benzene
  extract to produce artemisinic acid, (xv)
  reducing and photooxidizing the artemisinic acid,
  (xvi) chromatographing the acetonitrile phase
  over silica gel with hexane and collecting
  different eluted fractions, (xvii) evaporating
  the different eluted fractions crystallizing said
  fractions to produce substantially pure
  artemisinin. 2. A process claimed in claim 1,
  wherein dried parts of the plant used for the
  extraction are selected from any part of the
  plant. 3. A process as claimed in claim 1
  wherein partitioning between hexane and
  acetonitrile water mixture used in step (iv) is
  done in the ratio of 23 in liquid-liquid
  extraction column.

33
Contd.

• 4. A process as claimed in claim 1 wherein
  acetonitrile water mixture used in step (iv) is
  in the ration of 11 to 15. 5. A process as
  claimed in claim 1 wherein partitioning step (iv)
  is carried out between two phases for 3 hrs. 6.
  A process as claimed in claim 1, wherein the time
  taken for hydrodistillation of Marc ranges
  between 30 minutes to 120 minutes. 7. A process
  as claimed in claim 1, wherein the hexane residue
  is hydrodistilled for 30 minutes to 120 minutes
  to obtain the essential oil. 8. A process as
  claimed in claim 1 wherein fractionation between
  acetonitrile and hexane-benzene mixture after
  removal of water in step (viii) is done to
  isolate artemisinic acid.

34
Contd.

• 9. A process as claimed in claim 1 wherein
  benzene used in hexane-benzene mixture used as
  solvent ranges between 10-30. 10. A process as
  claimed in claim 1, wherein the base used in step
  (ix) is a 5 solution of sodium carbonate. 11.
  A process as claimed in claim 1 wherein basic
  solution in step (ix) is neutralized with 5 HCl
  solution, extracted with chloroform followed by
  drying of solvent and crystallisation with ethyl
  acetate yielding artemisinic acid. 12. A
  process as claimed in step (x) of claim 1,
  wherein reduction in step (x) comprises (i)
  dissolving artemisinic acid and
  NiCl.sub.2.6H.sub.2 O in dry methanol (ii)
  adding sodium borohydride to the resultant
  solution at 0.degree. C. over a 2 hr. period
  (iii) neutralising the solution obtained in step
  (ii) with 5 aqueous HCl solution and (iv)
  isolating and crystallizing the dihydro
  artemisinic acid in ethyl acetate to obtain pure
  dihydro artemisinic acid.

35
Contd.

• 13. A process as claimed in claim 1, wherein the
  photo oxidation comprises (i) dissolving the
  dihydro artemisinic acid in dichloromethane--ethyl
  acetate solvent (ii) oxidising the solution
  obtained in step (i) in the presence of
  fluorescence light daily for two hours up to 8
  days (iii) concentrating the solution obtained
  in step (ii) and recrystallizing the residue in
  hexane to isolate artemisinin. 14. A process as
  claimed in claim 1 wherein the chromatographic
  step is carried out in SiO.sub.2 columns
  comprises a solute having adsorbent ration 13.
  15. A process as claimed in claim 1 wherein the
  elution with n-hexane solvent is being done under
  vacuum at 100-150 mm Hg absolute pressure. 16.
  A process as claimed in claim 1 wherein
  chromatographic adsorbent used is Silica gel H
  with mesh size of about 200.

36
Contd.

• 17. A process for the simultaneous production of
  essential oil and artemisinin from the plant A.
  annua wherein the yield of essential oil obtained
  from the marc of the plant is about 50. 18. A
  process for the simultaneous production of
  essential oil and artemisinin from the plant A.
  annua wherein artemisinic acid and artemisinin
  are recovered in about 90 yield. 19. A process
  as claimed in claim 2, wherein the dried part of
  the plant is selected from the group consisting
  of leaves, infloroscence and small stems.

37
What is claimed is (US Patent No. 6,617,847)
Sensing device for the non-destructive
evaluation of steel structures or components

• 1. A portable, easily operable magnetic sensing
  device for the non-destructive evaluation of
  steel structures or components which have
  undergone an extended period of service in order
  to determine the extent of micro-structural
  degradation or residual stress within said
  structures or components which comprises the
  combination of a probe head adapted to be located
  proximate the structure or component to be
  evaluated and signal processing means,
  characterised in that said probe head comprises a
  sensing core of nonocrystalline Fe-based material
  having a first pair of coils wound thereabout
  such that in normal condition when current flows
  through said first pair of coils, each half of
  the sensing core is symmetrically magnetised and
  said signal processing means comprises a toroidal
  ferrite core having a second pair of coils wound
  thereon, one of the terminals of each of said
  first pair of coils of the sensing core being
  earthed while the other terminals thereof are
  each connected respectively to one terminal of
  each of said second pair of coils on said
  toroidal core, the other terminals of the second
  pair of coils being joined together and connected
  to an excitation source capable of generation of
  a frequency of 5 kHz, the combination of said
  first and second pairs of coils constituting a
  primary, coil, the sensed signal having different
  harmonics which emanates from said primary coil
  when the probe head is placed proximate a
  structure or component being evaluated in order
  to assess the micro-structural degradation or
  residual stress thereof being transmitted to the
  input of a secondary coil mounted on said
  toroidal core, the output of said secondary coil
  being connected to a filter means active to
  suppress only a first harmonic signal and to
  permit other harmonic signals to pass onward for
  measurement thereof.

38
Contd.

• 2. A device as claimed in claim 1 wherein the
  nanocrystallne Fe-based material forming said
  sensing core is a heat-treated Fe.sub.22k
  Nb.sub.4.5x Cu.sub.13.5 B.sub.9 in which x is a
  value from 0 to 1, said nanocrystalline ribbon
  having approximately the following properties
• Dimension 40 mm .times. 10 mm .times. 24 .mu.m
• Permeability 10.sup.4 .times. 10.sup.5
• Coercivity 10-30 mOe
• Saturation induction 8-10 kG 3. A device as
  claimed in claim 1 wherein said toroidal core is
  composed of Mn-Zn ferrite having a permeability
  of from 3000 to 4000 and a coercivity of from 1
  to 3 Oe.

39
Contd.

• 4. A device as claimed in claim 1 wherein said
  first pair of coils each has the same number of
  turns which can vary from 1500 to 2000. 5. A
  device as claimed in claim 1 wherein each of said
  second pair of coils has the same number of turns
  which can vary from 25 to 50. 6. A device as
  claimed in claim 1 wherein said secondary coil
  has from 50 to 100 turns. 7. A device as
  claimed in claim 1 wherein said excitation source
  is a constant current signal generator. 8. A
  device as claimed in claim 1 wherein said filter
  means in a notch filter active to suppress the
  first harmonic, i.e, a signal of 5 kHz and to
  permit other harmonics, i.e., all signals other
  than 5 kHz, to pass onward.

40
Contd.

• 9. A device as claimed in claim 1 wherein said
  means for measuring said second harmonic signal
  is multimeter. 10. A device as claimed in claim
  1 wherein an amplifier is connected to the output
  of said filter means to which said second
  harmonic signal is passed for amplification prior
  to being measured. 11. A device as claimed in
  claim 10 wherein said amplifier is tuned
  amplifier which amplifies the second harmonic,
  i.e. a signal of 10 kHz, to a desired level for
  the convenient measurement thereof.

41
What is claimed is (US Patent No.
6,610,332)Anti-leishmanial activity of betel
leaf extract

• 1. A method of treating visceral leishmaniasis
  or kala-azar in mammals, said method comprising
  the step of administering to the mammals a
  pharmaceutical composition comprising an
  effective amount of a betel leaf extract, wherein
  the betel leaf extract is obtained by crushing
  the betel leaf or extracting the crushed leafs
  with water or organic solvents selected from the
  group consisting of alcohol, carbon
  tetrachloride, chloroform and acetone. 2. The
  method according to claim 1, wherein the
  composition comprises betel leaf extract and a
  pharmaceutically acceptable additive. 3. The
  method according to claim 2, wherein the additive
  is selected from the group consisting of
  proteins, carbohydrates, sugar, talc, magnesium
  state, cellulose, calcium carbonate,
  starch-gelatin paste, pharmaceutically acceptable
  carriers, excipient, diluent and solvent. 4.
  The method according to claim 1, wherein the
  composition is administered orally or
  intramuscularly.

42
Contd.

• 5. The method according to claim 1, wherein the
  oral route is administered in the form of
  capsule, syrup, concentrate, powder or granules.
  6. The method according to claim 2, wherein the
  ratio of betel leaf extract to the additive is in
  the range between 1-10 to 10-1 by weight. 7.
  The method according to claim 1, wherein the
  composition is administered at a dosage level
  between 10 to 20 mg/kg of body weight for
  alternate days for one month. 8. The method
  according to claim 1, wherein administering the
  composition reduces the viability of Leishmania
  donovani promastigotes in vitro by 57 to 79 and
  reduces splenic and liver parasites load by 93 to
  95.

43
What is claimed is (US Patent No. 6,531,166)
Use of betel leaf extract to induce IFN-gamma
production from human peripheral blood T cells
and as a Th1 type immunomodulator

• 1. A method of enhancing a cellular immune
  response mediated by Th.sub.1 helper
  T-lymphocytes in a subject, said method
  comprising administering a pharmaceutically
  effective amount of a composition comprising a
  betel leaf extract to a subject in need of such
  enhancing, wherein the betel leaf extract is
  obtained by aqueous extraction of betel leaves,
  thereby enhancing a cellular immune response
  mediated by Th.sub.1 helper T-lymphocytes. 2.
  The method as claimed in claim 1, wherein the
  composition comprising the betel leaf extract is
  associated with or in combination with a
  pharmaceutically acceptable additive. 3. The
  method as claimed in claim 1, wherein the betel
  leaf extract has further been lyophilized. 4.
  The method as claimed in claim 3, wherein the
  composition comprising the betel leaf extract is
  associated with or in combination with a
  pharmaceutically acceptable additive. 5. The
  method as claimed in claims 2 or 4, wherein the
  additive does not interfere with the activity of
  said betel leaf extract.

44
Cotd.

• 6. The method as claimed in claims 2 or 4,
  wherein the additive is a pharmaceutically
  acceptable carrier, excipient, diluent or
  solvent. 7. The method as claimed in claims 1,
  2, 3 or 4, wherein the composition comprising the
  betel leaf extract is administered orally or
  intramuscularly. 8. The method as claimed in
  claim 7, wherein when administered orally, the
  composition comprising betel leaf extract is in
  the form of a capsule, syrup, concentrate, powder
  or granules. 9. The method as claimed in claims
  2 or 4, wherein the betel leaf extract and the
  additive are present in the composition at a
  ratio of between 10-11-10. 10. The method as
  claimed in claims 1, 2, 3 or 4, wherein the
  composition comprising the betel leaf extract is
  administered at a dosage level of between 5 to 10
  mg/ml/kg of body weight at least once a day for
  one month. 11. The method as claimed in claims
  2 or 4, wherein the additive is a selected from
  the group consisting of a protein, carbohydrate,
  sugar, talc, magnesium stearate, cellulose,
  calcium carbonate, and starch-gelatin paste.

45
What is claimed is

• 12. A method for enhancing a cellular immune
  response mediated by Th.sub.1 helper
  T-lymphocytes in a subject, said method
  comprising administering to a subject in need of
  such enhancing at least 5 to 10 mg/ml/kg of body
  weight of a composition comprising a betel leaf
  extract, wherein the betel leaf extract is
  obtained by aqueous extraction of betel leaves,
  wherein the composition is administered at least
  once a day for a period of at least one month,
  and wherein the composition is administered
  orally or intramuscularly, thereby enhancing a
  cellular immune response mediated by Th.sub.1
  helper T-lymphocytes.

46
What is claimed is (US Patent No. 6,413,553)
Herbal formulation of a combination of Piper
betel and Murrya koenigii extracts for blocking 5
lipoxygenase activity

• 1. A pharmaceutical formulation useful as a
  leukotrine and IL4 synthesis inhibitor and as a
  Th1 immunomodulator, said formulation comprising
  an effective amount to function as said inhibitor
  and immunomodulator of a combination of extracts
  or lyophilised extracts obtained from Piper betel
  and Murrya Koenigii. 2. A formulation as
  claimed in claim 1, further comprising one or
  more pharmaceutically acceptable additives. 3.
  A formulation as claimed in claim 2, wherein said
  extracts are obtained from plant parts selected
  from the group consisting of leaves, stems, bark,
  fruits, and seeds. 4. A formulation as claimed
  in claim 2, wherein said additive is selected in
  such a manner that it does not interfere with the
  activity of said extracts or lyophilized extracts
  of Piper betel and Murrya koenigii. 5. A
  formulation as claimed in claim 2, wherein said
  additive is selected from the group consisting of
  proteins, carbohydrates, sugar, talc, magnesium
  stearate, cellulose, calcium carbonate, and
  starch-gelatin paste.

47
Contd.

• 6. A formulation as claimed in claim 1, which is
  in a form to be administered through an
  inhalation, oral, intravenous, intramuscular or
  subcutaneous route. 7. A formulation as claimed
  in claim 6, wherein said form for oral route is
  selected from the group consisting of capsule,
  syrup, concentrate, powder and granules. 8. A
  formulation as claimed in claim 1, wherein the
  amount of Murrya koenigii extract or lyophilized
  extract is equal to or greater than the amount of
  Piper betel extract or lyophilized extract. 9.
  A formulation as claimed in claim 1, wherein the
  ratio of said Piper betel extract or lyophilized
  extract to said Murrya koenigii extract or
  lyophilised extract is in the range 11 to 15.
  10. A method of treating an animal or human
  subject for bronchial respiratory conditions,
  said method comprising administering to the
  subject an effective amount to treat said
  conditions of a formulation as claimed in claim
  1. 11. A method as claimed in claim 10, wherein
  said formulation further comprises a
  pharmaceutically acceptable additive.

48
Contd.

• 12. A method as claimed in claim 11, wherein
  said additive is selected in such a manner that
  it does not interfere with the activity of said
  extract or lyophilised extract of Piper betel and
  Murrya Koenigii.
• 13. A method as claimed in claim 11, wherein
  said additive is selected from the group
  consisting of proteins, carbohydrates, sugar,
  talc, magnesium stearate, cellulose, calcium
  carbonate and starch-gelatin paste. 14. A
  method as claimed in claim 10, wherein said
  formulation is administered through an
  inhalation, oral, intravenous, intramuscular, or
  subcutaneous route. 15. A method as claimed in
  claim 14, wherein said form for oral route is
  selected from the group consisting of capsule,
  syrup, concentrate, powder and granules. 16. A
  method as claimed in claim 10, wherein the ratio
  of said Piper betel extract or lyophilized
  extract to said Murrya Koenigii extract or
  lyophilized extract is in the range 11 to 15.
  17. A method as claimed in claim 10, wherein
  the proportion of Murrya Koenigii extract or
  lyophilised extract is equal to or greater than
  the amount of Piper betel extract or lyophilized
  extract.

49
Contd.

• 18. A method as claimed in claim 10, wherein
  said formulation is administered at a dosage
  level between 1 to 20 mg/kg of body weight at
  least once a day for a period of at least 4 weeks
  depending upon the respiratory conditions. 19.
  A formulation as claimed in claim 1, further
  comprising a pharmaceutically acceptable carrier,
  excipient, diluent or solvent. 20. A method as
  claimed in claim 10, further comprising a
  pharmaceutically acceptable carrier, excipient,
  diluent or solvent.

50
THANKS