PATENT OFFICE PROCEDURES

1. PATENT OFFICE PROCEDURES By Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: www.gnaipr.net Email: gopanair@gnaipr.net Bengaluru, 18th November, 2010

3. Filing of Patent Application • When to file :- Earliest – as provisional (First-to-File) • Could continue working & file complete specification later • Provisional Specification • To establish PRIORITY DATE / establish early ownership • To pre-empt others • Complete Specification • To be filed within 12 months of filing of Provisional Application

4. Complete Specification Title Technical Field Background and Prior Art Current Problem / Drawback / Gap Solution to the problem/ Improvement Summary of Invention Detailed Description Experiments/Trials/Examples (incld. Tabular column, if any) Claims Abstract Drawings

5. Pre / Post Grant Opposition & Revocation • Patent Specification - Techno-legal doc • Unity Of Invention - Single Inventive Concept • Clarity of Disclosure - State Clearly And Distinctly The Nature And Limits Of The Claims • Sufficiency Of Disclosure - Claims should be supported by Written Description. • Biological Material - Geographical Origin

6. Product claims …………  Process claims …………  Composition claims …………  Method of treatment …………  New physical forms with enhanced efficacy ………….  Living organisms ………….  (except microorganisms) Patent Claims In India

7. Receiving Office - Delhi, Kolkata, Chennai, Mumbai. • Language of Filing - English or Hindi • Forms (2nd Schedule) 1 (Application for Grant of Patent), 2 (Complete or Provisional Appln), 3 (Statement & Undertaking u/s 8 ), 5 (Declaration As to Inventorship) & 26 (Power of Attorney) • Fees (1st Schedule) Ratio of Fees – 1 : 4 (Natural Person : Others)

8. Prosecution of a Patent 1) Optional-Early Publication OR 18 months publication (automatic) 2) Request for Examination 3) First Examination Report – Inventor’s contribution 4) Responses – to & fro 5) Acceptance for Grant OR Rejection 6) Patent Term – 20yrs from date of filing.

9. Fees Ratio of Fees – 1 : 4 (Natural Person : Others) A few examples : NaturalOthers person Patent Application- Form 1 & 2 Rs.1000 Rs.4000 Request for early publication Rs.2500 Rs.10000 (optional) Request for Examination Rs.2500 Rs.10000 Maintenance Fee 3rd to 6th years    Rs.500 Rs.2000 7th to 10th years Rs.1500 Rs.6000 11th to 15th years Rs.3000 Rs.12000 16th to 20th years Rs.5000 Rs.20000

11. TypesOf Patent Provisional Application Complete Application Convention Application Application for Patent of Addition (CIP) Cognate Application Divisional Application PCT International Application PCT National Phase Application

12. Patent Filing Strategies Only National Filing Only Convention filing (US / EU etc.) National + Convention Country National + US + EU Only PCT National + PCT (With permission) Any or all 142 States (With permission) Any or all 142 States Patents RIGHTS ARE TERRITORIAL

13. CLAIMDRAFTING

14. Where To Begin • Meeting with inventors • Technical Draft & Experimental Results or • Thesis / Dissertation

15. What next Preliminary Search – Ask for more info – Distinguish from Prior Art No distinctive features N[N/NO-IS/IA] Return draft Explain how to proceed NOVEL/INVENTIVE Start drafting

16. How to Proceed • Explain elements of patentability • Novelty/Non-obviousness (inventive step) • What is not patentable • How to make “invention on hand” patentable • Create new results/data • Repeat step

17. Start Drafting • Read Technical matter with Prior Art. • Find key features of invention. • Process/Product/new use/new application. • What constitutes the invention ? • What are the gaps/drawbacks in prior art ? • What problem is being solved ? • Start noting down the elements/keywords (search once again) (and again) • Proceed with drafting (Ask more questions; seek more data) • Proceed

18. Field of Invention • Briefly describes the area of technology in which the invention falls. • Often not more then one or two sentences. • Useful in classification of patent. • Often starts “This invention relates to--” Ex. This invention relates to pharmaceutical tablet formulations of clopidogrel

19. Background • This section involves Discussion on progression of technology. • Description of prior art i.e. the present state of technology (state-of-art) • Discussion on existing problems in prior art. • Possible solutions offered by present invention.

20. Summary of Invention • Discloses a gist of present invention. • Highlights “problems solved by present invention.” • Reflects the broadest claim.

21. Brief Description of Drawings • Drawings are provided for better understanding of invention. • This section helps to identify the labels and figures disclosed in drawings.

22. Detailed Description of Invention • Starts with general overview of invention. • Narrows down to details of theory and all the processes and methods for making and using the invention. • Invention described with help of preferred embodiments (Best Mode). • Alternative embodiments can be disclosed.

23. Claims • Describe the essential elements and legal boundaries of an invention. • Should be supported in entirety by Specification. • First claim or Independent claim is often the broadest. • “comprising of ” –preferred term. • -------”characterised in that”-to distinguish • Dependent claims expand, qualify, limit, narrow, quantify the elements in Claim 1.

24. Element of a Claim 1) Preamble – Ex :- (1)A process for preparation of (comprising) (2) An anticancer oral dosage composition (comprising) 2) Transitional Phrases – including, consisting, using, employing, containing, composed of, constituted of. Preferred Phrase – “comprising” Limiting or Restrictive Phrase – “characterized in that” 3) Body or claim elements.

25. Basic Types of Claims • Independent Claim. • Dependent Claims. • Omnibus Claim

26. Independent Claim • Is the first claim. • Stands alone. • Often the broadest claim. • Broadly describes the invention thereby preventing competitors to circumvent the invention. • Prior Art and “inventiveness” determines broadness of the Claim 1.

27. Dependent Claims • Depend on first claim. • Refer to important distinguishing features of the invention as described in Claim 1. • Claims often narrow-down the scope of invention. • Subject to “Unity of Invention”, more than one Independent Claim possible. • Claims must not be independent sentences.

28. Relationships Title (key element in brief) is related to / similar to Claim 1 • Abstract (differs only in language) • Technical field (this invention relates to…..) • Summary (expanded claim 1 + combined with key elements of other important claims)

29. Care & Caution • Language • Choice of ‘Tense’ • Proof reading

30. Claim Drafting • Derive/Determine Keywords/Search • Distinguish Old from New Prior Art  Novelty • FOCUS – INVENTION – FEATURES • Property/Product/Process • Structure/Steps/Techniques/Concepts • “use of comprising”, “and/or”, “wherein” separating “Preamble” from “Body” • Independent Claim • Dependent Claim

31. Claim Drafting INVERTED PYRAMID - Broad to Narrow - Generic to Specific Broad Claim (Claim 1) Generic Narrow Claim Specific

32. Examples Of Innovation Of Inventions • Pencil • Ink pen • Ink-filled pen • Ball pen with cap • push, expose and write • click and withdraw • turn on cap

33. Claim Drafting Caution - Claim should not read on (overlap) Prior Art - Preferably not infringe

34. Claim Drafting Merits/Demerits – Benefits/Disadvantages of Broad vs. Narrow Claims. Opportunity for broad claim. Pencil A writing implement comprising: a structure causing a mark to be made on a surface, wherein said structure causes said mark on said surface upon physical contact with said surface, wherein said structure companies a writing material which makes said mark on said surface upon physical contact with said surface, and wherein said writing material comprises a solid material.

35. Patent Office Requirements Size, etc., of documents – (1) All documents and copies of documents, except affidavits and drawings, sent to or left at the patent office or otherwise furnished to the Controller shall be written or typewritten or printed either in Hindi or in English language (unless otherwise directed or allowed by the Controller) in large and legible characters with deep indelible ink with lines widely spaced upon one side only of strong white paper of a size A-4 of approximately 29.7 centimeters by 21 centimeters with a margin of at least 4 centimeters on the top and left hand part and part and 3 cm on the bottom and right hand part thereof. Any signature which is not eligible or which is written in a script other than Hindi or English shall be accompanied by a transcription of the name either in Hindi or in English in block letters:

36. Patent Office Requirements …..contd Provided that any document including drawing, if any, may also be filed in electronic form alongwith a copy of it on white paper: Provided further that in case the application for patent discloses sequence listing of nucleotides and/or amino acids, the same shall be filed in electronic form. (2) Additional copies of all documents shall be filed at the appropriate office, if required by the Controller. (3) Names and addresses of applicants and other persons shall be given in full together with their nationality and such other particulars, if any, as are necessary for identification.

37. Enablement Requirements Section 10 of Indian Patent Act, 1970 Section 112 Para. 6 of 35 USC Written Description Deposit and declaration of source for Microorganism

38. Examples of Claim 1 1. A process for measuring the potency of a test batch of glatiramer acetate relative to the known potency of a reference batch which comprises: a. incubating at least five reference samples, each of which contains a predetermined number of cells from the primary culture such as herein described and a predetermined amount of glatiramer acetate between 1 µg/ml and 25 µg/ml from a reference batch; b. incubating at least two samples, each of which contains a predetermined number of cells from the primary culture such as herein described & a predetermined amount of glatiramer acetate from the test batch; c. determining for each sample in steps (a) and (b), the amount of cytokine secreted by the cells in each sample after a predetermined time period of incubation of such sample; d. correlating the amounts of cytokine secreted by the samples incubated with the test batch of glatiramer acetate with the amounts of cytokine such as herein describe secreted by the samples incubated with the reference batch of glatiramer acetate so as to determine the potency of the test batch of glatiramer acetate relative to the reference batch of the glatiramer acetate, wherein in each sample in steps (a) and (b), the predetermined number of cells is substantially identical, and wherein for each sample containing a predetermined amount of glatiramer acetate from the test batch there is a corresponding reference sample containing a substantially identical predetermined amount of glatiramer acetate from the reference batch.

39. Examples of Claim 1 Claim 1. A pharmaceutical composition comprising: (a) activated botulinum toxin type B; and (b) at least one excipient; wherein at least 90% of said botulinum toxin type B is nicked. Claim 1. Biscuit comprising guar gum characterized in that said guar gum is a native guar gum, with a length between 0.25 and 8 mm, a width between 0.18 and 2mm and an average length to width ratio between 1.8 and 6. Claim 1. A facet-joint exercise device for massaging tissue around a spinal column of a user, said facet-joint exercise device characterized by: a pair of spheres mounted in a frame, the frame having a mounting yoke; a track for mounting the frame to a vertical support surface; and a means for adjustably securing the frame to the track; wherein the spheres are mounted on a shaft in the frame, so as to be freely rotatable about the shaft, and wherein the frame is height adjustable on the frame.

40. Examples of Claim 1 Claim 1. A device for testing a heat sensitivity in teeth comprising: a base; and a tip having a cushion, wherein the cushion comprises a heating element, and wherein the cushion conforms to a contour of a tooth tested for a heat sensitivity. Claim 1. A method for treating fibrosis in a mammal which comprises administering to the mammal a cell which expresses and secretes the Flt3 ligand in an effective amount to treat fibrosis. Claim 1. A method of extracting cardiac glycosides, comprising: intermixing a cardiac glycoside plant species with aloe under conditions selected to form an extraction mixture; conditioning the extraction mixture under conditions selected to extract cardiac glycosides from said cardiac glycoside plant species to thereby form a conditioned extraction mixture, wherein the conditioned extraction mixture comprises residua] cardiac glycoside plant species and a cardiac glycoside aloe mixture; separating at least a portion of the cardiac glycoside aloe mixture from the residual cardiac glycoside plant species to thereby form a cardiac glycoside aloe extract, wherein the cardiac glycoside aloe extract comprises cardiac glycosides extracted from said cardiac glycoside plant species; and wherein said cardiac glycoside aloe extract is substantially free of the residual cardiac glycoside plant species.