Suresh Kumar K

Handling Inventions for Patent Protection – Role of an IP Manager

(Role of IPMOs / TTOs)_

Suresh Kumar K.Scientist EPatent Facilitating CentreTechnology Information Forecasting & Assessment Council (TIFAC)

[email protected]

Training of Trainers CCS HAU, ICAR, MSU

February 11-20, 2008

mailto:[email protected]

Divisions

Part I

1. Some basic questions2. Identifying inventions/Driving out the inventions

Part II

1. Novelty issues 2. Inventive step / Non-obviousness3. Role of a manager

Part I

• Some basis questions• Driving out an invention

Question no. 1Are Ideas Patentable?

Examples: 1. A library of organic molecules generated using a high

end software that may have potential use as pesticides.

2. A tracheotomy forceps (a surgical scissor)

3. Evidence to show presence of a drought tolerant gene in Artocarpus heterophyllus (deep root system)

Question no. 1Are Ideas Patentable? A tracheotomy forceps

Sanjay Gandhi Post Graduate Institute of Medical Science (SGPGIMS)Lucknow

Question no. 1Are Ideas Patentable? A tracheotomy forceps

Sanjay Gandhi Post Graduate Institute of Medical Science (SGPGIMS)Lucknow

Question no. 2Is triviality a bar for patenting?

The story of the The story of the Gem ClipGem Clip

Triviality a bar?

PAPER / GEM Clip History

1867 Samuel B. Fay gets first patent on clips in the United States

1877 Erlman J. Wright gets a US patent for paper clips

1883 Henry J. Petroski gets a US patent with the first reference of “gem” in patent specs.

1890-1900 Patents in the area in Germany and UK1899 William Middlebrook of Waterbury, Connecticut gets a

US patent for a "Machine for making wire paper clips 1904 “Gem" name was registered as a trade mark in the

United States…2000’s One can still see US patents being granted

The story of the Gem ClipThe story of the Gem Clip

The patent awarded to Samuel B. Fay described this clip as a ticket fastener to be used, in lieu of a pin, to fasten tickets to fine fabrics. The patent noted that the clip could be used to attach a paper ticket to another piece of paper. A variation on this clip had longer legs.

http://www.officemuseum.com/IMagesWWW/Cinch_Paper_Clip_box.jpg

The story of the Gem ClipThe story of the Gem Clip

Cushman & Denison Mfg. Co.

A US Advt in 1898 An Improved Gem Paper Clip (US 1920)

A recent US patent“Paper Clip” (No D526,356)

Issued to Shinya et al, on August 8, 2006

Recent US Patents on Gem Clip

Question no. 3Are living organism Patenable?

Case Study I

US Patent 4,259,444 entitled “Microorganisms having multiple compatible degradative energy-generating plasmids and preparation thereof (Famous Diamond vs. Chakrabarty case)

Inventors: Chakrabarty; Ananda M. (Latham, NY)

Assignee: General Electric Company (Schenectady, NY)

Appl. No.: 260563

Filed: June 7, 1972

US Incentives to Inventions: Some Reflections in the Patent Laws

• Article I § 8 of the US Constitution: “(The Congress shall have power)… To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;

• Paramount importance to inventions and hence to the inventors (Filing procedure)

• Anything under the sun that is manmade is patentable (reinforced by Diamond v/s. Chakrabarthy case)

• Inventive step not a criteria (Only non-obviousness is)• First to invent system (Rather than first to file system – USPTO

Interference Proceedings)• Dual protection possible

Landmarks in the US History of IPR1930 Plant Patent Act1961 UPOV Convention (in Europe)1970 U.S. PVP Act 1980 U.S. Supreme Court – Chakrabarty (micro-org)1981 U.S. joins UPOV1986 First patent for a modified plant patent (Harvard Mouse) (A plethora of patents on cell lines (human cells included), EST, SNPs, etc.. Etc.)1995 U.S. Supreme Court – Winterboer (farmers exemption h expanded)1999 A patent application claiming human-animal hybrid (Rules out ownership of human beings)2000 U.S. Supreme Court – J.E.M. (dual protection)

What ‘life’ is owned?

Bacterium from the genus Pseudomonas containing two or more stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Essentially, the (GE) microbes had the potential to ‘eat’ away the oil and thus clean-up oil spills

Interesting process..1. GE files two applications in 1972

2. PTO grants the process patent

3. Refuses the micro-organism per se claims

4. Reason: “Product” of nature

5. GE appeals to PTO Board of Appeals : Argument: Different from their natural counterparts

6. Board of Appeals concedes it is not product of nature. Still rejects on the ground of patentability of live organisms

The saga continues..

1. GE goes to US CCPA2. The court rules 3-2 in GE’s favour3. Majority view:

(i) Microorganisms were much more akin to inanimate chemical compositions such as reactants/reagents than they are to horses/honeybees or….

(ii) No congressional intent to limit patents to dead inventions

CCPA did not see active chemicals (read dead) anything legally different from organisms (read alive) used for chemical reactions

The saga continues..

1. PTO appeals to Supreme Court 2. Several amicus briefs filed3. Patenting of life form not in public interest4. Patenting lower forms to lead to patenting of

higher forms (including mammals)5. Patenting essentially implies the life has no sacred

place and is essentially an arrangement of chemicals

The saga ends..1. The final Supreme Court verdict in 19802. 5-4 in favour of CCPA verdict3. Looks closely at 35 US § 101– “Any new/useful.. Manufacture..

or composition of matter of or any new/useful improvements thereof”

4. Plant Patents and US PVP specifically excluded bacteria5. No congressional intend to exclude microorganism from

patentability 6. The new microorganism in question was new composition of

matter, the product of human ingenuity and not natures handiwork

7. Thus patentable8. Ownership of life becomes a reality

Causality : USPTO Perspective Change

• Anything under the sun patentable (35 US § 101) (provided new, useful and non-obvious as per 35 USC § 102 and § 103)

• A deluge of patents in life forms, including plants, animals and microorganisms

Indian SituationPatentable: (YES) Microorganisms Genes, Plasmids, Promoters, Cell lines, Vectors… Non-biological processes of producing life forms Any process for the medicinal, surgical, curative, prophylactic or other

treatment of plants to render them free of disease or to increase their economic value or that of their products

Not Patentable: ↓ Plants and animals in whole or any part thereof other than micro-

organism, and essentially biological processes to produce these

↓ Any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings and animals to render them free of disease or to increase their economic value or that of their products

Question no. 4Are discoveries Patentable?

Case Study II: Rhinosporidiosis

• Rhinosporidosis is a disease manifested by tumor-like polypoidal growth in the nose (nasal polyp)

• Earlier a protozoa was considered as the cause

• A fungus named Rhinosporidium seeberi was considered to be the likely pathogen

• In 1996, a Professor at AIIMS establishes for the first time that a cyanobacterium called Microcystis aeruginosa is the causal microorganism.



What are the possible candidates for protection?

The bacterium?

The process of identifying the bacterium …?(lab protocols including collection of patient tissue samples, collection of the microorganisms, electronic microscopy, fluorescence, confocal microscopy, immuno-labelling, extraction /electrophoresis of DNA, etc..)

The statistical data…?



The research is of excellent quality and merits publication in renowned international medical journal

Does not constitute an invention under the provisions the patent acts anywhere* in the world.

*US could be an exception

Designing a treatment?Indian Situation

Negative list (Section 3)

The mere discovery of a new form….or mere discovery of any new property y or new use of a known substance…….[§ 3(d)]

Any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals…….[§ 3(i)]

Designing a treatment?US Situation

Method of treatment claims possible

US Patent 7,135,455 (Stern, et al) (Nov , 2006)Methods for the therapeutic use of cyclosporine components

Claim 1. A method of treating inflammatory bowel disease in a human or animal, the method comprising: topically administering to a human or animal having inflammatory bowel disease a therapeutically effective amount of a cyclosporin A component selected from the group consisting of cyclosporin A, salts thereof and mixtures thereof, in a rectal suppository, thereby treating the inflammatory bowel disease.

(Treatment of rhinosporidiosis also covered in the disclosure)

Question no. 5Are a technical paper and a patent specification contents the same?

Case Study III: Magneto-Conductive Polymer Composite

Applicant/Assignee : IIT Kanpur

Publication V/s Patents

Case Study III: Magneto-Conductive Polymer Composite

Invention Disclosure Details

A metal-polymer composite which has both magnetic as well as magneto-resistive features has been fabricated. The composite has excellent magnetic properties as well as magneto-resistive properties. The magnetic properties of these composites resemble that of the bulk magnetic alloys. Material. Further, the material shows conductive properties. The unique cone shape of the composite material makes it possible to use this where preferred orientation, size and desired properties. The composite was prepared by solidification of a suspension of magnetic alloys in a polymer host. The potential commercial applications, include electronic data recording/storage devices.

Publication V/s Patents

Magneto-Conductive Polymer…

Invention discloses..

Properties …


Properties …

Properties …

Question No. 6

Magneto-Conductive Polymer…

Are properties patentable?

The turmeric caseCase Study IV: US Pat No. 5,401,504 (March 28, ‘95)

Use of turmeric in wound healing

AbstractMethod of promoting healing of a wound by administering turmeric to a

patient afflicted with the wound.

Inventors: Das; Suman K. (Jackson, MS); Cohly; Hari Har P. (Jackson, MS) Assignee: University of Mississippi Medical Center (Jackson, MS)

Appl. No.: 174363 Filed: December 28, 1993

The turmeric caseClaims1. A method of promoting healing of a wound in a patient, which consists essentially of

administering a wound-healing agent consisting of an effective amount of turmeric powder to said patient.

2. The method according to claim 1, wherein said turmeric is orally administered to said patient.

3. The method according to claim 1, wherein said turmeric is topically administered to said patient.

4. The method according to claim 1, wherein said turmeric is both orally and topically administered to said patient.

5. The method according to claim 1, wherein said wound is a surgical wound.

6. The method according to claim 1, wherein said wound is a body ulcer.

The case of turmeric patent • Patent granted in 1995 by the UPTO to the

UNIVERSITY OF MISSISSIPPI• Wound healing “use” of haldi (topical/oral form)• Brought to notice in 1996• Revocation proceeding in 1996.Publication of 19th

Century : Novelty questioned• Defense: Freshly cut wounds (surgical wounds)• Documentation in 1879 application of turmeric

umbilical chord• Patent revoked in 1999

Divining Out the Invention(Identifying Inventions)

Case Study III: Magneto-Conductive Polymer…


A metalA polymer

A compositeCone in shape

Magneto polymer composite..Probing the Invention

Que. Que. : What is to be protected?: What is to be protected?Ans. Ans. : The excellent properties.: The excellent properties.Que.Que. : Of..?: Of..?Ans. : Of the compositeAns. : Of the compositeQue. Que. : Fair enough. What does the composite contain?: Fair enough. What does the composite contain?Ans. Ans. : Two components. The polymer part. The metallic part.: Two components. The polymer part. The metallic part.Que.Que. : What is the polymer component?: What is the polymer component?Ans. Ans. : PVP: PVPQue. Que. : PVP???: PVP???Ans. Ans. : Polyvinylpyrrolidone : Polyvinylpyrrolidone Que. Que. : ..and the metal part?: ..and the metal part?Ans. Ans. : A Chromium alloy..: A Chromium alloy..Que. : Cr-Fe?Que. : Cr-Fe?Ans. Ans. : Yes. Also Cr-Ni and Cr-Co.: Yes. Also Cr-Ni and Cr-Co.


Que. Que. : Excellent. How do you prepare this?: Excellent. How do you prepare this?Ans. Ans. : I completely dissolve some select weight of PVP in a solvent ambient: I completely dissolve some select weight of PVP in a solvent ambient conditions and …conditions and …Que.Que. : Can it be only PVP?: Can it be only PVP?Ans. Ans. : It can be any vinyl-keto based polymer: It can be any vinyl-keto based polymerQue. Que. : and the solvent …?: and the solvent …?Ans. Ans. : Ethanol.: Ethanol.Que.Que. : Any others?: Any others?Ans. Ans. : Other organic polar solvents. : Other organic polar solvents. Que.Que. : How do you make sure completeness of dissolution?: How do you make sure completeness of dissolution?Ans. Ans. : I should obtain a clear solution. (Clear to the eye? Yes): I should obtain a clear solution. (Clear to the eye? Yes)Que. Que. : Then….: Then….Ans. Ans. : I add simultaneously select weight of the alloy and a conducting carbon: I add simultaneously select weight of the alloy and a conducting carbon

by agitating by agitating Que. Que. : Why conducting carbon.?: Why conducting carbon.?Ans. Ans. : The mosaic of magnets should behave as a single entity. : The mosaic of magnets should behave as a single entity. Que. Que. : Agitation is done manually or mechanical or ..?: Agitation is done manually or mechanical or ..?Ans. Ans. : By sonication in a sonicator: By sonication in a sonicatorQue. Que. : Then : Then Ans. Ans. : I Allow it to settle down for half an hour and then the contents are poured : I Allow it to settle down for half an hour and then the contents are poured

into a non-metallic container. The solvent is allowed to vapor off, resulting into a non-metallic container. The solvent is allowed to vapor off, resulting in the formation of needle shaped…in the formation of needle shaped…


Applications ?Applications ?1.1. Thin FilmsThin Films2.2. Magnetic Read Head DeviceMagnetic Read Head Device3.3. GMR (EuGMR (Eu1-x 1-x .Gd.Gdx x .Se).Se)

Existing (prior-art) solutions:Existing (prior-art) solutions:In thin film, a paste of a magnetic alloy such as Cr-Fe In thin film, a paste of a magnetic alloy such as Cr-Fe is smeared on a polymer substrateis smeared on a polymer substrate

Prior-art Problems Prior-art Problems • Low Curie Tem (about 343K), above which the alloys Low Curie Tem (about 343K), above which the alloys

get oxidized get oxidized • Low distribution of magnetic materialLow distribution of magnetic material• Low Rate of Change of MR (2-3 %)Low Rate of Change of MR (2-3 %)• About 95% is the magnetic materialAbout 95% is the magnetic material


The objects of the inventionThe objects of the invention

1.1. A thin film where polymer is an integral partA thin film where polymer is an integral part2.2. Less amount of magnetic alloy Less amount of magnetic alloy 3.3. Uniform distributionUniform distribution4.4. Control shape and size (nano)Control shape and size (nano)5.5. Higher curie temp (> 473K)Higher curie temp (> 473K)6.6. High rate of change of MR (10-20%)High rate of change of MR (10-20%)

Case Study IV: US Patent No. 6627101Manoharan et al. September 30,

2003Magneto conductive polymer composite and process

for the preparation of the same Claimed:Claimed:

11. A magnetic polymer composite for read and write heads for use in magnetic . A magnetic polymer composite for read and write heads for use in magnetic storage devices, comprising 60-90% by weight polyvinylpyrrolidone 10-40% by storage devices, comprising 60-90% by weight polyvinylpyrrolidone 10-40% by weight of magneto resistive alloy; and 5-30% by weight of conducting carbon. weight of magneto resistive alloy; and 5-30% by weight of conducting carbon.

2. The polymer composite as claimed in claim 1, wherein the said magneto-2. The polymer composite as claimed in claim 1, wherein the said magneto-resistive alloys are selected from chromium-iron, chromium-cobalt or resistive alloys are selected from chromium-iron, chromium-cobalt or chromium-nickel. chromium-nickel.

3. The polymer composite as claimed in claim 1 wherein said composite is in the 3. The polymer composite as claimed in claim 1 wherein said composite is in the form of a powder. form of a powder.

4. A process for the preparation of a magnetic polymer composite, comprising: 4. A process for the preparation of a magnetic polymer composite, comprising: (a) dissolving polyvinylpyrrolidone in a solvent to obtain a clear colorless (a) dissolving polyvinylpyrrolidone in a solvent to obtain a clear colorless solution; (b) adding magneto-resistive alloy particles to said colorless solution; solution; (b) adding magneto-resistive alloy particles to said colorless solution; (c) simultaneously adding conducting carbon to said colorless solution; (d) (c) simultaneously adding conducting carbon to said colorless solution; (d) agitating said solution obtained from step (c) at a frequency of 15-20 kHz for a agitating said solution obtained from step (c) at a frequency of 15-20 kHz for a period of 5-30 minutes to produce an evenly dispersed dispersion of alloy period of 5-30 minutes to produce an evenly dispersed dispersion of alloy particles in said solution; (e) transferring said solution containing dispersed particles in said solution; (e) transferring said solution containing dispersed alloy particles to an open non-metallic container on a megneto-stirrer and alloy particles to an open non-metallic container on a megneto-stirrer and allowing said solvent to evaporate until polyvinylpyrrolidone coated magneto allowing said solvent to evaporate until polyvinylpyrrolidone coated magneto resistive alloy composite is isolated from the non-metallic container in the form resistive alloy composite is isolated from the non-metallic container in the form of cones. of cones.

Question no. 7Property / Characterization data an essential

part of patent disclosures ?

Hysteresis Data

Question no. 7Are Property / Characterization Data an essential part of patent disclosures ?

HysteresisCurve

Question no. 7Characterization / Property Data

an essential part of patent disclosures ?

Such data become imperative to identify a product, specifically when otherwise not possible to explicitly define the product.

Question no. 7Characterization / Property Data

an essential part of patent disclosures ?

The data also becomes critical to establish the inventive step from closely related prior art

Case Study V - Novel biocatalyst called Cross-Linked Protein

Coated Microcrystal (CLPCMC)

Problem

• Enzymes are used in many organic synthesis

• Some redox reactions require low water media

• Significant reduction in catalytic rate

Case Study VCross-Linked Protein Coated…

Prior-Art Solutions on bio-catalytic designs

Cross-Linked Enzyme Crystal (CLEC)

CLEC suitable for bio transformation in non-aqueous media(Khalaf et al 1996) as well as aqueous media

Enzyme conformation critical (Crystallization conditions)

Requires pure enzymes, increasing the cost and time

Expensive and time consuming

High conversion rates

Case Study V Cross-Linked Protein Coated…

Prior-Art Solutions

Protein / Enzyme Coated Micro-Crystals (PCMC)

• PCMC enables biomoeucles retain good bioactivity• Free flowing with specific particle size and morphology • Less expensive • Potential in drug delivery for protein therapeutics (Liposome composition)

Bismuto et al 1979 observes stability of immobilized enzyme linked to• Career interactions• No, of bonds• Freedom of the conformation• Microenvironment • Charge and properties of spacer• Immobilization conditions / method (covalent, h-bonding )

Stability issues (the salt core dissolves)Only in non-aqueous mediaLow rates of conversion

Advantages Heterogeneous typeControl of size and shape


Solution

• CLEA – High rates, though expensive and

laborious to make• PCMC – Easy to manipulate size, though

conversion rates are low

A combination??


Object of the Invention

• A Cross-Linked Protein Coated Microcrystal (CLPCMC) that has high conversion efficiency and stability and can work in low aqueous environs

Step I - Assessment of the disclosure for a publication prior-art search

Is this disclosure sufficient to conduct a good Is this disclosure sufficient to conduct a good publication search?publication search?

Has the investigator done extensive publication Has the investigator done extensive publication search?search?

Does it require a broad patent search or narrow Does it require a broad patent search or narrow search? search?

(Crowded vs. sparsely populated prior-art)(Crowded vs. sparsely populated prior-art)

Step II- Assessment of the disclosure for a Prior-art search

Is this disclosure sufficient to conduct a good patent search?Is this disclosure sufficient to conduct a good patent search?

YES – go to step IIIYES – go to step III

NO – Ask further detailsNO – Ask further details

Specific questions based on a sample search and get details (Novelty to be Specific questions based on a sample search and get details (Novelty to be disclosed..??)disclosed..??)

Ask for a more elaborate write-up Ask for a more elaborate write-up (Problems – How elaborative? Novelty to be disclosed..? )(Problems – How elaborative? Novelty to be disclosed..? )

Step III - Prior-art Patent Search

What are the possible databases that may be used?What are the possible databases that may be used?

A broad patent search or narrow search? A broad patent search or narrow search? (Crowded vs. sparsely populated prior-art)(Crowded vs. sparsely populated prior-art)

Possible search strategies Possible search strategies (Chemical structure, nucleotide sequence, keywords, (Chemical structure, nucleotide sequence, keywords,

classification, name search, combinations)classification, name search, combinations)

Selection of database(s) and strategy (ies) Selection of database(s) and strategy (ies)


Prior-Art searches

CLEA • US 20031449172 (A1) disclosed a cross-linked enzyme aggregate

(ULCEA) and a method of preparation• Other patents include US 3883394, 4760024, US 4292199, EP 1099997 and

JP 2133386 • US 6011001 discloses a method of therapeutic treatment, disclosing both

microcrystal and cross-linked enzymes

• Novelty Issue. Is the invented CLPCMC different ?


Prior-Art searches

PCMC • US 4292199 teaches improved loading of an enzyme onto a support matrix

that is porous and provided by impregnating inorganic oxide with polyamine at highly acidic pH. (Question the resultant product a crystal?)

• US 2002168414 talks about an inexpensive water soluble PCMC with enhanced catalytic activity and stability in non-aqueous media

• Novelty Issue. Is the invented CLPCMC different ?


Inventive Step Issues

Whether the method of incorporating CLEA on protein coated microcrystal different from method of incorporating enzymes on micro-crystal as disclosed in 20021648414

If yes, is such a method of incorporation of CLEA onto PCMC is a logical step for a person skilled in the art to pursue?

Step IV – Questions based on Prior-art search

SAFE OptionsSAFE Options

Novelty leave to the PI Novelty leave to the PI (You are SAFE)(You are SAFE) Inventive StepInventive Step(Leave it to the Examiner)(Leave it to the Examiner)

UtilityUtilityAnyway there would be some utility Anyway there would be some utility

Well then what is the role of a patent protection intervener?Well then what is the role of a patent protection intervener?

Step V – Drafting and Filing, Prosecution, Grant, Renewals, etc

Have a good patent attorney firm with youHave a good patent attorney firm with you

Part II

Some novelty and inventive step issues

What is not novel? (Difference from the Prior-Art)

Publication includesPublication includes• Publication in any journal/magazinePublication in any journal/magazine• NewspapersNewspapers• Patents granted earlierPatents granted earlier• ExhibitionExhibition• Oral disclosures Oral disclosures

Public usePublic use• Commercialization / SaleCommercialization / Sale• Public demonstrationPublic demonstration

How to keep confidentiality?1.1. I have got to conduct field trialsI have got to conduct field trials2.2. I have got to report to the funding agencyI have got to report to the funding agency3.3. I have to present the thesisI have to present the thesis4.4. Data need to be verified by technical expertsData need to be verified by technical experts5.5. Some data possible only with others’ helpSome data possible only with others’ help6.6. I have to have data on clinical trialsI have to have data on clinical trials7.7. How do you I prove the utility aspect of my inventionHow do you I prove the utility aspect of my invention8.8. I need to promote my product in the marketI need to promote my product in the market

Possibility of Provisional filing Possibility of Provisional filing ((§ 9) 9) Prototype not a prerequisite Prototype not a prerequisite ((§ 10 (3)) 10 (3)) Communication to Government Communication to Government ((§ 30) 30) Disclosure in confidence Disclosure in confidence (Indian Contract Act, 1872) (Indian Contract Act, 1872) Public working for “Reasonable” trials possible Public working for “Reasonable” trials possible ((§ 32) 32)

The case of a tube with a branch tube

Known Novel???c

o


Known Novel???Apply the conditions!!

Condition Novel Not novel

Published? No Yes No

Publicly used? No No Yes

5 methyl uridine

• An intermediate for anti-AIDS drugs

• Synthesis through chemical route

• Synthesis through biological route

5 Methyl ….

Japanese patent…(published)• Reacting ribose-1-phosphoric acid with 5

methyl uracil in presence of Micrococus luteusDrawbacks• Purification step not described• Size of 5-MU very small ( 20 – 30 um)• Reduced separation rate• Increased separator size

5 Methyl..

Steps • Precipitation of culture medium • Adding 5-M Uracil and ribose phosphoric acid

into the culture medium • Separation on 5-MU crystal of size 10-50µm

5 Methyl..

New patent (US patent) Used same chemicals and microorganismSteps1. Natural precipitation of the culture medium2. Removed 50-90 % of culture medium 3. Reaction allowed in the decanted culture4. Separation of 5-MU crystal size of 50-500 µm Advantages• High purity 5-MU• Increase separation efficiency

Etoposide Drug DeliveryTreatment of cancer

1. Chemotherapy / RadiotherapyDisadvantage : Cytotoxic to normal cells

2. Safer drugs (target specific)E.g. Etoposide (epipodophyllotoxin)

Advantage : Less side effectsProblem : Low solubility –vehicle induced

side effects

Etoposide Drug Delivery

Invention : Encapsulation of etoposide with liposomeProcess : Flash evaporation process

Advantages:• More stable• Improved efficacy• Reduced toxicity

Patents filed in India (Aug.’98) and through PCT (Aug. 99)

Etoposide Drug DeliveryPCT search report (April 2000)

US 5741516(Issued: Apr 21, ‘98) Priority: Dec 14, ‘95

1. A liposomal composition for delivery of a therapeutic compound to mammalian host which comprises a liposome having one or more membranes which comprise sphingomyelin and cholesterol, a lipsosomal interior have a pH less than that of the liposomal exterior, and a therapeutic compound contained in said liposome for delivery to the host

6. The liposomal composition of claim 1, wherein the therapeutic compound is selected from vicristine…or etoposide or prodrugs thereof

Etoposide Drug DeliveryArgumentNo example to substantiate an effective

etoposide encapsulation in US 5741516

Reality Even a single line enough to kill the novelty of

an invention

What is Inventive?(Distance from the Prior-Art)

Inventive step or non-obviousness is:Inventive step or non-obviousness is:

• Not obvious to person (s) Not obvious to person (s) skilled in the art*skilled in the art*. . Givens Givens

A+B is knownA+B is knownB+C is knownB+C is knownA+B+C is NOT knownA+B+C is NOT known

Question: Whether A+B+C is inventive?Question: Whether A+B+C is inventive?(* Who? Level of skill?(* Who? Level of skill?))


Known Novel Inventive???

Inventive step…Givens Givens

1.1. A+B is known A+B is known 2.2. B+C is knownB+C is known3.3. A+B+C is NOT knownA+B+C is NOT known

QuestionQuestion : Whether A+B+C is inventive?: Whether A+B+C is inventive?Problem Problem : Subjectivity: SubjectivityGuiding principleGuiding principle : Triviality is not bar for patenting.: Triviality is not bar for patenting.Approach Approach : Check out answers to :: Check out answers to :

Could 3 solve any problem not solved by 1 or 2?

Has it addressed a long felt solution to a prior art problem?

Acoustic Tide Gauge

Use: to measure the tide level in an oceanic environs

Device: A guide tube with one end open, the other end with transducer

Principle: Velocity of sound

Problem: Velocity of sound varies with temperature

C=C0 1+T/273-- - - - -- - - - - - -- - - -water- - - - - -- ---- - - - - - - --- - - - - - - - --- - - - - - - - - -

Acoustic Tide Gauge

Prior Art

1. Temperature sensors at different positions

2. A hole provided in the guide tube

3. Both 1 and 2 above

Others

1. Float Levelmeters

2. Ultrasonic liquid level sensor

Acoustic Tide Gauge

Patent no: US 6360599 B1

Year : March, 2002

Applicant : National Institute of Ocean Technology, Chennai

Use: to measure the tide level in an oceanic environs

Device: A guide tube with one end open, the other end with transducer

Principle: Velocity of sound

Problem: Velocity of sound varies with temperature

C=C0 1+T/273

Acoustic Tide Gauge

Known feature

A guide tubeWith dia d<0.586

Novel feature

Branch tube with length L=(2n-1) /4 = (2n-1) C/4ƒ

Acoustic Tide Gauge

Claims 1. A device measuring tide level in sea comprising:

a guide tube having its lower open end immersed at least 0.5 m below the lowest tide level to minimize the undesirable effects of the current and surface waves, means for generating processing and displaying the data signals, a transducer or a pair of transducers fixed substantially at the upper end of the guide tube for generation and reception of electrical as well as acoustical pulses, a switching circuit for isolating the transmitting and receiving signals, wherein a least one branch tube is provided near the upper end of the guide tube having its length determined by the formula

L=(2n-1) /4 = (2n-1) C/4ƒ

The issue of obviousness

Invention : A highly acidic heterogeneous microporous solid catalyst comprising

1. sulphated metal oxide (zirconia)

2. at least one carbon molecular sieve and/or heteroploy acid

3. pore volume in the rage of 0.1 - 0.2 m3/g and

4. pore size distribution in the range of 25 - 40 A0

Heterogeneous Microporous Catalyst…-Non-Obviousness

Microporous….

Applications of the catalyst

(1) Selective cyclyzation

(2) Selective mono-nitration of aromatic compounds (O:P selectivity)

Filed at : USPTO

Heterogeneous Microporous Catalyst…-Non-Obviousness

US Office Action The claimed invention is constructed from two known catalysts each of which is taught by prior art.

Prior Art 1. Process for preparing catalyst containing SMO and heteropoly acid known. Cited document also discussed pore volume and size distribution (SMO+HPA)

2. The specification admits that “combination of carbon molecular sieve (CMS) and metal oxide” is well known in the art as acidic microporous solid catalyst (CMS+MO)

Non-obvious…

Claims rejected on the basis of obviousness under 35 US.C. 103 (a), which states that

(quote) A patent may not be obtained though the invention is not identically disclosed or described, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. (unquote)

Novelty v/s Non-obviousness

Importantly the prior art does not teach:

(i) HPA + CMS + metal oxide

(ii) CMS + sulfated metal oxide

Therefore, novelty admitted.

Novelty v/s Non-obviousnessIssues addressed to establish non-obviousness

(i) What is the specific combination that is claimed ?(Ans: CMS + sulfated metal oxide; HPS is optional )

(ii) Whether improved selectively obtained with the invented catalyst (Ans: Yes)

(iii) Does such improved selectivity depends on specific pore volume and pore distribution (Ans: Yes)

Non-obviousness…

Amendments

Original claim An active highly acidic microporous solid catalyst comprising sulfated metal oxide and at least one carbon molecular sieve and /or heteropoly acid and have pore….

Amended claim An active highly acidic micro porous solid catalyst comprising sulfated metal oxide and at least one carbon molecular sieve coated with or without heteropoly acid and have pore….

Non-obviousnessSome Considerations:

• Distance from the prior-art• Long-felt need• Time elapsed • Unsuccessful prior art attempt• Scientific research• Surprising result • Overcoming a technical prejudice

Claim Language in Patents

Claim is the portion of the patent specification that defines the metes and bounds of the invention

Careful draftingBroad v/s narrow claimClaim dependencyCourts decides the rights as per claims

QUESTIONS FOR R & D QUESTIONS FOR R & D DEPARTMENTSDEPARTMENTS

1. DO YOU KEEP A TAB ON PATENT STATUS IN YOUR AREA IN INDIA OR ABROAD ? ANY PATENT APPLICATIONS IN THE PIPELINE ?

2. DID IT SOLVE THE PROBLEM IN YOUR MIND ?

3. IS THERE ALTERNATE SOLUTION TO EXISTING PROBLEM?

QUESTIONS FOR R & D QUESTIONS FOR R & D DEPARTMENTSDEPARTMENTS

4. HAVE YOU ENSURED CONFIDENTIALITY OF YOUR INVENTION BEFORE FILING OF A PATENT APPLICATION?

5. HAVE YOU CONSIDERED USE OF EXISTING PATENT INFORMATION TO REDUCE THE TIME & INVESTMENT OF R & D?

6. HAVE YOU ENGAGED A PATENT ATTORNEY/AGENT FOR LEGAL PROTECTION OF YOUR INVENTION?

Conclusions – Requirements..Broad understanding of

1. different science / technology disciplines2. Patent laws/practices globally (Do’s and don'ts)

Quick grasp

Deep understanding of some technology areas

Sound understanding of policy issues, other laws (contract law)

Understanding people (think from the clients perspective/user perspective)

Confidentiality (U are privy to some great technical data that has high commercial stakes)

Ability to meet deadlines

Conclusions - RoleIdentifying invention

Understanding invention – Publication V/s Patenting

Driving out the invention– Protectable v/s non-protectable. – Is the invention standing out of the prior-art landscape?

Effective prior-art search & Construction of the prior-art landscape

Asking right questions

Patent practices of different counties

Disclosures – What to and what not to?

An interface between attorney and the inventor - understanding of different perspectives

Conclusions - Role

Last word..

Answers are seldom in black and white

HENCE YOUR ROLE

Wify: What is in the locker?Hubby: Cant tell you.Wife (Weep..weep): I know. Love letters from your first GF..Hubby (helpless whisper): These are patent papers.Wife (outbursts): You never told me you had a GF by that name..

Some People Would Refuse to Understand

Contact…Suresh Kumar K.Scientist EPatent Facilitating CentreTechnology Information Forecasting & Assessment Council

(TIFAC)Vishwakarma BhawanShaheed Jeet Singh MargNEW DELHI 110 016

Phone : 11-26592713 / 42525713Email : [email protected]

Documents

Suresh Kumar K