Systematic and Methodical Approaches to Patent Searching€¦ · Approaches to Patent Searching Iterative Process – Continuous Cycle The search process is a continuous one (iteration)

Systematic and MethodicalApproaches to Patent Searching

James L. Grant, La Jolla, CA, USA

Senior Consultant – Chemistry and Biotechnology


IntroductionSearch Types

Patentability, Freedom-to-Operate, Validity, Landscape

IterationBuilding on previous searches

Building on client interactionsBuilding on research results

Search Approach – Six Steps For SuccessCase StudiesRecall and Precision


Iterative Process – Continuous Cycle

The search process is a continuous one (iteration) - the first and laststeps are not necessarily distinct.Typically, the process initiates when the business context isidentified, and approaches some point of closure when feedback isgathered in the follow-up phase.The information professional’s reference interview skills come intoplay at this point.Sharing the results and following up and getting feedback are wheretrue relationship building occurs.The client has to trust that it is meaningful to share the informationwhen questioned during the feedback phase.


Iterative Process – Continuous Cycle

The final step usually leads back to the first step.Follow-up and feedback begets new value-added research andanalysis opportunities, which leads to the identification of a newbusiness context, and so the cycle continues.You may have to have several discussions with the client as youwork your way through the project.


Objectives

Patent Search Examples: Walk-through of the approach; Chemicaland Mechanical StudiesCase Study • Freedom-to-Operate (FTO)

� Disclosure in ClaimsCase Study • Patentability, Novelty

� Disclosure in Specification, Written Description, Abstracts, etc.� Patents and Non-Patents (NPL)


Six rules for success

1. Verify and re-verify the scope with the customer2. Don't miss obvious reference3. Carry out the search in two or more independent parts4. Be sure you know why you are rejecting a reference and think

twice about it5. Present the results in the fashion that your customer can best use6. Expect to defend your search


Case StudyA client, Big Pharma, Inc., wishes to develop a Formulation involvinga theoretical drug example [“Virocillin”] along with other componentsThe client believes this discovery will net billionsThe client has insisted that you drop everything you are doing tohelp him get an application filedThe client has submitted the following draft claim based on his vastexperience in drug discovery:

A pharmaceutically acceptable tablet of Virocillin comprising:� A core selected from the group consisting of carboxymethyl cellulose,

lactose, sucrose [core material]� Coated on said core are particles comprising Virociliin and a suitable

excipient selected from the group consisting of carboxymethylcellulose, ethyl cellulose, methyl cellulose and lactose and saidparticles are coated with a mixture of sodium stearate andhydroxypropylmethyl cellulose


Case Study (continued)

At least one layer of one of the more basic substances selected fromthe group consisting of sodium carbonate, potassium carbonate,Mg(OH)2, Ca(OH)2 encasing said core and said particles to form apillCoating said pill with an enteric coatingThe tablet of claim 1 wherein said core is carboxymethyl celluloseThe tablet of claim 1 wherein said enteric coating is [favorite entericcoating’], e.g., polyvinyl acetate phthalate (PVAP)The tablet of claim 1 where in said basic substance is sodiumcarbonate


As a TISC searcher, what steps would you take tobegin discussions with this client?

� In all searches, regardless of technology area, recall theSIX STEPS OF SUCCESS

� Verify and re-verify the scope with the client

The client has listed all components of his pill, containingVirocillin, in language one might find in a claim .. discuss thispoint with the clientIf this is to be a commercialized product, then this is aFreedom-to-use (FTO) searchDoes the client have a patent on “Virocillin”?Does the client have a patent on the process of making“Virocillin”?


Key Ingredients (Related Terms) Search in Claims

Core‘Encasing Core’

Excipient Coat Enteric Coat

Drug (API) “Virocillin”carboxymethylcellulose, lactose,sucrose

sodium carbonate,potassiumcarbonate, Mg(OH)2,Ca(OH)2

carboxymethylcellulose, ethylcellulose, methylcellulose and lactose+sodium stearate andhydroxypropylmethylcellulose

Polyvinyl acetatephthalate (PVAP)



Carboxymethyl cellulose


Carboxymethyl cellulose


Carboxymethyl Cellulose: synonyms• Cellulose gum• Celluvisc• Carmellose• Celluvisc (TN)• 9004-32-4• Carmellose sodium (JP15)• CMC• C.M.C. (TN)• CHEMBL242021• CHEBI:487024• Carboxymethylcellulose (USP)• CID656594• D01544


Carboxymethyl cellulose: building a search

Search Terms – ‘OR’ (Boolean logic)(carboxymethylcellulose sodium or Celluvisc orCarmellose sodium or Celuvisc orcarboxymethlycellulose or carboxymethyl cellulose)


Lactose


Lactose: synonyms• Lactose• Milk Sugar• Lactosum anhydricum• Laktobios• Milchzucker• Laktos• Nchembbio.151-cmpd4• CHEMBL1159651• 1784 FLUKA• Beta-D-Gal-(1->4)-D-GLC


Lactose: building a search

Search Terms – ‘OR’ (Boolean logic)

(Lactose OR milk sugar OR lactosum anhydricum ORlaktobiose OR milchzucker OR laktose)


Sucrose: synonyms• Saccharose• Sugar• Sucrose• Table sugar• Can sugar• Amerfand• Amerfond• Rohrzucker• Saccharum• Microse


Hydroxpropylmethyl cellulose: synonyms• Hydroxypropylmethyl cellulose• HPMC• Hydroxypropyl methylcellulose• Hydroxypropyl methyl cellulose• E464• Hypromellose• 9004-65-3


Methyl /Ethyl CelluloseMethyl cellulose does not occur naturally and is syntheticallyproduced by heating cellulose with caustic solution (e.g. a solutionof sodium hydroxide) and treating it with methyl chlorideIn the substitution reaction that follows, the hydroxyl residues (-OHfunctional groups) are replaced by methoxide (-OCH 3

Ethyl celluose (-OCH2CH 3


Methyl Cellulose Ethyl Cellulose• Cellulose, methyl ether• Methylated cellulose• Methylcellulose• E461

• Ethyl Cellulose• Cellulose, ethyl ether• Ethylated cellulose• Ethylcellulose• E462


Potassium and Sodium Stearate•Potassium (sodium) octadecanoate


Polyvinyl acetate phthalate (PVAP): synonymsPolyvinyl acetate phthalate (PVAP) is a commonly used polymer phthalate inthe formulation of pharmaceuticals, such as the enteric coating of tablets orcapsules. It is a vinyl acetate polymer that is partially hydrolyzed and thenesterified with phthalic acid. Its main use in pharmaceutics is with entericcoatings and controlled-release formulations.

• PVAP• Polyvinylacetatephthalate• CID161821• 1,2-benzenedicarboxylic acid, polymer with ethenyl• Acetate• 34481-48-6• 53237-50-6• 67724-91-8• 75882-30-3


Major Ingredients – building a search for USPTOSearch Terms – ‘OR’ (Boolean logic) / ‘AND’ (Boolean logic)

("carboxymethylcellulose sodium" ORcarboxymethylcelluosesodium OR "Carmellosesodium" OR Celluvisc) AND (lactose OR "milk sugar"OR "lactosum anhydricum" OR laktobiose ORmilchzucker OR laktose) AND (sucrose ORSaccharose OR sugar OR sucrose OR Amerfand ORAMERFOND)


Advanced Search: USPTO


Results of Search in US Patent Collection:

((ACLM/((("carboxymethylcellulose sodium" ORcarboxymethylcelluosesodium) OR "Carmellose sodium") ORCelluvisc) AND ACLM/(((((lactose OR "milk sugar") OR "lactosumanhydricum") OR laktobiose) OR milchzucker) OR laktose)) ANDACLM/(((((sucrose OR Saccharose) OR sugar) OR sucrose) OR

Amerfand) OR AMERFOND)): 30 patents


Step 2: Don't miss obvious referenceThe following documents show major components:

US 200126804 – “Compressed Microparticles for DryInjection”US 5686104 – “Stable Oral CI-981 Formulation…”US 5350582 – “Stable Formulation of Enalapril…”US 5780057 – “Pharmaceutical Tablet Character…”US 5225202 – “Enteric Coated Pharmaceutical…”And 50 others…


Step 3: Carry out the search in two or moreindependent parts

Build searches and test each one separately beforecombining themInsure that all parts will run to completionCheck spellings and typos if too many or too little hitsare foundIn this case, both words and classification searchingwas used


Step 4: Be sure you know why you are rejectinga reference and think twice about it

The following documents show all components:US 200126804 – “Compressed Microparticles for DryInjection”US 5686104 – “Stable Oral CI-981 Formulation…”US 5350582 – “Stable Formulation of Enalapril…”US 5780057 – “Pharmaceutical Tablet Character…”US 5225202 – “Enteric Coated Pharmaceutical…”And 50 others…


Step 4: Be sure you know why you are rejecting areference and think twice about it (cont.)

The following documents show all components:US 5686104 – “Stable Oral CI-981 Formulation…”US 5350582 – “Stable Formulation of Enalapril…”And 50 others…Most likely, claims with drugs other than “Virocillin” can beeliminated from the list in a final report. Both CI-981 andEnalapril are different from “Virocillin”.


Step 5: Present the results in the fashion that yourcustomer can best use

This is your opportunity to be creative in highlighting results ofyour searches placing references of particular interest at the topof your reportUS 4853230 (‘230 Patent – “Pharmaceutical formulations of acidlabile substances for oral use”, AktiebolagetHassle (Molndal, SE) as Assignee) is a critical document asclaims 1-8 describe the “Virocillin” formulation suggested by BigPharma Inc.


Step 6: Expect to defend your search

Following the steps outline in the Six steps to success, youwill be able to confidently go over search results with theclientThe analysis is factual which makes things easierAmbiguity may enter if writing is indefinite, and this problemshould also be addressed with the clientDo not proffer legal opinion, the results are based onscientific opinion alone


Patentability Searching – NoveltyTo evaluate or argue the patentability of theinvention, use a two-step process:

Step 1: Determine what novel features the invention hasover the closest prior-art reference(s) – novelty can be a newphysical (hardware) feature, a new combination orrearrangement of two separate old features, or a new use ofan old featureStep 2: Determine if the novelty produces any new andunexpected results or otherwise indicates unobviousness


Patentability Searching – NoveltyValidation – Anticipation

Novelty applies to an anticipatory “dead ringer” type prior artrejection. That is where every element in the claims is disclosedin the prior art (documentary reference, sale, knowledge, etc.)and the essence of the invention is the same.Claim says A+B+C+D and prior art A+B+C+DNovelty rejections would not apply if an element is missingIn applying Novelty Rejections , the Examiner frequently saysthat the claimed invention is “anticipated by” some prior art


Patentability Searching – Novelty

Obviousness Rejections applies where there is a differencebetween the claim and the disclosure of prior art.Claim says A+B+C+D and the prior art shows A+B+C+D’.Question to be asked is: would changing D to D’ have beenobvious to a person of ordinary skill?


Case Study (Patentability – Novelty)Disclosure in Specification, Written Description, Abstracts, etc.

Patents and Non-Patents (NPL)

A Client has a great new idea for a bicycle.The inventor is very excited about ‘going global’ for hisNew ideas.


CASE STUDY

What must the TISC Searcher consider?

Narrowing the focus of the search by discussing the invention withthe client

Have the inventor prepare a “Inventor Disclosure”

Indentify this as a patentability search … is the invention novel?Has anyone ever reported ‘disclosed’ the invention in a patent,published application, journal, or magazine, etc.


For instance, given a disclosure about a bicycle with non-slippedals, the points of novelty might be:

the particular shape of the pedals

or the materials that the pedals are made ofor some type of locking mechanism that keeps your feet from coming off

the disclosure may talk about bicycles in general, and the diagrams mayinclude pictures of entire bicycles, not just pedals. That does not meanthat any patent about bicycles is relevant.

You need to understand which features are common knowledge andsimply present to put the invention in context versus which features arepotentially patentable


The six steps to creating value-added research &analysis

1. Verify and re-verify the scope with the customer2. Don't miss obvious reference

3. Carry out the search in two or more independent parts

4. Be sure you know why you are rejecting a reference and think twiceabout it

5. Present the results in the fashion that your customer can best use6. Expect to defend your search


Practical exercise:

Find all patents and non-patents that discuss the useof magnesium alloys in bicycle frames


Patent Databases: Wildcard Operators

PATENTSCOPE®: *esp@cenet: * (or none, fields like ECLA and file date)

esp@cenet: ? (string of length 0 to 1)

esp@cenet: # (string of length 1)

JPO IPDL: [implied wildcard]

USPTO: $


USPTOResults of Search in US Patent Collection db for:

SPEC/(((Magnesium OR Mg) AND (alloy OR alloys)) AND bicycle?)179 patents

SPEC/((((Magnesium OR Mg) AND (alloy OR alloys)) AND bicycle?)AND frame?):35 patents



USPTO – Some interesting titles

Products made of Al-Zn-Mg-Cu alloys with an improved compromisebetween static mechanical characteristics and damagetolerance [US 7,452,429]

Product for a welded construction made of AlMgMn alloy havingimproved mechanical strength [US 6,969,432]

Bicycle frame [US 6,837,506]Product for a welded construction made of AlMgMn alloy havingimproved mechanical strength [US 6,444,059]Bicycle frames and aluminum alloy tubing thereof and methods for theirproduction [US 5,507,888]

Light weight bicycle with improved chain stay structure and method[US 4,621,827]


WIPO

http://www.wipo.int/patentscope/search/en/search.jsf


WIPOResults 1-10 of 112 for Criteria:EN_ALLTXT:((magnesium or Mg) AND (alloy oralloys) And bicycle* and frame*) Office(s):all Language:EN Stemming:true





http://gb.espacenet.com/search97cgi/s97_cgi.exe?Action=FormGen&Template=gb/EN/home.hts

EPO esp@cenet(Magnesium or Mg) AND alloy* AND bicycle* AND frameApproximately 31 results found in the Worldwide database for:(Magnesium or Mg) AND alloy* AND bicycle* AND frame*


http://gb.espacenet.com/search97cgi/s97_cgi.exe?Action=FormGen&Template=gb/EN/home.hts


http://www.ipdl.inpit.go.jp/

JPO


http://www19.ipdl.inpit.go.jp/PA1/cgi-bin/PA1INIT?1290960203025

JPO



JPO



JPO


Non-Patent Literature (NPL)http://www.scirus.com


Non-Patent Literature (NPL)http://www.scirus.com


Similar ResultsRacing to the Finish with Magnesium Cycling athletes andracing... [PDF-2MB] Jul 2008...International Magnesium Association.All...intlmag.org Mg Showcase Issue...Cyclists relyon magnesium alloy racing bicycle components...for eachbike frame.


Iteration – Meeting the Client To Discuss ResultsResults: There is ample results showing that magnesiumcontaining alloys are used in bicycle frames in patents,published applications, and non-patents (journals,magazines,etc.)Limitations: All is not lost

% composition of magnesium in the alloy?ranges of %-compositions (5-10% or 1-2%)tensile strengths?advantages?


ConclusionsSearch Types

Patentability, Freedom-to-Operate, Validity, Landscape

IterationBuilding on previous searchesBuilding on client interactions

Building on research results

Search Approach – Six steps for successCase StudiesRecall and Precision

Documents

Systematic and Methodical Approaches to Patent Searching€¦ · Approaches to Patent Searching Iterative Process – Continuous Cycle The search process is a continuous one (iteration)