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Ten Most Common Mistakes Made by Faculty PIs with Their IP Suzannah K. Sundby, Esq., Canady + Lortz LLP The University of California Center for Accelerated Innovation (UC CAI) presents

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Page 1: Ten Most Common Mistakes Made by Faculty PIs with Their IP...Ten Most Common Mistakes Made by Faculty PIs with Their IP Suzannah K. Sundby, Esq., Canady + Lortz LLP The University

Ten Most Common Mistakes Made by Faculty PIs with Their IP

Suzannah K. Sundby, Esq., Canady + Lortz LLP

The University of California Center for Accelerated Innovation (UC CAI)

presents

Page 2: Ten Most Common Mistakes Made by Faculty PIs with Their IP...Ten Most Common Mistakes Made by Faculty PIs with Their IP Suzannah K. Sundby, Esq., Canady + Lortz LLP The University

1. Not staying informed of patent law basics

Page 3: Ten Most Common Mistakes Made by Faculty PIs with Their IP...Ten Most Common Mistakes Made by Faculty PIs with Their IP Suzannah K. Sundby, Esq., Canady + Lortz LLP The University

Because most types of common mistakes could have been avoided by understanding the basics which are…

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Patent Law Basics

Who – First Inventor to File (or assignee, e.g., UC)

101 – Utility and Eligibility102 – Novelty 103 – Non­obviousness112 – Specification and Claims

Specification – Written Description, Enablement, and Best ModeClaims – Clear and definite

Rule 1.56 – Duty to Disclose

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o Processeso A method of treating…o A method of making…o Diagnostic methods are questionable

o Machineso Assay devices, medical devices, etc.o Computers and computer systems questionable

o Articles of Manufactureo An article of clothing which comprises

o Compositions of Mattero A compound having the structural formula…o A composition comprising…o No isolated genes, other isolated and purified

biomolecules questionable

Utility and Eligibility

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o No wholly inoperable inventions, e.g., perpetual motion machines

o No inventions having “incredible” utility without specific evidence, e.g., cold fusion, methods of preventing cancer

o No immoral or mischievous inventionso No isolated genes and cloned animals

Utility and Eligibility

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o Patent protection must be pursued before being patented, described in a printed publication, or in public use, on sale, or otherwise available to the public

o The exact same invention being claimed must not be anticipated by the prior arto Prior art discloses Compound X

o One cannot obtain a granted patent claim on Compound X

o Prior art does not disclose using Compound X to treat Disease Yo Inventor discovers that Compound X can be used

to treat Disease Y and can therefore claim a method of treating Disease Y which comprises administering Compound X

Novelty

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o A species anticipates a genuso Compound X falls within the scope of broad

genus of compounds having the general structural formula A

o Compound X is in the prior arto Claims to compounds having the general

structural formula A are anticipatedo Anticipation by Inherency

o Prior art discloses method for treating a tumor by administering Compound X

o Inventors discover that Compound X induces apoptosis in tumor cells

o Inventors cannot obtain granted patent claims to a method of inducing apoptosis in tumor cells by administering Compound X because it is inherent in the prior art that Compound X induces apoptosis in tumor cells

Novelty

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o One cannot obtain a patent on an invention where the differences between the invention and the prior art would have been obvious to one of ordinary skill in the arto There must be some suggestion or motivation to

modify or combine the prior art to arrive at the invention as a whole with a reasonable expectation of success

o One of ordinary skill in the art is a hypothetical person

o Doesn’t matter if the inventor thinks it was not obvious BUT what the inventor says is obvious can be used against him

Non­Obviousness

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o The specification must provide sufficient written description and enabling support so that one skilled in the art can make and use the invention, including the best mode

o The claims must particularly point out and distinctly claim what the inventor regards as her invention

o After filing a patent application, no new matter may be introducedo The specification cannot be later amended to

include new data or additional embodiments o The claims cannot be later amended to include

new limitations which are not supported by the application as originally filed

Specification and Claims

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o Inventors, Applicants, Patent Attorneys, and others having an interest in the patent application must disclose information that is material to patentabilityo Information is material to patentability when it is not

cumulative to that already of record, and o (1) it establishes, by itself or in combination with other

information, a claim is not patentable, ORo (2) it refutes, or is inconsistent with, a position the

applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability

Duty of Disclosure

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ResourcesUCLA OIPo http://www.research.ucla.edu/tech/PatentFAQ.pdfo http://www.research.ucla.edu/tech/techtransferFAQ.pdf

Your Tech Transfer Officer (TTO)

The Patent Attorney assigned to your case

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2. Not understanding the meaning of Inventorship

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Inventorship

o ≠ Authorshipo Legal determination based on the claims

o Job of the patent attorney to determineo An inventor is one who contributes to the

conception of at least one claim o Conception is complete where one of ordinary skill in

the art can practice the invention without extensive research or experimentation

o Since conception is a mental act, proof of such requires corroborating evidence

o Sometimes actual reduction to practice is necessary for conception

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Inventorship

o Joint Inventorship requires collaboration in the final conception of the claimed inventiono Need not physically work together or at the same timeo Need not have made the same type or amount of

contributiono Need not have made an inventive contribution to each

claimo Providing an inventive contribution to just a part of a claim

may be enough

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Inventorship

o Not an inventor ifo Only provided an idea or suggested a desired resulto Just provided background data, general information,

funding, or equipment/materialso Merely followed instructionso Conducted exhaustive experiments after conception

was completeo Indicated what won’t work without any contribution as

to what would worko Inventorship is extremely important as misjoinder

can invalidate the patent thereby making everyone’s hard work meaningless

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3. Erroneously thinking one’s own actions can’t be used against one’s own invention

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One’s Own ActionsCan be used against your own invention

o As a statutory bar, e.g., offering to sell or selling the invention before timely filing for patent protectiono Consulting Agreements often contain terms that can be construed

as a sale or offer to sell in addition to other terms that conflict with one’s obligations to the University and policies

o To reduce IP rights and commercial viabilityo Talking with Companies/Third Parties before your TTO has

evaluated and defined the University’s IP position can: contaminate the IP rights, e.g., make another a joint­inventor, be a public disclosure, result in the company developing something else to side­step having to license your invention.

o Lesson = Don’t do without talking with your TTO first!o A patent application can be filed and/or a NDA implemented

beforehand in order to mitigate risks

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One’s Own ActionsCan be used against your own invention

o As Prior Arto Abstracts, even if on the Internet, are enough to be novelty

destroying and make your own invention obviouso Student theses: Abstracts are published, and even one copy available in a

library is prior arto Poster Sessions, even if not on the Internet (e.g., simply presented

at a conference), are enough to anticipate and/or make your invention obvious

o Seminars, even if within one’s own institution, e.g., at UCLA, can be a problematic public disclosure

o Journal Articleso Often published in advance on the Interneto Doesn’t matter how old and whether you knew at the time that it could be

combined or modified to result in your invention

o Lesson = Tell your TTO before submitting/presenting

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4. Inadvertently opening mouth and inserting foot

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Foot and Mouth Disease

o Using patent legalese in your writings can lead to diseaseo Avoid words like novel, obvious, enabling, etc.

o Grabbing the Examiner’s hand and walking down the path of obviousness can lead to deatho Avoid telling the inventive storyo Avoid writing “because X this and Y indicates that, we

decided to…”o Avoid inserting reference citations in parts specific to

your inventiono Instead, writing like one slipped in the shower is best

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Foot and Mouth Disease

o Avoid putting certain things in writing (including email) unless specifically asked by the patent attorneyo Answering questions not asked by the patent attorney can cause

illnesso When in doubt, pick up the phone

o Sending arguments and information in response to an Office Action before the patent attorney asks can cause infectiono The flip­side of non­obviousness is obviousness

o Often some arguments for non­obvious can be flipped around to make the case for obviousness

o Unless specifically asked by the patent attorney don’t write that you agree with what the Examiner wrote in an Office Action or the Examiner’s characterization of what a reference discloses

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5. Not providing information or waiting until the last minute

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Lack of Information

o Failing to disclose all publications (yours and others) and information related to the inventiono Decreases the chances of securing the best possible IP

protectiono If we know about something, we can usually address it before it

is an issue o File a provisionalo Write claim limitations that carve out the problem

o Violates the duty of disclosure and possibly the “112 requirements”, i.e., written description, enabling support, and best mode

o Hiding the ball only puts us behind the 8­Ball

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Last Minute Information

o Provide all information and data you have right away, especially at the start of the application being drafted

o Costs time and money which can be detrimental to the value of one’s inventiono No time to evaluate, plan, and/or address

o Application drafting nightmares and mistakeso Risk of Foot and Mouth Disease

o Certain decisions/actions are often made earliero Abandono Line of arguments that conflict with arguments which would

have been bettero Loss of potential licensee interest

o Last minute information is better than no information

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6. Thinking narrowly

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Narrow Thinking

o Can result in narrow patent protectiono In patent law land one is not limited to only those claims

which are supported by actual experimental datao Provide alternatives and optimizations

o Working example employs a glue to fasten A and B – Can a staple or a shoelace be used instead?

o Indicate the minimum required and then what additional things can be done to improve the results

o Can two things be substituted with one thing, or vice versa?o Provide prophetic exampleso Dream a little

o Why is your invention so wonderful – Why and how will others want to use your invention?

o But be realistic – Remember the “enablement requirement”o What can be extrapolated with a reasonable expectation of success?

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7. Being unrealistic

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Being Unrealistic

o Be realistic about the goals of patent protectiono Patents help make inventions commercially viableo A patent is the right to exclude, not the right to

practiceo One may get a patent, but not be able to practice the claimed

invention because of another’s superior patent rightso Few patents result in one becoming rich with royalties

o Greediness is like hubris, it causes downfall

o Being head­over­heals in love with your invention results in heartburno Lack of objectivity unrealistic claim scope and/or

poor arguments over the art no patent

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8. Failing to involve the technology transfer office

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NO PATENT

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9. Putting too much faith in the patent attorney

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Patent Attorneys

o Don’t know everythingo Patent attorneys know patent law

and some…

o You’re the expert on your inventiono For most seasoned patent attorneys, it’s

about 10 years since they tinkered in the lab

o You invention should be novel and unobviouso This means it should be completely new to

the patent attorneyo Don’t be afraid to ask questions and challenge the

patent attorney

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10. Not being involved all the way

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Be Involved All the Way

o The most valuable and robust patents result from the inventors being actively involved from beginning to end

o Review in detail draft applications and modify as requested by the patent attorney

o Spend time on understanding the claims and amendments to the claims

o Be involved in helping the patent attorney analyze the prior art and formulate arguments

o Keep the TTO and patent attorney informed of your research developments and future interests

o Provide updated contact information

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Suzannah K. Sundby, Esq.Canady + Lortz LLP

1050 30th Street, NWWashington, DC 20007

T: 202.486.8020F: [email protected]

Suzannah practices all aspects of intellectual property law including patentpreparation, and prosecution, licensing, opinion work, client counseling andlitigation relating to diverse technologies including biochemistry, molecularbiology, pharmaceuticals, microfluidics, diagnostics, medical devices, andnanotechnology.These materials are public information and have been prepared solely for educational and entertainment purposes tocontribute to the understanding of intellectual property law. While every attempt was made to ensure that thesematerials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed. Thesematerials and views are not a source of legal advice and do not establish any form of attorney­client relationship withthe author and Canady + Lortz LLP.