Patent Law Flashcards
3 types of patent
• 3 types: Utility patent, design patent (ornamental, not functional usually Copyright or TM), plant patent (making hybrid plants)
What is the Specification
• The Specification: o all background of the patent o Field of invention o Advantages, disadvantages o Summary of invention and all its embodiements o Detailed description of invention, how to use it, how to make it o Drawings o The CLAIMS (within specification)
The Claim consists of…
• Claim Drafting:
• 1) preamble (“I claim…”)
o preamble is non-limiting, short.
• 2) the transition (3 types used)
o comprising (most open ended claim)
• roller skate of 5 wheels include 5 wheels and above
o consisting (close ended)
• roller skate of 4 wheels means only 4 wheels
o consisting essentially of
• drug consisting essentially of acid (you can put all sorts of other stuff in it and that doesn’t matter b/c inventor only cares about the acid)
Utility Comes from…
Comes from Article 1 Section 8 of Constitution “…useful arts…”
• Section 35 U.S.C. 101: requires invention be useful
o “…any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof…”
Enablement comes from…
• 35 USC 112 (enablement requirement): requires applicant to disclose the manner and process of making and using the invention
3 major issues with utility:
• 3 major issues:
• practical or specific utility requirement
• what constitutes a substantial utility, most difficult of utility doctrine
• beneficial utility
• whether invention socially harmful or deleterious purpose
• operability of the invention
• whether the invention can actually accomplish the utility alleged
• enablement (Section 112)
o (no fantastic claims: perpetual motion machine, time machine)
• Mistakes: not allowed.
• Something works but theory behind it wrong: PTO wants accurate disclosures, quid pro quo: exclusive right to invention and public gets disclosure to spur innovation (how to make, use, manufacture invention: operability)
it’s a low bar for utility
- Judges of utility: PTO examiner, the public/consumers, judges/courts (subjective), and Congress (laws on morality).
- Utility not used to invalidate patents all that often b/c the bar is so low.
Timing is Key for Utility
• Timing: Application is judged from the time of the invention, must provide proof of the asserted utility AT THE TIME OF THE APPLICATION.
o Evidence obtained after the filing date is too late.
Burden of Proof PTO review v. litigation
Beneficial/moral Utility:
*Inventor has burden on proof for utility in PTO, in litigation the defendant has burden to prove the patent doesn’t meet the utility requirement.
Juicy Whip
- R: The fact that one product can be altered to make it look like another is in itself a specific benefit sufficient to satisfy the statutory requirement of utility.
- A: Court rejects Lowell. “The invention of the product or process that makes such imitation possible has “utility” – the imitation is the utility, so you have met utility requirement. Court is okay with this deception to consumers.
Utility Hypo: • New method of free basing cocaine:
o Operable utility: yes, you can get higher quicker
o Functional utility: yes
o Beneficial/moral utility: No, we don’t wait people an easy way to do cocaine, and cocaine is illegal in 50 States for use
Utility Hypo: Better way of free-basing Marijuana:
o Operable: yes
o Functional: yes
o Beneficial/moral: yes for medical purposes; but…
• Makes a difference that a few states have allowed recreational use, but still illegal to feds and feds issue patents
Utility Hypo: better way of running prostitution house
o Operable: yes
o Functional: yes
o Beneficial/moral: ….?…. Nevada has said this is okay. Yes, patent can be issued, but only enforceable in Nevada, not workable in other states.
• This is innovation, may benefit society.
Utility o As Examiner, you can’t test it, default for examiner is to presume useful, operable, and then Examiner can go back to inventor for evidence and inventor can respond.
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utility hypo: • New method of cooking chicken using a particle collider (3 or 4 in world):
o Operable: yes
o Functional/it works?: yes, it cooks
o Beneficial/moral: yes, not illegal, just super inefficient.
Utility hypo: • Newly isolated DNA molecule that can be used as paperweight:
o Operable, does it serve as a paperweight: yes
o Functional, work as a paperweight?: yes
o Beneficial/moral: yes, doesn’t harm society.
• PTO: said no, everything can be used as a paperweight, this is not good enough utility.
Utility hypo: • Device that interferes with traffic cameras or traffic lights:
o Operable: yes
o Functional: yes
o Beneficial/moral: it’s illegal in all 50 States; if it’s illegal in 49 states then maybe the calculus changes a bit.
In general for beneficial/moral utility:
*If illegal in all 50 states or is it not?
Brenner v. Mason:
• No Patent
• Process for making a known steroid
• Rule: “Unless and until a process is refined and developed to this point – where specific benefit exists in currently available form – there is insufficient justification for permitting an applicant to engross what may prove to be broad field.”
extending patent life unnecessarily (called evergreening).
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Hypo:
• Firm makes chemical X, Can firm get patent on process to make Chemical X.
o
Under Brenner, cannot get a patent b/c no known use for the chemical.
Hypo:
Invention designed for a thing just for entertainment/amusement?:
yes, patentable.
• See p. 231, santa clause detector.
• PTO very cautious on issuing patents for something that spark curiosity of scientist compared to a patent that sparks curiosity for a child.
o This is because it may inhibit/stop innovation and research.
In Re Brana:
• Patent valid
• Claim for antitumor substance
• Issue: Obviousness (103)
• Utility burden is met here, when it was not in Brenner v. Mason because Brana did experiments to actually show utility but Mason had no experiments and the chemical compounds in Mason were less predictable.
To clear the low bar utility requirement: • *Need experiments and test results to show utility
• Dr’s declaration of the test results
• Show predictability based on prior work.
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Cannot File patent and continue experiments; not allowed b/c must have utility at the time of filing.
• BUT you can file additional experiments later on to rebut the PTO or support your case in litigation.
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In Re Fisher, p. 241
• No patent.
• ESTs: the structure of ESTs and function of ESTs is same; All ESTs do is fish out coding of the proteins = very different
Specific Utility Requirement: “Application must disclose a use which is not so vague as to be meaningless.”
• Specific utility: show what is useful in your EST specifically.
*Must have general utility and specific utility
Utility hypo: • A painting that has artistic value by those skilled in the art:
o Copyright is better; doesn’t serve function; no utility
Utility hypo: • Toy for toddlers that are easy to hold and machine washable
o
Yes
o Used for amusement but has practical, functional, utilty
Utility Hypo: • Sculpture used as a door stop
o Like In re fisher, look at general utility and specific b/c almost everything can be used as a doorstop.o Can get design patent on making it ornamental or copyright on expressive elements
Enablement: Unlike utility, which comes from the Constitution, enablement is required by Section 112 Section a.
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112(a), enablement requires: quid pro quo: inventor gives society the invention and part of inventor giving the invention is the thing has to work.
• How does it function
• The process of making and using it in such full clear consice and exact terms as to enable
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Why do we have enablement standard?
- To limit how broadly patent claims may reach (p. 264)
- Regulates what degree of speculation is tolerable.
- Tell competition what to avoid; helps define metes and bounds of what the invention is so others can avoid it, invent around it, or license the technology.
- This is opposite to trade secret, you disclose advantage but get right to exlude others for a short period of time.
Enablement (policy, reasons for):
•
Bars inoperable inventions, and
• Overly broad claims (give inventor only that much that he has given to the public)
Enablement helps show the inventor possess the invention
Enablement must inform “anyone skilled in the art.”
not a person extremely excessive, just a regular practitioner.
Enablement does not require the mechanism of function.
• For enablement: it works and that’s all that matters.
• Aspirin: no one knew how it worked until 20 years later. It’s function was to treat headaches, but the process on how that worked wasn’t discovered until years later.
Timing of enablement.
• Just like utility, it must be enabled at the time the application was filed (through the eyes of a POISA); not at a later date.
Public policy: why can’t applicant add new material to show enablement after the fact?
• Must inform competitor of metes and bounds of invention;
• Procedural: “new matter rejection” definition…..
trying to claim what was later discovered and adding that material to your claims
o 2 procdural ways around new matter rejection if applicant:
1) file a new application (easy)
• disadvantage; preemption issues
• priority dates: everything judged from the date of filing;
• what can be used against your patent depends on when you file;
• 2) CIP: Continuation In Part Application:
• same application, adding new material but 2 priority dates:
o 1) is everything disclosed in previous application
o 2) all the new matter has a new priority date from filing of CIP (CIP Filing Date).
• Problem with CIP: you don’t disclose what new matter is, so examiner has to look at original application and the CIP to determine new matter.
Incandescent Lamp Patent
• Patent invalid
Sawyer and Mann claim to all carbonous fibrous filaments overly broad;
o To prove enablement:
• Think about predictability (really helps), what you must show to be enabled; a genus claim requires more species or common element to show that it works.
o Enablement prevents overly broad claims; narrow it to enable it.
In re Wands “The Wands Factors” (p. 275)
• Patent Valid at end of the day.
o Invention: an IGG or IGM antibody: a method.
• *The more predictable a field, the less disclosure is necessary to enable a broad claim.
o If experimentation standard for one skilled in art then low success rate okay/fine.
o Look to who is the person we are targeting when looking at enablement: the person skilled in the art (POISA).
What are the Wands Factors:
- 1) the quantity of expirimation necessary
- 2) the amount of direction or guidance presented
- 3) the presence or absence of working examples
- 4) the nature of the invention
- 5) the state of the prior art
- 6) the relative skill of those in the art
- 7) the predictability or unpredictability of the art
- 8) the breadth of the claims.
Wands Factors Applied to Incandescent Light:
• 1) the quantity of expirimation necessary
o high level, thousands of expirements performed.
o Hurts you as inventor arguing enablement
• 2) the amount of direction or guidance presented
o carbonized fibrous material is broad
o Hurts inventor
• 3) the presence or absence of working examples
o only a few examples
o hurts inventor
• 4) the nature of the invention
o is it hard or is it easy?
o In late 1800s, is tech. easy to understand or difficult?
o Hurts inventor, if more difficult need more disclosure
• 5) the state of the prior art
o what has been disclosed?
• Computer tech today is very well developed today
o Hurts inventor
• 6) the relative skill of those in the art
o this may be somewhat hard for someone to understand in 1800s
o Helps inventor
• 7) the predictability or unpredictability of the art
o is it predictable? S&M guys claimed all fibrous material without disclosing enough information. It was unpredictable.
o hurts inventor (this factor sunk the S&M guys)
• 8) the breadth of the claims.
o S&M was very broad
o Hurt inventor
^^7 out of 8 hurts inventor so invention not enabled.
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Do we need to enable starting materials?
• YES, you have to enable starting materials b/c the disclosure must teach someone skilled in the art on the method.
o Ex: cancer treatment using KFC recipe, but no mention of recipe, so what have you given to the public? No method of treating cancer, no info on recipe = not enabled.
• Good policy: disclose and give to public or keep trade secret (but beware, if someone patents it then they may be able to stop you from using your trade secret)
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ENABLEMENT HYPO: • Hypo: kryptonite hits earth, no one can make it, can someone get a patent on process to liquify kryptonite to inject people giving them superpowers?
o
Patentable. There is a market for it, kryptonite is a natural rock.
• You don’t have to enable metal when you submit a bicycle patent.
o As long as someone skilled in art knew how to obtain a piece of starting material (metal, kryptonite) then you don’t have to enable it.
Enablement Hypo: how would you describe Cheeto’s you use in a claim? What if the recipe changed?
o
PTO doesn’t allow use of Trademarks within the scope of the claim UNLESS you control the TM. You must give a statement disclosing what the TM item is comprised of.
Janssen Pharmaceutica v. Teva Pharms (2009)
• Patent invalid
o Claims on dosages extremely broad, large.
• The narrower claims will be harder to invalidate.
• Enablement tries to stop overly broad claims, a narrow claim usually won’t create enablement problems.
o You can have a patent and method for using something even if you don’t understand how it works (Ex: Aspirin, mechanism behind wasn’t understood until 1990s).
o Human trials are not required, but in vitro testing may establish a practical utility for the pharm compound.
o In vitro test results for a claimed pharmaceutical compound combined with animal test results for a structurally similar compound, shows a reasonable correlation between the disclosed in vitro utility and an in vivo activity, therefore a rigorous correlation is not necessary where the disclosure of pharm activity is reasonable baed upon the probative evidence.
• “if a patent claim fails to meet utility requirement b/c it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement.”
o How does inventor get rid of enablement problem without adding new evidence once application already filed (stuck with what you have)?
• Narrow your claims so it isn’t so broad.
What are the Economics behind enablement:
• quality not size of disclosure that counts
• don’t want enablement standard to be too harsh b/c then firms may move to trade secret and the patent system wouldn’t work, nobody disclosing research
• patents help stimulate R&D investments (2 arguments):
o broad patent hurts b/c 2nd gen patent will be subject to first, discourages improvement
o broad patent gives incentive for additional investment (Kisch theory)
Enablement Test for Final Exam:
- ID nature and scope of relative claim (name of the game is the claim)
a. What does the claim say: broader scope of claim the more you need to show enablement - ID the specification disclosure informing POISA how to make and use invention
a. Does specification guide POISA tomake/use invention, if clear then good; if confusing then enablement probs - ID the state of the prior art, relevant art.
a. What kind of tech. – well developed? New field = disclose more b/c things are not known. If well developed field may disclose less.
b. Looking through eyes of POISA at time of filing - Combine the specifications disclosure with the state of art to determine if POISA would have to perform undue experimentation
a. (Go through WANDS factors) - 1) the quantity of expirimation necessary
a. Success rates (1% success rate may be very good in certin field) - 2) the amount of direction or guidance presented
- 3) the presence or absence of working examples
- 4) the nature of the invention
- 5) the state of the prior art
- 6) the relative skill of those in the art
a. a genius, a grad student, or Joe Public?
b. If genius POISA then you don’t have to disclose as much;
i. Opposite of what we want for “obviousness”
c. For enablement, want genius POISA to disclose less. - 7) the predictability or unpredictability of the art
- 8) the breadth of the claims.
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Similar to utility, enablement doesn’t come up all that often.
• If not enabled, not useful = no market for something that doesn’t work (nobody sues for something that doesn’t work)
• If it doesn’t work, nobody notices it, nobody will sue on it.
- In addition to utility, enablement, Written description and best mode are also things that do not come up that often
- Indefiniteness, prior art, obviousness = ways to invalidate.
WRITTEN DESCRIPTION comes up…
- Where patent applicant amends their specification (to add new distinctions to narrow their claims)
- If you claim too broadly
Drawings enough to provide support or written description claims.
•
Low bar
• Unlike utility and enablement rejections, we do se written desc rejections more likely during prosecution, less during litigation
• Must have written description support: You can’t narrow claims without support
o Ex: in written description – tried 5 mg and 2,000 mg; later on: 100-200 mg works best
Regents of Univ. of California v. Eli Lilly Co.
*No Patent, lack of valid written description;
method of creating insulin for rats, obtained patent for making human insulin
*you can have enabling disclosure that does not meet written description requirement.
o Inventor doesn’t give the info on human insulin, don’t know what it looks like or how it works.
• Distinction is important between enablement and WD.
• Everything here in this case is enabled, but issue is WD.
o Must define item with distinction, define precisely what is trying to be claimed.
Regents v. Eli Lilly: a generic statement without more is not an adequate written description of the genus b/c it does not distinguish the claimed genus from others, except by function.”
- Doesn’t define any genes in that distinction
* Doesn’t define precisely what is trying to be claimed.
WD Policy from Regents v. Eli Lilly• would the inventor been unduly rewarded had the patent been upheld? (they were first to find rat DNA and they want to broaden that)
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• Ask these questions to determine if inventor had possession of invention; WD overlaps quite a bit with enablement.
o Would POISA know which works by looking at the specification?
• Is WD sufficient to cover Velcro in fastener claim?
Ariad Pharm v. Eli Lilly
No Patent, lack of written description
broad genus claim, very broad claim
• D Wants 3 requirements: separate enablement, separate WD, and separate best mode.
o Court agrees with D^
• Key takeaways:
o 1) timing issue (lot of stuff in 1991 application, but not in 1989 application)
o 2) lot of things between enablement and WD that are linked.
• Stops things needing undue expireimation
o WD ensures when you claim by genus buy function or result you must have specific examples that accomplish that result or function
Policy from Ariad:
We don’t want to close off invention in entire field with overly broad patent claim, but we want to award inventor for what they disclose.
Ariad Dissent:
• Would give Ariad a patent on all 3 hypos in patent b/c it’s a good idea; and Eli Lilly would have their own patent on the specific ones they found (the improvement), but would have to license from Ariad.
o Downstream and upstream innovators benefit from the ability to cross license
o Dissent: Innovation wont be blocked if we give licenses to Ariad.
o We are trying to reward disclosure of ideas.
o Dissent: Under the new regime, mere improvement will likely invalidate the genus patents. (Is this true? Prof says • If species claim comes after the genus then it’s fine.
• If species claim comes before the genus claim then genus invalidated. )
• Blocking patent:
patent on something, somebody makes improvement on it, they can’t use their patent without a license from you (even though they get their own patent).
WD is a Q of Fact. Enablement is a Q of Law.
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PTO guidelines on WD to see if WD is met: • Level of skill in knowledge in the art • Any partial structures • Physical or chemical properties • Functional characteristics
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Definiteness; positive def and negative def
• quid pro qui:
o positive definition: inventor give us something and give us an exact term so we understand what we have
o negative definition: telling us what the invention isn’t; the metes and bounds of the invention. Allows competitors to design around the invention; or design something completely new.
Orthokinetics v. Safety Travel Chairs
• handicap travel chair to fit into car; issue of definiteness
• patent valid
I: o Claim uses language “so dimensioned” to describe fitting the wheelchair into cars,
The claim itself does not have to enable the invention, but the specification must be enabled (know how to make and use); then distinctly claim within the claim.
- Whether those skilled in the art (subjective standard) would understand what is claimed when the claim is read in light of the specification.
- IF POISA understands what it would be (how to make and use, enablement) then we are definite enough.
o “if the language is as precsise as the subject matter permits, the courts can demand no more.”
• What kind of deference does a patent get when litigating?
Presumed valid, so to kill it, invalidate it you must meet clear and convincing evidence.
• (preponderance is lowest; 2nd highest is clear and convincing; highest: beyond reasonable doubt).
Deference during “RE-EXAMINATION” (: go back into Article 1 court and try to figure out if the patent is good or not. )
• When thrown into re-exam: no longer considered a patent, considered an application again and given NO DEFERENCE; No Clear and Convincing Evidence; Evidentiary standard much lower for Def compared to litigation.
o What technologies do we look for to take to re-exam versus litigation?
- If difficult technology: go re-exam (not litigation)
* Def controls choice to go to re-exam, even if P doesn’t want to
Advantages of Re-exam v. litigation
o ADVANTAGE #1:
• Def gets to talk to PTO too, better than litigation.
• You take side of examiner too b/c you can talk to examiner.
o ADVANTAGE #2:
• When thrown into re-exam: no longer considered a patent, considered an application again (given no deference)
o ADVANTAGE #3 OF REXAM V LITIGATION:
• Examiner is expert and is present for rexam, judge and juries are not experts in litigation
Nautilus v. Biosig June 2014 Supreme Court case
• Issue: Spacing for heart rate monitor (issue of definiteness with spacing): (like on a treadmill)
we are pulling back from insolubly ambiguous standard (low bar, easy for inventor).
o Supreme Ct - New standard/Rule w 3 parts:
• 1) Look at from POISA view
• 2) At the time the application was filed
• 3) Look at that standard from view of if the specification viewed through the lens of POISA at time of filing is enough to be definite.
o Supreme Court: here (spacing of heart monitor): NO, 112 (2nd) doesn’t tolerate that much ambiguity.
• Supreme Court New Rule: more exacting; better but harder to apply.
• POLICY ISSUES (why new Nautilus Rule versus insolubly ambiguous
o One one hand new tech so unsure of boundaries, but other hand want clear notice to competitors to know boundaries of invention
o SCOTUS: Want to stop gamesmanship; if standard is low, incentive to be very ambiguous. Competitors are forced to stay away or license – no matter what the innovator wins.
• SCOTUS: Don’t want zone of uncertainty to be large, want it small
• SCOTUS: 112 requires clear and concise language
o Who is lowest cost provider for definiteness: the inventor, the person drafting the patent.
• Competitor costs: high to det. Metes and bounds of invention
• Judge and juries: cost much higher than inventor draft patent
• Thus the burden of defitness is on the shoulders of the inventor.
112 (2nd) is a question of law (not a Q of fact).
• In reality it’s a mix of law and fact, although technically Q of law.
Standard Oil, p. 321
• Acrhylomide manufacturing process
• “Partially soluble” is term at issue here.
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o Prosecution history estoppel:
inventor is stuck with the term and stuck with the way the Examiner interpreted term.
Rationale for Definiteness standard:
• Know boundaries of claim.
• New matter is big issue: don’t add stuff to specification that will be considered new matter b/c if you do can get a new matter rejection.
o Don’t see all too often with def standard; unless you are trying to broaden the claim.
Energizer holdings Case: • Issue: don’t know what “said zinc anode” in claim is talking about.
o Antecedent basis (“said”): go back to the magic word
• Problem comes when you have 2 different types of magic words, don’t know which antecedent basis it refers to.
• Have “a” and “said” and make sure they match up.
• Nautilus Standard: POISA at time of filing – you’re okay.
Specification is what enables, but WD and Def. apply to claims.
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Definitiveness analysis:
• (1) think pre litigation (during prosecution) and (2) during or post litigation;
• before litigation we want to know the boundaries of patent;
o when under prosecution, not a patent yet, so let in declaration evidence, extrinsic evidence, let in what the applicant thinks, textbooks, journal articles, etc.
• Post patent prosecution: should not allow in outside extrinsic evidence; hindsight biased, they will narrow claim the way they want; don’t want inventor to have gamesmanship involved.
Definiteness test:
- draft claim with sufficient precisiosn to clearly set forth invention when read by POisa
- claim must be commensurate with subj matter with inventor’s claim with subj matter at time of filing
2 types of special cases with definiteness:
software patents: o don’t need code to explain what control mean does but need something like an algorithm, more than just general purpose microprocessor.
112(6) or 112f: means plus function claim
• A special way to allow applicants to cover function, giving only some structure.
- limited to claims in specification
Perspective for definitiveness:
- POISA: Under Nautilis: looking under lens of person skilled in the art to understand metes and bounds of invention.
- Can look to the technology in the field at the time to help clarify definiteness.
- Extrinsic evidence allowed during prosecution b/c we want metes and bounds defined.
- Just b/c you’re enabled doesn’t mean you’re definitite
- Enablement: specs
- Definiteness: claims