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10. Elements of Patentability
MML 233-275; 35 U.S.C. §§ 101, 112
Elements of Patentability 1) Novelty 2) Non-obviousness 3) Utility: specific and substantial 4) Disclosure: (i) enablement; (ii) written description; (iii) best mode 5) Subject Matter 3) Utility
- Statutory Basis for utility requirement
§ 101 "Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor…"
o S. 112(a) [see disclosure]
1) Operability: Does it do what it claims to do?
o It works (i.e. Newman and perpetual motion machine)
o If it does not operate to produce the results claimed by the patent applicant, it is not a 'useful'
2) Beneficial Utility: Does it produce some social benefit (or at least no social harm)?
o Immoral invention: patent denied for inventions that could be used only to defraud
Would not use patent law to regulate immoral behaviour
Getting a patent is not giving someone's right to do something, but right to exclude other people form doing that
E.g. getting a patent on ban consumer deception doesn't mean you have the right to do it only a right to stop others form copying their design
Illegality is different form immorality: e.g. if the use is illegal, patent would be declined [but people would not apply/ sue on patent that is illegal in some areas, as that would attract unwanted attention]
o Juicy Whip v. Orange Bang (Fed. Cir. 1999)
Facts: Juice dispensing system that only appear to circulate fresh juice, but actually circulate an undrinkable liquid, while the tanks hidden underneath the glass bowl display dispensed the actual justice (inventor claimed this arrangement reduce maintenance costs and avoid contamination)
Held: Patentable substantial, operational, beneficial utility
No basis in s.101 to hold that inventions can be ruled unpatentable for lack of utility simply because they have the capacity to fool the public
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, e.g. imitation gold leaf, synthetic fabrics, imitation leather all designed to look like the real thing
PTO/ courts are not arbiters of deceptive trade practices beneficial utility is forcing patent officers to do what they are not capable of doing
1 Patent 3) Practical or Specific Utility: is the utility identified by the inventor a 'substantial' and 'specific'
utility? (Brenner, Fisher)
o Specific: "provide a well-defined and particular benefit to the public
A statement that a composition has an unspecified "biological activity" that may be useful in treating unspecified disorders,
A process or a product, which has no known use or is only useful as an object of scientific research is not eligible for patent because it is not "useful."
Something that the invention is uniquely specialized to do, rather then something that lots of other things will do equally well -no throwaway or generic uses
Federal Circuit does not categorically rule out research tools as patentably useful matter
Substantial: show that the claimed invention has a significant and presently available benefit to the public, not that it may prove useful at some future date after further research.
Utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities.
Incentive: if no patent protection, people may be reluctant to create a process
Trade secret: companies may protect inventions as trade secrets to hide it form the public if they know they will not get a patent. This will lead to duplicative research.
o Windfall: Patentee patents something which may cover later useful invention don't want the patentee to gets the reward
Waste resources on PTO that can be better spent on useful patent applications o
oPatent is not a hunting license: granting patent may discourage others to research on downstream development, higher standard of utility forces people to narrow their claims +
test of utility will delay patentability, pushing it further downstream
Better to leave things in public domain (Fortis).
[counter: someone who gets a patent will be incentivized to find a concrete use as soon as possible to make money]
Boundary: utility test allows us to know the boundary of the claim (Brenner)
Brenner v. Manson (Supreme Court 1966):
o Facts: Patent Office rejected P's patent application for failing "to disclose any utility for" the chemical compound produced by the process. P argued that that steroids of a class which included the compound his product produced were undergoing screening for possibly reducing tumors in mice, and that a homologue close to his steroid had proven effective in doing so.
November 1956: Ringold and others publish an article revealing that a number of compounds, including the steroid at issue, were being tested for tumor-inhibiting effects. The article also shows that a compound closely related to the relevant steroid was effective in inhibiting tumors.
December 17, 1956: Ringold and Rosenkranz file a patent application seeking a patent on the new process for making the known steroid.
October 13, 1959: Ringold and Rosenkranz receive a patent on the process.
January 1960: Manson files a patent application for the same process
Held: Not patentable
P did not disclose a sufficient likelihood that the steroid yielded by his process would have similar tumor-inhibiting characteristics 2 Patent
Patentee didn't find the use of the steroid if later someone else find a use of the steroid (but nth to do with inhibiting a tumor) patentee would get a windfall
If patent claim is not relevant to its use it would cover all its uses
"Until the process claim has been reduced to production of a product shown to be useful the metes and bounds of that monopoly are not capable of precise delineation" If you don't have a use, no clear boundary of the claim
Prof: but utility doesn't determine the boundary of a claim, court is worried patentee would get a windfall/bonus from what they did not do
Patent is not a hunting license: only patent license when you successfully complete the hunt - it is not a reward for the research, but compensation for its successful conclusion
Could file a patent application, but if you are not there yet, keep working
Not that it cannot get a patent, but it is not ready yet but waiting is worrying for them as others would get there before them/ steal their idea
Duplicate research without disclosure
Research tools are likely to have utility concerns, as they are used to generate other things would prohibit downstream research
Counter: need to encourage others to invent such research tools
Brenner applied for patent then Manson later applied. Two competing claims on the same process, PTO decide whether it is patentable and who should get the patent
Manson tries to freeride the previous
Narrow definition of useful: frivolous and in-significant
Broad definition of useful: not positively harmful to society rejected
A process patent in the chemical field, which has not been developed and pointed to the degree of specific utility, creates a monopoly of knowledge which should be granted only if clearly commanded by the statute
Reject the narrow definition of 'useful'
To encourage one chemist/ research facility to invent and disseminate new processes and products may be vital to progress, although the product or process be without
'utility' as the Court defines the term, because the discovery permits someone else to take a further but perhaps less difficult step leading to a commercially useful item
Cases following Brenner state that a claimed invention must have a specific and substantial utility that is credible Substantial utility standard requires proof that an invention:
serves some practical purpose
not generally promising/ promising enough to pursue further
presently available benefit to the public
What counts as useful?
o [No] Project initiation: pure concept stage
[No] Promising experimental results: Brenner v Manson
[despite decent chance if it proceeds to clinical result]
---------------------------------------------------------------------------------o [Yes] Promising Clinical Results, e.g. in virtro - in re Brana
In virtro = (of a process) performed or taking place in a test tube, culture dish, or elsewhere outside a living organism.
o [Yes] Working model or prototype; in vivo effectiveness
In vivo = (of a process) performed or taking place in a living organism.
3 PatentDifferent treatment between experimental results and clinical result
Certain things are so important that we cannot over protect them worry that it would affect downstream research
Following innovation of an invention may goes into different fieldsIn re Fisher (US Court of Appeals Federal Circuit) (2005)
o Facts: P applied patent for an EST (Expressed sequence tag) relating to 5 purified nucleic acid sequences that encode proteins and protein fragments in maize plants. P did not know the precise structure or function of the gene and protein encoded for, P argue there are 7 uses.
Cannot predict what protein this EST would make, cannot use it to treat disease, don't know enough about what this sequence does but there are other uses: e.g.
molecular marker Whether enough for utility?
o Held: Not patentable, utility must be specific and substantial
P's alleged uses are so general as to be meaningless - applicable to every EST
gov asserts that the same generic uses could apply not only to the five claimed ESTs but also to any EST derived from any organism.
Any specific utility would be substantial (except for throwaway utility)
o E.g. putting red spider into a bag with chemical and see if the chemical kills the spider
Substantial utility [0: 40]
P admits that the underlying genes have no known functions
Claimed ESTs are objects of use-testing: objects upon which scientific research could be performed with no assurance that anything useful will be discovered in the end
Prof: why did the court not address whether it is marketable (if there is a market, it is useful)
o wanted to be further developed/ not to cut off downstream innovation
since utility is measured at the moment of patent application
difficult to know the marketability at the time of application (would not be on the market yet)
Claimed ESTs themselves are not an end of Fisher's research effort, but only tools to be used along the way in the search for a practical utility
ESTs are useful, but patenting it may lock up things far more useful but not discovered yet court concern about downstream research
Counter: people would hide their research from others duplicate researches - only one get patent
Operability: Does it do what it claims to do?
o Beneficial Utility: Does it produce some social benefit (or at least no social harm)?
o Practical or Specific Utility: Is the utility identified by the inventor a 'substantial' and
What counts as utility
A reasonable correlation between the evidence and the asserted utility is sufficient
Data from in vitro or animal testing is generally sufficient to support therapeutic utility.
Office personnel should not impose on applicants the unnecessary burden of providing evidence from human clinical trials.-
4 PatentWhat does not count as utility
Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved.
o A method of treating an unspecified disease or condition.
o A method of assaying for or identifying a material that itself has no "specific and/or substantial utility"
o A method of making a material that itself has no specific, substantial and credible utility.
o A claim to an intermediate product for use in making a product that has no utility.
o No throwaway/ generic utilities
4) Disclosure P.247
- Inherent Tension of Disclosure:
o Restricting patentee's right to that which the patentee actually invented permitting competitors to invent around the patentee's invention
In exchange for gov grant, inventor must disclose the workings of the invention in enough detail to be informative to other people working in the same field
Sufficiency of the patentee's disclosure and its relationship to the claims of a patent
1. Injects info into public domain to be used after patent expires
2. Disclose after 18 months of patent filing (before patent expires)
Inject info right away allow competitors to
invent around a patent (another way to do the same thing)
stimulate further innovation (blocking patents)
o E.g. chair rocking chair: patentee of rocking chair cannot make use without permission of patentee of chair; and patentee of chair cannot make rocking chair without patentee of rocking chair's permission need to license
inspire other inventions in other areas
e.g. nylon led to development of synthetic materials
3. Public to know boundary of the patent
4. Reduce duplicate effort/ wasting resources
5. Prevent others from keeping the invention secret, as economic growth is caused by companies' disclosures
Companies would need to license info from each other, difficult ad for newcomers
(who have nothing to bargain against)
- Example of disclosure
Cheese slicer specification's claim elements
Rotating handle at end of bar
Cutting element attached to bar
Base, with passageway
5 PatentContemporary patent disclosure requirements s.112
§ 112(a) "The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention."
o (b)-(f) deal with how patents are claimed (and not adequacy of disclosure)
3 requirements on disclosure:
1. Written description (of the invention)
2. Enablement (enable any person skilled in the art to make and use the same)
3. Best mode (of carrying out the invention)
Example for baking a cake
1. Written description type of cake Black Forest
2. Enablement recipe/ ingredients Step 1, 2, 3
3. Best mode preferred oven temperature 350F
- In re Wands (1988) P.263 Undue Experimentation Standards
Facts: Patent was refused by PTO applicant appeal
Only 4 out of 143 (2.8%) hybridomas were proved to fall within the claims low rate of demonstrated success suggest appellants' methods were not predictable/
Enablement is tested by asking whether the person having ordinary skill in the art would be able to make and use all the species covered by the patent without 'undue experimentation'
Someone skilled in the art (not just anyone) would not be able to produce these antibodies with any degree of certainty a person skilled in the art would have to engage in undue experiment to make antibodies in the claim
Patentee need not disclose so much info so others gets the result after a few times of experiment but not undue experiment/ shouldn't be too hard to do so
If need to do a lot of test to produce the antibody applicant could only produce a small fraction no enablement o
How much information do patentee has to give:
(1) quantity of experimentation necessary
The more other people has to do, the less likely it was enabled
(2) amount of direction or guidance presented
(3) presence or absence of working examples
Claim is invalid if there is a significant no. of inoperative combination,
forcing one of ordinary skill in the art to experiment unduly to practice the claimed invention
(4) nature of invention 6 Patent
(5) state of the prior art
(6) relative skill of those in the art
Difficult + time-consuming experiment doesn't necessarily mean it is undue
(7) predictability or unpredictability of the art
If an invention pertains to an art where the results are predictable a broad claim can be enabled by disclosure of a single embodiment. Spectra-Physics
Inc v Coherent Inc
(8) breadth of the claims
the broader the claims are, the more suspicious (Fisher)
O'Reilly v Morse (Supreme Court 1853) Telegraph
Ways in which the patentees draft patent claims to maximise patent scope and the balance underlying patent law's disclosure requirements
Facts: Morse invented an instrument for an electro-magnetic telegraph, arranged and noted down a system of signs composed of a combination of dots and spaces which were to represent figures, and these were to indicate words to be found in a telegraphic dictionary.
o Morse made 8 claims: invention and improvement of
(1) [Patentable] making use of the motive power of magnetism as means of operating or giving motion to machinery, which may be used to import signals upon paper/
other suitable material or to produce sound…
(3) [Patentable] the combination of machinery… constituting one apparatus of telegraphic machinery…
(5) [Patentable] the system of signs, consisting of dots, spaces… substantially illustrated for telegraphic purposes…
(8) [Not patentable] Morse claimed to be the first inventor to "the use of the motive power of the electric or galvanic current, which I call electro-magnetism, however developed, for making or printing intelligible characters, letters or signs, at any distances, being a new application of that power."
o Held: Claim (8) is not patentable - it is too broad comparing to what Morse actually did
Morse did not confine his claim to the machinery or parts of machinery which he specifies, but claims a monopoly in its use
It is possible that some future inventor may discover a mode of writing/ printing at a distance by means of the electric/ galvanic current, without using any part of the process/ combination set forth in P's specification
if the later patent is covered by this patent, the inventor cannot use it, nor the public have the benefit of it, without permission of this patentee o
Neilson v Harford (1829) (English case)
Neilson described his invention as for the improved application of air to produce heat in fires, forges, and furnaces where a blowing apparatus is required
Description was too general: patent for throwing hot air into furnace instead of cold,
and thereby increasing the intensity of the heat = patent for a principle not patentable
Under modern enablement law
Morse could argue that the enablement determination proceeds as of the effective filing date of the patent' hence his (8) claim is valid based on the primitive state of electromagnetism technology when he filed his application 7
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