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University of Florida School of Law
Rowe, Elizabeth A.

Patent Law Rowe

Fall 2017

35 U.S.C. § 101. Inventions patentable

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, subject to the conditions and requirements of this title.

35 U.S.C. § 102. Conditions for patentability; novelty and loss of right to patent

A person shall be entitled to a patent unless—

[(a) Enablement]

(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or

(c) he has abandoned the invention, or

(d) the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than twelve months before the filing of the application in the United States, or

[(e) Anticipation]

(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or

[(f) Derivation from Another]

(f) he did not himself invent the subject matter sought to be patented, or

[(g) Priority of Invention]

(g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person’s invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person’s invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

35 U.S.C. § 103. Conditions for patentability; non-obvious subject matter

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

35 U.S.C. § 112. Specification

(P1) 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 of carrying out his invention.

(P2) The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

(P3) A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form.

(P4) Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

(P5) A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.

(P6) An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

Introduction and Overview

The Patent Document

(1) INID Codes

“Internationally agreed Numbers for the Identification of bibliographic data”
Identify information contained on the first page of a patent

(2) U.S. Patent Number

Top right corner of the first page
Usually refer to patents by the last three digits of the patent number (total 7)

i.e. ‘473 patent

(3) Issue Date

Directly below the patent number
Patent term commences on the date that the patent issues
Prior to June 8, 1995 patent rights terminated 17 years after the date of issue
After June 8, 1995 patents generally end 20 years from the date of filing

(4) Title of the Invention

Should be merely descriptive and should not got to the substance of the invention

(5) Inventor and Assignee Information

For purposes of the Patent Act, only individuals invent, not corporations
Inventor can assign (corporations) the rights to their inventions

(6) Application Information

Application serial number and filing date

(7) Domestic and International Classifications
(8) Field of Search, References Cited and Other Information of Prosecution

The core of the application process or “prosecution” is the examiner’s search of the existing technology and the comparison of that prior art to the applicant’s claimed invention.

(9) Abstract

Brief summary of the technical disclosure in the patent.

(10) Drawing(s)

The Patent Act requires the applicant to submit one or more drawings “where necessary for the understanding of the subject matter sought to be patented.” 35 U.S.C § 113.

(11) Specification

Three requirements comprise the basic disclosure that entitles the inventor to the patent: written description, enablement and best mode requirements
Disclosure requirements must be satisfied at the time of the filing; thereafter, the specification cannot be amended to add any “new matter” that would be necessary to fulfill the statutorily required disclosure

(12) Claims

In litigation, the only thing that matters is the claims
The function of the claims is only to define the precise scope of the intellectual property rights that are warranted by the disclosure made earlier in the specification.
Claims are often modified extensively during prosecution of the application.
To infringe on a process claim you must follow the steps exactly and in the same order, that’s why they are harder to prove

Rationales for Patent Law

Provides incentives to engage in desirable behavior
Encourage the disclosure of information

The Patent Law Quid Pro Quo: In exchange for patent (20 yr. monopoly), inventor must disclose the invention to the public so that after the 20 years, it is in the public domain

Stimulate technological advancement
Serve as a facilitator of markets
Ingredients aren’t in patents because those are trade secrets

Patentable Subject Matter

Composition of Matter
Article of Manufacture

Types of Claims

Product—often set up in terms of structural elements

The strongest/most robust for litigation

Process—a series of steps/acts performed

Method of using
Method of making

New Use of Known Product—discovered a new way to use an existing patent
Newly Discovered Property of Known Product
Product by Process— “the product prepared by the process of…”

Patent Term

If filed after June 8, 1995 à 20 years from date patent application was filed
If filed before June 8, 1995 à 17 years after issuance or 20 years from filing, whichever is later
This is irrelevant today because all of them have expired*
There may be special circumstances where you could petition for more time (i.e. 10 years bopping around in the PTO)

Scope of Patent Protection

Unlike almost every other country, the U.S. policy is to award the patent to the first to invent, rather than the first to file.
18 months after you file, your application becomes public
What are your options if a patent infringement law suit is brought against you?

(1) attack validity of the patent and/or
(2) defendant against the infringement

U.S. patent only provides protection in the U.S.
Need to apply for and achieve patent in every country you wish to be protected in
Patent Cooperation Treaty (PCT)= gives benefit of filing date for all member countries but doesn’t guarantee protection

Patent System Overview

Administrative agency: PTO
Reviewing courts: District Courts, Federal Circuit, U.S. Supreme Court
Patent Prosecution Appeals

PTO Examiner à PTAB à DC for D.C. à Fed. Cir. à SCOTUS
Court affords deference to the agency’s decision—PTO decisions are reviewed for “clear and convincing error”

Patent Litigation (infringement) Appeals

D.C. à Fed. Cir. à SCOTUS
“presumption of validity” = the party challenging validity bears the burden of proof and the courts should afford some


AIA section 33(a)—codified the PTO’s stance

“Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.”
Effective immediately. Applies retroactively to existing applications

Current status: Still don’t know exactly what “encompassing” or “embracing” means. How much “human” is “too human” to be patentable?

Still trying to interpret “anything under the sun made by man”
Examples of bounds:

Cow that produces milk: patentable
Mouse that produces insulin: patentable
Harvard Oncomouse (entire mouse created entirely in the lab): patentable
Mammals w/human parts: patentable—this is where we are and it seems patentable
Stem cells: patentable

Medical Procedures

Why not patent medical procedures?

(1) Chilling effect on traditions within the medical profession that promote the open exchange of information and ideas.
(2) Medical procedures do not require patent protection.
(3) Patents will drive up the costs of care.
(4) Patents are subject to abuse.
(5) Patents impair the quality of care and endanger human life.

Morton v. New York Eye Infirmary (1862)

Struck down patent on using ether to anesthetize patients during dental surgery

Product of nature and lacked novelty (well-known substance with well-known properties)

View that ways of treating patients shouldn’t be patented

Ex Parte Scherer (1954)

Allowed method of injecting medicaments by pressure jet
View that you can have this patent, but you won’t actually use it to sue anybody

Pallin v. Singer (D. Vt. 1995)

Facts: Patent on performing cataract surgeries. Patent holder sued thousands of eye surgeons practicing the surgical method. Brought forward issue of patents on medical ethics, patient care, medical autonomy, and the propriety of granting these.

Lost on § 102 and § 103 grounds, § 101 wasn’t raised
Congress took action to avoid suits like this with 35 U.S.C. § 287(c)

35 USC § 287(c) – deprives patentees of all remedies (both monetary and injunctive) against medical practitioners engaged in infringing “medical activities”

Allows patent but no remedy UNLESS

The infringer’s activity also infringes an unexpired patent for a medical device, medical instrument, or a drug

Significantly limits the remedies available for infringement of medical procedure patents

Natural Products and Substances

Must make a significant change to a thing of nature for it to be patentable

Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

Facts: Myriad discovered location of BRCA1 and 2. Sells tests for mutations on genes. Have DNA (naturally occurring—can be isolated) and cDNA (non-naturally occurring needs modification to create)
Issue: Are human genes patentable?
USPTO: Yes, patentable. DNA sequences are patentable when isolated & purified. Focus on transformation to get them isolated
DC: Not patentable. DNA is the physical embodiment of the laws of nature. To be patentable would need something “markedly different”—a change that results in the creation of a fundamentally new product.
Fed. Cir.: Yes patentable. To isolate the gene, must separate from bonded materials. So the resulting isolated DNA is not a natural material but a new chemical entity
SC: Accept Cert then remand in light of Mayo
Fed. Cir.: Affirmed. Held yes patentable

DNA (naturally occurring) NOT patentable

Naturally occurring, unchanged, only isolated
Not modified/changed/transformed enough for § 101
Did not “create or alter any of the genetic information encoded in the genes or otherwise engage in an act of invention”
Recognize the importance/effort of the discovery but: “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry”

Phenomena of nature not patentable because discovered (Mayo)

cDNA YES patentable

Unquestionably creates something new
Not a product of nature

Leaves open: Method for isolating DNA, applications of BRCA genes, altered DNA

Would require significant change/alteration