Answer ... In the United States, patents are filed with, and prosecuted before, the US Patent and Trademark Office (USPTO).
Answer ... The United States has a patent examination system, as opposed to a registration system. Applicants seeking a patent (utility, design or plant) file an application requesting examination by the USPTO. Except for provisional applications, for which only a filing fee is required, each application for a patent requires payment of a basic filing application fee, plus the appropriate search and examination fees and an issue fee. Additional claim fees are also due based on the number of claims presented (more than three independent claims and more than 20 total claims) and whether multiple dependent claims are presented. Up-to-date information on filing fees may be found at www.uspto.gov/learning-and-resources/fees-and-payment/uspto-fee-schedule. If the applicant qualifies as a small entity (37 CFR § 1.27) or micro entity (37 CFR § 1.29), any fees are subject to reduction as set forth in the USPTO fee schedule.
Answer ... The USPTO may reject utility patent application claims for:
- failing to meet utility requirements or recite patentable subject matter (35 USC § 101);
- being anticipated by the prior art (or lacking novelty) (35 USC § 102);
- being obvious in view of the prior art (or lacking inventiveness) (35 USC § 103); or
- failing to meet the written description support, enablement and definiteness requirements (35 USC § 112).
The USPTO can also reject an application for failure to disclose the best mode (35 USC § 112), although this is no longer a basis on which any claim may be cancelled or held invalid or otherwise unenforceable in patent validity or infringement proceedings.
In addition to these statutory grounds, a patent application can be rejected on double patenting grounds. There are generally two types of double patenting rejections. One is a ‘same invention’ type double patenting rejection based on 35 USC § 101, where the USPTO can reject a claim that is identical to a claim in a previously issued patent or pending application. The second is a ‘non-statutory-type’ double patenting (ODP) rejection, where the USPTO can reject a claim that, while not identical, is also not patentably distinguishable from a claim in a previously issued patent or pending application. ODP is a judicially created doctrine that “is designed to prevent an inventor from securing a second, later expiring patent for the same invention” (AbbVie Inc v Mathilda & Terence Kennedy Inst of Rheumatology Tr, 764 F3d 1366, 1373 (Fed Cir 2014)). An ODP rejection can be overcome by filing a terminal disclaimer. For double patenting to apply, the patents or applications identified in the rejection must have at least one common inventor or common applicant, and/or be commonly assigned or owned, or non-commonly assigned or owned but subject to a joint research agreement.
Answer ... The USPTO takes part in the Patent Prosecution Highway programme, whereby an applicant may request fast-track examination of US claims corresponding to claims allowed by a participating patent office in another country.
Other ways to accelerate or fast track examination patent applications include:
- a petition to make special;
- the Accelerated Examination programme; and
- the Prioritised Examination (Track 1) programme.
A ‘petition to make special’ may be filed at any time during the pendency of a patent application in order to have the application examined sooner than a regular filed patent application. The goal of the USPTO is to examine and reach a final disposition (ie, allowance, final rejection or abandonment) of a patent application made special within one year of filing. Petitions based on the following grounds may be made without a fee:
- the age of the inventor (65 or older);
- the inventor’s failing health; or
- inventions associated with environmental protection, energy conservation, superconductive materials or counterterrorism.
Other applications can be subject to a petition to make special upon payment of a fee, including the following:
- The invention relates to DNA research, diagnosis, treatment or prevention of HIV, AIDS or cancer;
- The applicant has a prospective manufacturer that is prepared to begin manufacturing the invention, but will not manufacture unless it is certain that a patent will be granted;
- There is an infringing device or product on the market; or
- A small entity is filing a biotechnology application.
The Accelerated Examination programme allows for the examination of a patent application in an expedited manner and provides for a final disposition (ie, allowance, final rejection or abandonment) of a patent application within 12 months of the filing date of the patent application. To qualify for the Accelerated Examination programme, a patent applicant must file:
- a petition;
- the petition fee;
- a pre‑examination search document; and
- an accelerated examination support document.
There is a limit of three independent claims and 20 total claims in an Accelerated Examination programme application.
The Prioritized Examination (Track 1) programme allows for a patent applicant to reach final disposition (ie, allowance, final rejection or abandonment) of a patent application within 12 months of the filing date of the patent application. To qualify for this programme, a patent applicant must file:
- a petition;
- the petition fee at the time of filing the patent application;
- the USPTO publication fee; and
- the other publication processing fee.
There is a limit of four independent claims and 30 total claims in a Prioritized Examination programme application. One of the benefits of the Prioritized Examination programme versus the Accelerated Examination programme is that the former does not require a pre-examination search document or an accelerated examination support document.
Answer ... In the United States, applicants may claim any new and useful process, machine, manufacture or composition of matter (35 USC § 101). Claim formats may also include product-by-process claims, means-plus-function claims and improvement or Jepson-type claims. For pharmaceutical or medical inventions, methods of treatment claims are typically used in the United States, as Swiss-type claims are not permitted.
With regard to claim substance, as discussed in more detail in question 3.7, inventions directed to scientific theories, mathematical methods, business methods and mental acts are patent ineligible. In addition, no patent may issue on a claim directed to or encompassing a human organism (America Invents Act, § 33). Section 33 applies to any application that is pending on, or filed on or after, 16 September 2011.
Answer ... The USPTO automatically calculates and awards patent term adjustment (35 USC § 154(b)) to compensate for delays in examination. If the patentee disagrees with the USPTO’s calculation, it may request correction of the term. The additional patent term granted is printed on the patent or certificate of correction, as appropriate.
For pharmaceuticals and medical devices, US law (35 USC § 156) provides for a patent term extension (PTE) for a patent which claims a product, a method of using a product or a method of manufacturing a product that has been subject to pre-market regulatory review before it is approved for commercial marketing in the United States. PTE extends the patent term to compensate for commercialisation delays due to regulatory review. However, only one patent may be extended for the same regulatory review period for any product. Products potentially eligible for PTE include:
- new drugs, antibiotic drugs and human biological products;
- new animal drugs or veterinary biological products which are not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology or other processes involving site-specific genetic manipulation techniques; and
- any medical device, food additive or colour additive subject to regulation under the Federal Food, Drug and Cosmetic Act.
Answer ... To qualify as patentable subject matter under US law (35 USC § 101), an invention must satisfy two criteria: one statutory, one judicial. First, the subject matter of the invention must fall into the category of a process, machine, manufacture or composition of matter. Second, that subject matter cannot fall within a patent-ineligible exception recognised by the courts – namely, laws of nature, physical phenomena and abstract ideas.
Answer ... Final rejections from an examiner may be appealed to the Patent Trial and Appeal Board (PTAB). A decision from the PTAB may be appealed to the US Court of Appeals for the Federal Circuit. The decision from the Federal Circuit may in turn be appealed to the US Supreme Court.
Instead of appealing to the Federal Circuit, an applicant dissatisfied with a decision of the PTAB regarding a final rejection from an examiner may also file a civil action within 60 days of the PTAB’s decision in the US District Court for the Eastern District of Virginia (35 USC § 145).