Ten years after President Obama signed the America Invents Act (AIA) to modernise the US patent system, Robert J. Roby, partner, Knobbe Martens, discusses the impact the AIA has had on prospective and existing innovations in the medical plastics and medical devices industries.
When the Leahy-Smith America Invents Act (AIA) was enacted on September 16, 2011, it was proclaimed to be one of the most significant changes to the US patent system since the Patent Act of 1952. Most widely discussed at the time of enactment was the change of the US patent system from a ‘first to invent’ system to a ‘first inventor to file’ system — a change that sought to better align the US patent system with most other countries. Enacted in 2011, the change to ‘first inventor to file’ did not take effect until March 16, 2013.
As with the changes resulting from the signing into law of the General Agreement on Tariffs and Trade (GATT) on December 8, 1994, the AIA resulted in a crush of patent filings just prior to the March 16, 2013, effective date, which affected priority rules and certain bases for prior art rejection. The bulk of these filings were a result of applicants trying to remain in the pre-AIA regime, which allowed inventors to rely upon inventive activities to remove certain prior art references and which also were not subject to certain post-grant validity challenges at the Patent Office. By and large, however, most applicants in the medical plastics and medical devices industries already focussed upon being the first inventor to file. Moreover, many of the new forms of prior art in the US could affect foreign applications; applicants were careful in filing before such events could be used against them. Accordingly, the changes that transformed the US patent system to the ‘first inventor to file’ system had limited impact in the medical plastics and the medical devices industries.
Practical changes
In contrast, one of the more practical changes facilitated by the AIA has wide ranging impacts on the medical plastics and medical devices industries: Track One or Prioritised Examination. The ecosystem of the medical plastics and medical devices industries includes companies ranging from start-up ventures to multinational corporations and Track One or Prioritised Examination has something for everyone.
The AIA provided for the establishment of a program to allow the expedited examination of patent applications. The US Patent Office interchangeably calls this program “Track One” and “Prioritised Examination.” Entry into Prioritised Examination simply requires a certification and request for prioritised examination, the filing of the oath or declaration by the inventors or an Application Data Sheet (ADS) with the application, and payment of the applicable fees, including a special fee of $4200 ($2100 for a small entity and $1050 for a micro entity).
Regarding application preparation, prioritised examination also limits an applicant to four independent claims and up to 30 total claims. Because it is intended to speed initial examination, receipt of a ‘final’ office action from the Patent Office terminates the expedited program, but the applicant is free to opt back into the program when filing a Request for Continued Examination if all requirements for the program are met. Although there is a limit to the number of Prioritised Examination requests allowed in any given year, effective September 24, 2021, the Patent Office increased the maximum annual number of Prioritised Examination requests it would accept from 12,000 to 15,000.
Pendency
The practical effect of Prioritised Examination is that the program allows a patent applicant to get a final disposition (that is, an allowance or a final rejection) within about 12 months. According to the US Patent Office’s most recent data for non-prioritised cases, the US Patent Office currently has a pendency of 16.8 months before the issuance of a first office action and a traditional total pendency of 23.2 months.
Conversely, Prioritised Examination applications are, on average, pending for merely 1.4 months between grant of a petition for Prioritised Examination and receipt of a first Office Action. Under Prioritised Examination, average total pendency from grant of the petition to final disposal is 5.6 months, and average total pendency from petition grant to allowance is 4.4 months.
Currently, the Prioritised Examination application pendency from filing to petition grant is 1.4 months. Thus, a Prioritised Examination application can expect a first action on the merits in about 2.8 months and a final disposition in about 7 months, which is significantly quicker than the traditional route.
Allowance rate
Another significant advantage of Prioritised Examination is the allowance rate. During the past 12 months, 7,245 applications were allowed, and 6,561 applications were finally rejected, abandoned, or had rejections appealed. Thus, the rate of allowance exceeds 50% for prioritised examination applications, whereas the general population rate of allowance is lower.
Speed to allowance is crucial for at least two distinct scenarios:
- a start-up company attempting to demonstrate defensible intellectual property while seeking funding
- any company facing a competitive threat to the bottom line.
Through focussed use of the Prioritised Examination program, companies can better address both issues. For example, filing on the core features of a start-up company’s technology can quickly yield one or more patents that can comfort would-be investors that the technology is not only addressing a marketplace demand, but also doing so in a patentable way. In addition, as competitors begin to pop up in the marketplace, patent claims that are supported by a pending application can be quickly obtained and used to address those competitive challenges. In fact, the Kenan Institute of Private Enterprise found just last year that small firms with limited patent portfolios are the most likely to expedite their patent applications and that accelerated patents are cited and litigated at higher rates than other patents. For this reason, while much of the press has been focussed upon the change to first inventor-to-file and the post-grant proceedings before the Patent Trial and Appeal Board, the change that has had the most impact on the US patent system under the AIA just may have been the creation of the prioritised examination program.