REGULATORY UPDATE
TEN YEARS AFTER PRESIDENT OBAMA SIGNED THE AMERICA INVENTS ACT (AIA) TO MODERNIZE 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 DEVICE INDUSTRIES.
Prioritized examination — PATENTLY LEAR?
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hen 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 device industries already focused 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
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to the ‘first inventor to file’ system had limited impact in the medical plastics and the medical device 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 Prioritized Examination. The ecosystem of the medical plastics and medical device industries includes companies ranging from start-up ventures to multinational corporations, and Track One or Prioritized 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 “Prioritized Examination”. Entry into Prioritized Examination simply requires a certification and request for prioritized 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). With regard to application preparation, prioritized 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 Prioritized Examination requests allowed in any given year, effective September 24, 2021, the Patent Office increased the maximum annual number of Prioritized Examination requests it would accept from 12,000 to 15,000.1 PENDENCY The practical effect of Prioritized 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-prioritized 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.2 Conversely, Prioritized Examination applications are, on average, pending for merely 1.4 months between grant of a petition for Prioritized Examination and receipt of a first Office Action.3 Under Prioritized 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.3 Currently, the Prioritized Examination application pendency from filing to petition grant is 1.4 months.3 Thus, a Prioritized 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.
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