IP Law Bulletin

On August 14, 2012, the U.S. Patent and Trademark Office (USPTO) published its final rules for implementing the Inventor’s Oath or Declaration provisions of the America Invents Act (AIA). The final rules take effect on September 16, 2012, with respect to any application filed on or after this date, regardless of any claim for priority. The final rules provide a great deal of detailed explanation and include the new text of the relevant C.F.R. sections, but below is a brief summary of significant changes implemented by the final rules.

On May 16, 2012, the United States Patent and Trademark Office (PTO) launched a new “Quick Path Information Disclosure Statement (QPIDS)” pilot program.  The program is intended to reduce application pendency and applicant costs when it becomes necessary to submit an information disclosure statement (IDS) after the issue fee is paid for a patent application.

On July 2, 2012, the PTO announced plans to open regional PTO offices in Denver, Colorado, Dallas, Texas, and San Jose, California. These three offices, along with the regional office that just opened this past week in Detroit, Michigan, will be used to work with entrepreneurs to process patent applications, reduce the backlog of unexamined patents and appeals of examiner rejections, and speed up the overall patent application process. The PTO plans to establish a timeline for opening the newly announced offices in the coming months. The PTO is also currently working on establishing a model for how the regional offices will be set-up and operate in conjunction with the main office in Alexandria, Virginia. This model will likely evolve based on lessons learned from the new Detroit office. We note that the Boston Patent Law Association (BPLA) spearheaded an effort to bring one of the regional offices to the New England region. While we are disappointed that the exceptional bid prepared by the BPLA was unsuccessful, the new offices will certainly help our clients even if they do not have offices in Detroit, Denver, Dallas, or San Jose as these regional offices continue to support the PTO’s efforts to expedite patent prosecution. Stay tuned to future updates from Nutter about the set-up and operation of the regional offices.

On July 5, 2012, the United States Patent and Trademark Office issued a memorandum to all patent examiners providing guidelines for examining process claims for patent eligibility in view of the Supreme Court decision Mayo v. Prometheus. Entitled “2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature,” the much-anticipated guidance is intended to apply to process claims focused on a law of nature, natural phenomenon, or naturally occurring relation or correlation (“natural principle”). Although it is expected this guidance will predominantly impact claims examined in Technology Center 1600 (Biotechnology), the guidelines will be applicable to any process claim that refers to a natural principle. Process claims directed to abstract ideas, such as the claims in Bilski will continue to be examined using the previously issued guidance for determining subject matter eligibility under Bilski v. Kappos.

In our November 2010 and January 2010 issues, we reported on the Patent Office’s (PTO) then-new Green Technology Pilot Program (GTPP), which was one of several programs that allow an applicant to receive expedited prosecution of their application. The GTPP in particular allows an applicant to petition for his or her application to be examined more quickly if it pertains to the development of a renewable energy source, energy conservation, or the reduction of green house gas emissions. Earlier this year, the PTO officially closed the opportunity to file petitions under the GTPP because the number of granted petitions and pending applications reached the limit of 3,500 applications being accorded special status under the pilot program. Many applicants are now faced with the question of what to do to speed up prosecution of their applications, whether they are directed to “green tech” or not.

On March 9, 2012, the Indian Controller of Patents granted the first compulsory license to an Indian company to manufacture a patented drug. The decision could have wide-ranging implications for pharmaceutical companies holding patents in India, as well as in other countries throughout the world.

The United States Patent and Trademark Office (USPTO) recently implemented a new program that allows applicants to have Requests for Continued Examination (RCE) prioritized, thereby insuring their applications will be considered more quickly following the filing of a RCE. While this program will place applications on a faster track to further examination, and thus hopefully allowance, applicants should consider this new program as another tool in their toolbox for efficient and effective patent prosecution. In fact, because patent prosecution should be a collaborative effort between applicants and examiners, there are other tools applicants should consider using before paying the $4800 fee ($2400 for small entities) to essentially “force” examiners to pick-up their applications as prioritized RCE filings.

On February 9, 2012, the U.S. Food and Drug Administration (FDA) issued three draft guidance documents– the first since the Biologics Price Competition and Innovation Act passed in March 2010 – for the development of biosimilars. The biosimilars market is expected to reach $8 billion by 2020. The three guidance documents are:

The USPTO recently announced that the Extended Missing Parts Pilot Program that was implemented last year will be extended for another year. Under conventional missing parts practice, applicants must pay filing fees and submit an oath or declaration within a two-month time period after receiving a Notice to File Missing Parts. Under the Pilot Program, applicants must still pay the basic filing fee and submit an oath or declaration but can, under certain conditions, request a twelve-month period to pay the search, examination, excess claims fees, and the surcharge for late submission of these fees. The Pilot Program can benefit applicants by providing an additional year to decide whether the nonprovisional application should be completed by paying the remaining fees.

As of January 23, 2012, all Appeals filed at the U.S. Patent and Trademark Office (USPTO) are subject to new rules of practice before the Board of Patent Appeals and Interferences (BPAI). The new rules are generally intended to simplify the Appeal process.