Archive for December, 2010

Judge O’Malley to be Confirmed to Federal Circuit

December 21, 2010

Judge Kathleen O’Malley is finally expected to be confirmed today by the full Senate to a seat on the Federal Circuit.  As part of a deal between Senate Majority Leader Harry Reid (D-NV) and Minority Leader Mitch McConnell (R-KY), many judicial nominees that have been languishing will receive confirmation votes.  Most will be confirmed without opposition in exchange for Democrats not bringing some of the most controversial nominations to the floor.

Judge O’Malley was nominated to the Federal Circuit in March and unanimously cleared the Senate Judiciary Committee in September.  She will be the first judge on the court with previous experience as a district court judge.  She also brings some experience with patents and other intellectual property matters to the court.

Judge O’Malley is expected to be confirmed by the lame duck Senate without opposition.  She will bring the court’s active membership to 10 with two other nominations pending.  Edward DuMont was nominated by President Obama in April and Jimmie Reyna in September.  Neither has received a hearing before the Judiciary Committee.  These nominations will expire with the end of the 111th Congress; neither nomination should be controversial and both are expected to be renominated for the new Congress next year.


Federal Circuit Reconfirms Patentability of Method of Calibrating Drug Dosages

December 17, 2010

Last year, prior to the Supreme Court’s decision in Bilski v. Kappos, the Federal Circuit reversed a district court holding that Prometheus’s claims to methods of calibrating drug dosages were invalid as not directed to patentable subject matter.  The Federal Circuit has once again reversed the district court decision of unpatentability.

After the Bilski decision, the Supreme Court issued a GVR order in this case.  A GVR Order is where the Supreme Court Grants certiorari in the case, Vacates the lower court’s opinion, and Remands the case back to the lower court to reconsider its decision in light of the newly decided Supreme Court case.

The court reaffirmed its holding that the claims are not drawn to a law of nature, but to a particular application of naturally occurring correlations, and do not preempt all uses of such correlations between metabolite levels and drug efficacy or toxicity.  The Supreme Court decision did not eliminate the Bilski machine-or-transformation test, but merely indicated that it is not the only test.  The claims recite specific treatment steps and not merely the correlations.

Again, the Federal Circuit disregarded the District Court’s and Mayo’s extreme reliance on Justice Breyer’s dissent from the dismissal order in LabCorp.  The court again noted that the opinion is not controlling law as it comes from only three Justices in a dissenting opinion.  The claims in that case were also different from those of the present case.

The court also reiterated that the step of administering a drug is a transformative step within the human body and that determining metabolite levels requires a transformation of the substance being analyzed.  The Federal Circuit continued by noting that the district court erred in holding that the first two steps are merely data gathering steps. The Federal Circuit held that these steps are central to the claimed method and are themselves transformative.


This case has been presented as extremely important and even controversial.  How can methods of administering a drug and determining metabolite levels be patentable?  This would appear to be the reason for the GVR Order. 

In general, the Supreme Court’s Bilski opinion expanded patent-eligible subject matter beyond what the Federal Circuit’s Bilski test permitted.  In other words, the Supreme Court would grant patent eligibility to more patent claims than the Federal Circuit test (unless the claims are somehow directed to a machine or transformation, but are also found to be directed to abstract ideas).  Thus, if the claims in this case met the Federal Circuit’s more stringent test, they should also meet the Supreme Court’s less onerous test.  The court in this case seemed to state as much.

The other interesting case in this area in which the Supreme Court issued a GVR Order is Classen Immunotherapies, Inc. v. Biogen IDEC, where the Federal Circuit issued a ridiculous one paragraph merits opinion rejecting a claim to a method of determining an immunization schedule.  Although it was thought that these cases would come out at the same time, in Prometheus, the court was able to reuse much of its original opinion.  In Classen, presumably the court will feel inclined to issue a new opinion that is longer than 70 words.  They basically need to start over in that case. 

Stay tuned.

USPTO Officially Announces Detroit Regional Office

December 17, 2010

As reported by IP Watchdog, Secretary of Commerce Gary Locke announced yesterday that the first PTO satellite office will be opening in Detroit, Michigan during 2011.  The plan is to intially hire about 100 patent examiners along with related support staff. 

The PTO intends to focus technologies in the Detroit office on those that are represented by industry in the area.  This would obviously include the automotive industry, but also others.  There is still the question of PTO management presence in the Detroit office. 

Given its reliance on manufacturing and especially the automotive industry, the economy of Detroit in particular and Michigan generally has been depressed for a number of years.  Things there are worse than in most other areas of the country.  The PTO recognized this as a location with a lot of scientific and legal talent that is unemployed or at least underemployed (plus it can’t hurt for additional votes). 

The PTO also chose the location because it is near to a number of leading research universities.  This appears to be a recognition of the huge amount of research taking place at Big Ten universities, including my alma mater, the University of Michigan.

This appears to be another great step by the Kappos Aministration to improve the patent system.  There is no particular reason that the PTO has to be located exclusively in Northern Virginia.  Within the next year after the Detroit opening, the PTO is also looking at opening several more satellite offices.

Applying for a Patent

December 13, 2010

To obtain a U.S. Patent on a new invention, one must file a patent application that follows the rules and requirements of the PTO.  A patent application must include a written description and drawings to permit one of ordinary skill in the art to make and use the invention.  The application also includes one or more claims that designate what the patent applicant believes to be his invention.

A patent application is typically prepared by a patent attorney familiar not only with relevant legal requirements but also with the relevant area of technology.  The patent attorney typically begins by learning about the new invention from the person or persons who thought of it (or conceived of it), often referred to as the “inventor.” 

After preparing the patent application, the patent attorney submits it to the USPTO.  At this point, the patent applicant can mark products that are made according to the application with “Patent Pending.” 

Most patent applications are filed as non-provisional or “regular” patent applications, but may instead be filed as a provisional patent application.  A patent examiner at the PTO examines each regular patent application and decides whether to issue a patent, but the PTO does not examine provisional patent applications – it simply holds them in secrecy for a year, in which time the applicant must take additional steps to preserve patent rights, such as by filing a regular application.  There may be other reasons that require a patent applicant to file a regular patent application in less than a year from the date of the provisional application, such as a statutory bar.  With either type of application, a fee is due to the USPTO upon filing, but the fee for a regular application is much greater than for a provisional applciation.  

The main part of patent application prosecution is examination by the patent examiner.  For a new regular patent application, examination typically begins at least a year and often much longer after filing.  During examination, a patent examiner reviews the application and decides whether to allow it to issue as a patent.  Usually, the examiner sends the applicant a communication (an Office Action) with reasons the application is rejected, and the applicant can then respond with changes in the application, called amendments, with arguments, and with evidence to overcome the rejections.  Prosecution can last several years if the applicant and the examiner have difficulty reaching agreement.  In such cases, prosecution may include an appeal within the PTO and, in rare cases, to a federal appellate court. 

Finally, when the examiner allows the application, the applicant is required to pay an issue fee to obtain an issued patent.  After a patent issues, additional fees, called maintenance fees, are required to keep it in force; maintenance fees are currently due 3.5, 7.5, and 11.5 years after a patent issues.  If these maintenance fees are each paid, the patent will remain in effect until about 20 years from the patent application’s earliest filing date.

PTO Implements 24 Month Provisional Program

December 8, 2010

The PTO is implementing an “Extended Missing Parts Pilot Program” that will permit applicants to effectively extend the duration of a provisional application to 24 months.  The deails of the program were discussed earlier.

This type of program is very dangerous given the international treaty and US statutory guidelines and bars to patenting.  The PTO claims that it has taken comments on these issues to heart and providing warnings to help applicants proceed with the program with caution.  Applicants cannot have their applications accidentally fall into the program, as a specific certification and request are required to participate.

HT:  Hal Wegner.

Commissioner Stoll Speaks at GRIPLA Holiday Party

December 8, 2010

I am currently the president of the Greater Richmond Intellectual Property Law Association (GRIPLA).  Last night, we held our annual Holiday Party.  Robert Stoll, Commissioner for Patents at the PTO, was our keynote speaker.

Commissioner Stoll was very enthusiastic in his presentation.  He pointed out that patent issues are getting attention from Secretary of Commerce Locke and even from President Obama himself.

Stoll then went through the administration’s Strategic Priorities where he emphasized increasing patent quality, reducing the backlog, and improving relations with employees and stakeholders.  The PTO is trying to make its employees, including examiners at all levels and supervisors, work more collaboratively, while also giving them more opportunities to work from home outside the office.  Similarly, the PTO is taking more input from attorneys and inventors than in the past.

The pendency goals of 10 months to first office action and 20 months total were reiterated.  It is difficult to say if anyone (including at the PTO) actually believes this can happen by Secretary Locke’s stated goal of FY2014, but Commissioner Stoll did acknowledge that it will require a tremendous amount of examiner hiring.  He also referred to increasing transparency, such as through the Dashboard, and increasing collaboration with other IP offices through expansion of the Patent Prosecution Highway.

He referred to the new intiatives intended to give applicants more control over the pace of examination, such as the Three Track examination program, the Green Tech pilot program, and the Project Exchange

He was very enthusiastic about the increases in examiner interviews, especially those prior to the first office action.  Interview time in FY2010 was up nearly 40% to 138,222 hours.  Applications with interviews prior to the first office action have a higher allowance rate and a much lower number of actions per disposal.

On the quality front, he referred to the new quality metrics that should make examiners less apprehensive about allowing applications.  The old review system gave examiners an incentive to reject cases even when not warranted.  Negative consequences seemed to flow only from allowances.

In other news, Commissioner Stoll does not expect to see Patent Reform (particularly S. 515) pass in the lame duck congress.  He is particularly concerned with fee-setting authority.  This is the vital part of the legislation that the PTO needs to hire sufficient examiners and move toward the pendency goals. 

He is also concerned with several cases pending in the courts.  Depending on what the Federal Circuit does with the Therasense inequitable conduct case, and the Supreme Court in the Microsoft presumption of validity case, there could be a significant increase in the number of references that applicants dump on patent examiners.  If the Supreme Court says that the presumption of validity only applies to references actually considered by the examiner, applicants will obviously have the incentive to get more and more references considered.

There is also a forthcoming announcement about a regional patent office.  Commissioner Stoll did not specifically state where such an office would be located, but based on descriptions of the area and the fact that the Internet does not do a good job of keeping secrets, it seems that the location will be Detroit.  Does this mean other offices are in the plans as well?  Commissioner Stoll called the first one a “test case”.  Not that they would close the first office, but it will help determine whether there should be others.  Perhaps examiner interviews could be conducted at Patent and Trademark Depository Libraries (PTDL).