Attached is an article by Malcolm Lawrence of HLBBshaw, Epping, UK
1. Background
On 25th March 2009, the Administrative Council of the European Patent Organisation issued decision CA/D 2/09 which introduces stricter requirements regarding the filing of divisional applications. These stricter requirements have apparently been introduced because the EPO considers that some Applicants have abused the divisional system.
To read the entire article see attached Recent EPC Rule Changes.pdf
On December 8th, the Patent Office implemented a pilot program in which an applicant may have an unexamined application filed before December 8, 2009 made special upon a showing that the putative patent would “materially enhance the quality of the environment by contributing to the restoration or maintenance of the basic life sustaining natural elements.” 74 Fed. Reg. 64666 (Dec. 8, 2009) (a copy is attached at the end of this posting). The petition to make special must state the basis for the special status, but there are a lot of them. The notice lists them by classification, and they fall broadly into alternative energy production, energy conservation, environmentally friendly farming (including all of “plants and plant breeding ” – 800 (!)) and environmental purification, protection or remediation. The subclasses cover everything from swimming pool heating to wind-powered ships. Of course, biotech faves like “biofuel,” “toxic material clean-up,” and “recycling” are included, as well as “using microbes and enzymes [to destroy toxic materials], and “genetically engineered organism” [to produce fuel, I assume]. Somewhat more exotic ones include “emission trading” (a business method?), “drag reduction,” and nuclear power. One area I have worked in but couldn’t quite find was “herbicide alternative” or some such, although “fertilizer alternative” is present. Maybe this would fall within “yield enhancement” but so would quite controversial inventions like Bt corn or glyphosate-resistant soybeans.
Of course there are lots of strings attached. The program has a limit of 3000 petitions, which must be filed before December 8, 2010. The claims must be directed to a single invention and there can only be three independent and twenty total claims (shades of the recently departed rule package?). Both this Green Pilot program and the Abandon to Advance Pilot Program at least exhibit a startling level of creativity for an Office not known for that trait, but I worry that the resources may not be there to expeditiously process all these petitions. If you try it (and I intend to), please let me know if you like it!
On November 27, 2009, the USPTO published the “Patent Application Reduction Stimulus Plan” (74 Fed. Reg. 62285) (a PDF is found at the end of this posting). Briefly, a procedure has been established whereby a small entity applicant can have a petition to make special granted in an unexamined application that is ready for examination by submitting a request that documents that the applicant has expressly abandoned one of their co-pending applications that was also ready for examination but had not been examined. There are lots of conditions attached. The applications must be co-owned or have an inventor in common. All the fees must be paid and the applications must have actual filing dates prior to October 1, 2009.
I can see this being of some use to small pharma/biotech companies that have filed on technologies that they could not partner, or have otherwise decided to cease developing, and wish to speed up prosecution of newer, or more promising technologies. The program may also be of value to universities who have multiple portfolios, including older ones that may have “safety continuations” pending, but otherwise have little life left in them. Of course, even under the old rules, petitions to make special were rarely used, since it took as long, or almost as long, to have them reviewed and granted as it did to get the first office action. If this program catches on, it will provide some measure of how many paperweight file wrappers are really in the Office. The notice indicates that the procedure may be extended to all applicants if it is deemed a success. If it flops, it may be withdrawn, but at least this would show that most applicants have not given up on the value of their IP. After all, it is the season of hope, and it is about time for a little hope after the Pandora’s Box of miseries the PTO has released into the prep/pros world for the last decade or so.
By Paul Cole
Visiting Professor, Intellectual Property Law, Bournemouth University, UK
On Tuesday 24 November, David Kappos made a posting on the Director’s Forum including the following statement:
Some have suggested that the Office is determining obviousness in a way that stifles innovation by refusing patents for truly inventive subject matter. They’ve asked us to provide examples of non-obvious claims in view of KSR. Such examples would serve as a complement to the examples of obvious claims already in the guidelines.
Mr. Kappos gave a presentation at the AIPLA Annual Meeting in Washington in October, and in a question and answer session that followed there were three questions which concerned KSR, more than any other topic. The two questioners who preceded me expressed dissatisfaction with seemingly unjust and arbitrary rejections for lack of inventive step. I asked whether the US examination guidelines on inventive step could be brought into line with those of the EPO, where positive and negative examples are carefully balanced, and the suggestion created a burst of applause from the audience. More detained comments on the suggestion are found in a paper on KSR that was published in the John Marshall Review of Intellectual Property Law in 2008 (a copy is attached at the end of this posting).
It now seems that there is at least a chance that the suggestion that I and others have made may be acted on, and that the possibility is under active consideration in the USPTO. For the most to be made of this opportunity, we as students and users of the patent system can help by suggesting additional positive decisions which it would be good for the USPTO to include in the revised inventive step Guidelines.
For the avoidance of doubt, what we are looking at here is the Manual of Patent Examining Procedure at 2143 – Examples of Basic Requirements of a Prima Facie Case of Obviousness. There are various headings giving examples and the opportunity here is to submit counter-examples. Here are the various headings:
A. Combining prior art elements according to known methods to yield predictable results. Anderson’s Black Rock is one example and US v Adams is a counter-example but mentioned only for teaching away which is not really in point here. Do we have any more recent examples which could usefully go into the MPEP? The Adams case itself provides a good example of persuasive new function, and the nineteenth century examples of Winans and the Washburn & Moen Manufacturing (Glidden barbed wire) case are also instructive. But good recent examples should also be included e.g. compositions exhibiting surprising synergistic properties.
B. Simple substitution. Are there any decisions which could usefully be contrasted with In re Fout, In re O’Farrell, Ruiz v AB Chance and Ex parte Smith?
C. Use of known techniques to improve similar devices. Are there any decisions which it would be good to include in MPEP and which can be contrasted with In re Nilssen and Ruiz v Chance?
D. Applying known techniques to a known device. What decisions might be included to contrast with Dann v Johnson and In re Nilssen?
E. Obvious to try. What decisions should be included to contrast with Pfizer v Apotex, Alza v Mylan Laboratories and Ex parte Kubin? See also the MPEP at 2143.02.
F. Variations prompted by design incentives or other market forces. The examples here are Dann v Johnson, Leapfrog v Fisher Price, KSR itself and Ex parte Catan. Can we provide instructive and hopefully easily comprehended counter-examples?
G. The TSM test. Here Graham and DyStar are mentioned. Do we have any post-KSR examples where it was appropriate to continue to apply the TSM test and a positive finding of patentability was made?
Readers of this blog will obviously be looking for cases which emphasize the empirical nature of research in the chemical, biochemical and pharmaceutical arts. One suitable candidate might be the recent CAFC decision in Sanofi Synthelabo v Apotex which concerned the drug Plavix used for the treatment of heart attacks and strokes. It turned out that the enantiomers had the property of “absolute specificity’ with one isomer providing all of the anti-platelet activity, but no significant neurotoxicity whereas the other had no anti-platelet activity and all the neurotoxicity. Evidence was adduced that there was no scientific principle which allowed prediction of which isomer would be more active, and that weak stereospecificity was more common than strong stereospecificity; also that activity and toxicity were correlated so that the more active isomer would be expected to be the more toxic. Furthermore, in compounds where biological effectiveness is delivered through metabolism in the body, the acid environment of the stomach or other metabolic processes may restore the racemic state. On this basis the CAFC held that the biological activity of the claimed isomer could not reasonably have been predicted
Hopefully readers will respond with references to instructive Board of Appeals, District Court and CAFC cases where patents were held to have inventive character.
