Archive for December, 2009

Give A Little, Get A Little: New PTO Program Aims to Speed Examination

Thursday, December 10th, 2009

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 If it flops, it may be withdrawn, but at least this would show that most applicants have not given up on the value of their IP.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.

Patent Application Reducation Stimulus Plan.pdf

David Kappos and The Impact of KSR – A Unique Opportunity For Our Profession

Monday, December 7th, 2009

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.

Cole Paper

A Look Back at the Roots of the Thorny WDR Problem

Monday, December 7th, 2009

As the date for oral argument looms in Ariad v. Lilly, as does an en banc decision as to the existence and/or the role of the written description requirement (WDR) in Section 112, I thought it would be worthwhile to re-visit an article I published in the April 2003 issue of JPTOS. (A copy can be found at the end of this posting.) Please read the concluding part of this article in view of my posts on this site of August 24, 2009 and May 5, 2009. The article is entitled “Do-Over! — The Federal Circuit Takes a Second Look at Enzo v. Gen-Probe.”

Put simply, the debate within the Federal Circuit is between the Judges who want to return the WDR to its role in settling priority disputes, and the Judges who want the WDR to ensure that the specification demonstrates that the inventors had “adequate possession” of the invention – to do something more than simply teach the interested public how to make and use the invention. Even a disclosure of actual reduction to practice (e.g., of actual possession), is not, per se, sufficient for this group. (“While ‘possession’ is a relevant factor in determining whether an invention is described, it is only a criterion for satisfying the statutory written description requirement. Showing possession is not necessarily equivalent to providing a written description.”) The specification must also permit the art to “visualize or recognize the identity of the subject matter of the claim.” Enzo I, 285 F.3d at 1018.

Thus, in late 2002, the legal battle lines are sharply drawn. One camp of Judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the “right to use” the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by application of the very fact-specific Wands factors. In re Wands, 858 F.2d 731 (Fed. Cir. 1988). These eight factors, used for determining whether or not the enablement requirement is met, include the nature of the invention, the breadth of the claims, the level of ordinary skill in the art, the level of predictability in the art and the existence of working examples. See also M.P.E.P. 2164.01(a) (8th ed. 2001). The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the “right to claim” the invention at issue. That is nearly as equitable a mission as that assigned to the doctrine of equivalents.

The WDR is evolving one fact situation at a time, and without en banc review, entire classes of patents will move in and out of its invalidity shadow. Two hypothetical fact patterns may serve to illustrate the uncertainties in the current WDR. In the first, an inventor isolates a new protein, factor X, from liver cells. The inventor knows nothing about the structure, or even the class of protein, such as an enzyme or a hormone, only that it is not an antibody. However, the protein binds to a receptor site on prostate cancer cells and blocks their division completely. If the inventor files at this point, the court is presented with actual possession and purely functional claiming. If the inventor deposits some of factor X, a step usually not taken with a pure chemical compound, the claim to “factor X” and its functional language could presumably be within the Enzo safe harbor. The American Type Culture Collection does not list “proteins” as materials it will accept for deposit. If the inventor fails to deposit prior to issuance, the specification would not meet the WDR, the claims would be invalid, and a continuation-in-part fully characterizing factor X would not be entitled to the filing date of the parent, since the description of factor X in the parent would not meet the requirements of Section 112. 35 U.S.C. Section 120.

In the second hypothetical case, an inventor uses computational chemistry to identify consensus sequences that are responsible for the enzymatic activity of a protein encoded by a series of related plant genes. The software developed by the inventor then “mixes and matches” the consensus sequences on the inert peptidyl framework to optimize the bioactivity of the enzyme, arriving at a genus of hypothetical high-activity enzymes, all defined by complete sequences. If the inventor files at this point, with adequate directions as to how to assemble the synthetic enzymes, he has produced a presumably enabling specification with complete structural data, but with no actual reduction to practice whatsoever. Is this an example of a specification that should fail the heightened WDR, or one that should meet the precise definition test of the new WDR? Do we need more than the Wands factors to evaluate the ability of the specification to place the invention in the hands of the public? Should this inventor, who never walked into a laboratory receive a patent, while the inventor of factor X be left with nothing but the satisfaction of curing cancer?

If factor X is an antibody, and the target is known, perhaps binding affinity language would meet the WDR. But what if it is a hormone, or a small molecule, or an “anti-inflammatory steroid,” an example of inadequate description given by the Enzo II panel? And is it really the best use of the court’s time to resolve endless fact situations on the basis of five words in the statute that provide no guidance whatsoever as to what they require, beyond some degree of correspondence between the specification and the claims? With the clearly articulated division of opinions within the court, the fate of any patent appealed from a WDR decision below will depend entirely on the panel that appellant draws. Whether or not the interested public all agree with the Wands requirements, they have proved to be a workable test for meeting the make-and-use requirement of Section 112. It is time for the court to deliver Lilly and Enzo (I) to the doctrinal scrap heap where holdings like Durden and Druey ended up, and let the evolution of biotechnology patent law continue in a productive direction. However, we all know that “bad facts make bad law,” and I don’t see how Ariad will be able to move WDR jurisprudence in a direction that will favor patenting early-stage biotechnology.