Archive for July, 2009

UNIVERSITY OF PITTSBURGH v. HEDRICK – ON A (CLEAR) CONCEPTION DAY

Monday, July 27th, 2009

From a prosecutor’s standpoint, the ’231 patent (link at bottom of this post) has “dream claims” to a new class of stem cells. Claim 1 reads:

An isolated adipose-derived stem cell that can differentiate into two or more of the group consisting of a bone cell, a cartilage cell, a nerve cell, or a muscle cell.

Adipose is “fat”, and because there is so much of it around, and it is easy to obtain, it may nearly be an ideal source for “pluripotent stem cells.” During prosecution, the inventors had to convince the Examiner that these fat-derived stem cells were patentably distinct from mesenchymal stem cells (MSC). Other groups had derived these pluripotent MSCs from bone marrow, and they could be induced to form the same tissue types. Several companies are investigating the use of these cells to repair heart attack damage. For those two or three of you who have not been keeping up with stem cell technology and patent developments, I refer you to my article in JPTOS, vol. 83, 830 (2001).

An inventorship dispute arose between the two inventors who began the work that led to the ’231 patent at the University of Pittsburgh, and a visiting scientist who worked at Pittsburgh and then returned to UCLA and worked with another scientist to further characterize the cells. Although Pittsburgh listed both their inventors and the two UCLA inventors on a provisional, a PCT and the application that issued as the ’231 patent, Pittsburgh tried to remove the two UCLA inventors from the ’231 patent shortly after it issued. Not surprisingly, the UCLA inventors resisted being removed. (Decision is App. No. 2008-1468, July 23, 2009, a link is provided at the bottom of this post.)

The Federal Circuit found sufficient evidence to hold that the two Pittsburgh inventors had conceived of the claimed invention prior to the involvement of the UCLA researchers. The fact that the UCLA researchers confirmed certain properties of the cells was not a contribution sufficient to make them co-inventors, and ultimately, the court held that, while the Pittsburgh inventors were not certain that the stem cells would behave as expected, nonetheless they had the “firm and definite idea that these properties existed in [the cells].” At this point, work by others that confirms your educated guess is simply part of reduction to practice.

As interesting as is the resolution of the inventorship dispute, the resolution of the claim construction issue occupies almost four pages of the decision, and helps expand the notion of “patent profanity” that I discussed in the earlier post about the Sandoz decision. Here, the UCLA scientists urged a more limited definition of “adipose-derived stem cell” that they believed would encompass their contributions: “a species of stem cell distinct from the mesenchymal stem cell (MSC) that is obtainable from bone marrow tissue.”

The Federal Circuit affirmed that the plain meaning of the claim term was simply “derived from fat tissue.” The court then examined the specification and prosecution history to determine if there were any contradictory definitions in the specification or a “unmistakable disavowal” of the plain meaning by applicants during prosecution. The court found that the proposed narrower definition would require that the cells be a “separate species” than MSCs and that the specification did not assert that this was the case (even though the fat-derived stem cells have different isolation requirements).

Notably, even though the applicants submitted evidence derived from work at UCLA to establish that the cells were patentably distinct from MSCs, and the Examiner relied on this submission, the court specifically held: “This is not a disavowal.” The court found only a “weak inference from the summary [by the Examiner] that adipose-derived stem cells in this invention must be a different species from mesenchymal stem cells and a clear and unmistakable disavowal as required to limit a claim term.” The court even delved into the science to support its holding, stating that there was a theory that MSCs could travel to fat tissue and be changed by the new environment they encountered. (Are all adult stem cells the same cell?)

If there is a take-away lesson here, it is that unmistakable disavowal of otherwise undisturbed plain meaning must be really unmistakable before it will be used to narrow claim scope. Here, the patentee was saved from the effects of “patent profanity” because they apparently did not urge during prosecution that the claimed cells were a “distinct species” of stem cell, as opposed to simply having some distinct properties. A close call, but in the end, the Pittsburgh inventors were “safe” and the UCLA inventors were out at the plate.

Patent 206777231
Univ of Pittsburgh v Hedrick

BIOTECH INDUSTRY IN MINNESOTA – STAYIN' ALIVE

Monday, July 27th, 2009

In its July 3rd issue, the Minneapolis St. Paul Business Journal published a list of the “Top 25 Biotech Companies.” It tells a pretty sad story. The top 25 companies together employ fewer than 3000 workers in Minnesota. The top four employ 85% of them, and two of them, Beckman Coulter Inc. and Syngenta Seeds, are branches of much larger companies. I am also not sure how the companies were selected for the list. Most of them either sell reagents or test kits to the biotech industry or provide diagnostic services. Others, like Cima Labs, SurModics, Innovative Surface Technologies, and Receptors partner with pharma and med device companies to develop drug delivery technologies based on coating and other surface modification technologies. None are exclusively involved in developing biological therapeutic agents for the treatment of human afflictions, with the possible exception of Bioenergy, Inc., that is working on medical applications of ribose. I have lived here for 25 years and no one has ever been able to explain to my satisfaction why Minnesota is a leader in the medical device industry (you should see their list, which starts with Medronic), but has never developed a biotech industry. I am not an economist, and I dont want to over-analyze, but re ipsa loquitor.

Board Decision in Ex Parte Roberts Doesn't Make the Cut

Friday, July 24th, 2009

This 2008 pre-Bilski decision is of interest since the Board purportedly applied the Diamond v Diehr “standard” – “[t}ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines” (450 U.S. at 184) – that the Federal Circuit adopted as the rule by which to judge whether or not a process or method claim is patentable subject matter. The Board applied this much-criticized test to affirm the Examiner’s ruling that a claim to a method to provide LASIK corrective surgery that was patient-customized was not patentable subject matter under section 101. Here is some of the relevant language from the decision:

“The claimed invention deals with a methodology for improving refractive opthlamic treatment. The steps of claim 120 include (a) obtaining a first measurement of a cornea; (b) determining a first ablation specification based on this first measurement; (c) obtaining perturbation data from the cornea to obtain biodynamic response data; (d) correlating…Steps (a), (c) and (d) are actions that can be characterized as data gathering steps. Steps (b), (e) and (f) are actions that can be characterized as mental steps in forming an individualized ablation specification….The claim does not include any recitation of a particular machine used to implement the claimed steps. The steps could be performed entirely by a human being with no machine involvement whatsoever.” (Appeal No. 2008-1355 July 15, 2008)

Oh really! I’d like to see that (actually it would be to gruesome to watch). Step (c) of claim 120 actually reads “obtaining non-tissue removing perturbation data from the cornea.” In rebutting a section 112 rejection, appellants argued (and the Board did not dispute) that the non-tissue removing perturbation is accomplished by making an incision in the cornea to form a corneal flap (“cutting the corneal flap”), which is then put back into place after the measurements are taken. At the least, this is a transformation of matter (corneal tissue) with a machine adapted to do this delicate procedure (e.g., a very sharp knife called a microketratome). I would (not) like to see this procedure carried out “with no machine involvement whatsoever.”

In fact, in their later obviousness analysis, the Board appears to recognize that perturbing is cutting: “Further it is unclear what the Appellants deem constitutes a surgical procedure. For example, it appears to us as though the step of perturbing the cornea entails a surgical procedure on the eye. The claims do not recite any other steps that include another surgical procedure on the eye.”

Well, how many surgical procedures on the eye are required to transform the article into different state? Finally, I hope that Ohio State University, the owner of the application, was aware that claims to “medical activities,” just like this one, while impliedly patentable subject matter under section 101, may be infringed without any liability for damages, at least by doctors and their employers. See 35 USC 287(c)(1). This section was added to the patent statutes in 1996 after one eye doctor got a patent on a method of performing cataract surgery and sued a competitor who was using the same technique. But that’s another story.

I want to thank Michael D. Stein of Woodcock Washburn for bringing this decision to my attention. We will be presenting an AIPLA Webinar on the evolution of patentable subject matter on September 2, 2009. Keep an eye out for us.

Federal Circuit Mows Down Bean Patent – Reading Between the Rows

Wednesday, July 15th, 2009

On July 10, 2009, the Court of Appeals for the Federal Circuit in In re Pod-Ners, Appeal No. 2008-1492, affirmed the Board’s rejection of all of the claims of U.S. Pat. No. 5,894,079. The Board had rejected as obvious claims to, inter alia, a pinto bean plant producing yellow beans of a certain color, as well as claims to the beans themselves, which had been deposited in the ATTC. The claims were rejected over a publication argued to disclose the same yellow bean, in view of another non-prior art publication relied upon as demonstrating that the claimed bean and the “well known” yellow bean are gentically identical.

While only six pages long, and eminently predictable given the fact that the Mexican government had alleged theft of their biological heritage, the decision feels muddled. To begin with, the panel clearly would have preferred to invalidate the patent as anticipated by the “well-known” yellow bean, “Azufrado Peruano 87.” The law is well-settled that non-prior art publications can be relied upon to show that a prior art reference is, in fact, anticipatory. But whether anticipated by, or obvious in view of, the prior art publication, it seems that the panel should have acknowledged that the prior art publication which, after all, disclosed a plant variety, was enabling. Historically, a printed publication could not per se place a plant variety in the possession of the public; the public was believed to, in fact, need to have access to the plant. This gap was simply filled by the panel by noting that the older variety was “well known.” This is getting pretty exotic, but I seem to recall a decision which held that evidence of the commercial sale of a plant described in a printed publication was sufficient to render the publication enabling. This decision validated the PTO’s examination policy then in effect. Does anyone but me remember that decision?

Finally, the decision has an odd anti-biotech air about it that I don’t think I am imagining. In April, the Fed. Cir. overturned In re Dueul and In re Bell finding a previously unisolated and unexpressed cDNA sequence obvious, primarily because it would have been obvious to use known techniques to isolate the “gene” and to express it as a protein that was known to exist, but had not itself been isolated. In re Pod-Ners, the panel concluded:

“The Board correctly held that the subject matter of the ’079 patent – yellow beans, the plants they produced and a method for reproducing such plants by cross-breeding – would have been obvious to one [of] ordinary skill in what POD-NERS identifies as the “breeder-grower” art. … [Appelant] does not contend that he devised or applied new or unexpected techniques in reproducing the beans.”

Now substitute “cDNA encoding the NAIL protein, the NAIL protein produced thereby and a method for cloning the DNA” for the description of the holding of the Board given above, and you have the Kubin decision. The patentee in fact had isolated yellow beans (the DNA sequence) from a bag of beans of various colors (the genome) and bred (“cloned”) them so that they became a unique cultivar.

The panel affirmed the invalidity of the claims to the cultivar, which was recited to have a “yellow coat described as within a narrow range of shades of yellow on a particular color chart” without ever stating that the “prior art” bean was the same color. In fact, the panel conceded that the beans may only have been “substantially the same”. If patentee had obtained a Plant Patent instead of a utility patent, the opponents and the court would have had to find that the cultivars were indistinguishable in appearance in order to invalidate the patent. However, Plant Patents are not available for plants that reproduce via seed. My comment is becoming as long as the decision, as I try to turn it into a fable, but it is adamantly not “Jack and the Beanstalk.” These beans did not bring their owner a pot of gold. In the end, the patent wasn’t worth a hill o’ beans.

Pod-Ners Decision
ETCGroup