Archive for the ‘Patenting Methods/Processes’ Category

Claims to “New Uses of Old Compounds” – The Noose Tightens

Friday, February 19th, 2010

In Perricone v. Medicis, 432 F.3d 1368 (Fed. Cir. 2005), the court reversed the Board, and found that a claim to treating sunburn with certain vitamin esters was patentable in view of art disclosing the same compounds to benefit normal skin. The Board had found the claim invalid as inherently anticipated by the prior art use, but the court found no disclosure in the prior art of applying the compounds to sunburned skin.

In Ex parte Matsubara, Appeal 2009-006581 (Feb. 10, 2010), the Board affirmed the Examiner’s rejection of a claim to a method for improving bone metabolism by (a) selecting a human or animal having a tendency toward a decrease in bone density (e.g., afflicted with osteoporosis), and (b) therapeutically administering to said human or animal certain types of fermented soy milk or “FSM.”  The Examiner rejected the claim as inherently anticipated by a publication that disclosed studying the lipid metabolism in aged, ovariectomized rats after giving them FSM, in view of a publication that established that such rats were an art-recognized model of osteoporosis. Applicants argued that the prior art showed no effect of FSM on osteoporosis and no “selection step” of choosing the rats to evaluate, since the prior art was not concerned with studying osteoporosis.

After quoting sections of Perricone discussing inherency, that the Fed. Cir. panel found inapplicable to the decision that it reached, the Board affirmed the rejection, stating that “the claimed method ‘is inherent and in the public domain if it is the “natural result flowing from” the explicit disclosure of the prior art’…regardless of whether the inherent result is recognized.”  Although I have argued that the use of an old compound for a “different purpose” than disclosed in the art should be sufficient to distinguish the prior art use if a “new use for an old compound” is being claimed, Perricone may deserve a closer reading.

It may well be that the Fed. Cir. reversed in Perricone because no manipulative step of applying the esters to sunburned skin was disclosed in the prior art, not simply because the claimed purpose was not in the prior art. The panel did begin by agreeing: “If [the prior art] discloses the very same methods, then the particular benefits must naturally flow from those methods even if not recognized as benefits at the time of [the art's] disclosure. Thus [the art] anticipates if its disclosure of ‘topical application’ satisfies the application step in Dr. Perricone’s various asserted claims.” The panel went on to find that the art did not disclose the application step of applying the esters to sunburned skin.

So, given that new uses of old compounds remain statutory subject matter and can be extremely valuable, how do we claim them? I think it is important that the prior art rats given FSM and the rats treated by Matsubara were both models for osteoporosis. At least some Examiners give weight to the value of “selection” or recognition that a specific subpopulation can be helped by administration of an “old drug.” For example, consider a claim to “a method of treating a human male afflicted with prostate cancer comprising administering an effective anti-cancer amount of Lipitor to said human male.” Hopefully, the prior art does contain a publication on the treatment of prostate cancer with a chemotherapeutic agent, e.g., docetaxel, that also incidentally discloses that some of the patients were given Lipitor to lower cholesterol. Then you are left hoping that the inventor’s dosing regimen is different than the standard dosing regiment used to lower cholesterol. The noose tightens.


Wednesday, February 17th, 2010

In my post of April 22, 2009, I spent quite a lot of time discussing why “mechanism of action” claims may issue but, like the “Hail Mary” pass in football, remain vulnerable to invalidation as inherently anticipated by the prior art, taken with discoveries made long after the filing date of the claims. Much of this discussion was in the context of the reexamination of the NF-kB patent claims asserted by Ariad against Lilly. I posited that the PTO had effectively taken the position, with respect to such claims, that:

 (A) Method claims whose only recited steps are altering biological mechanisms of action are invalid as anticipated, under principles of inherency, by a prior use of a biologically active compound that meets two requirements:

1.  More than a year prior to the effective filing date of the claim at issue, an “old compound” was administered, so as to treat a condition or achieve a result encompassed by the condition or result recited by the claim at issue; and

2.  At any time, it is shown that the mechanism of action of the “old compound,” when used to treat the condition or achieve the result, is the mechanism of action recited in the claim.

 In the Ariad reexamination, at one point, the PTO Examiner cited the Old Testament of the Bible against the claims, in combination with a recent publication that demonstrated that reservatrol, a compound present in red wine, inhibited the NF-kB pathway. Thus, Bible stories in which red wine was consumed inherently anticipated claims to a method of inhibiting NF-kB activity in a cell by contacting the cell with an NF-kB inhibitor (some of the claims at issue in the patent asserted by Ariad were even broader than this).

This principle was applied by the Board on February 12, 2010, again in Lilly’s favor, to invalidate claim 24 of Pfizer’s Viagra patent (U.S. Pat. No. 6469012):

Claim 24. A method of treating erectile dysfunction in a male human, comprising orally administering … an effective amount of a selective cGMP PDEv inhibitor, or a pharmaceutically acceptable salt thereof, or a pharmaceutical composition containing either entity. (Ex parte Pfizer, Appeal No. 2009-004106, Bd. App. Feb. 12, 2010).

Pfizer had sued Lilly for infringing claim 24 by selling Cialis, admittedly a PDEv inhibitor. Lilly requested reexamination and urged that claim 24 was invalid as inherently anticipated by a (I assume “ancient”- as it is described in Chinese Herbal Medicine Materia Medica)  treatment for impotence involving inter alia, drinking rice wine and imbibing an herb whose Latin name translates as “horny goat weed,” in combination with later evidence that demonstrated that the herb in fact contained icariin, a selective cGMP PDEv inhibitor, that would be effective to treat ED when administered in regimens disclosed in the Chinese literature. The Board found the evidence convincing, and affirmed the Examiner’s invalidation of the claim.

So the next time a professor-client or tech transfer person wants you to write this sort of claim, based on a newly discovered mechanism of action, remember that, like the Hail Mary pass,  you can put it up there, but it might not stay up for long.

You can read more about it at Law36o.

"LOOKS BAD FOR BUSINESS METHODS" — A note by Erwin J. Basinski

Tuesday, November 17th, 2009

The Bilski case before the US Supreme Court came up for oral argument on November 9. After a couple of reads, My initial impressions are:

1. Most of the questions from the Justices (primarily Scalia, Breyer, Roberts, Sotomeyor, Stevens, Kennedy, Ginsburg) seemed focused on a concern that a) if they upheld the machine or transformation test they would interfere gravely with existing software, biotech and other patents as well as kill all business method patents; and b) if they negated the machine or transformation test but only killed business method patents, how would that square with BM processes that DO have a valid machine element or DO have an acceptable transformation involved.

2. Malcomb Stewart, Esq., Deputy Solicitor General, spoke for the US Patent Office and said that they fully believed that the hedging claim of Bilski was basically an abstract process with no physicality, and that they would be happy if the court so ruled. Chief Justice Roberts asked why the court shouldn’t so rule and avoid the issue of whether the machine or transformation test is OK. Justice Sotomayor asked “How about if we say something as simple as patent law doesn’t cover business matters instead of what the Federal Circuit has begun to say, which is technology is tied to a machine or a transformation of the substance, but I have no idea what the limits of that ruling would impose in the computer world, in the biomedical world, all of the amicii who are talking about how it will destroy industries? If we are unsure about that, wouldn’t it be safer to say it doesn’t involve business methods?” [I am not sure what this really means.] But Solicitor Stewart responded that this wouldn’t work because of the State Street Bank case , pointing out that the innovation in State Street was a “machine” whereas the Bilski case relates to “processes”. This led to a long and confused discussion between Stewart and several of the Justices about machines made to be unique by a specific computer program, etc., etc. Justice Ginsburg reminded Mr. Stewart that the PTO had proposed the machine or transformation test to the Federal Circuit and was now saying this test should not be supported by the Supreme Court because of the ambiguities about “what is a ‘machine’? and what exactly is an acceptable transformation?” She quoted Justice Meyer in the Federal Circuit Bilski opinion as saying ” . . . it has a simplicity to it. It says, if its technology, then its within the realm of patent, and if its not technology, it isnt, if it is based on science or technology, and that seems to be what is used in other places [i.e. she means countries]? Mr. Stewart said focusing on whether technology is involved would not make the patent eligibility argument any easier, and moreover such a test would not allow a court to avoid the difficulties that it has identified with the machine-or-transformation test.

3. Chief Justice Roberts, and Justices Kennedy, Stevens, Breyer and Ginsburg found difficulty in Mr. Stewart’s argument that State Street was decided correctly and would be today because it was claimed as a machine and was deemed by the Federal Circuit (and agreed by the PTO) to be a computer changed into a new machine by the computer program involved. All of them felt that State Street’s claim was merely a business process programmed to run on a general purpose computer in which the focus should rightly be on the “process,” and seemed to imply that it should have been rejected as a business method process. Mr. Stewart argued it would pass the machine or transformation test. So Justice Breyer summed up by saying – well all of the hypothetical business methods we seem to have excluded from patentability sound like that could be patented if we simply programmed a computer to execute the process according to the PTO. [These Justices appear to be leaning towards denying the patentability of business methods whether or not a computer is used to execute the process.]

4. Mr. Stewart said that the PTO would be happy if the court would affirm the machine-or-transformation test without trying to define what a machine or transformation is [sounds like the Europeans and their happiness with no court trying to define what technology is].

A majority of the Justices seem to be against the patenting of business methods in general but some worry about the impact on the Internet and new and emerging technology, including medical diagnostic methods.

My guess is that the Supremes will rule somewhat as follows:

A Business Method defined as a process of abstract steps of doing something NOT tied to any technology is NOT patent eligible. Implementing the process on a general purpose computer, whether claimed as a machine or process, does not make the business method patent eligible.

The “machine-or-transformation” test for determining patent eligibility for a process is not affirmed, but some non-trivial physical steps or elements must be included in a claim for a process to be patent eligible.

The fact that Congress has recognized some business methods as patentable in section 273 regarding prior user defenses, seems to be a nettlesome issue for the court here but I suspect they may find some way around this.

The Bilski claim at issue will likely be deemed a business method having abstract steps not tied to any technology and is therefore deemed not to be eligible for a patent.

The Court might even overturn the State Street Bank case.

Erv Basinski


Wednesday, November 11th, 2009

Reading the transcript of the oral arguments presented yesterday (a copy is attached at the end of this posting) as Bilski was presented to the Supreme Court, I was struck by how quickly certain Justices homed in on one of the last frontiers of patentable subject matter, namely whether or not the simple transmittal of information from one person to another should be patentable subject matter. Particularly, Justice Breyer’s first question was to ask whether or not a method of teaching antitrust law could be patentable subject matter [laughter]. Justice Sotomayor then mentioned “speed dating.” Bilski’s counsel replied that, while the data itself is not patentable, “but if it is a series of steps,” it might be. Breyer demanded that counsel “make that balance in terms of information.” Sotomayor asked “[Doesn't there have] to be something more substantive than the mere exchange of information; that it has to involve…’transformation’? [The Fed. Cir.] hasn’t defined the outer limits of what it means by that.” Counsel Jakes, “Yes.”

Suddenly, I thought of a fairly obscure but interesting decision, In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004). The claims in question were to a “kit” for amplifying RNA comprising certain known reagents and “instructions describing the [amplification] method of claim 1.” In other words, the only “point of novelty” was the instructional material. The court affirmed the rejection below, and distinguished In re Gulack (where a sort of circular slide rule was claimed), stating:

As the Gulack court pointed out,”[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product. This was not envisioned by Gulack. Ngai is entitled to patent his invention of a new RNA extraction method, and claims covering that invention were properly allowed. He is not, however, entitled to patent a known product by simply attaching a set of instructions to that product.”

“Hold on,” you may say, “this is a section 102 rejection, not a section 101 decision.” But I re-read this decision after being asked to opine about the potential patentability of claim in a published application. I will simplify it as follows: “A method of increasing the safety of drug x by providing instructions to a patient taking drug x to stop taking drug x if side effect y is observed.” One of the other claims recited the further step of providing drug x to the patient and then providing the patient with the warning (label, most likely). But there was no step involving administering the drug or adjusting the dosage.

This is about as pure a claim to a transmittal of information between two people as I can think of, that does not come off as a judicial joke (“speed dating”). It might be categorized broadly as a method of medical treatment. As Justice Sotomayor questioned, “Do you think that there is some benefit to society from patenting a method to cure someone that just involves human activity, as opposed to some machine, substance or other apparatus to help that process?” The answer is “yes.” In fact, there was some discussion before the Supreme Court relevant to the fact that pure surgical methods are patentable, even after Congress acted to limit damages for infringement.

The “warning claim” I summarized would also seem to be an attempt to answer this question affirmatively, and to patent “the mere exchange of information.” Hopefully the Bilski Court will not attempt to resolve this question, as they deal with the “machine or transformation test” that is before them, but a number of the Justices are certainly interested in the broader issue a la the Metabolite Labs, dissent by Justice Breyer et al. Mr. Stewart for the PTO made it clear that he hoped that the S. Ct. would not muck around in “software innovations or medical diagnostic techniques.” We can only hope.

Bilski Transcript.pdf