In Ex Parte Lee, the BPAI agreed with the examiner that the claimed methods and drug treatment were obvious, except, under secondary considerations by applicant declaration, unexpected synergistic effects which created "substantially improved results" overcame obviousness.

"If an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with [the] scope of the claims." In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).

A majority of the Board then required a terminal disclaimer for the child application under appeal, as obviousness-type double patenting, ignoring the dissenting opinion of the legal requirements.

This analysis was not performed by the Examiner and is error. The Examiner merely determined that Appellants evidence of non-obviousness in the Lee Declaration was not relevant to the obviousness-type double patenting rejection. The majority agrees.

The dissenter points out, if the child claims are nonobvious in claiming a different invention than the parent, there is no double patenting.

It has long been recognized in the law that unobvious improvement patents do not result in a timewise extension of a patent for the same invention or an obvious modification thereof. As there has been a showing of patentable distinctiveness on the facts in the present case in the Declaration of Lee, there is no timewise extension of a patent for the same invention or an obvious modification thereof.

Hal Wegner:

Ex parte Lee, __ Westlaw __ (PTO Bd. App. & Int. 2011), a divided Board panel affirms a double patenting rejection while simultaneously reversing a rejection on obviousness.  Nowhere is there a citation of In re Papesch, 315 F.2d 381 (CCPA 1963)(Rich, J.) nor the principles of Papesch that make the holding in this case difficult to comprehend.

Under In re Papesch, 315 F.2d 381 (CCPA 1963)(Rich, J), the nonobviousness of a chemical invention must be considered as a whole, both as to chemical structure and properties of the compound.

KSR and Pfizer v. Apotex manifest fundamental misunderstandings of chemical practice case law.

Because the case law at the Supreme Court has focused upon combination patents, there is an assumption made in some quarters that virtually all patents are to combinations. In fact, there has never been a modern Supreme Court grant of certiorari to consider the chemical obviousness case law line relating to a new compound nor any case in modern times to consider the obviousness of any invention other than a combination patent.

Pfizer v. Apotex Repudiates Papesch

More than forty years after the establishment of the current case law regime and after nearly twenty-five full years of judicial acceptance - throughout the history of the Federal Circuit - CCPA case law on chemical obviousness is under direct attack in a panel opinion. With the support of one additional member of the panel, the Chief Judge of the Federal Circuit has issued what is undoubtedly the single most controversial chemical practice ruling in the history of the Federal Circuit.

Also contrary to established precedent, the majority gives weight to the fact that the prior art is a patent that has a claim encompassing the claimed compound, a point relevant to infringement but less relevant to obviousness than the point as to whether there is a relevant teaching to suggest the claimed compound. A serious misunderstanding of "obvious to try" case law creates new problems particularly for the chemical industry.

Wegner thinks that chemistry deserves special consideration, but never addresses the inanity of the subjective standard of "obvious to try" that the Supreme Court crafted in creating Obzilla in KSR.

"The question of 'structural similarity' in chemical patent cases has generated a body of patent law unto itself." Unlike the world of mechanical incremental innovations that focus almost entirely upon the creation of new combinations of old elements, the organic entities are unique structures that may or may not have a close apparent relationship to prior art compounds. Given a particular organic structure, the skilled chemist can instantly visualize methods to make - quite literally - thousands if not millions of somewhat structurally related compounds that may or may not be expected to behave along the lines of the known prior art compound. But, knowing possible two dimensional structural formulae that could be made may or may not include an expectation of similar properties, a fact-intensive inquiry in an ever-changing state of the art.

Wegner points out the poison to rule of law that the courts have swallowed.

Going beyond the arcane world of chemical practice, the recent evolution of panel precedent has emphasized the balkanization of panel precedent, the erosion of the former approach where en banc and prior panel opinions created bedrock principles upon which the public can rely.

Like jurisprudential peanut butter, Wegner spreads the blame, but there can be no such excuse for imprudence at the appellate level.

It is easy to criticize mistakes in judicial opinions, but here a major share of the blame for the problems in both KSR and Pfizer v. Apotex is due to inadequacies of legal scholarship in the briefing process.

For those in chemical practice particularly, Mr. Wegner's paper is crucial. It is certainly a caution that the patent office and the courts have discarded justice by sowing confusion to rig the system to benefit large corporations at the expense of invention by smaller entities.