Patents are not barred just because it was obvious to explore a new technology that seemed to be a promising field of experimentation

In The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit held that the patent covering the active ingredient of ACTONEL was not obvious. Teva had argued that the claim covering the compound (risedronate) was obvious in view of an expired patent also owned by Procter. The previous patent did not claim or disclose the specific compound. The previous patent only disclosed a an intermittent dosing method for treating osteoporosis and listed 36 polyphosphonate compounds and Teva contended that the structural similarities between ACTONEL and one of the listed compounds rendered the claim covering ACTONEL obvious. The district court concluded that the earlier patent would not have led a person of skill in the art to identify the specific compound as the lead compound. The district court also found that due to the extremely unpredictable nature of bisphosphonates at the time of the invention there would not have been any motivation to make the specific modifications. The district court also found that the unexpected results of the potency of ACTONEL and the low toxicity rebutted any alleged obviousness and that the secondary considerations also supported its conclusions.

The court agreed with the district court explaining that "an obviousness argument based on structural similarity between claimed and prior art compounds 'clearly depends on a preliminary finding that one of ordinary skill in the art would have selected [the prior art compound] as a lead compound.'"

The CAFC framed the issue as stating that to decide whether residronate was obvious the court must determine whether there would have been a "reason to attempt to make the composition" known as risedronate and "a reasonable expectation of success in doing so." The court explained that even if a lead compound had been identified there was no factual support to find the reason to make the composition or that would have been a reasonable expectation of success. The CAFC and the district court relied upon Procter's expert witnesses that testified to the unpredictable nature of bisphosphonates and an article by the "preeminent authority on bisphosphonates that stated that "to infer one compound the effects in another is dangerous and can be misleading." The federal circuit agreed that the field was unpredictable and and that the district court had properly found that Teval failed "clear [the] hurdle, establishing insufficient motivation for a person of ordinary skill to synthesize and test risedronate."

The CAFC also agreed that there was no reasonable expectation of success. The court emphasized that there where there are a finite number of identified predictable solutions it is likely that the invention is obvious, but that where there are numerous possible choices "where the prior art [gives] either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful" the "courts should not succumb to hindsight claims of obviousness." The court explained that "patents are not barred just because it was obvious "to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it." Here, the CAFC found that it was not routine to make the structural modification. Therefore, the claims were not obvious.

The court also found that Proctor had provided sufficient evidence of unexpected results and secondary considerations of non-obviousness to rebut any prima facie obviousness even if it had been properly made. The court found that Proctor had satisfied a long-felt need at the time the application was filed. Teva had argued that the long-felt need must be unmet at the time the invention becomes available on the market, when it can actually satisfy that need. Actonel came on the market after Fosamax so it couldn't fill any need because it had already been met. The CAFC disagreed finding that they look to the filing date to asses the presence of a long-felt and unmet need.

As an alternative ground Proctor had attempted to show that the patent used by Teva to show obviousness was not prior art. Proctor only had a notebook page that was dated but was unwitnessed and was not corroborated by any other evidence. Since there was no other corroboration other than the dated page it was not sufficient to disqualify the patent as prior art.

The full opinion can be found here.

A proposed modification that would render the reference unsuitable for its intended use cannot be used to render a claim obvious

BPAI Case

Ex parte PAUL K. WOLBER,
ROBERT H. KINCAID, DOUGLAS AMORESE,
DIANE ILSLEY-TYREE, ANDREW S. ATWELL,
MEL N. KRONICK, and
ERIC M. LE PROUST,
Appeal 2009-2252
Application 11/008,6031
Technology Center 1600
Decided: April 24, 2009

Claim at issue:
1. A method comprising:
(a) subjecting an array comprising a plurality of features, each comprising nucleic acids immobilized on a surface of a solid support via a cleavable domain having a cleavable region, to conditions sufficient to generate a solution phase composition of nucleic acids;

(b) contacting said solution phase composition of nucleic acids with one or more reactants to produce a mixture of product nucleic acids; and

(c) contacting said product nucleic acids with an addressable array of probe nucleic acids.

The Examiner alleged that the claims were obvious based upon the combination of the two references. The appellants argued that the primary reference required an element that if modified would have made the invention unsatisfactory. The Board agreed with the appellants explaining:

"Thus, while [the primary reference] does not require the capture probes to be covalently linked to the affinity matrix, the Examiner has not explained why one of ordinary skill in the art would have attached the capture probes of Lipshutz to its affinity matrix with a technique which allows for the capture probes to be released from the affinity matrix during use due to competitive hybridization between the complementary nucleic acids in the matrix array and the complementary nucleic acids in the sample."

Therefore, the invention was not obvious because "Appellants have shown that the Examiner's proposed modification of the affinity matrix of Lipshutz by Nallur would render the affinity matrix of Lipshutz unsuitable for its intended use."

Full opinion can be found here.

Acceptance of Animal Model is sufficient for Enablement

Ex parte LAWRENCE M. BLATT, HUA TAN and
SCOTT D. SEIWERT
Appeal 2008-6024
Application 11/370,535
Technology Center 1600
Decided: April 27, 2009

1. A method of treating a flavivirus infection in an individual, the method comprising administering to an individual in need thereof an effective amount of an agent that inhibits enzymatic activity of a membrane-bound α-glucosidase, wherein the agent is not an imino sugar.

The Examiner rejected the claims for not being definite, for lacking utility and for not being enabled.

Indefiniteness:
The Examiner alleged that the phrase "wherein the agent is not an imino sugar" was indefinite. Appellants provided exhibits to support their position that imino sugars are recognized by those of skill in the art to be sugars in which the ring oxygen is replaced by a nitrogen atom. The Examiner argued that a compound in a dependent claim "“is arguably ‘an imino sugar’” but the Examiner had no evidence to support this argument. Therefore, the claims were definite.

Utility:
Examiner argued that it lacked utility because treatment included preventing the disease, which is "very unlikely to ever be demonstrated to be possible as a consequence of a medicinal treatment." The Appellants responded by pointing to the definition which included treating symptoms as well. The Board explained, "The Specification defines “treating” as including “completely or partially preventing a disease or symptom thereof” (FF 10); that definition does not require complete, 100% effective prevention of virus infection of any cell of the treated individual. The Examiner has not provided sufficient evidence to support a conclusion that the claimed method would not be useful for “completely or partially preventing a disease or symptom thereof,” as “treating” is defined in the Specification."

Enablement:
The Examiner alleged that the claims were not enabled because it only used an model of flavivirus infection but did not enable treating an HCV infection. The Examiner pointed to a reference that said that the prior art stated, "“validation of the utility of the BVDV surrogate virus model is incomplete, since most of the few drugs that are known to be active against HCV have not been tested against BVDV." However, the rest of the reference stated that although validation was not complete the BVDV model is used by the field and accepted as a model. The Board explained, "Based on that acceptance, persons of skill in the art would expect that a drug that is shown to be effective against BVDV would reasonably be expected to also be effective against HCV."

The Examiner also objected to another claim that used the phrase "and at least one additional therapeutic agent" because it could be an infinite number of agents. The Examiner explained "“reliance on the term ‘at least one’ extends the possible number of ‘additional therapeutic agents’ to infinity, a circumstance which is clearly not enabled by the instant disclosure." The Board reversed finding that this is not sufficient evidence to show that it is not enabled and that the Examiner has not shown that it would require undue experimentation.

The Board Explained:

"The Examiner has provided no reasonable basis for concluding that a person of ordinary skill in the art could not have practiced the method of claim 6 without undue experimentation. The Examiner has posited a potentially inoperative embodiment encompassed by the claim but that by itself does not show nonenablement without evidence that the number of inoperative embodiments is so large that distinguishing between operative and inoperative embodiments would itself require undue experimentation. No such evidence has been presented."

All rejections were reversed.

Full opinion can be found here.

BPAI rejects Examiner's Argument that "the meaning of the claims should be clear from the wording of the claim[s] alone"

Ex parte PETER N. KAO, RONALD G. PEARL,
TOSHIHIKO NISHIMURA, and JOHN L. FAUL
Appeal 2008-5150
Application 10/801,729
Technology Center 1600
Decided: April 29, 2009

Claim at issue had the following phrase:
1. A method of treating a lung proliferative vascular disorder in a patient comprising administering an HMG-CoA reductase inhibitor,

wherein the HMG-CoA reductase inhibitor is present in an amount effective to reduce vascular occlusion in the pulmonary arteries of the

patient, and which does not substantially increase endothelial cell nitric oxide synthase activity in the endothelial cells of the pulmonary arteries of

the patient; and wherein said lung proliferative vascular disorder is selected from the group consisting of primary pulmonary hypertension, secondary pulmonary

hypertension, Eisenmenger’s syndrome, chronic thromboembolic disease, pulmonary fibrosis, obliterative bronchiolitis, and lymphangioleiomyomatosis.

The Examiner alleged that the underlined phrase was indefinite because “the meaning of the claims should be clear from the wording of the claim[s] alone” The Board rejected this argument and found that the specification clearly defined the term for one of skill in the art. The term was specifically defined in the specification. Because of the definition the indefiniteness rejection was reversed. The claims were found to be anticipated and obvious for other reasons.

Full opinion can be found here.