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In claiming this ‘invention’, patent attorneys will layer a claim set to include claims to each of the components separately and to the system collectively in order to obtain the broadest protection possible.

However, each of these components may be deemed a different invention through they are all interrelated.

You will receive a restriction requirement in this case.

A more frustrating example is one where the examiner makes a restriction requirement between an apparatus and a method for using the apparatus.

invalidating a patent claim-82invalidating a patent claim-84invalidating a patent claim-43

In addition, while a party is generally permitted to offer alternative arguments to the court,[15] this strategy may impair a party's credibility when arguing that a clerical error is clear on the face of the patent.

The district court conducted a bench trial, and held claim 4 invalid as obvious and that the patent was not enforceable because of inequitable conduct. Obviousness The parties did not dispute the district court’s finding that Caraco had presented a case that “it was obvious to try combination therapy using metformin and repaglinide to treat Type II diabetes.” In particular, “[i]t was apparently well-known in the art that two drugs having different mechanisms for attacking diabetes may be more effective than one, and so drugs were often tested in combination therapy after demonstrating effectiveness in monotherapy.” Moreover, “[c]ombination therapy using insulin sensitizers and insulin secretagogues was common at the time, and metformin was the most widely-used insulin sensitizer as of the ’358 patent’s filing date.” Thus, the issue before the court was whether the combination therapy achieved surprising and unexpected results, such as “synergistic” results.” The district court found that it did not.

On appeal, Novo Nordisk lodged three main challenges to the district court decision, but the Federal Circuit was not persuaded by any of them.

In response, Novo Nordisk brought suit under the Hatch-Waxman patent litigation framework, asserting claim 4 of the ’358 patent.

Caraco filed a counterclaim asserting invalidity and unenforceability.

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