In Speck v. Bates, the Federal Circuit clarified a long-standing exception to section 135(b)(1), wherein an applicant can file its claim after the critical period but 'had already been claiming substantially the same invention as the patentee' during the critical period, are not time-barred.  The underlying issue is . . . whether amendments to the Bates '591 application after the critical date changed the claims so that they are not substantially the same as the claims before the critical date.  The Board denied Speck's motion to dismiss because it found that the later amended claims did not differ materially from the claims in other patents and patent applications Bates owned that were filed prior to the critical date because 'Speck had not directed the Board to a material limitation of the Bates involved claims that is not present in the earlier Bates claims.
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37 C.F.R. § 135(b)(1): A claim which is the same as, or for the same or substantially the same subject matter as, a claim of an issued patent may not be made in any application unless such a claim is made prior to one year from the date on which the patent was granted.
 
Holdings:
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 “[I]n effect, that claims are not for substantially the same subject matter if one of them contains one or more material limitations which are not found in the other. This articulation is the same as the two-way test, which requires comparing the two sets of claims to determine if either set contains material limitations not found in the other, rather than just looking to only see if the post-critical date claims contain material limitations not present in the pre-critical date claims.”
 
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 “That each of these applications were amended to have these different limitations in order to overcome rejections is evidence that these limitations are material to their respective applications and that their differences cannot be disregarded.  These actions are strong evidence of the materiality of the amendment to add the 'free of a containment material atop the drug layer' limitation to the '591 application.  There is also no evidence in the record . . . to support a finding that this limitation is not material.  On this record, we conclude that as a matter of law the pre-critical date claims are materially different from the post-critical date claims [and] [t]he '591 application is time-barred under section 135(b)(1).