Ex parte SAMUEL LOCKWOOD et al. (BPAI)
Appeal 2008-5693
Application 10/793,676
Technology Center 1600
Decided: March 2, 2009
Claim:
A method of reducing C-reactive protein (CRP) levels in a subject comprising administering to a subject who would benefit from such treatment, an effective amount of a pharmaceutically acceptable formulation to reduce the level of circulating CRP in the subject, said pharmaceutically acceptable formulation comprising a non naturally occurring carotenoid analog or derivative; wherein the synthetic carotenoid analog or derivative has the structure …
The Examiner rejected the claims as lacking written description and lacking enablement. The Examiner alleged that the specification "fails to disclose any treatable diseases caused by increased C-reactive protein (CRP), and how reducing CRP is the same as treating the diseases” and characterized the claims as reach through claims, which according to the Examiner are unpatentable. Applicants countered showing that there is a correlation with CRP and certain known diseases.
The Board stated reversed the Examiner. The Board found that the "specification provides direct descriptive support of an association between many ischemic disease states and reperfusion injury (FF 1-2). The Specification directly teaches that levels of C-reactive protein are associated with reperfusion injury and that treatment of these conditions with carotenoids “is expected to inhibit and/or ameliorate . . . disease conditions” (Spec. 7, ll. 2-5; FF 3-4). The Specification also teaches possession of a large number of specific carotenoids (FF 5)." The Examiner had argued that there was no "no conclusive evidence that reduction of circulating CRP is ‘a powerful anti-inflammatory therapeutic modality’ and/or ‘a strong therapeutic modality’” The Board held that for written description this standard is incorrect you only have to show possession of the invention, not conclusive evidence of a link.
The claims were also rejected as being non-enabled. The Examiner did not provide any evidence other than opinion that the claims were not enabled. The Examiner seemed to rely upon the step of detecting and diagnosing CRP to perform the claim. The Board noted that this is routine and not undue. The Examiner also argued that it is not known all diseases arising from CRP are known. The Board held that it is not a requirement and there can be some inoperative embodiments. The Examiner argued that there could be some mutations that cause constituve expression of CRP rather than heart injury. But this argument was not supported by any evidence just Examiner opinion.
The Board Concluded: "The Examiner has not provided the required evidence or scientific reasoning to show that one of ordinary skill in the art would find that reduction of CRP levels in a patient would have required “undue experimentation”. The Examiner's mere assertions to that effect are not sufficient for establishing a prima facie case of lack of enablement. Balancing the factors in the Wands analysis, upon which the rejection is based, demonstrates that there is no prima facie case of lack of enablement.
The claims were rejected for being indefinite but the Examiner failed to say why and thus the rejection was reversed. The claims were also rejected for containing new matter because an R group was not in the specification. This was a new ground of rejection and was remanded to the Examiner for further prosecution.
Case can be found here
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