Public Accessibility – The touchstone in determining whether a reference constitutes a “printed publication” within the meaning of 35 U.S.C. § 102(a) or 102(b)

February 6, 2012 – Blog Post

In Ex parte Knight Castro (Appeal 2011-000645; U.S. Application 10/510,454; Decided February 2, 2012) the issue before the Board was whether the Examiner erred in concluding that a reference constituted prior art as a “printed publication” within the meaning of 35 U.S.C. § 102(a) or 102(b).

Appellant’s invention is a method for improving radiostability of a 18F-fluor-deoxy-glucose (18F-FDG)-solution during autoclaving, the method comprising: (a) providing a 18F-fluor-deoxy-glucose (18F-FDG)-solution, (b) adding at least one buffer based on a weak acid to the 18F-fluor-deoxy-glucose (18F-FDG)-solution, wherein the buffer is selected from the group consisting of citrate, acetate, ascorbate and combinations thereof; and (c) autoclaving the buffered 18F-fluor-deoxy-glucose (18F-FDG)-solution.

The claims were rejected by the Examiner under 35 U.S.C. § 103(a) as being obvious over Manual of Operating Instructions (hereinafter “the Manual”) in view of Damhaut (U.S. Patent 6,172,207) and Asai (U.S. Patent 5,536,491), as evidenced by Stone-Elander (U.S. Patent 5,308,944).

The Manual described a method of avoiding decomposition and improving stability of a FDG solution, to be heated to a temperature of 135oC, by adjusting the pH of the FDG solution with a buffer.

The Examiner acknowledged that the Manual failed to describe that the FDG is labeled with an 18F isotope, the buffer is citrate, and the FDG solution is autoclaved, as claimed.

In an attempt to compensate for these deficiencies, the Examiner relied on the disclosures of Damhaut, Asai and Stone-Elander.

Damhaut described an 18F-FDG solution for nuclear magnetic resonance (NMR) having a pH adjusted by the addition of a citrate buffer. Asai described autoclave sterilization of an 19F-MRI contrast medium. Stone-Elander illustrated that an 18F isotope is stable at high temperatures.

The Examiner alleged that it would have been prima facie obvious for a skilled artisan to arrive at the claimed method based on the combined disclosures of the cited references.

The Appellant argued that the Office has not met the burden of establishing that the Manual has been disseminated or made available to the public prior to the effective filing date of the present application as required in order for the Manual to qualify as prior art as a printed publication, and cited MPEP § 2128 and In re Wyer, 210 USPQ 790 (CCPA 1981) (stating that the one who wishes to characterize the information as a “printed publication” should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art).

The Appellant also referred to the decision of ResQNet.com Inc v. Lansa Inc., 93 USPQ2d 1553 (Fed. Cir. 2010) (noting that public accessibility is the touchstone in determining whether a reference constitutes a “printed publication” and holding that in the absence of any evidence demonstrating that the user manuals were actually published or disseminated to the public prior to the critical date, the references are not “printed publications” and could not be considered prior art).

The Examiner responded by alleging, without any supporting evidence, that the Manual would be disseminated to those who purchase the laboratory equipment associated with the Manual.

In reversing the obviousness rejection, the Board reasoned that no evidence has been presented showing that the laboratory equipment associated with the Manual was actually sold and agreed with the Appellant’s position that the Examiner has not established on the record that the Manual has been disseminated or made available to the public prior to the effective filing date of the present application as required in order for the Manual to qualify as prior art as a “printed publication” within the meaning of 35 U.S.C. § 102(a) or 102(b).