Opinion ID: 1405856
Heading Depth: 1
Heading Rank: 9

Heading: PTO Representations

Text: The original application that led to the '551 patent was filed in 1984. Over the next thirteen years, Abbott pursued the patent through half-a-dozen continuation applications that were repeatedly rejected for anticipation and obviousness, including repeated rejections over the '382 patent. In 1997, Abbott formulated a new argument for patentability during a brainstorming session attended by Lawrence Pope (Pope), Abbott's patent attorney, and Dr. Sanghera, Abbott's Director of Research and Development. Thereafter, new claims were drafted including electrochemical sensors lacking a membrane. During an interview with the examiner, Pope presented the new claims with the argument that the claims of the application were not anticipated or obvious because the claims taught a new glucose sensor that did not require a protective membrane when testing whole blood. Pope and the examiner specifically discussed the [o]ptionally, but preferably language in the '382 patent. In Pope's own summary of the interview, he stated that he pointed out [to the examiner] that [the '382 patent] teaches that active electrodes designed for use with whole blood require a protective membrane. J.A. 7644. The examiner then agreed that if Abbott produced an affidavit or other evidentiary showing that at the time of the invention such a membrane was considered essential [for whole blood, it] would overcome [the '382 patent's] teaching. J.A. 7639. In accordance with that agreement, Dr. Sanghera submitted a declaration to the PTO urging that the language of the '382 patent concerning the membraneless sensor should not be taken at face value. It stated in relevant part: [B]ased on his historical knowledge he is confiednt [sic] that on the filing date of the earlist [sic] application leading to the present application on June 6, 1983 and for a considerable time thereafter one skilled in the art would have felt that an active electrode comprising an enzyme and a mediator would require a protective membrane if it were to be used with a whole blood sample. Therefore, he is sure that one skilled in the art would not read lines 63 to 65 of column 4 of U.S. Patent No. 4,545,382 to teach that the use of a protective membrane with a whole blood sample is optionally or merely preferred. J.A. 7637 (emphases added). Pope, in submitting the affidavit, further represented: The art continued to believe [following the '382 patent] that a barrier layer for whole blood sample was necessary for a considerable period .... One skilled in the art would not have read the disclosure of the Higgins patent (U.S. 4,545,382) as teaching that the use of a protective membrane with whole blood samples was optional. He would not, especially in view of the working examples, have read the optionally, but preferably language at line 63 of column [4] as a technical teaching but rather mere patent phraseology. This is supported by the Declaration under 37 C.F.R. 1.132 of Gordon Sanghera which accompanies the present amendment. . . . . ... The applicants have established that a new claim limitation supported by the present application provides a patentable distinction over U.S. Patent No. 4,545,382, the key reference in the prosecution of the present application and its predecessors. There is no teaching or suggestion of unprotected active electrodes for use with whole blood specimens in this patent or the other prior art of record in this application. J.A. 7645-46 (emphases added). Shortly thereafter, the PTO allowed the '551 patent with the newly added claims for a membraneless sensor.