In Ex parte Gilbert (Appeal 2012/005795; App. No. 11/200,749), the Patent Trials and Appeals Board (PTAB) held that the Examiner had not established that one of ordinary skill in the art would have had an apparent reason to combine the references because there is nothing that would “tie” the approaches of the references together.
The only independent claim at issue reads as follows:
8. (Previously Presented) A method for delivering a drug into tissue comprising the steps of:
providing a drug delivery device having at least one nozzle and a drug contained in a portion of the device;
identifying a site for delivery of the drug in the eye;
placing a portion of the device on or near the site; and
delivering the drug as a fine stream into the tissue at the site through the at least one nozzle of the device under needle-free microjet propulsion at a driving pressure from about 800 to about 2,000 psi such that the pressure of the drug leaving the nozzle is from about 4,000 to about 25,000 psi.
The Examiner rejected independent claim 8 as being obvious over U.S. Patent No. 6,010,478 to Bellhouse in view of U.S. Patent No. 4,137,804 to Gerber. Specifically, the Examiner stated that Bellhouse discloses every element of the claim except that “pressure of the drug leaving the nozzle is from about 4,000 to about 25,000 psi.” However, the Examiner argued that Gerber does teach such a feature.
Bellhouse is drawn toward a needleless syringe capable of accelerating a therapeutic agent across a mucosal tissue. Gerber, on the other hand, is drawn toward a cutting machine utilizing a high velocity fluid cutting jet for cutting sheet material. The Appellant argued that there “is simply no evidence or basis for suggesting that anything [Gerber] teaches would be applicable to the drug delivery field,” and that there is “nothing in the Gerber or Bellhouse patent, and nothing proposed by the Examiner that would tie these two approaches together.”
Relying on KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, the PTAB agreed with the Appellant. Specifically, the PTAB stated, “Establishing a prima facie case of obviousness of an invention comprising a combination of known elements requires ‘an apparent reason to combine the known elements in the fashion claimed…’” KSR Int’l at 418. The PTAB concluded that the Examiner did not establish an apparent reason to increase the fluid velocity of the drug delivery device of Bellhouse to pressures sufficient to cut fabrics or wood, as taught by Gerber, because “there is…nothing proposed by the Examiner would tie these two approaches together.
Takeaway: The Examiner must show more than the mere existence of each element in a combination of references and, instead, must provide rational basis for modifying a primary reference with a secondary reference. Further, Applicant arguments that the Examiner has failed to provide a rational basis for a combination may be crafted with limited, or no, harmful prosecution history because the arguments are merely drawn toward the combinability of two references, as opposed to distinctions of the claims over the prior art.