On February 9, 2016, in C.R. Bard, Inc. v. Medical Components, Inc., IPR2015-01660, the PTAB  refused to institute an IPR against US Patent No. 8,257,325, “Venous Access Port with Molded and/or Radiopaque Indicia.”  The challenged claims were directed to a venous access port assembly with a marking to indicate the port is rated for power injection of a contrast fluid, which marking is visible by X-ray examination when the port is implanted. 

The Petitioner’s (Bard’s) primary reference was its own brochure, which showed implantable titanium ports that included suture slots and orientation holes to simplify implantation and promote port securement.  Bard argued it would have been obvious to a person of ordinary skill in the art to modify the ports disclosed in the brochure to accommodate power injection.  A secondary reference described an access port with a feature to identify the port as being rated for power injection after implantation.  The identifying feature of the secondary reference was an alphanumeric message “CT” etched in a plate in the bottom of an implantable access port.  The plate could be metal, making letters visible on an X-ray.

The PTAB panel treated Bard’s arguments as a house of cards that could not sustain the petitioner’s burden to present a reasonable likelihood it would prevail in establishing that any of the challenged claims of the ‘325 patent are unpatentable.

Bard acknowledged that the titanium implanted port in its brochure was not power injectable, and did not have indicia indicating the port assembly was rated for power injection.  Bard argued one of ordinary skill in the art would have known, however, that the titanium ports of the brochure could be modified to handle higher pressures and flow rates associated with power injection.  Additionally, Bard asserted that it would have been obvious to provide such a modified titanium port with X-ray discernible indicia.  Bard further argued it would have been obvious to form such X-ray discernible indicia as voids extending through the flange, because the flange already includes suture slots and orientation holes that function as indicia of orientation under X-ray examination.

The PTAB found Bard did not provide adequate reasoning with rational underpinning as to why it would have been obvious to modify the titanium port of the brochure to be rated for power injection.  The panel conceded the challenged claims did not recite that the claimed port assembly had to actually accommodate power injection (as distinct from bearing X-ray discernible indicia that it was rated for power injection).  But because Bard built its obviousness arguments based on the assumption that the circular ports of the brochure could be modified to support power injection, the PTAB’s finding with respect to this premise led the rest of Bard’s positions to collapse.

The PTAB panel found the Petitioner’s assertion “is conclusory, and relies exclusively on … declaration testimony, which merely repeats the conclusory statements in the Petition without citation to the asserted prior art references or any other evidence. …  Accordingly, his testimony has little, if any, probative value.” (citing 37 CFR 42.65(a):  “Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”)

Petitioner’s assertion “is conclusory, and relies exclusively on … declaration testimony, which merely repeats the conclusory statements in the Petition without citation to the asserted prior art references or any other evidence. …  Accordingly, his testimony has little, if any, probative value.”

The patent owner had also cited Kinetic Technologies, Inc. v. Skyworks Solutions, Inc., IPR2014-00529, Paper 8 at 15 (P.T.A.B. Sept. 23, 2014) (“The Declaration does not explain the ‘how,’ ‘what,’ and ‘why’ of the proposed combination of references….  Accordingly, we give [the] Declaration no probative weight.”) to support its argument that the declaration testimony was insufficient.

The PTAB panel refused to find the secondary reference’s teaching of suture apertures would have led a person of ordinary skill in the art to modify the flange of the port in Bard’s brochure to include X-ray discernible voids indicating the port is rated for power injection. The PTAB panel agreed with the patent owner that the functions of the suture slots and orientation holes of the titanium port of the brochure were to simplify implantation and promote port securement, not to provide X-ray discernible indicia of orientation after implantation.  Bard’s declaration only cited to the entirety the brochure to support this point.  Again, the PTAB found declaration testimony that the flange is known as a location for X-ray discernible indicia was conclusory and lacked adequate explanation and support.

As earlier blog posts have stressed, the PTAB has little sympathy for petitioners whose expert declarations do not sufficiently explain how and why prior art references should be combined to result in the challenged claims.