`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`C.R. BARD, INC.
`Petitioner,
`
`v.
`
`MEDICAL COMPONENTS, INC.
`Patent Owner
`____________
`
`
`
`Case IPR2015-01660
`Patent 8,257,325 B2
`____________
`
`PETITIONER’S REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R § 42.71(d)
`
`
`
`Mail Stop PATENT BOARD, PTAB
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.71(d), Petitioner C.R. Bard, Inc. hereby requests
`
`rehearing of the Board’s Decision Denying Institution of Inter Partes Review 37
`
`C.F.R. § 42.108 (Paper 9, February 9, 2016)(“Decision”).
`
`I.
`
`INTRODUCTION
`
`Petitioner respectfully submits the Board overlooked or misapprehended
`
`important points regarding the ‘325 patent (Ex.1001), the prior art, Mr. Tallarida’s
`
`testimony (Ex.1009), and the knowledge of a person of ordinary skill in the art at
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`the time of invention (“POSA”), such that the Board improperly concluded that the
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`information presented does not show that there is a reasonable likelihood that
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`Petitioner would prevail in establishing that any of the challenged claims of the
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`‘325 patent are unpatentable. Paper 9, p.2.
`
`II.
`IMPORTANT POINTS OVERLOOKED OR MISAPPREHENDED
`A. The Board Overlooked And Misapprehended That The ‘325 patent
`Describes An Access Port That Can Be Constructed To Include X-ray
`Discernable Indicia Indicating That The Assembly Is Rated For Power
`Injection
`
`The Board stated that “[t]he Petition and Mr. Tallarida’s cited testimony do not
`
`explain how the Titanium Implanted Port of PORTS would have been modified so
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`as to be rated for power injection, nor do they point to any disclosure in Powers
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`that would have suggested how such a modification would have been made.” Paper
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`9, p. 12. The Board overlooked and misapprehended that the ‘325 patent does not
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`disclose how to construct an access port, and only provides general information
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`1
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`regarding the elements of an access port. (Ex.1001).
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`The ‘325 patent is directed to “a venous access port assembly that provides a
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`medical practitioner with the capability to discern an important property of the port
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`assembly after the port assembly has been implanted into a patient.” Ex.1001,
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`1:33-36. “One such characteristic could be power injectable capability; that is, an
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`indication that the venous access port is rated for the power injection of contrast
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`fluid. Power injection capability can be indicated with the letters ‘CT,’ for
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`‘computed tomography,’ or ‘contrast enhanced computed tomography.’” Ex.1001,
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`1:59-64. Thus, the ports disclosed in the ‘325 patent could be constructed with
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`indicia, such as letters “CT”, to show the port is rated for power injection.
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`The ‘325 patent, being written with respect to a POSA, does not provide details
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`regarding port construction or use, but discloses general structure of access ports.
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`Ex.1001, 3:24-45. A patent need not teach, and preferably omits, what is well
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`known in the art. In re Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991); Hybritech,
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`Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 (Fed. Cir. 1986); and
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`Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d
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`1452, 1463 (Fed. Cir. 1984).
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`The ‘325 patent discloses similar structures to the Titanium Implanted Port
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`including an access port with a flange that can be constructed to include X-ray
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`discernable indicia. Pet. 24-26. Power injectable ports and rating of ports as being
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`2
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`power injectable, such as by the use of letters “CT”, were clearly known at the time
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`the application for the ‘325 patent was filed. Thus, it was well within the
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`knowledge of a POSA how to construct a port to withstand the high pressures and
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`flow rates used for injection of contrast fluid, such as disclosed by Powers, so that
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`the port could be rated as power injectable. Ex.1009, ¶¶148,196-198; Pet.7, 31.
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`Like the ‘325 patent, each of PORTS, Powers and PowerPort discloses access
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`ports. Pet. 18-21. Powers and PowerPort disclose power injectable ports. Pet. 20-
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`21, 29. Because the Board overlooked the limited disclosure of the ‘325 patent,
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`and that it does not distinguish between conventional access ports and access ports
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`that can be marked as rated for power injection, the Board misapprehended the
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`knowledge of a POSA, and that the ‘325 patent was written with respect to the
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`knowledge of a POSA.
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`B. The Board Overlooked And Misapprehended The Knowledge Of A
`POSA, And That A POSA Would Have Known How To Modify A
`Conventional Access Port So As To Be Rated For Power Injection.
`
`The claims of the ‘325 patent are directed to an access port assembly with
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`indicia that the assembly is rated for power injection. Indeed, the ‘325 patent
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`discloses and claims structures having the same elements as the Titanium
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`Implanted Port, e.g., a base, a flange, a reservoir and a septum. Compare Titanium
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`Implanted Port (Ex.1002) with ‘325 patent (Ex.1001), Fig. 5; Ex.1009, ¶¶26-36,
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`47-75; Pet. 12, 24. Moreover, power injectable and non-power injectable ports
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`3
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`comprise similar structures, such that a POSA would have known that a Titanium
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`Implanted Port could be constructed to handle power injection as taught by
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`Powers. Ex.1009, ¶165.
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`As discussed in the Section A above, the ‘325 patent does not disclose how
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`to modify conventional access port structures to be rated for power injection. All
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`that the ‘325 patent discloses is that the port can include indicia that it is rated for
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`power injection, i.e., constructed as a power port by being rated for power
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`injection. The ‘325 patent does not disclose how to make or use power injectable
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`ports. Rather, the ‘325 patent merely discloses that a port can have indicia visible
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`by X-ray examination, identifying a characteristic of the port. One such
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`characteristic could be power injectable capability.
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`No distinction is made in the ‘325 patent between the structures of power
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`injectable and non-power injectable ports:
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`Venous access ports for the infusion and/or withdrawal of fluids from
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`a patient are well-known, secured to the proximal end of an implanted
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`catheter. …. The ports are assemblies of a needle-impenetrable
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`housing with a discharge port in fluid communication with a catheter
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`and a reservoir within the port housing, and provide a subcutaneous
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`self-sealing septum that defines an access site for multiple needle
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`sticks through the covering skin tissue of the patient, through the
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`septum, and into the reservoir, without the need to continuously
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`search for new access sites. Examples of such ports are disclosed, for
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`4
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`example, in U.S. Pat. Nos. 4,704,103; 4,762,517; 4,778,452;
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`5,185,003; 5,213,574; and 5,637,102. Ex.1001, 1:19-32.
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`The ‘325 patent discloses structures common to venous access ports, and
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`makes no distinction between power injectable and non-power injectable ports,
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`other than it is desirable to provide an identification that a venous access port is
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`rated for the power injection. As the Tallarida Declaration establishes, a port that is
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`rated for the power injection is constructed to withstand the high pressures and
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`flow rates associated with power injection, such as disclosed by Powers, so that the
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`port could be rated as power injectable. Ex.1009, ¶¶148, 196-198.
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`Thus, as power injectable ports and rating of ports as being power injectable,
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`were clearly known at the time the application for the ‘325 patent was filed, it was
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`well within the knowledge of a POSA how to construct a port to withstand the high
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`pressures used for injection of contrast fluid, such as disclosed by Powers, so that
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`the port could be rated as power injectable. Pet. 24-26, 31-34. It would have been
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`obvious for a POSA at the time of the invention in view of Powers to provide a
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`power injectable port with X-ray discernable indicia such as alphanumeric
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`characters which indicates, under X-ray examination, that the power injectable port
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`is adapted to withstand high pressures and flow rates used for injection of contrast
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`fluid. Ex.1009, ¶199, 228, 249; Pet. 24-26, 31-34.
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`As the Board is well aware, the specification shall contain a written description
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`of the invention, and of the manner and process of making and using it, in such
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`5
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`full, clear, concise, and exact terms as to enable any person skilled in the art to
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`which it pertains, or with which it is most nearly connected, to make and use the
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`same. § 35 U.S.C 112, first paragraph. Because the ‘325 patent specification does
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`not provide disclosure as how to make and use ports that are rated for power
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`injection, this is further evidence that the construction of power ports was within
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`the skill of the art at the time of filing of the ‘325 patent so that no written
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`description/enablement of the making and using of power injectable ports need be
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`disclosed in the ‘325 patent. A patent need not teach, and preferably omits, what is
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`well known in the art. Thus, the disclosure of the ‘325 patent supports Mr.
`
`Tallarida’s testimony that, “A person of ordinary skill in the art would have known
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`that the Titanium Implanted Port in view of Powers could be constructed to handle
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`power injection. Specifically, Titanium Implanted Port would be modified in view
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`of Powers to handle the higher pressures and flow rates associated with power
`
`injection for injecting contrast media.” Ex.1009, ¶¶146-148, 165, 199; Pet. 31-34.
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`By overlooking and misapprehending the disclosure of the ‘325 patent and
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`the knowledge of a POSA, the Board erred by providing Mr. Tallarida’s testimony
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`little weight, when Mr. Tallarida unequivocally testified (¶s are from Ex.1009):
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`148. A person of ordinary skill in the art would have known that the
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`Titanium Implanted Port in view of Powers could be constructed to handle
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`power injection. Specifically, Titanium Implanted Port would be modified
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`in view of Powers to handle the higher pressures and flow rates associated
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`6
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`with power injection for injecting contrast media, e.g., for a CT scan.
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`149. To identify the Titanium Implanted Port in view of Powers as a power
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`injectable port, at the time of the invention, it would have been obvious to a
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`person of ordinary skill in the art in view of Powers to provide the Titanium
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`Implanted Port with X-ray discernable indicia configured to indicate, under
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`X-ray examination, that the assembly is rated for power injection. 151.
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`Powers discloses a power injectable port with X-ray discernable indicia
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`configured to indicate, under X-ray examination, that the assembly is rated
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`for power injection.
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`165. [A]s both PORTS and Powers disclose venous access ports comprising
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`a housing, a base, a discharge port, a reservoir and a septum, a person of
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`ordinary skill in the art would have known that the Titanium Implanted Port
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`could be constructed to handle power injection as taught by Powers.
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`196. Powers discloses a power injectable port with X-ray discernable
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`indicia (alphanumeric characters) on the port, which indicates, under X-ray
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`examination, that the assembly is power injectable, i.e., adapted to withstand
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`high pressures used for injection of contrast fluid.
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`198. PowerPort also discloses a power injectable port with X-ray
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`discernable indicia (alphanumeric characters), which indicates, under X-ray
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`examination, that the assembly is power injectable, i.e., adapted to withstand
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`higher pressures and increased flow rates used for injection of contrast fluid.
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`199. It would have been obvious to a person of ordinary skill in the art at
`
`the time of invention in view of Powers and PowerPort to provide the
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`Titanium Implanted Port with alphanumeric X-ray discernable indicia, such
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`as “CT” or “C” and “T”, which indicates, under X-ray examination, that the
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`power injectable port is adapted to withstand high pressures and increased
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`flow rates used for injection of contrast fluid.
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`7
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`A POSA would have known that the Titanium Implanted Port has the same
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`structural elements as a power injectable port, e.g., see Powers, and would have
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`known that the Titanium Implanted Port could be constructed to handle power
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`injection. Ex.1009, ¶165. Accordingly, the Board overlooked the information
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`presented in the Petition and supporting exhibits which shows that there is more
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`than a reasonable likelihood that Petitioner would prevail in establishing the
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`unpatentability of the challenged claims of the ‘325 patent.
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`C. The Board Overlooked Mr. Tallarida’s First Hand Personal Knowledge
`Of Titanium Implanted Ports
`
`The Board overlooked that Mr. Tallarida has first-hand personal knowledge of
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`the structure and functions of the Titanium Implanted Port (Ex.1002) as Mr.
`
`Tallarida was involved with its production. Ex.1009, ¶¶12, 14, 16, 49-51. Mr.
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`Tallarida was also involved with the production of the power injectable PowerPort
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`(Ex.1004). Ex.1009, ¶17. Thus, Mr. Tallarida has first-hand personal knowledge
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`of the structures of both power injectable and non-power injectable ports.
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`The Board appears to have misapprehended the similarities between non-power
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`injectable ports and power injectable ports. The basic structures are the same as
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`shown by the ports disclosed in the ‘325 patent, PORTS, POWERS and
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`HICKMAN. Each of the disclosed ports comprises a housing with a base, a
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`reservoir, a discharge port extending from the reservoir and a septum. Exs. 1001,
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`1002, 1003, 1004, 1017. Specifically, the structures of the Titanium Implanted
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`8
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`Port and the port described in the ‘325 patent are substantially the same. Ex.1009,
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`¶¶26-36, 52-71; Pet. 11-12, 24-26. The difference between a non-power injectable
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`port and a power injectable port is that a power injectable port is constructed to
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`withstand high pressures and flow rates used for injection of contrast fluid. Ex.
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`1003, 3:42-59; Ex.1016, p.7/65 ([0034]). A POSA would have known that the
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`Titanium Implanted Port could be constructed so that it could be rated for power
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`injection, as clearly stated by Mr. Tallarida. Ex.1009, ¶¶148, 165; Pet. 24-26.
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`The portions of Mr. Tallarida’s unrebutted testimony reproduced in Section B.
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`are of an expert who has first-hand personal knowledge of the structures of power
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`injectable and non-power injectable ports, how to construct power injectable and
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`non-power injectable ports, and how to incorporate X-ray discernable indicia into a
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`power injectable port, e.g., with voids in the shapes of the letters “C” and “T,”
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`which upon X-ray examination indicate the assembly is rated for power injection.
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`Accordingly, the Board overlooked the information presented in the Petition
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`and supporting exhibits which establishes that there is more than a reasonable
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`likelihood that Petitioner would prevail in establishing the unpatentability of the
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`challenged claims of the ‘325 patent.
`
`D. The Board Overlooked The Stated Functions Of The Orientation Holes
`And That The Structure Of The Orientation Holes In The Titanium
`Implanted Port Are Voids Extending Through A Titanium Flange That
`Are X-Ray Discernable Indicia.
`
`The Board overlooked Mr. Tallarida’s testimony that “orientation holes are X-
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`9
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`
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`ray discernable indicia configured to indicate, under X-ray examination, the
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`orientation of the assembly.” Ex.1009, ¶¶62-67; Pet. 18-19, 32. The orientation
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`holes indicate the side of the access port where the catheter is or can be connected,
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`and also are capable of receiving sutures for securing the port when implanted.
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`Ex.1009, ¶¶66-67. The flange of the Titanium Implanted Port is made of titanium
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`(Ex.1009, ¶¶60, 133; Pet. 28) and the orientation holes extend completely through
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`the flange, such that the holes would be visible by X-ray. Ex.1009, ¶¶ 62-65; Pet.
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`30. Certainly, holes in a titanium metal flange would be naturally (inherently)
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`visible by X-ray examination. Ex.1001, 2:19-20; Pet. 12, 18-19. Powers discloses
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`that suture apertures 66 may be positioned so as to identify the access port 10 after
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`subcutaneous implantation. Ex.1009, ¶91; Pet. 15, 20, 25.
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`Thus, not only has the Board overlooked the testimony of Mr. Tallarida, the
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`Board misapprehended the inherent function of the orientation holes in the
`
`Titanium Implanted Port, which under X-ray examination would indicate to a
`
`POSA the orientation of the assembly. And further, the Board overlooked and/or
`
`misapprehended that the orientation holes on the Titanium Implanted Port are
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`voids extending through a titanium flange that are X-ray discernable. Thus, the
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`Board erred when it held that “We agree with Patent Owner that Petitioner has not
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`shown sufficiently that the suture slots and orientation holes in the flange of the
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`Titanium Implanted Port of PORTS function as X-ray discernable indicia.” Paper
`
`
`
`10
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`
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`9, p. 12. A POSA would have known that the orientation holes on the Titanium
`
`Implanted Port are inherently X-ray discernable indicia.
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`E. The Board Misapprehended Petitioner’s Arguments With Respect To
`PowerPort, Sayre And Meyer
`
`Petitioner cited PowerPort Guidelines for CT Technologists (Ex.1004,
`
`“PowerPort”), U.S. Patent No. 6,826,257 B2 (Ex.1007, “Sayre”), and French
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`Patent No. 1,509,165, (Ex.1005, “Meyer” with English translation Ex.1006) as
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`examples of voids in the shape of alphanumeric characters. Pet. 15-18, 20-24.
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`PowerPort (Ex.1004) discloses a power injectable port with X-ray
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`discernable indicia, i.e., voids in the shapes of the letters “C” and “T,” which upon
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`X-ray examination indicate the assembly is rated for power injection. Ex.1009,
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`¶¶93-101. Sayre (Ex.1007) and Meyer (Exs.1005 & 1006) similarly depict voids in
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`the shapes of alpha numeric characters. Ex.1009, ¶¶102-121; Pet. 15-18, 20-24.
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`A POSA would have readily understood that the voids in the flange of
`
`Titanium Implanted Port could have any shape which permitted sutures to pass
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`through, including alphanumeric shapes as shown in PowerPort, Sayre and Meyer.
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`Pet. 18-24, 29, 47, 50, 57. Further, a POSA would have known that PowerPort
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`discloses voids visible by X-ray in the shape of alphanumeric characters “C” and
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`“T”, which a POSA would have understood indicates that the port is power
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`injectable. Ex.1004; Ex.1009, ¶¶138-139, 148-166.
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`As discussed above, a POSA would have known that the orientation holes in
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`11
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`
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`the Titanium Implanted Port are X-ray discernable indicia. It would have been
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`readily apparent to a POSA that the shape of the orientation holes in the Titanium
`
`Implanted Port could be changed to indicate another characteristic, including that
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`the port is power injectable using voids in the shapes of “C” and “T” as disclosed
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`in PowerPort and suggested by Powers. Powers discloses that suture apertures
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`may be positioned to identify the access port after subcutaneous implantation.
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`Ex.1009, ¶91; Pet. 15, 20, 25. Sayre discloses apertures within an X-ray
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`discernable material to provide X-ray readable indicia that can also aid in
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`indicating orientation and receive sutures. Ex.1009, ¶¶255; Pet. 22-23, 50-54.
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`Thus, a POSA would have known that the orientation holes in the flange of
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`the Titanium Implanted Port are capable of receiving sutures as well as showing
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`the orientation of the port under X-rays. A POSA would have known that these
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`holes in the flange could have been modified to provide the additional function of
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`identifying a port as rated for power injection. Ex.1009, ¶¶183-186.
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`F. The Board Overlooked Mr. Tallarida’s Testimony That It Would Have
`Been Obvious To A POSA To Modify The Flange Of The Titanium
`Implanted Port To Include X-Ray Identifiable Alphanumeric
`Characters
`
`The Board stated that “we agree with Patent Owner that Petitioner has not
`
`provided adequate reasoning based on Powers and PowerPort for modifying the
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`Titanium Implanted Port of PORTS to include X-ray discernable indicia of power
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`injection capability in the flange. See Prelim. Resp. 23–29 [...] we are not
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`12
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`persuaded that Petitioner has shown sufficiently that a person of ordinary skill, in
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`view of Powers, would have modified the flange of the Titanium Implanted Port to
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`include X-ray discernable indicia in the form of voids indicating that the port is
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`rated for power injection, as Petitioner proposes.” These statements are incorrect
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`as the Board overlooked Mr. Tallarida’s testimony to the contrary (¶s are from
`
`Ex.1009):
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`210. Titanium Implanted Port includes holes (cutouts/voids) in the
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`flange which, under X-ray examination, function as indicia of
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`orientation. Exhibit 1002.
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`214. Titanium Implanted Port already has indicia extending through the
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`height of the flange of the port which, under X-ray examination,
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`indicate the orientation of the port.
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`215. It would have been obvious for a person of ordinary skill in the art
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`in view of PORTS in view of Powers to indicate that the Titanium
`
`Implanted Port is power injectable by including X-ray discernable
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`indicia comprising alphanumeric characters in the form of cutouts
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`(voids) extending through the height of the flange of the Titanium
`
`Implanted Port to indicate, under X-ray examination, that the assembly
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`is rated for power injection, because the flange of the Titanium
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`Implanted Port is already known as a location for X-ray discernable
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`indicia created by voids extending from the top of the flange to the
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`bottom of the flange.
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`216. The obviousness of including X-ray identifiable indicia in the
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`form of cutouts (voids) in the flange of the Titanium Implanted Port in
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`view of Powers to indicate that the assembly is rated for power
`
`
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`13
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`
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`injection is emphasized by PowerPort’s disclosure of X-ray discernable
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`indicia comprising alphanumeric characters in the form of cutouts
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`(voids) indicating that a port is power injectable.
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`217. Indicia in the form of cutouts (voids) in the flange of the Titanium
`
`Implanted Port would be expected to provide high contrast so that the
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`alphanumeric characters would be readily discernable, under X-ray
`
`examination, after implantation.
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`218. Moreover, the indicia in the flange of the Titanium Implanted Port
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`are already structured and arranged so as to be visually discernable
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`prior to implantation of the port as well as to be X-ray discernable after
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`implantation.
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`219. Accordingly, the same expected result would be understood to be
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`obtained with respect to indicia indicating that the assembly is rated for
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`power injection extending through the height of the flange from the top
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`to the bottom surface of the modified Titanium Implanted Port as for the
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`indicia already included in the flange of the Titanium Implanted Port.
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`Moreover, as pointed out in Section E. above, the Petition points out that
`
`Powers discloses that suture apertures may be positioned to identify the access port
`
`after subcutaneous implantation; and Sayre discloses apertures within an X-ray
`
`discernable material to provide X-ray readable indicia that can also aid in
`
`indicating orientation and receive sutures.
`
`Accordingly, the Board overlooked and/or misapprehended Mr. Tallarida’s
`
`testimony that a POSA would have modified the flange of the Titanium Implanted
`
`Port to include alphanumeric voids. Ex.1009, ¶¶210, 214-219. It was well within
`
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`14
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`the knowledge of a POSA that the alphanumeric voids could be added in addition
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`to or in place of the existing suture slots and/or orientation holes, since the
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`alphanumeric voids would still enable implantation and securing the port while
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`providing a further function of identifying that the port is rated for power injection.
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`III. CONCLUSION
`
`For the above reasons, Petitioner respectfully requests rehearing of the
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`Board’s Decision, and for the reasons set forth in the Petition, requests the Board
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`to institute IPR2015-01660.
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`Dated: March 9, 2016
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`Respectfully submitted,
`
`
`
`
`
`
`/Michael J. Fink/
`
`
`
`Michael J. Fink
`
`Registration No. 31,827
`Greenblum & Bernstein, P.L.C.
`Email: MFink@gbpatent.com
`
`
`
`
`
`
`
`
`/Arnold Turk/
`Arnold Turk
`Registration No. 33,094
`Greenblum & Bernstein, P.L.C.
`Email: ATurk@gbpatent.com
`
`
`
`
`
`Attorneys for Petitioner C.R. Bard, Inc.
`
`
`{R46637 02679690.DOC 4}
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`15
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`CERTIFICATE OF SERVICE
`
`I hereby certify that the attached Petitioner’s Request For Rehearing
`
`Pursuant To 37 C.F.R § 42.71(d) was served as of the below date by electronic
`
`mail on the lead and back-up counsels of the Patent Owners as follows:
`
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`BUCHANAN INGERSOLL & ROONEY PC
`Alfred W. Zaher
`Shawn Li
`Two Liberty Place
`50 S. 16th Street, Suite 3200
`Philadelphia, PA 19102-2555
`Alfred.Zaher@bipc.com
`Shawn.Li@bipc.com
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`BUCHANAN INGERSOLL & ROONEY PC
`Jonathan R. Bowser
`Roger H. Lee
`1737 King Street, Suite 500
`Alexandria, VA 22314-2727
`Jon.Bowser@bipc.com
`Roger.Lee@bipc.com
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`Dated: March 9, 2016
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` /Michael J. Fink/
`Michael J. Fink
`Registration No. 31,827
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`16