UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`C.R. BARD, INC.
`Petitioner
`
`v.
`
`INNOVATIVE MEDICAL DEVICES, LLC,
`MEDICAL COMPONENTS, INC.
`Patent Owners
`____________
`
`Case IPR _____________
`U.S. Patent No. 8,257,325
`Issue Date: September 4, 2012
`
`Title: VENOUS ACCESS PORT WITH MOLDED
`AND/OR RADIOPAQUE INDICIA
`
`____________
`
`DECLARATION OF STEVEN J. TALLARIDA
`
`
`
`
`
`
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`
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`Bard Exhibit 1009 Page 1 of 94
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`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`C.R. BARD, INC.
`Petitioner
`
`v.
`
`INNOVATIVE MEDICAL DEVICES, LLC,
`MEDICAL COMPONENTS, INC.
`Patent Owners
`____________
`
`Case IPR _____________
`U.S. Patent No. 8,257,325
`Issue Date: September 4, 2012
`
`Title: VENOUS ACCESS PORT WITH MOLDED
`AND/OR RADIOPAQUE INDICIA
`
`____________
`
`DECLARATION OF STEVEN J. TALLARIDA
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`
`
`
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`Bard Exhibit 1009 Page 1 of 94
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`I, Steven J. Tallarida, declare as follows:
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`Introduction
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`1.
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`I have been retained on behalf of C.R. Bard, Inc. (“Petitioner”) in this case
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`as an expert in the relevant art.
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`2.
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`I have been asked to provide my opinions concerning U.S. Patent No.
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`8,257,325 (“the ‘325 patent”)(Exhibit 1001), as well as the materials I have reviewed
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`that are related to the subject matter of the ‘325 patent.
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`3.
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`I have also been asked to provide my opinions concerning the state of the
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`relevant art in the field of access ports prior to around June 20, 2007 (which is also
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`referred to herein as “the relevant time frame” or “time of the invention”), and the
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`level and knowledge of one of ordinary skill in the art in the field of designing
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`implantable access ports during the relevant time frame.
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`4. My opinions and views set forth in this declaration are based on my
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`education, training, and experience in the field of designing access ports, as well as
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`the materials I reviewed and referenced in this declaration.
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`Documents Reviewed
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`I have reviewed U.S. Patent No. 8,257,325 (Exhibit 1001).
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`I have also reviewed the following documents: (1) PORTS – Bard Access
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`5.
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`6.
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`Systems, 2003 (“PORTS”) (Exhibit 1002); (2) U.S. Patent No. 7,785,302
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`(“Powers”)(Exhibit 1003); (3) PowerPort Guidelines for CT Technologists, February
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`
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`1
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`Bard Exhibit 1009 Page 2 of 94
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`
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`2007 (“PowerPort”)(Exhibit 1004); (4) FR 1,509,165 and its English translation
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`(“Meyer”)(respectively Exhibits 1005 and 1006); (5) U.S. Patent No. 6,826,257
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`(“Sayre”)(Exhibit 1007); (6) U.S. Provisional Application No. 60/658,518 filed on
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`March 4, 2005 (Exhibit 1016); and (7) Hickman® Subcutaneous Ports & Hickman® /
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`Broviac® Catheters, 1992 (“Hickman”)(Exhibit 1017).
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`7.
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`I have additionally reviewed the Affidavit of Christopher Butler (Exhibit
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`1008), the Declaration of Annemarie Boswell (Exhibit 1018) and the Declaration of
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`David Blaber (Exhibit 1019).
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`8.
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`1015.
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`9.
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`I have reviewed the dictionary definitions referenced herein. Exhibits 1010-
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`I have also reviewed the other documents referenced in this declaration.
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`Qualifications
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`10.
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`In 1985, I earned a Bachelor of Science from American University.
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`11. After graduating American University, I worked for STDMED, a privately
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`held medical device company.
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`12.
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`I have been President of President of Primo Medical Group, formerly
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`known as STDMED, for 25 years.
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`13.
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`I hold many U.S patents, several are in vascular access.
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`14. Primo Medical Group / STDMED has designed and built access ports for
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`implantation into a patient since 1991.
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`
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`2
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`Bard Exhibit 1009 Page 3 of 94
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`15. Primo Medical Group / STDMED has designed and built access ports for
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`many medical device companies, including C.R. Bard, Boston Scientific, Allergan
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`and Angiodynamics.
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`16.
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`In 1991, Primo Medical Group / STDMED began producing ports of the
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`type known as “Hickman ports”, including its version known as Titanium Implanted
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`Port (Exhibit 1002, p. 10 and 16).
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`17. Primo Medical Group / STDMED has also produced, beginning in
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`February 2010, the identification triangle disclosed in PowerPort (Exhibit 1004),
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`which is formed of titanium having voids (cutouts) “C” and “T” in the titanium.
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`A Person Of Ordinary Skill In The Relevant Art In The Relevant Time Frame
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`18.
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`I have been informed that “a person of ordinary skill in the relevant art” is a
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`hypothetical person who is presumed to have known the relevant art at the time of the
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`invention. Factors that may be considered in determining the level of ordinary skill in
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`the art may include: (1) type of problems encountered in the art; (2) prior art
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`solutions to those problems; (3) rapidity with which innovations are made; (4)
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`sophistication of the technology; and (5) educational level of active workers in the
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`field. In a given case, every factor may not be present, and one or more factors may
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`predominate. In many cases a person of ordinary skill will be able to fit the teachings
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`of multiple patents together like pieces of a puzzle.
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`3
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`Bard Exhibit 1009 Page 4 of 94
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`19. With respect to the ‘325 patent, the relevant art is the field of designing,
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`using, and building implantable access ports.
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`20.
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`I have been informed that the “time of the invention” with respect to the
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`‘325 patent would be the earliest effective filing date to which the ‘325 patent is
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`entitled. I have been further informed that based upon the information available on
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`the cover page of the ‘325 patent, the earliest effective filing date to which the ‘325
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`patent might be entitled is the date Provisional Application No. 12/143,377 (cited on
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`the cover page) was filed with the U.S. Patent and Trademark Office, i.e., June 20,
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`2007.
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`21. A person of ordinary skill in the relevant art would have been aware of the
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`structures of venous access port assemblies, including those access ports comprising
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`a housing with a base, a reservoir, a discharge port extending from the reservoir and a
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`septum. A person of ordinary skill in the relevant art would also have been aware of
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`power injectable access ports and would have known that power injectable access
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`ports could be used with CT scanning processes, where it is desirable to power inject
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`contrast media at a higher pressure and using a greater flow rate than can be handled
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`by conventional access ports.
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`22. A person of ordinary skill in the relevant art at the time of the invention
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`would also have known of the desirability to be able to identify an access port as
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`power injectable using X-rays subsequent to subcutaneous implantation of the port,
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`4
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`Bard Exhibit 1009 Page 5 of 94
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`such as by alphanumeric characters on the port, such as below the reservoir or on a
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`portion of the port spaced from a side wall of the reservoir.
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`23. Moreover, a person of ordinary skill in the art would also have known of
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`the desirability of overmolding ports with radiotransparent/radiolucent silicone
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`material to reduce ingrowth of tissue into the port to assist removal of the port as well
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`as to reduce tissue growth into suture/orientation openings.
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`24.
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`In my many years of experience in the medical device field, I have worked
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`with many access port designers.
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`25. A person of ordinary skill in the relevant art in the subject matter claimed
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`and disclosed in the ‘325 patent at the time of the invention would have included
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`doctors, nurses, practitioners, radiologists and technicians who are involved with the
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`implantation, use, maintenance and/or removal of venous access ports, or other
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`persons who had at least a bachelor’s degree in mechanical and/or biomedical
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`engineering and approximately 3-5 years’ experience working with and/or designing
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`venous access ports, and would have experience with power injectable access ports.
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`The ‘325 Patent
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`26. The ‘325 patent is entitled “Venous Access Port With Molded And/Or
`
`Radiopaque Indicia.”
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`
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`5
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`Bard Exhibit 1009 Page 6 of 94
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`27. Embodiments disclosed in the ‘325 patent include a venous access port
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`assembly having a housing, a housing base, a flange, a reservoir, a septum and a
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`discharge port. Exhibit 1001, Figs. 1-4.
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`28. The housing base defines an interior reservoir. Exhibit 1001, Figs. 3-4.
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`29. The flange can include integrally molded X-ray discernable indicia
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`identifying that the assembly is rated for power injection. Exhibit 1001, Abstract p.
`
`1.
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`30. The X-ray discernable indicia can extend through a height of the flange
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`from a top surface to a bottom surface of the flange. Exhibit 1001, Abstract p. 1.
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`31. The flange is formed from X-ray discernable material, and the X-ray
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`discernable indicia are formed from the X-ray discernable material of the flange, or
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`by voids in the X-ray discernable material. Exhibit 1001, Abstract p. 1.
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`32. Figures 1-6 of the ‘325 patent are reproduced below:
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`
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`6
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`Bard Exhibit 1009 Page 7 of 94
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`33. Figures 3 and 4 of the ‘325 patent (reproduced above) show “a skirt 42 is
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`
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`overmolded about housing base 28 and may be of silicone elastomer. It is seen that
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`skirt 42 encapsulates the outer surfaces of the bottom wall 44 and the bottom portion
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`of the side walls 46 of housing base 28, and is shown to fill in the suture holes 38,
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`40.” Exhibit 1001, col. 3, lines 36-40, Figs. 3 and 4.
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`34. Figures 5 and 6 of the ‘325 patent (reproduced above) show the housing
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`base of the access port of Fig. 1. Exhibit 1001, col. 2, lines 36-39.
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`35. Figures 9 and 10 of the ‘325 patent (reproduced below) show one
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`embodiment of the housing base having radiopaque indicia thereon. Exhibit 1001,
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`col. 2, lines 43-47:
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`7
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`Bard Exhibit 1009 Page 8 of 94
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`36. Figure 11 of the ‘325 patent (reproduced below) shows other embodiments,
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`i.e., top views of two alternative embodiments of the housing base showing integrally
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`molded “CT” markings. Exhibit 1001, col. 2, lines 48-51:
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`Fig. 11
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`Claim Interpretation
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`37.
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`In reviewing the claims of the ‘325 patent, I understand that claims are
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`generally accorded their broadest reasonable interpretation in light of the patent
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`specification, and should be free from any limitations disclosed in the specification
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`that are not expressly recited in the claims.
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`38.
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`I also understand that claim terms should be accorded their ordinary and
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`accustomed meaning unless the specification otherwise defines the terms.
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`39.
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`In my analysis, I have construed the terms stated in the claims, including
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`the terms for which dictionary definitions are provided in the paragraphs below,
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`
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`8
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`Bard Exhibit 1009 Page 9 of 94
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`using their ordinary and accustomed meaning, which would be the broadest
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`reasonable interpretation in light of the specification.
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`40. Regarding the term “housing” recited in the claims, Fig. 1 of the ‘325
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`patent depicts “housing 12.” Exhibit 1001, col. 3, lines 11-12, 26-29. The term
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`“housing” as recited in the claims should be construed as a case or enclosure.
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`(Exhibit 1010).
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`41. Regarding the term “base” recited in the claims, Figs. 5, 6, and 7 of the
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`‘325 patent depict “housing base 28.” Exhibit 1001, col.3, lines 33-35. “[H]ousing
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`base 28 … includes a well 30 having a bottom floor 32 and side walls 34 that define
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`the interior reservoir 22 beneath septum 14. … Housing base 28 includes a base
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`flange 36 extending radially outwardly from the bottom of well 30, and base flange
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`36 includes openings 38, 40.” Exhibit 1001, col.3, lines 26-33. Thus, as used in the
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`‘325 patent, the term “base” as recited in the claims should be construed as the part
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`on which something rests or is supported. (Exhibit 1011).
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`42. Regarding the term “reservoir” recited in the claims, Figs. 3 and 4 of the
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`‘325 patent depict reservoir 22. Exhibit 1001, col. 3, lines 26-29. The reservoir 22 is
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`defined as “a well 30 having a bottom floor 32 and side walls 34.” Exhibit 1001, col.
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`3, lines 27-28. Thus, the term “reservoir” as recited in the claims should be
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`construed as a part of an apparatus in which a liquid can be held. (Exhibit 1012).
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`9
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`Bard Exhibit 1009 Page 10 of 94
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`43. Regarding the term “flange” recited in the claims, a “base flange 36” is
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`shown in Fig. 4 and 10 of the ‘325 patent. Exhibit 1001, col. 3, lines 31-35, 63-64.
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`The term “flange” as recited in the claims should be construed as a rim extending
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`outwardly from the base for attachment of the port to a patient. See (Exhibit 1013).
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`44. Regarding the term “adjacent” recited in the claims, the term “adjacent”
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`appears once in the specification of the ‘325 patent (not including the claims) to
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`describe the position of discharge port 16 to recess 56. Exhibit 1001, col. 4, line 64.
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`The term “adjacent” as recited in the claims should be construed as close or near,
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`sharing a border, wall, or point. (Exhibit 1014).
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`45. Regarding the phrase “X-ray discernable material” recited in the claims,
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`this phrase should be construed as a material that can be seen using X-ray
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`examination. Exhibit 1001, col. 2, lines 17-20.
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`46. Regarding the terms “void” and “cutouts” recited in the claims, the ‘325
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`patent discloses “suture holes 38 and openings 40 through base flange 36.” Exhibit
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`1001, col. 3, lines 63-65, Figs. 10, 11, 12. The ‘325 patent additionally discloses
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`integrally molded markings within or alongside the suture openings, “where the
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`markings are voids in the base flange 36 material, as if cut or punched out of the base
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`flange 36 material.” Exhibit 1001, col. 2, lines 60-62; col. 4, lines 44-60. Thus, the
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`terms “void” and “cutout’ as recited in the claims of the ‘325 patent should be
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`construed as an empty space. Exhibit 1015. The “void” and “cutout” can be made in
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`10
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`Bard Exhibit 1009 Page 11 of 94
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`any manner as long as it constitutes an empty space that extends through the height
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`of the flange. Exhibit 1001, col. 4, lines 49-57.
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`PORTS – Bard Access Systems, 2003
`(“PORTS”)(Exhibit 1002)
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`47. PORTS has a copyright date of 2003. Exhibit 1002.
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`48.
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`I have been informed that PORTS (Exhibit 1002), which discloses the
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`Titanium Implanted Port at pp. 10 and 16, was publicly available as of 2003.
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`Declaration of David P. Blaber (Exhibit 1019); Affidavit Of Christopher Butler
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`(Exhibit 1008).
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`49.
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`I am very familiar with ports of the type disclosed in PORTS, including the
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`Titanium Implanted Port, because I have been involved with production of ports
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`known as “Hickman ports” beginning in 1991.
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`50.
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`“Hickman ports” are of the same overall structure as the Titanium
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`Implanted Port (Exhibit 1002, p.10), including the titanium flange having orientation
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`openings and suture slots, and a silicone overskirt. The Titanium Implanted Port is
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`one commercial form of “Hickman port.”
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`51.
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` Beginning in 1991, I have been involved with the production of Hickman
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`ports including the structurally similar version thereof known as the Titanium
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`Implanted Port (Exhibit 1002).
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`11
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`Bard Exhibit 1009 Page 12 of 94
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`52. Reproduced below the Titanium Implanted Port depicted on page 10 of
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`Exhibit 1002:
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`53. PORTS describes the Titanium Implanted Port as having a “biocompatible
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`
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`silicone-encapsulated base” which “helps promote pocket tissue recovery.” Exhibit
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`1002, page 10.
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`54. PORTS also describes that the suture slots and orientation holes simplify
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`implantation and promote port securement. Exhibit 1002, page 10.
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`55. The Titanium Implanted Port is a venous access port. Exhibit 1002.
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`56. The configuration of the Titanium Implanted Port depicted in Exhibit 1002
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`has been well known and in use since before 1991, when I became involved with
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`production of these types of ports.
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`12
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`Bard Exhibit 1009 Page 13 of 94
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`57. The Titanium Implanted Port has a housing, a base, a needle-penetrable
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`septum, a discharge port and a reservoir. Exhibit 1002; Exhibit 1017.
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`58. The Titanium Implanted Port has a base defining a reservoir, located below
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`the septum, and the base defines a bottom wall of the reservoir. Exhibit 1002;
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`Exhibit 1017.
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`59. The housing base is made of titanium, which is an X-ray discernable
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`material. Exhibit 1002.
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`60. The base includes a flange made of titanium. Exhibit 1002; Exhibit 1017.
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`61. The flange is adjacent to the reservoir and extends outwardly/radially from
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`the base about a perimeter of the reservoir. Exhibit 1002; Exhibit 1017.
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`62. The flange has suture slots and orientation holes which extend through the
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`height of the flange from the top surface of the flange to the bottom surface of the
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`flange. Exhibit 1002.
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`63. The suture slots and orientation holes are visually discernable to the naked
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`eye from both the top and bottom surfaces of the flange prior to implantation of the
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`port assembly. Exhibit 1002.
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`64. The suture slots and orientation holes are visible by X-ray examination
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`when the assembly is subcutaneously implanted in a patient.
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`65. The orientation holes are X-ray discernable indicia configured to indicate,
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`under X-ray examination, the orientation of the assembly. Exhibit 1002.
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`13
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`Bard Exhibit 1009 Page 14 of 94
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`66. The orientation holes indicate the side of the access port where the catheter
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`is or can be connected. Exhibit 1002.
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`67.
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` The orientation holes are capable of receiving sutures for securing the port
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`when implanted.
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`68. The Titanium Implanted Port has a silicone skirt overmolded about the
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`base, including the flange. Exhibit 1002.
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`69. The silicone skirt is radiotransparent.
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`70.
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`If the silicone skirt was not radiotransparent, the orientation holes would
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`not be discernable under X-ray examination to indicate the orientation of the
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`assembly.
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`71. Biocompatible silicone skirts such as shown on the Titanium Implanted
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`Port would encourage tissue recovery, and more importantly, prevent unwanted
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`tissue growth in the suture slots and orientation holes (voids), thereby making it
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`easier to later remove the port. Exhibit 1002.
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`72. The Titanium Implanted Port is shown with 2 orientation holes and 4 suture
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`slots in the base flange. Exhibit 1002.
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`73. Both the housing base of the Titanium Implanted Port (Exhibit 1002) and
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`the housing base depicted in Fig. 5 of the ‘325 patent (reproduced below) show
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`suture slots and orientation holes in the flange:
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`14
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`Bard Exhibit 1009 Page 15 of 94
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`74. The housing base and flange of the Titanium Implanted Port and the
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`housing base and flange of the port depicted in Fig. 5 of the ‘325 patent are
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`substantially the same configuration.
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`75. The silicone skirt overmolded about the housing base of the Titanium
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`Implanted Port is substantially the same as the silicone skirt overmolded about the
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`housing base of the port depicted in Figs. 1-4 of the ‘325 patent. In both, the silicone
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`skirt is overmolded about the flange.
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`Hickman® Subcutaneous Ports & Hickman® / Broviac® Catheters, 1992.
`(“Hickman”)(Exhibit 1017)
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`76. Hickman depicts a cutaway of a port, which is the same as the non-
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`illustrated inside of the Titanium Implanted Port disclosed in Exhibit 1002.
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`15
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`Bard Exhibit 1009 Page 16 of 94
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`77. The above figure from Hickman shows that Hickman ports, including the
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`Titanium Implanted Port, have a housing base defining at least one reservoir.
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`78. The above figure from Hickman also shows that Hickman ports, including
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`the Titanium Implanted Port, have a flange extending radially from the housing base.
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`79. The above figure from Hickman further shows in that in Hickman ports,
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`including the Titanium Implanted Port, the flange is adjacent to the reservoir.
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`80. The above figure from Hickman further shows that in Hickman ports,
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`including the Titanium Implanted Port, the base defines a reservoir and a bottom wall
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`of a reservoir.
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`81. The above figure from Hickman further shows that Hickman ports,
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`including the Titanium Implanted Port, have a reservoir below a septum. Exhibit
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`1017.
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`U.S. Patent No. 7,785,302 (“Powers”)( Exhibit 1003)
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`82. Powers discloses power injectable ports. Exhibit 1003, col. 3, lines 42-59;
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`Exhibit 1016, p.7/65 ([0034]), p. 48/65. A power injectable port is adapted to
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`withstand high pressures used for injection of contrast fluid. Exhibit 1003, col. 3,
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`lines 42-59; Exhibit 1016, p.7/65 ([0034]).
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`83. Powers discloses power injectable ports with X-ray discernable indicia
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`configured to indicate, under X-ray examination, that the assembly is rated for power
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`injection. Exhibit 1003, col. 3, lines 43-47, col. 11, line 41 to col. 12, line 2; Exhibit
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`16
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`Bard Exhibit 1009 Page 17 of 94
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`1016, p.7/65 (¶[0034]), p.8/65 (¶[0037]), p.17/65 (¶¶[0069]-[0070]), p.48/65 (Nos. 5-
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`7).
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`84. Powers discloses power injectable ports with radiopaque alphanumeric
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`characters that convey to a practitioner that the venous access port assembly is power
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`injectable when an X-ray is taken after implantation. Exhibit 1003, col. 3, lines 43-
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`47, col. 11, line 41 to col. 12, line 2; Exhibit 1016, p.7/65 (¶[0034]), p.8/65
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`(¶[0037]), p.17/65 (¶¶[0069]-[0070]), p.48/65 (Nos. 5-7).
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`85. Powers discloses a venous access port 10 with cap 14, base 16, septum 18
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`and reservoir (cavity) 36. Exhibit 1003, col. 4, lines 31-49, Fig 1B; Exhibit 1016,
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`p.8/65 ([0038]), Fig 1B.
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`86. Powers discloses a base 16 which forms a reservoir 36 having a bottom
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`floor and side walls beneath septum 18. Exhibit 1003, col. 4, lines 43-45, Fig. 1B;
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`Exhibit 1016, p.8/65 (¶[0038]), Fig. 1B.
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`17
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`Bard Exhibit 1009 Page 18 of 94
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`87. Powers discloses an alphanumeric message 122 on port 10 visible using x-
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`rays to identify the port as power-injectable. Exhibit 1003, col.11, line 58 to col. 12,
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`line 2; Exhibit 1016, p.48/65 (Nos. 5-7).
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`88. An access port marked with alphanumeric characters as disclosed in Powers
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`would be recognized by a person of ordinary skill in the art as a power injectable
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`port.
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`89. Powers discloses “a flange feature or lip feature 102 extends about at least a
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`portion of the periphery of the access port 10.” Exhibit 1003, col. 9, lines 18-22.
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`Exhibit 1016, p.15/65 ([0061]).
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`90. Powers discloses that such "a feature may comprise at least one identifiable
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`feature of an access port contemplated by the instant disclosure." Exhibit 1003, col.
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`9, lines 25-27; Exhibit 1016, p.15/65 ([0061]).
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`91. Powers discloses that suture apertures 66 may be positioned so as to
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`identify the access port 10 after subcutaneous implantation. Exhibit 1003, col. 10,
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`lines 16-18, Fig. 20; Exhibit 1016, p.16/65 (¶[0067]), Fig. 20.
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`92. Whether the housing is made of plastic or metal, the suture apertures in
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`Powers are discernable under X-ray examination. Exhibit 1003.
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`PowerPort Guidelines For CT Technologists, February 2007
`(“PowerPort”)(Exhibit 1004))
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`93. One of the access ports disclosed is the PowerPort*- M.R.I.* Device. The
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`PowerPort*- M.R.I.* Device is a power injectable port. Exhibit 1004.
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`18
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`Bard Exhibit 1009 Page 19 of 94
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`
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`94. The PowerPort*- M.R.I.* Device is a venous access port with a housing
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`base, a septum and a reservoir. Exhibit 1004.
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`95. The PowerPort*- M.R.I.* Device incorporates a radiopaque identifier.
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`Exhibit 1004.
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`96. A picture of the radiopaque identifier viewed under X-ray is depicted below
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`(Exhibit 1004):
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`97. The radiopaque identifier appears under X-ray examination as a triangle
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`with rounded corners and a circle inside the triangle. The circle has three inward
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`protrusions at positions corresponding to the corners of the triangle. The radiopaque
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`identifier also has two squares outside the base of the triangle, one showing the
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`alphanumeric character “C” and the other showing the alphanumeric character “T.”
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`Exhibit 1004.
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`98. The radiopaque identifier utilized in the PowerPort*- M.R.I.* Device is
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`made from an X-ray discernable material, i.e., titanium, and the alphanumeric
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`
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`19
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`Bard Exhibit 1009 Page 20 of 94
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`
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`characters “C” and “T” are formed by voids which extend through the top surface to
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`the bottom surface of the X-ray discernable material. Exhibit 1004.
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`99. Titanium is used as the X-ray discernable material and cutouts/voids of the
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`alphanumeric characters “C” and “T” are used to provide high contrast so that the
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`indicia is readily observable, under X-ray examination, after implantation.
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`100. The radiopaque identifier with the alphanumeric characters “C” and “T”
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`indicate, under X-ray examination, that the PowerPort*- M.R.I.* Device is rated for
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`power injection.
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`101. The PowerPort*- M.R.I.* Device is adapted to withstand higher pressures
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`and increased flow rates used for injection of contrast fluid. Specifically, the
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`PowerPort*- M.R.I.* Device is indicated for power injection of contrast media up to
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`300 psi and 5 ml/s. Exhibit 1004 (see left column, second and bottom paragraphs).
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`U.S. Patent No. 6,826,257 (“Sayre”)( Exhibit 1007)
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`102. Sayre discloses: “Indicia 124, also photoetched from the radiopaque
`
`material, aid in indicating orientation of each marker 116.” Exhibit 1007, col. 4,
`
`lines 8-10.
`
`103. Sayre further discloses indicia 124 photoetched from radiopaque material
`
`or formed in radiopaque markers 116 by stamping, laser cutting, or by other means in
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`which the indicia 124 are defined by one or more apertures formed through the
`
`
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`20
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`Bard Exhibit 1009 Page 21 of 94
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`
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`respective marker 116 to provide unique identifying information when viewed by X-
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`ray. Exhibit 1007, col. 4, lines11-31, Fig. 2A, claim 6.
`
`104. The apertures can extend through the radiopaque material, i.e., from the top
`
`surface to the bottom surface of radiopaque material.
`
`105. The radiopaque markers disclosed in Sayre would be discernable under X-
`
`ray examination. The indicia defined by one or more apertures disclosed in Sayre
`
`would likewise be discernable under X-ray examination.
`
`106. Sayre teaches X-ray discernable indicia configured to indicate, under X-ray
`
`examination, identification information.
`
`107. Fig. 2A of Sayre is reproduced below:
`
`108. Sayre disclose cutouts (voids) extending through the X-ray discernable
`
`material, from top to bottom, that are visually discernable to a naked eye from both
`
`
`
`
`
`21
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`Bard Exhibit 1009 Page 22 of 94
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`
`
`the top and the bottom. The radiopaque markers of Sayre can be made from metal,
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`such as titanium. Exhibit 1007, col. 5, lines 6-15.
`
`109. The apertures of Sayre can define letters that can receive sutures used to
`
`secure the markers. Exhibit 1007, col. 4, lines 41-57, Figs. 2A-2C.
`
`FR 1,509,165 (“Meyer”)( Exhibits 1005 & 1006)
`
`110. Meyer discloses a container (reservoir) with a flange 1 about the container.
`
`Exhibits 1005 & 1006.
`
`111. Meyer further discloses alphanumeric characters in the flange formed in
`
`whole or part by voids. Exhibits 1005 & 1006.
`
`112. Meyer Figs. 2, 3 and 4 depict alphanumeric characters formed by molding
`
`or cutting. Meyer Fig. 3 shows alphanumeric characters 6 which are formed by
`
`cutouts provided in the flange (collar 1). Exhibit 1006, p.2, left column, last
`
`paragraph; Fig. 3.
`
`
`113. The flange (collar 1) has a top surface and a bottom surface through which
`
`the cutout characters extend. Exhibit 1006, Fig. 3.
`
`114. The alphanumeric characters shown in Figs. 2, 3 and 4 of Meyer, formed in
`
`whole or part by creating voids, would be discernable under X-ray examination.
`
`
`
`22
`
`Bard Exhibit 1009 Page 23 of 94
`
`
`
`115. Although not radiopaque like metal, plastic is expected to be discernable
`
`under X-ray examination as compared to voids in the plastic, and the voids in the
`
`plastic would be expected to be discernable under X-ray examination.
`
`116. The alphanumeric characters shown in Fig. 3 of Meyer formed by cutouts
`
`in the flange (collar 1) would be discernable under X-ray examination.
`
`117. Meyer teaches using a flange with indicia created by voids. Exhibit 1006.
`
`118. Meyer teaches that cutouts in a flange can be used to provide identification
`
`indicia. Exhibit 1006.
`
`119. Figures 2, 3 and 4 of Meyer are reproduced below:
`
`
`
`
`
`
`
`120. Meyer further discloses a flange 1 comprising a height extending from a top
`
`surface of the flange to a bottom surface of the flange, the cutouts (voids) in the
`
`flange extend through the height of the flange from the top surface of the flange to
`
`the bottom surface of the flange.
`
`
`
`23
`
`Bard Exhibit 1009 Page 24 of 94
`
`
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`121. The cutouts (voids) are visually discernable to a naked eye from both the
`
`top surface of the flange and the bottom surface of the flange.
`
`Claims 1-2, 5-13, 15-19 And 21-22
`Would Have Been Obvious To A Person Of Ordinary Skill
`In The Art At The Time Of Invention Over PORTS In
`View Of Powers And Further In View Of PowerPort And Hickman
`
`122. For the reasons below, it is my opinion that claims 1-2, 5-13, 15-19 and 21-
`
`22 would have been obvious to a person of ordinary skill in the art over PORTS
`
`(Exhibit 1002) in view of Powers (Exhibit 1003) and in further view of PowerPort
`
`(Exhibit 1004) and Hickman (Exhibit 1017).
`
`123. PORTS and Powers disclose all of the elements of claim 1.
`
`124. PowerPort emphasizes the obviousness of the X-ray discernable indicia
`
`being in the form of cutout (void) alphanumeric characters.
`
`125. Hickman evidences that Hickman ports, such as the Titanium Implanted
`
`Port, include a base defining a bottom wall of a reservoir.
`
`126. PORTS (Exhibit 1002) and Powers (Exhibit 1003) disclose a venous access
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`port assembly for implantation into a patient comprising a housing including a base
`
`defining a bottom wall of a reservoir. Exs. 1002, p. 10; 1003; 1016; 1017.
`
`127. Titanium Implanted Port has a discharge port extending from the reservoir.
`
`Exhibit 1002, p.10; Exhibit 1017.
`
`
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`24
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`Bard Exhibit 1009 Page 25 of 94
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`
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`128. Powers similarly discloses an outlet stem 31 (discharge port) extending
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`from the reservoir. Exhibit 1003, col. 4, lines 43-45, Fig. 1A & 1B; Ex. 1016, Figs.
`
`1A & 1B.
`
`129. PORTS and Powers disclose a flange adjacent to the at least one reservoir.
`
`130. Titanium Implanted Port has a flange adjacent to the reservoir. Exhibit
`
`1002, p. 10.
`
`131. Powers discloses a flange that “extends about at least a portion of the
`
`periphery of the access port 10” and is adjacent to the reservoir. Exhibit 1003, col. 9,
`
`lines 18-22. Exhibit 1016, p.15/65 (¶[0061]).
`
`132. PORTS discloses a flange comprising a height extending from a top surface
`
`of the flange to a bottom surface of the flange. The flange of the Titanium Implanted
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`Port comprises a height extending from a top surface of the flange to a bottom
`
`surface of the flange. Exhibit 1002.
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`133. The flange of the Titanium Implanted Port is made of titanium, an X-ray
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`discernable material. Exhibit 1002.
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`134. Powers discloses a power injectable port which has X-ray discernable
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`indicia configured to indicate, under X-ray examination, that the port assembly is
`
`rated for power injection. Exhibit 1003, col. 3, lines 43-47, col. 11, line 41 to col. 12,
`
`line 2; Exhibit 1016, p.7/65 (¶[0034]), p.8/65 (¶[0037]), p.17/65 (¶¶[0069]-[0070]),
`
`p.48/65 (Nos. 5-7).
`
`
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`25
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`Bard Exhibit 1009 Page 26 of 94
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`
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`135. Powers discloses: “For example, the instant disclosure contemplates that at
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`least one feature of an access port may be observable through interaction with an
`
`imaging technology such as x-ray…” Exhibit 1003, col. 11, lines 44-47; Exhibit
`
`1016, p.17/65 (¶[0069]).
`
`136. Specifically, in Powers, an alphanumeric message, which under X-ray
`
`examination, indicates that the assembly is rated for power injection. Exhibit 1003,
`
`col. 3, lines 43-47, col. 11, line 41 to col. 12, line 2; Exhibit 1016, p.7/65 (¶[0034]),
`
`p.8/65 (¶[0037]), p.17/65 (¶¶[0069]-[0070]), p.48/65 (Nos. 5-7).
`
`137. Powers also discloses that suture apertures 66 may be positioned so as to
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`identify the access port 10 after subcutaneous implantation. Exhibit 1003, col. 10,
`
`lines 16-18, Fig. 20; Exhibit 1016, p. 16/65 ([0067]), Fig. 20.
`
`138. PowerPort discloses a power injectable port which has X-ray discernable
`
`indicia configured to indicate, under X-ray examination, that the assembly is rated
`
`for power injection. Exhibit 1004. The PowerPort® M.R.I.® Device disclosed in
`
`PowerPort has a radiopaque identifier depicted below:
`
`
`
`26
`
`
`
`Bard Exhibit 1009 Page 27 of 94
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`
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`139. The radiopaque identifier with voids comprising the alphanumeric
`
`characters “C” and “T” indicate, under X-ray examination, that the PowerPort®
`
`M.R.I.® Device is rated for power injection.
`
`140. PORTS discloses X-ray discernable indicia located in the flange and
`
`extending through the height of the flange from the top surface of the flange to the
`
`bottom surface of the flange. Specifically, the Titanium Implanted Port has suture
`
`slots and orientation holes which extend through the height of the flange fro
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