Angiodynamics, Inc. v. Patent of C.R. Bard, Inc.

• Decision Date: 29 March 2016
• Docket Number: Appeal 2015-004554
• Parties: ANGIODYNAMICS, INC. Respondent, Requester v. Patent of C.R. BARD, INC. Appellant, Patent Owner Inter Partes Reexamination Control 95/002, 090 Patent No. U.S. 7, 947, 022 B2 Technology Center 3900
• Court: United States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board

ANGIODYNAMICS, INC. Respondent, Requester v. Patent of C.R. BARD, INC. Appellant, Patent Owner

Inter Partes Reexamination Control 95/002, 090 Patent No. U.S. 7, 947, 022 B2^[1] Technology Center 3900

Appeal No. 2015-004554

United States Patent and Trademark Office, Patent Trial and Appeal Board

March 29, 2016

FILING DATE 08/20/2012

Before STEVEN D.A. McCARTHY, DANIEL S. SONG and BRETT C. MARTIN Administrative Patent Judges.

DECISION ON APPEAL

McCARTHY, Administrative Patent Judge.

STATEMENT OF THE CASE

The Appellant/Patent Owner appeals from the Examiner's decision rejecting unamended claims 1-20 of the '022 patent. (Patent Owner's Notice of Appeal under 35 U.S.C § 134, 37 C.F.R. § 1.959 and 37 C.F.R. § 41.61, " dated November 18, 2013). The Examiner's findings and conclusions are stated in a "Right of Appeal Notice, " mailed October 18, 2013 ("RAN").^[2] The Patent Owner relies on a "Patent Owner's Appeal Brief under 35 U.S.C. § 134, 37 C.F.R. § 1.959 and 37 C.F.R. § 41.67, " dated January 17, 2014 ("App. Br. PO"), with twenty-two exhibits including a "First Declaration of Kenneth A. Eliasen" ("Eliasen Declaration" or "Eliasen Decl."); and a "Patent Owner's Rebuttal Brief under 37 C.F.R. § 41.67, " dated August 29, 2014 ("Reb. Br. PO"). The Requester relies on "Third Party Requester's Respondent's Brief to Patentee's Appeal Brief dated January 17, 2014 in Inter partes Reexamination of U.S. Patent No. 7, 947, 022, " dated February 18, 2014 ("Resp. Br. Req'r"), citing seventeen exhibits including a "Declaration under 37 C.F.R. 1.132" of Hank LaForce ("LaForce Declaration" or "LaForce Decl."). A hearing was held on June 18, 2015, at the request of both the Patent Owner and the Requester. We have jurisdiction over the appeal under pre-AIA 35 U.S.C. § 134(b) and 35 U.S.C. § 315(a).

GROUNDS OF REJECTION AND DISPOSITION

Grounds A and C^[3] as applied to claims 1, 2, 6, 8 and 9: The Examiner adopts two proposed rejections of claims 1, 2, 6, 8 and 9 under pre-AIA 35 U.S.C. § 102(b) as being anticipated by Medtronic, Inc., IsoMed Constant-Flow Infusion System (bearing a 2000 copyright notice and the legend "Revised Sept. 2000") ("IsoMed"). (See RAN 4-6; see also "Request for Inter partes Reexamination of U.S. Patent No. 7, 947, 022, " dated August 20, 2012 ("Request"), at 31-34 & 38-42).

We AFFIRM Grounds A and C as applied to claims 1, 2, 6, 8 and 9. Because our affirmance of the Examiner's decision to reject claims 1, 2, 6, 8 and 9 on these two grounds constitutes a general affirmance of the rejection of these claims, see 37 C.F.R. § 41.77(a), we do not reach Grounds D or E as applied to claims 1, 2, 6, 8 and 9.

Ground D: The Examiner adopts a proposed rejection of claims 1-20 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over IsoMed in view of the Examiner's finding that "one skilled in the art would have also recognized the well-known techniques disclosed in the analogous prior art to convey to a practitioner various information, characteristics and/or intended uses of other implanted medical devices" (RAN 9, quoting Request 45-46). (See RAN 7-11; see also Request 42-46).

Ground E: The Examiner adopts a proposed rejection of claims 1-20 under § 103(a) as being unpatentable over IsoMed and Jones (US 6, 287, 293 B1, issued Sept. 11, 2001), in view of the Examiner's finding that "one skilled in the art would have also recognized the well-known techniques disclosed in the analogous prior art to convey to a practitioner various information, characteristics and/or intended uses of other implanted medical devices" (RAN 13, quoting Request 45-46). (See RAN 11-15; see also Request 46-52).

We AFFIRM Ground E as applied to claims 3-5, 7 and 10-20. Because our affirmance of the Examiner's decision to reject claims 3-5, 7 and 10-20 on these two grounds constitutes a general affirmance of the rejection of these claims, see 37 C.F.R. § 41.77(a), we do not reach Ground D as applied to claims 3-5, 7 and 10-20.

THE '022 PATENT

The '022 patent teaches implantable access ports providing subcutaneous access to a patient without requiring a needle to puncture the patient's skin. ('022 patent, col. 2, 1. 65 - col. 3, 1. 10). As depicted in Figures 1A and IB, an access port 10 includes a body 20 and a septum 18 cooperating to define a cavity 36. The cavity 36 communicates with the interior of the patient through an outlet stem 31. (See '022 patent, col. 4, ll. 2-8, 14-16 & 20-28).

The '022 patent teaches that access ports may be injectable by hand. Alternatively, power-injectable ports may be injected and pressurized with mechanical assistance. ('022, col. 3, ll. 14-18). The patent teaches that power injectable ports capable of mechanically-assisted injection and pressurization may be employed for injecting contrast media into a peripherally inserted intravenous line for use in computed tomography ("CT") imaging processes. ('022 patent, col. 3, ll. 19-23). "Because fluid infusion procedures are often defined in terms of a desired flow rate of contrast media, such power injection systems are, in general, controllable by selecting a desired flow rate." ('022 patent, col. 3, ll. 27-30).

Claims 1, 10 and 16 are independent. Claim 1, reformatted for clarity, is illustrative:

1. An access port for providing subcutaneous access to a patient, comprising:

a body defining a fluid cavity accessible by inserting a needle through a septum; and

at least one radiopaque identification feature of the access port observable via imaging technology subsequent to subcutaneous implantation of the access port,

the at least one radiopaque identification feature including one or more alphanumeric characters identifying the access port as a power-injectable port.

(App. Br. P0 41).

ISSUES

Seven issues are dispositive of this appeal:

First, is IsoMed a "printed publication" for purposes of § 102(b)? (See RAN 18-21; App. Br. PO 4-8; Resp. Br. Req'r 3-8; Reb. Br. PO 10).

Second, does IsoMed describe an access port including "a body defining a fluid cavity accessible by inserting a needle through a septum, " as recited in claim 1? (See App. Br. PO 10-11; Resp. Br. Req'r 10-14; Reb. Br. 9-10).

Third, does IsoMed describe an access port including "at least one radiopaque identification feature of the access port observable via imaging technology subsequent to subcutaneous implantation of the access port, the at least one radiopaque identification feature including one or more alphanumeric characters identifying the access port as a power-injectable port" as recited in claim 1? {See RAN 26-27; App. Br. PO 12-16; Resp. Br. Req'r 14-19 & 22-23; Reb. Br. PO 1-9 & 11).

Fourth, does IsoMed describe an access port in which the alphanumeric message includes the letters "C" and "T" as recited in claim 9? {See App. Br. PO 17; Resp. Br. Req'r 19-20; Reb. Br. PO 11).

Fifth, would an access port having "a radiopaque identification feature included on a bottom surface of the access port, the feature being an alphanumeric message observable via imaging technology subsequent to subcutaneous implantation of the access port, " as recited in claim 10, have been obvious from the teachings of IsoMed, Jones and the knowledge of one of ordinary skill in the art? {See RAN 15 & 35; App. Br. PO 23 & 28-29; Resp. Br. Req'r 30; Reb. Br. PO 14).

Sixth, would an access port having "at least one recessed identification feature defined by the body, observable via x-ray imaging technology subsequent to subcutaneous implantation of the access port, " as recited in claim 16, have been obvious from the teachings of IsoMed, Jones and the knowledge of one of ordinary skill in the art? {See RAN 15; App. Br. PO 24 & 25; Resp. Br. Req'r 30-32).

Seventh, would an access port in which "the at least one recessed identification feature includes an engraved feature and is relatively more x-ray transmissive with respect to other portions of the access port body, " as recited in claim 18, have been obvious from the teachings of IsoMed, Jones and the knowledge of one of ordinary skill in the art? (See RAN 14; App. Br. PO 24 & 26; Resp. Br. Req'r 38).

FINDINGS OF FACT

The record supports the following findings of fact ("FF") by a preponderance of the evidence. See Rambus Inc. v. Rea, 731 F.3d 1248, 1255 (Fed. Cir. 2013); Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988).

IsoMed

1. IsoMed anticipates claims 1, 2, 6, 8 and 9.

2. IsoMed describes an IsoMed Constant-Flow Infusion System including an IsoMed Constant-Flow pump and a Medtronic vascular catheter. (See IsoMed 2-2). The system is implantable. (See IsoMed 1-3).

3. The pump is depicted in drawing figures and photographs on pages 2-2 - 2-5 and A-6 of IsoMed. The pump includes a generally puck-shaped, titanium shell having an outlet or discharge port labeled in the drawing figures as a catheter port. (See IsoMed 2-3 and 2-5). The shell encloses a reservoir. A cap secured to one face of the shell retains a polymeric, needle-penetrable septum in place over a center reservoir fill port providing access to the reservoir from the exterior of the shell. (See IsoMed 2-3 and 2-4). As depicted on pages 2-2 and 2-5, the standard model number which includes the reservoir size and flow rate of the pump is printed or otherwise affixed to an upper surface of the pump. (Cf. IsoMed 2-7 (displaying chart listing IsoMed standard model numbers)).

4. A propellant chamber and pump drive located within the shell behind the reservoir uses pressurized gas to pump fluid from the reservoir toward the catheter port. (IsoMed 2-3 and 2-4). This description implies that the reservoir and the propellant chamber together act as a reciprocating pump to force the drug out of the reservoir and into the patient's bloodstream.

5. IsoMed discloses that the...