Ex Parte 7947022 et al

Patent Trial and Appeal Board

Mar 28, 2016

95002090 (P.T.A.B. Mar. 28, 2016)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/002,090 08/20/2012 7947022 99821.009US2 4355
109545 7590 03/29/2016
C.R. Bard, Inc.
c/o Greenblum & Bernstein, P.L.C.
1950 Roland Clarke Place
Reston, VA 20191
EXAMINER
WILLIAMS, CATHERINE SERKE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
03/29/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

ANGIODYNAMICS, INC.
Respondent, Requester

v.

Patent of C.R. BARD, INC.
Appellant, Patent Owner
________________

Appeal 2015-004554
Inter Partes Reexamination Control 95/002,090
Patent No. US 7,947,022 B21
Technology Center 3900
________________

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

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

1 Issued May 24, 2011, to Murtaza Yusuf Amin, Kevin Sheetz, David
M. Cise, Matt Draper and Kelly B. Powers (the “’022 patent”). The ’022
patent issued from Appl. 12/420,028, filed April 7, 2009. Page 1 of the
“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, identifies litigation and
administrative proceedings involving the ’022 patent and related patents.
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STATEMENT OF THE CASE 1
The Appellant/Patent Owner appeals from the Examiner’s decision 2
rejecting unamended claims 1–20 of the ’022 patent. (Patent Owner’s 3
Notice of Appeal under 35 U.S.C. § 134, 37 C.F.R. § 1.959 and 37 C.F.R. 4
§ 41.61,” dated November 18, 2013). The Examiner’s findings and 5
conclusions are stated in a “Right of Appeal Notice,” mailed October 18, 6
2013 (“RAN”).2 The Patent Owner relies on a “Patent Owner’s Appeal 7
Brief under 35 U.S.C. § 134, 37 C.F.R. § 1.959 and 37 C.F.R. § 41.67,” 8
dated January 17, 2014 (“App. Br. PO”), with twenty-two exhibits including 9
a “First Declaration of Kenneth A. Eliasen” (“Eliasen Declaration” or 10
“Eliasen Decl.”); and a “Patent Owner’s Rebuttal Brief under 37 C.F.R. 11
§ 41.67,” dated August 29, 2014 (“Reb. Br. PO”). The Requester relies on 12
“Third Party Requester’s Respondent’s Brief to Patentee’s Appeal Brief 13
dated January 17, 2014 in Inter partes Reexamination of U.S. Patent No. 14
7,947,022,” dated February 18, 2014 (“Resp. Br. Req’r”), citing seventeen 15
exhibits including a “Declaration under 37 C.F.R. 1.132” of Hank LaForce 16
(“LaForce Declaration” or “LaForce Decl.”). A hearing was held on June 17
18, 2015, at the request of both the Patent Owner and the Requester. We 18
have jurisdiction over the appeal under pre-AIA 35 U.S.C. § 134(b) and 19
35 U.S.C. § 315(a). 20

2 The Examiner’s Answer mailed August 1, 2014, incorporates the
RAN by reference.
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GROUNDS OF REJECTION AND DISPOSITION 1
Grounds A and C3 as applied to claims 1, 2, 6, 8 and 9: The Examiner 2
adopts two proposed rejections of claims 1, 2, 6, 8 and 9 under pre-AIA 3
35 U.S.C. § 102(b) as being anticipated by Medtronic, Inc., IsoMed 4
Constant-Flow Infusion System (bearing a 2000 copyright notice and the 5
legend “Revised Sept. 2000”) (“IsoMed”). (See RAN 4–6; see also 6
“Request for Inter partes Reexamination of U.S. Patent No. 7,947,022,” 7
dated August 20, 2012 (“Request”), at 31–34 & 38–42). 8
We AFFIRM Grounds A and C as applied to claims 1, 2, 6, 8 and 9. 9
Because our affirmance of the Examiner’s decision to reject claims 1, 2, 6, 8 10
and 9 on these two grounds constitutes a general affirmance of the rejection 11
of these claims, see 37 C.F.R. § 41.77(a), we do not reach Grounds D or E as 12
applied to claims 1, 2, 6, 8 and 9. 13
Ground D: The Examiner adopts a proposed rejection of claims 1–20 14
under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over IsoMed in 15
view of the Examiner’s finding that “one skilled in the art would have also 16
recognized the well-known techniques disclosed in the analogous prior art to 17
convey to a practitioner various information, characteristics and/or intended 18
uses of other implanted medical devices” (RAN 9, quoting Request 45–46). 19
(See RAN 7–11; see also Request 42–46). 20

3 The lettering of the grounds of rejection is based on that used by the
Examiner in the RAN. The Examiner’s lettering of the grounds of rejection
derives from the lettering used by the Requester in the Request. The two
grounds of rejection, A and C, represent two different rationales for finding
that IsoMed anticipates claims 1, 2, 6, 8 and 9. (Compare Request 31–34
with id. at 38–42; see also RAN 4 nn.2 & 3).
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Ground E: The Examiner adopts a proposed rejection of claims 1–20 1
under § 103(a) as being unpatentable over IsoMed and Jones (US 6,287,293 2
B1, issued Sept. 11, 2001), in view of the Examiner’s finding that “one 3
skilled in the art would have also recognized the well-known techniques 4
disclosed in the analogous prior art to convey to a practitioner various 5
information, characteristics and/or intended uses of other implanted medical 6
devices” (RAN 13, quoting Request 45–46). (See RAN 11–15; see also 7
Request 46–52). 8
We AFFIRM Ground E as applied to claims 3–5, 7 and 10–20. 9
Because our affirmance of the Examiner’s decision to reject claims 3–5, 7 10
and 10–20 on these two grounds constitutes a general affirmance of the 11
rejection of these claims, see 37 C.F.R. § 41.77(a), we do not reach Ground 12
D as applied to claims 3–5, 7 and 10–20. 13
14
THE ’022 PATENT 15
The ’022 patent teaches implantable access ports providing 16
subcutaneous access to a patient without requiring a needle to puncture the 17
patient’s skin. (’022 patent, col. 2, l. 65 - col. 3, l. 10). As depicted in 18
Figures 1A and 1B, an access port 10 includes a body 20 and a septum 18 19
cooperating to define a cavity 36. The cavity 36 communicates with the 20
interior of the patient through an outlet stem 31. (See ’022 patent, col. 4, ll. 21
2–8, 14–16 & 20–28). 22
The ’022 patent teaches that access ports may be injectable by hand. 23
Alternatively, power-injectable ports may be injected and pressurized with 24
mechanical assistance. (’022, col. 3, ll. 14–18). The patent teaches that 25
power injectable ports capable of mechanically-assisted injection and 26
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pressurization may be employed for injecting contrast media into a 1
peripherally inserted intravenous line for use in computed tomography 2
(“CT”) imaging processes. (’022 patent, col. 3, ll. 19–23). “Because fluid 3
infusion procedures are often defined in terms of a desired flow rate of 4
contrast media, such power injection systems are, in general, controllable by 5
selecting a desired flow rate.” (’022 patent, col. 3, ll. 27–30). 6
Claims 1, 10 and 16 are independent. Claim 1, reformatted for clarity, 7
is illustrative: 8
1. An access port for providing subcutaneous access to 9
a patient, comprising: 10
a body defining a fluid cavity accessible by inserting a 11
needle through a septum; and 12
at least one radiopaque identification feature of the access 13
port observable via imaging technology subsequent to 14
subcutaneous implantation of the access port, 15
the at least one radiopaque identification feature including 16
one or more alphanumeric characters identifying the access port 17
as a power-injectable port. 18
(App. Br. PO 41). 19
20
ISSUES 21
Seven issues are dispositive of this appeal: 22
First, is IsoMed a “printed publication” for purposes of § 102(b)? 23
(See RAN 18–21; App. Br. PO 4–8; Resp. Br. Req’r 3–8; Reb. Br. PO 10). 24
Second, does IsoMed describe an access port including “a body 25
defining a fluid cavity accessible by inserting a needle through a septum,” as 26
recited in claim 1? (See App. Br. PO 10–11; Resp. Br. Req’r 10–14; Reb. 27
Br. 9–10). 28
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Third, does IsoMed describe an access port including “at least one 1
radiopaque identification feature of the access port observable via imaging 2
technology subsequent to subcutaneous implantation of the access port, the 3
at least one radiopaque identification feature including one or more 4
alphanumeric characters identifying the access port as a power-injectable 5
port” as recited in claim 1? (See RAN 26–27; App. Br. PO 12–16; Resp. Br. 6
Req’r 14–19 & 22–23; Reb. Br. PO 1–9 & 11). 7
Fourth, does IsoMed describe an access port in which the 8
alphanumeric message includes the letters “C” and “T” as recited in claim 9? 9
(See App. Br. PO 17; Resp. Br. Req’r 19–20; Reb. Br. PO 11). 10
Fifth, would an access port having “a radiopaque identification feature 11
included on a bottom surface of the access port, the feature being an 12
alphanumeric message observable via imaging technology subsequent to 13
subcutaneous implantation of the access port,” as recited in claim 10, have 14
been obvious from the teachings of IsoMed, Jones and the knowledge of one 15
of ordinary skill in the art? (See RAN 15 & 35; App. Br. PO 23 & 28–29; 16
Resp. Br. Req’r 30; Reb. Br. PO 14). 17
Sixth, would an access port having “at least one recessed identification 18
feature defined by the body, observable via x-ray imaging technology 19
subsequent to subcutaneous implantation of the access port,” as recited in 20
claim 16, have been obvious from the teachings of IsoMed, Jones and the 21
knowledge of one of ordinary skill in the art? (See RAN 15; App. Br. PO 24 22
& 25; Resp. Br. Req’r 30–32). 23
Seventh, would an access port in which “the at least one recessed 24
identification feature includes an engraved feature and is relatively more x-25
ray transmissive with respect to other portions of the access port body,” as 26
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recited in claim 18, have been obvious from the teachings of IsoMed, Jones 1
and the knowledge of one of ordinary skill in the art? (See RAN 14; App. 2
Br. PO 24 & 26; Resp. Br. Req’r 38). 3
4
FINDINGS OF FACT 5
The record supports the following findings of fact (“FF”) by a 6
preponderance of the evidence. See Rambus Inc. v. Rea, 731 F.3d 1248, 7
1255 (Fed. Cir. 2013); Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. 8
Cir. 1988). 9
10
IsoMed 11
1. IsoMed anticipates claims 1, 2, 6, 8 and 9. 12
2. IsoMed describes an IsoMed Constant-Flow Infusion System 13
including an IsoMed Constant-Flow pump and a Medtronic vascular 14
catheter. (See IsoMed 2-2). The system is implantable. (See IsoMed 1-3). 15
3. The pump is depicted in drawing figures and photographs on 16
pages 2-2 – 2-5 and A-6 of IsoMed. The pump includes a generally puck-17
shaped, titanium shell having an outlet or discharge port labeled in the 18
drawing figures as a catheter port. (See IsoMed 2-3 and 2-5). The shell 19
encloses a reservoir. A cap secured to one face of the shell retains a 20
polymeric, needle-penetrable septum in place over a center reservoir fill port 21
providing access to the reservoir from the exterior of the shell. (See IsoMed 22
2-3 and 2-4). As depicted on pages 2-2 and 2-5, the standard model number, 23
which includes the reservoir size and flow rate of the pump, is printed or 24
otherwise affixed to an upper surface of the pump. (Cf. IsoMed 2-7 25
(displaying chart listing IsoMed standard model numbers)). 26
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4. A propellant chamber and pump drive located within the shell 1
behind the reservoir uses pressurized gas to pump fluid from the reservoir 2
toward the catheter port. (IsoMed 2-3 and 2-4). This description implies 3
that the reservoir and the propellant chamber together act as a reciprocating 4
pump to force the drug out of the reservoir and into the patient’s 5
bloodstream. 6
5. IsoMed discloses that the “Medtronic identifier, pump model, 7
reservoir volume and flow rate have been recorded on a small radiographic 8
tag located inside the pump housing.” As depicted in drawing figures 9
appearing on pages 2-4 and 2-5 of IsoMed, the standard model number 10
printed or otherwise affixed to the top surface of the titanium shell does not 11
overlie the radiographic tag. “This tag can be seen using standard x-ray 12
procedures.” (IsoMed 2-4). IsoMed teaches that the model number of an 13
implanted pump may be verified by a radiographic examination of the 14
radiographic tag. (IsoMed 7-7). In addition, IsoMed teaches that a 15
physician or allied professional may determine the orientation of an 16
implanted access port assembly by detecting the orientation of the model 17
number on the tag. IsoMed explains that, “[i]f the pump has been inverted 18
in the pocket (‘flipped’), the model number will appear backwards.” 19
(IsoMed 7-7). 20
6. IsoMed is entitled a “Clinical Reference Guide for Hepatic 21
Arterial Infusion Therapy.” (IsoMed, front cover). It explains that the: 22
Clinical Reference Guide for the IsoMed® Constant-Flow 23
Infusion System has been developed for physicians and allied 24
professionals who care for patients using the IsoMed System for 25
hepatic arterial infusion of chemotherapeutic agents. 26
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The goal of this guide is to provide clinically relevant 1
information for the safe and effective use of this therapy. 2
(IsoMed i). In other words, IsoMed was written to instruct physicians and 3
allied professionals how to perform a specific procedure using the IsoMed 4
Infusion System, namely, the infusion of the chemotherapeutic agent 5
floxuridine through an artery into the liver for the localized treatment of 6
colorectal cancer that has spread to the liver. (See IsoMed 1-2, 2-2 and A-7
11). 8
9
IsoMed as a Printed Publication 10
7. The parties do not appear to dispute that Medtronic authored 11
IsoMed. 12
8. The back cover of IsoMed includes a copyright notice, 13
“© Medtronic, Inc. 2000,” as well as the notation “Revised Sept. 2000.” 14
9. IsoMed’s statement that IsoMed “has been developed for 15
physicians and allied professionals who care for patients using the IsoMed 16
System for hepatic arterial infusion of chemotherapeutic agents” (IsoMed i) 17
is evidence that IsoMed was prepared by Medtronic for distribution to 18
physicians and allied professionals rather than for internal or restricted use 19
within Medtronic. 20
10. Hank LaForce, a sales representative for a medical products 21
company later acquired by the Requester (see LaForce Decl., paras. 1 and 3), 22
testifies to having distributed “numerous copies” of IsoMed to physicians 23
and allied professionals starting in or about January 2001 (LaForce Decl., 24
para. 4). This distribution was part of a co-promotion of the IsoMed 25
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Infusion System by LaForce’s employer and Medtronic. (See LaForce 1
Decl., para. 3). 2
11. The facts found in FF 2–10, and particular FF 6–10, persuade 3
us by a preponderance of the evidence that IsoMed was available to the 4
relevant public as of on or around January 2001. (See Resp. Br. Req’r 3). 5
12. The rear face of the front cover of IsoMed includes addresses, 6
telephone numbers and other information for contacting Medtronic 7
Customer Services, Medtronic Technical Services and Medtronic Patient 8
Services. The back cover includes a mailing address, Internet site, telephone 9
number and fax number for Medtronic Neurological. Page A-2 of IsoMed 10
lists an Internet site to which the relevant public might resort for further 11
information. 12
13. Based on the contact information appearing in IsoMed, as well 13
as LaForce’s experience during the co-promotion of the IsoMed Infusion 14
System, LaForce infers that IsoMed was available to any member of the 15
relevant public who requested a copy from Medtronic. (LaForce Decl., para. 16
5). We take into account the limited detail that LaForce provides with 17
respect to the dissemination of IsoMed as well as LaForce’s potential bias 18
due to current employment by the Requester. (See App. Br. PO 7; see also 19
LaForce Decl., paras. 1 and 2 (disclosing LaForce’s employment by the 20
Requester)). Nevertheless, we find that LaForce’s inference is sound. The 21
inference supports the finding that interested members of the relevant public 22
could have obtained a copy of IsoMed if they wanted to obtain one. 23
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Jones 1
14. Jones addresses the problem of determining the orientation of 2
an implanted injection port. (See Jones, col. 1, ll. 57–58 and col. 2, ll. 46–3
49). 4
15. Jones teaches addressing this problem by providing an 5
implanted injection port with radiopaque locators positioned along parallel 6
planes spaced along the height of the injection port. Jones teaches that 7
spacing the radiopaque locators along the height of the injection port creates 8
a three-dimensional or stereoscopic effect when the port is viewed 9
fluoroscopically after implantation. (See Jones, col. 2, ll. 55–63 and col. 5, 10
ll. 14–19). 11
16. In particular, Jones describes positioning one of the locators on 12
the bottom of the port (see Jones, col. 2, l. 66 – col. 3, l. 2 and col. 3, ll. 53–13
55). 14
17. Jones teaches two methods for producing the radiopaque 15
locators. According to one method, the rings are produced by filling 16
continuous or discontinuous depressions in the injection port with a resin 17
containing powdered radiopaque material and polymerizing the resin. (See 18
Jones, col. 4, ll. 1–4). 19
18. Jones teaches that, by determining which of the two locators is 20
above the other, a physician or allied professional viewing the locators 21
fluoroscopically can determine whether the injection port is oriented 22
correctly or upside-down. (Jones, col. 5, ll. 7–14). 23
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Industry Praise or Recognition Evidence 1
19. As evidence of industry praise, the Patent Owner cites 2
statements in two journal articles. (See App. Br. PO 34–35). In October 3
2008, one of these journal articles wrote that: 4
A literature search revealed no articles discussing power 5
injectable ports, port identification, or safety recommendations. 6
Manufacturers of power injectable ports have recommended that 7
at least two methods be used to identify the port 8
(AngioDynamics® Incorporated, 2008; Bard Access Systems, 9
2008; Smiths Medical, 2008). Ports can be labeled by 10
identification cards, wristbands, and key chains supplied by port 11
manufacturers; an operative note, which includes the type of port 12
implanted and the location of the catheter; and palpation of the 13
port. The triangular shape and three bumps on the septum of the 14
powerPORT Implanted Port offer another method of 15
identification; however, palpation for shape should not be the 16
only method used for port identification in patients with 17
additional subcutaneous tissue or deeper ports. 18
The most critical step in port identification should occur 19
in radiology prior to power injection. In addition to the methods 20
for port identification mentioned previously, a CT scout scan 21
prior to power injection will identify the shape of the port (e.g., 22
triangular for the PowerPORT Implanted Port). For many newer 23
power injectable ports, the letters “CT” will show up on the scan. 24
The letters may be in different orientations (e.g., sideways, 25
upside down) depending upon the orientation of the port when 26
placed. The CT letters can also help identify a flipped port. 27
(Smith, Implanted Ports, Computed Tomography, Power Injectors, and 28
Catheter Rupture, 12 CLINICAL J. ONCOLOGY NURSING 809, 810 col. 3 29
(Oncological Nursing Soc’y, Oct. 2008) (“Smith”), Exh. 2 to the Patent 30
Owner’s Appeal Brief). 31
20. The other of these journal articles wrote in March 2009: 32
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HOW WILL YOU KNOW IF A PATIENT’S PORT 1
IS POWER INJECTABLE? 2
Patients are given two identification cards to carry in their wallet, 3
plus a key ring identification card at the time of port placement. 4
All three cards carry the specific information on portal serial 5
number, implantation date and physician, as well as power 6
injection specifications. In addition the PowerPort® and 7
PowerPort M.R.I.® have three palpation points comprising 8
silicone in the septum of the catheter arranged in triangular 9
formation, and a radiopaque power symbol identifier that can be 10
seen under X-ray or Fluoroscopy guidance. The PowerPort 11
M.R.I.® has a unique “CT” symbol implanted in the radiopaque 12
identifier that can aid in the identification of a flipped port 13
(BARD Access Systems CT Guide, 2007a). 14
(Johnson, Power Injectable Portal Systems, 28 J. RADIOLOGY NURSING 27, 15
30 (Ass’n Radiological & Imaging Nursing, Mar. 2009) (“Johnson”), Exh. 16
15 to Patent Owner’s Appeal Brief). 17
21. The Patent Owner argues that the “industry has recognized and 18
praised the claimed power injectable access ports, making special note of the 19
‘radiopaque power symbol identifier that can be seen under X-ray or 20
fluoroscopy guidance.’” (App. Br. PO 34, quoting Johnson at 30). When 21
read in context, the cited journal articles do not support this assertion. When 22
read as a whole, these articles describe the use of radiopaque identifiers as 23
only one of several possible means for identifying implanted access port 24
assemblies as power injectable. Neither of the two articles suggests that the 25
use of radiopaque identifiers, as opposed to some other means of 26
identification, is either unique or necessary to the use of power injectable 27
ports. As the Examiner correctly finds, these articles teach the need to 28
identify whether an implantable port is power injectable, by whatever 29
means, before injecting material into the port. As such, these articles are 30
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weak evidence of either industry praise or patentability. (See RAN 38; 1
Resp. Br. Req’r 44). 2
22. The Patent Owner also cites to an article, Brown, Identification 3
is a Requirement for Power Injection of Contrast Media through an 4
Implanted Port (GDS Publ’g Ltd. 2013), Exh. 16 to Patent Owner’s Appeal 5
Brief. (See App. Br. PO 34). The author of this article appears from the 6
face of the article to be affiliated with the Patent Owner. The article was 7
published subsequent to the filing of this reexamination proceeding. The 8
article does not cite any persuasive supporting evidence for its assertions 9
regarding the use of radiopaque identification for implanted access port 10
assemblies. This article is entitled to little weight as evidence of industry 11
praise or recognition. 12
13
Commercial Success Evidence 14
23. As evidence of commercial success, the Patent Owner cites a 15
report entitled U.S. Market for Vascular Access Devices & Accessories 16
(iData Research Inc., Vancouver, BC 2011) (“U.S. Market”), Exh. 14 to 17
Patent Owner’s Appeal Brief. (See App. Br. PO 32–33). U.S. Market found 18
that, in 2010, the market for power injectable ports experienced double-digit 19
growth. (U.S. Market 2). More specifically, the report found that power 20
injectable ports were introduced into the United States in 2007. By 2010, 21
power injectable ports accounted for 49.4% of all implantable ports placed 22
in the United States. (Id. at 68). The report projected that the market for 23
power injectable ports would grow at an annual growth rate of 3.8% through 24
2017 (id. at 2) and that, by 2017, power injectable ports would represent 25
62.3% of all ports placed in the United States (id. at 68). 26
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24. The Patent Owner has not established a nexus between the 1
growth in the overall market for power injectable ports in the United States 2
since 2007 and the patentability of any of the appealed claims. The Patent 3
Owner argues that the “criticality and ability to identify a port as power 4
injectable clearly demonstrates a nexus between the commercial success of 5
power injectable access ports and the claimed identification features recited 6
in the patent claims.” (App. Br. PO 33; Reb. Br. PO 15). This argument is 7
not persuasive. For example, the Patent Owner has not shown that 8
radiopaque identifiers are critical to identifying power injectable ports. In 9
fact, Smith and Johnson suggest that radiopaque identifiers are only one of 10
several means for identifying implanted power injectable ports. Therefore, 11
the Examiner is correct in finding that “the commercial success of the power 12
injectable ports has not been shown to be a result of the claim limitations but 13
rather the desirable operation of the high power port itself.” (RAN 38; see 14
also Resp. Br. Req’r 45). In view of the Patent Owner’s failure to show an 15
adequate nexus between the entire market for power injectable ports and the 16
scope of any of the claims, the findings of U.S. Market are weak evidence of 17
commercial success. 18
19
Copying Evidence 20
25. As evidence of copying, the Patent Owner presents product 21
brochures for products of the Requester (Exhs. 18 and 19 to Patent Owner’s 22
Appeal Brief); and two competitors, Medcomp (Exhs. 20 and 21 to Patent 23
Owner’s Appeal Brief) and Smiths Medical (Exh. 22 to Patent Owner’s 24
Appeal Brief). (See App. Br. PO 36–39; Reb. Br. PO 16–17). Neither the 25
Examiner nor the Requester appears to dispute the Patent Owner’s assertion 26
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that Exhibits 18 and 19 are authentic product brochures of the Requester; 1
that Exhibits 20 and 21 are authentic product brochures of Medcomp; and 2
that Exhibits 17 and 22 are authentic literature from Smiths Medical. (See 3
generally RAN 38–39; Resp. Br. Req’r 46–47). 4
26. The Patent Owner has not shown that the products depicted in 5
the product brochures and literature reproduced in Exhibits 17–22 of the 6
Patent Owner’s Appeal Brief are copied from one or more products of the 7
Patent Owner covered by the ʼ022 patent. As the Requester correctly points 8
out, the Patent Owner has not shown access on the part of the Requester, 9
Medcomp or Smith Medical to one or more of the Patent Owner’s products 10
before the products shown in the product brochures were introduced to the 11
market. (See Resp. Br. Req’r 46–47). Neither has the Patent Owner 12
demonstrated sufficient similarity between the products shown in the 13
product brochures and Patent Owner’s products to establish an intent to 14
exploit the Patent Owner’s rights in an invention claimed in the ʼ022 patent. 15
(See id.). 16
27. Johnson describes the Patent Owner’s PowerPort MRI access 17
port assembly as having “a unique ‘CT’ symbol implanted in the radiopaque 18
identifier.” (See Johnson 30). We note that the products depicted in the 19
product brochures and literature reproduced in Exhibits 17–22 of the Patent 20
Owner’s Appeal Brief feature the letters “CT” etched or printed positioned 21
on the bases of the access port assemblies. (See App. Br. PO 36–39). 22
Nevertheless, both Gray (US 8,075,536 B2, issued Dec. 13, 2011) and Smith 23
indicate that the letters “CT” had become a standard indication of a power 24
injection port by 2008 or 2009, prior to copyright and revision dates 25
appearing on the product brochures and literature reproduced in Exhibits 17–26
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22. (See Gray, col. 1, ll. 32–34). Although Gray says that the Patent Owner 1
alone “includes an external metal component with ‘CT’ lettering at the base” 2
(see Gray, col. 1, ll. 53–54), the Patent Owner has not shown that any of the 3
products depicted in the product brochures reproduced in Exhibits 17–22 4
copied this particular structure (see generally App. Br. PO 36–39). 5
28. We agree with the Examiner that the Patent Owner has not 6
proven, on the basis of the record before us, that either the Requester, 7
Medcomp or Smiths Medical copied a product of the Patent Owner covered 8
by the ʼ022 patent in such a way as to demonstrate that any claim of the 9
patent is patentable. (See RAN 38–39). To the extent that the Requester or 10
Medcomp adopted the use of radiopaque identifiers including the letters 11
“CT,” it appears likely that they did so because these letters became the 12
standard identification for power injectable ports. The Patent Owner has not 13
shown a persuasive nexus between the alleged copying and the subject 14
matter of any appealed claim. 15
16
DISCUSSION 17
First Issue 18
The Examiner finds that the Requester has proven IsoMed was a 19
printed publication as of the March 4, 2005, filing date of the provisional 20
application underlying the ’022 patent. (See RAN 18–21; see also Resp. Br. 21
Req’r 3–8). The Patent Owner disagrees. (See App. Br. PO 4–8). 22
“Because there are many ways in which a reference may be 23
disseminated to the interested public, ‘public accessibility’ has 24
been called the touchstone in determining whether a reference 25
constitutes a ‘printed publication’ bar under 35 U.S.C. 26
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§ 102(b).” In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986) 1
(emphasis added). “A given reference is ‘publicly accessible’ 2
upon a satisfactory showing that such a document has been 3
disseminated or otherwise made available to the extent that 4
persons interested and ordinarily skilled in the subject matter or 5
art exercising reasonable diligence, can locate it.” Bruckelmyer 6
v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006). 7
“The decision whether a particular reference is a printed 8
publication ‘must be approached on a case-by-case basis.’” In re 9
Cronyn, 890 F.2d 1158, 1161 (Fed. Cir. 1989). 10
SRI Int’l, Inc. v. Internet Security Sys., Inc., 511 F.3d 1186, 1194–95 (Fed. 11
Cir. 2008). 12
We find that IsoMed was available to the relevant public as of on or 13
around January 2001 (FF 11); and that interested members of the relevant 14
public could have obtained a copy of IsoMed if they wanted to obtain one 15
(FF 13). Based on these findings, we find by a preponderance of the 16
evidence that IsoMed was publically accessible on or around January 2001. 17
The Patent Owner argues that the LaForce Declaration should be 18
afforded no weight in assessing whether IsoMed is a printed publication 19
because no evidence “corroborates” the testimony in the declaration. (See 20
App. Br. PO 6–7). Corroboration is only required when unpatentability is 21
based on oral testimony alone. See Juicy Whip, Inc. v. Orange Bang, Inc., 22
292 F.3d 728, 740 (Fed. Cir. 2002) (“Historically, courts have looked with 23
disfavor upon finding anticipation with only oral testimony.”). The 24
Examiner’s rejections rely on documentary evidence, namely, IsoMed itself, 25
and not on the testimony of LaForce alone. (See Resp. Br. Req’r 6). 26
The Patent Owner also argues that paragraph 5 of the LaForce 27
Declaration should be afforded no weight because it is “hearsay.” (See App. 28
Br. PO 7). In paragraph 5, LaForce testifies that IsoMed “was disseminated 29
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or otherwise made available upon request of Medtronic, itself.” We need 1
not address whether LaForce’s statement that Medtronic requested 2
dissemination of IsoMed is hearsay because we do not rely on any such 3
request as persuasive evidence that IsoMed is a printed publication. Even 4
were we to assume that Medtronic did not authorize LaForce to distribute 5
copies of IsoMed, there is adequate evidence proving that IsoMed was made 6
available to the relevant public and that interested members of the relevant 7
public could have obtained a copy of IsoMed from Medtronic if they wanted 8
to obtain one. 9
The Patent Owner argues that IsoMed cannot be a printed publication 10
because it is not in either the MEDLIB-L Archives or the Online Computer 11
Library Center (“OCLC”). (See App. Br. PO 7–8 and Exh. 1). Even 12
assuming that the Patent Owner is correct that a “customary search” would 13
have included checking the MEDLIB-L Archives and the OCLC database, 14
the evidence on the face of IsoMed and in the LaForce Declaration indicates 15
that IsoMed was publically accessible even if not indexed in these databases. 16
See Voter Verified, Inc. v. Premier Election Solutions, Inc., 698 F.3d 1374, 17
1380 (Fed. Cir. 2012) (although indexing is a relevant factor in determining 18
whether a document is a printed publication, the absence of indexing is not 19
determinative where other factors indicate that the document was publically 20
accessible). (See RAN 20). 21
The facts in this appeal as a whole support a finding by a 22
preponderance of the evidence that IsoMed was publically accessible on or 23
before January 2001. Therefore, we conclude that IsoMed is a printed 24
publication for purposes of § 102(b). (See Resp. Br. Req’r 3). 25
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Second Issue 1
Claim 1 recites an access port assembly including “a body defining a 2
fluid cavity accessible by inserting a needle through a septum.” The Patent 3
Owner argues that the IsoMed pump fails to satisfy this limitation. As 4
support for this argument, the Patent Owner uses general purpose 5
dictionaries to define the verb “define” as “to fix or mark the limits of” 6
(App. Br. PO 10, citing the Merriam Webster online dictionary); or as “to 7
delineate the outline or form of” (App. Br. PO 10, citing the Free Dictionary 8
online). The Patent Owner points out that the reservoir of the IsoMed pump 9
as labeled in the drawing figure on pages 2-3 and A-6 of IsoMed is bounded 10
below by the propellant chamber and pump drive. According to the Patent 11
Owner, the reservoir is not bounded below by a lower wall of the titanium 12
shell. Based on these facts, the Patent Owner argues that IsoMed’s housing 13
and needle-penetrable septum together do not define the reservoir. (See 14
App. Br. PO 11; Reb. Br. PO 9–10). 15
We assume for purposes of this appeal, because the Examiner does 16
not find otherwise, that the term “fluid cavity” reads only on the reservoir of 17
IsoMed’s access port and not on the entire interior of the titanium shell. We 18
find that the reservoir and the propellant chamber in IsoMed’s injection site 19
together act as a reciprocating pump to force a drug from the reservoir into 20
the patient’s bloodstream. (FF 4). In addition, we find that one necessary 21
characteristic of a reciprocating pump is that the reservoir expands or 22
contracts as the drug is drawn into, or expelled from, the reservoir. The 23
limits within which the reservoir may expand within the housing are fixed or 24
marked by the lower wall of the housing. In other words, the outline of the 25
reservoir in its most expanded state (that is, when the propellant chamber is 26
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in its most contracted state) is delineated by the lower wall of the housing. 1
Therefore, IsoMed describes an access port assembly including “a body 2
defining a fluid cavity accessible by inserting a needle through a septum,” 3
even when that limitation is interpreted as proposed by the Patent Owner. 4
Alternatively, the Requester correctly argues that the term “housing” 5
as used in claim 1 is sufficiently broad to include not only the titanium shell 6
depicted in the drawing figures on pages 2-3 and A-6 of IsoMed, but also the 7
propellant chamber and pump device, as well as other structure that might 8
contact the reservoir. (See Resp. Br. Req’r 13–14). The Patent Owner 9
responds by pointing out that IsoMed distinguishes between the “titanium 10
shell” and the “propellant chamber and pump device”; and by asserting that 11
one of ordinary skill in the art would have considered the propellant 12
chamber and the pump device to be inside, rather than a part of, the housing. 13
(Reb. Br. PO 10). 14
The Patent Owner fails to identify any formal definition or clear 15
disclaimer in the written description of the ’022 patent that might limit the 16
term “housing” to a shell such as the titanium shell depicted in the drawing 17
figures of IsoMed. Therefore, it is reasonable to interpret the term 18
“housing” sufficiently broadly to encompass the combination of the titanium 19
shell with the propellant chamber and pump device as well as other structure 20
that might contact the reservoir. “An anticipatory reference . . . need not 21
duplicate word for word what is in the claims.” Standard Havens Prods. v. 22
Gencor Indus., 953 F.2d 1360, 1369 (Fed. Cir. 1991). Thus, the fact the 23
IsoMed uses different names to refer to the titanium shell, on the one hand, 24
and the propellant chamber and the pump device, on the other, does not 25
imply that the term “housing” cannot encompass the combination. For this 26
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additional reason, IsoMed describes an access port assembly including “a 1
body defining a fluid cavity accessible by inserting a needle through a 2
septum,” as recited in claim 1. 3
4
Third and Fourth Issues 5
Claim 1 recites an access port including “at least one radiopaque 6
identification feature of the access port observable via imaging technology 7
subsequent to subcutaneous implantation of the access port.” We find that 8
the access port assembly of IsoMed includes a small radiographic tag 9
bearing, among other information, the model number of the assembly. 10
Although this tag is located inside the titanium shell of the assembly, 11
IsoMed teaches that the model number of an implanted pump may be 12
verified by a radiographic examination. (See FF 5). This description 13
satisfies the quoted limitation. 14
Claim 1 also recites that “the at least one radiopaque identification 15
feature includ[es] one or more alphanumeric characters identifying the 16
access port as a power-injectable port.” The Patent Owner argues that one 17
of ordinary skill in the art would have understood this language to imply that 18
the access port recited in claim 1 is a power injectable port. As support for 19
this argument, the Patent Owner cites an alleged concession by the Examiner 20
on page 26 of the RAN. (App. Br. PO 9; Reb. Br. PO 1). In addition, the 21
Patent Owner cites to the prosecution history of the ʼ022 patent, arguing that 22
claim 1 was allowed because it was limited to a power injectable port. (See 23
Reb. Br. PO 2). The Patent Owner also cites 21 U.S.C. § 352(a), which 24
requires that medical devices, including access port assemblies, be correctly 25
labeled. (App. Br. PO 9; Reb. Br. PO 7–8). 26
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As the Examiner correctly concludes, claim 1 does not recite that the 1
claimed access port assembly is power injectable. (See RAN 26). In 2
addressing this argument, a distinction must be made. A radiopaque 3
alphanumeric message that falsely described an access port assembly as 4
power injectable might have deceived one of ordinary skill in the art. One of 5
ordinary skill in the art would have expected an access port assembly to be 6
labeled as being power injectable only if it was. For example, 21 U.S.C. 7
§ 352(a) proscribed falsely labeling access port assemblies as power 8
injectable. This is the thrust of the Examiner’s concession on page 26 of the 9
RAN. 10
Nevertheless, the fact that 21 U.S.C. § 352(a) proscribed falsely 11
labeling access port assemblies as power injectable implies that it was within 12
the level of ordinary skill in the art to falsely label an assembly that was not 13
power injectable. The level of ordinary skill in the art is defined in terms of 14
technical knowledge and ability, not in terms of legal proscriptions. See In 15
re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (“The person of ordinary 16
skill in the art is a hypothetical person who is presumed to know the relevant 17
prior art.”); KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A 18
person of ordinary skill is also a person of ordinary creativity, not an 19
automaton.”). It is unlikely that Congress would have passed legislation to 20
prevent device manufacturers from falsely labeling medical devices unless 21
the manufacturers had the technical ability to do so. Thus, the recitation 22
limiting the subject matter of claim 1 to an access port having a radiopaque 23
identification feature including one or more alphanumeric characters 24
identifying the access port as a power-injectable port does not limit claim 1 25
to a power injectable port. The Examiner need not find that IsoMed’s access 26
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port assembly is power injectable in order to find that it satisfies the 1
limitations of claim 1. 2
The prosecution history quoted by the Patent Owner on page 2 of the 3
Patent Owner’s Rebuttal Brief does not change this conclusion. For 4
example, the Patent Owner quotes the reasons for allowance on pages 3 and 5
4 of the Statement of Allowability, mailed April 2, 2011, in Application 6
12/420,028, as saying that claim 1 had been indicated allowable “because 7
the prior art of record fail[ed] to disclose either singly or in combination the 8
claimed device of an implantable access port . . . ha[ving] a radiopaque 9
alphanumeric message to indicate that this port is specifically power 10
injectable.” (Reb. Br. PO 2). The Notice of Allowability did not say that 11
claim 1 was patentable because the prior art failed to show a power 12
injectable port, although the prior art of record during the initial prosecution 13
might not have described a power injectable port. As such, the prosecution 14
history does not limit the access port recited in claim 1 to a power injectable 15
port. 16
Because the Examiner has shown that IsoMed’s access port assembly 17
satisfies all of the limitations of claim 1 other than the information conveyed 18
by the radiopaque alphanumeric messages recited in the claims; and because 19
the information conveyed by the radiopaque alphanumeric messages does 20
not bear a functional relationship to the structure defined by the other 21
limitations of claim 1, IsoMed anticipates claim 1. See In re Ngai, 367 F.3d 22
1336, 1338–39 (Fed. Cir. 2004). 23
A reasonable analogy can be drawn between the facts of the present 24
case and those of Ngai. In Ngai, our reviewing court reviewed a claim 25
reciting a kit combining a pre-measured portion of a reagent chosen from a 26
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class of known reagents with instructions for performing normalization and 1
amplification of a ribonucleic acid (“RNA”) population. The court affirmed 2
a rejection of the claim as anticipated by a prior art kit satisfying all 3
limitations of the claim except the content of the instructions. See Ngai at 4
1338–39. The court concluded that “[a]ll that the printed matter [that is, the 5
content of the instructions] does is teach a new use for an existing product.” 6
Ngai at 1339. The court held that this did not constitute a sufficient 7
functional relationship between the content of the instructions and the 8
reagent to justify a finding that the claimed subject matter was novel. 9
In the present case, the information conveyed by the at least one 10
radiopaque identification feature recited in claim 1 is to identify the access 11
port as a power-injectable port. When read in view of the written 12
description of the ’022 patent, the identification does no more than tell a 13
physician or allied professional radiographically inspecting an implanted 14
access port assembly how the assembly is intended to be used. That is, the 15
radiopaque identification feature is an instruction that the assembly may be 16
mechanically injected at a relatively high pressure or flow rate. (See RAN 17
27 (“There is no function, other than providing information, that the message 18
performs.”)). Because claim 1 does not recite that the access port must be 19
power injectable, the argument seeking to give patentable weight to the 20
information conveyed by the radiopaque alphanumeric message effectively 21
seeks to limit the access port recited in claim 1 in terms of its intended use 22
rather than its structure. Generally speaking, an intended use recitation in an 23
apparatus claim is not entitled to patentable weight. See In re Schreiber, 128 24
F.3d 1473, 1477 (Fed. Cir. 1997). Applying the law of Ngai, we find that 25
IsoMed anticipates claim 1. 26
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The Patent Owner argues that the facts of the present appeal are more 1
similar to those of In re Miller, 418 F.2d 1392 (CCPA 1969), than to the 2
facts of Ngai. (See App. Br. PO 14–16). The claims at issue in Miller 3
recited a measuring device combining a measuring spoon and an indicium 4
indicating that the volume of the measuring spoon was some multiple of the 5
actual volume. The combination was designed to address the culinary 6
problem of preparing a fractional serving (for example, a half-serving) of a 7
dish based on a recipe describing how to make a full serving of the dish. For 8
example, a person seeking to prepare a half-serving of the dish would use a 9
measuring spoon, or a set of measuring spoons, bearing indicia indicating 10
that the volumes of the measuring spoons were twice the actual volumes. 11
Where the recipe called for a certain volume of a particular ingredient, the 12
user would measure out the ingredient using a measuring spoon bearing an 13
indicium corresponding to the volume called for in the recipe rather than a 14
measuring spoon having the actual volume for which the recipe called. In 15
this way, the person would end up with a half serving of the dish without 16
having to consciously calculate fractional volumes for the ingredients. See 17
Miller at 1394–95. A predecessor of our reviewing court found that this 18
constituted a sufficient functional relationship between the measuring cup 19
and the indicium to preclude a finding of anticipation. Id. at 1396. 20
In Miller, the functional relationship did not arise because the indicia 21
on the spoons correctly identified the spoons’ volumes (and hence the type 22
of measuring step in which each spoon might be used). Instead, the 23
functional relationship arose because the indicia misidentified the spoons’ 24
volumes, so that the measuring spoons and the indicia together created the 25
illusion that the user was following the recipe when in fact the user was only 26
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measuring out fractions of the ingredients called for by the recipe. The 1
indicia on the measuring spoons only performed their function in 2
relationship to the spoons when the user willingly suspended disbelief and 3
measured ingredients in accordance with the indicia rather than the actual 4
capacities of the spoons. 5
There exists no similar functional relationship between the at least one 6
radiopaque identification feature and the access port recited in claim 1. A 7
willing suspension of disbelief when injecting fluid into a falsely marked 8
access port assembly would merely lead a physician or allied professional to 9
make a potentially injurious or fatal mistake. Unlike the method claimed in 10
Miller, the utility of the at least one radiopaque identification feature recited 11
in claim 1 is dependent on the accurate statement of the uses for which the 12
access port is designed rather than a willing suspension of disbelief as to an 13
inaccurate statement. (See Resp. Br. Req’r 18, citing RAN 27). Miller is 14
inapposite. 15
The Patent Owner also argues that the radiopaque alphanumeric 16
messages are entitled to patentable weight because they are machine 17
readable (that is, they are detectable only by radiographic examination once 18
the access port assembly is implanted). (See App. Br. PO 12, citing In re 19
Lowry, 32 F.3d 1579, 1582 (Fed. Cir. 1994)). Lowry held that a data 20
structure saved in a computer memory was entitled to patentable weight 21
because the “data structures, which according to Lowry greatly facilitate 22
data management by data processing systems, are processed by a machine.” 23
Id. at 1583. In the present appeal, we find that the recited radiopaque 24
identification feature are read (that is, detected) by a machine, but processed 25
(that is, recognized and understood) by a physician or allied professional. 26
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(See Resp. Br. Req’r 20; see also RAN 27). Because the radiopaque 1
alphanumeric messages must be processed by a human being, their primary 2
functional relationship is with the human being rather than with the access 3
port assembly. (See RAN 27). Lowry is inapposite. 4
The recitation in claim 1 that “the at least one radiopaque 5
identification feature includ[es] one or more alphanumeric characters 6
identifying the access port as a power-injectable port” does not patentably 7
distinguish the subject matter of claim 1 from the disclosure of IsoMed. We 8
find that IsoMed anticipates claims 1, 2 and 8 under § 102(b). 9
Claim 9 recites that the “one or more alphanumeric characters 10
[identifying the access port as power injectable] includes the letters ‘C’ and 11
‘T.’” Once again, this limitation recites the informational content of the at 12
least one radiopaque identification feature and does not recite a novel 13
functional relationship between the feature and the access port. Despite the 14
Patent Owner’s reliance on this recitation (see App. Br. PO 17), the 15
recitation does not patentably distinguish claim 9 from the disclosure of 16
IsoMed. 17
We find that IsoMed anticipates claims 6 and 9 under § 102(b). 18
Furthermore, because the Patent Owner does not explain how dependent 19
claim 5 might be patentable if IsoMed anticipates claim 1, we sustain 20
Ground E as applied to claim 5. 21
22
Fifth Issue 23
Independent claim 10 recites an access port having “a radiopaque 24
identification feature included on a bottom surface of the access port, the 25
feature being an alphanumeric message observable via imaging technology 26
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subsequent to subcutaneous implantation of the access port.” Claim 3 1
depends from claim 1 and further recites a similar limitation. The access 2
port assembly described by IsoMed does not satisfy these limitations. 3
Instead, IsoMed describes an access port assembly in which the radiopaque 4
tag bearing the alphanumeric message is located within the titanium shell. 5
(See FF 5; see also RAN 28 & 29). The Patent Owner argues that an access 6
port satisfying this limitation would not have been obvious from the 7
combined teachings of IsoMed and Jones. (See App. Br. PO 23 & 28–29). 8
Nevertheless, IsoMed recognizes the injection site may be inverted or 9
“flipped” when implanted. (See FF 5). Jones teaches addressing the 10
problem of detecting whether an implanted access port assembly is inverted 11
within a patient by providing the assembly with radiopaque locators 12
positioned along parallel planes spaced along the height of the injection port. 13
(See FF 15 and 16; see RAN 15). Jones describes positioning one of the 14
locators on the bottom of the port. (See FF 17; see also Resp. Br. Req’r 30). 15
Although Jones does not provide an explicit reason for positioning one of 16
the locators on the exterior surface of the bottom wall, Jones does teach that 17
the locators must be spaced to provide a clear indication of orientation. (See 18
FF 16). The Examiner correctly finds that “it would have been obvious to 19
provide additional characters onto the housing base of IsoMed as taught by 20
the Jones patent . . . [because such] multiple identifiers on the port [could] 21
assist in preventing backside injections.” (RAN 15). 22
The Patent Owner argues that one of ordinary skill in the art would 23
not have had reason to add an additional alphanumeric message to the access 24
port assembly described by IsoMed in order to assist in detecting the 25
orientation of the assembly after implantation, because the shape of the 26
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access port assembly is such that the orientation is readily determined; and 1
because IsoMed already teaches using the model number on the radiographic 2
tag inside the shell for this purpose. (See App. Br. PO 28–29; Reb. Br. PO 3
14). As the Examiner correctly finds, it would have been obvious in view of 4
the teachings of Jones to position multiple alphanumeric messages on, as 5
well as in, the housing of an implanted IsoMed access port assembly to 6
assist a caregiver in determining radiologically the orientation of the 7
implanted port. Providing multiple alphanumeric messages, arranged along 8
the height of the port as taught by Jones, would have provided the caregiver 9
assurance, in addition to that provided by the orientation of the letters or 10
numbers in the alphanumeric message, that the port is oriented correctly to 11
receive an injection. 12
In addition, the Patent Owner asserts that, 13
since the IsoMed pump housing is [made of] titanium, one of 14
ordinary skill in the art would not [have] place[d] the 15
identification tag on the outwardly facing base of the pump as it 16
would not [be] expected to be visible through the top and bottom 17
titanium housings when looking from the top of the pump 18
subsequent to subcutaneous implantation of the assembly. 19
(App. Br. PO 28). The Patent Owner does not appear to provide any 20
evidence, in the form of declaration testimony or otherwise, to support this 21
assertion. The assertion is not entitled to weight in this proceeding. See In 22
re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Even if entitled to weight, 23
the teachings of IsoMed refute the assertion. (See RAN 35; see also Resp. 24
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Br. Req’r 32–33).4 1
We are persuaded that the subject matter of claim 10 is not patentable 2
despite the objective evidence presented by the Patent Owner. The two 3
journal articles cited by the Patent Owner on page 32 of its Appeal Brief are 4
weak evidence of industry praise or recognition. When read as a whole, 5
these articles discuss the functional advantages of power injectable ports 6
rather than singling out radiopaque identification for praise. (See RAN 38). 7
Rather than praising the radiographic identifier recited in claim 10, these 8
articles describe radiographic identifiers as one of a number of schemes that 9
would be used to identify an implanted access port assembly. (See Resp. Br. 10
Req’r 46; see also FF 19–21). 11
Likewise, the Patent Owner has not shown a persuasive nexus 12
between the overall growth of the market for power injectable ports and the 13
subject matter of claim 10. As we concluded earlier, claim 10 is not limited 14
to power injectable ports. At the other end of the spectrum, not all power 15
injectable ports make use of radiographic identifiers. As such, the Patent 16
Owner’s evidence regarding the overall growth of the market for injectable 17
ports is not commensurate with the scope of claim 10. Apart from this, the 18
Patent Owner has not shown that any commercial success is due to novel 19
features of the claimed subject matter. The Examiner is correct in finding 20
that “the commercial success of the power injectable ports has not been 21
shown to be a result of the claim limitations but rather the desirable 22

4 In view of the Examiner’s findings on page 35 of the RAN, the Patent
Owner’s assertion that the Examiner found otherwise on page 19 of the
“Action Closing Prosecution,” mailed June 12, 2013 (“ACP”) (see Reb. Br.
PO 14, erroneously citing ACP 18) is not persuasive.
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operation of the high power port itself.” (RAN 38; see also Resp. Br. Req’r 1
45; FF 23 and 24). 2
The Patent Owner’s copying evidence is not persuasive. The Patent 3
Owner has not shown that the Requester, Medcomp or Smiths Medical 4
copied a product of the Patent Owner satisfying the limitations of claim 7 5
with the intent of exploiting the Patent Owner’s rights in an invention 6
claimed in claim 10. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 7
F.3d 1317, 1324 (Fed. Cir. 2004). The Patent Owner argues that the 8
Requester knew of the ʼ022 patent. (See App. Br. PO 37). Knowledge of 9
the patent does not imply access to, or copying of, a product embodying 10
what is claimed in the patent. To the extent that the Requester, Medcomp or 11
Smiths Medical adopted the use of radiopaque identifiers including the 12
letters “CT,” it appears likely that they did so because these letters became a 13
standard identification for power injectable ports. (See FF 25–28; see also 14
RAN 38–39). 15
Considering the evidence as a whole, we conclude that the subject 16
matter of claim 10 would have been obvious. We sustain Ground E as 17
applied to claim 10. Because the Patent Owner has not offered a well-18
developed, separate argument for the patentability of dependent claim 12, 19
13, 14 or 15 (see generally App. Br. PO 24–25; see also Resp. Br. Req’r 26), 20
we also sustain Ground E as to dependent claims 12–15. See 37 C.F.R. 21
§ 41.67(c)(1)(vii) (“A statement which merely points out what a claim 22
recites will not be considered an argument for separate patentability of the 23
claim.”). For similar reasons, we sustain Ground E as applied to claim 3. 24
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Sixth Issue 1
Independent claim 16 recites an access port having “at least one 2
recessed identification feature defined by the body, observable via x-ray 3
imaging technology subsequent to subcutaneous implantation of the access 4
port.” Claim 4 depends from claim 1 and further recites a similar limitation. 5
Claim 11 depends from claim 10 and likewise includes a similar limitation. 6
With regard to claim 16, the Patent Owner argues that “IsoMed does not 7
disclose at least one recessed identification feature defined by the body. The 8
tag in IsoMed is not recessed nor is it defined by the body.” (App. Br. PO 9
25). With regard to claim 4, the Patent Owner argues that there “is no 10
teaching or suggestion in the any of the documents relied upon by the 11
[E]xaminer to modify IsoMed to include the recited recessed feature.” (App. 12
Br. PO 24). With regard to claim 11, the Patent Owner argues that there “is 13
not teaching or suggestion which would motivate a [person of ordinary skill 14
in the art] to relocate the tag in IsoMed to the bottom surface or to have the 15
tag recessed.” (Id.) 16
The Examiner rejects claim 16 as unpatentable under § 103(a). The 17
Patent Owner argues only that IsoMed fails to anticipate claim 16, an 18
assertion with which the Examiner agrees. (See RAN 29 (withdrawing 19
rejection of claim 16 under § 102(b)). This argument fails to suggest any 20
persuasive reason why the Examiner might have erred in rejecting claim 16 21
under § 103(a). 22
We note the conclusory nature of the Patent Owner’s arguments 23
regarding claims 4 and 11. See 37 C.F.R. § 41.67(c)(1)(vii) (“A statement 24
which merely points out what a claim recites will not be considered an 25
argument for separate patentability of the claim.”). Nevertheless, we also 26
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note the Examiner’s finding that Jones teaches forming a radiopaque 1
identification feature by polymerizing a resin containing a radiopaque 2
powder in situ within a recess in the bottom wall of an access port. (See 3
RAN 15, quoting Jones, col. 4, ll. 1–4; see also FF 17; Resp. Br. Req’r 30–4
32). The opportunity to use this technique to form the radiopaque 5
identification feature would have provided one of ordinary skill in the art 6
reason to recess the identification feature within the body of the access port 7
and, in particular, in the bottom wall of the port. The Patent Owner does not 8
address this finding. 9
Taking into account the objective evidence presented by the Patent 10
Owner, we nonetheless sustain Ground E as applied to claims 4, 11 and 16. 11
Because the Patent Owner has not offered a well-developed, separate 12
argument for the patentability of dependent claim 17, 19 or 20 (see generally 13
App. Br. PO 26–27), we also sustain Ground E as to these dependent claims. 14
15
Seventh Issue 16
Claim 18 depends from claim 16 and further recites that “the at least 17
one recessed identification feature includes an engraved feature and is 18
relatively more x-ray transmissive with respect to other portions of the 19
access port body.” Claim 7 depends from claim 1 and further recites that 20
“the at least one radiopaque identification feature includes at least one cavity 21
extending inward from a bottom surface of the body.” As to each claim, the 22
Patent Owner argues that there is no teaching or suggestion that might have 23
led one of ordinary skill in the art to the proposed modifications. (See App. 24
Br. 24 & 26). 25
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The Patent Owner has not disputed in any persuasive manner the 1
Examiner’s finding that “Alberhasky teaches using . . . x-ray identifiable 2
engraved alphanumeric coordinate markers, i.e. letters A through J and 3
number[s] 1 through 10, which are engraved into a top plate.” (RAN 14, 4
citing Alberhasky (US 5,002,735, issued Mar. 26, 1991), col. 4, ll. 13–38). 5
This teaching would have provided one of ordinary skill in the art reason to 6
use engraving to fabricate radiographically identifiable alphanumeric 7
characters in a radiopaque identification feature.5 As discussed earlier, the 8
nature of the information to be conveyed by the alphanumeric characters, 9
such as to identify that the access port is a power injectable port intended for 10
use at high pressures or flow rates, is not a patentable distinction over the 11
combined teachings of IsoMed, Jones and Alberhasky. See Ngai, 367 F.3d 12
1336. 13
With regard to claim 18, the Patent Owner correctly points out that the 14
shell of the access port described by IsoMed is formed from titanium. (See 15
App. Br. PO 26; see also FF 3). The Patent Owner argues that “[o]ne of 16
ordinary skill in the art would not [have] engrave[d] one surface of the 17
IsoMed pump based on the teaching of [Alberhasky], because, unlike 18
[Alberhasky], the IsoMed pump is not radiographically and optically 19
transparent.” (App. Br. PO 26). As the Requester correctly points out, the 20

5 In particular, although we do not rely on the finding for purposes of
deciding the present appeal, we note that one of ordinary skill in the art
following Jones’ teaching to form a radiopaque identification feature by
polymerizing a resin containing a radiopaque powder in situ within a recess
in the bottom wall of an access port might have found it relatively
convenient to form alphanumeric characters in the radiopaque identification
feature by engraving the characters after polymerizing the feature.
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Patent Owner has not explained persuasively why the lesser radiographic 1
and optic transparency of the titanium shell of IsoMed’s access port might 2
have discouraged one of ordinary skill in the art from using engraving to 3
fabricate alphanumeric characters on a radiopaque identification feature, 4
other than the suggestion that the engraved characters could not be read 5
through the top and bottom layers of titanium making up the shell of 6
IsoMed’s access port. This argument appears to be a variation on the Patent 7
Owner’s argument that, because the access port described by IsoMed has a 8
titanium shell, an identification tag positioned on the outwardly facing base 9
of the pump would not have been visible (or would not have been expected 10
to be visible) through the top and bottom layers of titanium defining the 11
shell. (See App. Br. PO 28). Absent supporting evidence, which the Patent 12
Owner does not provide, neither argument is persuasive. See Geisler, 116 13
F.3d at 1470. 14
We sustain Ground E as applied to claims 7 and 18. 15
16
CONCLUSIONS 17
We AFFIRM Grounds A and C as applied to claims 1, 2, 6, 8 and 9. 18
That is, we sustain the rejection of claims 1, 2, 6, 8 and 9 under § 102(b) as 19
being anticipated by IsoMed. Because this decision constitutes a general 20
affirmance of the rejection of these claims, we do not reach Grounds D and 21
E as applied to these claims. 22
We AFFIRM Ground E as applied to claims 3–5, 7 and 10–20. That 23
is, we sustain the rejection of claim 3–5, 7 and 10–20 under § 103(a) as 24
being unpatentable over IsoMed, Jones and the Examiner’s finding that “one 25
skilled in the art would have also recognized the well-known techniques 26
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disclosed in the analogous prior art to convey to a practitioner various 1
information, characteristics and/or intended uses of other implanted medical 2
devices” (RAN 13, quoting Request 45–46). Our affirmance of Ground E as 3
applied to claims 7 and 18 particularly relies on the teachings of Alberhasky 4
in support of the Examiner’s finding. Because this decision constitutes a 5
general affirmance of the rejection of claims 3–5, 7 and 10–20, we do not 6
reach Ground D as applied to these claims. 7
8
DECISION 9
We AFFIRM the Examiner’s decision rejecting claims 1–20. 10
Requests for extensions of time in this inter partes reexamination 11
proceeding are governed by 37 C.F.R. §§ 1.956 and 41.77(g). No time 12
period for taking any subsequent action in connection with this appeal may 13
be extended under 37 C.F.R. § 1.136(a). 14
In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the 15
appeal may file a request for rehearing of the decision within one month of 16
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A 17
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). 18
Comments in opposition to the request and additional requests for rehearing 19
must be in accordance with 37 C.F.R. § 41.79(c)–(d), respectively. Under 20
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) 21
of this section, for requesting further rehearing under paragraph (d) of this 22
section, and for submitting comments under paragraph (c) of this section 23
may not be extended. 24
An appeal to the United States Court of Appeals for the Federal 25
Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an 26
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inter partes reexamination proceeding “commenced” on or after November 1
2, 2002, may not be taken “until all parties' rights to request rehearing have 2
been exhausted, at which time the decision of the Board is final and 3
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See 4
also MPEP § 2682 (8th ed., Rev. 7, July 2008). In the event neither party 5
files a request for rehearing within the time provided in 37 C.F.R. § 41.79, 6
and this decision becomes final and appealable under 37 C.F.R. § 41.81, a 7
party seeking judicial review must timely serve notice on the Director of the 8
United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 9
1.983. 10
11
AFFIRMED 12

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Patent Owner:

C.R. BARD, INC.
C/O GREENBAUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON, VA 20191

Third Party Requester:

CADWALADER, WICKERSHAM & TAFT LLP
ONE WORLD FINANCE CENTER
NEW YORK, NY 10281