Ex Parte 7,959,615 B2 et al

Patent Trial and Appeal Board

Mar 24, 2016

95002092 (P.T.A.B. Mar. 24, 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.
95/002,092 08/20/2012 7,959,615 B2 99821.009US3 1228
109545 7590 03/24/2016
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
03/24/2016 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 2015-004506
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Patent US 7,959,615 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 June 14, 2011 to Jason R. Stats and Kelly B. Powers (the “’615
patent”). The ’615 patent issued from Appl. 12/023,280, filed January 31,
2008. 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 February 14, 2014,
identifies litigation and administrative proceedings involving the ’615 patent
and other 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 1–10 of the ’615 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 December 16, 2013). Claim 11 is not subject to 5
reexamination in this proceeding. (See “Patent Owner’s Appeal Brief under 6
35 U.S.C. § 134, 37 C.F.R. § 1.959 and 37 C.F.R. § 41.67,” dated February 7
14, 2014 (“Patent Owner’s Appeal Brief” or “App. Br. PO”), at 1; see also 8
“Third Party Requester’s Respondent’s Brief to Patentee’s Appeal Brief in 9
Inter partes Reexamination of U.S. Patent No. 7,959,615” dated March 14, 10
2014 (“Requester’s Respondent Brief” or “Resp. Br. Req’r”), at 1 (accepting 11
the Patent Owner’s statement of claim status)). 12
The Examiner’s findings and conclusions are stated in a “Right of 13
Appeal Notice,” mailed November 14, 2013 (“RAN”).2 The RAN includes 14
citations to the “Request for Inter partes Reexamination of U.S. Patent No. 15
7,959,615,” dated August 20, 2012 (“Request”). The Patent Owner relies on 16
its Appeal Brief, with six exhibits; and a “Patent Owner’s Rebuttal Brief 17
under 37 C.F.R. § 41.67,” dated August 29, 2014 (“Reb. Br. PO”). The 18
Requester relies on its Respondent’s Brief, citing twelve exhibits. A hearing 19
was held on June 18, 2015 at the request of both the Patent Owner and the 20
Requester. We have jurisdiction over the appeal under pre-AIA 35 U.S.C. 21
§ 134(b) and 35 U.S.C. § 315(a). 22

2 The Examiner’s Answer mailed August 1, 2014 incorporates the RAN
by reference.
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GROUNDS OF REJECTION AND DISPOSITION 1
In Grounds A and C,3 the Examiner adopts two proposed rejections of 2
claims 1–5 and 8 under pre-AIA 35 U.S.C. § 102(b) as being anticipated by 3
Reuter (EP 1 238 682 A2, publ. Sept. 11, 2002).4 (See RAN 3–5; see also 4
Request 37–40 & 44–48). The Patent Owner argues the patentability of 5
claims 5 and 8 together for purposes of Grounds A and C. (See App. Br. PO 6
19). 7
We REVERSE Grounds A and C as applied to claims 1–5 and 8. 8
In Ground D, the Examiner adopts a proposed rejection of claims 1–9
10 under 35 U.S.C. § 103(a) as being unpatentable over Reuter in view of 10
the Examiner’s finding that “one skilled in the art would have been aware of 11
well-known general knowledge in the art regarding using a structural feature 12
to identify the type of port subsequently implanted, palpating the port, and 13
feeling the structure for identification and would have found this function 14
and method steps obvious” (RAN 6–7). The Examiner cites Reinicke (US 15
4,626,244, issued Dec. 2, 1986); Sanfilippo (US 5,919,160, issued July 6, 16
1999); Montalvo (US 5,476,460, issued Dec. 19, 1995); Bunodiere (US 17
2005/0075614 A1, publ. Apr. 7, 2005); and Eliasen (WO 2004/091434 A2, 18

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 Reuter anticipates claims 1–5 and 8. (Compare Request 37–40 with id.
at 44–48; see also RAN 4 n.3).
4 “Reuter,” as used in this opinion, will refer to an English language
translation certified on May 3, 2012, by Ryan Drost of Transperfect. A copy
of the translation is in the record of the reexamination proceeding.
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publ. Oct. 28, 2004) as support for the Examiner’s finding regarding the 1
well-known, general knowledge in the art. (See RAN 6–8; see also Request 2
49–53). 3
We AFFIRM Ground D as applied to claims 1–5 and 8–10. In doing 4
so, we need only consider the teachings of Reuter, Sanfilippo and 5
Bunodiere. We REVERSE Ground D as applied to claims 6 and 7. 6
In Ground E, the Examiner adopts a proposed rejection of claims 1–10 7
under § 103(a) as being unpatentable over Reuter, Reinicke and “the 8
representative knowledge of the ability to recognize an access port by its 9
shape after implantation” (RAN 8). (See RAN 8–10; see also Request 53–10
59). 11
In view of our disposition of Ground D, it is unnecessary to reach 12
Ground E as applied to claims 1–5 and 8–10. We REVERSE Ground E as 13
applied to claims 6 and 7. 14
Only those arguments actually made by the Patent Owner have been 15
considered. Arguments that the Patent Owner could have made but chose 16
not to make have not been considered and are deemed to be waived. See 17
37 C.F.R. § 41.67(c)(1)(vii) (2011); In re Jung, 637 F.3d 1356, 1365 (Fed. 18
Cir. 2011). 19
20
THE ’615 PATENT 21
The ’615 patent teaches implantable access ports providing 22
subcutaneous access to a patient without requiring a needle to puncture the 23
patient’s skin. (’615 patent, col. 3, ll. 29–41). As depicted in Figures 1A 24
and 1B, an access port 10 includes a body 20 and a septum 18 cooperating to 25
define a cavity 36. The cavity 36 communicates with the interior of the 26
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patient through an outlet stem 31. (See ’615 patent, col. 4, ll. 31–39, 45–47 1
& 51–59). 2
The ’615 patent teaches that access ports may be injectable by hand. 3
Alternatively, power-injectable ports may be injected and pressurized with 4
mechanical assistance. (’615, col. 3, ll. 45–49). The patent teaches that 5
power injectable ports capable of mechanically-assisted injection and 6
pressurization may be employed for injecting contrast media into a 7
peripherally inserted intravenous line for use in computed tomography 8
(“CT”) imaging processes. (’615 patent, col. 3, ll. 50–54). “Because fluid 9
infusion procedures are often defined in terms of a desired flow rate of 10
contrast media, such power injection systems are, in general, controllable by 11
selecting a desired flow rate.” (’615 patent, col. 3, ll. 58–61). 12
Claims 1, 8 and 10 are independent: 13
1. An access port for providing subcutaneous access to 14
a patient, comprising: 15
a body defining a cavity accessible by inserting a needle 16
through a septum, the body including a plurality of side surfaces 17
and a bottom surface bounded by a bottom perimeter, the bottom 18
surface on a side of the port opposite the septum, the bottom 19
perimeter including a concave portion, the side surfaces 20
including a first side surface through which an outlet stem 21
extends; and 22
at least one structural feature of the access port identifying 23
the access port subsequent to subcutaneous implantation as a 24
particular type of access port, the at least one structural feature 25
comprising a concave side surface in a second side surface 26
different from the first side surface, the concave side surface 27
extending to the bottom perimeter concave portion. 28
(App. Br. PO 35). 29
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8. An access port for providing subcutaneous access to 1
a patient, comprising: 2
a body defining a cavity accessible by inserting a needle 3
through a septum, the body including a plurality of side surfaces 4
and a bottom surface bounded by a bottom perimeter, the bottom 5
surface on a side of the port opposite the septum, the bottom 6
perimeter including a concave portion, the side surfaces 7
including a first side surface through which an outlet stem 8
extends; and 9
at least one structural feature of the access port identifying 10
the access port as being power injectable subsequent to 11
subcutaneous implantation, the at least one structural feature 12
comprising at least one a concave side surface in a second side 13
surface different from the first side surface, the concave side 14
surface extending to the bottom perimeter concave portion. 15
(App. Br. PO 35–36 (italics added to indicate language differing from the 16
corresponding language of claim 1)). 17
10. A method of identifying a subcutaneously 18
implanted access port, comprising: 19
palpating a subcutaneously implanted access port, 20
wherein the port comprises a body including a plurality of 21
side surfaces, wherein one of the plurality of side surfaces 22
includes an outlet stem extending therefrom; 23
feeling at least one structural feature of the subcutaneously 24
implanted access port, the at least one structural feature 25
comprising one or more concave side surfaces in side surfaces 26
different from the side surface through which the outlet stem 27
extends, each of said one or more concave side surfaces 28
extending to a concave portion in a bottom perimeter of a bottom 29
surface; and 30
identifying the type of subcutaneously implanted access 31
port through the feeling of the at least one structural feature. 32
(App. Br. PO 36). 33
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ISSUES 1
Five issues are dispositive of this appeal: 2
First, does Reuter describe an access port including “at least one 3
structural feature of the access port identifying the access port subsequent to 4
subcutaneous implantation as a particular type of access port, the at least one 5
structural feature comprising a concave side surface in a second side 6
surface,” as recited in claim 1? (See App. Br. PO 7–10; Reb. Br. PO 5–6). 7
Second, would an access port including “at least one structural feature 8
of the access port identifying the access port subsequent to subcutaneous 9
implantation as a particular type of access port, the at least one structural 10
feature comprising a concave side surface in a second side surface,” have 11
been obvious over Reuter and the “well-known general knowledge in the 12
art” as found by the Examiner at RAN 6–7? (See App. Br. PO 15–22; Reb. 13
Br. PO 6–8). 14
Third, would an access port including “at least one structural feature 15
of the access port identifying the access port as being power injectable 16
subsequent to subcutaneous implantation, the at least one structural feature 17
comprising at least one concave side surface in a second side surface 18
different from the first side surface,” as recited in claim 8, have been 19
obvious over Reuter and the “well-known general knowledge in the art” as 20
found by the Examiner at RAN 6–7? (See App. Br. PO 13–15 & 24; Reb. 21
Br. PO 6). 22
Fourth, would the subject matter of claim 9 have been obvious over 23
Reuter and the “well-known general knowledge in the art” as found by the 24
Examiner at RAN 6–7? (See App. Br. PO 25–26; Reb. Br. PO 9–10). 25
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Fifth, would the subject matter of claims 6 and 7 have been obvious 1
from Reuter and either the “well-known general knowledge in the art” as 2
found by the Examiner at RAN 6–7; or Reinicke and “the representative 3
knowledge of the ability to recognize an access port by its shape after 4
implantation” as found by the Examiner at RAN 8? (See App. Br. PO 23–5
24; Reb. Br. PO 8–9). 6
7
PRINCIPLES OF LAW 8
A claim undergoing reexamination is given its broadest reasonable 9
interpretation consistent with the underlying specification. In re Am. Acad. 10
of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). In the absence of 11
an express definition of a claim term in the specification or a clear 12
disclaimer of scope, the claim term is interpreted as broadly as the ordinary 13
usage of the term by one of ordinary skill in the art reasonably would permit. 14
In re ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007); In 15
re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). 16
“To anticipate a claim, a prior art reference must disclose every 17
limitation of the claimed invention, either explicitly or inherently.” In re 18
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “Under the principles of 19
inherency, if the prior art necessarily functions in accordance with, or 20
includes, the claimed limitations, it anticipates.” In re Cruciferous Sprout 21
Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). On the other hand, a limitation 22
that is merely the probable result of the subject matter disclosed in a 23
reference is not inherent in that reference. In re Robertson, 169 F.3d 743, 24
745 (Fed. Cir. 1999). 25
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The burden of proving anticipation in an inter partes reexamination is 1
on the examiner and the third party requester. See Rambus Inc. v. Rea, 731 2
F.3d 1248, 1255 (Fed Cir. 2013)(a party taking a position adverse to the 3
patentability of a claim generally bears the burden of proving a factual 4
underpinning for a rejection of the claim). Nevertheless, as a matter of 5
procedure, identity or substantial identity between the structure of the 6
claimed subject matter and structure described in the prior art may give rise 7
to a rebuttal presumption that the prior art inherently shares the functional 8
characteristics of the claimed subject matter. If the examiner “shows [a] 9
sound basis for believing that the products of the applicant and the prior art 10
are the same, the [patent owner] has the burden of showing that they are 11
not.” See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). In particular, if 12
“the claimed and prior art products are identical or substantially identical, 13
. . . the PTO can require [a patent owner] to prove that the prior art products 14
do not necessarily or inherently possess the characteristics of [the] claimed 15
product.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977). 16
17
CLAIM INTERPRETATION 18
“At Least One Structural Feature of the Access Port Identifying the Access 19
Port Subsequent to Subcutaneous Implantation as a Particular Type of 20
Access Port,” as Recited in Claim 1; “At Least One Structural Feature of 21
the Access Port Identifying the Access Port as Being Power Injectable 22
Subsequent to Subcutaneous Implantation,” as Recited in Claim 8; and 23
“Identifying the Type of Subcutaneously Implanted Access Port” as Recited 24
in Claim 10 25
The ʼ615 patent does not formally define what is meant by a “type” of 26
access port. In fact, the written description of the ʼ615 patent only refers to 27
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the “type” of an access port twice. At column 1, ll. 42–43, the ʼ615 patent 1
teaches that: 2
Ports generally come in two different types, surgical and 3
cosmetic. Surgical ports may typically be used for delivering 4
medicinal substances, including chemotherapy drugs which may 5
be harmful to surrounding tissue, or for sampling blood. 6
Cosmetic ports, on the other hand, are utilized to deliver saline 7
or some other non-reactive substance to a prosthesis which 8
supplements a body feature. 9
(Id.) This quote is consistent with the “type of access port” being 10
sufficiently broad to encompass an access port dedicated to delivering a 11
particular substance. A port delivering a different substance might be of a 12
different “type” even if substantially identical in construction. At column 4, 13
ll. 6–12, the ʼ615 patent explains: 14
Of course, the at least one identifiable feature of an access port 15
contemplated by the instant disclosure may be further correlative 16
with any information of interest, such as type of port, catheter 17
type, date of manufacture, material lots, part numbers, etc. In 18
one example, at least one identifiable feature of an access port 19
may be correlative with the access port being power injectable. 20
(Id.) This latter quote is not inconsistent with such a reading. 21
We adopt the Examiner’s interpretation of the functional limitation “at 22
least one structural feature of the access port identifying the access port 23
subsequent to subcutaneous implantation as a particular type of access port,” 24
as recited in claim 1, as sufficiently broad to encompass structural features 25
capable of identifying an access port as a particular type of access port after 26
implantation. (See RAN 5). The Patent Owner has not identified any formal 27
definition or clear disclaimer in the ʼ615 patent inconsistent with this 28
understanding. 29
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Likewise, we interpret the functional limitation “at least one structural 1
feature of the access port identifying the access port as being power 2
injectable subsequent to subcutaneous implantation,” as recited in claim 8, 3
as sufficiently broad to encompass structural features capable of identifying 4
an access port as power injectable after implantation. There is no persuasive 5
evidence to suggest that there existed a correlation between any structural 6
feature and power injectability among physicians or allied professionals as 7
of the effective filing date of the ʼ615 patent.5 As such, any structural 8
feature detectable after implantation might be capable of identifying (that is, 9
being correlated with) power injectable ports, but no feature actually 10
identified such ports. 11
12
FINDINGS OF FACT 13
The record supports the following findings of fact (“FF”) by a 14
preponderance of the evidence. See Rambus, 731 F.3d at 1255; Ethicon, Inc. 15
v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988). 16
17
Reuter 18
1. Paragraphs 12–15 of Reuter describe an implantable access 19
port. (See Reuter, para. 1). Reuter includes only one drawing figure 20
depicting the access port described in paragraphs 12–15. An annotated copy 21

5 For example, Smith, Implanted Ports, Computed Tomography, Power
Injectors, and Catheter Rupture, 12 CLINICAL J. ONCOLOGY NURSING 809,
810 col. 3 (Oncological Nursing Soc’y, Oct. 2008), Exh. 2 to the Patent
Owner’s Appeal Brief, dates from over two years after the effective filing
date.
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of the sole drawing figure, which provides a top plan view of Reuter’s 1
access port, appears on page 38 of the Request: 2
3
(Id.) 4
2. We adopt the following findings of the Examiner appearing on 5
pages 4–5 of the RAN. 6
Regarding independent claims 1 and 8, and thereby 7
dependent claims 2–5, the Reuter application teaches: 8
Specifically, the Reuter Figure discloses an access port (labeled 9
A) for providing subcutaneous access to a patient, comprising: a 10
body (labeled B) defining a cavity accessible by inserting a 11
needle through a septum (labeled C), the body including a 12
plurality of side surfaces (labeled SIDE G, SIDE D and SIDE D´) 13
and a bottom surface (labeled E) bounded by a bottom perimeter 14
(labeled E´), the bottom surface (labeled E) on a side of the port 15
opposite the septum (labeled C), the bottom perimeter (labeled 16
E´) including a concave portion (labeled F), the side surfaces 17
including a first side surface (labeled SIDE G) through which an 18
outlet stem (labeled H) extends. (See Ex. 3, Reuter Application, 19
Figure at 3). 20
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The Reuter application further discloses . . . a concave side 1
surface (labeled Z) in a second side surface (labeled SIDE D) 2
different from the first side surface (labeled SIDE G), the 3
concave side surface (labeled Z) extending to the bottom 4
perimeter concave portion (labeled Z´). 5
(Id., quoting Request 38). 6
3. Reuter describes the implantable access port as “consist[ing] of 7
a housing 1 and a lower base plate 2.” (Reuter, para. 12). The housing 1 as 8
depicted in the sole drawing figure appears to comprise a hollow cylinder 9
projecting upwardly from an upper surface of the base plate 2. (See App. Br. 10
PO 5 (describing the housing 1 as “cylindrical”); Reb. Br. PO 1). The 11
interior of the hollow cylinder defines a cavity or port chamber 3. (See App. 12
Br. PO 6). Hence, Reuter teaches that “[w]ithin the housing [1] is formed a 13
port chamber 3, which serves as a reservoir for the respective medication. 14
At the top the port chamber 3 is covered with a septum.” (Reuter, para. 12). 15
4. Reuter’s access port also includes a catheter connection 8. (See 16
Reuter, para. 13). The port chamber 3 communicates with the catheter 17
connector 8 by way of a tubular outlet. The “tubular outlet leads from the 18
port chamber 3 through the base plate 2 to [the] catheter connection 8.” (See 19
id.) 20
5. More generally, Reuter describes the use of an implanted access 21
port to introduce medication into a vein of a patient. Reuter teaches 22
introducing the medication into the cavity of port chamber of the implanted 23
access port through a septum covering the cavity. (See Reuter, para. 3). 24
One of ordinary skill in the art would have recognized that one could access 25
the cavity or port chamber of an implantable access port such as that 26
depicted in the sole drawing figure of Reuter by inserting a hypodermic 27
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needle through the septum. (See, e.g., Reinicke, col. 5, ll. 34–54; Montalvo, 1
col. 1, ll. 31–37 & col. 4, ll. 9–13). The access port then delivers the 2
medication to the vein through a catheter connected to the catheter 3
connection of the port. (See Reuter, para. 3). 4
6. Reuter discloses that the outer contours of conventional access 5
ports were rounded. (See Reuter, para. 2). Such access ports were 6
implanted by surgeons. Typically, the surgeons wore gloves while 7
implanting access ports. Those gloves might become wet during an 8
implantation procedure. As a result, surgeons experienced difficulty holding 9
access ports with rounded sides during implantation, particularly while 10
fastening previously-implanted catheters to the catheter connections 8. (See 11
Reuter, para. 4). 12
7. Reuter teaches providing concave cut-outs 9, 10 in the base 13
plate 2 of an access port in order to assist a surgeon in handling the access 14
port during implantation. (See Reuter, paras. 14 & 15). The cut-outs 9, 10 15
oppose each other on the outer sides parallel to the axis of the catheter 16
connection 8. (See Reuter, para. 14). 17
8. The teachings of Reuter imply that the housing 1 is affixed to, 18
or unitary with, the base plate 2, such that the combination of the housing 1 19
and the base plate 2 constitutes a “body” within the ordinary meaning of the 20
word. (See Resp. Br. Req’r 8 & 15–16; see also App. Br. PO 6–7; Reb. Br. 21
PO 4–5). For example, Reuter teaches that the cut-outs 9, 10 in the base 22
plate 2 assist a surgeon in manipulating the access port while implanting the 23
port into a patient. (See Reuter, paras. 7, 10 and 15). Cut-outs in the base 24
plate 2 alone would be of limited value in manipulating the access port as a 25
whole if the housing 1 were not affixed to, or unitary with, the base plate 2. 26
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In addition Reuter teaches that the port chamber 3 defined in the housing 1 1
communicates with the catheter connection 8 by way of a tubular outlet 2
through the base plate 2. (Reuter, para. 13). If the housing 1 were not 3
affixed to, or unitary with, the base plate 2, the housing 1 could separate 4
from the base plate 2 after implantation of the port into a patient. This 5
separation could result in undesirable leakage between the reservoir and the 6
tubular outlet. 7
9. The housing 1 defines the cavity or port chamber 3. The base 8
plate 2 includes the first side surface, through which the catheter connection 9
8 extends, and the second and third side surfaces, which coincide with the 10
cut-outs 9, 10. Therefore, the body comprising the housing 1 and the base 11
plate 2 “defin[es] a cavity accessible by inserting a needle through a septum, 12
[and] include[es] a plurality of side surfaces and a bottom surface bounded 13
by a bottom perimeter,” as recited in claims 1 and 8. (See RAN 14). 14
15
Sanfilippo 16
10. Figure 8 of Sanfilippo is a plan view of a vascular access device 17
220. The vascular access device 220 includes an elongated implant body 18
232 with two longitudinally spaced and arrayed access openings 244, 245. 19
11. Sanfilippo’s vascular access device 220 comprises an elongated 20
implant body 232 including opposed side walls 250, 252 and a top wall 256. 21
The implant body 232 encloses a pair of access chambers 238, 239. The top 22
wall 256 includes two access openings 244, 245, each access opening 23
communicating with one of the access chamber 238, 239 in the implant body 24
232. (See Sanfilippo, col. 8, ll. 4–9). A fluid-impermeable closure 25
membrane 246a, 246b closes each of the access openings 244, 245. The 26
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closure membranes 246a, 246b permit transdermal communication with the 1
access chambers 238, 239 by needle. (Cf. Sanfilippo, col. 5, l. 59 – col. 6, l. 2
6 (describing corresponding structure of an embodiment depicted in Figures 3
1–3)). 4
12. Sanfilippo describes using a vascular access device having two 5
access chambers, coupled to a double lumen catheter, to deliver two 6
medications or treatment fluids to a part of a patient’s body without 7
commingling of the fluids. (See Sanfilippo, col. 7, l. 49 – col. 8, l. 3). This 8
description would have provided one of ordinary skill in the art reason to use 9
each of the access chambers 238, 239 of the vascular access device 220 to 10
deliver a different substance. When used in this fashion, each of the access 11
chambers 238, 239 would have acted as a different type of access port. 12
13. Sanfilippo teaches forming a curved indentation 261, 262 in 13
each of the side walls 250, 252 of the implant body 232 on opposite sides of 14
the access opening 244; and a curved indentation 261, 262 in each of the 15
side walls 250, 252 on opposite sides of the access opening 245. In addition, 16
Sanfilippo teaches forming the curved indentations 261 in the side wall 250 17
so as to have shapes different from the shapes of the curved indentations 262 18
in the side wall 252. (Sanfilippo, col. 8, ll. 9–14 & 24–27). 19
14. Sanfilippo teaches using the curved indentations to locate the 20
vascular access device 220 after implantation; and to differentiate the two 21
access openings 244, 245. (Sanfilippo, col. 3, ll. 18–25 & col. 8, ll. 14–27). 22
Because the access chambers 238, 239 accessible through the access 23
openings 244, 245 might be used to deliver different substances, this 24
teaching would have suggested the use of concave side surfaces of different 25
shapes to identify different types of access ports. Hence, the Examiner 26
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correctly found that it was “well-known general knowledge in the art” to 1
“us[e] a structural feature,” namely, one or more concave side surfaces, “to 2
identify the type of port [subsequent to implantation], palpat[e] the port, and 3
[feel] the structure for identification.” (RAN 6–7, citing Request 127–28). 4
15. Sanfilippo also teaches that a practitioner may use the curved 5
indentations 261, 262 to physically grasp the vascular access device 220 6
when locating one of the access openings 244, 245 and injecting a 7
medication or treatment fluid into the corresponding access chamber 238, 8
239. (Sanfilippo, col. 8, ll. 20–24). 9
16. Sanfilippo would have taught one of ordinary skill in the art 10
how to construct an implant body for an access port having a generally 11
triangular exterior and a pair of concave side surfaces parallel to the axis of 12
the body. The Requester correctly points out that each half of the vascular 13
access device depicted in Figure 8 of Sanfilippo is generally triangular-14
shaped. (See Resp. Br. Req’r 34). More specifically, one half (shown at the 15
left side of Figure 8) has an apex at the second end 236; a base that may be 16
drawn along the line of a raised ridge 264 at the middle of the implant body 17
232; and sides (corresponding to the side walls 250, 252) that extend from 18
the first end 234 at an angle to each other but curve into parallel alignment 19
before reaching the raised ridge 264. The access opening 244 and the pair of 20
curved indentations 261, 262 adjacent the opening are located closer to the 21
base of the triangle (that is, the raised ridge 264) than to the vertex (that is, 22
the second end 236). As such, the indentations 261, 262 are parallel to a 23
longitudinal axis of the implant body 232 in the sense that the sides (that is, 24
the side walls 250, 252) are nearly parallel adjacent to the indentations 261, 25
262. 26
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Bunodiere 1
17. Bunodiere describes a subcutaneously implantable access port. 2
(Bunodiere, para. 1). Bunodiere teaches that one drawback to the 3
implantation of access ports is that, once implanted, the access port is a 4
foreign body that may cause discomfort to the patient. The degree of 5
discomfort will depend on the size and shape of the port. The degree of 6
discomfort also will depend on how securely the port is fastened and 7
immobilized beneath the skin. (See Bunodiere, para. 10). 8
18. Bunodiere describes an implantable access port having a casing 9
17 with a substantially triangular base. (Bunodiere, para. 43 & Figs. 3–5). 10
Bunodiere teaches that, “[o]wing to its triangular shape, the implantable 11
chamber does not tend to rotate on itself nor to migrate beneath the skin.” 12
(Bunodiere, para. 27; see also id., para. 11). 13
14
ANALYSIS 15
First Issue 16
Reuter describes an access site meeting each of the structural 17
limitations of claim 1. (See FF 2–9). 18
Addressing claim 1 in particular, the Examiner identifies the concave 19
cut-out 9 as corresponding to the “at least one structural feature,” that is, the 20
“concave side surface,” recited in the claim. (See RAN 4–5, citing Request 21
38). In addition, the Examiner correctly characterizes the recitation, “at least 22
one structural feature of the access port identifying the access port 23
subsequent to subcutaneous implantation as a particular type of access port,” 24
as being functional, that is, as limiting the structure of the “at least one 25
structural feature” in terms of function. (See RAN 5). The Examiner finds 26
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that the structure of Reuter’s access port is substantially identical to the 1
structure of the access port recited in claim 1. (See RAN 14). Based on this 2
finding, the Examiner presumes that Reuter’s access port is inherently 3
capable of identifying the access port subsequent to subcutaneous 4
implantation as a particular type of access port. 5
In the present case, the Examiner has not shown that Reuter’s access 6
port is so substantially identical to the subject matter of claim 1 or claim 8 7
that the Examiner has a sound basis for belief that a physician or allied 8
professional could palpate Reuter’s access port after implantation and feel 9
the concave cut-outs 9, 10 in the base plate 2. Reuter does not describe, in 10
either absolute or relative terms, how far the housing 1 projects from the 11
base plate 2, or describe the depth or thickness dimension of the base plate 2. 12
Even assuming that the septum of Reuter’s access port would be implanted 13
at the same depth as an access port satisfying claim 1, Reuter does not 14
indicate how far beneath the skin the base plate 2 would seat. Without this 15
information, it cannot be said that Reuter’s access port is so similar to the 16
Patent Owner’s that it can be presumed that that a physician or allied 17
professional could palpate Reuter’s access port after implantation and feel 18
the concave cut-outs 9, 10 in the base plate 2. (App. Br. PO 8–9; see also 19
Reb. Br. PO 5). 20
Therefore, the Examiner has not shown a sound basis for belief that a 21
physician or allied professional could palpate Reuter’s access port after 22
implantation and feel the concave cut-outs 9, 10 in the base plate 2. 23
Therefore, no presumption arises on the basis of substantial structural 24
identity that Reuter’s access port includes “at least one structural feature of 25
the access port identifying the access port subsequent to subcutaneous 26
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implantation as a particular type of access port.” The Patent Owner need not 1
produce evidence to rebut such a presumption. 2
Neither the Examiner nor the Requester has proven that Reuter 3
describes an access port including “at least one structural feature of the 4
access port identifying the access port subsequent to subcutaneous 5
implantation as a particular type of access port, the at least one structural 6
feature comprising a concave side surface in a second side surface,” as 7
recited in claim 1. For similar reasons, neither the Examiner nor the 8
Requester has shown that Reuter’s access port includes “at least one 9
structural feature of the access port identifying the access port as being 10
power injectable subsequent to subcutaneous implantation, the at least one 11
structural feature comprising at least one concave side surface in a second 12
side surface different from the first side surface,” as recited in claim 8. We 13
do not sustain the rejection of claims 1–5 and 8 under §102(b) as being 14
anticipated by Reuter. 15
16
Second Issue 17
Contrary to the Patent Owner’s argument (see App. Br. PO 15–18), 18
the teachings of Sanfilippo support the Examiner’s finding that “one skilled 19
in the art would have been aware of well-known general knowledge in the 20
art regarding using a structural feature to identify the type of port 21
subsequently implanted, palpating the port, and feeling the structure for 22
identification and would have found this function and method steps 23
obvious.” (RAN 6–7; see FF 12–14; Resp. Br. Req’r 21 & 22). In 24
particular, Reuter’s access port included a base plate 2 having concave cut-25
outs 9, 10 to assist a surgeon in holding the access port while implanting the 26
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port in a patient. (See FF 6 & 7). Once again addressing claim 1, Sanfilippo 1
taught providing an access port with curved indentations that a physician or 2
allied professional might use to grasp the port, albeit after implantation. 3
(See FF 15). Contrary to the Patent Owner’s argument (see App. Br. PO 20–4
21 and 32), Sanfilippo also taught that these curved indentations might be 5
used to identify a particular type of access port, that is, to distinguish an 6
access port used to deliver one substance from an access port used to deliver 7
another substance (see FF 13 & 14). 8
As the Patent Owner points out, the concave cut-outs 9, 10 of Reuter’s 9
access port are not suited for use in identifying a particular type of access 10
port after implantation because a physician or allied professional seeking to 11
identify the port after implantation might not be able to feel the cut-outs 12
under the patient’s skin. Sanfilippo would have provided one of ordinary 13
skill in the art reason to lower the profile of Reuter’s access port, by 14
shortening the housing 1, so as to enable a physician or allied professional to 15
feel the concave side surfaces formed by the cut-outs 9, 10 after 16
implantation. If the physician or allied professional were able to feel the 17
cut-outs 9, 10 under the patient’s skin after implantation, the physician or 18
allied professional could use the cut-outs to identify the particular type of 19
access port in accordance with the teachings of Sanfilippo. 20
Therefore, the “well-known general knowledge in the art regarding 21
using a structural feature to identify the type of port subsequently implanted, 22
palpating the port, and feeling the structure for identification” (RAN 6–7) 23
would have provided reason to modify Reuter’s access port so as to satisfy 24
the limitation, “at least one structural feature of the access port identifying 25
the access port subsequent to subcutaneous implantation as a particular type 26
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of access port, the at least one structural feature comprising a concave side 1
surface in a second side surface.” Hence, the subject matter of claim 1 2
would have been obvious from the teachings of Reuter in view of the “well-3
known general knowledge in the art” (RAN 6–7). 4
With regard to claim 2, we find that the base plate 2 of Reuter’s 5
access port has a generally quadrilateral shape. Because the base plate 2 is 6
part of the body of Reuter’s access port, the body of Reuter’s access port has 7
a generally quadrilateral exterior. (See Request 64–65; see also App. Br. PO 8
22). 9
With regard to claim 4, the concave portion F defined by the concave 10
cut-out 10 constitutes a concave side surface in a third side, that is, SIDE D´, 11
different from the first and second sides, that is, SIDE G and SIDE D. (See 12
Request 69–70; see also App. Br. PO 22). 13
With regard to claim 10, the Patent Owner argues that the 14
“[R]equester does not address how or why a [person of ordinary skill in the 15
art] ‘feeling’ . . . the structural feature [that is, the concave side surfaces 16
formed by the cut-outs 9, 10] would [have] identif[ied] Reuter as a particular 17
type of access port subsequent to subcutaneous implantation.” (Reb. Br. PO 18
8; see also App. Br. PO 26). Sanfilippo teaches feeling concave side 19
surfaces of the body of a subcutaneously implanted vascular access device in 20
order to determine which of two different types each of the two access ports 21
of the device is (that is, which of two different substances each access port 22
delivers). This teaching would have provided one of ordinary skill in the art 23
reason to modify Reuter’s access port (that is, to provide Reuter’s access 24
port with a sufficiently short housing 1) to permit a physician or allied 25
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professional to feel the cut-outs 9, 10 through the skin. (See Request 27–1
28). 2
Therefore, we sustain Ground D as to claims 1–5 and 10, that is, the 3
rejection of claims 1–5 and 10 under § 103(a) as being unpatentable over 4
Reuter and the “well-known general knowledge in the art” (RAN 6–7). 5
6
Third Issue 7
The Patent Owner separately argues claim 8, asserting that Reuter 8
fails to describe an access port including “at least one structural feature of 9
the access port identifying the access port as being power injectable 10
subsequent to subcutaneous implantation.” More specifically, the Patent 11
Owner argues that one of ordinary skill in the art would have understood this 12
language to imply that the access port recited in claim 8 is a power injectable 13
port. (See App. Br. PO 13–15 and 24; Reb. Br. PO 6). As support for this 14
argument, the Patent Owner cites Food & Drug Admin., Reminders from 15
FDA Regarding Ruptured Vascular Access Devices from Power Injection, 16
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices 17
/TipsandArticlesonDeviceSafety/ucm070193.htm (“FDA Reminders”),6 18
Appendix 3 to the Patent Owner’s Appeal Brief. The FDA Reminders 19
recommended checking labeling on access ports for maximum pressure and 20
flow rate before using the ports for power injection of computer tomography 21
or magnetic resonance imaging contrast media. 22

6 A copy of a printout of the document is in the record of the
reexamination proceeding.
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As the Examiner correctly concludes, claim 8 does not recite that the 1
claimed access port assembly is power injectable. (See RAN 17–18; Resp. 2
Br. Req’r 18). The at least one structural feature recited in claim 8 need only 3
be capable of identifying the access port as being power injectable 4
subsequent to subcutaneous implantation in order to satisfy the limitation. It 5
need not have been recognized as actually doing so. Hence, a structural 6
feature might satisfy the limitation, “at least one structural feature of the 7
access port identifying the access port as being power injectable subsequent 8
to subcutaneous implantation,” without actually misidentifying the port as 9
being power injectable. The recitation “at least one structural feature of the 10
access port identifying the access port as being power injectable subsequent 11
to subcutaneous implantation” does not imply that the claimed access port is 12
power injectable. We affirm the Examiner’s decision to reject claim 8 under 13
§ 103(a) as being unpatentable over Reuter and the “well-known general 14
knowledge in the art” (RAN 6–7). 15
16
Fourth Issue 17
Claim 9 recites the “access port of claim 8, wherein the body has a 18
generally triangular exterior.” Bunodiere teaches providing an access port 19
with a generally triangular exterior in order to limit patient discomfort 20
resulting from movement of the port after implantation. (See FF 18). The 21
Examiner concludes that it would have been obvious “to modify the shape of 22
the access port to have a ‘relatively simple and accurate palpable 23
identification through the skin’. See [Request 97]. Furthermore, changes in 24
shape are obvious minus some persuasive evidence that the particular 25
configuration of the claimed device is significant. See M.P.E.P. § 2144 IV. 26
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B.” (RAN 8). The Requester’s arguments echo the Examiner’s findings and 1
reasoning. (See Resp. Br. Req’r 33–34). 2
The Patent Owner does not dispute the Examiner’s finding that an 3
access port having a generally triangular exterior would have facilitated 4
“relatively simple and accurate palpable identification through the skin” 5
(RAN 8). Instead, the Patent Owner points out Reuter’s teaching to provide 6
the concave cut-outs 9, 10 opposite each other on the outer sides of the base 7
plate 2, parallel to the axis of the catheter connection 8, in order to assist a 8
surgeon in handling the access port during implantation. The Patent Owner 9
argues that this teaching would have discouraged one of ordinary skill in the 10
art from modifying the shape of Reuter’s access port as proposed by the 11
Examiner, since the cut-outs of the modified base plate no longer would 12
have been parallel to the axis of the catheter. (See App. Br. PO 25). 13
The teachings of Sanfilippo belie this argument. The Requester 14
correctly characterizes the two halves of the implant housing 232 of the 15
vascular access device depicted in Figure 8 of Sanfilippo, up to the raised 16
ridge 264, as generally triangular. (See Resp. Br. Req’r 33). Nevertheless, 17
the indentations 261, 262 in each half are parallel to a longitudinal axis of 18
the implant housing 232 because of the curvature of the side walls 250, 252. 19
(See FF 16). One of ordinary skill in the art familiar with the teachings of 20
Reuter and Sanfilippo could have modified Reuter’s access port to have a 21
generally triangular exterior while keeping the concave cut-outs 9, 10 22
parallel to the axis of the access port (which corresponds to the axis of the 23
catheter connection as depicted in Reuter’s drawing figure). Therefore, we 24
sustain Ground D as applied to claim 9, that is, the rejection of claim 9 under 25
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§ 103(a) as being unpatentable over Reuter and the “well-known general 1
knowledge in the art” (RAN 6–7). 2
Our affirmance of Ground D as applied to claims 1–5 and 8–10, that 3
is, of the Examiner’s decision to reject claims 1–5 and 8–10 under § 103(a), 4
acts as a general affirmance of the rejection of those claims. See 37 C.F.R. 5
§ 41.77(a). For this reason, we do not reach Ground E as applied to those 6
claims. 7
8
Fifth Issue 9
Claim 6 recites the “access port of claim 4, wherein the at least one 10
structural feature further comprises a concave side surface in a fourth side 11
surface different from the first, second, and third side surfaces.” Claim 7 12
depends from claim 6. With regard to dependent claim 6, the Examiner 13
relies on Reuter’s teaching that: 14
The invention is, of course, not limited to the example 15
embodiment described. Thus it is possible without further ado 16
for an expert to adapt the concave cut-outs 9 and 10 to existing 17
ports or multiple ports through equivalent cut-outs. 18
(RAN 7, quoting Reuter, para. 16). The Examiner concludes from this 19
teaching that it would have been obvious to modify the base plate 2 of 20
Reuter’s access port to include an additional concave side surface opposite 21
the catheter connection 8. (See RAN 8; see also RAN 23; Request 75). In 22
addition, the Examiner finds, without citation or further reasoning, that 23
providing such an additional concave side surface would have resulted in 24
greater “ease of manufacturing or reduce[d] cost in processing.” (RAN 8; 25
see also RAN 23; Resp. Br. Req’r 32). 26
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The Examiner has not provided any persuasive evidence or technical 1
reasoning to support the finding that adding an additional cut-out at the end 2
of Reuter’s base plate 2 opposite the catheter connection 8 would have 3
resulted in greater ease of manufacturing or reduced cost in processing. (See 4
App. Br. PO 24). Reuter does not appear to provide a detailed description of 5
how the cut-outs 9, 10 are formed in the base plate 2. It is as reasonable to 6
believe that the addition of a cut-out might be as likely to increase the cost of 7
processing (such as by adding an additional manufacturing step) as decrease 8
the cost. We do not adopt the finding. 9
The passage quoted from Reuter would not have provided one of 10
ordinary skill in the art reason to modify the base plate 2 of Reuter’s access 11
port to include an additional concave side surface opposite the catheter 12
connection 8. Reuter teaches providing the concave cut-outs 9, 10 opposite 13
each other on the outer sides parallel to the axis of the catheter connection 8 14
in the base plate 2 of an access port in order to assist a surgeon in handling 15
the access port during implantation. (See FF 7). Reuter neither teaches the 16
provision of an additional cut-out opposite the catheter connection 8 nor any 17
functional advantage such an additional cut-out might offer. Likewise, 18
Sanfilippo’s vascular access device includes curved indentations 261, 262 on 19
opposite sides of each access opening 244, 245 (see FF 13), but does not 20
suggest any reason for adding concave surfaces at either axial end of the 21
device. 22
Consequently, the modification proposed by the Examiner would have 23
required one of ordinary skill in the art to do more than merely “adapt the 24
concave cut-outs 9 and 10 to existing ports or multiple ports through 25
equivalent cut-outs,” as taught in paragraph 16 of Reuter. The proposed 26
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modification would have required one of ordinary skill to add a cut-out to 1
Reuter’s base plate 2, which offered no apparent functional advantage. 2
Neither the Examiner nor the Requester has suggested a persuasive reason 3
why one of ordinary skill in the art might have done this. 4
The Requester identifies four concave surfaces in a manifold body 22 5
of an implantable medication infusion device described by Reinicke. 6
(Request 75–76). The Requester offers no reason why the presence of these 7
four concave surfaces on Reinicke’s manifold body 22, none of which 8
corresponds to an outlet stem, would have led one of ordinary skill in the art 9
to modify Reuter’s access port in the fashion claimed in claim 6. (See 10
generally Request 74–82). 11
Therefore, we do not sustain Ground D as applied to claims 6 and 7, 12
that is, the rejection of those claims under § 103(a) as being unpatentable 13
over Reuter and the “well-known general knowledge in the art” (RAN 6–7); 14
or Ground E as applied to claims 6 and 7, that is, the rejection of those 15
claims under § 103(a) as being unpatentable over Reuter, Reinicke and “the 16
representative knowledge of the ability to recognize an access port by its 17
shape after implantation” (RAN 8). 18
19
DECISION 20
We AFFIRM the Examiner’s decision rejecting claims 1–5 and 8–10. 21
We REVERSE the Examiner’s decision rejecting claims 6 and 7. 22
Requests for extensions of time in this inter partes reexamination 23
proceeding are governed by 37 C.F.R. §§ 1.956 and 41.77(g). No time 24
period for taking any subsequent action in connection with this appeal may 25
be extended under 37 C.F.R. § 1.136(a). 26
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In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the 1
appeal may file a request for rehearing of the decision within one month of 2
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A 3
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). 4
Comments in opposition to the request and additional requests for rehearing 5
must be in accordance with 37 C.F.R. § 41.79(c)–(d), respectively. Under 6
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) 7
of this section, for requesting further rehearing under paragraph (d) of this 8
section, and for submitting comments under paragraph (c) of this section 9
may not be extended. 10
An appeal to the United States Court of Appeals for the Federal 11
Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an 12
inter partes reexamination proceeding “commenced” on or after November 13
2, 2002 may not be taken “until all parties' rights to request rehearing have 14
been exhausted, at which time the decision of the Board is final and 15
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See 16
also MPEP § 2682 (8th ed., Rev. 7, July 2008). In the event neither party 17
files a request for rehearing within the time provided in 37 C.F.R. § 41.79, 18
and this decision becomes final and appealable under 37 C.F.R. § 41.81, a 19
party seeking judicial review must timely serve notice on the Director of the 20
United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 21
1.983. 22
23
AFFIRMED-IN-PART 24

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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 FINANCIAL CENTER
NEW YORK, NY 10281