Ex Parte 7785302 et al

Patent Trial and Appeal Board

Mar 10, 2016

95002089 (P.T.A.B. Mar. 10, 2016)

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 2015-001533
Inter Partes Reexamination Control 95/002,089
Patent No. US 7,785,302 B2
Technology Center 3900
________________

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

McCARTHY, Administrative Patent Judge.

DECISION ON REQUESTS FOR REHEARING

In a “Decision on Appeal,” mailed March 11, 2016 (“Decision”), the 1
Board reversed the Examiner’s decision rejecting claims 1–4 of Patent US 2
7,785,302 B2 (“ʼ302 patent”); and affirmed the Examiner’s decision 3
rejecting claims 5–10 of the ʼ302 patent. The Patent Owner requests 4
rehearing of our decision affirming Grounds of Rejection A and C as applied 5
to claims 5, 6 and 8–10; and affirming Grounds of Rejection E as applied to6
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claim 7. (See generally “Request for Rehearing,” dated April 11, 2016 1
(“Req. Reh’g PO”)). The Requester opposes the Patent Owner’s request. 2
(See “Third Party Requester’s Comments in Opposition to Patentee’s 3
Request for Rehearing under 37 C.F.R. § 41.79(c),” dated May 11, 2016 4
(“Comm. Req’r”), at 1). The Requester seeks rehearing of our decision 5
reversing Grounds of Rejection A and C as applied to claim 7; and Grounds 6
D and E as applied to claims 1–4. (See “Third Party Requester’s Request for 7
Rehearing of Board’s Decision dated March 11, 2016 of Inter partes 8
Reexamination of U.S. Patent No. 7,785,302,” dated April 11, 2016 (“Req. 9
Reh’g Req’r”), at 1). The Patent Owner opposes the Requester’s request. 10
(See “Patent Owner’s Comments in Opposition to Third Party Requester’s 11
Request for Rehearing of Board’s Decision dated March 11, 2016 of Inter 12
partes Reexamination of U.S. Patent No. 7,785,302,” dated May 11, 2016 13
(“Comm. PO”), at 1). We have continuing jurisdiction under pre-AIA 35 14
U.S.C. § 134(b) and 35 U.S.C. § 315(a). 15
We deny the Requester’s rehearing request to the extent that the 16
Requester seeks rehearing of our reversal of Grounds of Rejection A and C 17
as applied to claim 7. Claim 7 recites the venous access port assembly of 18
claim 5 “wherein the alphanumeric message is applied to the exterior of the 19
assembly.” The Requester’s argument asserts that the subject matter of 20
claim 7 would have been obvious. (See Req. Reh’g Req’r 14 (“[T]he choice 21
of location [for the alphanumeric message] is well within the level of 22
ordinary skill in the art.”). The argument is moot in view of our affirmance 23
of Ground of Rejection E as applied to claim 7. 24
Apart from this, we grant each request to the extent that we have 25
reviewed and considered the arguments presented by the Patent Owner and 26
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the Requester. In addition, we modify our discussion of the Third Issue on 1
pages 22–24 of the Decision, taking into account the technical arguments 2
presented by the Patent Owner and the Requester. Apart from this, we deny 3
both requests. 4
5
ERRATA 6
The Patent Owner challenges our characterization of the pump 7
described in Medtronic, Inc., IsoMed Constant-Flow Infusion System 8
(bearing a 2000 copyright notice and the legend “Revised Sept. 2000”) 9
(“IsoMed”), as a “reciprocating pump.” (Req. Reh’g PO 2). As the Patent 10
Owner correctly points out, the characterization was “not argued by the 11
[E]xaminer or either party.” (Id.) Because the Patent Owner had no 12
previous knowledge that we understood the pump described in IsoMed to be 13
a “reciprocating pump,” it is appropriate for us to exercise our discretion to 14
take Official Notice that, in a reciprocating pump, “a cylindrical piston, 15
plunger, or bucket, or round diaphragm [is] caused to pass or flex back and 16
forth in a chamber.” (Req. Reh’g PO 2, n.1). The fact is capable of instant 17
and unquestionable demonstration by appeal to the reference cited by the 18
Patent Owner, J. Perry, CHEMICAL ENG’RS’ HANDBOOK 6–9 (McGraw-Hill 19
Book Company, 4th edition 1963). Although the Requester disputes the 20
Patent Owner’s procedural entitlement to submit the dictionary definition at 21
this stage of the proceeding, the accuracy of the fact defies dispute. See In 22
re Ahlert, 424 F.2d 1088, 1091 (CCPA 1970). 23
As we found on page 8 of the Decision, IsoMed describes an IsoMed 24
Constant-Flow Infusion System including an IsoMed Constant-Flow pump 25
and a Medtronic vascular catheter. (See IsoMed 2-2). The system is 26
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implantable. (See IsoMed 1-3). The pump, as depicted in drawing figures 1
and photographs on pages 2-2 – 2-5 and A-6 of IsoMed, includes a generally 2
puck-shaped, titanium shell having an outlet or discharge port labeled in the 3
drawing figures as a catheter port. (IsoMed 2-3 & 2-5). The shell encloses a 4
reservoir. A cap secured to one face of the shell retains a polymeric, needle-5
penetrable septum in place over a center reservoir fill port providing access 6
to the reservoir from the exterior of the shell. (See IsoMed 2-3 & 2-4). 7
In addition, we find by a preponderance of the evidence that the 8
reservoir of the pump described by IsoMed necessarily expands or contracts 9
as the drug is drawn into, or expelled from, the reservoir. In the schematic 10
cross-sectional views of the pump reproduced at pages 2-3 and A-6 of 11
IsoMed, the space within the titanium shell includes the drug reservoir and a 12
propellant chamber. IsoMed teaches that a “pressurized gas is located 13
behind the reservoir, in the propellant chamber. The gas places a constant 14
pressure on the reservoir forcing the drug through the filter, capillary tubing 15
and catheter.” (IsoMed 2-3; see also id. at 4-7). In the schematic cross-16
sectional views reproduced at pages 2-3 and A-6, a divider appears to 17
separate the drug reservoir from the propellant chamber. One familiar with 18
the teachings of IsoMed could draw the reasonable inference that a gas-19
impermeable membrane should separate the reservoir from the propellant 20
chamber to prevent the pressurized gas in the propellant chamber from 21
dissolving or dispersing into the drug stored in the drug reservoir. 22
The divider separating the drug reservoir from the propellant chamber 23
cannot be rigid and fixed in position relative to the titanium shell. 24
Otherwise, the reaction forces generated by the gas pressure in the propellant 25
chamber would be borne by the divider rather than imposed on the drug 26
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stored in the drug reservoir, contrary to the quoted teachings of IsoMed. 1
This fact implies that the divider must be either flexible or moveable within 2
the titanium shell. IsoMed does not clearly indicate whether the divider is 3
flexible or moveable, or both. Either way, the lower bound of the drug 4
reservoir, corresponding to the facing surface of the divider, is not fixed. 5
The drug reservoir necessarily expands or contracts as the drug is drawn 6
into, or expelled from, the reservoir. 7
IsoMed does not disclose a mechanism for “caus[ing the divider] to 8
pass or flex back and forth in a chamber.” (See, e.g., 2-2, 2-3, 4-7 & A-6). 9
Neither does IsoMed teach connecting the pump to any such mechanism 10
during implantation. (See generally IsoMed 5-1 – 5-27). Although the 11
pump includes a “bellows” as labeled in the drawing figure reproduced on 12
page A-6 of IsoMed, IsoMed does not explain the function of the bellows. 13
In this sense, the disclosure of IsoMed does not prove by a preponderance of 14
the evidence that the disclosed pump is properly characterized as a 15
“reciprocating pump.” 16
For this reason, we vacate the second sentence of FF4, appearing at 17
lines 22–25 on page 8 of the Decision. FF 4 should read: 18
19
--4. A propellant chamber and pump drive located within the shell 20
behind the reservoir uses pressurized gas to pump fluid from the reservoir 21
toward the catheter port. (IsoMed 2-3 and 2-4).-- 22
23
In addition, we vacate the paragraph bridging pages 22 and 23 of the 24
opinion (that is, the paragraph extending from page 22, line 23, to page 23, 25
line 14, of the Decision) and substitute the following: 26
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1
--The reservoir necessarily expands or contracts within the titanium 2
shell as the drug is drawn into, or expelled from, the reservoir. The limits 3
within which the reservoir may expand within the shell are fixed or marked 4
by the lower wall of the shell. In other words, the outline of the reservoir in 5
its most expanded state (that is, when the propellant chamber is in its most 6
contracted state) is delineated by the lower wall of the shell. To the extent 7
that the titanium shell alone corresponds to the “housing” recited in claims 5, 8
8 and 10, these facts justify the Examiner’s finding that the “limits of the 9
reservoir . . . , which has expansion and contraction capabilities[,] are clearly 10
delineated or formed by the extent of the [shell].” (RAN 20). Therefore, the 11
access port assembly described by IsoMed satisfies the limitations, “the 12
needle-penetrable septum and the housing together defining a reservoir” as 13
recited in claim 5 and “a housing and a needle-penetrable septum together 14
defining a reservoir” as recited in claims 8 and 10, even when those 15
limitations are interpreted as proposed by the Patent Owner.-- 16
17
THE REQUESTER’S REQUEST FOR REHEARING 18
The Requester seeks rehearing of our decision reversing Grounds of 19
Rejection D and E as applied to claims 1–4. (See Req. Reh’g Req’r 1). 20
Under Grounds D and E, the Examiner rejects claims 1–4 under pre-AIA 35 21
U.S.C. § 103(a) as being unpatentable over IsoMed and either Jones (US 22
6,287,293 B1, issued Sept. 11, 2001) and “the representative knowledge of 23
radiopaque alphanumeric markers” (RAN 9); or the Examiner’s finding that, 24
although IsoMed “does not teach the radiopaque alphanumeric characters 25
being included on the housing base” as recited in claim 1 (RAN 8), “one 26
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skilled in the art would have found it an obvious design choice to locate the 1
characters on the housing base” (id.). The Requester’s arguments are not 2
persuasive. 3
Independent claim 1 recites an access port assembly including a 4
“housing having a housing base defining a bottom wall of at least one 5
reservoir, and an outwardly facing bottom surface.” The Requester argues 6
that we have construed this limitation too narrowly. We agree with the 7
Requester that claim 1 uses the transitional term “comprising” between the 8
preamble and the body of the claim. “Comprising,” as used in its patent law 9
sense, denotes that the claimed apparatus “may contain elements in addition 10
to those explicitly mentioned in the claim,” at least to the extent that such 11
additional elements do not conflict with the express limitations of the claim. 12
In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009). Hence, we agree with 13
the Requester that the mere fact the pump described by IsoMed includes 14
structures not separately recited in claim 1, such as the bellows and the 15
divider positioned between the drug reservoir and the propellant chamber as 16
depicted on page A-6, does not distinguish the subject matter of claim 1 17
from the disclosure of IsoMed. (See Req. Reh’g Req’r 11–14). 18
As discussed in more detail on pages 24 and 25 of the Decision, what 19
distinguishes the subject matter of claim 1 from the pump described in 20
IsoMed is that the pump described in IsoMed lacks a “housing having a 21
housing base defining a bottom wall of at least one reservoir, and an 22
outwardly facing bottom surface.” In particular, the fact that the bottom 23
wall of the titanium shell of the pump described by IsoMed defines the 24
reservoir in the broad but reasonable sense of setting a limit beyond which 25
the reservoir cannot expand does not imply that the bottom wall of the shell 26
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“defin[es] a bottom wall of at least one reservoir” in the ordinary sense of 1
the language. (See Comm. PO 10). 2
In order to demonstrate that the subject matter of claim 1 would have 3
been obvious, the Examiner and the Requester would have had to 4
demonstrate that one of ordinary skill in the art would have had reason to 5
modify the pump described in IsoMed so as to include a “housing having a 6
housing base defining a bottom wall of at least one reservoir, and an 7
outwardly facing bottom surface.” Such a requirement is consistent with the 8
holding of KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007).1 The 9
Requester correctly points out that Figure 4 of Jones depicts an injection site 10
having a housing base in the form of a bottom wall that defines both a 11
bottom wall of a reservoir and an outwardly facing bottom surface. (See 12
Req. Reh’g Req’r 3 & 4). The Requester also suggests reasons why it would 13
have been obvious for one of ordinary skill in the art to have modified the 14
pump described in IsoMed such that the housing base included radiopaque 15
characters. (See generally Req. Reh’g Req’r 4–10). The Requester does not 16
suggest a persuasive reason why it would have been obvious to modify the 17
pump described by IsoMed to include a “housing having a housing base 18
defining a bottom wall of at least one reservoir, and an outwardly facing 19
bottom surface.” The Requester has not shown that we misapprehended or 20

1 See id. at 418 (“Although common sense directs one to look with care
at a patent application that claims as innovation the combination of two
known devices, it can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claims new invention does.”); see also id. at 419
(“There is no necessary inconsistency between the idea undying the TSM
test and the Graham analysis.”).
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overlooked any point in reversing the Examiner’s decision rejecting claims 1
1–4 based on Ground D or E. 2
3
THE PATENT OWNER’S REQUEST FOR REHEARING 4
Grounds A and C 5
In its request for rehearing, the Patent Owner challenges our 6
affirmance of the Examiner’s decision rejecting claims 5, 6 and 8–10 under 7
pre-AIA 35 U.S.C. § 102(b) as being anticipated by IsoMed. Independent 8
claim 5 recites a venous access port assembly having a housing and a 9
needle-penetrable septum, “the needle-penetrable septum and the housing 10
together defining a reservoir.” Independent claims 8 and 10 similarly recite 11
venous access port assemblies, each including “a housing and a needle-12
penetrable septum together defining a reservoir.” 13
The Patent Owner argues that the word “housing” reads only on the 14
titanium shell of the pump described in IsoMed rather than on the 15
combination of the shell with the divider separating the drug reservoir from 16
the propellant chamber (see Req. Reh’g PO 5–8); and that the shell does not 17
define the drug reservoir together with the needle-penetrable septum of the 18
pump (see Req. Reh’g PO 3 & 4). During an appeal from a reexamination, 19
claims are given their broadest reasonable interpretation consistent with the 20
Specification. See In re American Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 21
1364–65 (Fed. Cir. 2004). The Patent Owner’s arguments require us to 22
interpret the words “housing” and “defining” as used in claims 5–10. 23
The Patent Owner does not formally define the word “housing,” either 24
in the ʼ302 patent or in the briefs. The ʼ302 patent does identify several 25
functions performed by the housings of disclosed embodiments, however. 26
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The housing captures the septum. (ʼ302 patent, col. 1, ll. 64–66; & col. 4, ll. 1
34–37). The housing, together with the septum, defines a cavity that acts as 2
a reservoir to supply fluid to an outlet. (ʼ302 patent, col. 1, ll. 22 & 23; & 3
col. 4, ll. 43–45). Although the word “housing” cannot be construed as 4
limited to one or more particular housings described in the ʼ302 patent, 5
defining the word “housing” as at least broadly enough to encompass 6
structure configured to support the septum, and to define the reservoir 7
together with the septum, is consistent with the ordinary meaning of the 8
word. 9
Furthermore, the ʼ302 patent contemplates the possibility that the 10
“housing” may be an assembly rather than a monolithic structure. (See ʼ302 11
patent, col. 1, ll. 21 & 22 (“A typical port typically includes a housing 12
assembly, a septum and an outlet.”). The assembly combining the titanium 13
shell described in IsoMed with the divider separating the drug reservoir from 14
the propellant chamber corresponds to the “housing” recited in independent 15
claims 5, 8 and 10. As depicted in drawing figures on pages 2-3 and A-6 of 16
IsoMed, the shell captures and supports the septum in a center reservoir fill 17
port. The divider, together with the septum, defines the drug reservoir in the 18
sense that facing surfaces of the divider and the septum coincide with outer 19
bounds of the reservoir. (See Comm. Req’r 6 & 8). 20
Even if one of ordinary skill in the art understood the word “housing” 21
to correspond only to the titanium shell, the needle-penetrable septum and 22
the housing together still would define the drug reservoir. The Patent Owner 23
defines the word “defining” as used in claims 5, 8 and 10 as “to fix or mark 24
the limits of” (citing “Merriam Webster online dictionary”), “to delineate the 25
outline or form of” (citing the “Free Dictionary online”) or “to determine or 26
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fix the boundaries or extent of” (citing “Dictionary.com”). (App. Br. PO 9). 1
As these definitions suggest, the scope of the word “defining” is relatively 2
broad. 3
The usage of the word in the ʼ302 patent is consistent with this 4
breadth. For example, one housing 20 described in the ʼ302 patent includes 5
a cap 14 and a base 16. The cap 14 and the base 16 cooperate to capture and 6
support the septum 18. (ʼ302 patent, col. 4, ll. 34–37). The ʼ302 patent 7
teaches that the “cap 14, base 16, and septum 18 may collectively define a 8
cavity 36 in fluid communication with a lumen 29 of outlet stem 31.” (ʼ302 9
patent, col. 4, ll. 43–45). Figure 1B of the ʼ302 patent depicts the cap 14, the 10
base 16, the septum 18 and the cavity 36. As depicted in Figure 1B, the cap 11
14 as depicted in Figure 1B does not share any surface with the cavity 36. 12
This reference indicates that the Patent Owner used the term “defining” 13
sufficiently broadly to encompass structure that lacks a surface coinciding 14
with one of the surfaces of the reservoir. 15
The limits within which the reservoir may expand within the shell are 16
delimited by the lower wall of the shell. This is true even though the 17
Examiner has not proven that the reservoir could expand sufficiently for the 18
divider to contact the lower wall of the shell. The usage of the term 19
“defining” in the ʼ302 patent is sufficiently broad to encompass structures 20
that do not contact the reservoir directly; and the reservoir cannot expand so 21
as to exceed the confines of the interior of the shell. Therefore, we adhere to 22
our finding that the needle-penetrable septum and the housing of the pump 23
described by IsoMed together define a reservoir as recited in claims 5, 8 and 24
10. 25
26
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Prosecution History of the Original Examination 1
The Patent Owner also argues that statements made during the 2
original examination of the application that issued as the ʼ302 patent require 3
us to construe claims 5–10 as limited to power injectable ports. (See Req. 4
Reh’g PO 8–10). During the reexamination of a patent, it is proper to take 5
into account the prosecution history of the original examination when 6
interpreting the claims under reexamination. See Tempo Lighting Inc. v. 7
Tivoli LLC, 742 F.3d 973, 977 (Fed. Cir. 2014). Nevertheless, the two 8
statements cited by the Patent Owner from the prosecution history of the 9
original examination do not persuade us that claims 5–10 are limited to 10
power injectable ports. (See Req. Reh’g PO 9). 11
Application claims 47, 49, 50, 52–54, 56–58 and 61, which 12
corresponded to issued claims 1–10, were added to Application 11/368,954 13
by an “Amendment” dated October 28, 2009. When first added to 14
Application 11/368,954, application claim 47, which corresponded to issued 15
claim 5, read as follows: 16
Claim 47 (New): A venous access port assembly for 17
implantation into a patient, comprising: 18
a housing having an outlet, and 19
a needle penetrable septum, the needle-penetrable septum 20
and the housing together defining a reservoir, 21
wherein: 22
the assembly includes at least one feature observable 23
through interaction with X-rays subsequent to subcutaneous 24
implantation of the assembly, and 25
the at least one feature conveys information indicative of 26
an attribute of the assembly. 27
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(“Amendment,” dated Oct. 28, 2009, at 2). In a Final Office Action mailed 1
January 27, 2010, the original examiner rejected claims 47, 49, 50, 52–54, 2
56–58 and 61, among others, under § 103(a) as being unpatentable over a 3
December 2003 product brochure by Inamed Health entitled “BioEnterics® 4
LAP-BAND® Adjustable Gastric Banding System.” In an Examiner’s 5
Interview Summary mailed May 12, 2010, the original examiner wrote that 6
the applicant and the applicant’s counsel discussed with the examiner 7
“potential amendments to independent claims to include the alphanumeric 8
radiopaque feature, as well as further describing the port and the attribute as 9
being power injectable.” 10
Subsequent to the interview, the applicant amended application claim 11
47 to the form subsequently issued as claim 5: 12
Claim 47 (New): A venous access port assembly for 13
implantation into a patient, comprising: 14
a housing having an outlet, and 15
a needle penetrable septum, the needle-penetrable septum 16
and the housing together defining a reservoir, 17
wherein: 18
the assembly includes a radiopaque alphanumeric message 19
at least one feature observable through interaction with X-rays 20
subsequent to subcutaneous implantation of the assembly, and 21
the alphanumeric message indicating that the assembly is 22
power injectable at least one feature conveys information 23
indicative of an attribute of the assembly. 24
(“Amendment Submitted with RCE,” dated June 2, 2010, at 2). Similar 25
amendments were made to application claim 57, which corresponded to 26
issued claim 8, and to application claim 61, which corresponded to issued 27
claim 10. In its summary of the interview, the applicant wrote that the 28
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“Applicant[ʼ]s proposed amendments to the independent claims . . . recite an 1
alphanumeric radiopaque feature and identif[y] the attribute as being power 2
injectable.” (Id. at 6). On page 2 of the “Notice of Allowability,” mailed 3
June 24, 2010, the original examiner explained that the independent claims, 4
including issued claim 5, were “indicated allowable because the prior art of 5
record fail[ed] to disclose either singularly or in combination the claimed 6
device of an implantable access port that ha[d] a radiopaque message to 7
indicate that this port is specifically power injectable.” 8
The Examiner’s Interview Summary indicates that the applicant 9
represented the claims would be amended to “further describ[e] the port and 10
the attribute as being power injectable.” As both the applicant’s summary of 11
the interview and the Notice of Allowability indicate, however, the actual 12
amendments only recited that that the feature (that is, the alphanumeric 13
message) “indicat[ed] that the assembly [was] power injectable” (in the case 14
of application claim 47 and issued claim 5), “identif[ied] the venous access 15
port assembly as suitable for power injection” (in the case of application 16
claim 57 and issued claim 8) or “convey[ed] to a practitioner . . . that the 17
venous access port assembly [was] suitable for power injection” (in the case 18
of application claim 61 and issued claim 10). None of the claims 19
“describ[ed] the port . . . as being power injectable,” as the Examiner’s 20
Interview Summary predicted the amendments would describe the port. The 21
absence from the claims as ultimately amended of language “describing the 22
port . . . as being power injectable,” as opposed to “describing . . . the 23
attribute as being power injectable,” is reflected in the applicant’s summary 24
of the interview as well as in the Notice of Allowability. The Patent Owner 25
has not pointed out anything in the prosecution history of the original 26
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examination limiting the venous access port assemblies recited in claims 5–1
10 to power injectable ports. The Patent Owner has not shown that we 2
misapprehended or overlooked any point in affirming the Examiner’s 3
decision rejecting claims 5, 6 and 8–10 based on Ground A or C. 4
5
Ground E 6
In its request for rehearing, the Patent Owner challenges our 7
affirmance of the Examiner’s decision rejecting claim 7 under § 103(a) as 8
being unpatentable over IsoMed, Jones and “the representative knowledge of 9
radiopaque alphanumeric markers” (RAN 9). As indicated earlier, claim 7 10
recites the “assembly of claim 5, wherein the alphanumeric message is 11
applied to the exterior of the assembly.” The pump described in IsoMed 12
includes a small, radiographic tag within the titanium shell. The tag is 13
marked with a “Medtronic identifier,” the model number, the reservoir 14
volume and the flow rate. (See IsoMed 2-4; see also Decision 9 (FF 5)). 15
IsoMed does not include an alphanumeric message applied to the exterior of 16
the pump. 17
IsoMed describes a refill procedure for the pump. One step of this 18
procedure is to “[p]alpate the pump area to confirm the general pump 19
location and location of the raised center reservoir fill port and side catheter 20
access port.” (IsoMed 6-7). IsoMed also teaches that, in the event that the 21
center reservoir fill port cannot be located by palpation, one should “x-ray 22
the pump to verify pump orientation. If the pump has inverted in the pocket 23
(‘flipped’), the model number will appear backwards on the x-ray.” 24
(IsoMed 7-6; see also Decision 9 (FF 5)). 25
In the Decision, we found that: 26
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Jones teaches addressing the problem of detecting whether an 1
implanted access port assembly is inverted within a patient by 2
providing the assembly with radiopaque locators positioned 3
along parallel planes spaced along the height of the injection 4
port. (See FF 15 and 16; see RAN 10). Jones describes 5
positioning one of the locators on the bottom of the port. (See 6
FF 17). Although Jones does not provide an explicit reason for 7
positioning one of the locators on the exterior surface of the 8
bottom wall, Jones does teach that the locators must be spaced to 9
provide a clear indication of orientation. (See FF 16). The 10
Examiner correctly finds that “it would have been obvious to 11
provide additional characters onto the housing base of IsoMed as 12
taught by the Jones patent . . . [because such] multiple identifiers 13
on the port [could] assist in preventing backside injections.” 14
(RAN 10). 15
(Decision 33). 16
The Patent Owner argues that it would not have been obvious to either 17
supplement the small, radiographic tag described in IsoMed with an 18
additional radiographic locator positioned on the exterior of the pump; or to 19
substitute spaced radiographic locators, one of which was positioned on the 20
exterior of the pump, for the described radiographic tag. More specifically, 21
the Patent Owner pointed out that, “[t]o determine whether the IsoMed 22
pump was inverted or ‘flipped’ when implanted an x-ray would be taken 23
from the top view to see if the model number appears backwards.” (Req. 24
Reh’g PO 12). The Patent Owner also points out that, “[w]hen Jones is 25
viewed by x-ray from the top, as the IsoMed pump would be viewed to 26
determine if it had been inverted or flipped, an x-ray would not reveal the 27
orientation.” (Req. Reh’g PO 13, citing Jones, col. 4, ll. 34–41). Based on 28
these facts, the Patent Owner argues that “there would [have] be[en] no 29
motivation for a [person of ordinary skill in the art] to incorporate the 30
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17
radiopaque locators from Jones on the IsoMed pump as it would provide no 1
benefit, as whether the IsoMed pump had been inverted is already readily 2
determinable using an x-ray.” (Id.) 3
The Requester correctly points out that Jones teaches locating an 4
access port incorporating Jones’s locators by means of a radiographic image 5
taken perpendicularly to the anticipated orientation of the port (that is, from 6
the top). Jones then teaches determining whether the access port has been 7
inverted by means of a second radiographic image taken at an oblique angle 8
to the anticipated orientation of the port (that is, from the side). (See Comm. 9
Req’r 12, quoting Jones, col. 4, ll. 41–59). 10
One of ordinary skill in the art would have had reason to merely 11
substitute one known means for detecting whether an implanted pump was 12
inverted, namely, the use of radiopaque locators positioned along parallel 13
planes spaced along the height of the injection port as taught by Jones, for 14
another known means, namely, the small, radiographic tag described by 15
IsoMed. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)(“The 16
Court recognized that when a patent claims a structure already known in the 17
prior art that is altered by the mere substitution of one element for another 18
known in the field, the combination must do more than yield a predictable 19
result.”). Alternatively, one of ordinary skill in the art had reason to 20
combine radiopaque locators positioned along parallel planes spaced along 21
the height of the injection port, as taught by Jones, with a small, 22
radiographic tag, as taught by IsoMed, to provide redundant indicators that 23
the pump was inverted. The Patent Owner has not identified any results that 24
such a substitution or combination might yield other than predictable results 25
suggested by the teachings of IsoMed and Jones. 26
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In order to implement the proposed substitution or combination, one 1
would have had to modify IsoMed’s instructions for locating the pump and 2
for determining whether the pump was inverted during a refill procedure. 3
Instead of locating the pump solely by palpation and then radiographically 4
imaging the pump from the top in the event that the caregiver was unable to 5
feel the center reservoir fill port, as instructed by IsoMed, one would have 6
had to locate the pump by radiographically imaging the pump from the top 7
and then, in the event that the caregiver was unable to feel the center 8
reservoir fill port, use another radiographic image taken from the side to 9
determine or confirm whether the pump was inverted, as taught by Jones. 10
This modification to the refill procedure would have been within the level of 11
ordinary skill as indicated by the teachings of IsoMed and Jones; and would 12
not have been so onerous as to have discouraged one familiar with the 13
teachings of Jones from making the proposed substitution. 14
Although the Patent Owner did not address the objective evidence in 15
its Rehearing Request, we have reconsidered that evidence in view of the 16
Patent Owner’s arguments regarding the patentability of claim 7. We adhere 17
to FF 19–28 on pages 12–18 of the Decision; and to our conclusion that the 18
probative weight of the evidence supporting Ground E as to claim 7 19
outweighs the probative value of the objective evidence. We are persuaded 20
that one of ordinary skill in the art would have had reason to make the 21
proposed substitution or combination despite the objective evidence 22
presented by the Patent Owner and discussed on pages 35 and 36 of the 23
Decision. The Patent Owner has not shown that we misapprehended or 24
overlooked any point in affirming the Examiner’s decision rejecting claim 7 25
based on Ground E. 26
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19
DECISION 1
Except as otherwise stated in this opinion, we DENY both requests for 2
rehearing. 3
Requests for extensions of time in this inter partes reexamination 4
proceeding are governed by 37 C.F.R. § 1.956 (2011). A party seeking 5
judicial review must timely serve notice on the Director of the United States 6
Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. 7
8
DENIED 9

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