Ex Parte 7947022 et al

Patent Trial and Appeal Board

Feb 17, 2017

95002090 (P.T.A.B. Feb. 17, 2017)

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 02/17/2017
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
02/17/2017 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 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 29, 2016 (“Decision”), the 1
Board affirmed the Examiner’s decision rejecting claims 1–20 of Patent US 2
7,947,022 B2 (“ʼ022 patent”). The Patent Owner requests rehearing of our 3
decision affirming Grounds of Rejection A and C as applied to claims 1, 2, 4
6, 8 and 9; and affirming Grounds of Rejection E as applied to claims 3–5, 7 5
and 10–20. (See generally “Request for Rehearing,” dated April 29, 2016 6
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(“Reh’g Req.”)). The Requester opposes the Patent Owner’s request. (See 1
“Third Party Requester’s Comments in Opposition to Patentee’s Request for 2
Rehearing under 37 C.F.R. § 41.79(c),” dated May 31, 2016 (“Comm.”), at 3
1). We have continuing jurisdiction under pre-AIA 35 U.S.C. § 134(b) and 4
35 U.S.C. § 315(a). 5
We grant the request to the extent that we have reviewed and 6
considered the arguments presented by the Patent Owner and the Requester. 7
In addition, we modify our discussion of the Second Issue on pages 20–22 of 8
the Decision, taking into account the technical arguments presented by the 9
Patent Owner and the Requester. Apart from this, we deny the request. 10
11
ERRATA 12
The Patent Owner challenges our characterization of the pump 13
described in Medtronic, Inc., IsoMed Constant-Flow Infusion System 14
(bearing a 2000 copyright notice and the legend “Revised Sept. 2000”) 15
(“IsoMed”), as a “reciprocating pump.” (Reh’g Req. 1 & 2). As the Patent 16
Owner correctly points out, the characterization was “not argued by the 17
Examiner or either party.” (Reh’g Req. 1). Because the Patent Owner had 18
no previous knowledge that we understood the pump described in IsoMed to 19
be a “reciprocating pump,” it is appropriate for us to exercise our discretion 20
to take Official Notice that, in a reciprocating pump, “a cylindrical piston, 21
plunger, or bucket, or round diaphragm [is] caused to pass or flex back and 22
forth in a chamber.” (Req. Reh’g PO 2, n.1). The fact is capable of instant 23
and unquestionable demonstration by appeal to the reference cited by the 24
Patent Owner, J. Perry, CHEMICAL ENG’RS’ HANDBOOK 6–9 (McGraw-Hill 25
Book Company, 4th edition 1963). Although the Requester disputes the 26
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Patent Owner’s procedural entitlement to submit the dictionary definition at 1
this stage of the proceeding (see Comm. 1–3), the accuracy of the fact defies 2
dispute. See In re Ahlert, 424 F.2d 1088, 1091 (CCPA 1970). 3
As we found on pages 7 and 8 of the Decision, IsoMed describes an 4
IsoMed Constant-Flow Infusion System including an IsoMed Constant-Flow 5
pump and a Medtronic vascular catheter. (See IsoMed 2-2). The system is 6
implantable. (See IsoMed 1-3). The pump, as depicted in drawing figures 7
and photographs on pages 2-2 – 2-5 and A-6 of IsoMed, includes a generally 8
puck-shaped, titanium shell having an outlet or discharge port labeled in the 9
drawing figures as a catheter port. (See IsoMed 2-3 & 2-5). The shell 10
encloses a reservoir. A cap secured to one face of the shell retains a 11
polymeric, needle-penetrable septum in place over a center reservoir fill port 12
providing access to the reservoir from the exterior of the shell. (See IsoMed 13
2-3 & 2-4). 14
In addition, we find by a preponderance of the evidence that the 15
reservoir of the pump described by IsoMed necessarily expands or contracts 16
as the drug is drawn into, or expelled from, the reservoir. In the schematic 17
cross-sectional views of the pump reproduced at pages 2-3 and A-6 of 18
IsoMed, the space within the titanium shell includes the drug reservoir and a 19
propellant chamber. IsoMed teaches that a “pressurized gas is located 20
behind the reservoir, in the propellant chamber. The gas places a constant 21
pressure on the reservoir forcing the drug through the filter, capillary tubing 22
and catheter.” (IsoMed 2-3; see also id. at 4-7). In the schematic cross-23
sectional views reproduced at pages 2-3 and A-6, a divider appears to 24
separate the drug reservoir from the propellant chamber. One familiar with 25
the teachings of IsoMed could draw the reasonable inference that a gas-26
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impermeable membrane should separate the reservoir from the propellant 1
chamber to prevent the pressurized gas in the propellant chamber from 2
dissolving or dispersing into the drug stored in the drug reservoir. 3
The divider separating the drug reservoir from the propellant chamber 4
cannot be rigid and fixed in position relative to the titanium shell. 5
Otherwise, the reaction forces generated by the gas pressure in the propellant 6
chamber would be borne by the divider rather than imposed on the drug 7
stored in the drug reservoir, contrary to the quoted teachings of IsoMed. 8
This fact implies that the divider must be either flexible or moveable within 9
the titanium shell. IsoMed does not clearly indicate whether the divider is 10
flexible or moveable, or both. Either way, the lower bound of the drug 11
reservoir, corresponding to the facing surface of the divider, is not fixed. 12
The drug reservoir necessarily expands or contracts as the drug is drawn 13
into, or expelled from, the reservoir. 14
IsoMed does not disclose a mechanism for “caus[ing the divider] to 15
pass or flex back and forth in a chamber.” (See, e.g., 2-2, 2-3, 4-7 & A-6). 16
Neither does IsoMed teach connecting the pump to any such mechanism 17
during implantation. (See generally IsoMed 5-1 – 5-27). Although the 18
pump includes a “[b]ellows” as labeled in the drawing figure reproduced on 19
page A-6 of IsoMed, IsoMed does not explain the function of the bellows. 20
In this sense, the disclosure of IsoMed does not prove by a preponderance of 21
the evidence that the disclosed pump is properly characterized as a 22
“reciprocating pump.” 23
For this reason, we vacate the second sentence of FF 4, appearing at 24
lines 3–6 on page 8 of the Decision. FF 4 should read: 25
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).-- 3
4
In addition, we vacate the paragraph bridging pages 20 and 21 of the 5
opinion (that is, the paragraph extending from page 20, line 16, to page 21, 6
line 4, of the Decision) and substitute the following: 7
8
--We assume for purposes of this appeal, because the Examiner does 9
not find otherwise, that the term “fluid cavity” reads only on the reservoir of 10
IsoMed’s access port and not on the entire interior of the titanium shell. The 11
reservoir necessarily expands or contracts within the titanium shell as the 12
drug is drawn into, or expelled from, the reservoir. The limits within which 13
the reservoir may expand within the shell are fixed or marked by the lower 14
wall of the shell. In other words, the outline of the reservoir in its most 15
expanded state (that is, when the propellant chamber is in its most contracted 16
state) is delineated by the lower wall of the shell. Therefore, IsoMed 17
describes an access port assembly including “a body defining a fluid cavity 18
accessible by inserting a needle through a septum,” even when that 19
limitation is interpreted as proposed by the Patent Owner.-- 20
21
GROUNDS A & C 22
In its request for rehearing, the Patent Owner challenges our 23
affirmance of the Examiner’s decision rejecting claims 1, 2, 6, 8 and 9 under 24
pre-AIA 35 U.S.C. § 102(b) as being anticipated by IsoMed. Independent 25
claim 1 recites an access port including “a body defining a fluid cavity 26
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accessible by inserting a needle through a septum.” We agree with the 1
Patent Owner that the term “fluid cavity” reads only on the drug reservoir of 2
IsoMed’s access port and not on the entire interior of the titanium shell. (See 3
Decision 20, as corrected). The Patent Owner asserts that the drug 4
“reservoir is only one of many elements located inside the titanium shell 5
(housing) of IsoMed.” (Reh’g Req. 4). The Patent Owner argues that the 6
titanium shell of IsoMed’s access port corresponds to the “body” recited in 7
claim 1; and that the shell fails to define the drug reservoir. (See id.) 8
During an appeal from a reexamination, claims are given their 9
broadest reasonable interpretation consistent with the Specification. See In 10
re American Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364–65 (Fed. Cir. 11
2004). The Patent Owner’s arguments require us to interpret the words 12
“body” and “defining” as used in claim 1. 13
The ʼ022 patent uses the names “body” and “housing” 14
interchangeably. (see, e.g., ʼ022, patent, col. 4, ll. 5–7). The Patent Owner 15
does not formally define the word “body,” either in the ʼ022 patent or in the 16
briefs. The ʼ022 patent does identify several functions performed by the 17
housings of disclosed embodiments, however. The body 20 captures the 18
septum 18. (See ʼ022 patent, col. 4, ll. 7 & 8; id., Fig. 1B). The body 20, 19
together with the septum 18, defines a cavity that acts as a reservoir to 20
supply fluid to an outlet. (See ʼ022 patent, col. 4, ll. 14–16 & Fig. 1B). 21
Although the word “body” cannot be construed as limited to one or more 22
particular housings described in the ʼ022 patent, defining the word “body” as 23
at least broadly enough to encompass structure configured to support the 24
septum, and to define the reservoir together with the septum, is consistent 25
with the ordinary meaning of the word. 26
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Nothing in the written description of the ʼ022 patent suggests that the 1
“housing” or “body” is limited to a monolithic structure rather than an 2
assembly of parts.1 The assembly combining the titanium shell described in 3
IsoMed with the divider separating the drug reservoir from the propellant 4
chamber corresponds to the “body” recited in independent claim 1. As 5
depicted in drawing figures on pages 2-3 and A-6 of IsoMed, the shell 6
captures and supports the septum in a center reservoir fill port. The divider, 7
together with the septum, defines the drug reservoir in the sense that facing 8
surfaces of the divider and the septum coincide with outer bounds of the 9
reservoir. As such, the combination of the titanium shell and the divider 10
constitutes the body of the access port; and the body defines the fluid cavity 11
or reservoir. (See Comm. 4–6). 12
Even if one of ordinary skill in the art understood the word “body” to 13
correspond only to the titanium shell, the needle-penetrable septum and the 14
housing together still would define the drug reservoir. The Patent Owner 15
defines the word “defining” as used in claim 1 as “to fix or mark the limits 16
of” (citing “Merriam Webster online dictionary”), “to delineate the outline 17
or form of” (citing the “Free Dictionary online”) or “to determine or fix the 18
boundaries or extent of” (citing “Dictionary.com”). (App. Br. PO 10). As 19
these definitions suggest, the scope of the word “defining” is relatively 20
broad. 21

1 The prosecution history of Application 12/420,028, which issued as
the ʼ022 patent, indicates that the language “a body defining a fluid cavity
accessible by inserting a needle through a septum” was part of claim 1 as
originally filed. The Patent Owner has not identified any amendment or
argument that might shed light on the meaning of the language.
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The usage of the word in the ʼ022 patent is consistent with this 1
breadth. For example, one housing 20 described in the ʼ022 patent includes 2
a cap 14 and a base 16. The cap 14 and the base 16 cooperate to capture and 3
support the septum 18. (See ʼ022 patent, col. 4, ll. 7 & 8; id., Fig. 1B). The 4
ʼ022 patent teaches that the “cap 14, base 16, and septum 18 may 5
collectively define a cavity 36 in fluid communication with a lumen 29 of 6
outlet stem 31.” (ʼ022 patent, col. 4, ll. 14–16). Figure 1B of the ʼ022 7
patent depicts the cap 14, the base 16, the septum 18 and the cavity 36. As 8
depicted in Figure 1B, the cap 14 as depicted in Figure 1B does not share 9
any surface with the cavity 36. This reference indicates that the Patent 10
Owner used the term “defining” sufficiently broadly to encompass structure 11
that lacks a surface coinciding with one of the surfaces of the reservoir. 12
The limits within which the reservoir of IsoMed may expand within 13
the shell are delimited by the lower wall of the shell. This is true even 14
though the Examiner has not proven that the reservoir of IsoMed could 15
expand sufficiently for the divider to contact the lower wall of the shell. The 16
usage of the term “defining” in the ʼ022 patent is sufficiently broad to 17
encompass structures that do not contact the reservoir directly; and the 18
reservoir of IsoMed cannot expand so as to exceed the confines of the 19
interior of the shell. Therefore, we adhere to our finding that the body of the 20
access port described by IsoMed defines the fluid cavity, as recited in claim 21
1, even were the term “body” read narrowly to correspond to the shell of the 22
access port alone. (See Comm. 7 & 8). 23
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GROUND E 1
In its request for rehearing, the Patent Owner challenges our 2
affirmance of the Examiner’s decision rejecting claims 3–5, 7 and 10–20 3
under § 103(a) as being unpatentable over IsoMed, Jones and “the well-4
known techniques disclosed in the analogous prior art to convey to a 5
practitioner various information, characteristics and/or intended uses of other 6
implanted medical devices.” (RAN 13; see also RAN 11). Claim 3 recites 7
the “access port according to claim 1, wherein the radiopaque identification 8
feature is defined on a bottom surface of the access port.” Independent 9
claim 10 similarly recites an access port having a “radiopaque identification 10
feature included on a bottom surface of the access port.” The pump 11
described in IsoMed includes a small, radiographic tag within the titanium 12
shell. The tag is marked with a “Medtronic identifier,” the model number, 13
the reservoir volume and the flow rate. (See IsoMed 2-4; see also Decision 14
8 (FF 5)). IsoMed does not include an alphanumeric message applied to the 15
bottom surface of the pump. 16
IsoMed describes a refill procedure for the pump. One step of this 17
procedure is to “[p]alpate the pump area to confirm the general pump 18
location and location of the raised center reservoir fill port and side catheter 19
access port.” (IsoMed 6-7). IsoMed also teaches that, in the event that the 20
center reservoir fill port cannot be located by palpation, one should “x-ray 21
the pump to verify pump orientation. If the pump has inverted in the pocket 22
(‘flipped’), the model number will appear backwards on the x-ray.” 23
(IsoMed 7-6; see also Decision 8 (FF 5)). 24
In the Decision, we found that: 25
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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 15). Jones describes 5
positioning one of the locators on the bottom of the port. (See 6
FF 17; see also Resp. Br. Req’r 30). Although Jones does not 7
provide an explicit reason for positioning one of the locators on 8
the exterior surface of the bottom wall, Jones does teach that the 9
locators must be spaced to provide a clear indication of 10
orientation. (See FF 16). The Examiner correctly finds that “it 11
would have been obvious to provide additional characters onto 12
the housing base of IsoMed as taught by the Jones patent . . . 13
[because such] multiple identifiers on the port [could] assist in 14
preventing backside injections.” (RAN 15). 15
(Decision 29). 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 bottom surface of the 19
pump; or to substitute spaced radiographic locators, one of which was 20
positioned on the exterior of the pump, for the described radiographic tag. 21
More specifically, the Patent Owner pointed out that, “[t]o determine 22
whether the IsoMed pump was inverted or ‘flipped’ when implanted an x-23
ray would be taken from the top view to see if the model number appears 24
backwards.” (Reh’g Req. 5). The Patent Owner also points out that, 25
“[w]hen Jones is viewed by x-ray from above, i.e., the top, the image shown 26
in Fig. 5a [of Jones] would be the same if the port were right-side up or 27
upside down. . . . In sum, viewing Jones from a top view would not reveal 28
whether the port is inverted.” (Reh’g Req. 6, citing Jones, col. 4, ll. 34–41). 29
Based on these facts, the Patent Owner argues that “there would have been 30
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no motivation for a [person of ordinary skill in the art] to incorporate the 1
radiopaque locators from Jones on the IsoMed pump as it would provide no 2
benefit.” (Reh’g Req. 6 & 7) 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 9 & 10, 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. We are 14
persuaded that one of ordinary skill in the art would have had reason to 15
make the proposed substitution or combination despite the objective 16
evidence presented by the Patent Owner and discussed on pages 35 and 36 17
of the Decision. 18
Although the Patent Owner did not address the objective evidence in 19
its Rehearing Request, we have reconsidered that evidence in view of the 20
Patent Owner’s arguments regarding the patentability of claims 3–5, 7 and 21
10–20. We adhere to FF 19–28 on pages 12–17 of the Decision; and to our 22
conclusion that the probative weight of the evidence supporting Ground E as 23
to claims 3–5, 7 and 10–20 outweighs the probative value of the objective 24
evidence. We are persuaded that one of ordinary skill in the art would have 25
had reason to make the proposed substitution or combination despite the 26
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objective evidence presented by the Patent Owner and discussed on pages 31 1
and 32 of the Decision. The Patent Owner has not shown that we 2
misapprehended or overlooked any point in affirming the Examiner’s 3
decision rejecting claims 3–5, 7 and 10–20 based on Ground E. 4
5
DECISION 6
Except as otherwise stated in this opinion, we DENY the request for 7
rehearing. 8
Requests for extensions of time in this inter partes reexamination 9
proceeding are governed by 37 C.F.R. § 1.956 (2011). A party seeking 10
judicial review must timely serve notice on the Director of the United States 11
Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. 12
13
DENIED 14

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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