Ex Parte Christenson

Patent Trial and Appeal Board

May 31, 2013

12105441 (P.T.A.B. May. 31, 2013)

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.
12/105,441 04/18/2008 Steven R. Christenson P0024851.00 5740
64619 7590 05/31/2013
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
05/31/2013 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
____________

Ex parte STEVEN R. CHRISTENSON
____________

Appeal 2011-010806
Application 12/105,441
Technology Center 3700
____________

Before TONI R. SCHEINER, ULRIKE W. JENKS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an implantable infusion device comprising a filter. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

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Application 12/105,441

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STATEMENT OF THE CASE
The Specification is directed to an “infusion device [that] has an
internal bacterial filter positioned between the reservoir and the pump,
configured to provide a pathway for fluid to be pulled from the reservoir to
the pump, regardless of the orientation of the infusion device.” (Spec.
Abstract.)
Claims 1-3, 5-7 and 11-25 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief (App. Br. 15-18). Claim 1 is
illustrative of the claims on appeal, and reads as follows:
1. An implantable infusion device comprising:
a reservoir (i) comprising an interior having a pressure of no
more than about 5 psig, and (ii) having an outlet;
a bulkhead housing a pump having an inlet, the inlet in fluid
communication with the reservoir interior; and
a bacterial filter (i) sealingly disposed about the reservoir outlet,
(ii) positioned in the bulkhead exterior to the reservoir, and (iii)
annularly extending at least about 180 degrees and at least partially
defining a fluid pathway in communication with the reservoir outlet.
The Examiner has rejected the claims as follows:
I. claims 1-3 and 5-7 under 35 U.S.C. § 103(a) as unpatentable
over Flaherty
1
in view of Watson
2
and Portner;
3

II. claims 11-14, 21, and 23-25 under 35 U.S.C. § 103(a) as
unpatentable over Flaherty in view of Portner;
III. claims 15, 19, 20 and 22 under 35 U.S.C. § 103(a) as
unpatentable over Flaherty in view of Chu;
4
and

1
J. Christopher Flaherty et al., US 5,695,490, issued Dec. 9, 1997.
2
David A. Watson et al., US 5,137,529, issued Aug. 11, 1992.
3
Peer M. Portner et al., US 4,360,019, issued Nov. 23, 1982.
4
Wen-Hwa Chu et al., US 5,770,076, issued June 23, 1998.
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IV. claims 16-18 under 35 U.S.C. § 103(a) as unpatentable over
Flaherty in view of Chu in further view of Portner.

I. Obviousness over Flaherty, Watson and Portner
The Examiner finds that
Flaherty discloses a bulkhead (170) housing a pump
(166) having an inlet (11), the inlet in fluid communication with
the reservoir interior via the plurality of outlets (Fig. 9). . . .
. . .
Flaherty illustrates that the bacterial filter completely surrounds
the outlets (Fig. 2; Fig. 4; Fig. 5; Fig. 6) such that all fluid that
passes through the outlet must pass through the filter, thereby
constituting a “sealingly disposed” relationship. . . . Watson
discloses that the filter is sealingly disposed about the reservoir
outlet by use of a gasket (76) to ensure that any fluid inserted
into the reservoir must pass through the filter. . . . Portner
discloses that the reservoir should be provided with an interior
pressure of negative psig . . . in order to ensure proper operation
of the pump mechanism. It would have been obvious for one
having ordinary skill in the art at the time the invention was
made to form the pressure of the reservoir of the device of
Flaherty to comprise a negative psig, i.e. less than about 5 psig,
as disclosed by Portner, in order to ensure proper functioning of
the pumping mechanism as described.
(Ans. 3-4.)
The issue is: Does the preponderance of evidence of record support
the Examiner‟s finding that Flaherty disclosed an infusion device with a
filter sealingly disposed about the reservoir outlet?

Findings of Fact
The following finding of fact (“FF”) are supported by a
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preponderance of the evidence of record.
FF 1. Flaherty disclosed an implantable device for delivering liquid
medication to a site remote from the site of port implantation shown in
Fig. 9. reproduced below:

(Flaherty FIG. 9; Ans. 3.) “Fig. 9 shows a schematic representation, partly
in section, of an infusion apparatus which incorporates two filter assemblies
in accordance with the invention.” (Flaherty, col. 4, ll. 23-25.)
FIG. 9 shows such an infusate pump apparatus 110, including
two access ports (a primary access port 158 and a secondary, or
side, access port 160), and including a pump 166, all within a
biocompatible housing 170. The primary access port 158 is
coupled to the input of pump 166 via cannula 11, and the output
of pump 166 is coupled to the inlet port IP of side access port
160 via line 138. The pump 166 is selectively operative to
drive fluid at its input to exit its output.
(Flaherty, col. 7, ll. 5-13.)
FF 2. Flaherty disclosed a fluid reservoir surrounded by a filter as
shown in Fig. 2 reproduced below:
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(Flaherty FIG. 2; Ans. 4.) Fig. 2 shows a sectional view of an implantable
device with an internal reservoir and filter assembly (Flaherty, col. 4, ll. 11-
14.) “The structure of first wall 25 may be selected to produce desired
filtering capability.” (Flaherty, col. 5, ll. 20-21.)
[S]econd wall 27 is also “substantially cylindrical” and fluid
permeable, being placed interior to and spaced apart from first
wall 25, establishing a second annular chamber 34 within first
reservoir chamber 30 and between first wall 25 and second wall
27. Second annular chamber 34 provides the only fluid flow
paths between the first central portion (i.e., along central axis
A) of reservoir chamber 30 and first annular chamber 32.
Second wall 27 allows 360° of fluid flow through that wall 27
to chamber 32. In accordance with the present invention,
second wall 27 may take the form of a toroidal substrate
extending about central axis A, and having a plurality of
radially extending apertures 35 extending therethrough (and
providing the fluid flow paths). The apertures 35 provide
filltering, removing particulate material that is too large to pass
therethrough. The number and size of apertures 35 is selected
to provide desired filtering and flow rates.
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(Flaherty, col. 5, ll. 27-43.)
FF 3. Flaherty disclosed that “second wall 27 is shaped to create an
upper cylindrical reservoir subchamber 36a and a lower cylindrical reservoir
sub-chamber 36b, respectively, within first reservoir chamber 30 and
underlying septum 3. The right-circular cylindrical geometry of those
reservoir sub-chambers provides sharp right angle corners within first
reservoir chamber 30.” (Flaherty, col. 5, ll. 46-50.)
FF 4. Watson disclosed the use of “[a]n elastomeric gasket 76 is
placed over the outer peripheral flange of the filter barrier 56 and is
compressed between the wall step 54 of the second base member 42 . . . .
This effectively provides a means for sealing the outer peripheral flange of
the filter barrier 56 adjacent to the second base member 42.” (Watson col. 6,
ll. 56-63; see also Fig. 2; Ans. 4.)
FF 5. Portner disclosed that “reservoir pressure is chosen to be
slightly less that atmospheric pressure (or negative psig).” (Portner, col. 6,
ll. 33-34; Ans. 5.) “A key advantage of this design stems directly from
holding the insulin or drug reservoir at less than atmospheric pressure . . .
[so] no insulin or drug will leak out of the system” in event of valve failure
preventing uncontrolled delivery of drug to patient. (Portner, col. 6, ll. 39-
46.)

Principle of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

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Analysis
Appellant contends that “Flaherty describes a filter disposed within
the reservoir.” (App. Br. 7, 8.) Appellant further contends that “the
apertures (35) of Flaherty are part of the filter and do not serve as a reservoir
outlet.” (Id. at 8.) “[T]he small chamber (30) within the two stage filter
(20), which is disposed within the reservoir (9) of Flaherty, would not be
understood by one of ordinary skill in the art to be a reservoir of an
implantable device as the term is used in the claims of the present
application.” (Reply Br. 4.)
We are not persuaded. The Examiner‟s position is that “[m]erely
because Flaherty labels the space defined by lateral surface (5) as a reservoir
does not mean that it is the only reservoir that would have been recognized
by one having ordinary skill in the art.” (Ans. 12.) The Examiner finds that
“Flaherty expressly calls this interior volume (30) a „first reservoir
chamber.‟” (Id.) “Flaherty describes the filter (25) to be disposed outside
this reservoir, showing the filter to be disposed exterior to the reservoir
interior (30), being separated therefrom by the annular wall (27) having a
plurality of outlets (35) therethrough so as to allow communication.” (Id.)
We agree with the Examiner findings, that the fluid flow in Flaherty
goes from the reservoir 30 disposed along the central axis A through the
second wall 27 via apertures 35 to an annular chamber 34, and fluid then
flows through the filter 25 into annular chamber 32 and eventually out of the
housing via cannula 11 to the pump (FFs 1-2). Additionally, filter 25 can be
selected to filter bacteria and can completely surround the outlets from the
reservoir (FF 2; Ans. 4). Flaherty further provides that wall 27 is made of a
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toroidal
5
substrate, meaning that it can have a solid surface with apertures 35
to allow for fluid flow (FF 2). “The interior space of the reservoir (30) or
the „first reservoir chamber‟ will temporarily hold a fluid injected therein
through seal 3[] before it is introduced to the filter element (25) via the
outlets/apertures (35).” (Ans. 13.) “While Flaherty does discloses [sic] that
the reservoir outlets (35) do provide a filtering function, restricting particles
of a certain diameter from passage therethrough, such a function is inherent
to all aperture outlets and does not preclude its function or its ability to be
labeled as „outlets.”” (Id. at 14.) The Examiner finds that “Flaherty clearly
discloses a reservoir interior (30) bounded by surfaces (3), (6), and annular
wall (27) so as to form a reservoir.” (Id. at 15; FF 2.) We do not find the
Examiner‟s interpretation of reservoir in the Flaherty reference
unreasonable. We agree with the Examiner‟s finding that the bacterial filter
surrounds the reservoir (Ans. 4).
Appellant contends that “like Flaherty, the filter (76) of Watson is
disposed in the reservoir (see FIGs. 1-3 of Watson) and is not disposed about
the reservoir outlet, exterior to the reservoir.” (App. Br. 9.)
We are not persuaded by Appellant‟s contention that Watson‟s filter is
disposed in the reservoir. “Watson discloses a filter element (56) which is
disposed exterior to a reservoir (74), the reservoir having one relatively large
outlet (the „passageway‟ disposed through floor 82; Col. 7, Ln. 1-22) in
order to filter a liquid passed through the outlet of the reservoir.” (Ans. 16.)

5
Toroidal (adj.) 1. Mathematics a. A surface generated by a closed curve
rotating about, but not intersecting or containing, an axis in its own plane. b.
A solid having such a surface. 2. A body having the shape of a toroid. The
Free Dictionary, http://www.thefreedictionary.com/toroidal (last visited May
25, 2013).
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The Examiner reasons that it would be obvious to the ordinary artisan to
“include gaskets to the interface between the filter element and the annular
wall (27) of the reservoir interior (30) in order to ensure that all fluid passes
through the filter and does not leak from the edges of the interface.” (Id.)
Appellant contends that “just because Portner teaches a negative
pressure reservoir does not make it obvious that such a reservoir should be
employed with a filter configuration as taught by Flaherty or Flaherty as
modified by Watson.” (App. Br. 10.)
We are also not persuaded with Appellant‟s contention that it would
not be obvious to have Flaherty‟s reservoir under negative pressurebased on
the teaching of Portner. The Examiner finds that “Portner discloses that the
reservoir should be provided with an interior pressure of negative psig (Col.
6, Ln. 33-34) in order to ensure proper operation of the pump mechanism.”
(Ans. 17.) In addition, Portner also recognizes that keeping negative
pressure in the system prevents accidental leaks of medication (FF 5). As
expressly recognized in KSR, any art recognized need or problem can
provide a reason for combining claim elements. KSR at 418.
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that the combination of Flaherty,
Watson and Portner renders obvious the implantable infusion device of
claim 1. As Appellant does not argue the claims separately, we focus our
analysis on claim 1, and claims 2, 3, and 5-7 fall with that claim, as
acknowledged by Appellant (App. Br. 11). 37 C.F.R. § 41.37 (c)(1)(vii).

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II. Obviousness over Flaherty and Portner
The Examiner takes the position that
Flaherty discloses an implantable infusion device (110)
comprising a reservoir (see 9, Fig. 1) comprising an interior
(30) and a plurality of outlets (35).
Flaherty discloses a bulkhead (170) housing a pump
(166) having an inlet (11), the inlet in fluid communication with
the reservoir interior via the plurality of outlets (Fig. 9). The
bulkhead defining an annular passage (32) in fluid
communication with the reservoir interior.
(Ans. 6.)
The issue is: Has the Examiner established by a preponderance of the
evidence that the combination of Flaherty and Portner renders obvious the
claimed implantable infusion device?

Analysis
With respect to claim 11, Appellant contends that “the apertures (35)
of Flaherty are part of the filter and do not serve as a reservoir outlet as
recited in the present claims.” (App. Br. 11.)
We find the Examiner has the better position. Flaherty disclosed that
wall 27 is made of a toroidal substrate, meaning that is has a solid surface,
having “plurality of radially extending apertures 35 extending therethrough”
(FF 2). “[The] plurality of outlets (35) which allow communication between
the interior and the exterior of the reservoir, allow[] liquid to pass through
the outlets and through a filter element (25) disposed exterior to the reservoir
interior (30).” (Ans. 20.) We agree with the Examiner‟s interpretation that
openings 35 constitute a plurality of outlets from the inner reservoir
chamber.
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We conclude that the preponderance of evidence of this record
supports the Examiner‟s conclusion that the combination of Flaherty and
Portner render obvious the claims to an implantable infusion device. We
thus affirm the rejection of claim 11 under 35 U.S.C. § 103(a) as being
obvious, as claims 12-14 and 21 fall with that claim as acknowledged by
Appellant (App. Br. 11). 37 C.F.R. § 41.37(c)(1)(vii).
With respect to claim 23, Appellant contends that “the filter assembly
of Flaherty does not house a pump, providing further evidence that it is
improper to equate the annular chamber of the filter assembly of Flaherty
with the annular passage of the bulkhead of claim 23.” (Id. at 12.)
We find that Appellant has the better position. Claim language
“should not [be] treated as meaningless.” Bicon, Inc. v. Straumann Co., 441
F.3d 945, 951 (Fed. Cir. 2006). Claim 23 requires “a bulkhead defining an
annular passage . . . the bulkhead further housing a pump.” We interpret the
claim to require that the part that houses the annular chamber is the same
that houses the pump. In Flaherty, bulkhead 170 contains reservoir
chambers 158 and 160 as well as a pump (FF 1). However, it is the reservoir
chambers that contain and define the annular passage and not the bulkhead
(FF 1). The element that is missing from the combination is the pump being
located within the same structure that contains the annular passage, in this
case filter housing 158 or 160 (FF 1). “[O]bviousness requires a suggestion
of all limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d
1333, 1342 (Fed. Cir. 2003). Accordingly we reverse the rejection with
respect to claim 23. Claims 24 and 25 depend from claim 23 and
incorporate all the limitations of claim 23, so we reverse the rejection with
respect to these claims as well.
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III. Obviousness over Flaherty and Chu
The Examiner takes the position that “Flaherty fails to explicitly
disclose that the device includes a plurality of filter elements. However,
Chu discloses an implantable therapeutic delivery device (204) comprising a
filter element (100) to filter fluid flow (108a). Chu discloses that this filter
element may comprise a single filter or a plurality of filters.” (Ans. 8.) The
Examiner concludes that it would have been obvious to the ordinary artisan
to “provide the device of Flaherty with a plurality of filter elements, as
disclosed by Chu, since it has been held that the duplication of the essential
working parts of an invention requires only routine and customary skill in
the art.” (Ans. 9.)
The issue is: Does the preponderance of evidence on this record
support the Examiner‟s conclusion that Flaherty and Chu disclosed the use
of a plurality of filter elements?

Additional Finding of Fact
FF 6. Chu disclosed that “joining a filter such as filter 100 of FIG. 1,
or a plurality of such filters integrated on a substrate.” (Chu, col. 8, ll. 63-
64; Ans. 8.)

Analysis
Appellant contends that “Flaherty fails to teach or suggest a reservoir
having more than one outlet. Chu, which is cited for teaching a plurality of
filter elements, fails to overcome this deficiency of Flaherty.” (App. Br. 13.)
We are not persuaded. As discussed above (II.), we have found that
the Examiner has reasonably interpreted Flaherty‟s apertures 35 in wall
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structure 27 to meet the claim limitation of having a “plurality of outlets.”
(FF 2.) The Examiner concludes that it would have been obvious to add
additional filter elements, and “[i]n providing such modifications [to
Flaherty,] each of the plurality of filter elements would be positioned to filter
fluid flowing through one of the plurality of outlets.” (Ans. 9.)
We conclude that the preponderance of evidence of this record
supports the Examiner‟s conclusion that the combination of Flaherty and
Chu renders obvious the implantable infusion device of claim 15. We thus
affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as being obvious,
and claims 19, 22, and 22 fall with that claim as acknowledged by
Appellants (App. Br. 13). 37 C.F.R. § 41.37(c)(1)(vii).

IV. Obviousness over Flaherty, Chu and Portner
The Examiner takes the position that “Portner discloses a similar
implantable infusion device (Fig. 1) including a reservoir (12) and a pump
(11) in fluid communication with the insulin reservoir via an inlet. Portner
discloses that the reservoir should be provided with an interior pressure of
negative psig . . . in order to ensure proper operation of the pump
mechanism.” (Ans. 9.)
Appellant contends that “Flaherty fails to teach or suggest a reservoir
having more than one outlet. Chu, which is cited for teaching a plurality of
filter elements, fails to overcome this deficiency of Flaherty. In addition,
Portner, which is cited for teaching a negative pressure reservoir, does not
overcome this deficiency in the teachings of Flaherty and Chu.” (App. Br.
13.)
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We are not persuaded. As discussed above (III.), we have found no
error in the Examiner‟s combination of Flaherty and Chu to arrive at an
implantable device having more than one outlet from the reservoir and
comprising multiple filter elements. The Examiner reasons that the
combination with Portner “ensures proper operation of the pump
mechanism” (Ans. 9). In addition, Portner disclosed that it is desirable to
have a reservoir under negative pressure in order to prevent accidental
administration of medication in the event of valve failure (FF 5). We agree
with the Examiner‟s finding that the optimum working pressure is a result
effective variable that is within the skill of the ordinary artisan.
We conclude that the preponderance of the evidence of record
supports the Examiner‟s conclusion that the combination of Flaherty, Chu,
and Portner renders obvious the implantable infusion device of claims 16, 17
and 18. We thus affirm the rejection of claim 16, 17, and 18 under 35
U.S.C. § 103(a) as being obvious.

SUMMARY
We affirm the rejection of claims 1-3 and 5-7 under 35 U.S.C. §
103(a) as unpatentable over Flaherty in view of Watson and Portner.
We affirm the rejection of claims 11-14, and 21 under 35 U.S.C. §
103(a) as unpatentable over Flaherty in view of Portner.
We reverse the rejection of claims and 23-25 under 35 U.S.C. §
103(a) as unpatentable over Flaherty in view of Portner.
We affirm the rejection of claims 15, 19, 20 and 22 under 35 U.S.C. §
103(a) as unpatentable over Flaherty in view of Chu.
We affirm the rejection of claims 16-18 under 35 U.S.C. § 103(a) as
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unpatentable over Flaherty in view of Chuin further view of Portner.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

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