Ex Parte Miesel et al

Patent Trial and Appeal Board

Mar 22, 2017

12793457 (P.T.A.B. Mar. 22, 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.
12/793,457 06/03/2010 Keith A. Miesel 1023-907US01/P0035143.00 6722
71996 7590 03/24/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
03/24/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
pairdocketing @ ssiplaw.com
medtronic_neuro_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEITH A. MIESEL, JAMES M. HAASE, CHRIS J. PAIDOSH,
DARREN A. JANZIG, and TIMOTHY J. DENISON
Appeal 2015-005985
Application 12/793,4571
Technology Center 3700
Before JOHN C. KERINS, STEFAN STAICOVICI, and LEE L. STEPINA,
Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Keith A. Miesel et al. (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner’s final decision rejecting claims 1—16, 25, and 44—52.2
We have jurisdiction over this appeal under 35 U.S.C. § 6(b).
1 According to Appellants, Medtronic, Inc. is the real party in interest.
Appeal Br. 3 (filed Jan. 13, 2015).
2 Claims 17—24, 26—31, 34, 36, and 37 are withdrawn from consideration
and claims 32, 33, 35, and 38—43 are canceled. Final Act. 2 (transmitted
Aug. 13, 2014).
Appeal 2015-005985
Application 12/793,457
SUMMARY OF DECISION
We REVERSE.
INVENTION
Appellants’ invention relates “to pressure sensors for use within
implantable medical devices including medical pumps.” Spec. 11.
Claims 1, 25, and 44 are independent. Claims 1 and 25 are illustrative
of the claimed invention and read as follows:
1. An implantable medical device (IMD) comprising:
one or more electrical components within the IMD;
a fluid enclosure wall partially defining a fluid enclosure
configured to accommodate a fluid within the IMD, wherein:
the fluid enclosure wall defines a channel opening, and
the IMD is configured to deliver the fluid out of the IMD;
and
a pressure sensor comprising an operative surface that
comprises a sensor housing configured to mate to the fluid
enclosure wall, wherein:
the operative surface is configured to partially define the
fluid enclosure and occlude the channel opening when the
sensor housing is mated to the fluid enclosure wall, and
occlusion of the channel opening by the pressure sensor
separates the fluid from the one or more electrical components.
25. A device comprising:
a bulkhead that defines a first portion of a fluid enclosure
configured to accommodate a fluid; and
a pressure sensor configured of a size and a shape to self-
align in a predetermined rotational orientation within a channel
opening defined by the bulkhead and occlude the channel
opening.
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Application 12/793,457
REJECTIONS
The following rejections are before us for review:
I. The Examiner rejected claims 25 and 49 under 35 U.S.C.
§ 102(b) as being anticipated by Jonsson (US 2007/0261496 Al, published
Nov. 15,2007).
II. The Examiner rejected claims 1—10, 14—16, 25, 44, 45, 49, and
52 under 35 U.S.C. § 103(a) as being unpatentable over Ginggen (US
2006/0089619 Al, published Apr. 27, 2006) and Jonsson.
III. The Examiner rejected claims 11—13 under 35 U.S.C. § 103(a)
as being unpatentable over Ginggen, Jonsson, and Hirata (US 2007/0168150
Al, published July 19, 2007).
IV. The Examiner rejected claims 46 and 47 under 35 U.S.C.
§ 103(a) as being unpatentable over Ginggen, Jonsson, and Robb (US
2008/0000531 Al, published Jan. 3, 2008).
V. The Examiner rejected claims 5, 44, 48, and 49 under 35 U.S.C.
§ 103(a) as being unpatentable over Ginggen, Jonsson, and Miesel (US
7,320,676 B2, issued Jan. 22, 2008).
VI. The Examiner rejected claim 50 under 35 U.S.C. § 103(a) as
being unpatentable over Jonsson and Robb.
VII. The Examiner rejected claim 51 under 35 U.S.C. § 103(a) as
being unpatentable over Jonsson and Miesel.
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Application 12/793,457
ANALYSIS
Rejection I
Based on a passage taken from Appellants’ previously filed Appeal
Brief (filed Jan. 27, 2014, hereinafter “January 2014 Brief’), the Examiner
finds that the limitation ‘“the pressure sensor is sized and shaped to self-
align[] in a predetermined rotational orientation to the channel opening’
refers [to a] pressure sensor [that] is positioned within a channel opening.”
Final Act. 2 (citing January Brief, p. 7, para. 2). The Examiner considers the
limitation of independent claim 25, which reads, “to self-align in a
predetermined rotational orientation within a channel opening” to be a
“functional limitation which only requires the capability of performing the
claimed function.” Id. Thus, according to the Examiner, as Jonsson’s
pressure sensor 6013 is located within channel 612, Jonsson’s pressure
sensor is capable of performing the above mentioned functional limitation.
Id. at 2—3.
Appellants argue that the Examiner “relies upon an erroneous
characterization of Appellants[’] remarks to support an unreasonable
interpretation of the claim language.” Appeal Br. 6. According to
Appellants, in the Examiner’s view, “the limitation of claim 25 merely
‘refers that the pressure sensor is positioned within a channel opening.’”
However, Appellants assert that the January 2014 Brief “clarifies that claim
25 requires that ‘the pressure sensor is sized and shaped to self-align in this
predetermined rotational orientation within a channel opening.” Id. at 7
3 Although the Examiner uses reference number “604,” we note this to be a
typographical error as Jonsson refers to sensor 601. See e.g., Jonsson para.
52.
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Appeal 2015-005985
Application 12/793,457
(citing January 2014 Brief, p. 7). Appellants contend that even if the
limitation “self-align in a predetermined rotational orientation” is considered
a functional limitation, “the Examiner has failed to explain why sensor 601
of Jonsson, or any other device, would have the capability of being
configured of a size and a shape to self-align in a predetermined rotational
orientation within a channel opening ... as set forth in claim 25.” Id. at 9.
The Examiner responds that Appellants’ Specification does not define
“the term ‘a size and shape to self-align [in a] predetermined rotational
orientation within a channel opening.’” Ans. 3. As Appellants’ Figure 5A
shows pressure sensor 112 fitted in a channel opening, the Examiner takes
the position that “[t]he term ‘self-align rotational orientation’ is interpreted
as ‘to fit in a slot or opening.’” Id. at 4.
Appellants reply that at least based on paragraph 82 of the
Specification, “one of ordinary skill would have understood that each
pressure sensor can only be placed into bulkhead 104 in one particular
orientation, i.e., the orientation in which the shape of the pressure sensor
matches the shape of the opening in the bulkhead.” Reply Br. 3.4 Hence,
Appellants assert that “the limitations of claim 25 require more than merely
a pressure sensor ‘to fit in a slot or opening.’” Id. at 4.
It is well established that claims are construed with an eye toward
giving effect to all terms in the claim. See Stumbo v. Eastman Outdoors,
Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (denouncing claim constructions
which render phrases in claims superfluous). Furthermore, claim language
4 Paragraph 82 of Appellants’ Specification states that the “channel opening
[of bulkhead 104] may be sized and/or shaped to only accept pressure sensor
112 in a predetermined orientation.”
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Appeal 2015-005985
Application 12/793,457
should be read in light of the Specification, as it would be interpreted by one
of ordinary skill in the art. In re Suitco Surface, Inc., 603 F.3d 1255, 1260
(Fed. Cir. 2010). In this case, we agree with Appellants’ position that claim
25 requires more than a pressure sensor fitting in a slot or opening. Each of
Appellants’ disclosed embodiments describes a pressure sensor housing
having an eccentric shape, which is defined as “any structure that can only
be matched to a similarly shaped opening in one position when rotated 360
degrees” and generally is a non-circular shape. Spec. 191. In addition,
Appellants’ Specification describes a technique for orienting pressure sensor
112 within bulkhead 104 of IMD 16 and states that because “pressure sensor
112 is configured as a shape that is self-aligning to the opening, there is only
one way that pressure sensor 112 will fit within the opening of bulkhead
104.” Id. 1130; Fig. 16.
As such, in light of Appellants’ Specification, a person of ordinary
skill in the art would understand that the limitation of “a pressure sensor
configured of a size and a shape to self-align in a predetermined rotational
orientation within a channel opening,” as recited in claim 25, requires that
the pressure sensor must be in a specific, predetermined rotational
orientation in order to fit in the opening. In contrast, Jonsson’s circular
sensor 601 (see Jonsson, Fig. 6a) does not require a specific, predetermined
rotational orientation because it would fit in any rotational position when
rotated 360 degrees merely by placing it in the opening. The Examiner’s
interpretation would in effect render meaningless, or superfluous, the term
“predetermined.”
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Appeal 2015-005985
Application 12/793,457
In conclusion, although Jonsson’s pressure sensor 601 fits in an
opening of housing 610, the Examiner does not point to any disclosure or
provide any technical reasoning that establishes that Jonsson’s pressure
sensor 601 has a shape that is self-aligning to the opening (in housing 610),
in a predetermined rotational orientation, or is capable of fitting within the
opening in a predetermined rotational orientation, as called for by
independent claim 25.
Accordingly, for these reasons, we do not sustain the rejection under
35 U.S.C. § 102(b) of claims 25 and 49 as anticipated by Jonsson.
Rejection II
Claims 1—10, 14—16, 45, and 52
The Examiner finds that Ginggen discloses most of the limitations of
independent claim 1 including, inter alia, a pressure sensor, but that
“Ginggen does not disclose the location of the pressure sensor ... at a
channel opening . . . formed in the fluid enclosure wall as required in claim
1.” Final Act. 4. Nonetheless, the Examiner finds that Jonsson discloses “a
pressure sensor 601 comprising an operative surface that comprises a sensor
housing configured to mate to the fluid enclosure wall (including elements
602 and 610).” Id. The Examiner concludes that it would have been
obvious to modify the device of Ginggen so that the pressure sensor is
“mated to the fluid enclosure wall, as taught by Jonsson, for the benefit of
sensing the pressure of the fluid at the outlet channel of the pump outlet and
the pressure of the fluid in the drug chamber, since the fluid in the drug
chamber is in communication with the outlet channel.” Id. According to the
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Application 12/793,457
Examiner, Jonsson’s pressure sensor 601 would be located in the wall of
Ginggen’s pump outlet 24. See Ans. 4—5.
Appellants argue that, “the Examiner has failed to explain why one of
ordinary skill in the art would have arrived at the Examiner-proposed
modification of ‘sensing the pressure of the fluid at the outlet channel of the
pump.’” Appeal Br. 14—15. Appellants assert that because Ginggen
discloses “a pressure sensor for sensing the pressure of the drug in drug
chamber 14 and/or refill port chamber 44,” “it seems that one of ordinary
skill in the art would have positioned the Jonsson pressure sensor for sensing
pressure of drug in drug chamber 14 or refill port chamber 44.” Id. at 15
(citing Ginggen para. 33). Appellants thus contend,
The Examiner has not articulated any rationale for why one of
ordinary skill in the art would have deviated from positioning a
pressure sensor within drug chamber 14 or refill port chamber
44, as disclosed by Ginggen, or why one of ordinary skill in the
art would have positioned a pressure sensor for sensing the
pressure of the fluid at the outlet channel of the pump.
Id.', see also Reply Br. 6—7.
The Examiner responds that, “one skilled in the art would recognize
that more than one pressure sensor[s] can be provided in the pump system
for measuring the pressure of fluid in different locations.” Ans. 7. The
Examiner notes that Jonsson teaches “a pressure sensor 601 located within
an opening within the wall tube 602 to measure the pressure of blood or
other fluid passing through the tube. Id. Based on this teaching, the
Examiner takes the position that
a person having ordinary skill in the art would have easily
recognize [d] that modifying the device of Ginggen with
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Application 12/793,457
providing/adding the pressure sensor mated to the opening of the
fluid enclosure wall, as taught by Jonsson, would provide the
benefits of measuring the pressur[]e of the fluid to prevent air
bubble or reduce leaking or occlusion.
Id. at 7—8.
We do not agree with the Examiner’s position because Ginggen
specifically discloses that “[cjontrol electronics 28 can also include a
pressure sensor for sensing the pressure of the drug in drug chamber 14
and/or refill port chamber 44.” Ginggen 133. Therefore, we agree with
Appellants that in view of Ginggen’s explicit teachings, the logical location
at which to position Jonsson’s pressure sensor would be in drug chamber 14
or refill port chamber 44 of Ginggen’s device. See Reply Br. 6—7. Although
the Examiner reasons that providing Jonsson’s pressure sensor 601 in the
wall of Ginggen’s pump outlet 24 “would provide the benefits of measuring
the pressure of the fluid to prevent air bubble or reduce leaking or
occlusion,” the Examiner has not provided adequate findings that the prior
art recognized a problem with air bubbles, leaking, or occlusion in devices
such as Ginggen’s implantable pump. Rather, Ginggen discloses the use of
capillary chip and filter 20 to release a constant flow of drug from drug
chamber 14 into fluidic connection channel 22 toward pump outlet 24,
which would appear to preclude these issues from arising. See Ginggen |
20; Fig. 1. Without an adequate articulated reasoning based on rational
underpinnings for providing Jonsonn’s pressure sensor for sensing the
pressure of the fluid at the outlet channel 24 of the Ginggen pump, the
Examiner’s rejection appears to be the result of hindsight analysis. See In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
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Application 12/793,457
Accordingly, for the foregoing reasons, we do not sustain the rejection
under 35 U.S.C. § 103(a) of independent claim 1, and claims 2—10, 14—16,
45, and 52 depending therefrom, as unpatentable over Ginggen and Jonsson.
See In re Fine, 837 F.2d 1071, 1073 (Fed. Cir. 1988).
Claims 25 and 49
The Examiner finds that Ginggen discloses most of the limitations of
independent claim 25, but fails to disclose “a pressure sensor configured of a
size and shape to self-align in a predetermined rotational orientation within a
channel opening.” See Final Act. 7—8. The Examiner relies on Jonsson to
disclose such a pressure sensor. See id. at 7. However, as discussed supra
in Rejection I, Jonsson’s pressure sensor 601 does not self-align in a
predetermined rotational orientation within a channel opening 612, as called
for by claim 25. Therefore, the Examiner’s legal conclusion of obviousness
is not supported by sufficient factual findings. See In re Warner, 379 F.2d
1011, 1017 (CCPA 1967) (holding that “[t]he legal conclusion of
obviousness must be supported by facts. Where the legal conclusion is not
supported by facts it cannot stand.”).
Thus, for the same reasons as discussed supra in Rejection I, we do
not sustain the rejection of independent claim 25, and claim 49 depending
therefrom, as unpatentable over the combined teachings of Ginggen and
Jonsson.
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Application 12/793,457
Claim 44
Similar to independent claim 25, independent claim 44 recites, in
relevant part, a “pressure sensor [that] is sized and shaped to self-align to the
channel opening defined by the fluid enclosure wall.” See Appeal Br. 40
(Claims App.). However, for the same reasons as discussed supra in the
rejection of claim 25, Jonsson’s pressure sensor 601 does not self-align in a
predetermined rotational orientation within a channel opening 612, as called
for by independent claim 44.
Accordingly, for the same reasons as discussed above in the rejection
of claim 25, we do not sustain the rejection of independent claim 44 as
unpatentable over the combined teachings of Ginggen and Jonsson.
Rejections III—V
The Examiner does not rely on Hirata, Robb, and Miesel in any
manner that would remedy the deficiencies in the rejection based upon
Ginggen and Jonsson discussed supra in Rejection II. See Final Act. 8—10.
Thus, for the same reasons as discussed above in Rejection II, we do
not sustain the rejections under 35 U.S.C. § 103(a) of claims 11—13 as
unpatentable over Ginggen, Jonsson, and Hirata; of claims 46 and 47 as
unpatentable over Jonsson, Ginggen, and Robb; and of claims 5, 44, 48, and
49 as unpatentable over Jonsson, Ginggen, and Miesel.
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Rejections VI and VII
The Examiner does not rely on Robb and Miesel in any manner that
would remedy the deficiencies in the rejection based upon Jonsson discussed
supra in Rejection I. See Final Act. 11.
Thus, for the same reasons as discussed above in rejection I, we do
not sustain the rejections under 35 U.S.C. § 103(a) of claim 50 as
unpatentable over Jonsson and Robb and of claim 51 as unpatentable over
Jonsson and Miesel.
DECISION
The Examiner’s decision to reject claims 1—16, 25, and 44—52 is
reversed.
REVERSED
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