Ex Parte Decré et al

Patent Trial and Appeal Board

Jul 30, 2018

14070628 (P.T.A.B. Jul. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/070,628 11/04/2013
71996 7590 08/01/2018
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Michel Marcel Jose Deere
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
l 123-229US01/C011062.USU4 9338
EXAMINER
EV ANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/01/2018 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
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHEL MARCEL JOSE DECRE,
JEROEN JACOB ARNOLD TOL, HUBERT CECILE FRANCOIS
MARTENS, and
FRANCISCUS PAUL US MARIA BUDZELAAR 1
Appeal2017-008160
Application 14/070,628
Technology Center 3700
Before: RICHARD M. LEBOVITZ, MICHAEL J. FITZPATRICK, and
RICHARD J. SMITH Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an implantable system that
provides stimulation pulses to the brain. The Examiner rejected the claims
as obvious under 35 U.S.C. § 103 and as indefinite and lacking written
description under 35 U.S.C. § 112. Appellants appeal the rejections
pursuant to 35 U.S.C. § 134. We have jurisdiction under 35 U.S.C. § 6(b ).
The rejections are affirmed.
1 The Appeal Brief ("Appeal Br.") 3 identifies the real parties in interest as
Medtronic, Inc. of Minneapolis, Minnesota, the assignee of record, and
Medtronic plc of Dublin, Ireland, the ultimate parent entity of Medtronic,
Inc.
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STATEMENT OF THE CASE
The claims stand finally rejected by the Examiner as unpatentable.
Appellants appeal the following grounds of rejection:
1. Claims 1, 3-5, 7-9, 11-14, 16, 17, 19-31, and 34--36 under 35
U.S.C. § I03(a) as obvious in view ofMiesel et al., U.S. Pat. No. 8,489,196
B2, issued Jul. 16, 2013 ("Miesel") and Zdeblick, U.S. Pat. Appl.
Publication No. 2006/0058588 Al, published Mar. 16, 2006 ("Zdeblick").
Ans. 2, 5.
2. Claim 36 under 35 U.S.C. § 112(b) as indefinite for failing to
particularly point out and distinctly claim the subject matter which the
inventor regards as the invention.
3. Claim 36 under 35 U.S.C. § 112(a) as failing to comply with the
written description requirement.
Claim 1, which is illustrative of the claimed subject matter, is
reproduced below.
1. An implantable system configured for brain applications, the
implantable system comprising:
an implantable lead having a plurality of electrodes at a
distal end of the lead;
an implantable main module comprising:
a first housing;
a pulse generator within the first housing and
configured to generate stimulation pulses;
an output configured to output at least the
stimulation pulses; and
a battery having a battery ground terminal and
connected to the pulse generator;
one or more connection lines, wherein a first connection
line of the one or more connection lines is connected to the
output; and
an active electronics module connected to the
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implantable main module with the one or more connection lines
and connected to the implantable lead, wherein the active
electronics module comprises:
a second housing separate from the first housing;
a switch within the second housing and connected
to the first connection line, and configured to provide the
stimulation pulses from the first connection line to at
least one of the plurality of electrodes; and
a local ground terminal, wherein the switch is
connected to the local ground terminal, and wherein the
local ground terminal of the active electronics module is
configured to be electrically connected via body tissue to
the battery ground terminal of the implantable main
module.
OBVIOUSNESS REJECTION
There are two independent claims on appeal, claims 1 and 19. Each
of the claims are directed to a system for implantation into the brain for
generating stimulation pulses to the brain. The "system" would be
understood to be the set of devices or parts ( e.g., leads, switches, battery,
etc.) that make-up the implantable system.
The system comprises: (1) an implantable lead having a plurality of
electrodes; (2) a pulse generator for generating stimulation pulses; (3) a
battery having a ground terminal; and (4) a module having a switch for
providing the stimulation pulses to at least one of the plurality of electrodes.
In claim 1, (2) the pulse generator and (3) battery are in an
"implantable main module" housing; and (4) the switch is in the "active
electronics module" housing. App. Br. 18, Claims App. Claim 1 requires
that "the local ground terminal of the active electronics module is configured
to be electrically connected via body tissue to the battery ground terminal of
the implantable main module." Id. (emphasis added). Claim 19 has the
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same ground requirement as claim 1, but uses different terms in naming the
modules.
The Examiner found that Miesel describes a system for brain
stimulation that has all the features of claims 1 and 19, but not the claimed
requirement that the battery terminal of the main module is connected to the
active electronics module "via body tissue." Final Act. 3--4. However, the
Examiner found that each of Miesel and Zdeblick teach reducing the number
of wires to be used in a stimulation device. Id. Further, the Examiner found
Zdeblick teaches that "electrical connections, such as connecting to the
ground, can be performed without wires." Id. at 5. Based on these findings,
the Examiner concluded that it would have been obvious to one of ordinary
skill in the art to have connected the battery ground terminal to the active
electronics module "via body tissue" without a wire "as taught by Zdeblick,
since it would provide the predictable results of cutting down on the number
of connection lines/wires used and/ or reduces the chance of line/wire
fractures or repairs since the line/wire is not there." Id. at 5.
Appellants contend that Zdeblick does not teach the ground path "S 1"
as a conductive path through the body, but rather in "every embodiment
describing ground path S 1, Zdeblick describes that the conductive path
formed by the body carries power and data (e.g., S2), while the ground path
is a wired connection." Appeal Br. 9.
Thus, the issue in this rejection is whether Zdeblick teaches or
suggests "the local ground terminal of the active electronics module is
configured to be electrically connected via body tissue to the battery ground
terminal of the implantable main module" as required by all the rejected
claims.
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Discussion
Zdeblick describes a device for "administering electrical signals to
local areas of living tissue and monitoring conditions in such tissue."
Zdeblick ,r 11. The device has a satellite which is placed in the body and a
controller coupled to the satellite. Id. ,r,r 13-15. The controller transmits
pulses to the satellite. Id. ,r 15. Zdeblick teaches that the satellite is
connected by first and second bus conduction paths to the controller. Id.
,r 13. The controller and the satellite roughly correspond to the claimed
implantable main module and active electronics module, respectively.
Zdeblick teaches that in some embodiments "a bus conduction path is
said to be insulated from the subject's body", where the "conduction path
includes a discrete conductive element ( e.g., a wire; namely a dedicated
conductor) that is distinct from the subject's body and an insulating material
separating the conductive element from the subject's body." Zdeblick ,r 17.
Zdeblick also teaches:
In other embodiments, a bus conduction path is not insulated
from the subject's body. Such a conduction path may include a
discrete conductive element that is in contact with the subject's
body, or may be defined by the subject's body so that the
conduction is through the subject's tissue and/or body fluids.
Zdeblick ,r 18. The non-insulated bus conduction path is a path "via body
tissue" as required by all the rejected claims.
Consistent with the broad disclosure, Zdeblick describes one-wire and
two-wire embodiments, where the two-wire embodiment has two insulated
conduction paths and the one-wire embodiment has one insulated path and
one path "via body tissue." Zdeblick teaches:
In one set of embodiments, referred to as two-wire
embodiments, the first and second bus conduction paths are
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insulated from each other and from the subject's body, and both
are typically associated with the carrier. In another set of
embodiments, referred to as one-wire embodiments, one of the
conduction paths is insulated from the subject's body, but the
other is defined in part or whole by the subject's body.
Zdeblick ,r 23.
In broad terms, the invention provides embodiments where one
or more individually addressable modular circuits ("satellites"
or "satellite units") are placed along a bus that includes at least
one conductor associated with a carrier such as a pacing lead.
The bus provides first and second conduction paths. In some
embodiments ("two-wire embodiments"), as will be described
below, both conduction paths are insulated from the subject's
body. In other embodiments ("one-wire embodiments"), only
one of the conduction paths is insulated from the subject's body
while the other conduction path is provided by the conductive
fluids in the subject's body.
Zdeblick ,r 52.
Zdeblick also discloses:
In a third set of embodiments, both conduction paths are
defined in whole or in part by the subject's body.
Zdeblick ,r 23.
Based on the teachings in Zdeblick reproduced above, the Examiner
takes the position that the one-wire embodiments in which one conduction
path is through or "via" the body is not restricted as to what type of
connection carried by the path, and thus would have been reasonably
understood to include a battery ground connection.
Appellants dispute the Examiner's findings with regard to whether
Zdeblick teaches that the ground connection can be via the body tissue.
Appellants contend that Zdeblick does not teach that the ground can be
removed and replaced by a connection via the body tissue, but rather
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Appellants argue that Zdeblick teaches that only "one or more data and/or
power paths may be removed" and routed through body tissue. Reply Br. 3.
Appellants contend that "in every embodiment of Zdeblick where one
electrical connection is through body tissue and another is through a wired
connection, the conductive path formed by the body carries power and data,
while the ground path is a wired connection." Id. at 4.
In support of this argument, Appellants cite Zdeblick' s teaching under
the heading of "One-Wire Embodiments" that states: "If other signals are not
carried on bus conduction path S2, bus conduction path S2 may be
eliminated and the subject's body fluids may be used as a power and data
conductor." Zdeblick ,r 165; App. Br. 9 (citing the same). Appellants cite
disclosure in Zdeblick that the other conduction path S 1 is the ground and
that in every embodiment of Zdeblick the ground S 1 is a wired connection,
not via the body as required by the claims. Id.
We agree with Appellants that the specific embodiments described in
Zdeblick show the ground connection S 1 between the satellite and controller
as wired. See, e.g., Figure 16B of Zdeblick described in paragraphs 1 71-
173. However, while the preferred and specifically disclosed embodiments
of Zdeblick having a ground S 1 show the ground as wired and not via body
tissue, we cannot ignore the broader teachings in paragraphs 18, 23, and 52
of Zdeblick (reproduced above), which teach that one of the two conduction
paths can be through the body, and which do not limit the body tissue to
carrying power and data as disclosed in paragraph 165 of Zdeblick. Indeed,
in paragraph 23, Zdeblick also "a third set of embodiments" in which "both
conduction paths are defined in whole or in part by the subject's body."
Zdeblick ,r 23 (reproduced above).
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The teaching of a prior art publication is not limited to its preferred
embodiments. Pfizer v. Apotex, Inc., 480 F.3d 1348, 1370 (Fed. Cir. 2007).
"[T]he fact that a specific [embodiment] is taught to be preferred is not
controlling, since all disclosures of the prior art, including unpreferred
embodiments, must be considered." Merck & Co. v. Biocraft Labs., Inc.,
874 F.2d 804,807 (Fed. Cir. 1989) (alteration in original) (quoting In re
Lamberti, 545 F.2d 747, 750 (CCPA 1976)). Accordingly, the Examiner
reasonably found, based on these broad disclosures that Zdeblick suggests
that the ground path could also be via body tissue as recited in all the
rejected claims.
In an attempt to disparage the teachings in Zdeblick, Appellants argue
that one of ordinary skill in the art "would recognize that the patient's body
tissue is not an electrical 'short,' but rather has resistance and impedance."
Appeal Br. 9--10. Appellants explained:
Thus, by using the patient's body tissue as a ground conduction
path, a ground terminal of the satellite units would not be
electrically shorted to a ground terminal of the control unit.
Accordingly, one of ordinary skill in the art would recognize
that the satellite units and control unit would not share common
reference point, and therefore it would be difficult to
reconstruct the data and embedded clock signal by referencing
"the 'ground voltage' of bus conduction path SI," which would
not be consistent for the control unit or each of the satellite
units. 39 Thus, one of ordinary skill in the art would recognize
that the system of Zdeblick would not function if it used the
patient's body tissue as a ground conduction path, and therefore
would recognize that Zdeblick teaches away from the subject
matter of the claims on appeal.
Appeal Br. 10 ( emphasis added).
This argument does not persuade us that the Examiner erred.
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First, Appellants' argument is based on what the ordinary skilled
worker "would recognize," but Appellants did not provide objective
evidence that such a worker would have known the facts alleged in
Appellants' discussion and made the conclusion that Zdeblick's system
would not work if the ground connection was though the patient's body
tissue.
Second, we find that evidence cited by Appellants does not support
their argument. Specifically, Appellants referenced paragraph 93 of
Zdeblick in footnote 39 (see above). Paragraph 93 of Zdeblick is reproduced
below:
By way of the example shown in FIG. 4, after an initial time
interval of 20 microseconds, during which the signals "V s2,"
"vref," and "vhigh" (which are explained in the description
corresponding to FIG. 7) are allowed to stabilize, octets
"00000000" "00100000" and "00011011" are transmitted with
' an embedded clock signal ("elk") on bus conduction path S2
(relative to the "ground voltage" of bus conduction path Sl). In
response, a selected satellite stores the configuration
information in its registers and prepares its electrodes to be
used for the subsequent pacing or signal collection operations.
After the configuration phase (i.e., after the specified satellites
are activated and the specified electrodes are coupled to their
respective bus conduction paths, or remain disconnected),
central controller 10 may initiate a pacing phase or a signal
collection phase.
We have reviewed paragraph 93, but cannot discern where it explains
why S2 may be a wire conduction path or through the body, while the S 1
ground must be wired. Thus, while Appellants argue that "Zdeblick would
not function if it used the patient's body tissue as a ground conduction path,"
Appellants do not adequately explain how the discussion in paragraph 93 of
the specific embodiment referenced in Figure 7 of Zdeblick supports their
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argument. Appeal Br. 10. Appellants have not even established that the
referenced discussion is with respect to a one-wire or two-wire embodiment.
An argument made by counsel in a brief does not substitute for evidence
lacking in the record. Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595
(Fed. Cir. 1997).
In the Answer, the Examiner responded to this argument and
explained why Zdeblick does not teach away from connecting the ground
through the body, stating that "Zdeblick notes that the ground will float
relative to a signal (e.g. para. 95, 156, etc.)." Ans. 3. Appellants filed a
Reply Brief responsive to the Examiner's Answer, but did not identify a
defect in this argument as to why Zdeblick does not teach away from the
claimed ground connection.
Appellants also contend "the Examiner has failed to establish why a
person of ordinary skill in the art would have modified the system of Miesel
to arrive at the subject matter recited by claim 1." Appeal Br. 10.
Appellants state that the Examiner did not explain why the ordinary skilled
worker "would have modified the Miesel system with the Zdeblick
disclosure having no wires connected to the satellite unit to selectively
remove only the ground wire connection of Miesel, while retaining other
wired connections, to arrive at the specific configuration of features recited
in claim 1." Id. at 11.
We do not find this argument to accurately reflect the Examiner's
reasoning. The Examiner found that Miesel teaches "that as few lines as
possible should be used," citing Miesel column 5, line 57. Final Act. 4. As
found by the Examiner, Miesel teaches "[p ]referably, conductor 22
comprises as few connectors as possible to transmit the desired power and
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stimulation signals." Miesel, col. 5, 11. 56-58. The Examiner also found that
Zdeblick teaches producing connections without wires, and explained that
reducing wire number would "cut down on the number of connection
lines/wires used and/or reduces the chance of line/wire fractures or repairs
since the line/wire is not there." Final Act. 5. Appellants did not identify a
defect in this reasoning.
The Examiner acknowledged that Zdeblick does not explicitly teach
the ground terminal as connected through the body as claimed, but found -
based on the teachings in paragraphs 18, 23, and 52-that "Zdeblick
teaches that any of the conductors can be removed and connected through
the body to reduce complexity/lines." Final Act. 7; see also Ans. 3--4. Thus,
because Appellants did not establish by objective evidence ground
connection "via body tissue" would not function, or provide another
adequate reason for not implementing it to reduce the number of wire
connections, we conclude that a preponderance of the evidence supports the
Examiner's determination that claims 1 and 19 would have been obvious to
one of ordinary skill in the art based on Zdeblick.
Separate arguments were not provided for dependent claims 3-5, 7-9,
11-14, 16, 17, 20-31, and 34--36. Appeal Br. 12, 13. These claims
therefore fall with independent claims 1 and 19. 37 C.F.R. § 4I.37(c)(l)(iv).
INDEFINITENESS AND WRITTEN DESCRIPTION
REJECTIONS OF CLAIM 36
Claim 3 6 depends from the system of claim 1 and further recites:
wherein a first voltage potential measured at the local ground
terminal of the active electronics module bounces relative to a
second voltage potential measured at the battery ground
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terminal of the implantable main module, the bounce of the first
voltage potential occurring in response to the switch receiving
the stimulation pulses from the first connection line.
Indefiniteness
The Examiner found that claim 3 6 is indefinite because "the use of the
first and second potentials being 'measured' is vague and makes the claim
incomplete as no element has been set forth to measure the voltages." Final
Act. 3. Appellants responded that, while claim 36 does not affirmatively
recite an element that measures the first or second voltage potential, the
absence of such a feature does not render unclear to a person of ordinary
skill in the art because "what a 'first voltage potential measured' or a
'second voltage potential measured' means in light of the claims and the
[S]pecification." Appeal Br. 16. Further, Appellants contend that one of
ordinary skill in the art would have understood "that a measurement circuit
or other structure would have been used to measure the first and second
voltage potential." Id.
This argument does not persuade us that the claim is not indefinite.
Claim 36 depends from claim 1, which is directed to an implantable system.
However, the limitation of claim 36 in dispute states that the first voltage
potential bounces relative to a second voltage potential in response to the
switch receiving the stimulation pulses from the first connection line. Such
limitation, as written, appears to be more like a process step, while the claim
is directed to a system, namely a device which is implanted into a subject.
Thus, we agree with the Examiner that the claim is indefinite because a
process step cannot further limit a system claim. Therefore, the Examiner
reasonably found the recitation of the voltage potentials indefinite and
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incomplete because they were stated as a process step, rather than as an
element to measure the voltage potential and configured to determine the
bounce in response to the switch receiving the stimulation pulse as recited in
claim 36.
Accordingly, the indefiniteness rejection under 35 U.S.C. § 112(b) of
claim 3 6 is affirmed.
Written Description
Claims 36 was added by an amendment filed on April 4, 2016. The
Examiner rejected claim 36 as lacking written description in the
Specification as originally filed. The Examiner explained:
The subject matter not disclosed is the bounce of the first
voltage potential occurring "in response to the switch receiving
the stimulation pulses from the first connection line[,]" in
combination with the other elements in the claim( s ). The
original disclosure stated the bounce occurs when the
stimulation pulses are applied to the brains.
Final Act 2.
Appellants acknowledge that the Specification discloses that the
bounce is disclosed in paragraph 109 of the Specification in the same rhythm
as the stimulation pulse applied to the brain, but contend one of ordinary
skill in the art would have recognized that the first voltage potential
measured at the local ground terminal of the active electronics module
bounces "'in response to the switch receiving the stimulation pulses from the
first connection line,' as recited by claim 3 6, due to the delivery of the
pulses to the patient and the 'relative resistance levels of RrM, RrL, and
RML·"' Appeal Br. 15.
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The inventor must "convey with reasonable clarity to those skilled in
the art that, as of the filing date sought, he or she was in possession of the
invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563---64 (Fed. Cir.
1991). "One shows that one is 'in possession' of the invention by describing
the invention, with all its claimed limitations." Lockwood v. Am. Airlines,
Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (citation omitted). In describing
the claimed invention, there is no requirement that the wording be identical
to that used in the specification as long as there is sufficient disclosure to
show one of skill in the art that the inventor "invented what is claimed."
Union Oil Co. v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000)
( citation omitted). The written description "need not recite the claimed
invention in haec verba but [it] must do more than merely disclose that
which would render the claimed invention obvious." ICU Med., Inc. v.
Alaris Med. Sys., Inc., 558 F.3d 1368, 1377 (Fed. Cir. 2009). Thus, as long
as a person "of ordinary skill in the art would have understood the inventor
to have been in possession of the claimed invention at the time of filing,
even if every nuance of the claims is not explicitly described in the
specification, then the adequate written description requirement is met." In
re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996).
In this case, Appellants admit that the claimed limitation is not
described in the Specification in the same wording as in the claim. Appeal
Br. 15. However, Appellants contend that one of skill in the art would have
"recognized" that the claimed limitation is met "due to the delivery of the
pulses to the patient" and the relative resistance levels. Id. This argument
does not demonstrate an error in the Examiner's rejection.
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First, Appellants have not provided objective evidence that one of
ordinary skill in the art, upon reading the Specification, would have
"recognized" that the recited limitation "bounces" as required by the claim.
Second, Appellants have not demonstrated that the inventors had
"possession" of the claimed feature as required to establish a written
description of a claimed feature when the limitation does not appear in the
Specification in the identical wording recited in the claim. Union Oil, 208
F.3d at 997. Appellants' explanation of why the skilled worker would have
"recognized" the claimed feature upon reading the Specification does not
distinguish what would have been obvious to one of ordinary skill in the art
(ICU Med., Inc., 558 F.3d at 1377) from a showing adequate to establish that
the inventors invented what is claimed (Union Oil, 208 F.3d at 997), the
proper standard to determine compliance with the written description
requirement of Section 112.
Accordingly, the written description rejection under 35 U.S.C.
§ 112(a) of claim 36 is affirmed.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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