Ex Parte Barker

Patent Trial and Appeal Board

Nov 15, 2017

13040760 (P.T.A.B. Nov. 15, 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.
13/040,760 03/04/2011 John Michael Barker 1362009-2189.1 3581
50638 7590 11/15/2017
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
EXAMINER
TON, MARTIN TRUYEN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
11/15/2017 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
____________________

Ex parte JOHN MICHAEL BARKER
____________________

Appeal 2015-000202
Application 13/040,760
Technology Center 3700
____________________

Before EDWARD A. BROWN, PATRICK R. SCANLON, and
BRANDON J. WARNER, Administrative Patent Judges.

SCANLON, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
John Michael Barker (“Appellant”)1 seeks our review under 35 U.S.C.
§ 134 of the Examiner’s decision, as set forth in the Final Office Action,
dated February 5, 2014 (“Final Act.”), rejecting claims 1 and 4–23, which
are all of the pending claims. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellant identifies Boston Scientific Neuromodulation Corporation, a
wholly-owned subsidiary of Boston Scientific Corporation, as the real party
in interest. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
Appellant’s claimed invention is directed to “insertable trial
stimulation leads having electrical connectors that couple to external trial
stimulators during operation.” Spec. 1:12–13. Independent claim 1 is
illustrative of the claimed subject matter and is reproduced below.
1. A trial stimulation lead assembly for providing electrical
stimulation of patient tissue during a trial stimulation, the trial
stimulation lead assembly comprising:
a trial stimulation lead configured and arranged for
insertion into a patient, the trial stimulation lead comprising
an elongated lead body having a proximal end portion, a
distal end portion, a longitudinal length, a circumference, and a
longitudinal axis defined by the longitudinal length of the lead
body along the proximal end portion, wherein the distal end
portion of the lead body is configured and arranged for insertion
into the patient,
a plurality of electrodes disposed along the distal end
portion of the lead body,
an electrical connector disposed at the proximal end
portion of the lead body and configured and arranged to remain
at least partially external to the patient during the trial
stimulation, the electrical connector comprising an outer case
and a plurality of contacts arranged into a contact array disposed
at least partially within the outer case, wherein the contact array
extends along an axis that is transverse to the longitudinal axis of
the lead body, wherein the outer case is coupled directly to the
lead body,
a plurality of electrical conductors electrically coupling
the plurality of electrodes to the plurality of contacts, and
a lead lumen extending from the proximal end portion of
the lead body along at least a portion of the longitudinal length
of the lead body,
a connector lumen defined in the electrical connector, the
connector lumen open to the lead lumen and extending from the
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lead lumen to an access port defined in the electrical connector,
and wherein each of the lead lumen, the connector lumen, and
the access port are configured and arranged for receiving a stylet,
wherein the lead body is isometric along the entire
longitudinal length of the lead body between the plurality of
electrodes and the electrical connector.
Appeal Br. 16, Claims App.
Claim 13 is directed to a kit for providing electrical stimulation of
patient tissue during a trial stimulation that includes “the trial stimulation
lead assembly of claim 1,” and claim 18 is directed to a method that includes
“inserting the distal end portion of the trial stimulation lead of the trial
stimulation lead assembly of claim 1 into [an] insertion needle.” Id. at 18,
19.
REFERENCES
The Examiner relies upon the following prior art references:
Pohndorf
Makower
Knapp
Kraus
Mamo
Schulman
Pianca
Hrdlicka
US 4,512,351
US 5,380,290
US 6,546,289 B2
US 6,641,564 B1
US 6,847,849 B2
US 2006/0253181 A1
US 7,343,205 B1
US 7,493,159 B2
Apr. 23, 1985
Jan. 10, 1995
Apr. 8, 2003
Nov. 4, 2003
Jan. 25, 2005
Nov. 9, 2006
Mar. 11, 2008
Feb. 17, 2009
Bartlett WO 2008/003126 A1 Jan. 10, 2008

REJECTIONS
The following rejections are before us on appeal:
I. Claims 1, 4–11, and 23 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Hrdlicka, Bartlett, Mamo, and Knapp.
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II. Claim 12 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Hrdlicka, Bartlett, Mamo, Knapp, and Pianca.
III. Claims 13–15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hrdlicka, Bartlett, Mamo, Knapp, and Kraus.
IV. Claims 16 and 17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hrdlicka, Bartlett, Mamo, Knapp, Kraus, and Makower.
V. Claims 18–20 and 22 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Hrdlicka, Bartlett, Mamo, Knapp, Pohndorf, and
Schulman.
VI. Claim 21 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Hrdlicka, Bartlett, Mamo, Knapp, Pohndorf, Schulman,
and Makower.
ANALYSIS
Rejection I
Appellant argues claims 1, 4–11, and 23 as a group. Appeal Br. 14;
Reply Br. 12. We take independent claim 1 as representative pursuant to 37
C.F.R. § 41.37(c)(1)(iv), with claims 4–11 and 23 standing or falling with
claim 1.
Regarding claim 1, the Examiner finds that Hrdlicka discloses a trial
stimulation lead assembly including a trial stimulation lead configured and
arranged for insertion into a patient. Final Act. 4. More specifically, the
Examiner finds that Hrdlicka discloses an elongated lead body as claimed
(stimulation lead 24), a plurality of electrodes disposed along the distal end
of the lead body (electrical contacts 34), an electrical connector disposed at
the proximal end of the lead body and configured and arranged to remain
external to the patient during a trial stimulation (therapy lead connector 76),
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and a plurality of electrical conductors electrically coupling the electrodes to
the contacts (citing column 2, lines 61–67 of Hrdlicka). Id. The Examiner
further finds that connector 76 of Hrdlicka comprises an outer case and a
contact array disposed along the outer case, wherein the contact array
extends along an axis that is transverse to the longitudinal axis of the lead
body. Id.
The Examiner concedes that Hrdlicka does not disclose: (1) the
contact array being disposed at least partially within the outer case; (2) the
outer case being coupled directly to the lead body; (3) the lead body being
isometric along its entire longitudinal length between the plurality of
electrodes and the electrical connector; and (4) the claimed lead lumen.2 Id.
at 4–5.
The Examiner proposes several modifications to address these
deficiencies of Hrdlicka. First, the Examiner finds that Bartlett teaches a
medical interface that uses a LEMO connector as a reliable connection for
handheld medical products, and that LEMO connectors were well known in
the art to have a contact array disposed at least partially within the outer
casing. Id. at 5. The Examiner then concludes that “it would have been
obvious to a person having ordinary skill in the art at the time of invention to
have the electrical connector of the Hrdlicka reference be a LEMO
connector to provide a more robust and reliable connection for the trial
stimulation system.” Id.
We agree with these findings and conclusion, none of which
Appellant disputes. Namely, Figure 7 of Bartlett shows a LEMO connector

2 Although not stated expressly, the Examiner appears to concede that
Hrdlicka also does not disclose the claimed connector lumen.
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having an array of contacts. Bartlett discloses that such a connector provides
a robust and reliable connection for medical products and avoids potential
damage due to twisting to disengage the connector. Bartlett, p. 11, ll. 5–11.
For these reasons, one of ordinary skill in the art would have viewed
Bartlett’s connector as a viable alternative for Hrdlicka’s connector 76.
Next, the Examiner finds that Mamo teaches stimulation lead 30
having connectors on its proximal end that may connect to either a lead
extension or directly to a trial neurotransmitter. Id. (citing Mamo, 6:8–32).
Based on this finding, the Examiner concludes that it would have been
obvious to one of ordinary skill in the art to remove Hrdlicka’s lead
extension 22, connector 32, and screening cable 36 because such a
modification would “eliminate extraneous parts and limit the number of
additional connections which may be unreliable.” Id. at 5–6. The Examiner
determines that this modification would result in the outer case of the
connector being coupled directly to the lead body and the lead body being
isometric along its entire longitudinal length. Id. at 6.
We agree with this finding and conclusion, which Appellant also does
not dispute. Specifically, in view of Mamo’s disclosure that the connectors
on the proximal end of stimulation lead 30 may be connected directly to the
trial neurotransmitter without a lead extension (Mamo, 6:16–20), we agree
that it would have been obvious to one of ordinary skill in the art to modify
the combination of Hrdlicka and Bartlett by connecting the proximal end of
stimulation lead 24 directly to the electrical connector.
Last, the Examiner finds that Knapp “teaches an implantable lead
(Figure 1), wherein the lead body (Figure 1; 12) and the electrical connector
(Figure 1; 14) may be provided with a lumen (Figure 2; 20) to permit
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insertion of a stylet.” Final Act. 6 (citing Knapp, 3:1–11). The Examiner
also finds that Knapp discloses an access port (self-sealing plug 33) defined
on the outer case of its electrical connector.3 Id. at 7 (citing Knapp, Fig. 3).
The Examiner concludes it would have been obvious to a person having
ordinary skill in the art to modify Hrdlicka by including a lumen in the lead
body and the electrical connector, as taught by Knapp, to allow for the
insertion of a stylet to stiffen the lead during implantation. Id. at 6. The
Examiner determines that this modification would have resulted in “the
connector lumen [being] open to the lead lumen and extending from the
proximal end portion of the lead body along at least a portion of the
longitudinal length of the lead body and extending from the lead lumen to an
access port defined in the electrical connector,” with the lead lumen,
connector lumen, and access port being “configured and arranged for
receiving a stylet.” Id.
Appellant argues that none of the cited references, alone or in
combination, discloses an electrical connector that is disposed at the
proximal end of a lead, includes contacts extending along an axis transverse
to the longitudinal axis of the lead, and includes an access port and
connector lumen suitable for receiving a stylet. Appeal Br. 8; Reply Br. 8,
11. Specifically, Appellant argues that it would not have been obvious to

3 This finding suggests the Examiner considers angled collar 16 to be part of
the electrical connector. We find no error in the Examiner’s finding, which
Appellant has not challenged. Indeed, regarding the embodiment of Figure
3, Knapp discloses that angled collar 16 is integral with connector assembly
14, and passage 32 (which is formed in collar 16 and contains plug 33) is at
the distal end of connector assembly 14. Knapp, 4:11–19.
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one of ordinary skill in the art to combine Hrdlicka and Knapp in the manner
proposed by the Examiner
because neither reference, alone or in combination, teaches an
electrical connector of a lead having both: 1) a contact array that
is transverse to a longitudinal axis of the lead; and 2) a stylet-
receiving lumen disposed in the electrical connector. As
acknowledged in the Office Action, Hrdlicka does not teach a
stylet-receiving lumen (Office Action, page 4) and Knapp does
not teach a contact array that it transverse to a longitudinal axis
(Office Action, page 2). Therefore, neither reference teaches
both recited elements.
Appeal Br. 12.
Although Appellant initially refers to the references “alone or in
combination,” the thrust of the argument is that neither Hrdlicka nor Knapp
individually teaches both of the recited elements. As such, the argument is
not persuasive because it fails to address the Examiner’s proposed
combination, in which the contact array of Hrdlicka (as modified by Bartlett)
is transverse to the longitudinal axis of the lead, and the modification taught
by Knapp results in a stylet-receiving lumen formed in the electrical
connector. See Ans. 3 (stating the incorporation of Knapp’s stylet-receiving
lumen reference, through the connector and the implantable lead of Hrdlicka
“would result in an electrical connector of a lead having a contact array that
is transverse to a longitudinal axis of the lead and a stylet-receiving lumen
disposed in the electrical connector”).
In addition, Appellant argues that there is no motivation in Hrdlicka to
include a stylet-receiving lumen in connector 76 because Hrdlicka discloses
attaching the connecter to lead 24 after lead 24 has been implanted, such that
“there is no apparent reason to insert a stylet into the connector.” Appeal
Br. 12; see also Reply Br. 8 (arguing similarly that Hrdlicka’s disclosed
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implantation technique involves attaching connector 76 to lead 24 after lead
24 is implanted). Appellant also argues that “there is no point in having a
stylet-receiving lumen that passes through the connector 76 because the
implantation procedure taught by Hrdlicka requires the stylet to be removed
prior to attaching the connector 76.” Appeal Br. 13.
These arguments are not persuasive. First, Hrdlicka discloses:
Implantation of an Implantable Neuro Stimulator (INS) 26
typically begins with implantation of at least one stimulation lead
24 usually while the patient is under a local anesthetic[.] The
stimulation lead 24 can either be percutaneously or surgically
implanted. Once the stimulation lead 24 has been implanted and
positioned, the stimulation lead’s 24 distal end is typically
anchored into position to minimize movement of the stimulation
lead 24 after implantation. The stimulation lead’s 24 proximal
end can be configured to connect to a lead extension 22.
Hrdlicka, 3:31–40 (emphasis added). The only act that Hrdlicka specifically
discloses as occurring after implantation of lead 24 is anchoring the distal
end of lead 24 in position. Hrdlicka’s disclosure of the proximal end of lead
24 being configured to connect to lead extension 22 is silent as to whether
the connection occurs before or after implantation of lead 24. As such,
contrary to Appellant’s assertion, Hrdlicka does not disclose that lead
extension 22 and, thus, connector 76 necessarily are connected after lead 24
is implanted.
Furthermore, Appellant’s arguments would be unpersuasive even if
Hrdlicka did require attaching connector 76 after implantation of lead 24.
Appellant asserts that that there is no motivation “in Hrdlicka” to include a
stylet-receiving lumen (Appeal Br. 12), but a reason to modify a reference
does not have to originate from the reference being modified. See DyStar
Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d
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1356, 1361 (Fed. Cir. 2006) (“The motivation need not be found in the
references sought to be combined, but may be found in any number of
sources, including common knowledge, the prior art as a whole, or the
nature of the problem itself.”). Here, Knapp discloses a medical lead
provided with lumen 20 extending through lead body 12 and connector
assembly 14 to permit insertion of a stylet during implantation. Knapp, 3:9–
11, 56–60, Figs. 2, 3. We agree with the Examiner that this teaching of
Knapp would have led one of ordinary skill in the art to modify Hrdlicka by
including a stylet-receiving lumen in the lead body and the electrical
connector to allow use of a stylet to implant the lead. See Final Act. 6.
Next, Appellant argues that “there is no motivation to modify the
system of Hrdlicka to include lumens suitable for receiving a stylet along
any of the lead connector 76, the screening cable 36, or the lead extension
22, as asserted in the Office Action.” Appeal Br. 13 (emphasis added); see
also Reply Br. 6–8 (making similar arguments that it would not have been
obvious to provide screening cable 36 with a stylet-receiving lumen); Reply
Br. 11 (arguing that modifying stimulation lead 24, lead extension 22, and
screening cable 36 to include a stylet-receiving lumen would require use of
an extremely long stylet that would be awkward and difficult to use).
These arguments are not persuasive because Appellant
mischaracterizes the combination set forth by the Examiner by failing to
address the entire modification as proposed. Namely, Appellant does not
account for the proposed modification taught by Mamo of removing
Hrdlicka’s lead extension 22, connector 32, and screening cable 36 because
such a modification would “eliminate extraneous parts and limit the number
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of additional connections which may be unreliable.”4 See Final Act. 5–6. In
other words, arguing it would not have been obvious to provide Hrdlicka’s
lead extension 22 or screening cable 36 with a lumen is not persuasive
because the combination proposed by the Examiner does not include the lead
extension or the screening cable.
Additionally, Appellant argues that Knapp’s lumen is disposed on a
portion of the lead that is implanted, while, in contrast, Hrdlicka’s connector
is not implanted, and a skilled artisan “would not look to the teachings of an
implantable device to modify a device that remains external to a patient
during use.” Appeal Br. 14; Reply Br. 4–5. We disagree. Although not all
components of Hrdlicka’s system are implanted, stimulation lead 24 is
implanted (Hrdlicka, 3:31–35), just like Knapp’s lead (Knapp, 1:7–9). Also,
Hrdlicka and Knapp both relate to the same field of endeavor as Appellant’s
invention. Therefore, one of ordinary skill would have considered the
teachings of Knapp in connection with Hrdlicka.
We also disagree with Appellant’s argument that the Examiner’s
position relies “entirely on hindsight reasoning.” See Reply Br. 9.
Appellant does not establish that the Examiner’s combination includes
knowledge gleaned only from the Appellant’s disclosure. Rather, for the
reasons discussed above, the proposed combination takes into account the
teachings of Hrdlicka and Knapp, i.e., knowledge which was within the level
of ordinary skill at the time the claimed invention was made. See In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).

4 As discussed above, we agree with the Examiner that this modification
would have been obvious to one of ordinary skill in the art.
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Appellant also argues that the proposed combination would change
the principle of operation of Hrdlicka. Reply Br. 9. In particular, Appellant
asserts that Hrdlicka teaches a multi-component assembly, while Knapp
teaches a lead that is implanted entirely and does not teach implanting a
single-component assembly with a portion of the assembly remaining
external to the patient. Id. Thus, according to Appellant, the Examiner’s
position of “‘allowing the assembly [of Hrdlicka] to be directly implanted
into a patient as a whole unit, as is taught in the Knapp reference’ (emphasis
added), . . . would require modifying the device of Hrdlicka to be a single-
component assembly and would also require implantation of the connector
76 into the patient.” Id. (brackets and parenthetical in original). Appellant
then contends that both (1) modifying Hrdlicka’s multi-component assembly
to a single-component assembly; and (2) modifying Hrdlicka to require
implantation of components intended to be external would change the
principle of operation of Hrdlicka. Id. at 9–10.
Regarding the first point, we disagree that modifying the multi-
component assembly to a single-component assembly would change the
fundamental operation of Hrdlicka’s device. The number of components
comprising Hrdlicka’s lead assembly does not impact the nature of the
device’s operation. The device, when modified in the manner proposed by
the Examiner, would still operate in substantially the same fashion as
Hrdlicka’s disclosed device.
Regarding the second point, it appears Appellant has misinterpreted
the Examiner’s statement. The statement Appellant refers to is:
incorporating the stylet-receiving lumen of the Knapp reference
and having the lumen extend from the connector to the distal end
of the stimulation lead, would allow for the entire assembly to be
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stiffened, therein allowing the assembly to be directly implanted
into a patient as a whole unit, as is taught in the Knapp reference.
Ans. 3–4. When viewed in isolation, the passage “allowing the assembly to
be directly implanted into a patient as a whole unit, as is taught in the Knapp
reference” may seem to convey fully implanting the entire assembly into the
patient, but this is not the case when the passage is considered in context.
For instance, the Examiner further states in the same paragraph that the
modification “would additionally eliminate the additional step of requiring
the user to remove the stylet and then connect the lead to the connector, but
would instead allow a user to implant the lead as a whole unit.” Id. at 4
(emphasis added). Thus, the Examiner is proposing that implantation of the
portion of the assembly being implanted can occur with the assembly fully
assembled (i.e., “as a whole unit”), as opposed to connecting the electrical
connector to the lead after implantation of the lead, as Appellant argues.
The Examiner is not suggesting that the entire assembly as modified is fully
implanted. See, e.g., Final Act. 4 (finding that electrical connector 76 is
“configured and arranged to remain at least partially external to the patient
during the trial stimulation”). For the above reasons, we are not persuaded
that the Examiner’s proposed modification would change Hrdlicka’s
principle of operation.
In view of the above, Appellant’s arguments do not apprise us of
error, and we sustain the rejection of claim 1, and of claims 4–11 and 23
grouped therewith.
Rejections II–VI
Appellant advances no separate arguments in connection with the
rejections of claims 12–22, but instead relies on these claims’ dependency
from independent claim 1 for patentability. Appeal Br. 14; Reply Br. 12.
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As we find no deficiency in the Examiner’s rejection of claim 1 as being
obvious over the combination of Hrdlicka, Bartlett, Mamo, and Knapp for
the reasons discussed above, we also sustain the rejections of claims 12–22.
DECISION
We affirm the decision of the Examiner rejecting claims 1 and 4–23.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136 (a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED