Boston Scientific Neuromodulation Corporation

Patent Trials and Appeals Board

May 6, 2020

15179840 - (D) (P.T.A.B. May. 6, 2020)

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.
15/179,840 06/10/2016 John Michael Barker BSNC-1-083.3 1076
50638 7590 05/06/2020
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
EXAMINER
MALAMUD, DEBORAH LESLIE
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
05/06/2020 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):
patentdocketing@lowegrahamjones.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN MICHAEL BARKER
__________

Appeal 2019-005726
Application 15/179,840
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

GREENHUT, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–4, 7–10, and 20.2 See Final Act. 1.
Claims 6, 18, and 19 have been canceled and claims 11–17 are objected to as

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Boston
Scientific Neuromodulation Corporation, which “is a wholly-owned
subsidiary of Boston Scientific Corporation.” Appeal Br. 2.
2 The rejection of claim 5 under 35 U.S.C. § 102(b) as being anticipated by
Sundquist has been withdrawn. Ans. 6. Claims 21–23 were added via the
amendment filed December 11, 2018, which is prior to the Final Office
Action; however, the Examiner did not indicate whether these claims are
rejected or objected to as being dependent upon a rejected base claim. See
Final Act., passim; Ans., passim; Appeal Br. 6; Reply Br. 2.
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being dependent upon a rejected base claim and indicated as containing
allowable subject matter. See Appeal Br. 14, 16 (Claims App.); Final Act. 1,
8. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

STATEMENT OF THE CASE
The claims are directed to implantable electrical stimulation systems
that include a lead. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. An electrical stimulation system, comprising
a control module comprising
a housing,
an electronic subassembly disposed in the housing,
and
a connector comprising
a connector housing defining at least one
port, and
a plurality of connector contacts disposed in
the connector housing; and
a lead electrically coupleable to the control module, the
lead comprising:
a lead body with a distal end, a proximal end, and a
longitudinal length;
a plurality of electrodes disposed along the distal
end of the lead body;
a plurality of terminals disposed along the proximal
end of the lead body;
a central lumen defined by the lead body and
extending from the proximal end of the lead body;
a plurality of conductive wires extending along the
longitudinal length of the lead body and electrically
coupling the electrodes to the terminals; and
a rod permanently disposed within the central
lumen at the proximal end of the lead body to stiffen the
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Application 15/179,840

3
proximal end of the lead body to facilitate insertion of the
proximal end of the lead body into the connector of the
control module, wherein the rod is hollow and defines a
lumen extending along a length of the rod;
wherein at least one of the at least one port of the connector
housing is configured for receiving the proximal end of the lead
body.

REFERENCES
The prior art relied upon by the Examiner are:
Name Reference Date
Sundquist US 6,567,704 B2 May 20, 2003
Calzada US 2006/0200216 A1 Sept. 7, 2006

REJECTIONS
Claims 1–4, 7, 8, and 10 are rejected under 35 U.S.C. § 102(b) as
being anticipated by Sundquist. Final Act. 5.
Claims 9 and 20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Sundquist and Calzada. Final Act. 7.

OPINION
Independent claim 1 requires, among other things, “a rod permanently
disposed within the central lumen at the proximal end of the lead body to
stiffen the proximal end of the lead body to facilitate insertion of the
proximal end of the lead body into the connector of the control module”
(emphasis added). Independent claim 3 requires, among other things, “a cap
physically and permanently attached to the rod and disposed outside of, and
proximal to, the proximal end of the lead body” (emphasis added).
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In regard to claim 1, Appellant contends that the Examiner finds that
“the guide wire 400 of Sundquist corresponds to the recited rod” (Final Act.
6) but “Sundquist explicitly discloses the removal of the guide wire.” Appeal
Br. 6 (citing Sundquist 10:50–52, 65–67). As such, Appellant argues that
“the guide wire of Sundquist is not permanently disposed within the central
lumen at the proximal end of the lead body, as recited in claim 1.” Id. at 7.
In regard to claim 3, Appellant contends that the Examiner finds that
Sundquist’s “connector pin 54 corresponds to the recited cap” (Final Act. 6),
but Sundquist’s “guide wire 400 is inserted through the connector pin 54 and
later, removed from the connector pin.” Id. at 8–9. As such, Appellant
argues that Sundquist’s “connector pin 54 of Sundquist is not physically and
permanently attached to a rod, as recited in claim 3.” Id. at 9.
In the Answer, the Examiner does not dispute that Sundquist’s guide
wire 400 is inserted through and is later removed from the connector pin
400. Ans., passim. Instead, the Examiner responds by pointing out that the
Specification does not provide a special definition for the term “permanent”
and does not recite this term in connection to the rod. Ans. 7. The Examiner
further points out that claims 1 and 3 are open-ended by reciting
“comprising” and thus, “a rod or cap that is permanently disposed in a lumen
could be included in a system that also includes removable components.” Id.
at 7–8. The Examiner takes the position that “Appellant has not explained
how the structure of Sundquist renders it incapable of use in the claimed
manner” and “[t]o structurally differentiate over the art of record, the
invention would need to claim some sort of structure or process, such as
sealing, welding, etc. that would prevent the elements from being removed
or reversibly attached.” Id. at 8.
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First, we note that prior art that must be modified to meet the disputed
claim limitation does not anticipate the claim. See, e.g., In re Chudik, 851
F.3d 1365, 1374 (Fed. Cir. 2017) (“Prior art that ‘must be distorted from its
obvious design’ does not anticipate a new invention.” (quoting In re Wells,
53 F.2d 537, 539 (CCPA 1931))). In this regard, the Examiner’s points
concerning the “comprising” language and “a rod or cap that is permanently
disposed in a lumen could be included in a system that also includes
removable components” are not relevant to the anticipation inquiry. In other
words, in making a rejection based on anticipation rather than obviousness,
the Examiner must establish that Sundquist discloses “a rod permanently
disposed within the central lumen at the proximal end of the lead body” as
recited in claim 1 and “a cap physically and permanently attached to the rod”
as recited in claim 3.
We agree with the Examiner that the Specification does not recite the
term “permanent” in connection to the rod. However, the Examiner did not
reject the claims for not failing to comply with the written description
requirement. Even if the Examiner were to make such a rejection, we note
that Appellant has possession of at least the following subject matter because
the Specification discloses: (1) rod 1016 being welded to end cap 1014
(Spec. 17:14–15); (2) lead 1102 and end cap 1106 are joined by injection
molding (id. at 18:26–27); and (3) Figure 10D shows conductive wires being
embedded within end cap 1004, which contains rod 1016.
We also agree with the Examiner that the Specification does not
provide a special definition for the term “permanent.” We thus look to its
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plain and ordinary meaning, which is “not easily removed.”3 This definition
is consistent with the above-noted disclosures of the Specification. We thus
construe claim 1’s limitation at issue as requiring “a rod that is not easily
removed from the central lumen at the proximal end of the lead body” and
claim 3’s limitation at issue as requiring “a cap that is not easily removed
from the rod.”
To the extent that the Examiner is asserting that the limitations
“permanently disposed” and “physically and permanently attached” are
functional limitations, we agree with Appellant that these are structural
limitations rather than functional limitations. See Appeal Br. 10; Reply Br.
8; see, e.g., MPEP § 2113(I) (citing In re Garnero, 412 F.2d 276, 279
(CCPA 1979)). In this regard, the Examiner errs in asserting that “Appellant
has not explained how the structure of Sundquist renders it incapable of use
in the claimed manner” (Ans. 8).
Further, as Sundquist discloses that its guide wire 400 is inserted
through the connector pin 54 and later, is removed from the connector pin
54, Sundquist does not disclose that its guide wire 400 is “not easily
removed” from its connector pin 54 or its lead body 12 (see Sundquist Fig.
1A). Accordingly, the Examiner fails to establish that Sundquist discloses “a
rod permanently disposed within the central lumen at the proximal end of
the lead body” as recited in claim 1 and “a cap physically and permanently
attached to the rod” as recited in claim 3.

3 https://www.merriam-webster.com/dictionary/permanent (last accessed
April 20, 2020).
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As both of the Examiner’s rejections presently before us are
predicated on these incorrect findings, we reverse the Examiner’s rejections
on the record presently before us.

CONCLUSION
The Examiner’s rejections are reversed.

DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–4, 7, 8,
10
102(b) Sundquist 1–4, 7, 8,
10
9, 20 103(a) Sundquist, Calzada 9, 20
Overall
Outcome
1–4, 7–10,
20

REVERSED