Ex Parte Brunnett et al

Patent Trial and Appeal Board

Aug 21, 2017

13969096 (P.T.A.B. Aug. 21, 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.
13/969,096 08/16/2013 William C. Brunnett M190.288.102/P0031460.USV 3638
63496 7590 08/30/2017
DICKE, BILLIG & CZAJA, PLLC
ATTN: MDT SURGICAL TECHNOLOGIES MATTERS
FIFTH STREET TOWERS, SUITE 2250
100 SOUTH FIFTH STREET
MINNEAPOLIS, MN 55402
EXAMINER
CARDINAL, ERIN M
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/30/2017 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):
USPTO.PATENTS @dbclaw.com
DBCLAW-Docket@dbclaw.com
medtronic_ent_docketing @ cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM C. BRUNNETT, DAVID C. HACKER,
CARLA A. PAGOTTO, and DENISE GRANT
Appeal 2015-0060231
Application 13/969,096
Technology Center 3700
Before JENNIFER D. BAHR, LINDA E. HORNER, and LISA M. GUIJT,
Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant seeks our review under 35 U.S.C. § 134(a) of the
Examiner’s decision rejecting claims 1, 2, 4, 5, and 7-21. Final Office
Action (June 16, 2014) (hereinafter “Final Act.”). Claim 6 is canceled, and
claim 3 is allowed. Id. at 1. We have jurisdiction under 35 U.S.C. § 6(b).
1 Medtronic Xomed, Inc. (“Appellant”) is the applicant as provided in
37 C.F.R. § 1.46 and is identified as the real party in interest. Appeal Brief 3
(November 17, 2014) (hereinafter “Appeal Br.”).
Appeal 2015-006023
Application 13/969,096
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
Appellant’s claimed subject matter relates to “electrodes adapted to
stimulate nerves or record neurogenic responses.” Spec. 12. Claims 1, 8,
and 18 are the rejected independent claims. Claims 1 and 8 are
representative of the subject matter on appeal and are reproduced below.
1. A nerve electrode assembly comprising:
an electrical lead including a first portion and a
second portion;
an elongate body housing the first portion of the
electrical lead within an interior of the elongate body, and
with the second portion of the electrical lead extending
proximally from a proximal end of the elongate body, the
elongate body including:
a recess defined in a first side of the elongate body,
the recess including a mouth facing away from the
proximal end of the elongate body and a closed end
opposite to, and spaced proximally from, the mouth; and
a distal contact portion including an electrode
contact, the electrode contact in communication with the
electrical lead and exposed at a surface of the distal contact
portion, wherein the distal contact portion is located
distally relative to the mouth of the recess and forms a
generally arcuate shape; and
a resilient arm including a distal portion and a
generally arcuate proximal portion extending from the
distal contact portion of the elongate body, the arm having
a length sufficient to cause the distal portion to extend in
a first orientation proximally beyond the distal contact
portion of the elongate body and into the recess upon
removable, slidable insertion of the distal portion of the
arm into the recess, wherein a combination of the proximal
portion of the arm and the distal contact portion of the
elongate body define a lumen.
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Appeal 2015-006023
Application 13/969,096
8. A nerve electrode assembly comprising:
an electrical lead; and
an at least partially resilient, elongate non-
conductive member including:
an elongate first portion housing the
electrical lead to extend generally through a length
of the first portion, the first portion having a
longitudinal axis extending in a first orientation, and
the first portion including:
an engaging portion; and
a distal contact portion including an
electrode contact in communication with the
electrical lead, wherein the distal contact
portion is located distally relative to the
engaging portion; and
a second portion extending distally from the
distal contact portion in the first orientation and
having a length sufficient to at least partially
encircle a nerve,
wherein the second portion includes a distal
end that is selectively engageable relative to the
engaging portion, and upon such selective
engagement, the distal end of the second portion
extends in the first orientation proximally beyond
the distal contact portion of the first portion,
wherein a segment of the second portion and the
distal contact portion of the first portion at least
partially define a closable lumen.
Appeal Br. 26, 28 (Claims Appendix).
REJECTIONS
The Final Office Action includes the following rejections:
1. Claims 1, 2, 4, and 7-21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Maschino et al. (US 2003/0040785 Al,
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Appeal 2015-006023
Application 13/969,096
published February 27, 2003) (“Maschino”) and Mrva et al.
(US 2006/0030919 Al, published February 9, 2006) (“Mrva”).
2. Claim 5 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Maschino, Mrva, and Grill, Jr. et al. (US 5,505,201, issued
April 9, 1996) (“Grill”).
ANALYSIS
First Ground of Rejection: Claims 1, 2, 4, and 7-21 as unpatentable over
Maschino and Mrva
Claims 1, 2, 4, and 7
Claim 1 defines the “first portion” of the electrical lead as being a
portion of the lead housed “within an interior of the elongate body” and the
“second portion” as being a portion of the lead “extending proximally from a
proximal end of the elongate body.”
The Examiner finds that Maschino discloses a nerve cuff electrode
substantially as recited in claim 1 except that it “does not disclose the
particular recited lead wire orientation.” Ans. 2-3 (citing Maschino, Figs.
1A, 2B). The Examiner finds that “Mrva discloses several variations of a
similar nerve cuff electrode, and also teaches that the orientation of the lead
can be adjusted to any angle.” Id. at 3 (citing Mrva, Figs. 2A, 2B, para. 37).
The Examiner states that it would have been obvious “to rotate [Maschino’s]
lead wire 90 degrees, specifically from into the page to toward the right,
while still maintaining essentially tangential contact to the closed cuff
circle.” Id. The Examiner provides a figure in the Answer showing the
proposed modification, which is reproduced below. See id. at 4 (showing
proposed modification in Figure B).
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Application 13/969,096
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Figure B, shown above, is a schematic view of the nerve cuff
electrode disclosed in Maschino with the modification to the orientation of
the lead, based on the teaching of Mrva, as proposed by the Examiner. The
Examiner states that “[t]he phrase ‘extending proximally from’ is not the
same as ‘exiting from the proximal end’ or similar. As modified, the lead
extends proximally past the proximal end of the elongate body.” Ans. 11.
Appellants contend the proposed modified nerve cuff electrode
assembly as shown in Figures B-D of the Examiner’s Answer does not have
a second portion of the electrical lead “extending proximally from a
proximal end of the elongate body” as recited in claim 1. Reply Br. 3.
Appellants assert that the Examiner’s proposed modification provides “a
lead having a first portion within a portion of [the] body, a second portion
exiting the body at an angle away from the body, and a third portion
extending alongside the body before extending beyond an end of the body.”
Id. Appellants argue that the Examiner erred in finding that Maschino’s
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Appeal 2015-006023
Application 13/969,096
lead, as modified, extends proximally past the proximal end of the elongate
body instead of finding that the lead extends proximally from the proximal
end of the elongate body. Id. at 4.
Although the Examiner labels the elongate body of Figure B as having
a “distal portion” and a “proximal portion,” the Examiner does not identify
the “proximal end” of the elongate body. We understand the “proximal end”
to refer to the rightmost endpoint on the elongate lead depicted in Figure B.
The lead in the proposed modified device of Figure B does not extend
proximally from the proximal end of the elongate body, and, instead, exits
the elongate body along the portion of the elongate body labeled by the
Examiner as the “distal portion.” Because the Examiner has not identified
the proximal end or shown how the proposed modified device has a lead
extending proximally from the proximal end of the elongate body, the
Examiner has not adequately supported a determination of obviousness. For
these reasons, we do not sustain the rejection of claim 1, and its dependent
claims 2, 4, 5, and 7, under 35 U.S.C. § 103(a) as unpatentable over
Maschino and Mrva.
Claims 18-20
Independent claim 18, similar to claim 1, recites “an elongate body
housing the first portion of the electrical lead with the second portion of the
electrical lead extending at least proximally from a proximal end of the
elongate body.” Appeal Br. 29-30 (Claims Appendix). For the same
reasons discussed above, the Examiner has failed to adequately set forth how
the combination of the device of Maschino, as modified by the teaching of
Mrva, renders obvious the subject matter of independent claim 18. For these
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Application 13/969,096
reasons, we do not sustain the rejection of claim 18, and its dependent claims
19 and 20.
Claims 8-17 and 21
Appellants present arguments for independent claim 8 and do not
present additional arguments for dependent claims 9-16 and 21. Appeal Br.
21-22. Appellants present additional arguments for dependent claim 17. Id.
at 22. We select claim 8 as representative of the claims argued as a group,
and claims 9-16 and 21 stand or fall with claim 8. See 37 C.F.R.
§ 41.37(c)(l)(iv). We address claim 17 separately infra.
Claim 8
Independent claim 8 recites a nerve electrode assembly comprising an
electrical lead and an at least partially resilient, elongate non-conductive
member including “an elongate first portion housing the electrical lead to
extend generally through a length of the first portion.” Appeal Br. 28
(Claims Appendix).
The Examiner finds that Maschino discloses a nerve cuff electrode
substantially as recited in claim 8 except that it “fails to further disclose
orienting the elongate body and lead in the substantially same direction.”
Final Act. 2-3 (citing Maschino, Figs. 1A, 2B). The Examiner finds that
“Mrva teaches that changing the lead orientation by 90° (compare Figs. 2A
and 2B), or any other angle, are equivalent.” Id. at 3 (citing Mrva 137).
The Examiner states that it would have been obvious “to turn the lead of the
Maschino device at another right angle as a matter of routine design choice,
as predictable results would ensue.” Id. The Examiner finds that, as
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Application 13/969,096
modified, “[t]he electrodes and the portions of the leads inside the cuff body
are aligned with the exiting lead portion.” Id. The Examiner provides a
figure in the Answer showing the proposed modification, which is
reproduced below. See Ans. 7 (showing proposed modification in Figure C).
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tew* i
Figur© Ci Masebteo ctevfsa modified by Mrva teachings.
As noted by the Examiner, Figure C “is essentially identical to Figure
B above, but has been relabeled with the terminology of claim 8 for
convenience.” Ans. 6. The Examiner, in addressing claim 8, states that
“[t]he electrode assembly has an electrical lead, and a non-conductive
member with an elongate first portion and a second portion” and “[t]he first
portion houses the distal section of the lead.” Id.
Appellants contend that independent claim 8 is patentable for the
same reasons presented in support of the patentability of claims 1,2, and 7.
Appeal Br. 21. With regard to the argument that was the basis for reversal
of the rejection of claim 1, we note that claim 8 does not contain the same
claim language requiring a second section of the electrical lead to “extending
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Application 13/969,096
proximally from a proximal end of the elongate body.” As such, this
argument is not commensurate with the scope of claim 8.
Appellants contend, with respect to an argument raised for dependent
claim 7, that the phrase “a length of the elongate body,” when interpreted in
light of the Specification, “refers to the entire length or substantially the
entire length of the elongate body.” Reply Br. 7 (providing a dictionary
definition of “length” as being “the distance from one end of something to
the other end.”) (citing Merriam-Webster’s online dictionary). Appellants
argue that the combination of the device of Maschino as modified by the
teaching of Mrva “does not provide for a first portion of a lead extending
from one end of the elongate body to the other end of the elongate body” and
thus the Examiner’s proposed combination fails to meet the claimed
invention. Id. We address this argument because claim 8 contains similar
language concerning “a length” as argued for claim 7.
The Examiner responds that “as shown in Figures B, C, and D above,
the lead does extend in a single direction through a (short) length of the
elongate body.” Ans. 12. We find that the Examiner’s interpretation of “a
length of the first portion” to refer to any discrete length of the first portion,
and to not require the lead to extend through the entire length of the first
portion, is reasonable in light of the claim language when read in light of the
Specification. Appellants’ Specification describes, with respect to the
embodiment of nerve electrode 150, that “[i]n one embodiment, the [body]
152 and a lead 182 extend [in] a substantially single direction throughout an
entire length of the [body] 152.” Spec. 1115 (emphasis added). The
Specification does not use this same language in describing the embodiment
of nerve electrode 300. Spec. 1128 (describing that “[a]s further shown in
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Application 13/969,096
the partial sectional view of Figure 11, lead 360 extends through the
elongate body 302.” Claim 8 recites simply “a length” as opposed to an
entire length. We decline to read into the phrase “a length” an embodiment
described in the Specification in which the lead extends through the entire
length of the first portion.
Appellants further argue Maschino, as modified by the teaching of
Mrva, does not disclose the recited “distal contact portion” and that when in
the curved configuration, “the distal contact portion would not be considered
distal to the mouth of the recess.” Reply Br. 4-5. Claim 8 recites “wherein
the distal contact portion is located distally relative to the engaging portion.”
Claim 8 does not recite a recess or a mouth. As shown in Figure C above,
the device of Maschino, as modified by the teaching of Mrva, contains a
distal contact portion (represented by the box labeled “electrode”) that is
located distally (i.e., to the left of) hook 24. Thus, we find no error in the
Examiner’s finding that the modified device of Maschino includes a distal
contact portion as recited in claim 8.
Appellants further contend that the Examiner “appears to conflate the
‘electrode’ and the ‘distal contact portion’ into a single element.” Reply
Br. 5 (arguing these two elements are shown as distinct elements in
Appellants’ Figures 9-11). Claim 8 recites “a distal contact portion
including an electrode contact in communication with the electrical lead.”
We see nothing in claim 8 that requires the distal contact portion to be
separate from the electrode contact. The claim recites that the former
includes the latter. The two can be coextensive, as in Maschino.
Appellants further contend that the Examiner engaged in
“impermissible hindsight reconstruction” in the proposed modification of
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Maschino’s device with the teaching of Mrva and that a person having
ordinary skill in the art would not have been led to modify Maschino in the
manner claimed. Appeal Br. 14-20. For example, Appellants argue the
unmodified Maschino device minimizes strain and torque caused by the lead
that extends from the cuff, and that the proposed modification would be
“more likely to produce undesirable torque on the nerve.” Id. at 19.
We are not persuaded by Appellants’ arguments. We agree with the
Examiner’s finding that Mrva shows it was well-known in the art at the time
of Appellants’ invention to change the lead orientation. Final Act. 3; Ans. 3
(citing Mrva 137). Mrva accounts for strain resulting at the connection of
the lead to the cuff body by use of a strain relief boot 40. Mrva 137, Figs.
2A, 2B. Thus, a person having ordinary skill in the art would know how to
change the orientation of the lead and still compensate for strain and torque
caused by the lead that extends from the cuff. We agree with the Examiner
that the difference between the device of Maschino and the device of
claim 8, i.e., the first portion housing the electrical lead to extend generally
through a length of the first portion, is not a patentable distinction over the
prior art. Rather, in light of the teaching of Mrva of various orientations of
the lead relative to the cuff, we agree with the Examiner that the proposed
modification to Maschino would have been a predictable variation to the
device of Maschino and an obvious matter of design choice. See KSR Int 7
Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“If a person of ordinary skill
can implement a predictable variation, § 103 likely bars its patentability.”).
For these reasons, Appellants have not demonstrated error in the
Examiner’s rejection of claim 8. Accordingly, we sustain the rejection of
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Application 13/969,096
claim 8, and dependent claims 9-16 and 21, which fall with claim 8, under
35 U.S.C. § 103(a) as unpatentable over Maschino and Mrva.
Claim 17
Appellants present separate arguments for dependent claim 17. Claim
17 depends from claim 8 and recites “wherein the electrode contact is sized
and shaped such that the entire electrode contact is in alignment with a
longitudinal axis of the first portion and in alignment with a longitudinal
axis of the lead extending through the first portion.” Appeal Br. 29 (Claims
Appendix). Appellants argue that the lead as depicted in Figure C “exhibits
several axes and not a single longitudinal axis” and that as depicted in Figure
D “the illustrated lead extends tangential to (and/or diverges from) the
curved electrode.” Reply Br. 9-10. Appellants further argue that in the
configuration of Figure D, the entire electrode contact is not in alignment
with a longitudinal axis of the first portion, as claimed. Id. For the reasons
that follow, these arguments do not demonstrate error in the rejection of
claim 17.
As to alignment between the electrode contact and the lead, the claim
does not require that the lead has a single longitudinal axis, and the depiction
of Figure C shows that the longitudinal axis of the section of the lead that
extends through a length of the first portion is in alignment with the
electrode contact. Further, despite claim 8 reciting the second portion
extending in a “first orientation” (e.g., a flattened orientation) and the
capability of the second portion to partially encircle around a nerve, the
language of claim 17 does not require that the electrode contact remain in
alignment with a longitudinal axis of the lead when the distal end of the
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Application 13/969,096
second portion is engaged with the engaging portion, i.e., when the second
portion is wrapped around a nerve. Also, we note that the section of the lead
that extends through a length of the first portion is in alignment with the
electrode contact when the distal end of the second portion is in both the
claimed “first orientation” and when the second encircles a nerve.
As to alignment between the entire electrode contact and a
longitudinal axis of the first portion, the claim language does not require that
the alignment between these elements occur when the distal end of the
second portion is engaged with the engaging portion, i.e., when the second
portion is wrapped around a nerve. We find that this limitation is met when
the second portion is in the first flattened orientation and that this showing is
sufficient to render obvious the subject matter of claim 17. For these
reasons, we sustain the rejection of claim 17 under 35 U.S.C. § 103(a) as
unpatentable over Maschino and Mrva.
Second Ground of Rejection: Claim 5 as unpatentable over Maschino,
Mrva, and Grill
The Examiner relies on Grill to further modify the device of Maschino
to replace the strip electrodes of Maschino with dot electrodes. Final Act. 4.
Grill does not cure the above-noted deficiencies in the rejection of
independent claim 1 based on Maschino, as modified by the teaching of
Mrva. Accordingly, we do not sustain the rejection of claim 5 as
unpatentable over Maschino, Mrva, and Grill.
DECISION
The decision of the Examiner rejecting claims 1, 2, 4, 5, 7, and 18-20
is reversed.
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Application 13/969,096
The decision of the Examiner rejecting claims 8-17 and 21 is
affirmed.
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)(l)(iv).
AFFIRMED-IN-PART
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