Ex Parte 7582058 et al

Patent Trial and Appeal Board

Mar 15, 2013

95001247 (P.T.A.B. Mar. 15, 2013)

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.
95/001,247 10/27/2009 7582058 03190.005600.36 7728
26191 7590 03/18/2013
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
03/18/2013 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
____________

MEDTRONIC, INC.
Requester and Appellant

v.

NUVASIVE, INC.
Patent Owner and Respondent
____________

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058
1

Technology Center 3900
____________

Before JEFFREY B. ROBERTSON, DANIEL S. SONG, and
JOSIAH C. COCKS, Administrative Patent Judges.

COCKS, Administrative Patent Judge.

DECISION ON APPEAL

1
The patent involved in this inter partes reexamination proceeding (the
“‟058 Patent”) issued to Miles et al. on September 1, 2009.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

2
A. STATEMENT OF THE CASE
I. Summary
Third Party Requester Medtronic, Inc. (“Medtronic”) appeals under 35
U.S.C. §§ 134(c) and 315(b) the Examiner‟s decisions favorable to the
patentability of claims 1, 2, 4-8, 10-55, and 57-64
2
Patent Owner NuVasive,
Inc. (“NuVasive”)
3
urges that the Examiner‟s decisions must be affirmed.
4

We have jurisdiction under 35 U.S.C. §§ 134 and 315.
Oral argument was heard on September 21, 2012.
II. The Invention
The ‟058 Patent summarizes its disclosed invention as follows (‟058
Patent, 2:60-3:4):
The present invention [provides] a novel access system and
related methods which involve: (1) distracting the tissue
between the patient‟s skin and the surgical target site to create
an area of distraction (otherwise referred to herein as a

2
See Medtronic‟s “Brief on Appeal” filed September 6, 2011 (“App. Br.”)
and “Rebuttal Brief” filed February 27, 2012 (“Reb. Br.”). We observe that
although Medtronic states that the Examiner‟s indication of the patentability
of each of claims 56 and 65 is also appealed (App. Br., 1), review of the
record reveals that Medtronic has proposed no rejection for those claims in
this inter partes reexamination proceeding.

3
See Patent Assignment Abstract of Title, Reel 016585 Frame 0978 which
was entered into the record of this proceeding as “Title Report” on October
16, 2009.

4
See NuVasive‟s “Corrected Respondent Brief” filed December 8, 2011
(“Resp. Br.”).

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

3
„distraction corridor‟); (2) retracting the distraction corridor to
establish and maintain an operative corridor; and/or (3)
detecting the existence of (an optionally the distance and/or
direction to) neural structures before, during and after the
establishment of the operative corridor through (or near) any of
a variety of tissues having such neural structures which[,] if
contacted or impinged, may otherwise result in neural
impairment for the patient.

Claims 1, 4, 6, 10, and 30 are independent claims and are each
directed to a method of accessing a surgical target cite. Claim 1, which is
illustrative of the appealed subject matter, reads as follows (App. Br. Claims
App‟x., i):
1. A method of accessing a surgical target site, comprising
the steps of:

creating an initial distraction corridor through tissue
extending between an incision point and a surgical target site
via an initial distraction assembly including a K-wire and at
least one dilator capable of being slideably passed over said K-
wire;

distracting said tissue from said initial distraction
corridor to a secondary distraction corridor with an instrument
capable of being guided to said surgical target site along said at
least one dilator of said initial distraction assembly;

introducing a plurality of retractor blades for retracting
said tissue from said secondary distraction corridor to create an
operative corridor to said surgical target site; and

introducing a plurality of retractor blades for retracting
said tissue from said secondary distraction corridor to create an
operative corridor to said surgical target site; and

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

4
providing a control unit capable of electrically
stimulating at least one stimulation electrode provided on said
initial distraction assembly, sensing a response of a nerve
depolarized by said stimulation, determining at least one of
nerve proximity and nerve direction from said initial distraction
assembly to the nerve based pn [sic] the sensed response, and
communicating to a user at least one of visual indicia and audio
communications representing at least one of said determined
nerve proximity and said determined nerve direction.

III. The Prior Art
Medtronic relies on the following prior art in urging that NuVasive‟s
claims should be rejected:
U.S. Patents
Mathews (“Mathews ‟279”) 5,171,279 Dec. 15, 1992
Neubardt 5,474,558 Dec. 12, 1995
Michelson 5,772,661 Jun. 30, 1998
Finneran et al. (“Finneran”) 6,004,312 Dec. 21, 1999
Koros et al. (“Koros”) 6,139,493 Oct. 31, 2000
Foley et al. (“Foley ‟871”) 6,152,871 Nov. 28, 2000
Mathews et al. (“Mathews ‟826”) 6,206,826 Mar. 27, 2001
Mamo et al. (“Mamo”) 6,847,849 Jan. 25, 2005
Smith et al. (“Smith”) 7,261,688 Aug. 28, 2007

International Patent Applications

Marino et al. (“Marino”) WO 00/38574 Jul. 6, 2000
Kelleher et al. (“Kelleher”) WO 01/37728 May 31, 2001

Non-Patent Documents
Mathews et al., Laparoscopic Discectomy With Anterior Lumbar Interbody
Fusion, Spine, Vol. 20, No. 16, pp. 1797-1802 (1995) (“Mathews Article”)

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

5
Rose et al., Persistently Electrified Pedicle Stimulation Instruments in Spinal
Instrumentation: Technique and Protocol Development, Spine, Vol. 22(3),
pp. 334-343 (February 1, 1997) (“Rose”)

A document characterized as “Epoch 2000 Neurological Workstation
510(k), FDA No. K971819 (published December 30, 2997 [sic])” (“Epoch
2000”)
5

Foley et al., Microendoscopic Discetomy, Techniques in Neurosurgery, Vol.
3, No. 4, pp. 301-307 (December 1997) (“Foley Article”)

Medtronic Xomed Surgical Products, Inc., NIM-Response Nerve Integrity
Monitor Intraoperative EMG Monitor User‟s Guide, Revision B (March
2000) (“NIM Guide”)

Schick et al., Microendoscopic Lumbar Discectomy Versus Open Surgery:
an Intraoperative EMG Study, European Spine Journal, Vol. 11, pp. 20-26
(published online July 31, 2001) (“Schick”)

IV. Other Evidence
Medtronic‟s “Declaration of Hallett Mathews, M.D. Under 37 C.F.R.
§ 1.132” dated March 18, 2010 (“Mathews Decl.”)

Medtronic‟s “Declaration of David Hacker Under 37 C.F.R. § 1.132” dated
March 19, 2010 (“Hacker Decl.”)

NuVasive‟s “Declaration of Dr. Steven Garfin Under 37 C.F.R. § 1.132”
dated February 13, 2010 (“Garfin Decl.”)

V. The Involved Rejections
Medtronic characterizes this inter partes reexamination appeal
proceeding as directed to the following rejections proposed by Medtronic
but which have not been adopted or maintained by the Examiner:
6

5
App. Br., Evidence App‟x, xv.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

6
Proposed Prior Art Rejections
“[C]laims 1 and 4, and the claims that depend therefrom” as
unpatentable under 35 U.S.C. § 103(a) over:
7

(1) Foley Article and Kelleher;
(2) Foley ‟871 and Marino;
(3) Smith and Rose;
(4) Foley Article and Epoch 2000; and
(5) Mathews „279 and Neubardt.

“[C]laim 4, and the claims that depend therefrom” as unpatentable
under 35 U.S.C. § 103(a) over:
8

(6) Mathews Article and Kelleher;
(7) Mamo and Foley ‟871; and
(8) Mathews ‟826 and Kelleher.

Claim 6, and the claims that depend therefrom,
9
as unpatentable under
35 U.S.C. § 103(a) over:

(9) Foley Article, Kelleher, and Schick;
(10) Foley ‟871, Marino, and Michelson;
(11) Mathews Article, Kelleher, and Michelson;
(12) Smith, Rose, and Schick;
(13) Foley Article, Epoch 2000, and Schick;
(14) Mathews ‟279, Neubardt, and Michelson; and
(15) Mathews ‟826 and Kelleher.

6
App. Br., 2-3.
7
Id. at 2-3.
8
Id. at 3.
9
Although page 3 of Medtronic‟s Appeal Brief does not expressly indicate
that the rejection of claims that depend from claim 6 are appealed, it is
apparent from the record, including the Notice of Appeal filed July 6, 2011,
that rejections of those dependent claims are also before us in this appeal.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

7
“[C]laim 10, and the claims that depend therefrom” as unpatentable
under 35 U.S.C. § 103(a) over:
10

(16) Mathews ‟826, Michelson, Kelleher, and Finneran;
(17) Koros, Michelson, Foley ‟871, Kelleher, and NIM Guide;
and
(18) Smith, Michelson, Koros, Marino, and NIM Guide.

“[C]laim 30, and the claims that depend therefrom” as unpatentable
under 35 U.S.C. § 103(a) over:
11

(19) Mathews ‟826, Michelson, and Kelleher;
(20) Koros, Foley ‟871, Michelson, and Kelleher; and
(21) Smith, Michelson, Marino, and NIM Guide.

Other Proposed Rejections

(22) A proposed rejection of claims 10-50 under 35 U.S.C.
§ 314 for improper broadening.

(23) Proposed rejections of claims 10-50 and 57 under 35
U.S.C §112, first paragraph.
B. ISSUES
1. Was the Examiner correct in not rejecting claims 10-50 as being
impermissibly enlarged in scope under 35 U.S.C. § 314?
2. Was the Examiner correct in not rejecting any of claims 10-50
and 57 as lacking adequate written description in the specification of the
‟058 patent for any recited claim features?
3. Does the record show that a person of ordinary skill in the art
would have regarded a tubular type working cannula as a retractor blade or a
plurality of retractor blades?

10
Id.
11
Id.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

8
4. Does the record show that a person of ordinary skill in the art
would have understood from the prior art that a surgical target site in a
patient‟s spine may be reached via a “lateral trans-psoas” approach or path?
5. Has Medtronic adequately shown that the Examiner was not
correct in concluding that none of NuVasive‟s claims would have been
obvious in light of the teachings of prior art?
C. ANALYSIS
This inter partes reexamination appeal proceeding involves proposed
grounds of rejection based on the prior art as well as rejections proposed
under 35 U.S.C. §§ 314 and 112, first paragraph.
I. The Rejection Under 35 U.S.C. § 314
Title 35 U.S.C. § 314(a) provides that in connection with an inter
partes reexamination proceeding:
[T]he patent owner shall be permitted to propose any
amendment to the patent and a new claim or claims, except that
no proposed amended or new claim enlarging the scope of the
claims of the patent shall be permitted.

Medtronic submits that NuVasive‟s claims 10-50, which were added
via amendment during the course of this reexamination proceeding,
improperly enlarge the scope of the claims of the „058 Patent and should
thus be rejected as violating 35 U.S.C. § 314(a). Medtronic argues that
independent claims 10 and 30
12
are each based on original claim 4 but are

12
Claims 11-29 ultimately depend on claim 10 and claims 31-50 ultimately
depend on claim 30. The dependent claims include all the limitations of the
independent claim on which they ultimately depend.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

9
broader in scope than claim 4. (App. Br., 44-45.) In particular, Medtronic
makes the following contentions with respect to each of claims 10 and 30
(id.) (emphasis in original):
Independent claim 30 is based on original claim 4, which
recites “a secondary instrument advanceable to said surgical
target site along said at least one dilator of said initial
assembly” (emphasis added). New claim 30 broadens the scope
of this feature by reciting “a secondary instrument advanceable
to said surgical target site along the lateral, trans-psoas path
after insertion of said at least one dilator of said initial
assembly” (emphasis added). This new recitation does not
require that the secondary instrument be advanced along a path
after insertion of the dilator. Thus, with the new recitation, the
dilator could be removed prior to advancing the secondary
instrument as long as the secondary instrument later followed a
similar path, a scenario not covered by original claim 4. Thus
claim 30 broadens the scope of the invention claimed in the
patent.
Independent claim 10 is also based on original claim 4.
Original claim 4 recites a step of “sensing a response of a nerve
depolarized by said stimulation” (emphasis added). New claim
10 broadens this feature by reciting “sensing an
electromyographic (EMG) response of a muscle coupled to a
nerve depolarized by said stimulation” (emphasis added).
Because claim 10 changes the sensing step to focus on muscles
instead of nerves, the Patent Owner has impermissibly changed
the scope of the claims.

NuVasive challenges the above-noted contentions and urges that
claims 10 and 30 are instead narrower in scope than claim 4. (Resp. Br., 24-
25.) Thus, NuVasive contends that the Examiner was correct in “refusing to
adopt” the proposed rejections. (Id. at 24.)
In a reexamination proceeding, “[a]n amended claim has been
enlarged if it includes within its scope any subject matter that would not
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

10
have infringed the original patent.” Quantum Corp. v. Rodime PLC, 65 F.3d
1577, 1584 (Fed. Cir. 1995) (citing In re Freeman, 30 F.3d 1459, 1464 (Fed.
Cir. 1994)). As noted above in connection claim 30, Medtronic offers a
plausible scenario in which the process laid out in claim 30 may be
performed in a manner not required by claim 4. That is, the process of claim
30 would seemingly not have infringed the process of claim 4, because in
claim 30, the dilator could be removed prior to advancing the secondary
instrument and the secondary instrument could later follow a similar path.
As a result, claim 30 is broader than claim 4. Although NuVasive generally
urges that claim 30 is narrower in all respects as compared to claim 4,
NuVasive does not address the scenario raised by Medtronic or explain why
it is incorrect.
With respect to claim 10, we also agree with Medtronic that sensing
the response of a nerve, as in claim 4, is not the same act as sensing the
response of a muscle, as in claim 10. The record suitably demonstrates that
a nerve and a muscle are not the same. NuVasive offers only the following
statement in connection with its position (Resp. Br., 25):
There are many options of how to sense a response of a nerve
(thus providing a boarder scope in claim 4), and sensing the
EMW response of the muscle coupled to the nerve is merely
one of those options (thus providing the narrower scope in
claim 10).

That statement is, however, merely argument of counsel. Such
argument cannot take the place of evidence lacking in the record. Estee
Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997). Notably,
NuVasive does not accompany its statement with citation to any portion of
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

11
the record which provides underlying support for its position that sensing the
response of a muscle is simply a “narrower” form of how to “sense a
response of a nerve.” (Id.)
In light of the record before us, and after due consideration of each
party‟s position, we agree that claims 10-50 are enlarged in scope as
compared with the original claims of the „058 Patent. We, therefore, are of
the opinion that the Examiner erred in not adopting the proposed rejections
of those claims as violating 35 U.S.C. § 314. That the rejections were not
applied is effectively a decision by the Examiner favorable to the
patentability of those claims. We reverse that decision.
Accordingly, we conclude that the Examiner should have entered a
rejection of claims 10-50 under 35 U.S.C. § 314(a). By operation of 37
C.F.R. § 41.77 (b), our above-noted reversal of the Examiner’s decision
is designated a new ground of rejection.
II. The Rejection Under 35 U.S.C. § 112
Medtronic proposed rejections to claims 10-50 and 57 under 35
U.S.C. § 112, first paragraph. Medtronic argues the claims in five separate
groupings: (a) claims 10-29 and 57; (b) claims 30-50; (c) claims 10-29; (d)
claims 28, 29, and 44; and (e) claims 17 and 37.
a. Claims 10-29 and 57
Medtronic submits that claims 10-29 and 57 lack adequate written
description support in the specification of the „058 Patent. To satisfy the
written description requirement of 35 U.S.C. § 112, an applicant, or as here a
patentee, must convey with reasonable clarity to those skilled in the art that
he or she was in possession of the claimed invention. See Vas-Cath Inc. v.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

12
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). One shows
“possession” of the invention by describing the invention using such
descriptive means as words, structures, and figures that fully set forth the
claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565,
1572 (Fed. Cir. 1997). It is, however, not necessary that the exact terms that
appear in the claim must also appear in the description. Id.
The dispute here centers on a feature that, but for minor differences in
terminology, is common to each of claims 10 and 57. The pertinent feature
as it appears in claim 10 is reproduced below (App. Br. Claims App‟x, iii)
(emphasis added):
creating an operative corridor through tissue extending
between an incision point and a surgical spinal target site in a
lumbar spine via a distraction assembly that creates a tissue
distraction corridor along a lateral, trans-psoas path to the
spinal target site in the lumbar spine and a retraction assembly
comprising a pair of directly opposed retractor blades that are
advanced along the lateral, trans-psoas path to the spinal target
site in the lumbar spine only after the distraction assembly
creates said tissue distraction corridor[.]

According to Medtronic, although the specification of the ‟058 Patent
describes an embodiment of its disclosed invention in which retractor blades
are advanced to a target site “after” the creation of a distraction corridor the
temporal restriction arising from the term “only” allegedly runs afoul of the
written description requirement. (App. Br., 45; Reb. Br., 19.) However, as
is pointed out by NuVasive (Resp. Br., 25), the ‟058 Patent includes a
lexicographic definition for the term “retraction” and “retracting” which
establishes that an operative corridor is formed “by increasing the cross-
sectional area of” a distraction corridor that has already been formed. (‟058
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

13
Patent, 3:9-12.) It is the “operative corridor” through which surgical
instruments, such as retractor blades, are ultimately advanced. (Id. at 3:13-
15.) Thus, although the term “only” does not appear in that context, the ‟058
Patent clearly provides that the formation of the operative corridor
necessarily occurs only after the formation of the distraction corridor.
Therefore, we find that the ‟058 Patent suitably conveys that the
inventors of the „058 Patent were in possession of the above-discussed
feature. We therefore affirm the Examiner‟s decision not to adopt the
proposed rejection.
b. Claims 30-50
Independent claim 30 introduces “an elongate inner element” as a part
of a distraction assembly and requires the step of electrically stimulating “at
least one stimulation electrode during insertion of said elongate element
through psoas muscle tissue….” (App. Br. Claim App‟x, vii.) In reciting
“at least one stimulation electrode” associated with an elongate inner
element, the claim contemplates multiple such electrodes. According to
Medtronic, however, the ‟058 Patent lacks suitable written description
support for more than one electrode in connection with each elongate inner
element. (App. Br., 46; Reb. Br., 20.) NuVasive contends otherwise.
(Resp. Br., 26.) We agree with NuVasive.
The ‟058 Patent explains that (‟058 Patent, 12:56-60):
The initial distraction assembly 12 (FIGS. 2-4) may be
provided with one or more electrodes for use in providing the
neural monitoring capabilities of the present invention. By way
of example only, the K-wire 44 may be equipped with a distal
electrode 200.

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

14
The „058 Patent also describes that “one or more stimulation
electrodes are provided on the various components of the distraction
assemblies and/or retraction assemblies[.]” (Id. at 4:7-9.) Furthermore,
throughout the specification of the ‟058 Patent, reference is made to
“electrode(s)” in the context of one or more of such components. (E.g., id.
at 10:51-52.)
Although it is clear that the ‟058 Patent contemplated benefits to more
than one electrode associated generally with its various assemblies, such as
its distraction assemblies, Medtronic is of the view that the patent conveys
only that the inventors possessed that a single electrode is associated with
any given component that makes up those assemblies. The apparent basis
for that view is that as noted above in connection with column 12, the ‟058
Patent sets forth an “example” in which a particular component, i.e., “K-wire
44” is expressed as being equipped with “a” distal electrode. Evidently,
Medtronic extrapolates from the use of “a” in that context to justify its
position that only a single given electrode was envisioned as being
implemented on any given component.
In light of our review of the record, we view Medtronic‟s tenuous
reliance on a single “example,” which discusses only one single electrode, as
an overly limited assessment of what the ‟058 Patent discloses with respect
to electrode configurations. Given the multiple disclosures in the ‟058
Patent involving more than one electrode associated with various surgical
assemblies, we are unpersuaded that the ‟058 Patent demonstrates that the
involved inventors were not in possession of the “at least one stimulation
electrode” feature of claim 30.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

15
Accordingly, because we find that the “at least one stimulation
electrode” feature of claim 30 has adequate written description support in the
„058 Patent, we affirm the Examiner‟s decision not to adopt the proposed
rejection.
c. Claims 10-29
In challenging the adequacy of the written description of claims 10-
29, Medtronic takes the position that the ‟058 Patent does not support the
requirement of those claims that retractor blades are “directly opposed.”
(App. Br., 46; Reb. Br., 20.) NuVasive challenges Medtronic‟s position,
urging that Figures 1, 8, and 32 illustrate retractor blades 90 and 92 as
directly opposed from one another. (Resp. Br., 26.) We agree with
NuVasive.
Medtronic does not address NuVasive‟s reliance on the above-noted
figures as depicting a directly opposed configuration of the retractor blades.
In our view, the figures clearly illustrate retractor blades that are directly
opposed with respect to, or are across from, one another. The illustrated
content of a patent‟s figures can provide appropriate descriptive means for
aspects of a claimed invention. Lockwood, 107 F.3d at 1572.
We discern no error in the Examiner‟s decision not to adopt the
rejection proposed with respect to claims 10-29. We, therefore, affirm the
decision.
d. Claims 28, 29, and 44
Claims 28, 29, and 44 each require that an initial assembly and
secondary instrument of a distraction assembly be removed “while” the
retraction assembly maintains an operative corridor. (App. Br. Claims
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

16
App‟x, vii, x.) Medtronic submits that the pertinent feature of the claims is
not supported in the ‟058 Patent. Pointing to column 15, line 12 through
column 16, line 16, Medtronic contends that the „058 Patent sets forth only
that the initial assembly and secondary instrument are removed “before” the
retractor assembly is operated to maintain an operative corridor, not “while.”
(App. Br. 46, Reb. Br., 20.) Relying on the very same content at columns 15
and 16, NuVasive generally contends otherwise without further elaboration.
(Resp. Br., 26.)
In our review of the noted portions at columns 15 and 16 of the „058
Patent, we conclude that Medtronic has the better assessment of what is
disclosed therein. The initial assembly of the distraction assembly
constitutes, by our understanding, the inner dilator 46, the outer dilator 48,
and the K-wire 44. (See „058 Patent, 6:49-54.) Column 15, line 12 through
column 16, line 16 express that the initial assembly, including the dilators 46
and 48, are removed prior to the introduction of any retractor blades for
maintaining an operative corridor. We do not discern how removal of the
initial assembly before the introduction of the retractor assembly, provides
the requisite support for the claimed recitation that at least the initial
assembly is removed “while” the retractor assembly maintains an operative
corridor.
Accordingly, we conclude that the above-noted written description
rejection under 35 U.S.C. § 112, first paragraph, as proposed by Medtronic,
should have been adopted by the Examiner. Accordingly, we reverse the
Examiner‟s decision not to adopt that rejection. Our reversal constitutes a
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

17
new ground of rejection pursuant to 37 C.F.R. § 41.77(b) as to claims
28, 29, and 44 and is hereby designated as such.
e. Claims 17 and 37
Each of claims 17 and 37 requires a step directed to “releasably”
connecting a cable of a nerve monitoring system to a component of the
distraction assembly. (App. Br. Claims App‟x, v, ix.) Medtronic contends
that such a feature has no adequate underlying written description support.
NuVasive provides the following statement in challenge to Medtronic‟s
contention: “The „058 patent also provides a clear teaching for the
embodiments dependent claims 17 and 37. (‟058 Patent at 10:41-45; FIG.
12.)” (Resp. Br., 26.) Accordingly, we look to column 10, lines 41-45 and
Figure 12 as guided by NuVasive.
Column 10, lines 39-45 is reproduced below and constitutes a single
sentence:
The connectors 156a, 156b, 156c are suitable to establish
electrical communication between the hand-held stimulation
controller 152 and (by way of example only) the stimulation
electrodes on the K-wire 44, the dilators 46, 46, the speculum
blades, 20, 22, the retractor blades 90, 92, and/or the guard
members 114 (collectively “surgical access instruments”).

The above-quoted portion conveys that the connectors operate to
“establish electrical communication” but provides no elucidation as to a
releasable nature of the connection. Neither do we discern what, if anything,
is conveyed in Figure 12 concerning “releasably” connecting cables.
Although a step of releasing a cables connection may well be obvious, a
disclosure that merely renders the later-claimed invention obvious is
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

18
insufficient to meet the written description requirement. See Tronzo v.
Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998).
Accordingly, because NuVasive has not suitably demonstrated
adequate written description support in the ‟058 Patent for features added by
claims 17 and 37, and because we also cannot find suitable underlying
support, we reverse the Examiner‟s decision not to enter the pertinent
rejections concerning the limitation of the claims drawn to “releasably”
connecting a cable of a nerve monitoring system to a component of the
distraction assembly.
We enter a new ground of rejection to claims 17 and 37 as
violating the written description requirement of 35 U.S.C. § 112, first
paragraph. Because claim 18 is dependent on claim 17 and thus also
includes the inadequately supported feature, we also enter a ground of
rejection of claim 18 on the same basis.
III. The Prior Art Rejections
By our count, Medtronic has proposed twenty-one grounds of
rejection based on prior art which were not adopted by the Examiner and
which are involved in the present appeal. All of the rejections proposed are
based on obviousness. In urging that the Examiner erred in declining to
adopt any of the involved prior art rejections, Medtronic focuses its
arguments on the content of the independent claims 1, 4, 6, 10, and 30 and in
the following groupings: (a) claims 1 and 4; (b) claim 4; (c) claim 6; (d)
claim 10; and (e) claim 30.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

19
a. Claims 1 and 4
In dispute in connection with claims 1 and 4 are five grounds of
rejection numbered (1)-(5) in this opinion.
i. Rejection (1) over the Foley Article and Kelleher
With respect to this rejection, there appears to be several bases of
dispute between the parties. In particular, one basis centers on the
requirements in each of claims 1 and 4 pertaining to the use of a “retractor
blade” or “blades.” Although we observe that claim 4 refers only to a
“retraction assembly,” NuVasive argues that the presence of at least one
retractor blade is an intrinsic requirement of claim 4 when the term
“retraction assembly” is considered in light of the ‟058 Patent. (Resp. Br.,
11.) Another basis emerges in connection with the use of the retraction
components of the claims which create an “operative corridor” to a surgical
target site in the manner required by claims 1 and 4. Yet another basis
hinges on whether there is adequate motivation to combine the teachings of
the Foley Article and Kelleher. We proceed to evaluate the points of
dispute.
“Retractor Blades” or
“At Least One Retractor Blade”

At the outset, we agree with NuVasive that its claim 4 requires at least
one retractor blade. A patentee may act as his own lexicographer by clearly
setting forth an explicit definition in the patent for a claim term. Johnson
Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990, 50 USPQ2d
1607, 1610 (Fed.Cir.1999). That is the case here. The ‟058 Patent states the
following (‟058 Patent, 3:9-15) (emphasis added):
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

20
„[R]etraction‟ or „retracting‟ is defined as the act of creating an
operative corridor by increasing the cross-sectional area of the
distraction corridor (and/or modifying its shape) with at least
one retractor blade and thereafter maintaining that increased
cross-sectional area and/or modified shape such that surgical
instruments can be passed through operative corridor to the
surgical target site.

Thus, in connection with the ‟058 Patent, the term “retraction” in
connection with a “retraction assembly” as in claim 4 requires the presence
of at least one retractor blade. With that in mind, we turn to the content of
the Foley Article with respect to the “plurality of retractor blades” as
required by claim 1 or “at least one retractor blade” as required by claim 4.
The Foley Article describes “a new percutaneous procedure for
lumbar disc disease, microendoscopic discectomy (MED)” (Foley Article,
Abstract) which incorporates insertion of a “tubular retractor” (id. at 303).
At issue is whether a “tubular retractor” is understood as constituting one or
more retractor blades. Although that is a position taken by Medtronic (e.g.,
Reb. Br., 2), the record reveals a different understanding to those of ordinary
skill in the art.
In particular, NuVasive‟s expert witness, Dr. Garfin, testifies that “a
working cannula or tubular retractor is different from a retractor blade of a
retraction assembly.” (Garfin Decl., ¶ 5.) The ‟058 Patent itself also
expresses disparagement of “the generally cylindrical nature of the so-called
„working cannula[]” as being limited or restrictive in allowing a surgeon to
access the surgical target site. (‟058 Patent, 1:67-2:5.) That the patent then
proceeds to describe the invention as operating with retractor blades
undermines any implication that a working cannula of a general cylindrical
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

21
nature, i.e., a tubular retractor, is itself a retractor blade or blades. In light of
the record, we reject Medtronic‟s argument to the contrary.
We observe that Medtronic also takes a different approach in
accounting for the retractor blade requirement of claims 1 and 4 in the
context of the Foley Article and Kelleher combination. That approach
amounts simply to an allegation that the use of claimed retractor blades is
“obvious.” (App. Br., 19; Reb. Br., 2.) The only basis urged for that
allegation is paragraph 7 of Mathews‟ declaration testimony. (Id.) To that
end, Dr. Mathews testifies that “Tubular retractors and retractors formed of
separate blades are obvious variations of each other.” (Mathews Decl., ¶ 7.)
Obviousness is a question of law based on underlying findings of fact. In re
Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009).
Here, the factual basis underpinning Mathews‟ testimony is unclear.
It is not apparent that either the Foley Article or Kelleher provides an
adequate underlying factual showing of the claimed retractor blades.
Indeed, Medtronic relies on Kelleher for disclosure of a nerve response
monitoring or sensing components and not for any teachings with respect to
retractor blades. Evidently, Mathews‟ testimony is itself offered as the
factual basis to support Mathews‟ subsequent conclusion of obviousness.
Yet, the involved proposed ground of rejection which was not adopted by
the Examiner was not premised on Mathews‟ testimony as itself forming
part of the ground. Moreover, the opinion of expert witness as to the legal
conclusion of obviousness is of limited value, particularly, where, as here, it
rests on an inadequately established factual assertion.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

22
Accordingly, on the record before us, we are unpersuaded that the
recitation of “retractor blades” in claim 1 or the “at least one retractor blade”
as required by claim 4 are accounted for by the teachings of the Foley
Article or Kelleher.
“Operative corridor”
Each of claims 1 and 4 also requires the creation of an “operative
corridor” to a targeted surgical site. In claim 1, the operative corridor is
created by a plurality of retractor blades which are for “retracting” tissue. In
claim 4, the corridor is formed by operation of a “retraction” assembly. As
discussed above, the terms “retracting” and “retraction” have been given
special meaning in the context of the ‟058 Patent and require the formation
of an operative corridor via at least one retractor blade by increasing the
cross-sectional area, or modifying the shape, of a distraction corridor. (See
‟058 Patent, 3:9-15.)
Medtronic argues that NuVasive‟s definition of “retracting” and
“retraction” in the claims is “improper” because it imports an “overly
restrictive definition” from the specification. (App. Br., 19-20.)
Medtronic‟s position appears not to consider that, in this case, the ‟058
Patent has defined “retracting” and “retraction” so as to impart a special
meaning to these claim terms. Furthermore, although Medtronic proceeds to
assert that the Foley Article still “meets” the noted definition of retracting or
retraction, the apparent premise for that assertion is that “nothing in that
definition precludes a tubular retractor from being considered a retractor
blade.” (Id. at 20.) As discussed above, however, that is a position not
supported by record and with which we do not agree.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

23
After due consideration of the record, and for the foregoing reasons,
we conclude that the rejection predicted on the combination of the Foley
Article and Kelleher is inadequate to account for all the limitations recited in
claims 1 and 4. Accordingly, we are not persuaded that the Examiner erred
in declining to adopt the proposed rejection.
We affirm the Examiner‟s decision in that regard. We also affirm the
Examiner‟s decision not to so adopt a rejection of the claims 2, 51, and 52
which depend from claim 1 and claims 5, 7, 8, and 53-56 which ultimately
depend from claim 4 based on the Foley Article and Kelleher.
ii. Rejections (2) and (4)
Medtronic proposed rejections of claims 1 and 4 based on Foley „871
and Marino (rejection (2) in this opinion), and Foley Article and Epoch 2000
(rejection (4)). Foley „871 is similar in its disclosure to the Foley Article
and is directed to a device for performing percutaneous surgery that is
characterized as a “cannula” which is illustrated as having a tubular
configuration. (Foley „871, Abstract.) Medtronic characterizes the cannula
as constituting a “tubular retractor” (App. Br., 21.) Each of Marino and
Epoch 2000 are relied upon to account for nerve monitoring features of the
claims and not for teachings of retractor blades. (Id.)
Rejections (2) and (4) demonstrate deficiencies which are essentially
the same those discussed above with respect to rejection involving the Foley
Article and Kelleher. Correspondingly, we are persuaded that the Examiner
was correct in not adopting proposed rejection (2) based on Foley „871 and
Marino, or rejection (4) based on the Foley Article and Epoch 2000.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

24
We affirm the Examiner‟s decision in that regard with respect to
claims 1 and 4 and those claimed which depend therefrom.
iii. Rejection (3) Smith and Rose
Smith is directed to a method and device for performing percutaneous
surgery in a patient. (Smith, Abstract.) As a part of its disclosed invention,
Smith describes the use of a “retractor” 20 including a first portion 22 and a
second portion 42. (Id. at 5:18-31.) Medtronic contends that the portions 22
and 42 constitute “retractor blades” of retractor 20. (App. Br., 25.)
NuVasive does not challenge that contention. Medtronic urges that all the
features required by claims 1 and 4 are disclosed in Smith with the exception
of those features characterized by Medtronic as being directed to “nerve
monitoring.” (Id.)
Rose is a journal article that sets forth its “[o]bjectives” as (Rose,
334):
To describe in sufficient detail the technique of persistently
electrified pedicle stimulation instruments, so that this
technique will be available generally to all clinical
neurophysiologists and spine surgeons; and to demonstrate the
use, typical results, interpretation, and protocol of the
technique.

As a part of its disclosed technique, Rose describes components
operable to provide “appropriate neurophysiologic monitoring[.]” (Id. at
334, second column.) Medtronic argues that Rose‟s disclosure accounts for
the “nerve monitoring functions” required by each of claims 1 and 4. (App.
Br., 25.)
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

25
NuVasive offers two reasons why the proposed combination of Smith
and Rose is inadequate to account for claims 1 and 4. In particular,
NuVasive summarizes its reasons as follows (Resp. Br., 7; see also 13-14)
First, neither Smith nor Rose, alone or combined, discloses or
suggests a method in which nerve monitoring is utilized in
initial distraction, and it is pure hindsight to say this would have
been obvious. Second, the Rose Article, which is relied upon
as disclosing the claimed “control unit,” does not disclose or
suggest a control unit capable of performing the claimed
functions of “sensing,” “determining” and “communicating.”

We are not persuaded by NuVasive‟s arguments. With respect to the
first argument, although NuVasive is of the view that it is “pure hindsight”
to conclude that a skilled artisan would have applied Rose‟s teachings of
nerve monitoring to Smith, NuVasive‟s position in this regard is premised
on its belief that the spinal surgical procedure disclosed in Rose is something
different than the spinal surgery disclosed in Smith. Even assuming that is
true, however, Rose does not limit its disclosure of nerve monitoring to any
one particular surgical procedure to the exclusion of any and all others.
Thus, one of ordinary skill in the art would have had a reason to apply
Rose‟s teachings of nerve monitoring to Smith.
We are cognizant of NuVasive‟s reliance on the testimony of Dr.
Garfin at paragraph 6 of his declaration as supporting its view of the non-
obviousness of its claims involving the teachings of Smith and Rose. (See
Resp. Br., 7.) That paragraph, however, is limited to discussion of the Foley
article and the Foley ‟871 patent and provides little, if any, insight as to the
Smith and Rose combination.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

26
In any event, even were we to attempt to draw significance from the
testimony in connection with the Smith and Rose combination, NuVasive‟s
non-obviousness position in that regard is unavailing. Dr. Garfin testifies
that a certain spinal surgical technique, termed a “posterior approach” occurs
at a location “in which exiting nerve roots are not present.” (Garfin Decl., ¶
6.) On that basis, Dr. Garfin states that employing nerve monitoring would
thus be “considered unnecessary and an inefficient use of a surgeon‟s
time[.]” (Id.)
However, we observe that Smith does not limit its teachings to any
one particular type of spinal surgery and instead describes a wide variety of
types of surgeries to which Smith‟s invention may be applied. To that end
Smith discloses (Smith, 2:37-42; 51-54):
The present invention provides instruments and methods for
performing percutaneous surgery, including spinal surgeries
that include one or more techniques such as laminotomy,
laminectomy, foramenotomy, facetectomy, discectomy,
interbody fusion, spinal nucleus or disc replacement, and
implant insertion, for example.
---
The retractor can be used with any surgical approach to the
spine, including anterior, posterior, posterior mid-line, lateral,
postero-lateral, and/or anterolateral approaches, and in other
regions besides the spine.

NuVasive does not address the above-noted teachings of Smith with
respect to the multiple surgical procedures other than the “posterior”
approach. Neither does NuVasive explain why the various other disclosed
procedures would not have benefited from nerve monitoring, including
nerve monitoring during initial distraction when proceeding with other of the
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

27
surgical approaches noted above, such as a “lateral” approach. In our view,
it would have been obvious to a skilled artisan to combine Rose‟s teachings
involving nerve monitoring with the invention of Smith and, as a result,
perform nerve monitoring during initial distraction.
We are also not persuaded by NuVasive‟s second argument. That is,
we share Medtronic‟s view (App. Br., 26-27) that Rose discloses an
electronic component which operates to perform each of the “stimulating,”
“sensing,” “determining,” and “communicating” functions of the control unit
of claims 1 and 4. NuVasive‟s challenge is essentially that, while Rose
discloses determining nerve proximity, the determination is not performed
by a “control unit.” (Resp. Br., 8.) However, Rose describes a monitoring
component which records and displays electromyographic (EMG) activity
reflective of nerve responses to stimulation, including the determination of
“[n]erve thresholds” and “ascertain[ing] nerve location.” (Rose, 336-337.)
NuVasive does not adequately explain why that description in Rose is not
understood reasonably as disclosure of a control unit which determines
nerve proximity as required by claims 1 and 4.
After due consideration of the record, we conclude that the Examiner
erred in declining to adopt or maintain the rejection of claims 1 and 4 over
the combined teachings of Smith and Rose as proposed by Medtronic.
Those rejections are set forth in a claim chart titled “Claim Chart D” which
was filed with Medtronic‟s request for inter partes reexamination on
October 14, 2009. Claims 2, 51, and 52 depend from claim 1 and claims 5,
7, 8, and 53-55 depend from claim 4. Medtronic‟s proposed rejections of
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

28
claims 1, 2, 4, 5, 7, 8, and 51-55
13
are laid out in “Claim Chart D” and the
“Claim Chart D – Continued” filed March 19, 2010.
Pursuant to 37 C.F.R. § 41.77(b), our conclusion that the
Examiner erred in declining to adopt the above-noted rejections, and
our entry of the rejections herein as proposed by Medtronic, constitutes
a new ground of rejection of claims 1, 2, 4, 5, 7, 8, and 51-55.
iv. Rejection (5) Mathews ’279 and Neubardt
In conjunction with the proposed rejection involving Mathews ‟279
and Neubardt, NuVasive offers three reasons why the Examiner was correct
in declining to adopt the rejection. In particular, according to NuVasive; (1)
the two involved references “teach away from one another” (Resp. Br. 9; see
also 14); (2) the combined teachings of the references do not suggest a
stimulation electrode associated with an “initial distraction assembly” (Id. at
10; see also 14); and (3) “Neubardt does not disclose the claimed „control
unit‟ capable of performing the „sensing,‟ „determining‟ and
„communicating‟ functions recited in the” claims. (Id.) Medtronic takes an
opposing view with respect to the above-noted claim features. (App. Br.,
30-32.)
After careful review of the parties conflicting positions, we agree with
Medtronic‟s assessment of what the combined teachings of Mathews ‟279
and Neubardt would have conveyed to one of ordinary skill in the art.
NuVasive‟s teaching away argument is premised on a comparison of the

13
As noted supra Medtronic has proposed no prior art rejection of claim
56 which depends from claim 4. Claim 56 requires that the “secondary
instrument” introduced in claim 4 is a “speculum assembly.” (App. Br.,
Claims App‟x, xi.)
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

29
discussion in Mathews ‟279 of known detriments to a known prior art spine
surgery technique taken alongside Neubardt‟s Figure 2. Yet, Neubardt‟s
Figure 2 is itself characterized as “prior art” and, evidently, depicts a
surgical practice with recognized disadvantages, which Neubardt‟s invention
seeks to overcome. (Neubardt, 2:66-3:2.) NuVasive does not explain why
the recognition in each reference as to deficiencies in known prior art
surgical techniques establishes that they “teach away” from one another.
NuVasive‟s second argument narrowly focuses on the content of
Neubardt and does not adequately account for what the combined teachings
of Mathews ‟279 and Neubardt would have suggest to one of ordinary skill
in the art. See In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991) (“The test for
obviousness is what the combined teachings of the references would have
suggested to one of ordinary skill in the art.”) As observed by Medtronic
(App. Br., 31), each of the references discloses a similar guide wire
associated with a spinal surgery tool. In Mathews ‟279, the guide wire
forms part of an initial distraction assembly. (E.g., Mathews ‟279, col. 5, ll.
17-39.) In Neubardt, the guide wire incorporates an electrical stimulation
device to stimulate nerves. (E.g., Neubardt, col. 9, l. 58-col. 10, l. 28.) In
our view, a person of ordinary skill in the art, who is also one of ordinary
creativity, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), would
have appreciated readily from the combined teachings of the references that
an electrical stimulation component may be associated with an initial
distraction assembly.
NuVasive‟s third argument is also unavailing. It is clear from
Neubardt‟s disclosure that an electrical stimulating component is presented
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

30
which functions to stimulate nerves. Neubardt also provides that a
“electromyography (EMG) unit” may be included which “will provide either
visual or audible signals as an indication of nerve twitching.” (Neubardt,
7:11-17.) Given those teachings, we are unpersuaded that Neubardt does not
convey a control unit which performs the operations set forth in claims 1
and 4.
For the foregoing reasons, we are persuaded by Medtronic that the
Examiner was incorrect in declining to adopt rejections of NuVasive claims
based on the combined teachings of Mathews ‟279 and Neubardt. Thus, the
Examiner erred in not adopting the rejections which are set forth in
Medtronic‟s “Claim Chart F” filed October 14, 2009 directed to claims 1, 2,
4, 5, 7, and 8. Accordingly, we reverse the Examiner‟s decision not to enter
the above-noted rejections. Our decision in that regard, and our entry of
the rejections herein as proposed by Medtronic, constitutes a new
ground of rejection pursuant to 37 C.F.R. § 41.77(b).
b. Claim 4
Medtronic contends that additional prior art rejections to “claim 4, and
the claims that depend therefrom” should have been adopted. Those
rejections are numbered in this opinion as: (6) Mathews Article and
Kelleher; (7) Mamo and Foley ‟871; and (8) Mathews ‟826 and Kelleher.
(App. Br., 3.)
In reviewing Medtronic‟s Appeal Brief, we observe that Medtronic is
of the view that NuVasive‟s claim 4 does not require a retractor “blade.” As
discussed above, we do not agree with that view given the explicit definition
of “retraction” and “retracting” set forth in the ‟058 Patent. It is evident that
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

31
with respect to rejections (6) and (7), Medtronic applies tubular cannula
assemblies of the Mathews Article and Foley‟871 as constituting the
retraction assembly set forth in claim 4. (E.g., App. Br., 32-34.) Because
we do not agree that a tubular cannula assembly constitutes a retractor
“blade” we are not persuaded that the Examiner was incorrect in declining to
adopt rejections (6) and (7).
With respect to rejection (8), it is clear that Mathews ‟826 discloses at
least one retractor blade (components 10 of Mathews ‟826). In urging that
the rejection should not be adopted, NuVasive submits that Mathews ‟826 is
deficient as it allegedly fails to account of a “secondary instrument” that is
“advanceable to said surgical target site” as is set forth in claim 4. (Resp.
Br., 15-16.) Medtronic likens the “sleeve 118” in Mathews ‟826 to the
required secondary instrument and urges that it, in use, is indeed advanced to
a surgical target site and thus satisfies the above-noted requirement of claim
4. (App. Br., 36-37.)
In reviewing Mathews ‟826, we agree with Medtronic. We think it
clear from the content of Mathews ‟826, such as Figure 21, that sleeve 118 is
readily understood as being positioned at the surgical target site and is thus
“advanceable to said surgical target site” as required by claim 4. We, thus,
reject NuVasive‟s argument to the contrary.
Accordingly, after full consideration of Medtronic‟s and NuVasive‟s
arguments, and for the above-noted reasons, we are not persuaded that the
Examiner was incorrect in declining to adopt rejection (6) and (7). The
Examiner‟s decision in that regard is affirmed.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

32
However, we are persuaded that rejection (8) should have been
adopted. Accordingly, the Examiner‟s decision with respect to that rejection
is reversed. Medtronic‟s “Claim Chart I” filed October 14, 2009 lays out
Medtronic‟s proposed rejection of claim 4 and dependent claims 5, 7, and 8
and, in our view, should have been adopted. Pursuant to 37 C.F.R.
§ 41.77(b), our reversal of the Examiner’s decision not to adopt the
rejections of claims 4-8 of Medtronic’s Claim Chart I, and our entry of
those rejections, constitutes a new ground of rejection.
c. Claim 6
At issue with respect to claim 6 and claims that depend therefrom are
seven grounds of rejection that were proposed by Medtronic but were not
adopted by the Examiner. Those proposed rejections are numbered (9)-(15)
in this opinion.
At the outset, we observe that the Examiner‟s basis for declining to
adopt any of the involved rejections of claim 6 is premised on a single
required feature of the claim. In particular, the feature concerns the
establishment of an operative corridor at a spinal target site “via a lateral,
trans-psoas approach.” (App. Br., Claims App‟x, ii.) According to the
Examiner, each of the proposed rejections of claim 6 relies on the disclosure
of Schick, Michelson, or Mathews ‟826 for disclosing the application of a
“lateral trans-psoas approach to the spine” in connection with spinal surgery.
(RAN, 5.) In reaching that conclusion, the Examiner credited the testimony
of NuVasive‟s expert witness, Dr. Garfin, over the testimony of Medtronic‟s
expert, Dr. Mathews. (Id.)
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

33
i. Claim Construction (Claim 6)
In resolving the involved appeal, we find it necessary to construe the
term “lateral, trans-psoas approach” as appears in claim 6. Claims terms are
usually given their ordinary and customary meaning as would be understood
by one of ordinary skill in the art in the context of the underlying patent
disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005)
(en banc). The written description underlying a claim usually provides
authoritative guidance in determining claim meaning. See id.
Turning to the specification of the ‟058 Patent, we take note of the
following passages (‟058 Patent, 1:52-62; 2:30-39; 15:3-8):
One drawback associated with prior art surgical access systems
relates to the ease with which the operative corridor can be
created as well as maintained over time, depending upon the
particular surgical target site. For example, when accessing
surgical target sites located beneath or behind musculature or
other relatively strong tissue (such as, by way of example only,
the psoas muscle adjacent to the spine), it has been found that
advancing an operative corridor-establishing instrument directly
through such tissues can be challenging and/or lead to
unwanted or undesirable effects (such as stressing or tearing the
tissues).
---
This can be seen, by way of example only, in the spinal arts,
where the exiting nerve roots and neural plexus structure in the
psoas muscle have rendered a lateral or far lateral access path
(so-called trans-psoas approach) to the lumbar spine virtually
impossible. Instead, spine surgeons are largely restricted to
accessing the spine from the posterior (to perform, among other
procedures, posterior lumbar interbody fusion (PLIF)) or from
the anterior (to perform, among other procedures, anterior
lumbar interbody fusion (ALIF)).
---
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

34
This is to prevent the unnecessary distraction of the psoas
muscle 304 (which must be passed through in order to approach
the surgical target site in the lateral or far-lateral approach
shown) in the instance significant nerves or neural structures
are encountered in the initial advancement of the K-wire 44.

From the content of the ‟058 Patent, including the above-quoted
passages, one with ordinary skill in the art would understand that the
claimed “lateral, trans-psoas approach” describes a spinal surgery technique
in which the target area of the spine is accessed laterally, or from the side of
a patient‟s spine, as opposed to a posterior or anterior approach, and which
passes through the psoas muscle.
ii. Each of Schick, Michelson, and Mathews ’826

Each of Schick, Michelson and Mathews ‟826 describes surgical
techniques directed to regions of a patient‟s spine. In particular, Schick
describes the recognition in the art that “percutaneous treatment of lumbar
disc herniations” may be accomplished through practices expressed as
“[l]ateral percutaneous techniques.” (Schick, Introduction.)
In Michelson, the inventive spinal surgery techniques disclosed are
characterized in the following manner (Michelson, 3:46-56):
The present invention is directed to methods and
instrumentation for performing surgery on the spine along its
lateral aspect (side) and generally by a lateral or an anterolateral
surgical approach, from a position anterior to the transverse
processes of adjacent vertebrae of the spine, such that the
instruments enter the body from an approach that is other than
posterior and make contact with the spine along its lateral
aspect. The present invention provides for the entire surgical
procedure to be performed through a relatively small incision
and may be performed in either the thoracic or lumbar spine.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

35

Mathews ‟826 discloses that its invention is directed to “techniques
for percutaneous, minimally invasive spinal surgery.” (Mathews ‟826, 1:11-
15.) The invention is further explained as being applicable “at various levels
of the spine including the cervical, thoracic and lumbar spine,” and may be
“used in various approaches to the spine.” (Id. at 12:62-66.) In describing
one particular embodiment directed to the thoracic region of the spine,
Mathews ‟826 explains that one such approach that is envisioned is a
“translateral approach.” (Id. at 13:9-11.)
Thus, the prior art, specifically each of Schick, Michelson, and
Mathews ‟826, reasonably conveys that either a “lateral” approach or a
“translateral” approach may be employed in areas of the spine which include
the lumbar region and the thoracic region. With that in mind, we consider
the declaration testimony of NuVasive‟s and Medtronic‟s expert witnesses,
Dr. Garfin and Dr. Mathews, respectively.
Regarding the location of the psoas muscle in a patient‟s spine, Dr.
Garfin testifies (Garfin Decl., ¶ 4):
It is well known that the psoas muscle originates at the lower-
most thoracic vertebral bone (T12) and, in some patients,
originates at the upper-most lumbar vertebra (L1). In either
case, the psoas muscle originates as a very narrow connection
located toward the posterior aspect of the vertebra (T12 or L1).

Dr. Mathews does not disagree with Dr. Garfin‟s testimony in that
regard. Indeed, Dr. Mathews also testifies that the psoas muscle is located in
the “lumbar” region of the spine. (Mathews Decl., ¶ 5.) The record thus
reflects that the psoas muscle is generally understood as being located in
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

36
areas adjacent the lumbar region and portions of the thoracic region
alongside a patient‟s spine.
In light of the above, including the teachings of the prior art and the
expert testimony, it is evident that in the spinal surgery art those with
ordinary skill would have readily recognized that a “lateral” or “translateral”
surgical approach in the area of the spine in which the psoas muscle resides
were known and viable techniques. Both Dr. Garfin and Dr. Mathews testify
that it was known in the art that such a lateral approach may be
accomplished in a manner in which the psoas muscle is either avoided or
retracted such that the approach is not a “trans-psoas” lateral approach, i.e.,
the psoas muscle is not passed through. (See Garfin Decl., ¶ 3; Mathews
Decl., ¶ 5.) However, that a “trans-psoas” approach may not “necessarily”
occur, as is testified by Dr. Garfin (Garfin Decl., ¶ 3), provides little
meaningful guidance in evaluating the obviousness of such an approach,
which is the inquiry before us.
We observe that Dr. Mathews testifies that a surgeon would have
recognized that a “lateral approach” may involve a procedure which passes
through the psoas muscle. (Mathew Decl., ¶ 5.) Dr. Garfin does not dispute
that testimony. Indeed, as support for that testimony, Dr. Mathews makes
reference to other extrinsic evidence including U.S. Patent 5,313,962 (the
“‟962 Patent”). The „962 Patent is directed to a method of performing
surgery characterized as laparoscopic lumbar discectomy (Abstract) and
clearly conveys that when taking a “lateral” approach “the surgery may
traverse through the psoas muscle.” (‟962 Patent, 6:14-32.) We credit Dr.
Mathews‟ testimony and conclude that those of ordinary skill in the art
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

37
would have generally recognized that a lateral surgical approach to the spine
may traverse through the psoas muscle.
References are available for all of their specific teachings, as well as
the inferences one of ordinary skill in this art would have reasonably been
expected to draw therefrom. In re Fritch, 972 F.2d 1260, 1264-65 (Fed. Cir.
1992). One of ordinary skill in the art is also presumed to have knowledge
apart from what the prior art references explicitly state. See KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Here, although each of Schick, Michelson, and Mathews ‟826 do not
make explicit that their disclosure of “lateral” or “translateral” approaches
encompasses “trans-psoas lateral” approaches, the record suitably conveys
that one of ordinary skill in the art of spinal surgery would have known that
traversing the psoas muscle is an available and viable option when
performing such surgery. We thus reject NuVasive‟s argument to the
contrary.
After due consideration of the record, we are of the opinion that the
Examiner was incorrect in not adopting the rejections proposed by
Medtronic which incorporate the teachings of either Schick, Michelson, or
Mathews ‟826 based on the position that none of those references teach a
“lateral trans-psoas approach.” (RAN, 5-6.) In our view, such a position
does not fully consider what a skilled artisan would have understood about a
“lateral” or “translateral” surgical approach from the teachings in those
references. We conclude, therefore, that the Examiner has not adequately
explained why the rejections proposed by Medtronic, and numbered in this
opinion as (9)-(15), do not demonstrate the obviousness of claim 6. We
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

38
observe that the claim charts filed October 14, 2009 and labeled A-F and I
appropriately inform the basis of the rejections of claim 6 which were
proposed by Medtronic, but not adopted by the Examiner.
Claims 57-64 ultimately depend from claim 6. Medtronic‟s proposed
rejections of claims 57-64 are laid out in the claim charts designated “Claim
Chart A – Continued,” “Claim Chart B – Continued,” and “Claim Chart D –
Continued” filed March 19, 2010.
For the foregoing reasons, we reverse the Examiner‟s decision not to
adopt the rejections of claims 6 and 57-64
14
numbered in this opinion as (9)-
(15). Pursuant to 37 C.F.R. § 41.77(b), our reversal in that regard, and
our entry of the rejections herein as proposed by Medtronic, constitutes
a new ground of rejection.
d. Claim 10
Also at issue in this appeal are three proposed rejections of claim 10,
numbered (16)-(18) in this opinion. Those rejections are as follows:
(16) Mathews ‟826, Michelson, Kelleher, and Finneran
(17) Koros, Michelson, Foley ‟871, Kelleher, and NIM Guide
(18) Smith, Michelson, Koros, Marino, and NIM Guide

Claim 10, like claim 6, is directed to a method of accessing a surgical
target site and includes a requirement that an operative corridor is formed
“along a lateral, trans-psoas path.” NuVasive makes essentially the same

14
As noted supra Medtronic has proposed no rejection of dependent
claim 65 which depends from claim 6. Claim 65 specifies that the
“secondary instrument” introduced in claim 6 is a “speculum assembly.”
(App. Br. Claims App‟x, xiii.)

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

39
argument with respect to that requirement as it did with claim 6. Namely,
according to NuVasive, the prior art does not disclose a spinal surgical path
or approach that is a “lateral, trans-psoas” one. We disagree.
Each of the above-noted rejections includes the teachings of either
Mathews ‟826 or Michelson. As discussed above in connection with claim
6, those references describe a “lateral” or “translateral” path for accessing a
targeted surgical area of the spine. For the same reasons noted above with
respect to claim 6, we conclude that a person of ordinary skill in the art
would have recognized that traversing the psoas muscle, i.e., a lateral trans-
psoas path, would have been a recognized option when undertaking a lateral
or translateral approach. We reject NuVasive‟s contention which conflicts
with that conclusion.
NuVasive, however, also offers additional reasons as to why the
Examiner‟s refusal to adopt the involved rejections of claim 10 was correct.
In that regard, NuVasive contends that the prior art does not account for the
feature in claim 10 directed to a “locking member” that is “releasably
received within a passageway of the first retractor blade” of the retractor
assembly. (Resp. Br., 22.) Medtronic takes the position that the above-
quoted requirement is accounted for in each of Mathews ‟826 and Koros.
In particular, Medtronic relies on component 115 in Mathews ‟826 as
forming the “locking member” required by claim 10. (App. Br., 38-39.)
Mathews ‟826‟s component 115 is described as “a pair of guide pins” or
“fixation pin[s]” which extend through “pin bores 60, 61” provided in the
outer wall 51 and inner wall 54 of ring member 50 and anchor the ring
member to the surgical cite. (Mathews ‟826, 7:24-46; 9:38-42.) Medtronic
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

40
also relies on Koros as disclosing “screws 83” acting as the required locking
members. (App. Br., 39-41.) Koros‟ screws 83 are described as “fixation
screws” which extend through tubular guides 82 and 86 associated with
Koros‟ distractor blades 32. (Koros, 6:53-67.)
After careful review of Medtronic‟s position, we are not persuaded
that it has suitably accounted for the locking members configured as
required by NuVasive‟s claim 10. In particular, while we agree that
Mathews ‟826‟s pins 115 and Koros‟ screws 83 are themselves locking
members, it is not evident how those members are “received within a
passageway of the first retractor blade.” In Mathews ‟826, the pin bores 60
and 61 are located in ring member 50 and are not passageways “within” any
retractor blade. In Koros, the tubular guides 82 and 86 are associated with
Koros‟ distractor blades 32 and not the separate retractor blades 30 of its
assembly. Although Medtronic generally contends that the locking
components of Mathews‟826 and Koros are within a “passageway” (App.
Br., 38-39), lacking from those contentions is a suitable explanation as to
how the referenced passageways are “a passageway of the first retractor
blade.” (App. Br. Claims App‟x, iv) (emphasis added).
Accordingly, for the foregoing reasons, we are not persuaded that
Medtronic has appropriately accounted for all the requirements of
NuVasive‟s claim 10 in the rejections numbered (16)-(18) in this opinion.
Accordingly, we do not discern error in the Examiner‟s decisions declining
to adopt those rejections of claim 10 of the claims 11-29 which ultimately
depend therefrom. The Examiner‟s decisions are affirmed.
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

41
e. Claim 30
Medtronic‟s appeal in connection with claim 30 involves the
following rejections:
(19) Mathews ‟826, Michelson, and Kelleher
(20) Koros, Foley ‟871, Michelson, and Kelleher
(21) Smith, Michelson, Marino, and NIM Guide

Claim 30 is drawn to a method of accessing a surgical target site.
Similar to claims 6 and 10, claim 30 includes recitation of a corridor formed
“along a lateral trans-psoas path.” Claim 30, like claims 1 and 4, also
requires steps directed to nerve monitoring including sensing, determining,
and communicating nerve proximity. With respect to the above-noted
features, NuVasive relies on the same arguments that were advanced in
conjunction with claims 6 and 10 and also claims 1 and 4.
As discussed supra, we are persuaded that the prior art of Mathews
‟826 and Michelson suitably accounts for “a lateral trans-psoas path” with
respect to targeting a surgical site of the spine. We also are persuaded that it
would have been obvious to one with ordinary skill in the art to combine
Kelleher‟s teachings directed to nerve monitoring to a variety of types of
spinal surgery, including the prior art associated with rejections (19)-(21)
noted above. The teachings of NIM guide, which is titled “Nerve Integrity
Monitor,” are similar in nature to those of Kelleher in so far as nerve
proximity sensing, determining, and communicating is concerned.
In connection with rejection (21) involving Smith, NuVasive also
takes a position that the reference lacks disclosure of retractor blade portions
which are “similarly sized.” (Resp. Br., 24.) Pointing to Smith‟s Figures 1
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

42
and 7 and column 3, lines 53-56, NuVasive urges that Smith‟s retractor
blades must be different sizes. (Id.) We do not agree with NuVasive.
The cited portion of Smith at column 3 does not require that the
retractor blades have different sizes, and instead simply sets forth that in one
embodiment of Smith‟s invention, one of the blades is greater in length than
the other. It is not apparent that the blades of Smith, even if having different
lengths or some variation in their respective sizes, are nevertheless not
understood as being “similarly” sized. Moreover, as argued by Medtronic
(Reb. Br., 17), it is clear from the disclosures of other involved references,
such as Koros, that it is understood in the art that retractor blades may have
the same size.
We have considered NuVasive‟s arguments but are not persuaded that
they point out deficiencies in the prior art in accounting for the features
required by claim 30. We are in agreement with Medtronic that the
Examiner should have adopted the proposed rejections of claim 30,
numbered in this opinion as (19)-(21). Accordingly, we reverse the
Examiner decision not to adopt the rejections of claim 30 and dependent
claims 31-47, 49, and 50 that are set forth in Medtronic‟s Claim Charts J, K,
and L filed March 19, 2010.
15
Pursuant to 37 C.F.R. § 41.77(b), our
reversal of the Examiner’s decision with respect to claims 30-47, 49, and
50, and our entry of the rejections herein as proposed by Medtronic,
constitutes a new ground of rejection.

15
Upon review of the record, including the noted claim charts, it is evident
that Medtronic proposed no prior art rejection of claim 48 which depends
from claim 30. Claim 48 requires that a “secondary instrument” introduced
in claim 30 be a “speculum assembly.” (App. Br. Claims App‟x, x.)
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

43
D. CONCLUSION
1. The Examiner should have rejected claims 10-50 as being
impermissibly enlarged in scope under 35 U.S.C. § 314.
2. The Examiner was correct in not rejecting claims 10-16, 19-27,
30-36, 38-43, 45-50, and 57 as lacking adequate written description in the
specification of the ‟058 patent for any recited claim features. The Examiner
was not correct in declining to so reject claims 17, 18, 28, 29, 37, and 44.
3. The record does not show that a person of ordinary skill in the
art would have regarded a tubular type working cannula as a retractor blade
or a plurality of retractor blades.
4. The record shows that a person of ordinary skill in the art
would have understood from the prior art that a surgical target site in a
patient‟s spine may be reached via a “lateral trans-psoas” approach or path.
5. Medtronic has adequately shown that the Examiner was not
correct in concluding that none of NuVasive‟s claims would have been
obvious in light of the teachings of prior art.
The ORDER appearing below sets forth our reversals and affirmances
of the Examiner‟s decisions in light of the above-noted conclusions. We
observe that, based on those conclusions, at least one rejection should have
been applied to each of the claims 1, 2, 4-8, 10-55, and 57-64 involved in
this appeal. No rejection has been proposed for either claim 56 or claim 65,
nor do we enter any rejection of those claims.
E. ORDER
REVERSALS
35 U.S.C. § 314
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

44
The Examiner‟s decision not to adopt Medtronic‟s proposed rejection
of claims 10-50 under 35 U.S.C. § 314 as being improperly broadened
(numbered as rejection (23) in this opinion) is reversed.

35 U.S.C. § 112
The Examiner‟s decision not to adopt Medtronic‟s proposed rejection
of claims 28, 29, and 44 under 35 U.S.C. § 112, first paragraph (see section
II.d. of this opinion) is reversed.

The Examiner‟s decision not to adopt Medtronic‟s proposed rejection
of and claims 17 and 37 under 35 U.S.C. § 112, first paragraph (see section
II.e. of this opinion) is reversed.
We also enter a new ground of rejection of claim 18 on the same
basis.

Prior Art Rejections
The Examiner‟s decision not to adopt Rejection (3) based on Smith
and Rose and involving claims 1, 2, 4, 5, 7, 8, and 51-55 is reversed.

The Examiner‟s decision not to adopt Rejection (5) based on Mathews
„279 and Neubardt involving claims 1, 2, 4, 5, 7, and 8 is reversed.

The Examiner‟s decision not to adopt Rejection (8) based on Mathews
‟826 and Kelleher and involving claims 4, 5, 7, and 8 is reversed.

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

45
The Examiner‟s decision not to adopt Rejections (9)-(15)
16
involving
claims 6 and 57-64 is reversed.

The Examiner‟s decision not to adopt Rejections (19)-(21)
17
involving
claims 30-50 is reversed.

AFFIRMANCES

35 U.S.C. § 112
The Examiner‟s decision not to adopt Medtronic‟s proposed rejection
of claims 10-29 and 57 under 35 U.S.C. § 112, first paragraph (see section
II.a. of this opinion) is affirmed.

The Examiner‟s decision not to adopt Medtronic‟s proposed rejections
of claims 30-50 under 35 U.S.C. § 112, first paragraph (see section II.b. of
this opinion) is affirmed.

16
(9) Foley Article, Kelleher, and Schick;
(10) Foley ‟871, Marino, and Michelson;
(11) Mathews Article, Kelleher, and Michelson;
(12) Smith, Rose, and Schick;
(13) Foley Article, Epoch 2000, and Schick;
(14) Mathews ‟279, Neubardt, and Michelson; and
(15) Mathews ‟826 and Kelleher.

17
(19) Mathews ‟826, Michelson, and Kelleher;
(20) Koros, Foley ‟871, Michelson, and Kelleher; and
(21) Smith, Michelson, Marino, and NIM Guide.

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

46
The Examiner‟s decision not to adopt Medtronic‟s proposed rejections
of claims 10-29 under 35 U.S.C. § 112, first paragraph (see section II.c. of
this opinion) is affirmed.

Prior Art Rejections
The Examiner‟s decision not to adopt Rejection (1) based on Foley
Article and Kelleher and involving claims 1, 2, 4, 5, 7, 8, and 51-55 is
affirmed.

The Examiner‟s decision not to adopt Rejection (2) based on Foley
‟871 and Marino and involving claims 1, 2, 4, 5, 7, 8, and 51-55 is affirmed.

The Examiner‟s decision not to adopt Rejection (4) based on Foley
Article and Epoch 2000 and involving claims 1, 2, 4, 5, 7, 8, and 51-55 is
affirmed.

The Examiner‟s decision not to adopt Rejection (6) based on Mathews
Article and Kelleher and involving claims 4, 5, 7, and 8 is affirmed.

The Examiner‟s decision not to adopt Rejection (7) based on Mamo
and Foley ‟871 and involving claims 4, 5, 7, and 8 is affirmed.

The Examiner‟s decision not to adopt Rejections (16)-(18)
18
involving
claims 10-29 is affirmed.

18
(16) Mathews ‟826, Michelson, Kelleher, and Finneran;
(17) Koros, Michelson, Foley ‟871, Kelleher, and NIM Guide; and
(18) Smith, Michelson, Koros, Marino, and NIM Guide.

Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

47
This opinion, including the above-noted reversals, contains new
grounds of rejection pursuant to 37 C.F.R. § 41.77(b) which provides that
“[a]ny decision which includes a new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.” 37 C.F.R.
§ 41.77(b) also provides that the Patent Owner, WITHIN ONE MONTH
FROM THE DATE OF THE DECISION, must exercise one of the
following two options with respect to the new grounds of rejection to avoid
termination of the appeal as to the rejected claims:
(1) Reopen prosecution. The owner may file a response
requesting reopening of prosecution before the examiner. Such
a response must be either an amendment of the claims so
rejected or new evidence relating to the claims so rejected, or
both.
(2) Request rehearing. The owner may request that the
proceeding be reheard under § 41.79 by the Board upon the
same record. …

Any request to reopen prosecution before the examiner under 37
C.F.R. § 41.77(b)(1) shall be limited in scope to the “claims so rejected.”
Accordingly, a request to reopen is limited to issues raised by the new
ground(s) of rejection entered by the Board. A request to reopen prosecution
that is directed to issues other than those raised by the new ground(s) is
unlikely to be granted. Likewise, comments of the requester under 37
C.F.R. § 41.77(c) shall be limited in scope to the issues raised by the Board's
opinion reflecting its decision to reject the claims and the owner's response
under paragraph (b)(1). New proposed rejections are not permitted unless
presented in response to an amendment and/or new evidence submitted by
the owner which is properly limited to issues raised by the new ground(s) of
Appeal 2012-009491
Reexamination Control 95/001,247
Patent 7,582,058

48
rejection entered by the Board. The Examiner will issue a determination
under 37 C.F.R. § 41.77(d) as to whether the Board's rejection is maintained
or has been overcome, and return the proceeding to the Board together with
any comments and reply submitted by the owner and/or requester under
37 C.F.R. § 41.77(e) for reconsideration and issuance of a new decision by
the Board as provided by 37 C.F.R. § 41.77(f).

AFFIRMED-IN-PART; REVERSED-IN-PART

PATENT OWNER:
FISH & RICHARDSON P.C.
P.O. Box 1022
Minneapolis, MN 55440-1022

THIRD-PARTY REQUESTER:
FITZPATRICK, CELIA, HARPER & SCINTO
1290 AVENUE OF THE AMERICAS
NEW YORK, NY 10104-3800