Ex Parte 7905840 et al

Patent Trial and Appeal Board

Apr 29, 2015

95001890 (P.T.A.B. Apr. 29, 2015)

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.
95/001,890 02/09/2012 7905840 20330.0002.RX840 1564
26191 7590 04/29/2015
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
WILLIAMS, CATHERINE SERKE
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
04/29/2015 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
____________

GLOBUS MEDICAL, INC.
Requester and Appellant

v.

NUVASIVE, INC.
Patent Owner and Respondent
____________

Appeal 2014-008965
Reexamination Control 95/001,890
Patent 7,905,840 B21
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, DANIEL S. SONG, and BRETT C. MARTIN,
Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Third Party Requestor from Patent
Examiner’s decision to withdraw previously adopted rejections of claims 1-10, 12-
15, and 17-29 in the above-identified inter partes reexamination of United States
Patent 7,905,840 B2. The Board’s jurisdiction for this appeal is under 35 U.S.C.

1 “The ’840 patent”
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§§ 6(b), 134, and 315 (pre-AIA). We reverse the Examiner’s decision and set forth
new grounds of rejection of claims 1-10, 12-15, and 17-29.

I. BACKGROUND
The patent in dispute in this appeal is United States Patent 7,905,840 B2,
which issued March 15, 2011. The real party in interest and owner of the ’840
patent is NuVasive, Inc. (“Patent Owner”). Owner Resp’t. Br. 1. The Third Party
Requester is Globus Medical, Inc. (“Requester”). Requester Appeal Br. 1.
A request for inter partes reexamination of the ’840 patent was filed Feb. 9,
2012, by Requester under 35 U.S.C. §§ 311–318 (pre-AIA) and 37 C.F.R.
§§ 1.902–1.997 (pre-AIA) (“Request”).
The claimed subject matter of the ’840 patent is directed to spinal surgery.
The method involves guiding a dilation member within a retroperitoneal space
from a lateral incision using at least a portion of a surgeon’s finger. The dilation
member is guided by the surgeon’s finger from the lateral incision, through the
retroperitoneal space toward the psoas muscle located on the side of the spine in
the spine’s lumbar region. The dilation member is then advanced through the
psoas muscle (called a “trans-psoas” approach) in a substantially lateral direction
toward a spinal target while monitoring for the presence of nerves in the vicinity of
the dilation member (claim 1).
Requester appeals from the Examiner’s decision to withdraw previously
adopted rejections of claims 1-10, 12-15, and 17-29. There are two sets of
withdrawn rejections in this appeal. The first set, Rejections 1-4, relies on Mayer
and Zdeblick. The second set, Rejections 5-8, relies on Brau and Zdeblick. The
withdrawn rejections are as follows:
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1. Claims 1-7, 10, 12-14, 18-23, and 29 under 35 U.S.C. § 103(a) as
obvious in view of Mayer,2 Zdeblick,3 and Blewett.4
2. Claim 8 under 35 U.S.C. § 103(a) as obvious in view of Mayer, Zdeblick,
Blewett, and Branch.5
3. Claims 9 and 24-28 under 35 U.S.C. § 103(a) as obvious in view of
Mayer and Zdeblick.
4. Claims 15 and 17 as under 35 U.S.C. § 103(a) as obvious in view of
Mayer, Zdeblick, and Branch.
5. Claims 1-7, 10, 12-14, 18-23, and 29 under 35 U.S.C. § 103(a) as
obvious in view of Brau,6 Zdeblick, and Blewett.
6. Claim 8 under 35 U.S.C. § 103(a) as obvious in view of Brau, Zdeblick,
Blewett, and Branch.
7. Claims 9 and 24-28 under 35 U.S.C. § 103(a) as obvious in view of Brau
and Zdeblick.

2 MINIMALLY INVASIVE SPINE SURGERY: A SURGICAL MANUAL 67–73, 98, 117–
144, 153–158, 217–223 (H. M. Mayer ed., Springer 2000). “Mayer” is a book
edited by H. Michael Mayer titled “Minimally Invasive Spine Surgery.” The book
contains a number of chapters written by different authors. Only Chapters 7, 8
(incomplete), 12, 13, 15, and 22 are part of the record.
3 ANTERIOR APPROACHES TO THE SPINE 193–201, 219–241, 243–255 (Thomas A.
Zdeblick ed., Quality Medical Publishing, Inc. 1999). “Zdeblick” is a book edited
by Thomas A. Zdeblick containing chapters written by different authors. Only
Chapters 11, 13, and 14 are part of the record.
4 WO Patent Application 03/005887 A2, published January 23, 2003, to Jeffery
Blewett.
5 US Patent No. 6,945,933 B2, issued September 20, 2005, to Charles L. Branch et
al.
6 Salvador Brau, Anterior Retroperitoneal Muscle-Sparing Approach to L2-S1 of
the Lumbar Spine, Surgical Approaches to the Spine 165–181 (Robert G. Watkins,
ed., Springer 2003).
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8. Claims 15 and 17 under 35 U.S.C. § 103(a) as obvious in view of Brau,
Zdeblick, and Branch.
Because neither party provided separate arguments for the dependent claims,
we focus only on independent claims 1 and 9. These claims read as follows
(numbering added in brackets for reference to the steps in each claim) (underlining
relative to original claims):
1. A method included in providing surgical access to a spinal
target site in a human patient through a substantially lateral,
retroperitoneal approach, the method comprising:
{1} inserting at least a portion of a finger of a surgeon through
a first, posteriolateral incision and into a retroperitoneal space;
{2} sweeping at least a portion of the finger in the
retroperitoneal space;
{3} inserting a distal tip of a dilation member through a second,
substantially lateral incision and into the retroperitoneal space;
{4} using at least a portion of the finger to guide the distal tip
of the dilation member within the retroperitoneal space toward a psoas
muscle; and
{5} advancing the distal tip of the dilation member in a
substantially lateral direction through the psoas muscle toward a
spinal target site {6} while using a stimulation electrode on the
dilation member to monitor for the presence of nerves in the vicinity
of the dilation member.

9. A method of accessing a spinal target site in a human patient,
comprising:
{1} creating a distraction corridor to a spinal target site through
a substantially lateral, retroperitoneal approach, comprising:
{2} inserting at least a portion of a finger of an operating
surgeon through a first, posteriolateral incision and into a
retroperitoneal space,
{3} sweeping at least a portion of the finger in the
retroperitoneal space;
{4} inserting a distal end of a dilation member through a
second, substantially lateral incision
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{5} and into the retroperitoneal space, using at least a portion of
the finger to guide the distal end of the dilation member within the
retroperitoneal space, and
{6} advancing the dilation member in a substantially lateral
direction toward the spinal target site; and
{7} retracting said distraction corridor to produce an operative
corridor to said spinal target site.

In addition to the cited prior art publications, testimony in the form of
written declarations was provided by two declarants.
Jim Youssef, M.D., executed a declaration on behalf of Patent Owner.
Dr. Youssef is a board certified orthopedic surgeon who has been a
practicing spine surgeon for the past 15 years at the time the declaration was
executed. Youssef Decl. ¶ 1. Dr. Youssef has authored peer reviewed
publications and given numerous presentations on spine maladies, treatment,
and surgery. Id. at ¶ 3. Dr. Youssef is not an employee of Patent Owner,
but was compensated for the time he spent on this matter. Id. at ¶ 4.
A declaration on behalf of Requester was executed by Isador H.
Lieberman, M.D. Dr. Lieberman is a board certified orthopedic surgeon,
specializing in spine surgery. Lieberman Decl. ¶ 6. Dr. Lieberman has
authored numerous publications on spine surgery, as well as given invited
lectures nationally and internationally. Id. Dr. Lieberman was compensated
for his time on the matter. Id. at ¶ 13.
We conclude that both Drs. Youssef and Lieberman are qualified to
testify on the matters discussed in their declarations.

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II. REJECTIONS OVER MAYER AND ZDEBLICK
Requester contends that the Examiner erred in withdrawing the rejections
involving the Mayer and Zdeblick publications.

A. Claim 1
Steps {1} and {2}
For steps {1} and {2} of the claimed method comprising “inserting at least a
portion of a finger of a surgeon . . . into the retroperitoneal space” and “sweeping
at least a portion of the finger in the retroperitoneal space,” Requester cited the
description of Thalgott’s endoscopic retroperitoneal procedure in Chapter 22 of
Mayer. Request 59-60. Mayer teaches: “With a dissecting finger, palpate the
superior and anterior boarder of the left kidney as well as the psoas muscle at its
most lateral aspect (Fig. 22.3).” Claim chart, CC-A (attached to Request), p. 3;
Mayer 218-219 (Chapter 22). Figures 22.3a and b are reproduced below:

Figures 22-3a and b of Mayer show the “digital [finger] dissection” of the
retroperitoneal space. Mayer 219 (Chapter 22). This figure resembles Fig. 35 of
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the ’840 patent, which also shows a finger in the retroperitoneal space. Fig. 35 is
reproduced below.

Fig. 35 shows “finger 275 . . . used to direct the distal end 41 of the initial
dilator 40 through the retroperitoneal space 215 toward the psoas muscle 220.”
’840 patent, col. 14, ll. 21-23.

Step {3}
Step {3} comprises inserting a “dilation member” into the retroperitoneal
space. Patent Owner did not supply a definition of a dilation member. At column
9, lines 46-60, of the ’840 patent, an “initial dilator 44” is described. The dilator
contains a K-wire 42. ’840 patent, col. 9, ll. 46-60. The dilator is used for dilating
and distracting the tissue. Id. Because the dilator contains a wire, it also appears
to serve as a cannula. A dilating cannula is also described. Id. at ll. 15-25.
Accordingly, based on this description, it is reasonable to find that the dilation
member can be a cannula.
Requester cited evidence from both Murray and Zdeblick that step {3} of
inserting a “dilation member” into the retroperitoneal space was known. Request
60-61. Specifically, Requester stated:
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Mayer discloses that a cannula is inserted into the incision and
advanced into the retroperitoneal space. Mayer at Section 22.3.1,
pages 218-219. The cannula serves as a dilation member that expands
the corridor and facilitates the passage of additional instruments inside
of it (such as a dissecting balloon or endoscope).
Request 61.
Requester appears to be referring to Mayer’s description of Thalgott’s
balloon-assisted endoscopic retroperitoneal gasless (BERG) lumbar discectomy
and fusion procedure in which:
[a] dissecting balloon and cannula are advanced into the
retroperitoneal space through 1.5 –cm incision (Fig. 22.4). The
dissection balloon cannula . . . has a 1-1 capacity. Through the
cannula, an intraluminal endoscope is inserted so that while the
balloon is inflated the retroperitoneal space may be visualized
directly.
Mayer 219 (first column).
Because we have construed the claimed dilation member to include a
cannula instrument, we agree with Requester that Thalgott’s cannula (Mayer 219)
meets the claimed limitation of a dilation member. It is, therefore, unnecessary for
us to reach Zdeblick which was said by Requester to also describe a dilation
member.

Step {4}
Step {4} comprises guiding the distal tip of the dilation member using a
finger. There is insufficient evidence that either Mayer or Zdeblick uses a finger to
guide their cannula into the retroperitoneal space.
Claim chart CC-A, which was part of the original Request, cites to Mayer’s
description of de Peretti’s procedure published in 1996. CC-A, p. 12. However,
we have not been directed to where finger guidance is described in Mayer’s
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characterization of de Peretti, and in our independent review of de Peretti, we
could not find it. Requester also did not explain why de Peretti’s procedure would
be combined with Thalgott’s.
Requester further cited Litwin7 as teaching “finger/hand guidance of
laparoscopic instruments and preparation of the surgical pathway” as “applicable
to the method of the ’840 Patent and supports that this skill was known in the art.”
Requester Appeal Br. 6. Requester states:
Litwin discloses inserting a hand into the abdomen to assist
laparoscopic instruments. See Litwin at pp. 715-723. Litwin
describes that the inserted hand allows “the surgeon’s fingers to touch,
feel, and manipulate tissues.” Litwin at p. 722. Litwin further
discloses the preferred method of using triangulation, where the
fingers and surgical tool approach the target at a 60-90 degree angle.
The fingers can “facilitate the dissection” in the pathway of the tool.
See Litwin at p. 723. Thus, the fingers help prepare the pathway to
guide the instrumentation to the target.
Id. at 9.
Litwin describes a “hand-assist device” called the “HandPort System.”
Litwin 716. The device is inserted into the incision after the abdomen has been
insufflated with a gas. Id. The surgeon’s hand is inserted into the abdomen
through the base retractor of the device. Id. at 716-717. As discussed by
Requester, Litwin describes the tactile feedback facilitated by the device as an
advantage of the hand-assisted laparoscopic procedures. Id. at 718. However,
Litwin does not describe using a finger to guide a laparoscopic instrument as
claimed. For example, Litwin teaches that its “approach provides excellent means
to explore, to retract safely, and to apply immediate hemostasis when needed.” Id.

7 Demetrius E. M. Litwin et al., Hand-Assisted Laparoscopic Surgery (HALS)
With the HandPort System: Initial Experience With 68 Patients, 231 ANNALS OF
SURGERY 715-723 (2000).
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at 715. Litwin also teaches its advantages in spleen removal because “the hand
allows improved manipulation of the spleen and easier bagging for extraction and
ensures immediate hemostasis.” Id. at 721. Litwin concludes that “the HandPort
device . . . may allow surgeons to perform more complex operations by offering
the surgeon the advantages of tactile feedback, safe retraction, and the ability to
perform blunt dissection.” Id. This disclosure in Litwin does not describe step {4}
of “using at least a portion of the finger to guide the distal tip of the dilation
member within the retroperitoneal space toward a psoas muscle.” Requester has
not identified disclosure in Litwin that would suggest the claimed finger guidance
limitation.
Dr. Lieberman testified that “spinal surgeons utilize their fingers a multitude
of ways, from palpating anatomic structures to performing blunt dissection.”
Lieberman ¶ 39. He further stated that it “is common knowledge to the point of
instinctual for surgeons to utilize their fingers to guide surgical instruments.” Id.
However, Dr. Lieberman did not provide a factual basis for this testimony nor
explain how Litwin or any of the other cited publications would have suggested
using finger guidance of an instrument.

Step {5}
Step {5} of claim 1 comprises “advancing the distal tip of the dilation
member in a substantially lateral direction through the psoas muscle toward a
spinal target site.” With respect to this limitation, Requester states:
In addition, Mayer discloses using “a blunt muscle-splitting
approach” in the lateral, retroperitoneal pathway, in which “the psoas
must be incised 1 cm - 1.5 cm.” Mayer at Section 12.13, pages 129-
130. As further support, Zdeblick also discloses that the psoas muscle
may be split to access the spine. Specifically, Zdeblick discloses,
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“The psoas muscle is dissected in an anterior-to-posterior direction
overlying the disc spaces. This allows exposure of the vertebral
column.” Zdeblick at page 198.
Request 71.
Dr. Youssef, however, testified that the teaching in Mayer that “the psoas
must be incised 1 cm - 1.5 cm” is “not a disclosure of a trans-psoas approach (that
is, an approach that goes through the psoas muscle, instead of around the psoas
muscle).” Youssef ¶ 19. Dr. Youssef supported his testimony from disclosure in
the same chapter, which referred to incising the psoas muscle from the spine:
For example, the Mayer Book explains that the psoas muscle is
“incised” away from the spine, not cut in half or otherwise partially
split. (Mayer Book at p. 122 (explaining that, in the MINIALIF
surgery, the “attachments of the psoas muscle to the lumbar spine can
now be identified and incised and sharply dissected . . . from the disc
space”).) In other words, the connective tissue between the psoas
muscle and the spine is cut so that the psoas muscle is incised away
from the spine, thereby making it easier for the surgeon to retract the
psoas muscle in a posterior direction away from the surgical path.
(Mayer Book at p. 124 (explaining that a retractor blade “is attached
laterally to deflect the psoas muscle” and referring to this portion of
the psoas muscle as the “incised psoas muscle”).)
Id.
Dr. Youssef also discussed Thalgott’s procedure in Chapter 22 of Mayer,
testifying that “one of skill in the art would recognize that the Thalgott Procedure
does not go through the psoas muscle (that is, it is not a ‘trans-psoas’ approach),
but rather involves a pathway to the spine that is anterior to the retracted psoas
muscle.” Id. at ¶ 15. Dr. Youssef stated that he witnessed Thalgott’s procedure
being performed by Dr. Thalgott, himself, and the procedure does not reproduce or
teach the claimed subject matter. Id. at ¶ 9.
Dr. Youssef’s testimony is credible and factually supported.
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Requester also cited from page 198 of Chapter 11 of Zdeblick as showing an
approach through the psoas muscle. Request 71. The cited disclosure states in
Figure 11-5 that the “psoas muscle is dissected in an anterior-to-posterior
direction.” Zdeblick, p. 198 (Chapter 11). This figure shows the muscle being
retracted consistent with the description in the text of Fig. 11-5 that the “psoas
muscle is retracted laterally to expose the vertebral bodies.” Id. Dr. Youssef also
testified that “one of skill in the art at the time would have understood this passage
to have been referring to the dissection of the psoas muscle from the lumbar spine
and subsequent retraction in the posterior direction, not dissection of the psoas
muscle.” Youssef Decl. ¶ 35.
Similarly, page 229 of Chapter 13 of Zdeblick refers to “dissection of the
psoas muscle,” but Figure 13-6 shows the muscle being retracted.
Thus, neither disclosure in Mayer or Zdeblick firmly establishes “{5}
advancing the distal tip of the dilation member in a substantially lateral direction
through the psoas muscle toward a spinal target site.”
Dr. Lieberman, Requester’s expert, testified that “trans-psoas approach was
a readily available technique for surgeons wishing to access the spine for such
procedures as lateral lumbar interbody fusions.” Lieberman Decl. ¶ 35. He also
testified that he had used such approach since 1993. Id. However, Dr. Lieberman
did not cite any factual support for this opinion.
In the Rebuttal Brief, Requester cited to the 1996 de Peretti article8 cited in
Mayer. Requester Rebuttal Br. 14. Dr. Lieberman provided testimony on this
article:

8 F. de Peretti et al., New possibilities in L2-L5 lumbar arthrodesis using a lateral
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Further, Mayer describes and references a procedure by de Peretti
from the European Spine Journal from 1996. In the article, de Peretti
discloses a lateral retroperitoneal approach to the spine in which the
“psoas muscle is incised longitudinally” in exactly the same fashion as
the psoas muscle split described in the ’840 patent (de Peretti at p.
214). In Figure 4C, de Peretti conclusively shows the psoas muscle
being split in line with its fibers and one of ordinary skill in the art
would have understood this. A Love or Cobb retractor is then inserted
through the lateral incision and into the incised psoas muscle.
Lieberman Decl. ¶ 34 (emphasis added).
Dr. Lieberman did not quote de Perettiin its entirety. The passage reads as
follows:
The sympathic chain is visualized and the fascia of the psoas muscle
is incised longitudinally. The muscle is retracted dorsally by a Love
retractor and the targeted disc is localized using fluoroscopic control
and a blunt pin.
de Peretti 214 (emphasis added.)
A “fascia” is the sheet of tissue surrounding the muscle.9 Thus, contrary to
Dr. Lieberman’s statement, de Peretti does not teach incising the psoas muscle in
the quoted passage, but the tissue sheet surrounding the muscle. Consequently, we
do not find Dr. Lieberman’s testimony on this publication credible and shall
discount it.
Nonetheless, Requester cited three alternative publications that were said to
describe the trans-psoas approach to accessing the spine: Kossmann,10 Traynelis,11

retroperitoneal approach assisted by laparoscopy: preliminary results, 5 EUR.
SPINE J. 210-216 (1996).
9 http://www.thefreedictionary.com/fascia (referenced April 3, 2015).
10 Kossman et al., Minimally Invasive Vertebral Replacement with Cages in
Thoracic and Lumbar Spine. 27 EUROPEAN JOURNAL OF TRAUMA 292-
300 (2001).
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and Pimenta.12 Requester Rebuttal Br. 15. These publications were cited in the
related inter partes reexaminations specifically for teaching accessing the spine
through the psoas muscle, but were not cited in the ground of rejection. Request 5,
71-72. We therefore cannot ignore their teachings, even if they were not included
in the statement of the rejection. The following teaching from Kossmann is
pertinent:
To reach the vertebral bodies of the lumbar spine, the psoas muscle
was mobilized at least in part and pushed backwards to reach the
lateral aspect of the vertebra. In some cases, tilting the table to the
side of the surgeon eased the access procedures. Splitting of the psoas
muscle along its fibers had to be done in some very athletic patients,
since the excessive size of the muscle did not allow a direct lateral
access to the vertebra.
Kossmann 296.
The Pimenta publication, which is in Spanish with no English translation,
has the following disclosure in its abstract:
Two different approaches were used: the posterior microendoscopic
approach, with the implantation of the PDN through the METRIX
tube(Medtronic), and another, the retroperitoneal transpsoas
laparoscopic approach. In four cases we introduced two PDN by
posterior approach. Two of them extruded. We introduced in other
two posterior approach cases only one PDN. Afterwards, we started
to use the retroperitoneal approach, introducing only one PDN.
Both publications indicate that the trans-psoas muscle approach has been
used to access the spine. Therefore, even if Mayer and Zdeblick describe
retraction of the psoas muscle to access the spine, a preponderance of the evidence

11 Vincent C. Traynelis, Spinal Arthroplasty, NEUROSURGICAL FOCUS (Posted
10/28/2002), www.medscape.com.
12 Luiz Henrique Mattos Pimenta et al., Implante de próteste de núcleo pulposo:
análise inicial, 12(2) JOURNAL BRASILEIRO DE NEUROCIRURGIA 93-96(2001).
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supports the determination that going through the psoas muscle was an obvious
alternative, particularly in “very athletic patients.”

Step {6}
Requester provided persuasive argument that it would have been obvious to
one of ordinary skill in the art to have used “a stimulation electrode on the dilation
member to monitor for the presence of nerves in the vicinity of the dilation
member.” Specifically, Blewett’s teaching of using a stimulation electrode to
prevent nerve damage was referenced. Request 62.

Summary
There is insufficient evidence in this record that cited publications describe
or suggest: {4} “using at least a portion of the finger to guide the distal tip of the
dilation member within the retroperitoneal space toward a psoas muscle.”
Accordingly, we conclude that the Examiner did not err in withdrawing the
previously adopted rejection of claim 1 as obvious in view of Mayer, Zdeblick, and
Blewett, and of dependent claims 2-8, 10, 12-14, 18-23, and 29 (rejections 1 and
2).

B. Claim 9
Independent claim 9 also requires {4} “using at least a portion of the finger
to guide the distal tip of the dilation member within the retroperitoneal space
toward a psoas muscle.” Accordingly, we conclude that the Examiner did not err
in withdrawing the rejection of claim 9 as obvious in view of Mayer, Zdeblick and
Branch, and dependent claims 15, 17, 24-28 (rejections 3 and 4).
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III. REJECTIONS OVER BRAU AND ZDEBLICK
A. Claim 1
Requester contends the Examiner erred in withdrawing the rejection of claim
1 as obvious in view of Brau and Zdeblick.
In the Request, Brau was said to disclose accessing a spinal target site as
recited in the claim. Request 136. Disclosure from Brau was identified in which a
distraction corridor was created using a portion of a finger as in steps {1} and {2}
of claim 1. Request 136, 140, 142; Brau 169-171, 174. Specifically, Brau
discloses:
Using your index finger, carefully push the peritoneum posteriorly at
the edge of the fascial incision and slowly develop a plane between it
and the undersurface of the internal oblique and transverse muscles
and fascia, this will lead you into the retroperitoneal space.
6. Continue careful blunt finger dissection . . . .
Brau 169.
For steps {3} and {4} of inserting a dilation member into a second incision
and guiding the distal end of the dilation member with a finger, Requester cited
Brau’s description of using a retractor to create an operative corridor and the use of
a finger to guide the distal tip of the retractor blade to the spine. Request 137, 144;
Brau 173-177. Brau teaches a “blade with a small reverse lip is then placed blindly
onto the right side of the spine using the finger(s) as a guide. (Fig. 22R). This
blade is then attached to table-held retractor system, then pushed to the right to
elevate the vascular structures and expose the anterior surface of the spine.” CC-E
11, citing Brau 173, 177. The preponderance of the evidence supports Requester’s
contention that Brau describes {4} finger guidance of a surgical instrument.
Requester further cited Zdeblick for its teaching of dilation member
(“trocar”). Request 143-144. For step {5} of advancing the dilation member
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through the psoas muscle, Requester cited Zdeblick’s discussion of dissecting the
psoas muscle. Id. at 146. Requester also referred to the Kossmann publication as
teaching the trans-psoas approach, although it was not included by Requester in the
statement of the proposed rejection. Id. Blewett was referenced by Requester for
teaching step {6} of monitoring for the presence of nerves in the vicinity of the
dilator. Id. at 147.
The Examiner initially adopted the rejection, but later withdrew it.
Requester Appeal Br. 5. Requester argues that the Examiner was incorrect in
withdrawing the rejection.
We address each of the parties’ arguments below.

Surgical approach
Claim 1 requires a retroperitoneal surgical approach comprising 1) a first,
posteriolateral incision and 2) a second, substantially lateral incision. Patent
Owner contends that the Examiner correctly withdrew the rejection because Brau’s
approach is anterior and that Zdeblick’s is lateral and that there would have been
no reason to combine these two very different approaches. Owner Resp’t. Br. 24.
To support this argument, Patent Owner relied on the testimony of Dr. Youssef.
Dr. Youssef testified in his written declaration about the deficiency in Brau:
The Brau reference discloses a procedure that is significantly different in
numerous respects from the procedure described and claimed in the ’840
patent. In particular, the Brau reference discloses an anterior
retroperitoneal approach to L2 to S1 of the lumbar spine, with the patient
placed in a supine position. (Brau reference, at p. 165.) In my opinion,
this anterior approach reference has very little reference to the question
of whether or not the procedures described and claimed in claims 1 and 9
of the ’840 patent would have been obvious to a person of skill before
the filing of the ’840 patent.
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Youssef ¶ 37.
Dr. Lieberman, in contrast, testified that the combination of Brau and
Zdeblick makes the claimed surgical approach with two incisions obvious. Dr.
Lieberman explained that the “surgeon uses his/her knowledge of the anatomy,
verified by some form of guidance, for instance intra operative x-rays, and manual
palpation i.e. finger dissection to get to where they need to be. Thus, the incisions
can be located anywhere around the abdomen and flank to get to the same spinal
location.” Lieberman Decl. ¶ 19. Dr. Lieberman further discussed the incision
made by Zdeblick and concluded that “Figure 11-3 [p. 196 of Zdeblick] satisfies
the definitions of ‘substantially lateral’ incision and posteriolateral incision as it
traverses the flank from the anterior axillary line beyond the posterior axillary line.
Thus, the incision disclosed by Zdeblick is a precursor to the ‘substantially lateral’
and posteriolateral incisions as described in the ’840 patent.” Id. at ¶ 23. Citing
evidence from Zdeblick, Dr. Lieberman also declared that Zdeblick teaches
multiple incisions, including one that is “substantially lateral,” as recited in claim
1. Id. at ¶ 26.
Dr. Lieberman’s testimony is factually supported and credible. Dr. Youssef
did not persuasively address the disclosure in Zdeblick, which is said by Dr.
Lieberman to meet the claim limitations. Thus, Requester’s reliance on Zdeblick
for the position on the body where the spinal target is accessed, and then for using
Brau’s minimally-invasive finger dissection to access the spinal target (limitations
{1} and {2} of claim 1), is supported by a preponderance of the evidence.

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Dilation member
Patent Owner contends the Examiner did not err in withdrawing the rejection
because it would not have been obvious to one of ordinary skill in the art to have
substituted a sealing trocar as described in Zdeblick for the retractor described in
Brau. Owner Resp’t. Br. 26. “In particular, one of skill in the art at the time would
not have combined the trocars used for gas insufflation as disclosed in the Zdeblick
Book in place of any retractor used in the ‘gasless’ Procedure described in the Brau
Book Chapter.” Id. at 27. Dr. Youssef explained that the trocars utilized in
Zdeblick are for the purposes of gas insufflation. Youssef Decl. ¶ 21. However,
Dr. Youssef argued that the spinal access procedure in Brau is gasless, so no gas
insufflation trocar would be necessary. Id. at ¶ 22. Furthermore, Dr. Youssef
stated that “the very purposes of a ‘gasless’ procedure was to avoid the additional
complexity of using Zdeblick’s gas insufflation trocar and the side effects of the
resulting gas insufflation.” Id.
Requester challenged Dr. Youssef’s testimony. Dr. Lieberman explained
that “[a]ll forms of spinal surgery require incisions and pathways to be created to
the spine. As the field progressed from ‘open’ procedures to ‘minimally-invasive,
procedures, additional tools were required to create and maintain the surgical
pathways.” Lieberman Decl. ¶ 27. Dr. Liebermann further stated that “guidewires
and dilators were utilized in practice to locate and create the distraction or
operative corridors and safely mobilize the anatomic structures in that pathway,
respectively.” Id. Blewett, according to Dr. Lieberman, disclosed cannulas as a
tool to create pathways and used this term interchangeably with dilator. Id.
We find Dr. Lieberman’s testimony more persuasive than Dr. Youssef’s.
While Dr. Youssef may be correct that a sealing trocar would not have been
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utilized in a gasless procedure such as Brau’s, this does not mean it would not have
been obvious to have utilized a dilator to create a distraction corridor in place of
Brau’s retractor. As explained by Dr. Lieberman, it is necessary to create surgical
pathways when performing minimally invasive procedures, and there are a number
of different tools available to perform this function. Lieberman Decl. ¶ 27.
Blewett, as cited by Dr. Lieberman, specifically teaches that dilating cannulas are
used to access surgical targets during spinal surgery.
The surgical accessories 20 may include, but are not necessarily
limited to, surgical access components (such as a K-wire 24, one or
more dilating cannula 26, and a working cannula 28).
Blewett 6:28-30.
Cannulae of increasing diameter are then guided over the previously
installed cannula 26 until the desired lumen is installed. By way of
example only, the dilating cannulae 26 may range in diameter from 6
mm to 30 mm. In one embodiment, each cannula 26 has four
orthogonal stimulating electrodes at the tip to allow detection and
direction evaluation, as will be described below. The working
cannula 28 is installed over the last dilating cannula 26 and then all
the dilating cannulae 26 are removed from inside the inner lumen of
the working cannula 28 to establish the operative corridor
therethrough.
Id. at 10: 1-12.
In view of this disclosure and Dr. Lieberman’s testimony, we agree with
Requester that it would have been obvious to one of ordinary skill in the art to have
used a dilator to create a surgical pathway in place of a retractor.

Finger guidance
Patent Owner argues that the Examiner did not err in withdrawing the
rejection because there is no disclosure or suggestion in either Brau or Zdeblick of
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a surgeon using at least a portion of his or her finger (inserted in a posteriolateral
incision) to guide the advancement of a distal tip of a dilation member (inserted in
a substantially lateral incision) in the retroperitoneal space toward the psoas
muscle, as required by claims 1 and 9 of the ’840 patent. Owner Resp’t Br. 27.
This argument has little merit. As discussed above, Brau describes using a
finger to guide the retractor, making it obvious to guide other instruments with the
finger through the surgical pathway. Patent Owner’s statements in the Brief and
Dr. Youssef’s in the declaration are not adequately supported by factual or logical
reasoning, nor do they adequately address the specific disclosure in Brau
describing using a finger to guide an instrument.

Through the psoas muscle
With respect to the requirement of claim 1 of “{5} advancing the distal tip of
the dilation member in a substantially lateral direction through the psoas muscle
toward a spinal target site,” Kossmann and Pimenta describe such approach as an
alternative to muscle retraction. See supra at p. 14. For the reasons discussed
above at p. 14, we conclude that it would have been obvious to one of ordinary
skill in the art to have utilized the trans-psoas approach in Brau and Zdeblink’s
surgical procedures.

Summary
For the foregoing reasons, we reverse the Examiner’s determination to
withdraw the rejection of claim 1 as obvious in view of Brau, Zdeblick, and
Blewett (rejection 5), and denominate the rejection as a new ground, further
relying on Kossman and Pimenta. A decision by the Board reversing the
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examiner’s determination not to make a rejection proposed by a requester shall be
designated a new ground of rejection under 37 C.F.R. § 41.77(b). Dependent
claims 2-8, 10, 12-14, 18-23, and 29 (rejections 5 and 6) were not argued
separately. We reverse the Examiner’s determination to withdraw the rejections of
these claims, as well, for the reasons given by Requester in the original Request for
Reexamination.

B. Claim 9.
Claim 9 is similar to claim 1, but does not require the trans-psoas approach.
For the same reasons as for claim 1, we reverse the Examiner’s determination to
withdraw the rejection of claim 9 as obvious in view of Brau and Zdeblick
(rejection 7). Dependent claims 15-17 and 24-28 (rejections 7 and 8) were not
argued separately. We reverse the Examiner’s determination to withdraw the
rejections of these claims, as well, for the reasons given by Requester in the
original Request for Reexamination.

SUMMARY
The Examiner’s determination to withdraw the previously adopted
Rejections 1-4 is AFFIRMED.
The Examiner’s determination to withdraw the previously adopted
Rejections 5-8 is REVERSED. Because additional prior art was cited by the
Requester but not referenced in the statement of the rejection, the rejections have
been modified as follows (underlining indicates added publications):
5. Claims 1-7, 10, 12-14, 18-23, and 29 under 35 U.S.C. § 103(a) as
obvious in view of Brau, Zdeblick, Blewett, Kossmann, and Pimenta.
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6. Claim 8 under 35 U.S.C. § 103(a) as obvious in view of Brau, Zdeblick,
Blewett, Branch, Kossmann, and Pimenta.
7. Claims 9 and 24-28 under 35 U.S.C. § 103(a) as obvious in view of Brau
and Zdeblick.
8. Claims 15 and 17 under 35 U.S.C. § 103(a) as obvious in view of Brau,
Zdeblick, and Branch.

NEW GROUND OF REJECTION

This decision contains a new ground 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.” Correspondingly, no portion of the decision is final for purposes of
judicial review. A requester may also request rehearing under 37 C.F.R. § 41.79, if
appropriate; however, the Board may elect to defer issuing any decision on such
request for rehearing until such time that a final decision on appeal has been issued
by the Board.
For further guidance on new grounds of rejection, see 37 C.F.R. § 41.77(b)-
(g). The decision may become final after it has returned to the Board. 37 C.F.R.
§ 41.77(f).
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 prosecution is limited to issues raised by the new ground(s) of
rejection entered by the Board. A request to reopen prosecution that includes
issues other than those raised by the new ground(s) is unlikely to be granted.
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Furthermore, should the patent owner seek to substitute claims, there is a
presumption that only one substitute claim would be needed to replace a cancelled
claim.
A requester may file comments in reply to a patent owner response.
37 C.F.R. § 41.77(c). Requester comments 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 patent owner’s response under paragraph 37 C.F.R.
§ 41.77(b)(1). A newly proposed rejection is not permitted as a matter of right. A
newly proposed rejection may be appropriate if it is presented to address an
amendment and/or new evidence properly submitted by the patent owner, and is
presented with a brief explanation as to why the newly proposed rejection is now
necessary and why it could not have been presented earlier.
Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for all
patent owner responses and requester comments, is required.
The examiner, after the Board’s entry of a patent owner response and
requester comments, 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. The
proceeding will then be returned 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).

REVERSED; 41.77(b)

peb
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PATENT OWNER:

FISH & RICHARDSON P.C. (TC)
PO Box 1022
Minneapolis, MN 55440-1022

THIRD PARTY REQUESTOR:

NDQ SPECIAL REEXAM GROUP
1000 Louisiana Street,
Fifty-Third Floor
Houston, TX 77002