Ex Parte 7905840 et al

Patent Trial and Appeal Board

Dec 19, 2016

95001890 (P.T.A.B. Dec. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
95/001,890 02/09/2012
21971 7590 12/19/2016
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
FIRST NAMED INVENTOR
7905840
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
41701.706.999 1564
EXAMINER
WILLIAMS, CATHERINE SERKE
ART UNIT PAPER NUMBER
3993
MAILDATE DELIVERY MODE
12/19/2016 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.
Patent of
NUV ASIVE, INC.
Patent Owner and Respondent
Appeal2017-001163 1
Reexamination Control 95/001,890
Patent 7 ,905,840 B22
Technology Center 3900
Before RICHARD M. LEBOVITZ, DANIELS. SONG, and BRETT C. MARTIN,
Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
§ 41.77(f) DECISION
1 The real party in interest and owner of the US 7 ,905,840 B2 is Nu Vasive, Inc.
("Patent Owner"). The Third-Party Requester informed the Board that it reached a
"settlement" and will no longer participate in the reexamination. Notice ofNon-
Participation (Feb. 19, 2015).
2 "The ' 840 patent."
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This is a final decision under 37 C.F.R. § 41.77(f).
The Third-Party Requester in the above-identified inter partes
reexamination of United States Patent No. 7,905,840 B2 appealed the Examiner's
decision to withdraw previously adopted rejections of claims 1-10, 12-15, and 17-
29. Third-Party Requester Appeal Brief (Jul. 15, 2013). The appeal was decided
by the Patent Trial and Appeal Board Decision on April 29, 2015 ("the 8965
Decision"). The Board agreed with the Requester that the Examiner erred in not
adopting Rejections 5 through 8, as follows, and designated them as new grounds
of rejection. The full citations to the cited prior art are listed in the 8965 Decision.
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.
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.
In response to the 8965 Decision, Patent Owner filed a request to
reopen prosecution under § 41. 77 (b )( 1) accompanied by a second
declaration by Jim A. Youssef, M.D. (Youssef 2 Deel.). Patent Owner
Response after Board Decision (Jun. 29, 2015) ("PO Resp. Board Dec."). A
first declaration by Dr. Youssef had previously been considered in the 8965
Decision (Youssef 1 Deel.). 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 1 Deel. i-f 1.
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Subsequent to Patent Owner's response to the 8965 Board Decision, the
Examiner made a determination under§ 41.77(d) ("41.77d Determination") that
Patent Owner's arguments and new evidence did not overcome the new grounds of
rejection. Patent Owner responded under§ 41.77(±) with comments on the
Examiner's determination ("PO Resp. Examiner Determination"). The proceeding
has now been returned to the Board pursuant to§ 41.77(±) to reconsider the
rejections and issue a final decision. As explained in detail below, we agree with
the Examiner's determination and maintain the new grounds of rejection 5-8.
Lieberman declaration
In addition to the second declaration of Dr. Youssef, a declaration on behalf
of Requester by Isador H. Lieberman, M.D. was also considered in the 8965
Decision. Dr. Lieberman is a board certified orthopedic surgeon, specializing in
spine surgery. Lieberman Deel. iJ 6. Dr. Lieberman's declaration is again relied
upon in this§ 41.77(±) Decision.
Claimed subject matter
The claimed subject matter of the '840 patent is directed to spinal surgery.
The method involves guiding a dilation member within a retroperitoneal space (the
abdominal space behind the peritoneum, which serves as the lining of the
abdominal cavity) 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
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substantially lateral direction toward a spinal target while monitoring for the
presence of nerves in the vicinity of the dilation member.
Claim 1 reads as follows (numbering added in brackets for reference to the
steps in each claim):
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.
Subject matter jurisdiction
Patent Owner contends that the Board does not have jurisdiction to enter
new grounds of rejection because Requester withdrew from the proceeding, and
that a decision in favor of the Patent Owner, or terminating the reexamination
should have been entered. PO Response Board Dec. 2. To support this position,
Patent Owner cited a Federal Circuit case, unrelated to inter partes reexamination,
said to hold that settlement moots an action. Id.
An inter partes reexamination is a reexamination by the USPTO of granted
patent claims upon Request by a Third-Party. 35 U.S.C. § 311 (pre-AIA). The
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Third-Party Requester may participate in the conduct of the examination ("[T]he
third-party requester shall have one opportunity to file written comments
addressing issues raised by the action of the Office or the patent owner's response
thereto .... "). 35 U.S.C. § 314(b)(2) (pre-AIA). Consequently, the Requester's
participation in the reexamination proceeding is optional. Appeals by either Patent
Owner or Third-Party Requester to the Board are based on a decision by the
USPTO adverse or favorable to the patentability of claims. 35 U.S.C. § 315 (pre-
AIA). The issue to be resolved is, therefore, the patentability of the claims, of
concern not only to the Requester and Patent Owner, but also to the public. The
proceeding involves the patentability of claims as determined by the USPTO, not a
private dispute between Requester and Patent Owner. The statute does not
expressly require the Requester to participate in the reexamination for it to go
forward. 35 U.S.C. § 314 (pre-AIA). Indeed, as mentioned, Requester's
participation is optional and not necessary for the reexamination to proceed. We
have not been directed to a statutory basis as to why, when the Requester has
decided not to participate in the reexamination, the reexamination should be
terminated. See also Consumer Watchdog v. Wisconsin Alumni Research
Foundation, 753 F.3d 1258 (Fed. Cir. 2014), where there Third-Party Requester
lacked standing to appeal the decision affirming the patentability of the amended
claims. Moreover, any requests for termination of a reexamination proceeding
should have been requested via a petition.
With regard to Patent Owner's argument that they did not have an
opportunity to be heard (PO Resp. Board Dec. 3), we note that Patent Owner filed
two responses (PO Resp. after Board Decision; PO Response after Examiner
Determination) after the Board's 8965 Decision and new evidence that has been
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thoroughly considered below. Consequently, we are not persuaded the Patent
Owner was denied due process.
Brau (2003) as prior art
Brau is cited in all rejections. Because the Examiner discussed another Brau
publication published in 1983, we refer to the cited Brau publication as "Brau
(2003)" and to the second Brau publication as "Brau (1983)."
Brau (2003) was published in 2003, the same year the provisional
application to which the '840 patent claims benefit was filed. The provisional
application was filed Oct. 1 7, 2003. Patent Owner contends that the Examiner did
not establish that Brau (2003) is prior art, i.e., published prior to Oct. 17, 2003. PO
Response Board Dec. 3. For this reason, Patent Owner contends all the rejections
should be withdrawn "due to the failure of Brau [2003] to be qualified as available
[as] prior art." Id., 4.
We are not persuaded by this argument.
We have not been directed to where this argument had been made previously
by Patent Owner in this record. Consequently, in our opinion, Patent Owner is
barred from raising it now because Patent Owner has not established that this
argument is supported by the record in this inter partes reexamination. Rexnord
Industries LLC. v. Kappas, 705 F.3d 1347, 2355-56 (Fed. Cir. 2013).
Furthermore, Patent Owner's Respondent Brief (Aug. 15, 2013) addresses
Brau (2003) substantively, without raising the issue of whether it is prior art to the
rejected claims. Patent Owner Respondent Br. 24-29. Similarly, Brau (2003) was
addressed substantively in Patent Owner's response to the Office Action of Apr.
12, 2012, rejecting claims as obvious in view of Brau (2003). Patent Owner Reply
25 (Jun. 12, 2012). From these explicit actions, it appears that Patent Owner
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conceded in this record that Brau (2003) is prior art, and has waived any arguments
to the contrary.
Patent Owner argues that Brau (2003) has not been qualified or proven to be
prior art, but provided no information to establish that it is not prior art to the
rejected claims. PO Resp. Examiner Determination 6. Patent Owner has merely
raised the question of whether Brau (2003) is prior art because its copyright date is
2003, while the provisional application was filed the same year on Oct. 17, 2003,
but does nothing to answer the question. In fact, Patent Owner did not assert that
Brau (2003) is not prior art. The thrust of their argument is that the Examiner did
not prove it was published prior to Oct. 17, 2003; however, we have not been
directed to where in the record Patent Owner asked the Examiner for proof
previously. For example, Patent Owner did not challenge Brau (2003) as prior art
in their Respondent Brief in arguing why the rejection over Brau (2003) should not
be adopted.
Patent Owner contends that the "Examiner essentially concedes that Brau
has not been established as prior art under 35 U.S.C. § 102(a)." PO Resp.
Examiner Determination 6. We do not agree. Patent Owner's statement is
apparently based on the Examiner's response that the disclosures relied upon in the
2003 edition of Brau are supported back to a 1983 edition of Brau. Examiner's
Determination 3--4. This is not a concession that Brau (2003) is not prior art;
rather, it was an attempt to show that the teachings in Brau (2003) were available
as far back as 1983. Nonetheless, we have not considered the disclosure in Brau
(1983).
Youssef declaration
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Patent Owner contends that the Examiner did not consider the second
declaration of Dr. Youssef because the Examiner indicated that certain arguments
were not new to the second declaration, but had been previously addressed in the
Board decision. PO Resp. Board Dec. 10.
We do not agree. The Examiner indicated she considered "Patent Owner's
response with arguments including the second Declaration of Dr. Jim Youssef,"
but found that they did not overcome the rejection. 41.77d Determination 3.
While the Examiner may not have addressed all arguments made by Dr. Youssef in
the Determination, this does not mean the declaration was not considered.
Alleged impermissible hindsight and lack of reasoned explanation
Patent Owner contends that "the proposed combination [of cited prior art
publications] lacks objective or logical support." PO Resp. Board Dec. 12. Patent
Owner also asserts that the "record lacks any objective evidence or reasoned
explanation that the cited references would have suggested the claimed invention
to a person of ordinary skill in the art." Id., 13. Furthermore, Patent Owner
contends: "Neither the Board in its Decision nor the Examiner has expressly
indicated what the combined teachings of the references would have suggested to
those of ordinary skill in the art." Id., 15.
We disagree. Patent Owner has simply made general unsupported
statements about the lack of reasoning in the 8965 Decision.
To the contrary, on page 18 of the 8965 Decision, it was explained why the
claimed surgical approach with two incisions would have been obvious based on
Zdeblick. On pages 19-20 of the Decision, it was explained that the one of
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ordinary skill in the art would have had reason to use a dilator in place of the
retractor in Brau:
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 Deel. i-f 27. Blewett, as cited by Dr. Lieberman,
specifically teaches that dilating cannulas are used to access surgical
targets during spinal surgery.
8965 Decision 20.
The 8965 Decision also explained why finger guidance ("Brau describes
using a finger to guide the retractor, making it obvious to guide other instruments
with the finger through the surgical pathway") and a trans-psoas approach
("obvious alternative, particularly in 'very athletic patients"') would have been
employed. Id., 14-15, 21. Patent Owner did not identify a defect in the reasoning,
but rather appeared to ignore it by making the general and erroneous allegation that
such reasoning was missing from the 8965 Decision.
Rejection 5. Rejection over Brau (2003), Zdeblick, Blewett, Kossmann, and
Pimenta
A. Can Brau (2003) and Zdeblick be combined?
Patent Owner contends that a person of ordinary skill in the art "would not
and could not have combined" Brau (2003) and Zdeblick to have arrived at the
claimed invention. PO Response Examiner Determination 15. Patent Owner
states:
Open procedures such as Brau typically use surgical tools such as
retractors to hold vessels away from the surgical site. 2nd Youssef
Deel. i-f 13. On the other hand, endoscopic procedures such as
Zdeblick typically use gas insufflation to hold the peritoneum and its
contents away from the surgical site. 2nd Youssef Deel. i-f 15. The
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size constraints placed on surgical tools used in open and endoscopic
procedures, in addition to differences in the physical structures to be
avoided, generally result in a lack of interchangeability between
surgical tools associated with these two types of lumbar surgical
procedures. 2nd YoussefDecl. 17, 18, 21-25.
Id., 14.
Patent Owner has misapprehended the rejection.
Brau (2003) is cited for the first four steps of the claim in which an incision
is made, a distraction corridor is made using a finger ("sweeping at least a portion
of the finger in the retroperitoneal space") as in steps 1 and 2 of claim 1, and in
which an instrument is inserted into a second incision, where a finger is used to
guide the instrument's distal end as in steps 3 and 4. 8965 Decision 16, 17-18.
Zdeblick is cited for the specific orientation of the incision as recited in steps 1 and
3 of claim 1. Id., 18. Zdeblick, Kossmann, and Pimenta are cited for step 5 in
which "the distal tip of the dilation member [is advanced] in a substantially lateral
direction through the psoas muscle toward a spinal target site." Id., 16-17, 21.
Blewett is cited for teaching step 6 of claim 1 of monitoring for the presence of
nerves in the vicinity of the dilator to avoid nerve injury. Id., 17.
It is evident from the rejection that Brau (2003) is primarily relied upon for
using a finger to assist in surgery. As explained in the 8965 Decision,
"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." 8965 Decision 18. Zdeblick was also cited for
teaching a dilation member ("Trocar"; cutting instrument shaped like a cannula).
Id., 19. Dr. Lieberman's testimony, citing Blewett and common practices in
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surgical procedures, was also relied upon for suggesting the claim dilation
member:
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." [Lieberman Deel. i-f 27]. Blewett, according to Dr.
Lieberman, disclosed cannulas as a tool to create pathways and used
this term interchangeably with dilator. Id.
8965 Dec. 19.
Patent Owner's argument that Brau (2003) and Zdeblick would not have
been combined by a surgeon at the time of the invention ignores the fact that Brau
(2003) is primarily relied upon for teaching the use of a finger in surgical
procedures, which Dr. Lieberman testified "is as old as the art of surgery."
Lieberman Deel. i-f 31. Patent Owner did not persuasively explain why the skilled
worker would not have used a finger in Zdeblick' s procedure to manually
manipulate tissue. Dr. Youssef stated that "open hand surgical procedure of Brau
[2003] could not be accomplished using the Zdeblick surgical access approach, at
least because the small incisions utilized in Zdeblick's surgical access approach
would not be amenable to insertion of the hand." Youssef 2 Deel. i-f 25. However,
as indicated by Dr. Lieberman, using a finger in surgical procedures was not new.
Dr. Youssef did not explain why a finger could not be used in Zdeblick.
Therefore, Patent Owner's argument that the procedure suggested by Brau (2003)
and Zdeblick must accommodate "an entire human hand" (PO Resp. Examiner
Determination 17) is improper because it attempts to bodily incorporate Brau
(2003) into Zdeblick without considering that the ordinary skilled worker, namely
a surgeon, would have understood how to use a finger in the retroperitoneal
approach using either large or small incisions.
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B. Incision
The claim requires "a first, posteriolateral incision" and "a second,
substantially lateral incision." A "posteriolateral incision" is one that starts from
the back of the patient and cuts through in a lateral direction. Dr. Youssef testified
that "Brau [2003] discusses an anterior retroperitoneal approach." Youssef 2 Deel.
ii 12. However, in the Decision, Dr. Lieberman's testimony was cited that
Zdeblick describes an incision that meets the claimed orientation and that it would
have been obvious to the ordinary skilled worker to have implemented the incision
in Brau (2003)'s procedure. 8965 Dec. 18.
Dr. Youssef did not challenge Dr. Lieberman's testimony regarding the
orientation of the incision in Zdeblick. Rather, Dr. Youssef argued that Zdeblick' s
procedure is "fundamentally distinct" from Brau (2003) "in a number of respects"
leading him to conclude "that the references of Brau [2003] and Zdeblick could not
reasonably be combined in the first place." Youssef 2 Deel. ii 17. Dr. Youssef
stated:
Id.
Brau [2003] discloses an open anterior approach to the lumbar spine
utilizing a relatively large incision, held open by retractors, for direct
visualization of the vertebral bodies involved and insertion of the
surgeon's hand. (Brau [2003], pp. 173-77.) Zdeblick, in contrast,
discloses use of gas-tight trocars in the context of accessing the
retroperitoneal space using a laparoscopic gas insufflation procedure.
(Zdeblick, pp. 223-25, 231-32, 236, 252-53.)
Dr. Youssef also stated that a person of ordinary skill at the time of the
invention "would not have considered combining the teachings of the references so
as to use the surgical incision and access approach of Zdeblick to conduct the
lumbar access procedure of Brau [2003], as suggested in the Decision (e.g., pp. 17-
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18)" because "the open surgery anterior access approach disclosed in Brau [2003]
would be viewed as fundamentally different and incompatible with the surgical
access disclosed in Zdeblick." Id., i-f 23.
Zdeblick expressly teaches that "posterolateral approaches" were used to
access the spine, but that more recently developed procedures utilize anterior
approaches. Zdeblick 221. Thus, while the anterior and posterior approaches are
clearly different, one of ordinary skill would have understood that both procedures
can be used, and were used, to successfully to access the spine. Dr. Lieberman
testified that Kossmann also used a posteriolateral incision. Lieberman Deel. i-f 24.
Thus, a preponderance of the evidence supports the determination that access from
the anterior or posterior lateral side could be routinely implemented in Brau
(2003). Indeed, the main teaching in Brau (2003) relied upon by the Examiner and
Requester is using a finger to sweep into the retroperitoneal space and guide a
dilation member. Dr. Youssef stated that blind placement using finger guidance
would not be used, and argues that both Brau (2003) and Zdeblick rely on
visualization (Youssef 2 Deel. i-f 15). However, as explained below, we have not
been pointed to language in the claims that would exclude visualization of the
finger as it guides an instrument to its desired location.
C. Finger guidance
Dr. Youssef attempted to distinguish the claims from Brau (2003) and
Zdeblick, stating that "the '840 patent teaches a retroperitoneal procedure without
gas insufflation or expanding mechanisms to enlarge the retroperitoneal space, and
without visualization either by direct visualization during an open surgical
procedure or endoscopic viewing." Id., i-f 10. Dr. Youssef stated that, instead, "the
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procedures recited in the '840 patent claims involve ... finger-guiding of
instruments that are advanced in a substantially lateral direction within the
retroperitoneal space without the aid of any visualization." Id. (emphasis added.)
Dr. Youssef stated that Brau employed "direct visualization by the surgeon in an
open surgical site." Id., i-f 11. Dr. Youssef further stated that "a true 'blind'
placement of any instruments in Brau would in fact put vital anatomic structures at
risk of iatrogenic injury and one of ordinary skill in the art would not perform such
maneuvers in a truly 'blind' fashion." Id., i-f 14.
Patent Owner has not directed us to language in the claim that would
exclude "direct visualization" and require guidance of instrumentation "without
visualization," which Dr. Youssef argues distinguishes the claimed method from
Brau (2003). For this reason, we find Dr. Youssefs testimony on this issue to be
unpersuasive because such limitations do not appear in the claims. Dr. Youssef
attempts to distinguish Zdeblick on the same basis. Id., i-f 15.
The claim 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." Dr. Youssef contends:
The open hand surgical procedure of Brau could not be accomplished
using the Zdeblick surgical access approach, at least because the small
incisions utilized in Zdeblick' s surgical access approach would not be
amenable to insertion of the hand, the Brau tools (e.g., retractor blade)
or the corresponding surgery. Zdeblick' s surgical approach and small
incisions would be too small to permit insertion of the hand as
described in Brau. As such, using only the Zdeblick surgical access
would preclude the ability to perform the surgical operation of Brau,
including hand insertion and retractor blade positioning.
Id., i-f 25.
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First, we have not been directed to language in the claims that would
exclude a surgeon from inserting a whole hand into the incision. Consequently,
Dr. Youssef' s argument is directed to a limitation that is not recited in, nor
required by, the claims. Second, Zdeblick is not relied upon for finger-guidance.
Brau (2003) was cited for this feature:
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 [Claim Chart E appearing in the
Request for Inter Partes Reexamination] 11, citing Brau 173, 177.
8965 Dec. 16.
Patent Owner has not provided adequate evidence that a finger could not be
used to guide an instrument as suggested in Brau through a posteriolateral incision
as described in Zdeblick. Dr. Youssef's main argument appears to be that hand
could not be inserted using Zdeblick's incisions, but he fails to account the level of
ordinary skill in the art, i.e., that if a hand doesn't fit, the surgeon would
understand that a finger could still be used to access and guide the instrument. As
stated by Dr. Lieberman:
I find it incredible that this is considered a novel element in a claim.
Utilizing a finger for guidance of surgical tools is intuitive and
obvious and is commonly used in every surgical discipline. Further,
the use of a finger is even instinctive when wanting to increase
stability or positioning accuracy when inserting or manipulating any
manner of surgical tools through any surgical approach.
Lieberman Deel. i-f 31.
D. Dilation member
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The claim requires a "dilation member" to be guided within the
retroperitoneal space and then "advancing the distal tip of the dilation member in a
substantially lateral direction through the psoas muscle toward a spinal target site."
The '840 does not provide a definition of a "dilation member." However, "dilating
cannula 44" and "split-dilator 48" are shown in Fig. 9 which are depicted as hollow
members that hold wires and electrodes, and which can be used to distract tissue.
'840 patent, col. 9, 11. 15--46. The '840 patent also describes using sequential and
larger diameter dilators which are shown in Figs. 12 and 41 as fitting over the
initial dilating cannula 44. Id., col. 9, 11. 47-60; col. 15, 11. 13-24. Retractor
blades can be introduced over the dilator. Id., col. 15, 11. 25-33. Based on this
disclosure, the claimed "dilation member" is interpreted to be a hollow tube that
can accommodate wires and electrodes, that can be used to create a distraction
corridor, and that a retractor blade assembly can fit over.
Brau (2003) utilizes a retractor with blades to keep the incision open. Brau
(2003) 169. 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." Id., 173. The reverse lip "keeps
the blade anchored to the edge of the spine and prevents it from slipping anteriorly
once tension is applied." Id., 177. Brau (2003) states that "[w]ithout this reverse
lip, the retractor blade will not work effectively and the exposure will not be secure
or stable." Id.
Based on these teachings, Dr. Youssef states:
[I]t would [be] dangerous and make no sense to replace the reverse-
lipped retractor blade of Brau [2003] with a trocar of Zdeblick. The
reverse-lipped retractor blade of Brau [2003] is selected to retract and
protect the vascular structures and expose the anterior surface of the
spine .... In contrast, the trocar of Zdeblick lacks the reverse lip
structure is designed to seal in gas in the retroperitoneal cavity.
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(Zdeblick, pp. 223-25, 231-32, 236, 252-53.) As Brau [2003]
expressly indicates the trocar of Zdeblick would "not work
effectively" in Brau [2003].
Youssef 2 Deel., i-f 21.
Furthermore, Dr. Youssef states:
Zdeblick discloses that "[t]his instrument [an optical trocar] is a lens-
tipped trocar that may contain a knife or simply sharp edges that will
either cut or split the muscle layers of the abdominal wall ... "
(Zdeblick, p. 223.) A surgeon would not use a trocar to retract tissue
or hold open the surgical site as in Brau [2003] because such a trocar
is not designed or suitable for that purpose.
Id., i-f 22.
Dr. Youssef is addressing the publications individually.
Brau (2003) identifies the psoas muscle (Brau (2003) 169, 170), but does not
describe going "through the psoas muscle toward a spinal target site." Fig. 22S of
Brau (2003) (id., 176) shows the psoas muscle retracted aside by the reverse lip
retractor blade. The 8965 Decision, citing Kossmann and Pimenta, found that
alternatively the spine could be accessed through the psoas muscle. 8965 Dec. 14.
The 8965 Decision further explained, relying on Dr. Lieberman's testimony, that
cannulas, namely dilation members, were routinely used to create corridors in
spinal surgery. Id., 19. The 8965 Decision also cited Dr. Lieberman's testimony
that Blewett, which describes a nerve monitoring system, utilizes cannulas to
create an operative corridor in the tissue in the same way described in the '840
patent. Blewett 10: 1-8; Lieberman Deel. i-f 27. As explained by Dr. Lieberman,
when splitting the psoas muscle, the risk of severing a nerve in the muscle would
be minimized by using Blewett's nerve monitoring system. Lieberman Deel. i-f 37.
The skilled worker would have had reason to replace Brau (2003)'s curved lip
retractor with cannulas (i.e., dilation members) because Blewett uses such
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instruments to access the spine when using its electronic nerve monitoring system
to avoid nerve injury. See Kossmann discussion below, providing the reason to
have utilized Blewett' s nerve monitoring system.
Dr. Youssef' s argument about the danger of utilizing the specific trocar
(cannula) of Zdeblick (Youssef2 Deel. iJ 22) fails to address Dr. Lieberman's
testimony as discussed above and in the 8965 Decision about cannulas being
conventionally utilized in spinal surgery. 8965 Dec. 19-20. While Dr. Youssef
cited disclosure from Brau (2003) (cited above) that the reverse lip was necessary
for the retractor to work effectively (Youssef 2 Deel. iJ 21 ), Dr. Youssef did not
address the fact that the rejection modified the approach described in Brau (2003)
for accessing the spine, citing the alternative technique taught by Kossmann of
going through the psoas muscle using Blewett's nerve monitoring system. Neither
Dr. Youssef nor Patent Owner established the need for Brau (2003)' s reverse lip
retractor when utilizing the trans-psoas approach in combination with Blewett's
nerve monitor to minimize nerve damage. Consequently, we find Dr. Youssef's
testimony unavailing.
Patent Owner also argues that the skilled worker would not have viewed
retractors and cannulas as interchangeable. PO Response Examiner Determination
20. In support of this argument, Patent Owner identifies the difference between the
different instruments utilized in Brau (2003) and Blewett. Id., 20-21. Patent
Owner misapprehends the rejection by focusing on the cited prior art individually,
without considering what the prior art as a whole suggests. Kossmann expressly
teaches that the spine can be accessed through the psoas muscle. Kossmann 296.
When using such approach, the skilled worker would have had the knowledge, as
established by Dr. Lieberman (iii! 35-37), to have employed a dilator rather than
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the retractor of Brau (2003). As explained above, Brau (2003)'s retractor was
employed when access to the spine was gained by moving the psoas muscle aside,
rather than splitting it. Thus, Patent Owner's contention that Brau (2003)'s
retractor is not interchangeable with Blewett (PO Response Examiner
Determination 21) is unpersuasive because that was not the reasoning for utilizing
a dilation member to pass through the psoas muscle as claimed.
E. Trans-psoas approach
Kossmann was cited for its teaching of splitting the psoas muscle in spinal
surgery ("the trans-psoas approach"). Dr. Youssef criticizes Kossmann' s
teachings, stating that the trans-psoas approach is carried out in only a "few cases"
and would not have been performed with dilators or retraction blades. Youssef 2
Deel. ,-r 36.
Dr. Youssef did not provide objective evidence to substantiate his opinion.
Kossmann, as admitted by Dr. Youssef, clearly describes a trans-psoas approach.
Id. ("Kossman describes 'splitting of the psoas muscle.' (Kossman, p. 296. )")
Even if carried out in few patients, it still is a procedure which was utilized in
spinal surgery as claimed:
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. During blunt dissection,
care was taken to preserve the iliohypogastric/ilioinguinal nerves
which may cross the surgical field.
Kossmann 296.
Because Kossmann teaches to be careful to preserve nerves when splitting
the psoas muscle, the skilled worker would have had reason to have utilized
Blewett' s nerve monitoring system to avoid nerve damage. Dr. Youssef' s
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testimony about the problem of nerve injury when using the trans-psoas is
unpersuasive because Blewett teaches a solution, namely using its monitor and
dilators. Dr. Youssef s argument addresses the rejection one publication at a time,
rather than considering what is taught by the cited prior art as whole and in
combination.
Dr. Youssef states that dilators or retractors would not be used in the trans-
psoas approach, but does not explain why his suggested finger approach could only
be used to create the operative corridor rather than a dilator equipped with a nerve
monitor as described by Blewett to avoid nerve damage. See Blewett 9-10. Dr.
Youssef also indicates that a "blunt instrument" could be used to dissect through
the psoas muscle (Youssef 2 Deel. i-f 36), but did not distinguish such instrument
from the cannula in Blewett used to produce the operative corridor (Blewett 9-10)
which is explicitly used to avoid nerve injury.
Patent Owner contends that "there is no evidence of record to provide any
motivation or rationale for combinations involving Kossmann and Pimenta." PO
Response Examiner Determination 21.
The 8965 Decision explained that the trans-psoas approach was an obvious
alternative, particularly in athletic patients. 8965 Dec. 14-15.
As held in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007):
[I]f a technique has been used to improve one device, and a person of
ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill .... [A] court must ask
whether the improvement is more than the predictable use of prior art
elements according to their established functions.
In this case, the evidence shows that Kossmann' s approach is being utilized for its
established function in accessing the spine through the psoas muscle.
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Rejections 6, 7, and 8
Patent Owner did not provide separate arguments for these rejections. We
thus maintain these rejections for the reasons stated in the 8965 Decision.
SUMMARY
Rejections 5-8 are maintained. This decision is final.
TIME PERIOD FOR RESPONSE
In accordance with 37 C.F.R. § 41.79(a)(l), the "[p]arties to the appeal may
file a request for rehearing of the decision within one month of the date of: ...
[ t ]he original decision of the Board under § 41. 77 (a)." A request for rehearing
must be in compliance with 37 C.F.R. § 41.79(b). Comments in opposition to the
request and additional requests for rehearing must be in accordance with 3 7 C.F .R.
§ 41.79(c)-(d), respectively. Under 37 C.F.R. § 41.79(e), the times for requesting
rehearing under paragraph (a) of this section, for requesting further rehearing under
paragraph ( d) of this section, and for submitting comments under paragraph ( c) of
this section may not be extended.
An appeal to the United States Court of Appeals for the Federal Circuit
under 35 U.S.C. §§ 141-144 and 315 and 37 C.F.R. § 1.983 for an inter partes
reexamination proceeding "commenced" on or after November 2, 2002 may not be
taken "until all parties' rights to request rehearing have been exhausted, at which
time the decision of the Board is final and appealable by any party to the appeal to
the Board." 37 C.F.R. § 41.81. See also MPEP § 2682 (8th ed., Rev. 7, July
2008).
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In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable
under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice
on the Director of the United States Patent and Trademark Office. See 37 C.F.R.
§§ 90.1 and 1.983.
PATENT OWNER:
WILSON, SONSINI, GOODRICH & ROSATI
650 Page Mill Road
Palo Alto, CA 94304-1050
THIRD PARTY REQUESTOR:
NDQ SPECIAL REEXAM GROUP
1000 Louisiana Street,
Fifty-Third Floor
Houston, TX 77002
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