Ex Parte 7691057 et al

Patent Trial and Appeal Board

Jun 30, 2014

95001888 (P.T.A.B. Jun. 30, 2014)

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.
95/001,888 02/09/2012 7691057 20330.0002.RX057 7222
26191 7590 07/01/2014
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
07/01/2014 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 2013-009128
Reexamination Control 95/001,888
Patent 7,691,057 B2
Technology Center 3900
____________

Before DANIEL S. SONG, RAE LYNN P. GUEST, and
BRETT C. MARTIN, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON APPEAL

Third Party Requester, Globus Medical, Inc. (“Requester”) appeals
under 35 U.S.C. §§ 134(c) and 315(b) the Examiner’s decision not to reject
claims 17-22 and 24-27.
1
We have jurisdiction under 35 U.S.C. §§ 134(c)
and 315(b).

1
See Requester’s Appeal Brief 1-2 (filed January 16, 2013) (hereinafter
“Req. App. Br.”); Examiner’s Answer (mailed March 29, 2013),
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2
We heard oral arguments from Requester and Patent Owner on April
30, 2014, a written transcript of which will be entered into the electronic
record in due course.

STATEMENT OF THE CASE
United States Patent 7,691,057 B2 (hereinafter the “’057 patent”),
which is the subject of the current inter partes reexamination, issued to
Patrick Miles, et al. on April 6, 2010.
The ’057 patent is related to U.S. Patent 7,582,058, which is the
subject of Reexamination Control 95/001,247, in which a final decision on
appeal was entered April 15, 2014. The ’057 patent is also related to U.S.
Patent 7,819,801, which is the subject of Reexamination Control
95/001,889, currently on appeal and heard on April 30, 2014 along with this
reexamination. The ’057 patent is also related to U.S. Patent 7,905,840 and
U.S. Patent 7,207,949, which are the subjects of Reexamination Control
95/001,890 and 95/001,202, respectively, also currently on appeal.
The ’057 patent is the subject of a currently pending litigation in the
U.S. District Court for the District of Delaware styled NuVasive, Inc. v.
Globus Medical, Inc., Case No. 1:10-cv-00849.
Patent Owner, NuVasive, Inc.
2
(hereinafter “Patent Owner”) filed a
Respondent Brief in this appeal.

incorporating by reference the Examiner’s Right of Appeal Notice (mailed
October 16, 2012) 1 and 5 (hereinafter “RAN.”).
2
See Patent Owner Respondent Brief 1 (filed February 19, 2013)
(hereinafter “PO Res. Br.”).
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The ’057 patent relates to a system and method for accessing a
surgical target site, particularly for use in surgical procedures wherein tissue
having significant neural structures must be passed through or near, such as
spinal surgery. ’057 patent, Abstract and col. 2, ll. 61-64. Claim 17 is the
sole independent claim on appeal and was not amended during
reexamination. Claims 17 reads as follows:
1. A method of accessing a surgical target site within a
spine, comprising the steps of:
(a) creating a distraction corridor along a lateral, trans-
psoas path to a targeted lumbar spinal disc in a lumbar spine
using a distraction assembly comprising at least two dilators
that are sequentially inserted along the lateral, trans-psoas path
to the targeted lumbar spinal disc;
(b) slidably advancing plurality of retractor blades of a
retraction assembly along an outermost dilator of the at least
two dilators of the distraction assembly, the retraction assembly
comprising a handle assembly coupled to the plurality of
retractor blades such that the retractor blades extend generally
perpendicularly relative to arm portions of the handle assembly,
each of said plurality of retractor blades having a generally
concave inner face and a generally convex exterior face, said
handle assembly being capable of moving said plurality of
retractor blades from a closed position to an open position, said
closed position being characterized by said plurality of retractor
blades being positioned to abut one another and form a closed
perimeter, said open position characterized by said plurality of
retractor blades being positioned generally away from one
another and forming an open perimeter;
(c) simultaneously introducing said plurality of retractor
blades over the outermost dilator of said distraction assembly
along the lateral, trans-psoas path to the targeted lumbar spinal
disc while in said closed position;
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(d) actuating said handle assembly to move said plurality
of retractor blades to the open position so that the plurality of
retractor blades create an operative corridor along the lateral,
trans-psoas path to the targeted lumbar spinal disc;
(e) releasably engaging a fixation element with at least
one of the plurality of retractor blades so that a distal portion of
the fixation element extends distally from the at least one
retractor blade and penetrates into a lateral aspect of the lumbar
spine, wherein the fixation element secures the at least one
retractor blade to the lumbar spine;
(f) inserting an implant through the operative corridor
created by the plurality of retractor blades along the lateral,
trans-psoas path to the targeted lumbar spinal disc.
(Req. App. Br. 20, Claims App’x.)
Requester appeals the Examiner’s decision not to reject the claims as
follows:
I. claims 17, 18, and 24 as rendered obvious by Branch3 in view
of Kossmann,
4
and Koros
5
(Ground 1; RAN 2);
II. claims 19-22 as rendered obvious by Branch in view of
Kossmann, Koros, and Kelleher
6
(Ground 2; RAN 2);
III. claim 25 as rendered obvious by Branch in view of Kossmann,
Koros, and Michelson
7
(Ground 3; RAN 2);

3
US 6,945,933 B2, issued September 20, 2005 to Charles L. Branch et al.
4
Thomas Kossmann, et al., “Minimally Invasive Vertebral Replacement
with Cages in Thoracic and Lumbar Spine,” European J. of Trauma,
27(6):292-300 (2001).
5
US 5,928,139, issued July 27, 1999 to Tibor B. Koros, et al.
6
WO 01/37728 A1, published May 31, 2001 and naming Brian S. Kelleher,
et al. as inventors.
7
US 5,772,661, issued June 30, 1998 to Gary Karlin Michelson.
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IV. claim 26 as rendered obvious by Branch in view of Kossmann,
Koros, and Tsou
8
(Ground 4; RAN 2);
V. claim 27 as rendered obvious by Branch in view of Kossmann,
Koros, Tsou, and Kelleher (Ground 5, RAN 2).

The Requester relies on the Declaration of Isador H. Lieberman
executed July 5, 2012 and attached exhibits (Appendix 1, App. Br. 22,
Evidence App’x) (hereinafter “Lieberman Declaration” or “Lieberman
Decl.”).
Patent Owner relies on the Declaration of Jim Youssef executed June
4, 2012 (Appendix 2, App. Br. 22, Evidence App’x; PO Res. Br. 16,
Evidence App’x) (hereinafter “Youssef Declaration” or “Youssef Decl.”).

PROPOSED REJECTIONS 1 and 4
Branch, Kossmann, and Koros
Claims 17, 18, 24, and 26
The Proposed Rejection
Requester contends that Branch teaches a method for accessing a
surgical target site within a spine having most of the steps recited in claim
17. Request for Inter Partes Reexamination (filed February 9, 2012)
(hereinafter “Request”) 16-19 and 26-35; Req. App. Br. 6-7. The method
taught by Branch is described for use in different surgical approaches
including a “lateral, postero-lateral, and/or antero-lateral approaches.”

8
US 2002/0077632 A1, published June 20, 2002 and naming Paul M. Tsou
as the sole inventor.
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Branch, col. 2, ll. 32-51. Requester acknowledges that Branch’s method is
not specifically described for use in a lateral, trans-psoas path as recited in
claim 17 (Request 27; Req. App. Br. 6) and that Branch does not specifically
describe releasably engaging a fixing element as recited in element (e) of
claim 17.
Kossmann discloses
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, p. 296, col. 1, first ¶. Requester contends that “[a]s described in
Kossmann, one type of surgical procedure to access a spinal disc is via a
lateral, trans-psoas path and one of ordinary skill in the art would be
motivated to create a lateral, trans-psoas path to a targeted lumbar spinal disc
using well-known tissue dilators and retractors as disclosed in Branch.”
Req. App. Br. 8-9. Requester contends that “Branch in view of Koros
provides for fixation elements releasably engaged with at least of a plurality
of retractor blades so that a distal portion of the fixation element extends
distally from the at least one retractor blade and penetrates into a lateral
aspect of the lumbar spine, wherein the fixation element secures the at least
one retractor blade to the lumbar spine.” Request 34.
Issues
The issues for this rejection are:
By preponderance of the evidence, would it have been obvious to one
of ordinary skill in the art to have used the method of Branch in not only a
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lateral approach to the spine as described in Branch, but in “a lateral, trans-
psoas path to a targeted lumbar spinal disc in a lumbar spine” as described in
Kossmann?
By preponderance of the evidence, would it have been obvious to one
of ordinary skill in the art to have modified the method of Branch to include
a step of releasably engaging a fixation element with a retractor blade to
secure the retractor blade to the spine, as described in Koros?
Discussion
Patent Owner contends that Kossmann’s “blunt dissection” of the
psoas muscle would not have been done by a dilator and retraction blades,
but would only be safely done by a surgeon’s finger or blunt instrument. PO
Res. Br. 6-8. In support of this argument, Patent Owner relies on the
testimony of Dr. Youssef, who opines that the “blunt dissection” described
in Kossmann is not equivalent to dilation and retraction and that Kossmann
does not disclose that dilation and retraction can be safely done. Id.; see
Youssef Decl. ¶ 14. Relying on this argument, the Examiner agreed with
Patent Owner and determined that “[t]he Lieberman declaration does not lift
the Kossman [sic] declaration to the level of teaching a lateral trans-psoas
approach using the dilators and multi-blade retractor of Branch.” RAN 4.
The Examiner was also persuaded by Patent Owner’s argument regarding
the limited disclosure of a trans-psoas approach in Kossmann for “some very
athletic patients” where the general approach was to move aside the psoas
muscle rather than transversing the psoas muscle. See RAN 4, PO Res. Br.
7-8; Kossmann, p. 296, col. 1, first ¶. Patent Owner further contends that
there was skepticism in the art that a lateral, trans-psoas approach could be
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done safely and effectively. PO Res. Br. 8 (citing Youssef Decl. ¶ 7 and In
re Brimonidine Patent Litigation, 643 F.3d 1366, 1374 (Fed. Cir. 2011)).
We are not persuaded by Patent Owner’s arguments and determine
that the Examiner erred in concluding that one of ordinary skill in the art
would not have considered the use of a dilator, as taught by Branch, to be an
alternative “blunt instrument” suitable for use in a “blunt dissection” of the
psoas muscle.
Kossmann describes the blunt dissection as being performed “either
by finger or with a wet sponge mounted on a stick.” Kossmann, p. 296, col.
1, first ¶. Kossmann further describes the use of “retractors . . . placed onto
the table-fixed SynFrame . . . and adjusted to the needs of the surgeons.” Id.
at p. 295, col. 1, last ¶. Dr. Youssef describes “blunt dissection” as being
“most safely achieved with the use of the surgeon’s fingers or a blunt
instrument.” Youssef Decl. ¶ 14. While Dr. Youssef states that such a
“blunt dissection” is “not equivalent to dilation and retraction” and “would
not have been accomplished with the use of dilators and retraction” (id.), Dr.
Youssef has not identified any structural characteristics of a dilator, such as
that taught by Branch, that would distinguish it from any other “blunt
instrument” that might be used, particularly when a dilator is similarly used
to create a pathway through tissue. For example, Branch states that
skin 60 and tissue 68 can be sequentially dilated via dilation
instrument set 66 which can include guidewires and/or one or
more tissue dilators of increasing size. The tissue dilators are
inserted one over another to form a pathway 62 through skin 60
and tissue 68 to the surgical site in the patient. In such
procedures, retractor 20 is positioned over the last inserted
dilator to form pathway 62 in the skin and tissue. Working
channel 50 through retractor 20 provides access to a working
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space 64 at the distal end of retractor 20 when the guidewires
and dilators, if used, are removed therefrom.
Branch, col. 6, ll. 48-58.
Thus, Branch evinces that a dilator is an alternative “blunt instrument”
that would appear to provide a more precise and gradually increasing
pathway as compared to a surgeon’s finger or wet sponge on a stick, as
taught by Kossmann. Accordingly, we find Dr. Youssef’s testimony, that a
dilator is not a “blunt instrument” and would not be considered by a skilled
artisan, to be unsupported by an underlying factual basis and at odds with
the discussion in Branch of how a dilator works. Further, Dr. Youssef has
not fully explained why a dilator and retractor device would inherently be
considered a less safe means for dissection than a surgeon’s finger or wet
sponge on a stick. Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089,
1092 (Fed. Cir. 1997) (“Nothing in the rules or in our jurisprudence requires
the fact finder to credit the unsupported assertions of an expert witness.”).
Instead, the dilator discussion in Branch is more consistent with the
testimony of Dr. Lieberman that “[t]he use of instruments such as dilation
and retraction assemblies is no more invasive than the use of blunt
dissection, both techniques do the exact same thing for the exact same
purpose.” Lieberman Decl. ¶ 21.
We are also not persuaded by the limited use of a trans-psoas
approach in Kossmann for only “very athletic patients.” “[A]ny need or
problem known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the elements in
the manner claimed.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 420
(2007). The problem of providing a lateral approach in “very athletic
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patients” is a reason that the skilled artisan would have used a lateral trans-
psoas approach as taught by Kossmann. No more analysis is needed to
reach a conclusion that a lateral, trans-psoas approach would have been
obvious for the skilled artisan when performing spinal surgery on a very
athletic patient.
We are further unpersuaded by Dr. Youssef’s testimony that spinal
surgeons were skeptical that a lateral, trans-psoas approach could be done
safely. Youssef Decl. ¶ 7. Dr. Youssef’s testimony refers to his personal
skepticism and lacks any supporting evidence of what the spinal surgeon
community as a whole would have regarded as a safe approach at the time of
the invention. Moreover, considering that Kossmann was actually
performing such an approach for “very athletic patients” when alternative
approaches were not possible, appears to weigh against the assertion that
such skepticism was widely held by spinal surgeons at the time of the
invention.
Accordingly, we disagree with the Examiner’s determination and
conclude that, based on a preponderance of the evidence, it would have been
obvious for one of ordinary skill in the art to create a distraction corridor
along a lateral, trans-psoas path in very athletic patients, as taught by
Kossmann, using a dilator and retractor assembly of the type taught by
Branch as an alternative “blunt instrument” to a surgeon’s finger or wet
sponge on a stick.
Patent Owner further contends that one of ordinary skill in the art
would not have combined Koros’ “screw fixation mechanism” with the
Branch retractor because Koros’ “tubular guides 86” positioned on Branch’s
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access system would result in “retractor blades having inner convex bulges,
not a generally concave face as claimed.” PO Res. Br. 9. According to
Patent Owner, “the inclusion of the tubular guides 86 in the Branch retractor
blades would prevent the blades from being put in a closed position . . . or
would require that the retractor be made much larger.” Id. at 10-11 (citing
Youssef Decl. ¶ 10). Further, Patent Owner contends that the tubular guides
82 and 86 are incompatible with the use of a dilator, as taught by Branch.
Id. at 11. Dr. Youssef testifies that he
believe[s] that if a device combining the guide tubes of Koros
were to be added to the retractor portions of Branch, that
combination would result in a device that would be dangerous
when used in conjunction with a dilator. For example, the
addition of the guide tubes would prevent the retractor of
Branch from closing completely around the dilator during
insertion. Instead, the retractor would be partially open where it
could likely damage the surrounding tissues during insertion, or
allow for tissue or nerves to creep beneath the retractor blades,
thus restricting appropriate visualization of the disc space.
Youssef Decl. ¶ 10.
Patent Owner’s arguments and Dr. Youssef’s declaration are not
persuasive of nonobviousness.
Koros describes that prior art distractor (i.e., retractor) blades used in
spinal surgery were known in the art to “include a channel or slot for
receiving a single fixation screw,” but Koros discovered that additional
fixation screws would provide improved stability and support. Koros, col. 6,
ll. 26-31. Koros teaches that tubular guides 82 and 86 allow for pairs of
fixations screws 83 and can support a light for the surgical site. Id., col. 6,
ll. 35-40. Koros further teaches that “screws 83 are inserted through tubular
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guides 82 . . . and screwed into adjacent disc 94 and 96.” Id., col. 6, ll. 66-
col. 7, l.1.
Dr. Youssef’s declaration is based on unsupported speculation about
the operation of a non-existent device. Moreover, the arguments are based
on the bodily incorporation of not only the fixations screws but the tubular
screw guides disclosed in Koros into the device of Branch, including the
relative size of the screws and tubular guides, without consideration of how
one of ordinary skill in the art would have considered and adapted the
teachings of Koros to the device of Branch. Notably, Koros discloses that
alternative embodiments of configuring fixations screws were known in the
art, and, thus, the skilled artisan was not limited to the precise tubular-guide-
with-screws embodiment described in Koros. “The test for obviousness is
not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference. . . . Rather, the test
is what the combined teachings of the references would have suggested to
those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA
1981). “A person of ordinary skill is also a person of ordinary creativity, not
an automaton.” KSR, 550 U.S. at 421.
We note that the claims require a method step of “releasably engaging
a fixation element with at least one of the plurality of retractor blades so that
a distal portion of the fixation element extends distally from the at least one
retractor blade and penetrates into a lateral aspect of the lumbar spine,
wherein the fixation element secures the at least one retractor blade to the
lumbar spine.” Based on the teachings of Koros, the skilled artisan would
have recognized the benefit of fixation elements to fix retractors to aspects
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of the lumbar spine for stability and support. “[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.”
KSR, 550 U.S. at 417. In this case, it is the technique of fixing the retractor
to the spine with a fixation element, and not the actual incorporation of the
structure, which would have been obvious to the skilled artisan.
Moreover, claim 17 requires “each of said plurality of retractor blades
having a generally concave inner face.” Claim 17 does not require that the
fixation element also have a generally concave inner face. We note that the
retractor blades of Koros have generally concave inner faces, demonstrating
the compatibility of the fixation elements of Koros with retractor blades
having a concave inner face.
For this reason, we REVERSE the Examiner’s decision not to adopt
the proposed rejections of Requester. Accordingly, we enter New Grounds
of Rejection of claims 17, 18, and 24 under 35 U.S.C. § 103(a) as being
obvious over Branch in view of Kossmann and Koros. Patent Owner
incorporates the rejection of claim 26 into the arguments presented above
with respect to claim 17. PO Res. Br. 3 and 11. Accordingly, we also enter
New Grounds of Rejection of claim 26 under 35 U.S.C. § 103(a) as being
obvious over Branch in view of Kossmann, Koros, and Tsou. We adopt the
findings and reasoning of the Requester put forth in the Request in light of
our findings and reasoning presented above for all of the claims so rejected.
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PROPOSED REJECTIONS 2 and 5
Branch, Kossmann, Koros, and Kelleher
The Rejection
Claims 19-22 and 27
Claims 19-22 and 27 depend from claim 17. The claims further recite
“the steps of performing neuromonitoring during at least one of steps (a),
(c), and (d), wherein a control unit of a neuromonitoring system displays a
result of said neuromonitoring to a user.” Relying on the rationale discussed
above with respect to claim 17, the Examiner did not adopt the proposed
rejections of claims 19-22 and 27. We review these rejections in light of our
decision above that the Examiner erred in withdrawing the rejection of
claims 17.
Requester contends that Kelleher describes a neuromonitoring method
for use in spinal surgery falling within the scope of the claims on appeal that
is use to inform the operator that a surgical tool or probe is approaching a
nerve. Request 36-37 and 45-46. According to Requester, it would have
been obvious to one of ordinary skill in the art to employ the method of
neuromonitoring disclosed in Kelleher with the spinal surgical techniques
disclosed in Branch, Kossmann, and Koros. Id. at 37 and 46.
Issue
The issue for this rejection is:
By preponderance of the evidence, would it have been obvious to one
of ordinary skill in the art to have used the neuromonitoring method
described in Kelleher in the dilation and retraction methods described in
Branch in view of Kossmann?
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Discussion
In addition to the argument discussed above with respect to the
teachings of Branch, Kossmann and Koros, Patent Owner contends that
there is no disclosure or suggestion in Kelleher of “performing nerve
monitoring during at least one of steps (a), (c), and (d)” of claim 17,
“wherein a control unit of a neuromonitoring unit displays a result of said
neuromonitoring to a user,” as recited in claim 19. PO Res. Br. 12.
Requester identified specific findings that the system of Kelleher
described performing nerve monitoring “while accessing a surgical site
within a spine wherein a control unit of a neuromonitoring system displays a
result of said neuromonitoring to a user.” Request 37-38; Req. Reb. Br. 13
(citing Kelleher, 2:19-23, 4:1-14, 6:1-6, 15:17-27, and Figure 1). Likewise,
Requester made specific findings for each of the limitations of claims 19-22
and 27. See Request 37-41 and 46-48. These findings were acknowledged
and accepted by the Examiner during Reexamination. See Non-Final Office
Action mailed April 4, 2012 at 5-6 and 8-9. Patent Owner has not
adequately explained why these findings by the Requester do not meet the
requirements of the claims.
Moreover, we agree with Requester that “[b]ecause each reference
[namely, Branch and Kossmann] teaches the desireability of avoiding nerves
for patient safety and Kelleher’s neuromonitoring would achieve this, it
would have been obvious to look to a reference such as Kelleher, which
similarly discloses a minimally-invasive spinal surgical system.” Req. Reb.
Br. 11-12. One of ordinary skill in the art would have recognized the benefit
of using a neuromonitoring system as taught by Kelleher for the purpose
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taught by Kelleher, namely “to inform the operator that a surgical tool or
probe is approaching a nerve.” See Request 37. To do so would have been
no more than the predictable use of a known neuromonitoring system
according to its established function of detecting nerves during spinal
surgery. See KSR, 550 U.S. at 417 (The question to be asked is “whether the
improvement is more than the predictable use of prior art elements according
to their established functions.”).
For this reason, we REVERSE the Examiner’s decision not to adopt
the proposed rejections of Requester. Accordingly, we enter New Grounds
of Rejection of claims 19-22 under 35 U.S.C. § 103(a) as being obvious over
Branch in view of Kossmann, Koros, and Kelleher and claim 27 under 35
U.S.C. § 103(a) as being obvious over Branch in view of Kossmann, Koros,
Tsou, and Kelleher. Patent Owner incorporates the rejection of claim 27
into the arguments presented above with respect to claim 19. PO Res. Br.
11-12. We adopt the findings and reasoning of the Requester put forth in the
Request in light of our findings and reasoning presented above for all of the
claims so rejected.

PROPOSED REJECTION 3
Branch, Kossmann, Koros, and Michelson
The Rejection
Claim 25
Claim 25 depends from claim 17. The claim further recites “the
fixation element comprises a shim structure to penetrate into the targeted
lumbar spinal disc.” Relying on the rationale discussed above with respect
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to claim 17, the Examiner did not adopt the proposed rejections of claim 25.
We review this rejection in light of our decision above that the Examiner
erred in withdrawing the rejection of claim 17.
Requester acknowledges that Koros does not describe a fixation
element comprising a shim. However, Requester finds that Michelson
describes such a fixation element for use in spinal surgery. Request 41-42.
According to Requester, it would have been obvious to one of ordinary skill
in the art to employ the disc-penetrating shim structure of Michelson with
the spinal surgical instrumentation disclosed in Branch, Kossmann, and
Koros. Id. at 42.
Issue
The issue for this rejection is:
By preponderance of the evidence, would it have been obvious to one
of ordinary skill in the art to have used the disc-penetrating shim structure of
Michelson as an alternative to the releasably engaging screw fixation
elements of Koros in the dilation and retraction methods described in Branch
in view of Kossmann?
Discussion
In addition to the argument discussed above with respect to the
teachings of Branch, Kossmann and Koros, Patent Owner contends that “one
of skill would not have looked to Michelson for teachings on how to modify
tissue retractors or a retractor-based access system” and rather teaches away
from such a combination “because Michelson discloses a tubular-based
access system including a tubular access cannula 140.” PO Res. Br. 13-14.
Patent Owner further contends that “the resulting combination would be a
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permanent retractor blade extension, not an intradiscal shim element that is
releasably engaged with a retractor blade, as required by claim 17.” Id. at
14.
We are not persuaded by Patent Owner’s arguments and agree with
Requester that it would have been obvious to one of ordinary skill in the art
to have used a shim as an alternative fixation element to the releasably
engaging screws of Koros for disc penetration.
Michelson describes “two prongs ‘sufficiently spaced apart to
penetrate and hold fixed the two adjacent vertebrae’ as well as a shim-like
extension member that penetrates into the disc space.” Request 41-42
(quoting Michelson, col. 10, ll. 58-67 and citing Michelson, Figs. 7A and
10). Michelson’s shim performs the same purpose in the spinal access
device of Michelson as the screws do in the device of Koros, namely “to
maintain the distraction and alignment of the adjacent vertebrae created by
the distractor 100.” Michelson, col. 11, ll. 45-47. Accordingly, Michelson
describes a shim as a predictable alternative to a screw for use in a spinal
access device. See KSR, 550 U.S. at 416 (“when a patent claims a structure
already known in the prior art that is altered by the mere substitution of one
element for another known in the field, the combination must do more than
yield a predictable result.”). The fact that the shim structure of Michelson is
used with a different type of spinal access device does not teach away from
using a shim rather than the screw of Koros. In re Fulton, 391 F.3d 1195,
1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004) (explaining “[t]he prior art’s
mere disclosure of more than one alternative does not constitute a teaching
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away from any of these alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed”).
We further disagree with the Patent Owner that combining the
teachings of Branch, Koros, and Michelson would necessarily result in a
fixed shim element. Using a shim as an alternative releasably engaging
fixation element would have been obvious to the skilled artisan because the
Koros reference describes that the screws releasably engage with the
retractor blades. We find that replacing a screw with a shim would have
been within the skill of the ordinary artisan, as both are described in the art
as fixation elements for spinal surgery.
For this reason, we REVERSE the Examiner’s decision not to adopt
the proposed rejection of Requester. Accordingly, we enter New Grounds of
Rejection of claim 25 under 35 U.S.C. § 103(a) as being obvious over
Branch in view of Kossmann, Koros, and Michelson. We adopt the findings
and reasoning of the Requester put forth in the Request in light of our
findings and reasoning presented above for all of the claims so rejected.

DECISION
In sum, we reverse the Examiner’s decision not to reject the claims as
follows and enter new grounds of rejections based on the reasoning and
discussion above:
claims 17, 18, and 24 as rendered obvious by Branch in view of
Kossmann, and Koros (Ground 1; RAN 2);
claims 19-22 as rendered obvious by Branch in view of Kossmann,
Koros, and Kelleher (Ground 2; RAN 2);
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claim 25 as rendered obvious by Branch in view of Kossmann, Koros,
and Michelson (Ground 3; RAN 2);
claim 26 as rendered obvious by Branch in view of Kossmann, Koros,
and Tsou (Ground 4; RAN 2); and
claim 27 as rendered obvious by Branch in view of Kossmann, Koros,
Tsou, and Kelleher (Ground 5, RAN 2).

NEW GROUND OF REJECTION
This decision 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.” 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
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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. 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.
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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; NEW GROUNDS OF REJECTION UNDER 41.77(B)

PATENT OWNER:
FISH & RICHARDSON P.C. (TC)
PO BOX 1022
MINNEAPOLIS MN 55440-1022

THIRD-PARTY REQUESTER:

Jay Guiliano, Esq.
NOVAK DRUCE & QUIGG LLP
300 New Jersey Ave., NW
Fifth Floor
Washington, DC 20001