Zimmer Holdings, Inc. et alv.Bonutti Skeletal Innovations LLC

Patent Trial and Appeal Board

Jun 4, 2014

10795887 (P.T.A.B. Jun. 4, 2014)

Trials@uspto.gov Paper 11
571-272-7822 Entered: June 4, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

ZIMMER HOLDINGS, INC.
and ZIMMER, INC.,
Petitioner,

v.

BONUTTI SKELETAL INNOVATIONS LLC,
Patent Owner.
____________

Case IPR2014-00311
Patent 7,959,635 B1
____________

Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
RICHARD E. RICE, Administrative Patent Judges.

RICE, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

Case IPR2014-00311
Patent 7,959,635 B1

2
I. INTRODUCTION
Zimmer Holdings, Inc. and Zimmer, Inc. (“Petitioner”) filed a corrected
Petition (Paper 6, “Pet.”) requesting an inter partes review of claims 1, 7, 8, 11, 12,
15, 16, and 30-39 of U.S. Patent No. 7,959,635 B1 (Ex. 1001, “the ’635 Patent”).
The owner of the ’635 Patent, Bonutti Skeletal Innovations LLC (“Patent Owner”),
timely filed a Preliminary Response (Paper 10, “Prelim. Resp.”). We have
jurisdiction under 35 U.S.C. § 314.
The standard for instituting an inter partes review is set forth in 35 U.S.C.
§ 314(a), which provides as follows:
THRESHOLD -- The Director may not authorize an inter partes
review to be instituted unless the Director determines that the
information presented in the petition filed under section 311 and any
response filed under section 313 shows that there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of
the claims challenged in the petition.
Based upon this standard, we determine that the information presented in the
Petition does not establish that there is a reasonable likelihood that Petitioner
would prevail with respect to at least one of challenged claims 1, 7, 8, 11, 12, 15,
16, and 30-39 of the ’635 Patent. Accordingly, we do not authorize an inter partes
review as to any claim of the ’635 Patent.

A. Related Proceeding
Petitioner represents that the ’635 Patent is asserted by Patent Owner against
Petitioner in Bonutti Skeletal Innovations LLC v. Zimmmer Holdings Inc.,
No. 1:2012-cv-01107-GMS (D. Del). Pet. 1; see Paper 5, 2.

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Case IPR2014-00311
Patent 7,959,635 B1

4
The specification describes the manner of making an anterior skim cut on
end portion 124 of femur 126, including anterior portions of the lateral and medial
condyles. Id. at 16:32–18:33. As depicted in Figure 13, guide surface 178 of
cutting guide 138 extends only part way across end portion 124 of femur 126. Id.
at 16:17-18. The specification describes pivoting saw blade 170 so that the cutting
end of the blade reaches areas of bone beyond the ends of the cutting guide. Id. at
16:32-45. The specification also describes removing the cutting guide, and using
previously cut surfaces on end portion 124 of femur 126 to guide blade 170 in
completing the cut. Id. at 16:50-62. The specification discloses that “[u]tilizing
cut surfaces formed during an initial portion of the anterior skim cut to guide the
saw blade 170 enables the size of the anterior resection guide 138 to be
minimized.” Id. at 17:8-11.

C. Illustrative Claim
Claims 1, 30, 38, and 39 are independent. Claims 7, 8, 11, 12, 15, and 16
depend directly or indirectly from claim 1, and claims 31-37 depend directly or
indirectly from claim 30. Claim 1, which is reproduced below, is illustrative of the
claimed subject matter:
1. A method of performing total knee
arthroplasty on a patient’s knee, through an incision
through skin of the patient’s body, the method
comprising:
positioning a cutting guide member in alignment
with a bone of the knee;
cutting bone of at least first and second condyles
of the knee, including
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Patent 7,959,635 B1

5
initiating a cut in the bone while guiding a cutting
tool along a guide surface of the cutting guide member to
form a cut surface having an initial cut length, the guide
surface having a length;
angularly disposing the cutting tool along the
guide surface to extend the cut surface from the initial cut
length to an extended cut length, the extended length
being longer than the length of the guide surface, at least
a portion of said cut surface being located within the
body with respect to the incision;
removing the cutting guide member from against
the bone, and then completing the cut in the bone without
using the guide surface of the cutting guide, while
guiding the cutting tool along the cut surface; and
positioning a knee replacement component against
the cut surface of the bone of the knee.

Id. at 75:13-35.

D. The Asserted Prior Art
Petitioner contends that the “priority date” (earliest effective filing date) for
the challenged claims of the ’635 Patent is August 28, 2001. Pet. 16. Petitioner
relies upon the following references (id. at 17-27):

MG II Guide Zimmer, MG II Total Knee
System Surgical Technique
Using Zimmer Intramedullary
Instrumentation
1989 and
1990
Ex. 1008
MG II
Brochure
Zimmer, MG II Total Knee
System
1992 Ex. 1009

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6
MG II Distal
Cut Guide
Drawing
Zimmer, Drawing for Item No.
00-5120-930-01 (released for
production)
Prior to
19951
Ex. 1010
NexGen Epi
Guide
Zimmer, NEXGEN®
COMPLETE KNEE
SOLUTION – Epicondylar
Instrumentation Surgical
Technique For Legacy™
Posterior Stabilized Knee
1996 Ex. 1011
NexGen
Brochure
Zimmer, NexGen™
POSTERIOR STABILIZED –
The Complete Knee Solution
1994 Ex. 1012
NexGen Epi
Distal Cut
Guide
Drawing
Zimmer, Drawing for Item No.
00-5967-930-01 (superseded)
Prior to
19952
Ex. 1014
Zimmer
Catalog
Zimmer, Hips, Knees, & Other
Prosthetic Implants
1997 Ex. 1015
M/G Uni
Guide
Zimmer, Minimally Invasive
Solution – The M/G
Unicompartmental Knee
2000 Ex. 1016

1 Petitioner asserts: “Although the dates have been redacted in Ex. 1010, all the
dates are earlier than 1995.” Id. at 19 (citing Ex. 1002 (Rolston Decl.) ¶ 69).
Petitioner also states that the drawing “may not have been published.” Id.
2 Petitioner asserts: “Although the dates have been redacted in Ex. 1014, all the
dates are earlier than 1999.” Id. at 21 (citing Ex. 1002 ¶ 71). Petitioner also states
that the drawing “may not have been published.” Id.

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p.c.a. Guide Pfizer/Howmedica, p.c.a.®
modular total knee system –
Surgical Technique
1989 Ex. 1017
AMK Guide DePuy, LEGEND II SURGICAL
TECHNIQUE - AMK® Total
Knee System Using Legend II
Instruments
1994 Ex. 1018
Radermacher WO 93/25157 Dec. 23,
1993
Ex. 1019
Micro-Mill
Guide
Zimmer, MICRO-Mill®
INSTRUMENT SURGICAL
TECHNIQUE For Mobile
Bearing Knees
1997 Ex. 1022

Patent Owner contends that Petitioner’s reliance upon Exhibits 1010 and
1014 is improper under 35 U.S.C. § 311(b), which limits inter partes review to
“prior art consisting of patents or printed publications.” Prelim. Resp. 2. Patent
Owner asserts that Exhibits 1010 and 1014 are unpublished confidential drawings,
not printed publications. Id. at 2-4. We do not need to decide this issue, however,
because it is not the dispositive issue in our decision denying institution.

E. The Asserted Grounds
Petitioner challenges claims 1, 7, 8, 11, 12, 15, 16, and 30-39 of the
’635 Patent as obvious under § 103 based on the combinations of references
summarized in the table below (see Pet. 3-5):

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Reference(s) Claims Challenged
MG II Guide and MG II Brochure 1, 7, 8, 11, 12, 15, 16, 30-33, 35-37, and 39
MG II Guide and MG II Brochure, in view
of AMK Guide and/or p.c.a. Guide
1, 7, 8, 11, 12, 15, 16, 30-33, and
35-37
NexGen Epi Guide and NexGen Brochure 1, 7, 8, 11, 12, 15, 16, 30-33, 35-37, and 39
NexGen Epi Guide and NexGen Brochure,
in view of AMK Guide and/or p.c.a. Guide
1, 7, 8, 11, 12, 15, 16, 30-33, and
35-37
MG II Guide, MG II Brochure, NexGen epi
Guide, and NexGen Brochure
1, 7, 8, 11, 12, 15, 16, 30-33, 35-
37, and 39
MG II Guide, MG II Brochure, NexGen
Epi Guide, and NexGen Brochure, in view
of AMK Guide and/or p.c.a. Guide
1, 7, 8, 11, 12, 15, 16, 30-33, and
35-37
MG II Guide, MG II Brochure, and Micro-
Mill Guide 16
MG II Guide, MG II Brochure, and Micro-
Mill Guide, in view of AMK Guide and/or
p.c.a. Guide
16
NexGen Epi Guide, NexGen Brochure, and
Micro-Mill Guide 16
NexGen Epi Guide, NexGen Brochure, and
Micro-Mill Guide, in view of AMK Guide
and/or p.c.a. Guide
16
MG II Guide, MG II Brochure, NexGen epi
Guide, NexGen Brochure, and Micro-Mill
Guide
16
MG II Guide, MG II Brochure, NexGen epi
Guide, NexGen Brochure, and Micro-Mill
Guide, in view of AMK Guide and/or p.c.a.
Guide
16
MG II Guide, MG II Brochure, and
Radermacher 34 and 38
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Reference(s) Claims Challenged
MG II Guide, MG II Brochure, and
Radermacher, in view of AMK Guide
and/or p.c.a. Guide
34
NexGen Epi Guide, NexGen Brochure, and
Radermacher 34
NexGen Epi Guide, NexGen Brochure, and
Radermacher, in view of AMK Guide
and/or p.c.a. Guide
34
MG II Guide, MG II Brochure, NexGen epi
Guide, NexGen Brochure, and
Radermacher
34
MG II Guide, MG II Brochure, NexGen epi
Guide, NexGen Brochure, and
Radermacher, in view of AMK Guide
and/or p.c.a. Guide
34
MG II Guide, MG II Brochure, and M/G
Uni Guide 37
MG II Guide, MG II Brochure, and M/G
Uni Guide , in view of AMK Guide and/or
p.c.a. Guide
37
NexGen Epi Guide, NexGen Brochure, and
M/G Uni Guide 37
NexGen Epi Guide, NexGen Brochure, and
M/G Uni Guide, in view of AMK Guide
and/or p.c.a. Guide
37
MG II Guide, MG II Brochure, NexGen epi
Guide, NexGen Brochure, and M/G Uni
Guide
37
MG II Guide, MG II Brochure, NexGen epi
Guide, NexGen Brochure, and M/G Uni
Guide, in view of AMK Guide and/or p.c.a.
Guide
37

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Reference(s) Claims Challenged
MG II Guide, MG II Brochure, and
Radermacher, in view of AMK Guide, M/G
Uni Guide, and/or p.c.a. Guide
38
NexGen Epi Guide, NexGen Brochure, and
Radermacher 38
NexGen Epi Guide, NexGen Brochure, and
Radermacher, in view of AMK Guide, M/G
Uni Guide, and/or p.c.a. Guide
38
MG II Guide, MG II Brochure, NexGen
Epi Guide, NexGen Brochure, and
Radermacher,
38
MG II Guide, MG II Brochure, NexGen
Epi Guide, NexGen Brochure, and
Radermacher, in view of AMK Guide, M/G
Uni Guide, and/or p.c.a. Guide
38
MG II Guide and MG II Brochure, in view
of AMK Guide, M/G Uni Guide, and/or
p.c.a. Guide
39
NexGen Epi Guide and NexGen Brochure,
in view of AMK Guide, M/G Uni Guide,
and/or p.c.a. Guide
39
MG II Guide, MG II Brochure, NexGen
Epi Guide, and NexGen Brochure, in view
of AMK Guide, M/G Uni Guide, and/or
p.c.a. Guide
39

II. ANALYSIS
A. Claim Construction
Consistent with the statute and legislative history of the Leahy-Smith
America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), we
interpret claims using the “broadest reasonable construction in light of the
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specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b); see
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012).
There is a “heavy presumption” that a claim term carries its ordinary and
customary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366
(Fed. Cir. 2002). However, a “claim term will not receive its ordinary meaning if
the patentee acted as his own lexicographer and clearly set forth a definition of the
disputed claim term in either the specification or prosecution history.” Id.
“Although an inventor is indeed free to define the specific terms used to describe
his or her invention, this must be done with reasonable clarity, deliberateness, and
precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Also, we must be
careful not to read a particular embodiment appearing in the written description
into the claim if the claim language is broader than the embodiment. See In re Van
Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (“[L]imitations are not to be read into
the claims from the specification.”).

1. “completing the cut in the bone . . . while guiding
the cutting tool along the cut surface” (claim 1)
Method claim 1 recites, inter alia, the sequential steps of:
[(1)] initiating a cut in the bone while guiding a cutting tool along a
guide surface of the cutting guide member to form a cut surface
having an initial cut length, the guide surface having a length; [(2)]
angularly disposing the cutting tool along the guide surface to extend
the cut surface from the initial cut length to an extended cut length,
the extended length being longer than the length of the guide surface;
and [(3)] removing the cutting guide member from against the bone,
and then completing the cut in the bone without using the guide
surface of the cutting guide, while guiding the cutting tool along the
cut surface.
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Ex. 1001, 75:20-33 (emphasis added).
The specification provides guidance as to the broadest reasonable
interpretation of the phrase “completing the cut in the bone . . . while guiding the
cutting tool along the cut surface.” As described in the specification, a “partially
complete” cut in a bone is made using a guide surface of a cutting guide to guide a
cutting tool; and the cut is “completed” by removing the cutting guide from against
the bone, and using surfaces of the previously-made cut in the bone to guide the
blade while extending the cut to completion. Ex. 1001, 16:50–17:8; see id. at
19:48–20:11, 20:56–21:23. With respect to making the anterior femur (skim) cut,
for example, the specification states:
Due to the limited length of the anterior resection guide 138,
the saw blade 170 is moved along the guide surface 178 to only
partially complete the anterior skim cut on the end portion 124 of the
femur 126. . . . The anterior resection guide 138 is then disconnected
from the femoral alignment guide 134 (FIGS. 14 and 15) and the
anterior femur cut is completed.
During completion of the anterior femur (skim) cut, previously
cut surfaces on the end portion 124 of the femur 126 are used to guide
the saw blade 170 (FIG. 13). . . . After the anterior resection guide 138
has been disconnected from the femoral alignment guide 134, the saw
blade 170 is positioned in engagement with the cut surfaces on the
distal end portion 124 of the femur 126. This is accomplished by
inserting the saw blade 170 into a slot or saw kerf formed in the distal
end portion 124 of the femur during the initial portion of the anterior
skim cut.
The saw blade 170 is then moved along the previously cut
surfaces on the distal end portion of the femur 126 to guide the saw
blade during completion of the anterior skim cut.

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Id. at 16:50–17:8 (emphasis added). There are similar descriptions in the
specification for the distal femoral cut (id. at 19:59–20:11) (“Thus, cut
surfaces formed during movement of the saw blade 170 along the guide
surface 202 are utilized to guide movement of the saw blade during
completion of the distal femoral cut.”), as well as the femoral anterior,
posterior, and chamfer cuts (id. at 20:59–21:3, 21:16-23) (“To complete a
cut in this manner, the saw blade 170 or other cutting tool is moved along
the previously cut surfaces to guide the saw blade as the cuts are
extended.”).
Accordingly, the broadest reasonable interpretation consistent with the
specification of the phrase “completing the cut in the bone . . . while guiding
the cutting tool along the cut surface,” in claim 1, is “extending the
previously-made cut in the bone, to completion, while moving the cutting
tool along the previously-cut surface of the bone to guide the cutting tool.”
Under this interpretation, “completing the cut in the bone . . . while guiding
the cutting tool along the cut surface” does not encompass making a cut that
only flattens the previously-cut surface of the bone.
We note that our claim interpretation with respect to claim 1 is
consistent with the language of claim 38, which explicitly requires
“completing the cut in the bone, by guiding the cutting tool along the cut
surface, thereby extending the cut surface from the second cut length to a
final cut length” (emphasis added). It is also consistent with the language of
claim 30, which recites “continuing the cut . . . while guiding the cutting tool
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along the cut surface to extend the cut surface to a final cut length”
(emphasis added).
In summary, we construe “completing the cut in the bone . . . while
guiding the cutting tool along the cut surface,” in claim 1, to mean
“extending the previously-made cut in the bone, to completion, while
moving the cutting tool along the previously-cut surface of the bone to guide
the cutting tool.”

2. “completing the cut of the section of bone, while guiding the
cutting tool along the cut in the section of the bone” (claim 39)
Method claim 39 recites, inter alia, the sequential steps of:
[(1)] initiating a cut in the bone while guiding a cutting tool along a
guide surface of the cutting guide member, the guide surface having a
length, to form a cut section of the bone; [(2)] angularly disposing the
cutting tool along the guide surface in order to further cut the cut
section of the bone such that the cut section of the bone has a cut
length longer than the length of the guide surface; and [(3)] removing
the cutting guide member from against the bone, and then completing
the cut of the section of bone, while guiding the cutting tool along the
cut in the cut section of the bone.

Ex. 1001, 78:44-57 (emphasis added). As discussed above, the specification
describes making a “partially complete” cut in a bone using a guide surface of a
cutting guide to guide a cutting tool; and “complet[ing]” the cut by removing the
cutting guide from the bone, and using surfaces of the previously-made cut in the
bone to guide the blade while extending the cut to completion. Ex. 1001, 16:50–
17:8; see id. 19:48–20:11, 20:56–21:23.
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Accordingly, the broadest reasonable interpretation consistent with the
specification of the phrase “completing the cut of the section of bone, while
guiding the cutting tool along the cut in the cut section of the bone,” in
claim 39, is “extending the previously-made cut in the section of bone, to
completion, while moving the cutting tool along previously-cut surfaces of
the section of bone to guide the cutting tool.” Under this interpretation,
“completing the cut of the section of bone, while guiding the cutting tool
along the cut in the cut section of the bone” does not encompass making a
cut that only flattens the previously-cut surface of the bone.

B. Alleged Grounds of Unpatentability
We turn now to Petitioner’s asserted grounds of unpatentability to determine
whether Petitioner has met the threshold standard of 35 U.S.C. § 314(a). For each
of the combinations of references on which Petitioner challenges independent
claim 1, 30, 38, or 39 as obvious, Petitioner contends that the MG II and NexGen
Epi guides, alone or in combination with the p.c.a. Guide, render obvious the
similarly-recited method steps of: (1) “removing the cutting guide member from
against the bone, and then completing the cut in the bone without using the guide
surface of the cutting guide, while guiding the cutting tool along the cut surface”
(claim 1); (2) “continuing the cut in the bone while guiding the cutting tool along
the cut surface to extend the cut surface to a final cut length, . . . wherein the
cutting guide member is removed from against the bone of the joint prior to said
step of continuing the cut in the bone” (claim 30); (3) “removing the cutting guide
member from against the bone, and then completing the cut in the bone, by guiding
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the cutting tool along the cut surface, thereby extending the cut surface from the
second cut length to a final cut length” (claim 38); and (4) “removing the cutting
guide member from against the bone, and then completing the cut of the section of
bone, while guiding the cutting tool along the cut in the cut section of the bone”
(claim 39). See Pet. 37-38, 46-48, 56, 58-59. For the reasons discussed below, we
do not agree that the MG II and NexGen Epi guides, alone or in combination with
the p.c.a. Guide, render obvious those similarly-recited method steps of the
challenged independent claims.
With respect to the method step of “removing the cutting guide member
from against the bone, and then completing the cut in the bone without using the
guide surface of the cutting guide, while guiding the cutting tool along the cut
surface,” recited in claim 1, Petitioner first contends that the MG II and NexGen
Epi guides “both inherently disclose completing the distal femoral cut by guiding
the cutting tool along the cut surface.” Id.. 36-37. Petitioner directs our attention
to the following instruction, set forth in each of the references: “Check the flatness
of the distal femoral cut with a flat surface. . . . If necessary, modify the distal
femoral surface so that it is completely flat.” Id. at 37 (quoting Ex. 1008, 22;
Ex. 1011, 7). Petitioner further asserts that “[i]t would have been within the
routine skill and discretion of a person of ordinary skill in the art to remove the
distal cutting guide before undertaking this step.” Id. (citing Ex. 1002 ¶¶ 84-92,
97).
Petitioner’s declarant, Dr. Rolston, testifies that, after completing a cut in the
bone using the guide surface of a cutting guide to guide a cutting tool, the cut
surface may be found to be not sufficiently flat due to a prominence extending
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from the cut area of bone. See Ex. 1002 ¶ 85. Dr. Rolston further testifies that “it
would have been obvious to have guided the cutting tool along the previously cut
surface to remove the prominence and extend the cut surface to the final cut
length.” Id. ¶ 86.
Petitioner’s position regarding the MG II and NexGen Epi guides is
predicated on the doctrine of inherency. “To establish inherency, the extrinsic
evidence ‘must make clear that the missing descriptive matter is necessarily
present in the thing described in the reference, and that it would be so recognized
by persons of ordinary skill.’ ‘Inherency, however, may not be established
by probabilities or possibilities. The mere fact that a certain thing may result from
a given set of circumstances is not sufficient.’” In re Robertson, 169 F.3d 743, 745
(Fed. Cir. 1999) (citations omitted). “The inherent teaching of a prior art
reference, a question of fact, arises both in the context of anticipation and
obviousness.” In re Napier, 55 F.3d 610, 613 (Fed. Cir. 1995) (citation omitted).
To establish that the cited references “inherently disclose completing the distal
femoral cut by guiding the cutting tool along the cut surface” (see Pet. 37
(emphasis added)), therefore, the references must make clear to a person of
ordinary skill in the art that the distal femoral cut necessarily is completed in the
manner alleged.
As construed above, “completing the cut in the bone . . . while guiding the
cutting tool along the cut surface,” in claim 1, requires “extending the previously-
made cut in the bone, to completion, while moving the cutting tool along the
previously-cut surface of the bone to guide the cutting tool.” Under this
construction, merely passing the cutting tool over the previously-cut surface in a
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manner that does not extend the previously-made cut, but only flattens it, does not
satisfy the claim requirement. Petitioner has not persuaded us that the cited
references disclose or suggest extending the previously-made cut in the bone while
moving the cutting tool along the previously-cut surface of the bone to guide the
cutting tool, as required by claim 1. In particular, Petitioner has not provided
sufficient argument or evidence to persuade us that modifying the distal femoral
surface so that it is completely flat would involve necessarily extending the
previously-made cut, as claim 1 requires.
Petitioner contends, alternatively, that in view of the p.c.a. Guide, it would
have been obvious to a person of ordinary skill using the procedures described in
the MG II and NexGen Epi guides “to remove the distal femoral cutting guide and
then complete the cut without using the cutting guide.” Pet. 37-38. Petitioner
relies (id. at 38) on the following disclosure in the p.c.a. Guide:
The jigs are now removed and the distal femoral cuts are
completed. In completing these cuts, the anterior aspect of the distal
femoral cut will serve as the “cutting block” for the remaining
posterior aspect. It is, therefore, important that the saw blade be
inserted to the full depth of the initial cut before the oscillation is
started. Otherwise, one runs the risk of starting a new plane. Once
the posterior part has been completed, the broadest blade should be
passed over the surface to be sure that the cut is a single flat plane.

Ex. 1017, 29. As a reason for combining the teachings of the p.c.a. Guide
with the MG II and NexGen guides, Petitioner states that “[i]t would have
been within the routine skill and discretion of a person of ordinary skill in
the art to use this cutting step in connection with the distal femoral cutting
steps disclosed in the MG II and NexGen epi technique guides.” Pet. 38
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(citing Ex. 1002 ¶¶ 91, 99). In this regard, Dr. Rolston testifies that the
disclosure in the p.c.a. Guide is “evidence of guiding a cutting tool along a
previously cut surface to complete a femoral cut during knee replacement
surgical procedures.” Ex. 1002 ¶ 91.
Petitioner has not articulated a reason with rational underpinning to
combine the teachings of the p.c.a. Guide with the MG II and NexGen
guides. In particular, Petitioner has not explained adequately why a person
of ordinary skill in the art would have used the cutting step disclosed in the
p.c.a. Guide in connection with the distal femoral cutting steps disclosed in
the MG II and NexGen epi guides. Merely stating that use of the cutting
step would have been within the routine skill and discretion of a person of
ordinary skill in the art is nothing more than a conclusory statement and, in
our view, does not support a conclusion of obviousness.
Dr. Rolston also testifies that a person of ordinary skill would have
encountered situations in which removing the cutting guide would have been
necessary to complete a previously-made cut. Ex. 1002 ¶ 87. In particular,
Dr. Rolston states that “[t]his situation would have occurred, for example,
when the cutting tool blade selected and used by the surgeon was not long
enough to reach the ends of the bone being cut while being guided by the
cutting guide.” Id. ¶ 87. In such situations, Dr. Rolston testifies, “the
surgeon would have removed the cutting guide member from against the
bone, and continued the cut in the bone while guiding the cutting tool blade
along the cut surface to extend the cut surface to the final cut length.” Id.
Dr. Rolston’s testimony, however, does not persuade us that a surgeon of
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ordinary skill in the art would have selected and used a blade that was not
long enough to reach the ends of the bone being cut while being guided by
the cutting guide.
As such, we determine that Petitioner has not demonstrated a
reasonable likelihood of prevailing on its contention that the claimed subject
matter recited in claim 1, and dependent claims 7, 8, 11, 12, 15, and 16,
would have been obvious based on any of the alleged combinations of
references set forth in the table above (see pages 8-10, supra).
Claims 30, 38, and 39 are similar to claim 1 because they require an
extension or continuation of the previously-made cut while using the previously-
made cut to guide the cutting tool. As with claim 1, merely passing the cutting tool
over the previously cut surface in a manner that does not extend or continue the
previously-made cut, but only flattens it, does not satisfy this requirement of
claims 30, 38, and 39. For essentially the same reasons as discussed above with
respect to claim 1, Petitioner has not persuaded us that any of the alleged
combinations of references renders obvious the claimed subject matter recited in
claims 30, 38, and 39, or claims 31-37, which depend from claim 30. See Pet. 46-
48, 56, 58-59.

III. CONCLUSION
For the forgoing reasons, we determine that the information presented in the
Petition does not establish a reasonable likelihood that Petitioner would prevail
with respect to at least one of challenged claims 1, 7, 8, 11, 12, 15, 16, and 30-39
of the ’635 Patent.
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IV. ORDER
Accordingly, it is
ORDERED that no inter partes review will be instituted pursuant to
35 U.S.C. § 314 as to any claim of the ’635 Patent on any of the grounds of
unpatentability alleged in the Petition.

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For PETITIONER:

Walter C. Linder
Daniel Lechleiter
Kenneth Liebman
FAEGRE BAKER DANIELS LLP
Walter.Linder@FaegreBD.com
Daniel.Lechleiter@FaegreBD.com
Ken.Liebman@FaegreBD.com

For PATENT OWNER:

Cary Kappel
William Gehris
DAVIDSON, DAVIDSON & KAPPEL, LLC
ckappel@ddkpatent.com
wgehris@ddkpatent.com