Ex Parte 7344541 et al

Patent Trial and Appeal Board

Apr 30, 2014

95001469 (P.T.A.B. Apr. 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.
95/001,469 10/15/2010 7344541 BIOMET1 7743
7590 04/30/2014
BRAD PEDERSEN
PATTERSON, THUENTE, SKAAR & CHRISTENSEN, P.A.
4800 IDS CENTER
80 SOUTH 8TH STREET
MINNEAPOLIS, MN 55402-2100
EXAMINER
REIP, DAVID OWEN
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
04/30/2014 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
____________________

BIOMET ORTHOPEDICS, LLC and
BIOMET MANUFACTURING CORPORATION
Third Party Requester, Cross-Appellant

v.

HUDSON SURGICAL DESIGN, INC.
Patent Owner, Appellant

____________________

Appeal 2014-001731
Reexamination Control 95/001,469
US Patent No. 7,344,541 B2
1

Technology Center 3900
____________________

Before: STEVEN D.A. McCARTHY, DANIEL S. SONG, and
BRETT C. MARTIN, Administrative Patent Judges.

MARTIN, Administrative Patent Judge.

DECISION ON APPEAL

1
Issued to Haines et al. on March 18, 2008 (hereinafter referred to as "the
'541 patent").
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US Patent No. 7,344,541 B2

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STATEMENT OF THE CASE
Patent Owner/Appellant appeals under 35 U.S.C. §§ 134(b) and 315
from the Examiner’s rejection of claims 1-54. Third Party Requester/Cross-
Appellant appeals under 35 U.S.C. §§ 134(c) and 315, the non-adoption of
the proposed rejection of certain claims as anticipated by either Matsen or
Ferrante as well as certain non-adopted indefiniteness rejections. We have
jurisdiction under 35 U.S.C. §§ 134 and 315.
The '541 patent is currently involved in the following and past
litigation proceedings (App. Br. 1):
Hudson Surgical Design, Inc. v. Biomet Orthopedics, LLC and Biomet
Manufacturing Corporation, Case No. 3:10-CV-00465-PPS-CAN, N.D.
Ind., stayed pending the result of the present reexamination;
Hudson Surgical Design, Inc. v. Depuy Orthopaedics, Inc., Case
No.3: 1 O-CV -00463-HD-CAN, N.D. Ind., stayed pending the result of the
present reexamination;
Hudson Surgical Design, Inc. v. Zimmer Holdings, Inc., Zimmer, Inc.,
Rush System for Health and Rush University Medical Center, Civil Action
No. 08 C 1566, N.D. Ill., dismissed with prejudice; and
Hudson Surgical Design, Inc. v. Smith & Nephew, Inc., Case No.
2:2011cv01371, W.D. Wash., dismissed with prejudice.
Reexamination Control 95/002,152 was also filed on September 7,
2012 by Depuy Orthopaedics, Inc., against U.S. Patent No. 7,967,822, which
is a continuation of and claims priority to the '541 patent. App. Br. 2.
We AFFIRM-IN-PART.

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THE INVENTION
Patent Owner's invention is directed generally to "methods and
apparatus for femoral and tibial resection to allow for the interconnection or
attachment of various prosthetic devices." Spec. col. 1, ll. 34-36. Claim 1,
reproduced below with bracketing and underlining to show amendments
made during reexamination prosecution, is illustrative of the claimed subject
matter:
1. A method for a knee arthroplasty procedure comprising:
positioning at least one generally planar cutting guide
surface that is adapted to interface with and guide a saw blade
such that at least a portion of the at least one guide surface is
positioned along only one of a medial side or a lateral side and
proximate an end of a long bone of a knee joint with no other
portion of the guide surface positioned along a corresponding
compartment of the other of the medial side or the lateral side
of the long bone, the at least one guide surface also being
positioned generally transverse to a long axis of the long bone
with the portion of the at least one guide surface having a
longer dimension generally along the [at least] one of the
medial side or the lateral side and a shorter dimension generally
transverse to the longer dimension;
using a cutting tool having a saw blade with a cutting
edge at a distal end of a long axis of the saw blade to create at
least a portion of one resected surface on the end of the long
bone by guiding the saw blade with at least the portion of the at
least one guide surface and moving the saw blade in a direction
along the long axis of the saw blade, the direction of the long
axis of the saw blade being generally parallel to the shorter
dimension; and
implanting a knee arthroplasty implant on the at least one
resected surface.

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REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Woolson
Matsen
Ferrante
Samuelson
US 4,841,975
US 4,979,949
US 5,364,401
US 5,611,802
Jun. 27, 1989
Dec. 25, 1990
Nov. 15, 1994
Mar. 18, 1997

Freeman Samuelson Total Knee System Brochure by Biomet, Inc.
("Biomet") (1994)
Mark II Total Knee Replacement System by Protek ("Mark II") (1985)
F/S Modular Total Knee Replacement System by Protek ("Protek") (1991)
THE REJECTIONS ON APPEAL
The Examiner made the following rejections:
1. Claims 1-29, 31-43, and 45-54 stand rejected under 35 U.S.C.
§ 102(e) as being anticipated by Samuelson. RAN 10, 11.
2. Claims 1-29, 31-43, and 45-54 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Samuelson and Protek. Id.
3. Claims 1-12, 21-25, 28-33, and 42-47 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Samuelson and Matsen. Id.
4. Claims 1-29, 31-43, and 45-54 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Biomet. Id.
5. Claims 1-5, 8, 21, and 22 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Mark II. Id.
6. Claims 1-29, 31-43, and 45-54 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Protek. Id.

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7. Claims 1-3, 5-12, 21-25, 28-33, and 42-47 stand rejected under
35 U.S.C. § 102(b) as being anticipated by Woolson. Id.
8. Claims 5, 13-20, 26, 39, 53, and 54 stand rejected under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement. RAN 20-21.
9. Claims 1-4, 6-8, 21, and 23 stand rejected under 35 U.S.C.
§ 112, second paragraph as being indefinite. RAN 21-22

ANALYSIS
Claim Construction
Patent Owner first challenges the Examiner's claim construction as
failing to consider alleged past disavowals and improperly interpreting
amended claim language to cover references over which the claim was
originally allowed. See App. Br. 11-13. We first note that one purpose of
reexamination is to correct previous examiner error, including errors in
claim construction. The mere fact that a construction during reexamination
covers such prior art is not dispositive because claim construction may be
the error that the reexamination corrects. We therefore are not persuaded
that a new construction that encompasses past prior art is improper.
Patent Owner argues that the statement, "Bert et al. shows the slot
facing the end of both the medial and lateral aspects, whereas claim 43
(issued as claim 9) requires the slot to face only one of a medial or a lateral
aspect," from the original prosecution amounts to a clear disavowal. App.
Br. 13-14 (emphasis removed). This statement, however, refers only to a
single slot and does not reference a guide surface, which is what is claimed.
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Further, in Bert, there are multiple slots depicted (122 and 123), and it is not
entirely clear whether the statement in the original prosecution somehow
referred to both slots (plural) or just one of the two slots. Also, given the
present Examiner's decision to divide tools like that shown in Bert into two
halves, the alleged disavowal would be irrelevant because the Examiner
considers the medial side to be the claimed "at least one guide surface,"
while the opposing lateral side would not be limited by the claims as
currently written. Ultimately, it is unclear from this single statement that the
type of disavowal suggested by Patent Owner was actually made.
Additionally, as noted above, the disavowal to which Patent Owner
points was only to claim 43 (which issued as claim 9), and its dependent
claim 46, and further accompanied an amendment unrelated to the alleged
disavowal. It is unclear whether it was the amendment or the statement,
again unrelated to the amended language, that convinced the Examiner to
allow the claims. Accordingly, we do not agree that this is the type of clear
disavowal necessary to limit claim construction as applied to all claims
presently before us.
Turning to the claim language itself, claim 1 recites "positioning at
least one generally planar cutting guide surface…." While the claim then
further limits placement of the claimed at least one generally planar cutting
guide surface, the presence of "at least one" allows for the presence of
additional cutting guide surfaces that would not be subject to those same
limitations. As the Examiner states, "'the at least one guide surface,' 'the
cutting guide,' etc. as recited in the claims can be defined by only a portion
of one of the guides of Samuelson." RAN 12. The claims as currently
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written limit only the claimed guide surface and do not preclude other guide
surfaces as are found in Samuelson. This is a reasonable interpretation of
the claims.
Anticipation by Samuelson
Claims 35-38 and 49-52
Patent Owner argues that regardless of construction, these claims are
not anticipated because Samuelson does not disclose using a medial- or
lateral-placed guide to cut from that side to the other side using only the
single guide. App. Br. 15. The claim limitation at issue states, "wherein
positioning the tibial cut guide locates the tibial cut guide generally medially
and…further includes cutting a lateral side of the tibia." Claim 35
(emphasis added). Patent Owner notes that "[t]here is simply no teaching or
suggestion in Samuelson that the blade is extended from the medial or lateral
side of the tibia all the way through to the opposite side." App. Br. 16-17.
We agree because as Patent Owner states, "by the express teachings of
Samuelson, when the reference discusses positioning the medial swing
arms 334 and 360 around the tibia and utilize[s] the medial slot 370 to resect
the tibia, the lateral swing arms 334', 360' and slot 370' are also used in the
same exact manner when the bone is resected." App. Br. 16. In other
words, Samuelson teaches a medial cutting guide to cut the medial side of
the bone and a lateral cutting guide to cut the lateral side, but nowhere
explicitly discloses a single guide placed on one side or the other and used to
cut into the other side (i.e., from the lateral into the medial side or vice
versa), for example as in claim 35.
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Third Party Requester ("Requester") asserts that Samuelson
specifically teaches using one swing arm to perform a resection, but we do
not agree that the portion cited by Requester clearly states that this is the
case. See Requester's Resp. Br. 7-8. In referring to the operation of the
swing arms 200 and 200', we agree with Patent Owner that the description
appears only to describe cutting the portion of the bone on the same side as
the swing arm and subsequently using the opposite guide to cut the opposite
side. Regardless, we do not find this disclosure to be sufficiently explicit to
support an anticipation rejection and do not sustain the Examiner's rejection
of claims 35-38 and 49-52 as anticipated by Samuelson.
Claims 1-4, 6-8, 21, and 23
Patent Owner argues claims 1-4, 6-8, 21, and 23 as a group. We
select claim 1 as representative. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
Patent Owner argues that even discounting swing arm 334' so that there is no
swing arm positioned along the lateral side of the bone, "the cutting guide
slot 361 extends along the entire anterior (or front) face of the bone" in
contradiction with the claim language requiring "no other portion of the
guide surface positioned along a corresponding compartment of the other of
the medial side or the lateral side" of the bone. App. Br. 17-18.
We disagree with this assertion because it is not commensurate with
the scope of the claims as construed by the Examiner. The Examiner utilizes
swing arm 334 to meet the language of "at least one generally planar guide
surface." The fact that guide portion 361 does not satisfy this limitation is of
no moment because the rest of the claim applies only to the recited "at least
one guide surface," which is swing arm 334, not slot 361. As noted above
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with respect to claim construction, the claims as written allow for other
guide surfaces that may be placed anywhere on the bone. In order not to
satisfy the claim language, Patent Owner needs to show that swing arm 334
is positioned along something other than the medial side of the bone, which
it has not done. Accordingly, we sustain the Examiner's rejection of claims
1-4, 6-8, 21, and 23 as anticipated by Samuelson.
Claims 5 and 22
Patent Owner makes essentially the same argument as above in
reference to claims 5 and 22 by relying on its claim construction and
asserting the slot 361 "extends along the entire anterior face of the bone and,
as such, extends along greater than one-half of a width of the anterior side."
App. Br. 20. As with claim 1, the Examiner does not use slot 361 to meet
the claim language, but only uses slot 200, which meets the claim language.
Accordingly we sustain the Examiner's rejection of claims 5 and 22 as
anticipated by Samuelson.
Claims 9-12, 24, 25, 27-29, 34, 41-43, and 48
Patent Owner reasserts the arguments presented above with respect to
claims 5 and 22, which we have already rejected. App. Br. 21. Again,
Patent Owner points to portions of Samuelson that are not used by the
Examiner to meet the claim limitations at issue. As such, we sustain the
Examiner's rejection of claims 9-12, 24, 25, 27-29, 34, 41-43, and 48 as
anticipated by Samuelson.
Claims 13-15, 17, 18, and 26
As above, Patent Owner makes arguments that are not commensurate
with the scope of these claims or the rejection made by the Examiner. For
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the same reasons as stated supra, we sustain the Examiner's rejection of
claims 13-15, 17, 18, and 26 as anticipated by Samuelson.
Claims 16, 19, 31-33, 39, 40, 45-47, 53, and 54
Patent Owner essentially restates arguments made with respect to the
independent claims from which these claims depend. App. Br. 22-23.
Having already rejected these arguments, we sustain the Examiner's
rejection of these claims as anticipated by Samuelson.

Anticipation by Woolson
Having already sustained the Examiner's rejection of most of the
claims subject to the rejections over Woolson as anticipated by Samuelson,
we need not address the cumulative rejection of these claims over Woolson.
Claims 30 and 44, however, do not stand rejected as anticipated by
Samuelson, but are rejected as anticipated by Woolson.
In general, Patent Owner argues the rejections over Woolson under
the same rationale as that with respect to Samuelson, namely that the
Examiner improperly relies on aspects of Woolson that extend along both
lateral and medial aspects. See App. Br. 34-37. As with Samuelson,
however, these aspects to which Patent Owner points are in addition to the
portions the Examiner uses to meet the claim language at issue. As noted
above, the claims are not so narrow as to preclude the presence of other
guide surfaces and so we are not persuaded generally as to the asserted error
in the rejections over Woolson. Patent Owner also makes no specific
argument relating to claims 30 and 44 and so we have no basis to reverse the
Examiner specifically with regard to these two claims. As such we affirm
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the Examiner's decision to reject claims 30 and 44 as anticipated by
Woolson.

Anticipation by Biomet
Claims 35-38 and 49-52
As with Samuelson, above, we agree with Patent Owner that Biomet
fails to teach cutting all the way across the bone utilizing the cutting guide
positioned on one side. As Patent Owner states, "Biomet expressly states
that both arms, plural, are used to resect the femur." App. Br. 24. For the
same reasons as stated above with respect to Samuelson, we do not sustain
the Examiner's rejection of claims 35-38 and 49-52.
Remaining Claims
Having already sustained the Examiner's rejection of claims 1-29, 31-
34, 39-43, and 45-54 as anticipated by Samuelson, we need not address the
cumulative rejection of these claims over Biomet.

Anticipation by Protek F/S Modular
Claims 35-38 and 49-52
As with Samuelson and Biomet, above, we agree with Patent Owner
that Protek fails to teach cutting all the way across the bone utilizing the
cutting guide positioned on one side. As Patent Owner states, "[t]here is no
express teaching in Protek F/S Modular that the lateral side of the tibia is
actually cut from the medial side guide surface, rather than the anterior guide
surface." App. Br. 30. For the same reasons as stated above with respect to
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Samuelson and Biomet, we do not sustain the Examiner's rejection of
claims 35-38 and 49-52.
Remaining Claims
Having already sustained the Examiner's rejection of the remaining
claims as anticipated by Samuelson, we need not address the cumulative
rejection of these claims over Protek.

Obviousness over Samuelson and Protek F/S Modular
Having already sustained the Examiner's rejections above as
anticipated by Samuelson as to some of the claims, we need not reach the
cumulative rejections over the combination of Samuelson and Protek as to
those claims. Regarding claims 35-38 and 49-52, having already determined
that neither of Samuelson nor Protek teaches the pertinent limitations of
these claims, it follows that the combination cannot make up for these
deficiencies. Accordingly we do not sustain the Examiner's rejection of
claims 35-38 and 49-52 as unpatentable over Samuelson and Protek.

Obviousness over Samuelson and Matsen
Having already sustained the Examiner's rejection of the claims
subject to the rejections over the combination of Samuelson and Matsen as
anticipated by Samuelson or Woolson, we need not address the cumulative
rejection of these claims over Samuelson and Matsen.
Non-Adopted Rejections
Requester appeals the Examiner's non-adoption of anticipation
rejections over each of Matsen and Ferrante. Because these rejections deal
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with claims that were rejected and sustained as anticipated by Samuelson or
Woolson, we will not address the non-adoption due to their cumulative
nature.

Indefiniteness/Written-Description Rejections
Claim 5
Patent Owner argues that the Examiner has misconstrued the claims,
as well as that the language at issue is original language and cannot properly
be rejected under 35 U.S.C. § 112 during reexamination. See App. Br. 40-
41. Patent Owner further argues that the claims are fully supported as
shown at least in Figure 18. Id. We agree with Patent Owner on all counts
and thus do not sustain the Examiner's written description rejection of
claim 5.
Claims 13, 16, and 26
The Examiner asserts that these claims lack written description
because the '541 patent discloses the cutting guide of Figure 18 as being
used only with the tibia and not the femur. See RAN 21. As Patent Owner
correctly argues, however, these claims are sufficiently supported by
adequate written description by way of the fact that the Specification
explains how the cutting guide is useful for avoiding the problem of quad
tendon interference. See App. Br. 42. Because the quad tendon interacts
only with the femur, we agree with Patent Owner that the Specification
sufficiently supports the device being used with either the femur or the tibia.
Accordingly, we do not sustain the written description rejections of these
claims.
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Claims 1-4, 6-8, 21, and 23
As the Patent Owner points out, the Examiner rejects these claims "as
being indefinite for using the phrase 'corresponding compartment,' stating
that there was no antecedent basis for use of the word 'corresponding.'"
App. Br. 43. The claim language at issue is "with no other portion of the
guide surface positioned along a corresponding compartment of the other of
the medial or lateral side of the long bone." Because this language refers to
"a" corresponding compartment and we are persuaded by Patent Owner's
assertion that one of skill in the art would understand that "it is inherent that
a 'corresponding compartment' of either the medial or lateral side refers to
either the medial compartment or the lateral compartment, respectively," we
agree that the claim language is not indefinite. App. Br. 44. Furthermore,
because we agree that one of ordinary skill in the art would understand what
is meant by the lateral and medial compartments, we conclude that there is
no lack of written description as suggested by Requester. Requester App.
Br. 19. Accordingly, we do not sustain the Examiner's rejection of claims 1-
4, 6-8, 21, and 23 for lack of antecedent basis.
Claims 9, 10, 24, and 25
Requester appeals the Examiner's decision not to adopt proposed
indefiniteness rejections because the claim terms at issue, "medial aspect"
and "lateral aspect," are original claim language and therefore not subject to
review under 35 U.S.C. § 112. We agree with the Examiner that this
language is non-reviewable in this reexamination. Requester further argues
that the Examiner failed to properly consider the newly added negative
limitation regarding "no other portion of the slot positioned along the other
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of the medial aspect or the lateral aspect." Requester App. Br. 20, 22. We
are not persuaded by Requester's argument that Figure 18 is insufficient to
support this limitation. Regardless of whether there is a distinct boundary,
we conclude that the disclosure is sufficiently clear to support that the
cutting guide is only on one of the medial or lateral aspects, but not on the
other.
Claims 5 and 22
Likewise, we agree with the Examiner that the rejection relating to "at
least a portion" was properly not adopted because such language is original.
Regarding claim 22, Requester further argues that there is insufficient
support for there being "only two portions." Requester App. Br. 21, 24.
Again, we conclude that Figure 18, as explained by Patent Owner,
sufficiently supports the pertinent recitations regarding the two portions and
one of skill in the art would understand the claim language at issue.
Accordingly, we agree with the Examiner's decision not to reject claims 5
and 22 as indefinite.
Claims 13 and 26
The Examiner chose not to adopt Requester's proposed rejection of
claims 13 and 26 "because the phrase 'positioning the femoral cut guide to
extend toward and generally along only a portion of the anterior side of the
femur and only one of a medial side or a lateral side of the knee' can be
understood by one of ordinary skill in the art." RAN 23. For the reasons
stated by the Examiner in the RAN, we agree that one of skill in the art
would understand the language and therefore sustain the Examiner's decision
not to adopt Requester's proposed rejection.
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DECISION
For the above reasons, we AFFIRM the Examiner’s decision to reject
claims 1-29, 31-34, 39-43, 45-48, 53, and 54 as anticipated by Samuelson
and claims 30 and 44 as anticipated by Woolson. We REVERSE the
Examiner's decision to reject claims 35-38 and 49-52 as anticipated by any
of Samuelson, Biomet, and Protek as well as the all of the Examiner's
rejections under 35 U.S.C. § 112. We also AFFIRM the Examiner's non-
adoption of the various rejections under 35 U.S.C. § 112.
Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. §§ 1.956 and 41.77(g).
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.

AFFIRMED-IN-PART
ak

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Brad Pedersen
Patterson, Thuente, Skaar & Chistensen, P.A.
4800 IDS Center
80 South 8
th
Street
Minneapolis, MN 55402-2100

Third Party Reqeuster:

Troutman Sanders, LLP
5200 Bank of America Plaza
600 Peachtree Street, N.E.
Suite 5200
Atlanta, GA 30308-2216