Ex Parte Andriacchi et al

Patent Trial and Appeal Board

Oct 15, 2018

12815730 (P.T.A.B. Oct. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/815,730 06/15/2010
104326 7590 10/17/2018
Schwegman Lundberg & Woessner/ Zimmer
P.O. Box 2938
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Thomas P. Andriacchi
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.
5394.021US 1 1986
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/17/2018 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
SLW@blackhillsip.com
USPTO@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS P. ANDRIACCHI and JORGE 0. GALANTE
Appeal2017-008851
Application 12/815,730 1
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 5-8, 11, 12,
and 30-50 (Final Act. 2 1). Examiner entered rejections under 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify "Biomet Manufacturing, LLC" as the real party in
interest (App. Br. 2).
2 Office Action mailed August 11, 2016.
Appeal2017-008851
Application 12/815,730
STATEMENT OF THE CASE
Appellants' disclosure "relates generally to the knee arthroplasty field,
and more specifically to an improved knee replacement system for enabling
natural knee movement over a broad range of activities in the knee
replacement field" (Spec. ,r 2). Appellants' claims 1 and 50 are
representative and reproduced below:
1. A knee replacement system for enabling natural knee
movement in a leg with a femur having medial and lateral
condyles and a tibia having medial and lateral tibial plateaus in
a patient, comprising:
a femoral component including:
a medial femoral portion, implantable on the
medial condyle and having a medial femoral articulating
surface, wherein the medial femoral articulating surface has a
medial femoral sagittal plane profile including first superior,
first posterior, first distal, and first anterior femoral arcuate
portions scaled by a first femoral scaling factor wherein the first
distal femoral arcuate portion sweeps a greater number of
degrees than each of the first posterior femoral arcuate portion
and the first anterior femoral arcuate portion, wherein the first
superior, first posterior, first distal, and first anterior femoral
arcuate portions have first superior, first posterior, first distal,
and first anterior femoral radii of curvature, respectively,
wherein the first distal femoral radius of curvature is longer
than each of the first posterior and first anterior femoral radii of
curvature, and wherein the first femoral scaling factor
comprises a measure of the offset from a posterior edge of the
medial condyle in a central sagittal plane to the first distal
femoral radius of curvature which extends to intersect a point of
initial articular contact between the medial femoral portion and
a medial tibial portion of a tibial component; and
a lateral femoral portion, implantable on the lateral
condyle and having a lateral femoral articulating surface,
wherein the lateral femoral articulating surface has a lateral
femoral sagittal plane profile including second superior, second
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Application 12/815,730
posterior, second distal, and second anterior femoral arcuate
portions scaled by a second femoral scaling factor wherein the
first distal femoral arcuate portion sweeps a greater number of
degrees than the second distal femoral arcuate portion, wherein
the second distal femoral arcuate portion has a second distal
femoral radius of curvature, wherein the second distal femoral
radius of curvature is longer than the first distal femoral radius
of curvature, and wherein the second femoral scaling factor
comprises a measure of the offset from a posterior edge of the
lateral condyle in a central sagittal plane to the second distal
femoral radius of curvature which extends to intersect a point of
initial articular contact between the lateral femoral portion and
a lateral tibial portion of the tibial component; and
the tibial component including at least one of:
the medial tibial portion, implantable on the medial
tibial plateau and having a medial tibial articulating surface that
articulates with the medial femoral articulating surface, wherein
the medial tibial articulating surface includes a first plateau and
a first raised medial edge that increases in width in an anterior
direction and curves distally to the first plateau; and
the lateral tibial portion, implantable on the lateral
tibial plateau and having a lateral tibial articulating surface that
articulates with the lateral femoral articulating surface, wherein
the lateral tibial articulating surface includes a second plateau
and a second raised medial edge that increases in width in the
anterior direction and curves distally to the second plateau.
(App. Br. 28-29.)
50. A knee replacement system for enabling natural knee
movement in a leg with a femur having medial and lateral
condyles and a tibia having medial and lateral tibial plateaus,
the system comprising:
a plurality of medial femoral components each having a
medial femoral articulating surface scaled to a distinct medial
femoral scaling factor;
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Application 12/815,730
a plurality of lateral femoral components each having a
lateral femoral articulating surface scaled to a distinct lateral
femoral scaling factor;
a plurality of medial tibial components each having a
medial tibial articulating surface configured to articulate with
the medial femoral articulating surface and scaled to a distinct
medial tibial scaling factor; and
a plurality of lateral tibial components each having a
lateral tibial articulating surface configured to articulate with
the lateral femoral articulating surface and scaled to a distinct
lateral tibial scaling factor;
wherein:
the distinct medial femoral scaling factor
comprises a measure of the offset from a posterior edge of the
medial condyle in a central sagittal plane to a first distal
femoral radius of curvature which extends to intersect a point of
initial articular contact between the medial femoral articulating
surface and the medial tibial articulating surface; and
the distinct lateral femoral scaling factor comprises
a measure of the offset from a posterior edge of the lateral
condyle in a central sagittal plane to a second distal femoral
radius of curvature which extends to intersect a point of initial
articular contact between the lateral femoral articulating surface
and the lateral tibial articulating surface.
(Id. at 36-37.)
The claims stand rejected as follows:
Claim 50 stands rejected under 35 U.S.C. § I03(a) as unpatentable
over the combination of Clemow3 and Kubein-Meesenburg. 4
3 Clemow et al., US 2006/0190086 Al, published Aug. 24, 2006.
4 Kubein-Meesenburg et al., US 5,879,390, issued Mar. 9, 1999.
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Application 12/815,730
Claims 1, 5-8, 11, 12, and 30-49 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over the combination ofClemow, Aram, 5 and
Kubein-Meesenburg.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
The rejection over the combination of Clemow and Kubein-Meesenburg:
Clemow "relates to prosthetic devices for use in partial or complete
knee replacement and associated methods" (Clemow ,r 2). More
specifically, Clemow discloses:
A modular prosthetic device is provided for replacement of the
knee. The device is assembled from a plurality of components,
each of which can be inserted through a small incision. After
inserting the components through the incision, the device can
be assembled within the knee cavity. The modularity of the
device enables a surgeon to replace only those regions of the
knee that are diseased or damaged, thereby avoiding a complete
knee replacement.
(Clemow, Abstract; see App. Br. 20; see generally Clemow ,r,r 13, 14, 103
and Tables.) Given the modular aspect of Clemow's prosthetic device,
Examiner
takes the position that the medial tibial articulating surface of
Clemow is scaled to a distinct medial tibial scaling factor, and
the lateral tibial articulating surface of Clemow is scaled to a
distinct lateral tibial scaling factor, at least to the same extent as
[Appellants'] ... reasonably assuming that various sizes [of
5 Aram et al., US 2006/0058883 Al, published Mar. 16, 2006.
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Appeal2017-008851
Application 12/815,730
Clemow 's modular prosthetic device] are proportionally sized
given different sizes mix and match.
(Final Act. 4 (citing Clemow ,r,r 13, 14, 103, and Tables) (emphasis added).)
Therefore, Examiner concludes that because
the medial and lateral femoral components cooperate or
articulate in a matching joint construction they can be
considered to be directly correlated with the medial and lateral
tibial scaling factors and thus inherently the knee replacement
system comprises the components with the scaling factors as
[ required by Appellants'] claim[].
(Final Act. 5.) We are not persuaded.
"Inherency ... 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 and internal quotation marks omitted). On this record
Examiner failed to establish an evidentiary basis to support a conclusion that
Clemow necessarily discloses a scaling factor and, if so, that such a scaling
factor necessarily fulfills the requirements of Appellants' claim 50 such that
the distinct medial femoral scaling factor comprises a
measure of the offset from a posterior edge of the medial
condyle in a central sagittal plane to a first distal femoral radius
of curvature which extends to intersect a point of initial
articular contact between the medial femoral articulating
surface and the medial tibial articulating surface; and
the distinct lateral femoral scaling factor comprises a
measure of the offset from a posterior edge of the lateral
condyle in a central sagittal plane to a second distal femoral
radius of curvature which extends to intersect a point of initial
articular contact between the lateral femoral articulating surface
and the lateral tibial articulating surface.
(App. Br. 36-37; see App. Br. 20 (Clemow, as relied upon by Examiner,
fails to disclose the scaling factors required by Appellants' claim 50).) See
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In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ("rejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness").
Consistent with the foregoing analysis, Examiner alternatively finds
that Clemow does not disclose the "distinct medial femoral scaling factor" or
"distinct lateral femoral scaling factor" required by Appellants' claimed
invention (Final Act. 3--4; see App. Br. 17 (Examiner's Final Action
"appears to assert to alternative positions")). To make up for the foregoing
deficiency in Clemow, Examiner relies on Kubein-Meesenburg to disclose
that knee joint prosthetics include a distinct measure offset from
a posterior edge of the[: ] medial condyle in a central sagittal
plane to a first distal femoral radius of curvature which extends
to intersect a point of initial articular contact between the
medial femoral articulating surface and the medial tibial
articulating surface [and] ... lateral condyle in a central sagittal
plane to a second distal femoral radius of curvature which
extends to intersect a point of initial articular contact between
the lateral femoral articulating surface and the lateral tibial
articulating surface.
(Final Act. 3--4 (citing Kubein-Meesenburg Figures 5 and 10).) In this
regard, Examiner asserts that Kubein-Meesenburg's Figures 5 and 10
"clearly convey[ s] the point of offset measured is to the posterior edge of a
component as inherently the knee components possess posterior edges of
which the illustrated radius of curvature drawings show how far the
components articulate and stay in contact" (Ans. 3--4). In addition,
Examiner finds that Kubein-Meesenburg discloses "that all knees have a
posterior condylar offset and the objective in knee surgery when replac[ing]
with a prosthesis is the restoration of the offset to closely match the patient
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anatomy for a natural feel of restored flexion when articulation between the
tibial component moves against the femoral component" (Ans. 4 (citing
Kubein-Messenburg column 6)). We are not persuaded.
As Appellants explain, "column 6 of Kubein-Messenburg or indeed
anywhere in Kubein-Meesenburg" does not support Examiner's finding
regarding "a posterior condylar offset" or the asserted "objective of knee
surgery" (Reply Br. 7; cf Ans. 4 ). In addition, Appellants explain that
Kubein-Meesenburg's Figures 5 and 10 do not disclose a scaling factor, as
required by Appellants' claimed invention (App. Br. 18-19; see also Reply
Br. 3-8; Reply Br. 3 (although Kubein-Meesenburg's Figure 10 "does
discuss an offset, this offset does not comprise a scaling factor")). Examiner
has not shown Appellants' analysis of Kubein-Meesenburg to be inaccurate.
For the foregoing reasons, we find that the weight of the evidence on
this record falls in favor of Appellants. Therefore, we are not persuaded by
Examiner's conclusion that the combination of Clemow and Kubein-
Meesenburg makes obvious Appellants' claimed invention (see Final Act.
4--5). In this regard, we recognize Examiner's assertion that
finding a distance or measurement of[] a patient's knee offset
[] can be determined in a finite number of ways, the end result
is providing the appropriate dimensions for the femoral
component to be formed with the offset as best matching the
normal range of motion that was provided by the anatomy.
Thus, Appellant[ s] [are] not creating something novel, the
posterior condylar offset is known existing anatomical design
of human knee and performing or taking a measurement does
not involve any undue experimentation or technique, but
utilizes common knowledge and ordinary skill in the art. As a
result one of ordinary skill in the art can scale the lateral and
medial condyles to establish the scaling factor as claimed.
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(Ans. 4.) We note however, it is Examiner's "initial burden, on review of
the prior art ... , [to] present[] aprimafacie case ofunpatentability." In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). On this record, Examiner
failed to meet this initial burden. Further, "rejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness." Kahn, 441 F.3d at 988.
Absent some articulated rationale, a finding that a combination
of prior art would have been "common sense" or "intuitive" is
no different than merely stating the combination "would have
been obvious." Such a conclusory assertion with no
explanation is inadequate to support a finding that there would
have been a motivation to combine.
In re Van Os, 844 F.3d 1359, 1361 (Fed. Cir. 2017).
The rejection over the combination of Clemow, Aram, and Kubein-
Meesenburg:
Each of Appellants' independent claims 1, 33, and 44 require a
scaling factor (see App. Br. 28-29, 30-32, and 34--35). Appellants' claims
5-8, 11, 12, 30-32, 34--43, and 45--49 dependent directly or indirectly from
claims 1, 33, and 44 respectively.
Examiner finds that Clemow discloses Appellants' claimed invention
with the exception of a scaling factor as required by Appellants' claimed
invention or a "second distal femoral radius of curvature [that] is longer than
the first distal femoral radius of curvature" (Final Act. 6-9). Examiner relies
upon Kubein-Messenburg to make up for Clemow's deficiency with respect
to the scaling factor (see Final Act. 7-8; see Ans. 6 ("Kubein-Meesenburg
was used for the teaching of the offset and scaling factor")). Examiner relies
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upon Aram to make up for Clemow's deficiency with respect to a "second
distal femoral radius of curvature [that] is longer than the first distal femoral
radius of curvature" (Final Act. 9-10).
For the reasons set forth above, with respect to Appellants' claim 50,
we are not persuaded that Examiner provided an evidentiary basis on this
record to support a conclusion that the combination of Clemow, Aram, and
Kubein-Meesenburg discloses a scaling factor within the scope of
Appellants' claim invention (see generally App. Br. 26 ("Independent claims
1, 33, and 44 ... recite scaling factors ... [, which] are not rendered obvious
by the combination of Clemow, in view of Aram in further view of Kubein-
Meesenburg") ). Therefore, we are not persuaded by Examiner's conclusion
that the combination of Clemow, Aram, and Kubein-Meesenburg makes
obvious Appellants' claimed invention (see Final Act. 11; see also id. at 11-
14).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claim 50 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Clemow and Kubein-Meesenburg is reversed.
The rejection of claims 1, 5-8, 11, 12, and 30-49 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Clemow, Aram, and
Kubein-Meesenburg is reversed.
REVERSED
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