Ex Parte Hanssen et al

Patent Trial and Appeal Board

Apr 25, 2018

13619091 (P.T.A.B. Apr. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/619,091 09/14/2012
104326 7590 04/27/2018
Schwegman Lundberg & Woessner/ Zimmer
P.O. Box 2938
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Arlen D. Hanssen
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.
4394.374US7 7504
EXAMINER
PREBILIC, PAUL B
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
04/27/2018 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 ARLEN D. HANS SEN and DAVID G. LEW ALLEN
Appeal2017-007059
Application 13/619,091 1
Technology Center 3700
Before FRANCISCO C. PRATS, ELIZABETH A. LA VIER, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal2 under 35 U.S.C. § 134(a) involves claims to a method for
supporting an acetabular cup implant and restoring lost bone stock in an
acetabular cavity in a patient. The Examiner entered final rejections for
anticipation, obviousness, and that the claims lacked written description.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-
PART.
1 Appellants identify Zimmer, Inc. as the real party in interest. Appeal Br. 2.
2 Appellants state "U.S. Application Serial Nos. 11/560,276 and 13/619,134
are related appeals known to Appellants that may have a bearing on the
Board's decision in the present appeal." App. Br. 3.
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Application 13/619,091
STATEMENT OF THE CASE
Background
The replacement of joints, such as the shoulder, hip,
knee, ankle and wrist, with prosthetic implants has become
widespread. One problem commonly encountered by surgeons
replacing joints is the loss of strong bone stock near the joint
being replaced. Defects in a bone adjacent a joint, such as the
hip or knee, can occur due to wear and arthritis of the joint,
congenital deformity, and following the removal of a failed
prosthetic implant. Defects can be of a cavitary contained type
or segmental and uncontained. Because such bone defects are
quite common, various methods have been proposed for
minimizing the adverse effects of such bone defects on joint
replacement procedures.
Spec. ,r 4. The disclosure "relates to prosthetic devices for implantation
within a bone, and more particularly to support structures that are affixed to
a bone and that support prosthetic implants." Id. ,r 3.
The Claims
Claims 21-24, 27-33, 36, 38--41, 43, 44, and 46-64 are on appeal.
Claim 21 is illustrative and reads as follows:
21. A method for supporting an acetabular cup implant
and restoring lost bone stock in an acetabular cavity in a patient,
the method comprising:
implanting a partially-hemispherical support component
and an acetabular cup implant in an acetabular cavity in a
patient, wherein the partially-hemispherical support component
provides support to the acetabular cup implant in the acetabular
cavity with an adhesive located between an outer surface of the
acetabular cup implant and an inner surface of the partially-
hemispherical support component to secure the partially-
hemispherical support component to the acetabular cup implant,
said partially-hemispherical support component consisting
essentially of a porous metal material that is a bone ingrowth-
receptive material with a porous structure for encouraging
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Application 13/619,091
bone ingrowth and attachment throughout the partially-
hemispherical support component for restoring lost bone stock
in the acetabular cavity, said partially-hemispherical support
component including a convex outer surface facing an inner
surface of the acetabular cavity and providing a surface through
which bone of the patient can grow into said partially-
hemispherical support component, wherein the partially-
hemispherical support component is formed separately from
said acetabular cup implant for subsequent connection to said
acetabular cup implant, and wherein the partially-hemispherical
support component is capable of being positioned, by itself, in
the acetabular cavity prior to being secured to said acetabular
cup implant and is capable of being impacted, by itself, into the
acetabular cavity for obtaining a press fit of the partially-
hemispherical support component in the acetabular cavity.
App. Br. 97-98 (Claims App.) (Emphases added).
The Issues
The following rejections are before us to review:
I. Claims 21-24, 27-33, 36, 38--41, 43, 44, and 46-64 are rejected under
35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph.
Final Act. 3. 3
II. Claims 30, 394, 40, 49, 53, and 60 are rejected under pre-AIA 35
U.S.C. § 102(b) as anticipated by Ducheyne5 or, in the alternative,
under pre-AIA 35 U.S.C. § 103(a) as obvious over Ducheyne alone.
Id. at 4.
3 Examiner's Final Action, mailed October 11, 2016 ("Final Act.").
4 The Examiner states on pg. 2 of the Answer that the rejection of claim 38
under 35 U.S.C. § 102(b) was withdrawn as inadvertently included; thus, we
exclude claim 3 8 from our analysis.
5 US 4,693,721, issued September 15, 1987 ("Ducheyne").
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III. Claims 30, 32, 36, 39-41, 43, 47, 48, 59, and 61---64 are rejected under
pre-AIA 35 U.S.C. § 102(b) as anticipated by Christie 6 or, in the
alternative, under pre-AIA 35 U.S.C. § 103(a) as obvious over
Christie and Draenert 7 or Ducheyne. Id. at 6, 11.
IV. Claims 30, 32, 36, 41, 43, 51, and 59---64 are rejected under pre-AIA
35 U.S.C. § 102(b) as anticipated by Grimes8 or, in the alternative,
under pre-AIA 35 U.S.C. § 103(a) as obvious over Grimes and
Draenert or Ducheyne. Id. at 7.
V. Claims 31, 44, and 55 are rejected under pre-AIA 35 U.S.C. § 103(a)
as obvious over Grimes, Draenert, and Kampner. 9 Id. at 9.
VI. Claims 21-24, 28, 29, 33, 49, 51, 56, and 58 are rejected under pre-
AIA 35 U.S.C. § 103(a) as obvious over Christie, Draenert or
Ducheyne, and Tullos. 10 Id.
VII. Claims 50 and 57 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Christie, Draenert, Ducheyne, Tullos, and Kampner. Id.
at 10.
VIII. Claims 27, 38, and 46 are rejected under pre-AIA 35 U.S.C. § 103(a)
as obvious over Christie, Draenert, and Ducheyne or Christie,
Draenert, Ducheyne, and Tullos, and further in view of Eichler. 11 Id.
IX. Claims 52-54 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Christie and Draenert or Ducheyne. Id. at 11.
6 US 5,192,329, issued March 9, 1993 ("Christie").
7 US 5,958,314, issued September 28, 1999 ("Draenert").
8 US 5,176,711, January 5, 1993 ("Grimes").
9 US 4,840,632, issued June 20, 1989 ("Kampner").
10 US 5,658,338, issued August 19, 1997 ("Tullos").
11 US 3,918,102, issued November 11, 1975 ("Eichler").
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X. Claim 53 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Grimes and Draenert or Ducheyne. Id.
I - WRITTEN DESCRIPTION
The Examiner finds that the rejected claims contain "new claim
language requiring that the hemispherical support structure 'consisting
essentially of a porous material," but that the Specification "lacks clear
original support" for this language because the Examiner finds "it is not
clear from the original specification what is essential to the invention or
what is the basic and novel characteristic is of the invention." Ans. 3. The
Examiner interprets the claim language "consisting essentially of' as
"comprising" pursuant to MPEP § 2111.03. Id. at 3--4. With this
interpretation, the Examiner finds the claims lack "clear original support" for
"the claim language that the support structure is formed entirely with porous
material" and further that the "terminology 'a porous structure for
encouraging bone ingrowth and attachment throughout the partially
hemispherical support component' ( see claim 21, lines 9-11) or similar such
language lacks clear original support as well." Id. at 3.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the Specification fails
to adequately describe the claimed method.
Appellants argue that the language "consisting essentially of a porous
metal material" describes "a porous structure that is receptive to bone
ingrowth [ and] has the ability to restore lost bone stock in an area occupied
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by the porous structure." App. Br. 11, citing Lewallen Deel. ,r 6. 12
Appellants further argue the Specification explains that the claimed
invention solves the problem of lost or deficient bone by providing a
prosthetic implant support structure, including a "porous sleeve" to permit
ingrowth of new bone in the area of bone loss. Id. at 11-18. Appellants
argue that a person of ordinary skill, reading the Specification, would
understand the disclosure to explain "that the entire sleeve has a porous
structure which will allow bone of the patient to grow into and throughout
the sleeve upon implantation." Id. at 17.
The Examiner responds that the portions of the Specification cited by
Appellants do not clarify the extent of the porosity: "the depth of the pores is
not indicated by this language such that the pores could be on the surface as
a coating." The Examiner finds this limitation is disclosed in prior art
references Christie and Grimes. Ans. 3. The Examiner further finds that the
"pores could be provided by a coating on the inner and outer sleeves" and
that "all the acetabular support components have large openings, grooves, or
holes that allow the cement to extend therethrough suggesting the pores are
not needed for this." Id. at 4.
Appellants reply that the Examiner has not responded to the points
raised in the Appeal Brief. Reply Br. 2---6. Appellants further reply that,
based on evidence previously entered into the record, the skilled artisan
would have understood that "pores suitable for bone ingrowth are often in
the range of about 100-600 µm," and thus the large openings, grooves, or
12 Declaration of David G. Lewallen under 37 C.F.R. § 1.132, executed
November 4, 2015 ("Lewallen Deel.").
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holes indicated by the Examiner are not suitable for sustaining bone
ingrowth. Id. at 8.
We agree with Appellants that the Examiner has not shown that the
Specification fails to adequately describe the claimed implant. A description
adequate to satisfy 35 U.S.C. § 112, first paragraph,
must "clearly allow persons of ordinary skill in the art to
recognize that [the inventor] invented what is claimed." In
other words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject
matter as of the filing date.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
( en bane) ( citation omitted, alteration in original).
Here, the relevant claim terms are "consisting essentially of a porous
material" and "a porous structure for encouraging bone ingrowth and
attachment throughout the partially hemispherical support component."
The Specification discloses Figure 17 as reproduced below, annotated to
identify the support component (sleeve) as identified therein:
Support component (sleeve)
F\G. 17
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Annotated Figure 1 7 is "is an exploded perspective view of an acetabular
cup of a hip prosthesis being placed in still another embodiment of a
prosthetic implant support structure according to the invention secured in the
acetabular cavity of a hip." Spec. ,r 37. The Specification discloses, in
reference to Figure 17:
[A]n acetabular cup implant 36 having an outer surface 37 and
a periprosthetic support structure, indicated generally at 60c,
that is secured to the inner surface 16 of the acetabular cavity
15 of a hip bone 14. The periprosthetic support structure 60c
comprises two support components 61 c having a configuration
approximating a quarter of a sphere. The support components
61 c of the periprosthetic support structure 60c are impacted,
screwed or cemented into the inner surface 16 of the acetabular
cavity 15 of a hip bone 14 in a spaced apart relationship.
Each support component 61 c may be formed from a
metal alloy such as titanium alloys ( e.g., titanium-6-aluminum-
4-vanadium), cobalt-chromium alloys, stainless steel alloys and
tantalum alloys; nonresorbable ceramics such as aluminum
oxide and zirconia; nonresorbable polymeric materials such as
polyethylene; or composite materials such as carbon fiber-
reinforced polymers (e.g., polysulfone). Preferably, each
support component 61c isformedfrom a metal alloy.
Spec. ,r,r 70, 71 ( emphasis added). The Specification also discloses "In
another version of the invention, the support structure comprises a hollow
porous cylindrical sleeve . ... The sleeve can accommodate any number of
prosthetic designs and can achieve fixation to remaining host tissue by soft
tissue or bone ingrowth" and "[t]he prosthetic system allows for the insertion
of a cylindrical porous sleeve into a large cavernous diaphyseal bone
defect." Id. ,r 13, 55 (emphasis added). None of these disclosures specifies
that the porous nature of the support structure is restricted to a coating on a
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non-porous portion of the structure. Rather, we agree with Appellants that
"the sleeve" is described as a single unit of consistent composition.
We further agree with Appellants that, based on the disclosures above
and those cited by Appellants, the skilled artisan would have understood the
claim language "consisting essentially of' and "a porous structure for
encouraging bone ingrowth and attachment throughout the partially
hemispherical support component" to include a metal alloy support structure
that is porous throughout the structure. See Ariad, 598 F.3d at 1351. We
therefore reverse the rejection under 35 U.S.C. § 112, first paragraph, for
lack of adequate written description. As the other challenged claims contain
or depend from claims containing the same challenged claim terms, we
likewise reverse the rejection of those claims.
II-ANTICIPATION/OBVIOUSNESS OVER DUCHEYNE
Claims 30, 39, 40, 49, 53, and 60 are rejected under pre-AIA 35
U.S.C. § 102(b) as anticipated by Ducheyne 13 or, in the alternative, under
pre-AIA 35 U.S.C. § 103(a) as obvious over Ducheyne alone.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's finding that Ducheyne describes the
claimed subject matter or, in the alternative, renders the subject matter
obvious. We select claim 30 as representative of the claims subject to this
ground of rejection. See 37 C.F.R. § 4I.37(c)(l)(iv).
Findings of Fact (FF)
FF 1. The Specification discloses "a prosthetic system that includes a
prosthetic implant and a support structure secured to an inner surface of the
13 US 4,693,721, issued September 15, 1987 ("Ducheyne").
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cavity in the end of the bone. Press fit, cement or other fixation techniques
can be employed in conjunction with the methods and prosthetic systems
according to the invention." Spec. ,r 4 7.
FF2. With regard to the acetabular cup implant embodiment, the
Specification discloses:
Once the acetabular cavity 15 has been prepared, each support
component 61 c is impacted into or cemented onto the end
portion 17 of the acetabular cavity 15 of the hip bone 14 in
spaced apart relationship to form the periprosthetic support
structure 60c. Preferably, each support component 61 c is not
cemented to the hip bone and therefore is available for bone
ingrowth into the textured outer surface 63c of the support
component 61 c.
Spec. ,r 74.
FF3. Ducheyne discloses:
Titanium or other biocompatible metal fibers having a diameter
of from about 20 to about 200 µm, a length-of from about 2 to
50 mm and a length-to-diameter ratio of at least about 100 are
formed into a flexible and deformable mass, for example, a
sheet, of interlocked fibers, which may be sintered for
additional coherence, to a thickness of from about 0.5 to 30
mm. The amount of fibers is such that the sheet has a voids
volume of at least 65%, preferably about 90%. The diameter of
the pores of the porous sheet are at least about 150 µm such that
bony tissue can grow in the pores. These porous sheets are
highly malleable without loss of structural integrity or pore size
distribution. Accordingly, the porous metal fiber mesh sheets
are useful for stabilizing prosthetic devices or for general repair
of defective bone structures.
Ducheyne Abstract.
FF4. Ducheyne discloses that the
porous metal fiber mesh material is resilient, i.e. flexible, and it
is also highly deformable by simple hand or tool manipulation.
That is, the porous mesh of this invention is capable of being
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deformed without loss of structural integrity and without
diminution of pore volume or pore size. . . . Still further, the
porous mesh of this invention can be easily deformed to the
desired configuration at the time of surgery using available
instruments and acceptable operating room procedures.
Therefore, unlike prior porous insert materials, it is not
necessary to preform the porous mesh by complicated molding
or other shaping procedures and it is also not necessary to bond
the shaped porous mesh to the orthopedic or prosthetic
appliance or wear surface.
Id. at 5:61---6:8.
FF5. Ducheyne discloses:
For an acetabular prosthes[i]s, as shown in FIG. 7, the
acetabular floor 20 is covered with at least one layer 22 of the
porous insert material. A layer of polymethyl methacrylate
bone cement 24 is provided on the porous insert layer and the
acetabular prosthesis, for example, a high density polyethylene
cup prosthesis 26, is placed on the cement with sufficient
pressure to force the viscous bone cement into at least the pores
on the surface of the porous fiber insert material, as shown at
27, to provide initial stabilization. Long term stabilization is
provided as bony tissue grows into the pores of the insert, for
example, to a depth shown by dotted line 28, which has been
placed in close contact and conformity with the bone stock of
the acetabular floor.
Id. at 11:5-18.
Principles of Law
"[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification." In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
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Analysis
The Examiner finds that Ducheyne discloses all of the limitations of
the method of claim 21. Final Act. 4--5. Specific to the issues on appeal, the
Examiner finds:
Id.
[T]he method of supporting an acetabular cup implant as
claimed is met by the disclosure on column 11, lines 5-18 and
by Figure 7 of Ducheyne, the step of implanting a support
component and an acetabular cup implant in an acetabular
cavity as claimed is disclosed on column 11, lines 5-18, the
support component as claimed is the at least one layer (22) of
porous insert material, the acetabular cup implant as claimed is
the acetabular prosthesis (26), the support material consisting
essentially of a porous metal material as claimed is disclosed in
the abstract and on column 5, lines 37-59 of Ducheyne, the
restoration of lost bone stock as claimed is described on column
1, lines 13-15 as providing for the repair and reconstruction of
defective bones, the convex outer surface and inner surface to
accommodate the acetabular cup implant is best seen in Figure
7 of Ducheyne, and the support component of Ducheyne is fully
capable of being impacted into the acetabular cavity by itself
such that it becomes press fit as described on column 5, line 60
to column 6, line 55 and on column 11, lines 5-18. The support
component is considered capable of being impacted by itself to
obtain a press fit in the acetabular cavity because Ducheyne
teaches that the mesh can be deformed without losing its
diminution of its pore volume/pore size and without losing it[ s]
structural integrity; see column 5, lines 62-67.
We have reviewed the Examiner's rejection in light of Appellants'
arguments that the Examiner erred. Appeal Br. 33-37; Reply Br. 6-7. We
are not persuaded by Appellants' contentions of Examiner error.
Accordingly, we adopt as our own the Examiner's findings and reasons set
forth in the Final Action and the Answer. See also FF1-FF5. Only those
arguments actually made by Appellants have been considered in this
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Decision. Arguments that Appellants did not make in the Brief are waived.
See 37 C.F.R. § 4I.37(c)(l)(iv). We address Appellants' arguments below.
Appellants argue that Ducheyne does not teach the claim term
"wherein the partially-hemispherical support component is capable of being
positioned, by itself, in the acetabular cavity prior to being secured to said
acetabular cup implant and is capable of being impacted, by itself, into the
acetabular cavity for obtaining a press fit of the partially-hemispherical
support component in the acetabular cavity." Appeal Br. 35-37. Appellants
submit two definitions for press-fit: 1) "press-fit technique- used to secure
orthopedic implants, commonly total joint prostheses, where the bone is
under-reamed compared to the implant, creating a tight initial fit of the
component" 14 and 2) "Press fit-' An interference fit between two parts in
which one is forced under pressure into a slightly smaller hole in the
other. "' 15 Id. at 35-36. Appellants argue the skilled artisan
would readily understand, when a bone is reamed to create a
cavity in the bone for receiving an implant/component, saying
that the bone is "under-reamed compared to the implant"'
means that the cavity is made slightly smaller than the implant
so that when the implant is forced ( e.g., impacted) into the
cavity, a tight, interference-type fit of the implant in the cavity
is achieved.
Id. at 36. Appellants argue that "layer (22) in Ducheyne is not capable of
being impacted, by itself, into the acetabular cavity for obtaining a press fit
of the layer (22) in the acetabular cavity, as claimed" and that "[ n Jo matter
14 Appellants cite "page 489 from Essentials of Orthopedic Surgery, Wiesel,
Sam W., Delahay, John N., Springer Science & Business Media, Sept. 10,
2010 (EVIDENCE APPENDIX, M.)."
15 Appellants cite Oxford English Dictionary (https://en,oxforddictionaries,
com/definition/us/press fit) (EVIDENCE APPENDIX, N.)
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how someone might try to impact the layer (22), by itself, into the acetabular
cavity, they would never be able to obtain a press fit of the layer in the
cavity because the layer is so highly deformable/flexible." Id. at 35.
We begin with claim construction. The Specification does not define
"press-fit" or "impacted" but states that fixing of the support component can
be made by press-fit and that each component of 61 c "is impacted into or
cemented onto the end portion 17 of the acetabular cavity 15 of the hip bone
14 in spaced apart relationship to form the periprosthetic support structure
60c." FF 1, FF2. The Specification further states "[p ]referably, each support
component 61 c is not cemented to the hip bone and therefore is available for
bone ingrowth into the textured outer surface 63c of the support component
61 c. FF 1. Accordingly, we find that a support component that is
"impacted" is installed onto the end portion of the acetabular cavity in a
spaced apart relationship to form the periprosthetic support structure in a
manner that is not cementing, because cementing is distinguished from
impacting. Id. FFl-2.
Based on this construction, we find the Examiner has the better
position. Ducheyne discloses porous metal fiber mesh sheets that are useful
for stabilizing prosthetic devices and repairing bone structures that are
flexible, and highly deformable. FF3, FF4. Ducheyne discloses that:
For an acetabular prostheses ... the acetabular floor 20 is
covered with at least one layer 22 of the porous insert material.
A layer of polymethyl methacrylate bone cement 24 is provided
on the porous insert layer and the acetabular prosthesis, for
example, a high density polyethylene cup prosthesis 26, is
placed on the cement with sufficient pressure to force the
viscous bone cement into at least the pores on the surface of the
porous fiber insert material, as shown at 27, to provide initial
stabilization. Long term stabilization is provided as bony tissue
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grows into the pores of the insert, for example, to a depth
shown by dotted line 28, which has been placed in close contact
and conformity with the bone stock of the acetabular floor.
FF5. Appellants do not provide evidence or persuasively explain why the
implanted porous floor material is not "capable of being impacted, by itself,"
or why the further installation of the prosthesis, described as "a high density
polyethylene cup prosthesis 26, is placed on the cement with sufficient
pressure to force the viscous bone cement into at least the pores on the
surface of the porous fiber insert material, as shown at 27, to provide initial
stabilization" is not a "press-fit," particularly as Ducheyne describes using a
cement on the prosthetic side of the porous material, which would stabilize
the sheet that Appellants argue is overly flexible, while still permitting bony
ingrowth from the hip side of the joint. Accordingly, we find that Ducheyne
discloses both elements of claim 21. Cf In re De Blauwe, 736 F.2d 699, 705
(Fed. Cir. 1984) (explaining that arguments and conclusions unsupported by
factual evidence carry no evidentiary weight). Accordingly, we affirm the
rejection of claim 30.
Conclusion of Law
We affirm the rejection of claim 30 as anticipated by Ducheyne.
Claims 39, 40, 49, 53, and 60 have not been argued separately and,
therefore, fall with claim 30. See 37 C.F.R. § 4I.37(c)(l)(iv). We do not
reach the alternative rejection under§ 103(a) in light of our affirmance of
the rejection under § 102.
III - ANTICIPATION OVER CHRISTIE /OBVIOUSNESS OVER
CHRISTIE and DRAENERT or DUCHEYNE
Claims 30, 32, 36, 39--41, 43, 47, 48, 59, and 61---64 are rejected under
pre-AIA 35 U.S.C. § 102(b) as anticipated by Christie or, in the alternative,
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under pre-AIA 35 U.S.C. § 103(a) as obvious over Christie and Draenert or
Ducheyne.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's finding that Christie teaches the
claimed subject matter or, in the alternative, renders the subject matter
obvious in combination with Draenert or Ducheyne. We select claim 30 as
representative of the claims subject to this ground of rejection. Independent
claim 30 recites:
30. A method for supporting an acetabular cup implant
and restoring lost bone stock in an acetabular cavity in a patient,
the method comprising:
implanting a support component and an acetabular cup
implant in an acetabular cavity in a patient, wherein the support
component provides support to the acetabular cup implant in
the acetabular cavity, the support component consisting
essentially of a porous metal material that is a bone ingrowth-
receptive material with a porous structure for encouraging bone
ingrowth and attachment throughout the support component for
restoring lost bone stock in the acetabular cavity, said support
component including a convex outer surface facing an inner
surface of the acetabular cavity and providing a surface through
which bone of the patient can grow into said support
component and including an inner surface accommodating an
outer surface of the acetabular cup implant, wherein the support
component is formed separately from said acetabular cup
implant for subsequent connection to said acetabular cup
implant, and wherein the support component is capable of being
positioned, by itself, in the acetabular cavity prior to being
secured to said acetabular cup implant and is capable of being
impacted, by itself into the acetabular cavity for obtaining a
press fit of the support component in the acetabular cavity.
Appeal Br. 100-101 (Claims Appendix).
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Findings of Fact (FF)
FF6. Christie discloses:
The prostheses of the invention are preferably implanted
by being press fit into the prepared cavity in the patient's bone.
Bone screws which pass through screw holes 48 can be used to
provide additional fixation for the prosthesis. Preferably, the
outside surface of the prosthesis includes porous coating 113 to
provide long term fixation through bone ingrowth. To provide
a tight initial fit between the prosthesis and the prepared cavity,
the prosthesis with its porous coating is dimensioned
approximately 1 millimeter larger in diameter than the cavity.
Christie 9:31--41.
FF7. Draenert discloses:
A process is disclosed for producing a positive-material
with a skeleton made of shell-like structures and an
interconnecting pore system designed between the skeleton
structures. Also disclosed is a process for producing a
negative-material made of shaped bodies interconnected by
bridges a process for producing a positive/negative-material,
materials produced by this process and their use as bone
replacement materials, implants, filters and drug delivery
systems. According to this process deformable shaped bodies
in bulk are poured into a mold that forms a negative model of
the material.
Draenert Abstract.
Analysis
The Examiner finds that Christie discloses all of the limitations of the
method of claim 30. Final Act. 6-7. However, the Examiner acknowledges
that, if the claim language is construed to require a fully porous support
structure, that "Christie et al would not fully meet the claim language
because it would not have the porous material extending throughout the
entire support structure." Id. at 7. As discussed above in Section I, we agree
with Appellants that the skilled artisan would have understood the claim
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language "consisting essentially of' and "a porous structure for encouraging
bone ingrowth and attachment throughout the partially hemispherical
support component" to describe a metal alloy support structure that is porous
throughout the structure. Accordingly, we reverse the anticipation rejection.
With regard to obviousness, the Examiner finds that Christie discloses
a "method of supporting an acetabular cup implant as claimed is disclosed
by the use of component (64)," and a porous coating on the component. Id.
at 6. The Examiner finds Christie discloses an acetabular cup implant as
component 62, and that
Component ( 64) is formed separately and is fully capable of
being positioned by itself in the acetabular cavity prior to be
secured to the acetabular cup because it has screws placed
through screw holes to attach it to the acetabular cavity and it
has a cavity to receive the component (62) to snugly fit to it
when it is attached to the cavity via screws.
Id. The Examiner further finds that the disclosed acetabular cup implant and
support structure "are fully capable of being implanted in this manner and
being impacted separately to press fit them into the cavity as claimed." Id.
The Examiner finds that Draenert and Ducheyne both teach "that it
was known to make similar implants out of porous materials where the pores
extend throughout the entire piece." Id. at 7.
The Examiner concludes that the skilled artisan would have found it
obvious to use "porous material, as taught by Draenert or Ducheyne, to
make the component ( 64) of Christie et al for the same reasons that Draenert
utilizes the same or for the reason that it would have been a mere
substitution of one known material for another to yield a predictable result."
Id.
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Appellants argue Draenert does not "teach anything about acetabular
support components" or their interaction with implants. App. Br. 75.
Appellants argue Christie does not teach how "having bone grow throughout
component ( 64) would affect the efficacy of that particular component
and/or things connected to it in the body, e.g., acetabular cup implant (62),
over time" and that the proposed modification is not a mere substitution with
a predictable result. Id. at 78-79. Appellants reiterate their arguments
discussed above with regard to Ducheyne, and argue that Christie does not
teach or suggest "that one should form the entirety of component (64) out of
a porous/bone ingrowth-receptive material." Id. at 79-80.
Appellants further argue that the inventiveness of the claimed subject
matter is supported by evidence of secondary considerations, including
evidence of recognition and praise in the industry and copying by others in
the field in efforts to sell a similar product. See Appeal Br. 49-77.
The Examiner responds that Ducheyne and Draenert show the
"knowledge and ability to [ make the part of Christie out of entirely porous
material] was clearly known by the art at the time the invention was made"
and that joining the components in vitro would have been obvious to the
artisan. Ans. 7-8.
Appellants argue in reply that the Examiner has not addressed the
majority of their responsive arguments, and reiterate points raised in the
Appeal Brief. Reply Br. 2-10.
We agree with Appellants that a preponderance of the evidence does
not support the Examiner's findings that the skilled artisan would have been
motivated to combine Christie and Draenert or Ducheyne.
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A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup International Corp., 349 F.3d
1333, 1342 (Fed. Cir. 2003) and "a reason that would have prompted a
person of ordinary skill in the relevant field to combine the elements in the
way the claimed new invention does," KSR International Co. v. Teleflex
Inc., 550 U.S. 398,418 (2007).
As acknowledged by the Examiner, Christie discloses a porous
coating on the surface of component 64. FF6. The Examiner has not
identified any other teaching in Christie regarding the porous coating, such
as a reason that the coating material would not need to be a different
substance from that of the remainder of the prosthesis. To the contrary,
Christie's only other mention of the porous coating indicates that it "can be
chemically pure titanium, and the bearing can be ultra high molecular weight
polyethylene," which suggests that the artisan would have understood
Christie to instruct that the porous coating should differ from the bearing
material. Christie 9 :46-4 7.
Draenert teaches a process for making a skeleton of shell-like
structures, an interconnected pore system, and a process for making
negative-material of shaped bodies. FF7. Along with the Abstract, the
Examiner points to Draenert's Figures 1-10, which depict porous substances
made by the process. Final Act. 7.
Ducheyne discloses titanium or other biocompatible metal fibers
arranged in sheets that are flexible and deformable, and may be used to
stabilize prosthetic devices or for general repair of defective bone structures.
FF3-5.
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Upon review of the disclosures identified by the Examiner, we are not
persuaded that the ordinarily skilled artisan would have found it obvious to
use the porous materials taught by Draenert or Ducheyne to make the
support component of Christie as reasoned by the Examiner. The Examiner
has not identified a teaching that would have prompted the artisan to
combine the elements in the way the claimed new invention does. KSR, 550
U.S. at 418. And even if a wholly porous support component were desired,
the Examiner has not pointed us to teachings in Draenert or Ducheyne that
suggest the artisan would have reasonably believed that the proposed
"substitution of one known material for another to yield a predictable result"
(Ans. 7) would be successful, particularly as the materials disclosed by
Draenert and Ducheyne are not the same size or shape as component 64 of
Christie.
With regard to the evidence of secondary considerations submitted by
Appellants, even assuming, as the Examiner contends, that the evidence
lacks probative weight (Ans. 9--11), given that we conclude the references
do not suggest the claimed subject matter, we find that a preponderance of
the evidence does not support the Examiner's conclusion that the rejected
claims are obvious. We reverse the rejection. As noted above in Section II,
however, we find that Ducheyne alone anticipates claims 30, 39, 40, 49, 53,
and 60.
IV -ANTICIPATION BY GRIMES/ OBVIOUSNESS OVER GRIMES
and DRAENERT or DUCHEYNE
Claims 30, 32, 36, 41, 43, 51, and 59--64 are rejected under pre-AIA
35 U.S.C. § 102(b) as anticipated by Grimes or, in the alternative, under pre-
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AIA 35 U.S.C. § 103(a) as obvious over Grimes and Draenert or Ducheyne.
Final Act. 7.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's finding that Grimes teaches the
claimed subject matter or, in the alternative, renders the subject matter
obvious in combination with Draenert or Ducheyne. We select claim 30 as
representative of the claims subject to this ground of rejection.
Findings of Fact (FF)
FF8. Grimes discloses a hip prosthesis as follows, with reference to Figure
2:
Primary shell 14 is substantially hemispherical in shape, and is
provided with a porous metal coating on at least a portion of its
outer surface 22 to promote bone ingrowth and long-term
fixation. A plurality of holes 24 are also provided to accept one
or more cancellous bone screws which are used to secure shell
14 to a surgically prepared acetabulem. Shell 14 has a polar
axis 26 which extends through the approximate hemispherical
center of the shell. Augmentation piece 16 is attached to shell
14 along another axis 28 which extends through the
hemispherical center of shell 14 at an angle A, relative to axis
26. In the preferred embodiment of the invention illustrated,
angle A is approximately 45°. Augmentation piece 16 is also
provided with a porous metal coating on at least a portion of its
outer surface 30, and is further provided with a plurality of
holes 32 by which it is attached to surrounding bony tissue by
one or more self-tapping cancellous bone screws 18.
Grimes 3:51--4:2.
Analysis
The Examiner finds that Grimes discloses all of the limitations of the
method of claim 30. Final Act. 7-8. However, the Examiner acknowledges
that, if the claim language is construed to require a fully porous support
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structure, as we have found is the case, that "Grimes would not fully meet
the claim language because it would not have the porous material extending
throughout the entire support structure." Id. at 8. As discussed above in
Section I, we agree with Appellants that the skilled artisan would have
understood the claim language "consisting essentially of' and "a porous
structure for encouraging bone ingrowth and attachment throughout the
partially hemispherical support component" to describe a metal alloy support
structure that is porous throughout the structure. Accordingly, we reverse
the anticipation rejection.
With regard to obviousness, the Examiner finds that Grimes discloses
a "method of supporting an acetabular cup" comprising implantation of an
augmentation piece (16), and an acetabular shell (14) that is the acetabular
cup implant. Final Act. 7-8. The Examiner find Grimes discloses "porous
metal coating on the outsides of the [augmentation piece], and the support
structure (piece (16)) is formed separately and is fully capable of being
positioned by itself in the acetabular cavity prior to be secured to the
acetabular cup." Id. at 8. The Examiner finds the support structure piece
can be attached to the acetabular cavity by a bone screw and because it "is a
load bearing bone supporting piece, it is fully capable of being impacted into
an acetabular cavity and being press fitted into that cavity when the cavity is
sized for press fitting therewith." Id.
The Examiner finds that Draenert and Ducheyne both teach "that it
was known to make similar implants out of porous materials where the pores
extend throughout the entire piece." Id.
The Examiner concludes that the skilled artisan would have found it
obvious to use "utilize porous material, as taught by Draenert in making the
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piece (16) of Grimes for the same reasons that Draenert [ or Ducheyne 16]
utilizes the same or for the reason that it would have been a mere
substitution of one known material for another to yield a predictable result."
Id. at 8-9.
Appellants' arguments regarding the teachings of Ducheyne and
Draenert are summarized above. With regard to Grimes, Appellants argue
that its disclosed porous coating "do[es] nothing in terms of encouraging
bone ingrowth and attachment throughout the components .... [T]he
overwhelming majority of the components in ... Grimes remain[ s]
completely non-porous and thus overwhelmingly not receptive to bone
ingrowth." App. Br. 42--43, 82 (citing Lewallen Declaration ,r 5).
Appellants argue that the Examiner's proposed modification is not a
substitution of like materials that would yield a predictable result because
bone growth throughout Grimes was not predicted. Id. at 83.
Appellants further argue that the inventiveness of the claimed subject
matter is supported by evidence of secondary considerations, including
evidence of recognition and praise in the industry and copying by others in
the field in efforts to sell a similar product. See Appeal Br. 49-77, 84.
The Examiner responds that Ducheyne and Draenert show the
"knowledge and ability to [ make the part of Grimes out of entirely porous
material] was clearly known by the art at the time the invention was made"
16 Although the Examiner omits reference to Ducheyne here, we include the
reference in our analysis as we understand the rejection to include Ducheyne
(Final Act. 7), and the Examiner uses the same reasoning applied in Section
III.
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and that joining the components in vitro would have been obvious to the
artisan. Ans. 7-8.
Appellants argue in reply that the Examiner has not addressed the
majority of their responsive arguments, and reiterate points raised in the
Appeal Brief. Reply Br. 2-10.
We agree with Appellants that a preponderance of the evidence does
not support the Examiner's findings that the skilled artisan would have been
motivated to combine Grimes and Draenert or Ducheyne.
As acknowledged by the Examiner, Grimes discloses a porous coating
on the surface of the augmentation piece 16. FF8. The Examiner has not
identified any other teaching in Grimes regarding the porous coating, such as
a reason that the coating material would not need to be a different substance
from that of the remainder of the augmentation piece, as Grimes discloses.
The teachings of Draenert and Ducheyne have been summarized
above.
Upon review of the disclosures identified by the Examiner, we are not
persuaded that the ordinarily skilled artisan would have found it obvious to
use the porous materials taught by Draenert or Ducheyne to make the
augmentation piece of Grimes as reasoned by the Examiner. The Examiner
has not identified a teaching that would have prompted the artisan to
combine the elements in the way the claimed new invention does. KSR, 550
U.S. at 418. And even if a wholly porous support component were desired,
the Examiner has not pointed us to teachings in Draenert or Ducheyne that
suggest the artisan would have reasonably believed that the proposed
"substitution of one known material for another to yield a predictable result"
(Ans. 7) would be successful, particularly as the materials disclosed by
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Draenert and Ducheyne are not the same size or shape as the augmentation
piece 16 of Grimes.
With regard to the evidence of secondary considerations submitted by
Appellants, even assuming, as the Examiner contends, that the evidence
lacks probative weight (Ans. 9--11 ), given that we conclude the references
do not suggest the claimed subject matter, we find that a preponderance of
the evidence does not support the Examiner's conclusion that the rejected
claims are obvious. We reverse the rejection. As noted above in Section II,
however, we find that Ducheyne alone anticipates claims 30, 39, 40, 49, 53,
and 60.
V - OBVIOUSNESS OVER GRIMES, DRAENERT, and KAMPNER
Claims 31, 44, and 55 are rejected under pre-AIA 35 U.S.C. § 103(a)
as obvious over Grimes, Draenert, and Kampner. Final Act. 9. This
rejection, however, is based on the Examiner's finding that claims 30 and
41, from which the rejected claims depend, are obvious over Grimes and
Draenert. Id. The obviousness rejection therefore suffers from the same
deficiency discussed above in Section IV, and is reversed for the same
reason.
VI- OBVIOUSNESS OVER CHRISTIE, DRAENERT or DUCHEYNE,
and TULLOS
Claims 21-24, 28, 29, 33, 49, 51, 56, and 58 are rejected under pre-
AIA 35 U.S.C. § 103(a) as obvious over Christie, Draenert or Ducheyne, and
Tullos.
Claims 21-24, 28, 29, 33, 51, and 58
The rejection of claims 21-24, 28, 29, 33, 51, and 58 is based on the
Examiner's finding that claims 21 and 30, from which these rejected claims
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depend, are obvious over Christie and Draenert or Christie and Ducheyne.
Final Act 9. The obviousness rejection therefore suffers from the same
deficiency discussed above in Section III, and is reversed for the same
reasons.
Claims 49, 5 6
Claim 49 is independent, and rejected claim 56 depends from it. The
issue with respect to this rejection is whether a preponderance of the
evidence supports the Examiner's finding that Christie, in combination with
Draenert or Ducheyne and Tullos, suggest the claimed subject matter. We
select claim 49 as representative of the claims subject to this ground of
rejection
Claim 49 recites:
49. A method for supporting an acetabular cup implant
and restoring lost bone stock in an acetabular cavity in a patient,
the method comprising:
implanting a porous support component and an
acetabular cup implant in an acetabular cavity in a patient,
wherein said porous support component provides support to the
acetabular cup implant in the acetabular cavity with a bone
cement located between a convex outer surface of the
acetabular cup implant and a concave inner swface of the
porous support component to secure the porous support
component to the acetabular cup implant, and wherein said
implanting includes impacting the porous support component
into the acetabular cavity and obtaining a press fit of said
porous support component in the acetabular cavity despite said
porous support component consisting essentially of a porous
metal material that is a bone ingrowth-receptive material with a
porous structure for encouraging bone ingrowth and attachment
throughout the porous support component for restoring lost
bone stock in the acetabular cavity, said porous support
component including a convex outer surface facing an inner
surface of the acetabular cavity and providing a surface through
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which bone of the patient can grow into said porous support
component, wherein the porous support component is formed
separately from said acetabular cup implant for subsequent
connection to said acetabular cup implant and is capable of
being impacted, by itself, into the acetabular cavity for
obtaining said press fit prior to being secured to said acetabular
cup implant.
Appeal Br. 105-106 (Claims Appendix) (Empahsis added).
The Examiner does not make separate findings with regard to
Christie, Draenert, or Ducheyne despite that claim 49 is independent and
was not included in the rejection of claim 30 discussed in Section III, which
we have reversed for the reasons discussed above. The Examiner cites
Tullos for its teachings on methods of joining portions of an implant,
including the use of bone cement. Final Act. 9-10.
Because claim 49 recites "implanting a porous support component"
and the Examiner has not established that the cited combination of
references suggest this limitation, we reverse the rejection. As noted above
in Section II, however, we find that Ducheyne alone anticipates claims 30,
39, 40, 49, 53, and 60.
VII-OBVIOUSNESS OVER CHRISTIE, DRAENERT or DUCHEYNE,
TULLOS, and KAMPNER
Claims 50 and 57 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Christie, Draenert, Ducheyne, Tullos, and Kampner. This
rejection, however, is based on the Examiner's finding that claim 49, from
which the rejected claims depend, is obvious over Christie, Draenert or
Ducheyne, and Tullos, in further view of Kampner. Final Act. 10. The
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obviousness rejection therefore suffers from the same deficiency discussed
above in Section VI, and is reversed for the same reason.
VIII-OBVIOUSNESS OVER CHRISTIE, DRAENERT or DUCHEYNE,
TULLOS, and EICHNER
Claims 27, 38, and 46 are rejected under pre-AIA 35 U.S.C. § 103(a)
as obvious over Christie, Draenert, and Ducheyne, in further view of Eichler,
or Christie, Draenert, Ducheyne, and Tullos, and further in view of Eichler.
This rejection, however, is based on the Examiner's finding that claims 21,
30, and 41, from which the rejected claims depend, are obvious over
Christie, Draenert or Ducheyne, and Tullos, in further view of Eichler. Final
Act. 10. The obviousness rejection therefore suffers from the same
deficiencies discussed above in Sections III and VI, and is reversed for the
same reasons.
IX-OBVIOUSNESS OVER CHRISTIE and DRAENERT or DUCHEYNE
Claims 52-54 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Christie and Draenert or Ducheyne. Final Act. 11. Claims 52,
53, and 54 depend from independent claims 21, 30, and 41, respectively.
Appeal Br. 107. Claims 52-54 recite that the support component or support
body "is formed entirely with said porous metal material." Id.
In rejecting the claims, the Examiner applies the same rationale to the
combination of Christie with Draenert or Ducheyne that was applied in
Section III. Final Act. 11. The obviousness rejection therefore suffers from
the same deficiency discussed above in Section III, and is reversed for the
same reason.
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X---OBVIOUSNESS OVER GRIMES and DRAENERT or DUCHEYNE
Claim 53 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Grimes and Draenert or Ducheyne. Claim 53 depends from
independent claim 30. Appeal Br. 107. Claim 53 recites that the support
component "is formed entirely with said porous metal material." Final Act.
11.
In rejecting the claim, the Examiner applies the same rationale to the
combination of Grimes with Draenert or Ducheyne that was applied in
Section IV. Final Act. 12. The obviousness rejection therefore suffers from
the same deficiency discussed above in Section IV, and is reversed for the
same reason.
SUMMARY
We reverse the rejection of claims 21-24, 27-33, 36, 38--41, 43, 44,
and 46-64 under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first
paragraph.
We affirm the rejection of claims 30, 39, 40, 49, 53, and 60 under pre-
AIA 35 U.S.C. § 102(b) as anticipated by Ducheyne.
We reverse the rejection of claims 30, 32, 36, 39--41, 43, 47, 48, 59,
and 61---64 under pre-AIA 35 U.S.C. § 102(b) as anticipated by Christie or,
in the alternative, under pre-AIA 35 U.S.C. § 103(a) as obvious over
Christie and Draenert or Ducheyne.
We reverse the rejection of claims 30, 32, 36, 41, 43, 51, and 59---64
under pre-AIA 35 U.S.C. § 102(b) as anticipated by Grimes or, in the
alternative, under pre-AIA 35 U.S.C. § 103(a) as obvious over Grimes and
Draenert or Ducheyne.
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We reverse the rejection of claims 31, 44, and 55 under pre-AIA 35
U.S.C. § 103(a) as obvious over Grimes, Draenert, and Kampner.
We reverse the rejection of claims 21-24, 28, 29, 33, 49, 51, 56, and
58 under pre-AIA 35 U.S.C. § 103(a) as obvious over Christie, Draenert or
Ducheyne, and Tullos.
We reverse the rejection of claims 50 and 57 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Christie, Draenert, Ducheyne, Tullos, and
Kampner.
We reverse the rejection of claims 27, 3 8, and 46 under pre-AIA 35
U.S.C. § 103(a) as obvious over Christie, Draenert, and Ducheyne or
Christie, Draenert, Ducheyne, and Tullos, and further in view of Eichler.
We reverse the rejection of claims 52-54 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Christie and Draenert or Ducheyne.
We reverse the rejection of claim 53 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Grimes and Draenert or Ducheyne.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
31