Ex Parte Metzger et al

Patent Trial and Appeal Board

Nov 7, 2018

14173280 (P.T.A.B. Nov. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/173,280 02/05/2014
104326 7590 11/09/2018
Schwegman Lundberg & Woessner/ Zimmer
P.O. Box 2938
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Dianne S. Metzger
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.
4394.813US1 5891
EXAMINER
SWEET, THOMAS
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
11/09/2018 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 DIANNE S. METZGER,
IAN R. VAUGHAN, and CALIE B. GREY
Appeal2017-009216 1
Application 14/173,280
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims to devices for augmenting a tibial stem
for a human knee. The Examiner rejected the claims under 35 U.S.C. § 102
as anticipated and under 35 U.S.C. § 103 as obvious. Pursuant to 35 U.S.C
§ 134, Appellants appeal the Examiner's determination that the claims are
unpatentable. We have jurisdiction under 35 U.S.C. § 6(b). The rejections
are affirmed-in-part. A new ground of rejection pursuant 37 C.F.R.
§ 41.50(b) is set forth under 35 U.S.C. § 103.
1 The Appeal Brief ("Br.") (Feb. 1, 2017), page 1, identifies Zimmer, Inc., as
the real-party-in-interest.
Appeal2017-009216
Application 14/173,280
STATEMENT OF THE CASE
Claims 1-6, 8-15, and 17-24 stand finally rejected by the Examiner
as follows:
1. Claims 1 and 11 under pre-AIA 35 U.S.C. § I02(a) as anticipated
by Phlipot (US Pat. 5,344,461, issued Sept. 6, 1994). Ans. 2.
2. Claims 17, 18, 20, 21, 23, and 24 under pre-AIA 35 U.S.C.
§ I02(a) as anticipated by Zubok (US Pat. Appl. Publ. 2012/0310361 Al,
published Dec. 6, 2012). Ans. 3.
3. Claims 1-6, 8-10, 12-15, 19, and 22 under pre-AIA 35 U.S.C.
§ I03(a) as obvious in view of Zubok. Ans. 4.
Independent claim 1 is illustrative and reads as follows:
1. A device for augmenting a tibial stem for a human knee,
the tibial stem coupled to a distal side of a tibial platform, a
proximal side of the tibial platform coup lab le to a surface for
articulation with a femoral component, the device comprising:
a tibial augment configured to couple to the tibial
platform proximate a distal side of the tibial platform, the tibial
augment including a medial side, having a medial taper on at
least a portion of its periphery extending continuously from a
proximal side of the tibial augment to a distal side of the tibial
augment, and a lateral side, having a lateral taper on at least a
portion of its periphery extending continuously from the
proximal side of the tibial augment to the distal side of the tibial
augment;
wherein at least a portion of the medial taper is different
from at least a portion of the lateral taper.
ANTICIPATION BY PHLIPOT
Claim 1
Claim 1 is directed to a device for augmenting a tibial stem for a
human knee. The device is utilized in knee repair and replacement surgery.
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Spec. 2:7-24. During knee surgery, a proximal end of the tibia is cut to a
particular size or shape, and then the tibial stem is attached to the proximal
end of the tibia. Id. at 1:29-31; 2: 10-11. The stem is coupled to a tibia
platform which is attached to the proximal end of the tibia using a tibial
augment. The claim requires that the device comprise "a tibial augment
configured to couple to the tibial platform proximate a distal side of the
tibial platform." The Specification explains that the augment
can reduce or eliminate a lateral overhang of the tibial platform
with respect to the cut proximal end of the tibia. The tibial
augment may have a tapered periphery. The taper may extend
inward in a distal direction. The taper may vary along the
periphery of the tibial augment, so that at least a portion of a
medial taper is different from at least a portion of a lateral taper.
Such a taper that varies along the periphery of the tibial
augment may help reduce or eliminate the lateral overhang of
the tibial platform with respect to the cut proximal end of the
tibia, and may do so better than a taper that does not vary along
the periphery of the tibial augment.
Id. at 2: 12-20.
In accordance with the Specification's explanation, the claimed tibial
augment has medial and lateral tapers "on at least a portion of its periphery,"
where "at least a portion of the medial taper is different from at least a
portion of the lateral taper."
For illustrative purposes, Figure 1 of the Specification is reproduced
below showing the platform and tibial augment ( shading of the augment has
been added for clarity):
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Application 14/173,280
114
I o:,o---,----\ \
I '.: 1·:) 1-50
ms
o,-,..; 0+1:,,.,a 1(>:3
FIG. 1
' >\·------!
' I
fh7p:;,.~-ttG~:: ·:tc: cf tiH~.
,~:.i+ d~1:-:nj :.c,i'::::~~-y
PROXIMAL
ANTERIOR}
;_,, T!'R.o,[,<1------- -------_•_ -MH. liAL
f'05 TERiOR
DIS:/..,;_
Figure 1 shows the tibial platform 120 having a hole 126 for the tibial
stem, the tibial augment 100 coupled to the tibial platform 120, and the tibial
augment 100 lying against the flat portion 110 of the proximal end of the
tibia 108. The figure shows the lateral and medial tapers 116 and 118,
respectively. 148 and 150 are the lateral posterior taper and medial posterior
taper, respectively. Spec. 9: 13-19.
Rejection
The Examiner rejected claims 1 and 11 as anticipated by Phlipot.
Ans. 2. The Examiner found that Phlipot describes a device comprising the
same elements as recited in the claim, including a tibial stem, tibial platform
("tibial tray" in Phlipot), and tibial augment. Final Act. 8. The Examiner
further found that Phlipot teaches that the augment has lateral and medial
tapers as required by claim 1 and that the tapers are different. Id. The
Examiner identified Figures 6 and 8, and column 2, lines 50-60 of Phlipot as
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Application 14/173,280
evidence that the tibial augment meets the taper limitations of claim 1. Id. at
3--4 and 8.
Figure 6 of Phlipot, with the Examiner's annotations, is reproduced
below:
Figure 6 of Phlipot shows tibial augment 14. Phlipot teaches:
Modular augmentation blocks 14, only one shown, are
shaped having an outer periphery 34 which is angled from the
proximal surface 36 toward the distal surface 38 such that the
edge of the proximal surface 40 of the outer periphery of the
block 14 is in alignment with the edge of the distal surface 18
of the tibial tray 16. The outer periphery 34 follows the
periphery of approximately one half of the tibial tray 16 as
illustrated in FIG. 6.
Phlipot 2:51-59 (underlining added for emphasis). The "tibial tray 16"
corresponds to the claimed tibial platform. Thus, as found by the Examiner,
Phlipot shows an augment having tapers as required by the claim.
Figure 6 of Phlipot only shows one augment on the medial side. The
claims, however, require both medial and lateral augments, each having
tapers. However, Phlipot teaches that the use of augmentation blocks is
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Appeal2017-009216
Application 14/173,280
known to one of ordinary skill in the art. Phlipot 2:23-25. Phlipot teaches
that only one augmentation block is shown in Figure 6 for illustrative
purposes, but in practice, "a set of augmentation blocks would be provided
to the surgeon each having a different thickness and angular orientation" and
that, with the set, "the surgeon may build the optimum implant provisional
for the patient." Id. at 2: 18-23. Thus, while only a medial tibial augment is
shown in Figure 6, a lateral augment would also be present to ensure that the
platform tray is placed evenly on the surface of the resected tibia.
The Examiner found that, in use when both lateral and medial
augments are present, the "anterior portion of the medial taper can be
considered the taper portion of the medial portion," that the "posterior
portion of the lateral taper can be considered the tapered portion of the
lateral portion," and that "[ w ]hen compared, the taper of these portions will
differ." Final Act. 3--4; Ans. 3. The Examiner also explained why the tapers
are angled differently ("in order to achieve the same height change over
differing lengths, the taper must be at different angles at the anterior vs.
posterior portions"). Final Act. 3.
Discussion
Appellants contend that Phlipot "does not disclose, teach, or even
suggest 'wherein at least a portion of the medial taper is different from at
least a portion of the lateral taper', as recited by independent claim 1." Br.
6. Appellants acknowledge the Examiner's annotation of Figure 6 of
Phlipot, but argue that it does not provide a teaching as to medial and lateral
tapers, and that "only one of the medial or lateral sides of the tibial tray 16
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Application 14/173,280
has a taper; the other of the medial or lateral sides lacks such a taper." Id. at
7.
Appellants' argument does not persuade us that the Examiner erred.
Appellants refer to the tibial tray 16 as having a taper (above), but the
taper required by the claim and referenced by the Examiner is the taper of
the tibial augment 14. We, therefore, understand Appellants' reference to
the taper of the tibial tray to be an error, and for Appellants to have intended
to refer to the tibial augment's taper because that is the only taper described
in Phlipot and required by the claims.
With regard to the taper of the augment, Appellants state that only one
of the sides has a taper. Br. 7 (see passage reproduced above).
We do not agree. As explained in Phlipot, although only one augment
14 is shown in Figure 6, Phlipot teaches that this is for illustrative purposes
and that in practice, "a set of augmentation blocks would be provided to the
surgeon each having a different thickness and angular orientation" and that
with the set, "the surgeon may build the optimum implant provisional for the
patient." Phlipot 2: 18-23. Thus, while an augment 14 is shown on the right
side of the tibial tray 16 of Figure 6, "in use" (Ans. 3), there would also be
an augment on the left side to make sure the tray is set evenly against the
resected bone.
To illustrate the anterior, posterior, lateral, and medial anatomical
positions, Figure 2 of the Specification is reproduced below with labels
added by annotation to show the tapers:
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Application 14/173,280
2D4
hit-et~ i: +~~:-
l: :~::
236
248 ::r~:o;:·!·~1 f;,:·'.'.'t~o~~ t1"p-e? 2.4.S
,0:-.. ';'.:::n': ?;:'..':~·.:\~SJ·
FJG 2
2~)6~ :.~: bp€~-
,_ ____ /
A~nEmOR
LATER/\.:c+ MErnAL
POSTERIOR
As shown in Figure 2 of the Specification, 216 is the lateral taper
because it is on the lateral side of the augment, namely facing away from the
midline of the body. 206 is the medial taper because it is on the medial side
of taper, namely facing toward the midline of the body. "The lateral
posterior portion 212 includes a lateral portion taper 248 on at least a portion
of its periphery." Spec. 10:3--4. "The medial posterior portion 214 includes
a medial portion taper 250 on at least a portion of its periphery." Id. at 10:9-
10. Figure 2 of the Specification looks similar to Figure 6 of Phlipot, which
is reproduced above.
For the reasons described above, Phlipot's device necessarily has both
lateral and medial augment blocks (Phlipot 2: 18-23). The anterior and
posterior portions are shown in Fig. 6 (supra 5) of Phlipot as having
different tapers and as explained in Phlipot's description ("angular
orientation"; "angled" (Phlipot 2:20-22; 2:51-56)).
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Application 14/173,280
The medial anterior taper in Figure 6 of Phlipot (shown) is different
from the lateral posterior taper of Figure 6 of Phlipot (not shown) because
the anterior and posterior tapers are different (see the Examiner's
annotations to Fig. 6 of Phlipot at page 5 supra.) and there is an augment on
both lateral and medial sides of the tibial tray 16. Thus, Phlipot meets the
claim limitation of "wherein at least a portion of the medial taper is different
from at least a portion of the lateral taper." Appellants deny this feature is
described by Phlipot, but did not adequately identify a flaw in the
Examiner's findings which are supported by a preponderance of the
evidence described above.
Accordingly, the rejection of claim 1 as anticipated by Phlipot is
affirmed. Dependent claim 11 was not argued separately and therefore falls
with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
ANTICIPATION REJECTION BY ZUBOK
The Examiner rejected claims 17, 18, 20, 21, 23, and 24 as anticipated
by Zubok.
Independent claim 1 7 is directed to a device for augmenting a tibial
component for a human knee. The device comprises a tibial augment having
medial and lateral tapers, where "the lateral side of the tibial augment
including a lateral posterior portion having a lateral posterior taper on at
least a portion of its periphery." The claim also requires that "at least a
portion of the lateral posterior taper is different from at least one other
portion of the lateral taper."
Independent claim 21 is directed to a system of augmenting a tibial
stem for a human knee. The system comprises a plurality of augments
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Application 14/173,280
having different lateral sizes. Each augment has a lateral and medial side
having tapers, where at least one augment "includes a medial taper portion
that is different from a lateral taper portion. "2
The Examiner identified Figures 2A-2D of Zubok as describing a
tibial augment. Final Act. 6. The Examiner found that the augment has
tapered portions as shown in the figures and described in paragraph 98 of
Zubok. Id. The Examiner found that this disclosure describes that the
lateral portions are different as required by claim 17. Id. The Examiner
made similar findings with respect to clam 21. Id. at 7.
Fig. 2A of Zubok is reproduced below:
Fl G~2,L\
Fig. 2D shows platform 114 with tapered portion 115. Zubok ,r 98.
Appellants contend "that Zubok does not indicate that a taper varies at
any point around a periphery" and thus does not meet the requirements of
claims 17 and 21 of an augment having different tapers along its periphery.
Br. 8. Appellants contend that paragraph 98 of Zubok teaches that platform
114 can have one side with a smaller size, "e.g., a smaller width and a
2 It is not clear from the rejections why the Examiner did not include claim
21 in the rejection based on Phlipot.
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Application 14/173,280
smaller length," than the other side. Id. at 9. Appellants argue that, for
example, "the platform 114 can taper from the anterior side to the posterior
side, in order to accommodate the different anterior and posterior sizes, but
the cited portions of Zubok do not appear to disclose how the taper is
configured." Id. Appellants provide an annotated drawing of Zubok's Fig.
2E which is said to show the same taper along the periphery of the platform.
Id. at 10.
The issue in dispute between the Examiner and Appellants is whether
Zubok teaches a varying taper of the augment as required by both claims 1 7
and 21, rather than a variance in just its width and size as asserted by
Appellants.
Paragraph 98 of Zubok teaches:
For example, referring to FIG. 2A, platform 114 includes
tapered portion 115, which may taper in overall width and
anteroposterior length in a similar fashion to a natural proximal
tibia. Tapered portion 115 is beneficial when a large amount of
the natural proximal tibia is resected, thereby requiring a large
thickness TL ofplatform 114 to maintain the natural joint line of
the knee ( as discussed above).
Zubok ,r 98.
Paragraph 98 states that the tapered portion of the platform "may taper
in overall width and anteroposterior length in a similar fashion to a natural
proximal tibia." The Examiner found that this teaching established a
variance in the taper along the periphery to match the natural taper of the
bone extending down the vertical axis. Ans. 9. In other words, the
Examiner appears to have read "width" and "length" to mean that the angle
of the taper differed along its periphery.
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Application 14/173,280
However, as discussed by Appellants, Fig. 2A does not show a
difference in the angle of the taper. The Examiner did not adequately
explain why changing the width and length of the augment would
necessarily mean the angle of the taper is also changed to match the taper of
the bone. For example, Fig. 4A of Zubok shows a varying width of the
platform 314 (tibial augment), but the taper is not shown as different along
the periphery. Zubok ,r 104. The Examiner pointed to the natural taper of
the tibia (Ans. 4), but Zubok does not explicitly teach that the platform's
taper matches the natural taper of the tibia, rather it teaches the taper is
beneficial for thickness reasons to maintain the natural joint line. Zubok
,r 98 (reproduced above). The Examiner also did not establish that a "taper
in overall width and anteroposterior length in a similar fashion to a natural
proximal tibia" necessarily means that the angle of the taper in the inward or
outward direction is necessarily changing, rather than the width of the
augment.
Thus, while Zubok shows a taper, we are compelled to agree with
Appellants that Zubok does not describe how the taper is configured along
its periphery and the Examiner did not adequately explain why the augment
must necessarily have both a medial and lateral taper as required by claim
17, where the lateral taper is different in different portions. The Examiner
also did not adequately explain why the augment must necessarily have both
a medial and lateral taper as required by claim 21, where the medial and
lateral taper is different in different portions.
Anticipation "may not be established by probabilities or possibilities."
In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal citation and
quotation marks omitted). The Examiner did not explain why the claimed
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Application 14/173,280
configurations of claims 17 and 21 are necessarily described by Zubok in the
manner required by 35 U.S.C. 102. Consequently, the rejection of claims 17
and 21, and dependent claims 18, 20, 23, and 24, as anticipated by Zubok is
reversed.
OBVIOUSNESS BASED ON ZUBOK
Claims 1---6, 8-10, 12-15, 19, and 22 are rejected as obvious in view
of Zubok.
As explained in paragraphs 14, 15, and 77, Zubok teaches that the
platform 114 is installed on the resected tibia to match its shape, with the
medullary portion inserted into the tibia. Zubok teaches:
In one form thereof, the present disclosure provides a
support structure for use in conjunction with a prosthesis
component, the support structure comprising: a platform having
a proximal surface and a distal surface defining a platform
thickness therebetween, the proximal surface and the distal
surface cooperating to define a platform outer periphery shaped
to correspond with a periphery of a resected proximal tibia, the
platform outer periphery defining a platform medial-lateral
width and a platform anteroposterior length.
Zubok ,r 14 ( emphasis added).
Because Zubok teaches that the platform has an "outer periphery
shaped to correspond with a periphery of a resected proximal tibia," it would
have been obvious to make different portions of the platform have different
tapers to match the varying taper of the natural tibia. Ans. 9-10.
With respect to the limitation of claim 1 that the taper is "extending
continuously," the Examiner found
Where the only difference between the prior art and the claims
is a recitation of the size and shape of the claimed device and
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the device having the claimed relative dimensions would not
perform differently than the prior art device, the claimed device
is not patentably distinct from the prior art device (MPEP
2144.4). Applicant does not disclose why it is critical for the
medial and lateral peripheries tapering continuously from the
proximal to distal sides of the implant. Therefore, it would be
obvious to one of ordinary skill in the art, prior to the time of
the invention, to modify Zubok's device to have the taper
extend from the proximal to distal side for situations where a
shorter augment is needed due to a thicker tibial tray or lesser
resection of the bone, thus obviating the need for the non-
tapered portion of the device.
Final Act. 10-11.
Appellants contend that the Examiner erred in stating the
Specification lacks a statement of the advantage of having a continuous
taper. Br. 13. Appellants cite the following disclosure in the Specification:
The present inventors have found that having a taper that
varies along its periphery may be further advantageous. Such a
varying taper may more closely follow the footprint of the bone
at the proximal end of the tibia 108, and may desirably reduce
the amount of exposed bone or overhang over the edge of the
bone.
Spec. 8:19-22.
However, as indicated above, Zubok teaches "a platform outer
periphery shaped to correspond with a periphery of a resected proximal
tibia" (Zubok ,r 14), making it obvious to vary the taper to match the natural
taper of the bone. Thus, the Examiner's determination that claim 1 would
have been obvious to one of ordinary skill in the art based on Zubok is
supported by a preponderance of the evidence. Accordingly, the
obviousness rejection of claim 1 in view of Zubok is affirmed. Claims 2-6,
8-10, 12-15, 19, and 22 were not argued separately and therefore fall with
claim 1. 3 7 C.F .R. § 41.3 7 ( c )(1 )(iv).
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NEW GROUND OF REJECTION BASED ON ZUBOK
Claim 17
The Examiner did not include claim 17 in the obviousness rejection
based on Zubok. Claim 17 recites that "wherein at least a portion of the
lateral posterior taper is different from at least one other portion of the lateral
taper." Based on Zubok' s teachings ("outer periphery shaped to correspond
with a periphery of a resected proximal tibia"), we find that it would have
been obvious to one of ordinary skill in the art to vary the taper along the
periphery to match the natural taper of the tibial bone to produce an augment
where the lateral posterior taper is different from at least one other lateral
portion taper. See Zubok ,r,r 14, 15, 16, 77. This is a new ground of
rejection pursuant to 37 C.F.R. § 4I.50(b).
With respect to claims 18, 20, 21, 23, and 24, which we found not to
be anticipated by Zubok, we leave to the Examiner to determine whether
such claims would have been obvious based on Zubok.
SUMMARY
1. The rejection of claims 1 and 11 as anticipated by Phlipot is
affirmed.
2. The rejection of claims 17, 18, 20, 21, 23, and 24 as anticipated by
Zubok is reversed.
3. The rejection of claims 1-6, 8-10, 12-15, 19, and 22 as obvious in
view of Zubok is affirmed.
4. A new ground of rejection of claim 17 is set forth pursuant to 37
C.F.R. § 4I.50(b) under 35 U.S.C. § 103(a) as obvious in view of Zubok.
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TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). Section 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." Section 4I.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
( 1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§§ 41.50(±), 4I.52(b).
AFFIRMED-IN-PART; 37 C.F.R. § 4I.50(b)
17