Ex Parte Long

Patent Trial and Appeal Board

Aug 22, 2017

11904079 (P.T.A.B. Aug. 22, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
1671-0427 2504
EXAMINER
PRESTON, REBECCA STRASZHEIM
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
11/904,079 09/26/2007
28078 7590 08/22/2017
MAGINOT, MOORE & BECK, LLP
One Indiana Square, Suite 2200
INDIANAPOLIS, IN 46204
Jack F. Long
08/22/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JACK F. LONG1
Appeal 2016-001935
Application 11/904,079
Technology Center 3700
Before ULRIKE W. JENKS, JOHN G. NEW, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
orthopedic implant, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
Appellant’s “invention relates to the field of orthopaedics and more
particularly to . . . instrumentation used in orthopaedic procedures.” (Spec.
11.) The Specification explains that “[t]he ankle joint, or the joint between
the tibia, fibula and the talus, is frequently a source of osteo or rheumatoid
1 Appellant identifies the Real Party in Interest as DePuy Synthes Products,
Incorporated. (App. Br. 2.)
Appeal 2016-001935
Application 11/904,079
arthritis.” (Id. 12.) According to the Specification, “a need exists for an
ankle prosthesis that provides improved support for a wide range of patient
anatomies and disease states” and that “is easily replaced when the
articulating portion of the prosthesis becomes worn.” (Id. 112.)
Appellant’s drawings help to understand the invention. Figure 18
from the Specification is reproduced below.
Figure 18 is a side view of a talar implant assembly (200). The implant
includes, among other structures, a distal portion (202), a base (204), and an
articulating component (206). (Spec. 1 50.) The articulating component
includes an articulating surface (222), which articulates with a tibial
component (not shown). (Id. H 37, 51.) The base (204) includes a female
coupling portion (208) with an internal bore (210). (Id. 1 50) In an
exemplary use, distal portion (202) is implanted into a bone and female
coupling portion (208) is coupled to distal portion (202) — the generally
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Application 11/904,079
spherical “head” of the distal portion is inserted into internal bore (210). (Id.
1 53; see also id. Tflf 36, 41.) Next, the channel (228) and guide (212) are
aligned and articulating component (206) is slid into position on the base
(204). A fastener (234) may then be inserted through bores in the
articulating component (206) and base (204) to further secure the
articulating component and base to each other. (Id. 1 55.)
Claims 1—3, 5—7, 9-11, 19—21, 26—28, and 30-34 are on appeal.
Claim 1 is illustrative:
1. A talar implant comprising:
an articulation component with an articulating surface
extending upwardly from a first plane and configured to
articulate with a tibial component, the articulation component
defining a first fastener receiving bore;
a base portion extending along the first plane, the base
portion including a first coupling member and a second fastener
receiving bore, the second fastener receiving bore defining a
longitudinal axis extending along the first plane and configured
to align with the first fastener receiving bore;
a fastener configured to be received within the first
fastener receiving bore and the second fastener receiving bore to
rigidly secure the base portion and the articulation component;
and
a distal portion for implanting in a bone, the distal portion
having a second coupling member configured to be rigidly
frictionally coupled with the first coupling member at any
angular position selected from a range of angular positions
within a second plane perpendicular to the first plane upon
coupling of the first coupling member and the second coupling
member.
(App. Br. 24 (Claims App.) (emphasis added).)
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Application 11/904,079
Claims 1—3, 5—7, 9-11, 19—21, 26—28, and 30-34 stand rejected under
35 U.S.C. § 103(a) based on Berelsman2 and Barbone.3
DISCUSSION
Issue
Has the Examiner established by a preponderance of the evidence that
claims 1—3, 5—7, 9-11, 19—21, 26—28, and 30-34 would have been obvious
over Berelsman and Barbone?
Findings of Fact (FF)
The Examiner’s findings and statement of the rejection are provided at
pages 2—7 of the Final Office Action dated December 17, 2014. (See also
Ans. 2—6.) We provide the following findings for emphasis and easier
reference.
FF 1. Berelsman teaches a modular prosthesis for replacement of a
head portion of the radius (i.e., an implant for repair of the elbow joint).
(Berelsman Abstract; see id. at Fig. 14.)
FF 2. Figure 24 of Berelsman is reproduced below.
2 Berelsman et al., US 2005/0075735 Al, published Apr. 7, 2005.
3 Barbone, US 5,073,110, issued Dec. 17, 1991.
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Application 11/904,079
37
76
—to
!
t~12
Figure 24 is a perspective view of an embodiment of Berelsman’s implant
assembly. It shows, inter alia, head component (30), collar component (68),
and stem component (10). {Id. 1 80.) In exemplary use, the components
may be coupled by sliding engagement (e.g., channel (84) on collar
component (68) is configured to accept the T-shaped protrusion (82) of the
mounting portion (14) of stem (10)). {Id. H 80—81.) The components may
also be further secured by a fastener (60) inserted through fastener aperture
(92). {Id. 181.) Berelsman teaches collar angle (96) can be variable
through use of multiple/altemative collar components. (Id. 1 82; id. at Figs.
21A (collar (62)) and Fig. 24 (collar (68)).)
FF 3. Barbone teaches an insert adapted for use with a dental implant.
(Barbone Abstract.) The insert includes head and shaft elements “joined by
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Application 11/904,079
a ball and socket type joint for allowing angular positioning of the head end
relative to the shaft.” (Id.; see also id. at Fig. 2.)
FF 4. Barbone teaches
a ball and socket type joint for allowing angular positioning of
the head end relative to the shaft means. The ball and socket type
joint includes cooperating surfaces which ffictionally engage to
allow the head end and the shaft means to be positioned in
predetermined relative relationships and maintained in those
relationships until they are permanently bonded through the use
of an adhesive or the like.
(Id. at 1:42-49; see also id. at 3:25—44.)
Analysis
Claim 1
The Examiner finds that Berelsman discloses the invention
substantially as claimed, except that Berelsman “does not disclose the
second coupling member . . . coupling with the first coupling member ... at
any angular position selected from a range of angular positions . . .” as
recited in claim 1. (Final Act. 5.) The Examiner thus turns to the ball-and-
socket coupling disclosed in Barbone. (Id. at 6.)
According to the Examiner, “Barbone explicitly recites the coupling
between the two components [the ball and socket] to be frictional.” (Ans.
2.) And the Examiner explains that Barbone’s teaching of “maintaining of
the position of the two components prior to the adhesive” is considered to be
a “rigid” coupling. (Id. at 2—3.) Alternatively, the Examiner finds
Barbone’s teaching of placing an adhesive between the ball and socket to
permanently bond the components in the desired angular orientation satisfies
the element of claim 1 requiring “a second coupling member configured to
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Application 11/904,079
be rigidly fractionally coupled with the first coupling member at any angular
position.” (Mat 3.)
The Examiner concludes it would have been obvious to modify the
coupling between the collar component and stem of Berelsman’s implant
with the ball-and-socket arrangement of Barbone. (Final Act. 6.) The
Examiner reasons, “both coupling systems are known structures for
connecting modular medical implants (and are therefore obvious variants for
each other).” (Id.) Also, according to the Examiner, using Barbone’s
coupling structures “allow for precise angular adjustment between the two
components . . . which will allow for better matching/ mimicking the natural
anatomy of the patient.” (Id.)
Except as otherwise noted, we agree with the Examiner’s findings of
fact, reasoning, and conclusion of obviousness. We are unpersuaded of
reversible error in the rejection of claim 1. We address below the
Appellant’s arguments.
Appellant argues the Examiner misconstrued claim 1. (App. Br. 5.)
Appellant provides dictionary definitions for “rigid” and “frictional” and
contends the plain meaning of the claim requires “the relative position of the
two coupling members is inflexibly fixed by friction.” (Id. at 6—7.)
Appellant also cites portions of the Specification, which Appellant contends
show “no possible movement of the ‘rigid’ coupling is contemplated, and
the coupling is achieved solely by frictional forces.” (Id. at 7.)
Appellant’s argument is unpersuasive. Instead, we agree with the
Examiner that “rigid” is a relative term and a “rigid” engagement “does not
require that absolutely no movement is possible between [the] components.”
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Application 11/904,079
(Final Act. 2—3.) Appellant’s proffered dictionary definitions are not to the
contrary. One of the definitions for “rigid” encompasses something that is
merely stiff (App. Br. 6) — consistent with the Examiner’s assertion that a
“rigid” engagement includes one where “movement is difficult.” (Final Act.
2-3.)
But more important, the Specification does not limit the meaning of
“rigidly ffictionally coupled” to Appellant’s narrow interpretation. The
Specification does not describe the ball-and-socket joint (i.e., the coupling
between the head and the bore) as inflexible, immovable, or permanently
fixed. And, when describing the coupling between two components (the
base and articulating component) that can be moved relative to each other,
the Specification states that “male coupler 134 and the female coupler 128
frictionally engage thereby rigidly coupling the base 106 and the articulating
component 104.” (Spec. 139 (emphasis added) and Fig. 1; see also id. 11
56—57 (describing removal and replacement of the articulating component
by moving the articulating component off and on the base).) This suggests
that “rigidly frictionally coupled” does not require an entirely inflexible or
immovable attachment.4
4 The fact that a fastener may also be used to press against the surface of the
articulating component to “ensur[e] rigid coupling,” does not mean that the
coupling without the fastener lacks rigidity. (Spec. 140; App. Br. 7.) It
simply is a way to increase the frictional force and make the coupling even
more rigid. In other words, the fastener increases the amount of force that
would be required to overcome the frictional engagement and slide the
articulating component off the base.
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Application 11/904,079
As noted by the Examiner, Barbone teaches that its ball-and-socket
are in cooperative frictional engagement, and that the angular orientation is
“maintained” even without an adhesive. (Ans. 2—3; FF 3—4.) This suggests
a rigid-frictional coupling, and Appellant’s assertions to the contrary are
unpersuasive. (Reply Br. 2-4.) And, as the Examiner further finds, the
rigidity of the engagement between the ball and socket can be increased by
application of an adhesive as taught in Barbone. (Ans. 3; FF 3—4.)
In the Reply Brief, Appellant contends the Examiner has not
established that the adhesives disclosed in Barbone inherently provide
frictional coupling. (Reply Br. 2—4.) We are, however, unpersuaded. First,
Barbone suggests a rigid-frictional coupling without an adhesive. Second,
we are unpersuaded that an adhesive that works by mechanical action —
filling in crevices or pores, and hardening — would not be considered a
frictional coupling. {Id. at 2.) The issue is not inherency (i.e., whether
Barbone’s adhesive create a chemical versus a mechanical bond), but
whether it would have been obvious to a skilled person to use any suitable
adhesive that provides a permanent bond. Barbone suggests that it would.
(Barbone 1:47—49 (teaching that the ball and socket may be “permanently
bonded through the use of an adhesive or the like”.)
Appellant argues the Examiner’s construction is also flawed because
it renders claim terms superfluous — in particular, the phrase “rigidly
frictionally.” (App. Br. 8—9.) We are unpersuaded for the reasons explained
above. Although one can envision a ball-and-socket connection with little or
no frictional engagement (e.g., a small-diameter ball held in the large-
diameter socket only by virtue of a narrower socket opening), allowing the
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ball to twist and wobble freely in the socket, that is not what the art shows
here. With adhesive and without it, Barbone’s ball and socket is “configured
to be rigidly frictionally coupled ... at any angular position selected from a
range of angular positions” as recited in claim 1. We are thus unpersuaded
the Examiner’s interpretation neglected certain claim elements; it is simply
that the art teaches or suggests those elements.
Appellant argues the “Examiner has failed to clearly articulate the
reasons for obviousness.” (App. Br. 9.) In support, Appellant contends
“[t]he ball and socket of Barbone ... is not taught as acceptable for use in an
implant” and, instead, is only part of a temporary jig. (Id.) Appellant also
contends “Berelsman teaches away from incorporating a ball and socket
coupling mechanism.” (Id. at 10 (citing Berelsman | 8).)
We remain unpersuaded. It is true that Barbone’s insert is later
removed from the body and used as a model for molding a permanent (e.g.,
metal) prosthesis. (See Barbone 3:63 4:3.) But the insert is implanted at
least temporarily. In any event, it is not necessary that Barbone teach a
permanent or semi-permanent implant. That is clearly taught in Berelsman.
(FF 1—2.) The Examiner also provided a reasoned explanation why the
skilled person would have predictably modified Berelsman to use a ball-and-
socket coupling like in Barbone — to allow for precise angular adjustment
and better matching of the natural anatomy of the patient. (Final Act. 6.)5
Appellant provided insufficient persuasive argument or evidence otherwise.
5 Indeed, the ball and socket would appear to provide certain advantages
over the kits and methods described in Berelsman, which require numerous
pre-formed angular collars be available to allow for appropriate adjustment.
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Appellant’s teaching away argument fares no better. Berelsman is
silent about a ball-and-socket arrangement specifically. Inasmuch as
Appellant points to a paragraph in Berelsman’s background that discusses
potential problems with designs where the head component is “impacted”
over and onto the stem component, it is unclear what “impacted” means in
this passage or whether a ball-and-socket arrangement requires the head be
“impacted.” (App. Br. 10; Berelsman | 8.) The cited paragraph of
Berelsman does state that “[t]he surgical exposure must therefore allow
sufficient room for the head to be maneuvered over the stem prior to being
impacted.” {Id.)* * * 6 Avoiding that spacing and the “impacting” described
above may be why most of Berelsman’s embodiments couple the
components through a lateral-sliding motion. {See, e.g., Berelsman | 62,
Figs. 21 A—25.) Modifying Berelsman to include a ball-and-socket
connection would likely require some space be allowed to maneuver the
head/collar over the stem before coupling. Yet, when we consider other
embodiments in Berelsman including Figures 26B—D, which show a
modular design where the stem and collar are connected via a vertical
threaded post, we are unpersuaded Berelsman teaches away from a design
(FF 2; see also Berelsman 178 and Fig. 27.) Because the ball and socket
would allow a broad range of angular positions in a single coupling, the need
for numerous collars with different pre-set angles could be reduced.
6 We are not persuaded the Examiner’s interpretation of paragraph 8 of
Berelsman in response to Appellant’s argument is entirely accurate. {See
Ans. 4 and Final Act. 3 (responding that paragraph 8 appears to identify the
implant as a whole rather than its substructures).) But neither are we
persuaded that paragraph 8 teaches away from the combination of
Berelsman and Barbone for the reasons explained here.
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Application 11/904,079
where space over the stem is required during implantation and coupling.
Indeed, these embodiments would seem to require similar spacing as would
be required to couple a ball and socket.
Claim 5
Appellant argues “claim 5 requires rigid coupling to be the result of
insertion of the head into the bore.” (App. Br. 11.) On this point, we agree.
But, as explained with respect to claim 1, Barbone teaches this. (FF 3 4.)
Appellant also argues claim 5 excludes adhesive. It does not. Claim
5 recites, inter alia, “insertion of the head into the bore produces a rigid
friction coupling,” which is present in the ball-and-socket assembly of
Barbone. Claim 5 does not exclude an adhesive or its use to make the
coupling more rigid or even permanent.
Appellant’s arguments are unpersuasive. We agree with and adopt the
Examiner’s findings and conclusion of obviousness with respect to claim 5.
Claims 10 and 26
Claims 10 and 26 each require a “fin.” Claim 10 recites “a fin
extending from the base portion for insertion into the bone.” (App. Br. 25)
and claim 26 recites, in relevant part, “each of the plurality of base members
comprises a fin extending downwardly from the plane.” {Id. at 27.)
Appellant argues the Examiner misconstrued claim 10 because the
Examiner “arbitrarily called a portion of the stem which is indistinguishable
from another portion of the stem a ‘fin’.” (App. Br. 13.) Appellant also
cites various prior-art patents, which Appellant contends evidence that a
“fin” is a known term of art of prosthetic devices that requires a structure
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Application 11/904,079
that locks into bone and resists rotational movement. (Id. at 14; Reply Br.
5.)
We agree with Appellant. The Specification is consistent with
Appellant’s argument that a fin is distinctly structured, such as with at least
one substantially flattened surface in a plane perpendicular to the base, to
resist rotation once implanted in the bone. (See, e.g., Spec. 1 60 and Fig. 23
(structure 278).) Based on the Specification and other evidence submitted
by Appellant, we are unpersuaded that the skilled person would consider
Berelsman’s conical stem to be a “fin.”
On the record here, we are also unpersuaded by the Examiner’s
determination that Berelsman’s stem satisfies both the claimed “distal
portion” and “fin.” (Ans. 5.) As used in claims 10 and 26, we find these
terms relate to distinct structures and the Examiner improperly relied on
Berelsman’s stem alone in meeting both claim elements. Cf. Lantech, Inc. v.
Keip Machine Co., 32 F.3d 542, 556-47 (Fed. Cir. 1994) (holding the
district court erred in relying on the same structure to meet two distinct
claim elements).7
For these reasons, we reverse the rejection of claims 10 and 26.
7 We recognize the Specification discloses an alternative embodiment where
“the stem 164 is more of a four-sided fin shape.” (Spec. 149 and Fig. 17.)
We are, however, not persuaded this is what is encompassed by claims 10 or
26, which do not recite that the distal portion comprises or includes a “fin”
or that the distal portion is a “fin-shape.” In any event, even in this
embodiment, the fin includes flattened surfaces that would resist rotation
once implanted — a structure that is not clearly present in Berelsman’s stem.
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Claim 30
Claim 30 depends from claim 1, adding that the “first fastener
receiving bore opens to a posterior surface portion of the articulation
component.” (App. Br. 28.) Appellant argues the Examiner failed to
explain how the elements of the claim are disclosed in the art. {Id. at 15.)
Appellant’s argument is unpersuasive. The Examiner explains that
“the location of the opening to the fastener aperture (92) within the radial
head component (30)” of Berelsman is being considered the posterior
surface portion of the articulation component. (Ans. 5—6.) Appellant does
not show the Examiner is mistaken. Also, Berelsman teaches the fastener
(and the bore/aperture) can be oriented in a variety of positions. {See, e.g.,
Berelsman | 81 and Figs. 22, 24, 25.) Arranging so the bore opens to a
posterior surface is thus an obvious design choice in view of the art.
Claim 33
Claim 33 requires, inter alia, a “second dovetail coupling portion [on
the base] includes an upwardly extending guide” and the “articulation
component defines a channel above the first dovetail coupling portion, the
channel sized to receive the upwardly extending guide.” (App. Br. 16.)
Appellant argues the Examiner “chooses to arbitrarily call a portion of a
male dovetail coupling a guide and a portion of a female dovetail coupling a
channel.” (Id. at 16.)
Appellant’s argument is unpersuasive. Appellant has not shown how
the claimed structure is different from and nonobvious over the structures in
Berelsman. {See Final Act. 7.) Indeed, Berelsman shows a sliding
engagement between a relatively T-shaped protrusion on the collar
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Application 11/904,079
component (a base) and a corresponding T-shaped “open channel 26” of the
head component (an articulating component). (FF 2; see Berelsman Figs.
24—25 and Tflf 80-81.) The claim does not require the guide and channel be
wholly separate from the articulating component and base, or the dovetail
coupling. To the contrary, the claim requires the base’s second dovetail
coupling portion “includes” a guide, and that the articulating component,
which itself includes the first dovetail coupling portion, “defines” a channel.
On this record, we are unpersuaded the Examiner erred in identifying the
respective upper-halves of the dovetail engagements of Berelsman’s collar
and head as the claimed guide and channel.
Other Claims
Appellant identifies other claims on appeal under separate headings
but provides no substantive argument specific to the other claims, instead
relying on the arguments concerning claims we have addressed above. (See,
e.g., App. Br. 18—19 (asserting that claim 19 is patentable for the same
reasons given with respect to claim 1), and 21 (asserting that claim 28 is
patentable for the same reasons given with respect to claim 19).)
The arguments concerning the remaining claims are thus unpersuasive
based on the discussion above. 37 C.F.R. § 41.37(c)(l)(iv).
Conclusion of Law
The Examiner established by a preponderance of the evidence that
claims 1—3, 5—7, 9, 11, 19—21, 27, 28, and 30-34 would have been obvious
over Berelsman and Barbone. The preponderance of the evidence does not,
however, support the Examiner’s rejection of claims 10 and 26.
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SUMMARY
We affirm the rejection of claims 1—3, 5—7, 9, 11, 19-21, 27, 28, and
30-34 as obvious over Berelsman and Barbone.
We reverse the rejection of claims 10 and 26 as obvious over
Berelsman and Barbone.
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
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