Ex Parte Warburton

Patent Trial and Appeal Board

Sep 8, 2016

13433908 (P.T.A.B. Sep. 8, 2016)

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.
13/433,908 03/29/2012 Mark J. Warburton 9218-5CT2 3427
20792 7590 09/08/2016
MYERS BIGEL & SIBLEY, P.A.
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
WATKINS, MARCIA LYNN
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
09/08/2016 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 MARK J. WARBURTON
________________

Appeal 2014-004382
Application 13/433,908
Technology Center 3700
________________

Before: JILL D. HILL, LISA M. GUIJT, and ERIC C. JESCHKE
Administrative Patent Judges.

HILL, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Mark J. Warburton (“Appellant”) appeals under 35 U.S.C. § 134(a)
from the Examiner’s final decision to reject claims 1–13 and 21–24. Claims
14–20 are withdrawn. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

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CLAIMED SUBJECT MATTER
Claims 1, 12, and 24 are independent. Independent claim 1,
reproduced below, illustrates the claimed subject matter.
1. A thumb Carpo-MetaCarpal (CMC) joint implant,
comprising:
a thumb trapezium implant defining an articulating
surface, wherein the trapezium implant comprises at least one
keel that has a flat segment that merges into a second segment
with a substantially circular cross-sectional shape, wherein the
flat segment of each respective at least one keel has parallel,
straight outer short sides and a width that is greater than a length
of the short sides, and wherein the substantially circular shape
has a cross-sectional size that is greater than a cross-sectional
size of the flat segment, and wherein the at least one keel is
configured to reside in a correspondingly shaped channel formed
in a target trapezium; and
a cooperating thumb first metacarpal implant with a base
of the first metacarpal implant defining an articulating surface,
wherein the base of the first metacarpal implant is configured to
articulate against the trapezium implant articulating surface,
wherein the trapezium implant and the first metacarpal
implant articulating surfaces have shapes similar to natural
articular surfaces of a CMC joint, wherein at least one of the
articulating surfaces has a saddle shaped configuration, and
wherein the at least one keel is sized and configured to slidably
snugly enter a bone channel with substantially parallel closely
spaced trapezium bone sidewalls in a target trapezium from a
volar radial surgical approach.

REJECTIONS
I. Claims 1–13 and 21–24 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite.
II. Claims 1–3, 6, 8–12, and 21–24 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Whipple (US 5,702,469; iss. Dec. 30, 1997), Bailie
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(US 2006/0111787 A1; pub. May 25, 2006), and Hollister (US 5,549,690;
iss. Aug. 27, 1996).
III. Claims 4, 5, 7, and 13 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Whipple, Bailie, Hollister, and Rydell (US
2006/0247787 A1; pub. Nov. 2, 2006).
ANALYSIS
Rejection I
The Examiner determines that claims 1–13 and 21–24 are indefinite
because the claim term “substantially” is not defined by the claim, and “the
specification does not provide a standard for ascertaining the requisite
degree.” Final Act. 2–3.
Appellant argues that “[t]he term ‘substantially’ is customarily used to
qualify geometrical terms in patent claims” and “one skilled in the art would
understand what is claimed when the claim is read in light of the
specification.” Appeal Br. 7.
Regarding use of the term “substantially” to describe geometric
shapes in claims 1, 3–13, 21, and 23, we agree with Appellant that use of the
term does not render the claims indefinite. “Claim language employing
terms of degree has long been found definite where it provided enough
certainty to one of skill in the art when read in the context of the invention.”
Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014).
The Specification provides examples of the claimed geometric shapes and
configurations, e.g., the “substantially circular cross-sectional shape” of the
second segment of the keel (see Spec. ¶ 64, Fig. 5C), such that a skilled
artisan would understand the metes and bounds of the term “substantially” as
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used in these claims. Accordingly, we do not sustain the Examiner’s
rejection of claims 1, 3–13, 21, and 23 as indefinite.
In contrast, claim 2 recites a “substantially natural anatomic distal
articular surface” and a “substantially natural anatomically shaped
articulating surface,” and claims 22 and 24 similarly recite a “substantially
natural anatomically shaped distal articular surface” and a “substantially
natural anatomically shaped articulating surface,” respectively. See Appeal
Br. 20 and 25–26, Claims App. The Specification provides little guidance
regarding the scope of these terms. The implants 45 and 60 in Figure 4D are
described as including “articulating surfaces 40s, 60s having more natural
surface contours.” Spec. ¶ 59, Fig. 4D. It is not clear, for example, if the
articulating surfaces 40s and 60s, illustrated in Figure 4D, fall within the
scope of one or more of these terms or if one or more other disclosed shapes
fall within the scope of these terms. As such, we are not persuaded that one
skilled in the art could ascertain the metes and bounds of these recited terms.
Accordingly, we sustain the Examiner’s rejection of claims 2, 22, and 24 as
indefinite.
Rejection II
Claims 1, 6, and 21
Appellant argues claims 1, 6, and 21 as a group. Appeal Br. 7–13.
We select independent claim 1 as representative. See 37 C.F.R.
§ 41.37(c)(1)(iv). Claims 6 and 21 stand or fall with claim 1.
The Examiner finds that Whipple discloses the claimed CMC joint
implant, except for the at least one keel including a second segment having a
substantially circular cross-sectional shape with a cross-sectional size greater
than a cross-sectional size of the flat segment, and at least one of the
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articulating surfaces having a saddle shaped configuration. Final Act. 3–6.
The Examiner also finds that “Bailie teaches an anchoring member (23, 24)
that is a pair of transversely spaced apart keels (figures 1–2 and 6), each
comprising a planar portion (23) merging into a lowermost substantially
circular (i.e. semi-circular) portion (24) . . . wherein the substantially circular
portion has a greater cross-sectional size than the planar first portion.” Id. at
5. The Examiner finds that Bailie is directed to a glenoid implant, and
determines it is in the same field as CMC implants because Whipple teaches
that “the interchangeability of prosthetic component configurations in any
boney area of the body . . . [was] well-known in the art.” Id. (citing
Whipple, col. 7, ll. 1–10). The Examiner determines that it would have been
obvious:
to substitute the configuration of the retaining portion of the
anchoring member of Whipple for the configuration of the
retaining portion of the anchoring member of Bailie as a
functional equivalent and as an obvious matter of design choice
with predictable results and a reasonable expectation of success
with the added benefit that the circular portion is [more]
capable of preventing pullout under high loads than the
roughened surfaces of Whipple. Additionally and/or
alternatively, it would have been obvious to one of ordinary
skill in the art at the time of the invention to try to substitute the
entire anchoring member configuration of Whipple for at least
one of the plurality of anchoring member configuration[s]
taught by Bailie (so as to form a pair of spaced apart anchoring
members as required by claim 12), as a functional[ly]
equivalent anchoring mechanism with predictable results and a
reasonable expectation of success, and/or in order to provide
reinforcement of the anchoring mechanism in case of
component failure or loosening.
Id. The Examiner further finds that Hollister discloses trapezium and first
metacarpal implants having substantially natural anatomic distal articular
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surfaces with cooperating saddle shaped configurations, and concludes that
it would have been obvious to modify Whipple to include the articulating
surfaces of Hollister “to provide a prosthetic device that more closely
mimics the anatomical configuration in a human body.” Id. at 6.
Appellant contends that the CMC implant of Whipple and the glenoid
joint implant of Bailie are not functional equivalents, such that there is no
motivation to modify Whipple’s CMC joint implant with Bailie’s glenoid
joint implant. Appeal Br. 8–9. According to Appellant, Whipple is
incorrect that “all joint replacement devices are suitable for all joints,” and
Bailie’s glenoid joint implant differs functionally from Whipple’s CMC joint
implant in such aspects as the force exerted, depth of the bone, and rotational
needs. Appeal Br. 8–9; see also Reply Br. 2–3.
The Examiner responds that one skilled in the art would be aware of
the requirements for a CMC implant (e.g., large forces and shallow implant
depth) and would be able to apply teachings from other implant devices,
taking such joint-specific requirements into consideration. Ans. 3 (citing
Whipple, col. 7, ll. 1–9).
The Examiner has the better position. Appellant provides no evidence
to support the contention that Whipple’s teaching of “the interchangeability
of prosthetic component configurations in any boney area of the body” is
inaccurate, or that one skilled in the art could not apply teachings from
Bailie’s device, taking CMC joint requirements into consideration. Final
Act. 5.
Appellant also argues that there is a long-felt need for CMC joint
implants that can provide immediate fixation. Appeal Br. 9. However,
Appellant fails to provide any evidence of the alleged long-felt need to
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outweigh the Examiner’s prima facie case of obviousness, and fails to
explain why such a need evidences patentability. We therefore are not
persuaded by this argument.
Appellant further argues that Whipple would not function properly
“were the ridge 23 and expanded portion 24 of Bailie employed instead of
the stem S2 of Whipple,” because Whipple discloses press-fitting the
implant into a recess in the bone and “[t]his anchor configuration would not
allow for proper press-fitting.” Appeal Br. 10. The Examiner responds that
“direct bodily incorporation of one element for another was never a part of
the rejection.” Ans. 3. We agree with the Examiner. “A person of ordinary
skill in the art is also a person of ordinary creativity, not an automaton.”
KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007). Appellant has not
persuaded us that one skilled in the art could not employ Bailie’s ridge 23
and expanded portion 24 with Whipple’s articulating surface and yield an
implantable device.
Appellant also argues that the claim limitation “from a volar radial
surgical approach” has not been given proper weight as denoting an actual
state of configuration that ties the volar radial surgical approach “to the
physical characteristics of the implant.” Appeal Br. 12. The Examiner
responds that functional language “must result in a structural difference
between the claimed invention and the prior art in order to patentably
distinguish the claimed invention from the prior art.” Ans. 5. We agree with
the Examiner. Appellant has failed to point to any structural differences
resulting from this functional language. Accordingly, Appellant fails to
apprise us of error.
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Appellant finally argues there would be no motivation to modify
Whipple to include the saddle-shaped surfaces of Hollister, because Whipple
is directed to improvements to ball-and-socket implants. Appeal Br. 13;
Reply Br. 3. According to Appellant, Whipple addresses problems
associated with ball-and-socket implants by providing a concave surface that
is adapted for non-captive rotational abutment with the convex surface.
Reply Br. 3.
Appellant’s argument is not persuasive. The issue is whether the
Examiner’s reason for modifying the CMC joint of Whipple to include the
saddle-shaped surfaces of Hollister, i.e., in order to provide a prosthetic
device that more closely mimics the anatomical configuration in a human
body (see Final Act. 6), is supported by a rational underpinning. Whipple is
directed to CMC joints, and Hollister is directed to “a prosthetic joint for
duplicating anatomical movement of a joint in the human skeleton,” and
describes the disclosed prosthetic joint as being particularly advantageous in
the CMC joint because the CMC joint does not have the six muscles
necessary to properly articulate a ball-and-socket joint. Hollister, col. 1, ll.
14–17; col. 2, l. 62 through col. 3, l. 11; and col. 3, ll. 32–36. Hollister thus
supports the Examiner’s proposed combination that modifies Whipple’s
CMC joint with a configuration that Hollister teaches is preferable.
For these reasons, we sustain the rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over Whipple, Bailie, and Hollister, and claims 6
and 21 fall therewith.

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Claim 2
Claim 2 recites “the trapezium implant has a substantially natural
anatomical distal articular surface with the saddle shaped configuration and
the first metacarpal implant articulating surface also has a substantially
natural anatomical shape with a cooperating saddle shaped configuration.”
Appeal Br. 20, Claims App. Appellant argues that “one of ordinary skill in
the art would not modify the Whipple design to include the saddle shaped
surfaces at least because Whipple is directed to a very specific problem
associated with ball-and-socket prostheses.” Appeal Br. 13–14. As
discussed supra, this argument is not persuasive. Accordingly, we sustain
the rejection of claim 2 under 35 U.S.C. § 103(a) as unpatentable over
Whipple, Bailie, and Hollister.
Claim 3
Claim 3 recites “the flat segment of each respective at least one
trapezium keel extends in a vertical orientation with a width that is greater
than a length thereof, with the length being between about 0.1 and 0.25
inches.” Appeal Br. 20–21, Claims App. The Examiner finds that the cited
references are silent regarding the length of the flat segment of the keel, but
one skilled in the art would recognize that the length of the keel is “a result
effective variable effecting the retention ability of the device and effected by
the size of the target bone for implantation therein.” Final Act. 6–7. The
Examiner concludes that it would have been obvious to employ a length of
between 0.1 and 0.25 inches “to obtain desired retention of the device and/or
. . . to fit a particular target bone.” Id. at 7.
A particular parameter must first be recognized as a result-effective
variable before a determination can be made of the optimum or workable
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ranges of the variable. See In re Antoine, 559 F.2d 618 (CCPA 1977). Here,
the Examiner determines that one skilled in the art would recognize length
as a result-effective variable, but fails to provide any supporting reasoning or
evidence. We therefore do not sustain the Examiner’s rejection of claim 3.
Claims 8–11 and 24
Claim 8 depends from claim 1 and recites “at least one trapezium
implant jig with at least one downwardly extending flat slot with parallel
straight sides.” Appeal Br. 21, Claims App. Claims 9–11 depend from
claim 8 and recite additional features of the jig. See id. at 21–22.
Independent claim 24 also recites “at least one trapezium implant jig with at
least one downwardly extending flat slot with parallel straight sides.”
Appeal Br. 24–25, Claims App.
Appellant argues that Bailie fails to disclose the structural limitations
of the claimed jig. Appeal Br. 14–15, 16–17. We agree with Appellant.
The Examiner equates Bailie’s drill guide to the claimed jig. Final Act. 7–9
(citing Bailie ¶ 36). Bailie teaches that the bores in the bone may be formed
with a drill guide having a “generally L-shaped body” preferably including
at least one elongated bore, and maybe including slots. Bailie ¶¶ 35 and 36.
However, Bailie fails to disclose the drill guide including at least one
downwardly extending flat slot with parallel straight sides, as required by
claims 8 and 24. We therefore do not sustain the Examiner’s rejection of
claims 8–11 and 24.
Claims 12, 22, and 23
Appellant argues claims 12, 22, and 23 as a group. Appeal Br. 15–16.
We select independent claim 12 as representative. See 37 C.F.R.
§ 41.37(c)(1)(iv). Claims 22 and 23 stand or fall with claim 12.
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Appellant argues that claim 12 is patentable “for the reasons set forth
above in connection with Claims 1 and 2.” Appeal Br. 16. Appellant does
not present any additional arguments for the patentability of claim 12.
Accordingly, for the reasons discussed supra, we sustain the rejection of
claim 12, and claims 22 and 23 fall therewith.
Rejection III
Claims 4, 5, and 7
Claim 4 recites “a plurality of trapezium trials, wherein the trials have
a substantially planar bottom surface devoid of any downwardly projecting
anchoring member.” Appeal Br. 21, Claims App. Claims 5 and 7 are also
directed to trapezium trials and recite “at least one downwardly extending
anti-rotational post” and “a planar fin with a length that is shorter than a
length of the keel of the trapezium implant and has a flat configuration,”
respectively. Id. The Examiner finds that Whipple, Bailie, and Hollister are
silent regarding a trial, but finds that Rydell discloses trials “hav[ing] a
substantially planar bottom surface devoid of any downwardly projecting
anchoring member or the trials have at least one post that mimics the post of
the implant member.” Final Act. 10–11 (citing Rydell ¶¶ 40 and 46). The
Examiner concludes that it would have been obvious “to include trapezium
trial implants in the kit of Whipple in view of Bailie, according to the
concepts taught by Rydell, to be able to accurately choose the size of the
implant during surgery.” Id. at 11.
Appellant argues that Rydell fails to disclose the structure of the trials
recited in the claims, such as the anti-rotational post of claim 5 and the fin of
claim 7. Appeal Br. 17–18.
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We agree with Appellant. Rydell discloses trial implants 828 that
include a fixation shank that may or may not have stabilizing means, e.g.,
barbs or diamond patterns. Rydell ¶¶ 26, 40; Fig. 8. Because the trials
include fixation shanks, Rydell does not disclose a trial including a
substantially planar bottom surface devoid of any downwardly projecting
anchoring member, as required by claim 4. Further, Rydell is silent
regarding the structure of the fixation shank, such as whether it includes an
anti-rotational post having parallel, straight outer short sides, as required by
claim 5, or a planar fin with a length that is shorter than a length of the keel
of the trapezium implant, as required by claim 7. The Examiner’s finding
that Rydell discloses the claimed trial is not supported by a preponderance of
the evidence. Further, the Examiner’s conclusion that it would have been
obvious to include a post or fin with the trials of Rydell does not explain
how the trials would meet the claim requirements of the claimed post or fin,
e.g., flat with parallel, straight outer short sides. We therefore do not sustain
the Examiner’s rejection of claims 4, 5, and 7.
Claim 13
Claim 13 recites “at least one trapezium implant trial” and “a jig
defining at least one narrow channel in trapezium bone.” Appeal Br. 22–23,
Claims App. Appellant argues that claim 13 is patentable for the reasons
discussed with respect to claim 12, from which it depends. Id. at 13.
Accordingly, for the reasons discussed supra with respect to claim 12, we
sustain the Examiner’s rejection of claim 13.1

1 Claim 13 does not recite any of the features of the trials or jigs addressed
in Appellant’s arguments for the patentability of claims 4, 5, and 7–11.
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DECISION
We REVERSE the Examiner’s rejection of claims 1, 3–13, 21, and 23
as being indefinite.
We AFFIRM the Examiner’s rejection of claims 2, 22, and 24 as
being indefinite.
We AFFIRM the Examiner’s rejection of claims 1, 2, 6, 12, and 21–
23 as obvious over Whipple, Bailie, and Hollister.
We REVERSE the Examiner’s rejection of claims 3, 8–11, and 24 as
obvious over Whipple, Bailie, and Hollister.
We REVERSE the Examiner’s rejection of claims 4, 5, and 7 as
unpatentable over Whipple, Bailie, Hollister, and Rydell.
We AFFIRM the Examiner’s rejection of claim 13 as unpatentable
over Whipple, Bailie, Hollister, and Rydell.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRM-IN-PART