Ex Parte Hananouchi et al

Patent Trial and Appeal Board

Sep 18, 2017

13180688 (P.T.A.B. Sep. 18, 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.
13/180,688 07/12/2011 Takehito Hananouchi MTRL/M022US 2923
7590 09/18/2017
Patterson & Sheridan LLP
Suite 1600
24 Greenway Plaza
Houston, TX 77046-2472
EXAMINER
RAMANA, ANURADHA
ART UNIT PAPER NUMBER
3775
MAIL DATE DELIVERY MODE
09/18/2017 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 TAKEHITO HANANOUCHI and DIETER VANGENEUGDEN
__________

Appeal 2016-007817
Application 13/180,688
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a patient-
specific surgical fixture for positioning an alignment element. The
Examiner rejected the claims as indefinite, as anticipated, and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Statement of the Case
Background
“[I]n hip and shoulder joint surgery, a joint is replaced by a prosthetic
implant. . . . The general consensus in the field is that the orientation of the

1 Appellants identify the Real Party in Interest as Materialise N.V. (see App.
Br. 3).
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implant determines the success of the surgery and the lifespan of the
implant” (Spec. 1:10–33). The “current procedure shows several
shortcomings for obtaining a good orientation. Indeed, the only anatomical
visual reference during final placement is the orientation of the transverse
ligament” (Spec. 2:1–3). “[R]otation around the axis of the transverse
ligament remains a variable parameter. In addition, the transverse ligament
is generally obscured from the surgeon’s view, further hampering the
orientation process” (Spec. 2:4–7).
“[T]here is a need for alternative and improved surgical devices, and
in particular surgical guiding instruments, which provide the ability to
correctly and accurately insert, place and orient an implant into a patient’s
joint” (Spec. 2:14–16).
The Claims
Claims 1, 4–8, 10–12, and 14–17 are on appeal. Claim 1 is
representative and reads as follows:
1. A patient-specific surgical fixture for positioning an
alignment element, comprising:
one or more patient-specific contact elements configured
to fit onto a socket of a ball-and-socket joint, the one or more
patient-specific contact elements being configured to contact
the socket in at least three contact areas, wherein a rim of the
socket defines at least one of a substantially circular shape
having a center defined by a circle best fitting the substantially
circular shape or roughly elliptical shape having a center
defined by an ellipse best fitting the roughly elliptical shape,
wherein the one or more patient-specific contact elements are
configured so that, when fit onto the socket, for each point on
the at least three contact areas an angle defined by a first line
connecting the point and the center and a second line
connecting an adjacent point and the center is not greater than
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180°, wherein the adjacent point is on the at least three contact
areas and is adjacent to the point in a clockwise direction
around the circle or ellipse best fitting the shape; and
a positioning element having one or more holes, wherein
at least one of the one or more holes is configured to receive the
alignment element, and wherein the positioning element is
detachably coupled to at least one of the one or more patient-
specific contact elements,
wherein one of the one or more patient-specific contact
elements is configured to interact with an anatomical feature
present on the socket when fit onto the socket, wherein the
anatomical feature is one of a posterior notch of a transverse
ligament or a coracoid process.
The Issues
A. The Examiner rejected claims 1, 4–8, 10–12, and 14–17 under
35 U.S.C. § 112, second paragraph as indefinite (Ans. 2–3).
B. The Examiner rejected claims 1, 4, 5, 7, 8, 10, 12, and 15–17 under
35 U.S.C. § 102(e) as anticipated by Meridew2 (Ans. 3–4).
C. The Examiner rejected claim 6 under 35 U.S.C. § 103(a) as obvious
over Meridew and Banko3 (Ans. 4–5).
D. The Examiner rejected claim 14 under 35 U.S.C. § 103(a) as obvious
over Meridew and Fitz4 (Ans. 5).

2 Meridew et al., US 8,608,749 B2, issued Dec. 17, 2013
(“Meridew”).
3 Banko et al., US 4,719,907, issued Jan. 19, 1988 (“Banko”).
4 Fitz et al., US 7,981,158 B2, issued July 19, 2011 (“Fitz”).
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A. 35 U.S.C. § 112, second paragraph
The Examiner finds:
In claim 1, the recitation “for each point on the at least
three contact areas” renders the claim vague and indefinite
because it is unclear what structural relationship is being
claimed. If there is only one contact element how can there be
three contact areas.
In claim 1, the recitation “clockwise direction” renders
the claim vague and indefinite because it is unclear what the
reference point is for determining the clockwise direction.
Again, this is a functional recitation and does not imply any
unique structural characteristics as Applicant appears to be
arguing.
In claim 5, the recitation “positioning element is one the
at least two contact elements” renders the claim vague and
indefinite because this recitation is inconsistent with
Applicant’s disclosure.

(Ans. 2–3).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that claims 1 and 5 are indefinite?
Findings of Fact
1. The Specification teaches
in the fixtures of the present invention, the contact elements fit
onto the socket and/or socket rim by contacting said socket
and/or rim at different contact points. The contact elements fit
onto areas of (or around) a socket and/or a socket rim in at least
three contact points, wherein the contact points have an
arrangement, preferably so as to surround the socket, wherein
the angle between a line drawn between one contact point and
the center of the circle or ellipse best fitting the socket rim and
a second line drawn between an adjacent contact point and said
center is never greater than 180° or similarly the sector angle
defined by two adjacent contact points is never greater than
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180°. These contact points may all be located on the same
contact element (i.e. one contact element comprises these three
contact points), or distributed over two or more contact
elements.

(Spec. 11:16–26).
2. The Specification teaches the “contact element comprises of a
plurality of contact points (corresponding to a contact surface)” (Spec.
11:31–32).
3. Figure 1, panel A’’ of the Specification is reproduced below:

“Figure 1 . . . A": Schematic representation of the relative position of
patient-specific contact points (4) and their orientation relative to the
acetabular rim (7) or glenoid cavity rim (16) and the acetabulum (13) or
glenoid cavity (15)” (Spec. 5:21–23).
4. The Specification teaches that a “positioning element and a
contact element may form a single unit, thus the positioning element may
also function as a contact element. Where a positioning element is located
onto a contact element, the hole(s) in the positioning element continue(s)
through the contact element” (Spec. 16:6–9).
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Principles of Law
“[I]f a claim is amenable to two or more plausible claim
constructions, the USPTO is justified in requiring the applicant to more
precisely define the metes and bounds of the claimed invention by holding
the claim unpatentable under 35 U.S.C. § 112, second paragraph.” Ex parte
Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008).
Analysis
We will address each of the Examiner’s indefinite issues
separately.
“clockwise”
Appellants contend: “It is clear that what is meant is that points are
chosen around the circle or ellipse, which is clearly defined” (App. Br. 8).
Appellants contend “it would be clear that there is only one direction to view
the socket from, the outside of the socket, and that clockwise would be in
reference to that viewable angle” (id.).
The Examiner responds “angular measurements and directions are
relative and must be defined with respect to fixed reference points or axes”
(Ans. 7).
We find that Appellants have the better position because the
relationship of three points, such as contact areas, necessarily forms a plane,
and viewed from outside the fixture, the ordinary artisan would recognize
which direction on that plane is “clockwise” for the three points and which
direction is counterclockwise as evidenced by Figure 1 of the Specification.

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“for each point on the at least three contact areas”
Appellants contend “‘[a] person of ordinary skill in the art would
readily understand that a contact element can make contact with another
object in more than one area based on the teachings of Appellant’s
specification’” (App. Br. 6). Appellants contend that, as explained in the
Specification “contact points may all be located on the same contact element
(i.e. one contact element comprises these three contact points), or distributed
over two or more contact elements. ([citing Spec. 11:24–26]). . . . This
leave no doubt about what is meant by the recited phrase” (id.). Appellants
contend “the language recited in claim 1 essentially states that in order to be
covered by the claim, the device needs to contact the socket in at least
distinct places, and that those three places cannot all be within the same half
of the socket” (Reply Br. 4).
The Examiner responds that “each contact element has a contact
surface with an area, the contact surface having an infinite number of points”
(Ans. 6). The Examiner contends “claim 1 does not clearly recite the
association between the points and the contact elements, i.e. whether the
points are on the same contact element or different contact elements, so that
the points have the claimed angular relationship, thereby rendering the claim
indefinite” (id.).
We find that the Examiner has the better position. In the ex parte
context where
the patent drafter is in the best position to resolve the
ambiguity in the patent claims, and it is highly desirable that
patent examiners demand that applicants do so in
appropriate circumstances so that the patent can be amended
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during prosecution rather than attempting to resolve the
ambiguity in litigation.

Halliburton Energy Servs., Inc. v. M–I LLC, 514 F.3d 1244, 1255 (Fed.Cir.
2008).
The functional recitation of “three contact areas” does not clearly
describe what structure is required by claim 1. As the Examiner points out,
any physical element that makes contact with the patient can be subdivided
into multiple “contact areas” because neither claim 1 nor the Specification
provide specific limitations on the size of the “contact areas” recited in claim
1. The Specification supports this reading by stating “the contact element
comprises of a plurality of contact points” (Spec. 11:31–32) and that the
“surface of a contact element typically spans an area which varies between
one square micrometer (μm2) and fifty square centimeters (cm2)” (Spec.
12:1–2).
Thus, claim 1 is indefinite because it is unclear what limitation is
imposed by the term “contact area” on the socket or surgical fixture. That is,
the “contact areas” may be any size and any distance apart. Therefore, a
single element that contacts a socket will have, in the Examiner’s words, “an
infinite number” of contact areas that may be selected. Consequently, it is
unclear whether the term “contact area” limits the socket or surgical fixture
to requiring three separate contact components each with its own “contact
area,” a single contact component with multiple “contact areas,” two contact
components where one has a single “contact area” and the other has two
“contact areas,” or some other configuration. Thus, claim 1 is open to
multiple plausible interpretations.
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Moreover, because any specific contact element may have three
“contact areas” and because they may be chosen from any location on that
element, any contact element whatsoever necessarily can be interpreted as
having “three contact areas” arbitrarily chosen to be separated by angles less
than 180° in the clockwise direction, satisfying the recitation of claim 1.
Therefore, this limitation fails to provide the skilled artisan with sufficient
guidelines that allow for the determination of whether another device is, or is
not, infringing upon claim 1.
“positioning element is one of the at least two contact elements”
Appellants contend “the specification states ‘a positioning element
and a contact element may form a single unit, thus the positioning element
may also function as a contact element.’ Spec., p. 16, ll. 6-7. The
specification goes on to describe how the positioning element would
function as a contact element” (App. Br. 9).
The Examiner responds “claim 5 is indefinite because the relationship
between the contact elements and the positioning element already recited in
claim 1 is not stated for e.g., ‘the positioning element is part of one of the
two contact elements’” (Ans. 7).
We find that Appellants have the better position. Claim 5 is
reasonably interpreted as simply limiting claim 1 to require that one of the
contact elements is also a positioning element. While this is broad, it is not
indefinite because “breadth is not to be equated with indefiniteness.” In re
Miller, 441 F.2d 689, 693 (CCPA 1971).

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Conclusions of Law
The evidence of record does not support the Examiner’s conclusion
that the terms “clockwise direction” and “positioning element is one of the at
least two contact elements” are indefinite.
The evidence of record supports the Examiner’s conclusion that the
term “contact areas” is indefinite.
We therefore affirm the indefiniteness rejection as to all claims
because all of the claims depend, either directly or indirectly, from claim 1.

B.–D. 35 U.S.C. § 102(b) and 103(a)
Because we affirm the rejection of claims 1, 4–8, 10–12, and 14–17 as
indefinite, we reverse, pro forma, the Examiner’s prior art rejections because
the claims are not sufficiently definite to allow determination of whether
Meridew’s teachings anticipate or render obvious the claims.
In particular, Meridew teaches a device that contacts the acetabulum
(see Meridew 7:1–4 and Fig. 4) that the Examiner might ordinarily find
anticipates under the burden shifting rationale of In re Best, 562 F.2d 1252,
1254–55 (CCPA 1977). However, in light of the indefiniteness of the
claims, it is not clear what conditions would be used “to require the
applicant to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.” Best, 562 F.2d at 1255.
Therefore, we reverse these rejections because “substantial confusion
exists in the record at all levels of the prosecution as to the proper
interpretation to be given to the appealed claims. We believe that this
confusion arose and has continued because the claims do not particularly
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point out and distinctly claim the invention as required by 35 U.S.C. § 112.”
In re Steele, 305 F.2d 859, 863 (CCPA 1962). As in Steele, “[o]ur decision
is not to be construed as meaning that we consider the claims on appeal to be
patentable as presently drawn.” Id.

SUMMARY
In summary, we affirm the rejection of claims 1, 4–8, 10–12, and 14–
17 under 35 U.S.C. § 112, second paragraph as indefinite.
We reverse, pro forma, the rejections of claims 1, 4, 5, 7, 8, 10, 12,
and 15–17 under 35 U.S.C. § 102(e) as anticipated by Meridew, of claim 6
under 35 U.S.C. § 103(a) as obvious over Meridew and Banko, and of claim
14 under 35 U.S.C. § 103(a) as obvious over Meridew and Fitz.

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