Ex Parte 7,736,389 B1 et al

Patent Trial and Appeal Board

Sep 26, 2014

95002082 (P.T.A.B. Sep. 26, 2014)

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.
95/002,082 08/22/2012 7,736,389 B1 PRES06-00513 1040
7590 09/26/2014
Edwin H. Crabtree
3773 Cherry Creek N. Drive
Suite 575
Denver, CO 80209
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
09/26/2014 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
____________________

REFOCUS OCULAR, INC.
Requester, Respondent

v.

READING ENHANCEMENT CO.
Patent Owner, Appellant
____________________

Appeal 2014-006759
Reexamination Control 95/002,082
US Patent No. 7,736,389 B1
1

Technology Center 3900
____________________

Before: STEVEN D. A. MCCARTHY, DANIEL S. SONG, and
BRETT C. MARTIN, Administrative Patent Judges.

MARTIN, Administrative Patent Judge.

DECISION ON APPEAL

1
Issued on June 15, 2010 to Richard E. Damiano (hereinafter referred to as
the '389 patent).
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STATEMENT OF THE CASE
Patent Owner appeals under 35 U.S.C. §§ 134(b) and 315(a) from the
Examiner’s rejection of claim 1. We have jurisdiction under
35 U.S.C. §§ 134(c) and 315(b). US Patent No. 8,167,938, which is a
continuation of the '389 patent, is also on appeal as Appeal Number 2014-
006856.
We REVERSE.

THE INVENTION
Appellant’s invention is directed to "a reading enhancement device
sutured to the sclera of the eye for preventing and/or treating presbyopia and
more particularly… for buckling and compressing a portion of the sclera and
the ciliary body inwardly and perpendicular to the plane of the sclera."
Spec. col. 1, ll. 16-22. Claim 1 is the only claim in the '389 patent and is
reproduced below:
1. A suture device for preventing and/or treating presbyopia
of the eye, the suture device configured for suturing to the outer
wall of the sclera to effect buckling and compressing a portion
of the sclera and the suture device having a convex portion
shaped to force the ciliary body inwardly thereby exerting a
posterior compression force perpendicular to the sclera, wherein
the compression force strengthens the muscle of the ciliary
body by reducing the stretching of the scleral spur occurring
with age, the suture device comprising: an I-beam shaped
compression body having an elongated semi-circular convex
center portion, the center portion of the I-beam terminating in
transverse first and second ends wherein the first end is adapted
for receiving a first suture thereon and the second end is
adapted for receiving a second suture thereon; wherein each of
the first end and second end having a configuration preventing
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the first suture and the second suture from slipping off the
center portion, respectively; the semi-circular convex center
portion having a tissue engaging surface extending outwardly
from a front of the center portion and extending between the
transverse first and second ends; and whereby when the
transverse first end is sutured to the outer wall of the sclera
using the first suture and the transverse second end is sutured to
the outer wall of the sclera using the second suture, the tissue
engaging surface of the semi-circular convex portion is
compressed against a portion of the outer wall of the sclera
thereby exerting a compression force to the sclera.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Schachar US 7,416,560 B1 Aug. 26, 2008
Zdenek
Caro
Straub
US 2002/0002403 A1
US 2006/0004386 A1
WO 01/17460 A1
Jan. 3, 2002
Jan. 5, 2006
Mar. 15, 2001

THE REJECTIONS ON APPEAL
The Examiner made the following rejections:
1. Claim 1 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Zdenek and Straub. RAN 5.
2. Claim 1 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Zdenek, Straub, and Caro. RAN 7.
3. Claim 1 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schachar and Straub. RAN 10.
4. Claim 1 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schachar, Straub, and Caro. RAN 12.
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ANALYSIS
Claim Construction
Before turning to the rejections, it is necessary in this case to deal with
claim construction, namely whether the preamble of claim 1 is to be given
any weight. It is undisputed that the references at issue collectively (via
specific teachings in Straub) teach a device that has a convex surface that is
capable of some form of compression. What is at issue, however, is not
whether compression occurs, but the type of compression such a device
would impart to the eye. Claim 1, in its preamble, details the type of
compression (e.g., "for preventing and/or treating presbyopia," "to effect
buckling and compressing a portion of the sclera," and "to force the ciliary
body inwardly thereby exerting a posterior compression force perpendicular
to the sclera"), but the body of the claim does not include the same level of
detail and requires only "exerting a compression force to the sclera."
According to the Examiner, "[t]he only function that is properly
recited in claim 1 is 'exerting a compressive force to the sclera.'" RAN 17.
The Examiner also states, "the preamble of claim 1…is given no patentable
weight." Id. Both the Requester and the Examiner agree that regarding this
limited form of compression, "Zdenek and Straub inherently perform this
function." Id. The Patent Owner disagrees and asserts that "the
configuration recited in the preamble and body of the claims is significant,
and the preamble must be read as a limitation affecting patentability." App.
Br. 18.
If the claim preamble, when read in the context of the entire claim,
recites limitations of the claim, or, if the claim preamble is “necessary to
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give life, meaning, and vitality” to the claim, then the claim preamble should
be construed as if in the balance of the claim. Pitney Bowes, Inc. v. Hewlett-
Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (citation omitted). In
this particular case, the preamble details a specific type of compression that
is created on the sclera via the device's convex surface. While the claim
body recites only "exerting a compressive force to the sclera," we conclude
that this recitation relates back to the preamble's description of compression
because the preamble "gives life, meaning, and vitality" to the claim.
Accordingly, the broadest reasonable interpretation in view of the
specification of the '389 patent requires consideration of the preamble
language to be limiting and the force applied must be as described in the
preamble and of the type that would be used to treat presbyopia.
Rejections
Rejections 1 and 2 rely on the teaching in Zdenek that describes a
suture device whereby, in an alternative embodiment, "the bottom surface of
the central body portion may be convex along the long axis of the
prosthesis." Para. 40. It is important to note, as Patent Owner points out,
that Zdenek, as well as Straub and Schachar, discloses a device for treating
presbyopia in the exact opposite way as that of the '389 patent. Namely,
Zdenek's device is used to expand the sclera, not compress it, which is
apparent from the title, "Scleral Expansion Device Having Duck Bill."
Although Zdenek discloses a convex surface, a reasonable conclusion would
be that even with a convex bottom surface, the device still results in
expansion, not compression. From this scant disclosure, as well as Zdenek's
disclosed outcome of expansion, we simply cannot agree that Zdenek
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teaches a device capable of exerting the compression recited in the preamble
for treating presbyopia.
As the Patent Owner further notes, "[t]he examiner's argument
[regarding Zdenek's compression] is pure speculation." App. Br. 14. The
fact that a certain result or characteristic may occur or be present in the prior
art is not sufficient to establish the inherency of that result or characteristic.
In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993) (rejection reversed
because alleged inherency was based on what would result due to
optimization of conditions, not what was necessarily present in the prior art);
see also, In re Oelrich, 666 F.2d 578, 581-82 (CCPA 1981).
To establish inherency, the extrinsic evidence must make clear
that the missing descriptive matter is necessarily present in the
thing described in the reference, and that it would be so
recognized by persons of ordinary skill. Inherency, however,
may not be established by probabilities or possibilities. The
mere fact that a certain thing may result from a given set of
circumstances is not sufficient.
In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal
quotations omitted). In relying upon the theory of inherency, the Examiner
must provide a basis in fact and/or technical reasoning to reasonably support
the determination that the allegedly inherent characteristic necessarily flows
from the teachings of the applied prior art. Ex parte Levy, 17 USPQ2d 1461,
1464 (Bd. Pat. App. & Inter. 1990). Not only is the claimed compression
not necessarily present, it is not even clear that any compression would be
present given that Zdenek's disclosure, even with a convex surface, is
directed to devices producing expansion, not compression.
Rejections 3 and 4 similarly rely upon the teaching in Schachar "that a
scleral prosthesis can have a convex bottom surface that would inherently
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bend and compress the underlying portion of the sclera (see col. 5, lines 42-
50)." RAN 10. As with Zdenek, though Schachar does teach the possibility
of a convex bottom surface, this surface exerts "an outward force on the
scleral pocket to elevate the portion of the sclera attached thereto." Col. 5,
ll. 42-50. Again, it is not even clear from Schachar that compression occurs,
but whatever compression does occur is not the type claimed, seeing as
Schachar is concerned with scleral expansion, not compression, to treat
presbyopia. As the Patent Owner states, "[t]he examiner does not explain
how the intrascleral device of Schachar '560 necessarily does both (1) treat
presbyopia by expanding the sclera (through expansion from within the
tunnel) and (2) inherently compresses the ciliary body so as to treat
pre[s]byopia at the same time." App. Br. 23.
Further to the alleged compression provided by Schachar, Zdenek,
and Straub, we note that the Requester relies on the fact that Straub
specifically contemplates compression due to its warning to avoid
implantation where compression of the ciliary arteries or vasculature in the
eye may occur. Resp. Br. 7. As Patent Owner rebuts, "[t]he references of
Zdenek, Schachar, and Straub teach that compression does not treat
presbyopia (but merely causes ischemia, as discussed by Straub)." Patent
Owner's Rebuttal Br. 7. Accordingly, it is clear that any compression
created by these references actually results, or may result, in the undesirable
ischemia condition rather than effecting any type of compression that would
result in treatment of presbyopia, thereby teaching away from such
implementation. As such, we do not sustain rejections 1 and 3.
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The Examiner also makes two rejections that add Caro (rejections 2
and 4) to the combinations of rejections 1 and 3. First, it is somewhat
unclear why the Examiner adds Caro as the original combinations allegedly
render the claims unpatentable without Caro. Further, as detailed below, the
Examiner provides no rationale for adding Caro to the combinations.
Although Caro teaches a convex bottom surface, as the Patent Owner
states, "Figs. 4 and 5 of Caro clearly show that Caro's convex portion (42)
should be about flush with the opposed feet (44) of the Caro device,"
whereas claim 1 requires that the convex center portion extend outwardly
from the center portion. App. Br. 24. Patent Owner also points out correctly
that Caro's ends are inserted into pockets in the eye, whereas the claimed
device is sutured to the surface of the sclera using ends that urge the
outwardly extending convex portion against the eye to effect the claimed
compression. Id. Accordingly, whatever compression that is achieved by
Caro is quite different from the expansion achieved by Zdenek or Schachar
and also different from the claimed invention and we see no reason why one
of skill in the art would attempt to combine the teachings of Zdenek or
Schachar with the convex, but recessed, center portion of Caro.
As stated supra, the Examiner provides no basis for the combinations
that include Caro and only asserts, for example, that "the device of Schachar,
when considered with the teachings of Straub and Caro regarding
compression applied to the eye when the prosthesis is in use, is inherently
capable of performing the recited compression function." RAN 14; see also
RAN 9. We do not consider this to be a reasonable basis with rational
underpinnings sufficient to support the combination of Zdenek or Schachar
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and Straub with Caro. Additionally, Caro does not cure the deficiencies of
the combinations noted above with respect to Zdenek or Schachar with
Straub. Accordingly, we do not sustain rejections 3 and 4.
DECISION
For the above reasons, we REVERSE the Examiner’s decision to
reject claim 1 as stated in each of rejections 1-4.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). In the event
neither party files a request for rehearing within the time provided in
37 C.F.R. § 41.79, and this decision becomes final and appealable under
37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice
on the Director of the United States Patent and Trademark Office. See
37 C.F.R. §§ 90.1 and 1.983.

REVERSED

PATENT OWNER:
EDWIN H. CRABTREE
3773 CHERRY CREEK N. DRIVE
SUITE 575
DENVER, CO 80209

REQUESTER:
WILLIAM A. MUNCK, ESQ.
C/O DOCKET CLERK
P.O. DRAWER 800889
DALLAS, TX 75380