Ex Parte 8,167,938 B1 et al

Patent Trial and Appeal Board

Sep 26, 2014

95002083 (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.
95/002,083 08/17/2012 8,167,938 B1 PRES06-00515 1083
7590 09/26/2014
EDWIN H. CRABTREE
3773 CHERRY CREEK N. DRIVE
SUITE 575
DANVER, 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 2014-006856
Reexamination Control 95/002,083
US Patent No. 8,167,938 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 May 1, 2012 to Richard E. Damiano (hereinafter referred to as
the '938 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 claims 1-16. We have jurisdiction under
35 U.S.C. §§ 134(c) and 315(b). Reexamination Control 95/002,082 of
US Patent No. 7,736,389 B1, of which the '938 patent is a continuation, is
also on appeal as Appeal Number 2014-006759.
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. 18-24. Claim 1, reproduced below, is illustrative of the
claimed subject matter:
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, 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 shaped compression body 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 and second
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ends have a configuration preventing the first and second
sutures from slipping off the center portion respectively; and
the convex center portion having a tissue engaging
surface extending outwardly from a front of the convex center
portion and extending between the transverse first and second
ends, the tissue engaging surface made of a compressible
material, the compressible material reducing direct pressure on
the blood vessels and nerves of the eye when engaging the outer
wall of the sclera;
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 semicircular
convex center 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:
Silverstrini
Baikoff
Schachar
US 6,214,044 B1
US 6,712,847 B2
US 7,416,560 B1
Apr. 10, 2001
Mar. 30, 2004
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. Claims 1-8 and 10-12 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Zdenek and Straub. RAN 5.
2. Claims 1-8 and 10-12 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Zdenek, Straub, and Caro. RAN 8.
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3. Claims 1-8 and 10-12 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Schachar and Straub. RAN 11.
4. Claims 1-8 and 10-12 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Schachar, Straub, and Caro. RAN 13.
5. Claims 1-16 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Zdenek, Straub, and Baikoff and/or Silverstrini. RAN 16.
6. Claims 1-16 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Zdenek, Straub, Baikoff and/or Silverstrini, and Caro.
RAN 19.
ANALYSIS
Claim Construction
It is necessary here to deal first with claim construction, namely
whether the preambles of claims 1, 7, and 13, which are all effectively the
same for the purposes of this appeal, are to be given any weight. It is
undisputed that the references at issue collectively 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, as well as similar language in claims 7 and 13, details the type of
compression (e.g., "for preventing and/or treating presbyopia," "to effect
buckling and compressing a portion of the sclera," and "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."
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According to the Examiner, "[t]he only function that is positively
recited in claim 1 is 'exerting a compressive force to the sclera.'" RAN 25-
26. The Examiner also states, "the preamble of claim 1…is given no
patentable weight." RAN 25. Both the Requester and the Examiner agree
that Zdenek and Straub "inherently perform the recited function of 'exerting
a compressive force to the sclera.'" Id. at 26. 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
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 '938 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.

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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 '938 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." Even
though 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 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
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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
bend and compress the underlying portion of the sclera (see col. 5, lines 42-
50)." RAN 11. 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 may 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 do[es] not explain
how the intrascleral device of Schachar '560 necessarily does both expand
the sclera (through expansion from within the tunnel) and inherently
compress the ciliary body to treat pre[s]byopia at the same time." App.
Br. 23.
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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.
The Examiner also makes two rejections that add Caro (rejections 2
and 4), which teaches a convex bottom surface, but 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 claims 1, 7, and 13 require 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 both Zdenek or
Schachar and we see no reason why one of skill in the art would attempt to
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combine the expansion devices of Zdenek or Schachar with the convex
bottom portion of Caro that does not extend beyond its outer ends.
We note that 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 regarding compression applied
to the eye when the prosthesis is in use, is inherently capable of performing
the recited compression function." RAN 12; see also RAN 10. We do not
consider this to be a reasonable basis with rational underpinnings sufficient
to support the combination of Zdenek or Schachar 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 2 and 4.
Rejections 5 and 6 add Baikoff and/or Silverstrini to address
additional limitations present in claim 13, but these references do not cure
the deficiencies noted above with the combinations of Zdenek and Straub or
Schachar and Straub. Accordingly, we reverse these rejections for the
reasons stated above with respect to rejections 1 and 3.
DECISION
For the above reasons, we REVERSE the Examiner’s decision to
reject claim 1-16 as variously stated in each of rejections 1-6.
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
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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