Ex Parte Shiuey

Patent Trials and Appeals Board

May 3, 2019

13189337 - (D) (P.T.A.B. May. 3, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/189,337 07/22/2011
28083 7590 05/07/2019
Goldberg Cohen LLP
1350 A venue of the Americas
3rd Floor
New York, NY 10019
FIRST NAMED INVENTOR
Yichieh Shiuey
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
6076.103.20l(keramed) 9973
EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
05/07/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mcohen@goldbergcohen.com
lwigder@goldbergcohen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YICHIEH SHIUEY1
Appeal 2018-003886
Application 13/189,337
Technology Center 3700
Before STEFAN STAICOVICI, JAMES P. CALVE, and
JEREMY M. PLENZLER, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Final Office
Action rejecting claims 39, 40, and 43-64. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Keramed, Inc. is identified as the real party in interest. Appeal Br. 1.
Appeal 2018-003886
Application 13/189,337
CLAIMED SUBJECT MATTER
Claims 39 and 50 are independent. Claim 39 is reproduced below.
39 A corneal implant comprising:
a reversibly deformable scaffold for implanting in a corneal
pocket, the scaffold comprising a relaxed state in which the
scaffold has a predetermined peripheral shape before implantation
in the corneal pocket, and a deformed state, the scaffold
configured to be implanted into the cornea in the deformed state
and further configured to return to the relaxed state inside the
corneal pocket;
the scaffold comprising at least two spaced apart rings, the
two spaced apart rings comprising an upper ring and a lower ring,
wherein the upper ring comprises a circumference, and the lower
ring comprises a circumference;
the scaffold further comprising at least two connecting
elements joining the at least two spaced apart rings, the two
connecting elements comprising a first connecting element and a
second connecting element;
wherein the first connecting element and the second
connecting element are each arcuate;
wherein, in the relaxed state, the first connecting element
connects the circumference of the upper ring to the circumference
of the lower ring, and wherein the second connecting element
connects the circumference of the upper ring to the circumference
of the lower ring, such that the first connecting element and the
second connecting element form boundaries of a segment of the
upper ring and boundaries of a segment of the lower ring, such
that the first connecting element, the second connecting element,
the segment of the upper ring, and the segment of the lower ring
form a quadrilateral comprising curved sides;
wherein in the relaxed state the at least two spaced apart
rings and the at least two connecting elements define the
predetermined peripheral shape, the predetermined peripheral
shape comprising a truncate dome, the upper ring forming a top of
the truncate dome, and the lower ring forming a bottom of the
truncate dome, the connecting elements forming sides that are
curved from the top to the bottom of the truncate dome, and are
curved outward from the center of the scaffold, the truncate dome
2
Appeal 2018-003886
Application 13/189,337
being selected to provide a vision correction when placed in the
corneal pocket;
wherein the scaffold is formed from a reversibly
deformable material;
wherein the rigidity of the material is greater than that of
the cornea such that implantation into the corneal pocket of the
scaffold having the peripheral shape of the truncate dome results
in a flattening of a central region of the cornea towards the
peripheral shape of the truncate dome; and
wherein implantation of the scaffold into the corneal pocket
results in a steepening of a central region of the cornea.
Appeal Br. 20-21 (Claims App.).
REJECTIONS
Claims 39, 40, 43, 44, 47-53, and 56-64 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Klima (US 6,543,453 Bl, iss. Apr. 8, 2003)
and Barrett (US 5,391,201, iss. Feb. 21, 1995).2
Claims 45 and 54 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Klima, Barrett, and Kirk (US 2002/0116056 Al, pub.
Aug. 22, 2002).
Claims 46 and 55 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Klima, Barrett, and Shadduck (US 6,006,756, iss. Dec. 28,
1999).
2 The heading of this rejection does not identify claims 60-62 as subject to
this rejection, but the body of the rejection includes findings for claims 60-
62. Final Act. 3, 7.
3
Appeal 2018-003886
Application 13/189,337
ANALYSIS
Claims 39, 40, 43, 44, 47-53, and 56--64
As Unpatentable Over Klima and Barrett
Appellant argues claims 39, 40, 43, 44, 47-53, and 56-64 as a group.
See Appeal Br. 6-18. We select claim 3 9 as representative, and claims 40,
43, 44, 47-53, and 56-64 stand or fall with claim 39.
Regarding claim 39, the Examiner finds that Klima teaches all of the
features of a corneal implant including a truncate dome with outer walls that
can be curved from the top to the bottom of the dome by treating them with
electromagnetic radiation. Final Act. 3-6. The Examiner finds that first and
second connecting elements (bridging elements 24) shown in Figure 21 of
Klima provide curved sides between the upper and lower rings ( upper and
lower edge portions 26, 28) to create a truncate dome as claimed. Id. at 5.
The Examiner also finds that Klima discloses embodiments that provide
curved profiles in cross-section when treated with electromagnetic radiation
such that even though the rings are illustrated as straight in Figure 21, they
are capable of being bent to form a truncate dome as claimed. Id. at 5-6.
The Examiner illustrates these teachings with annotations on Figures 21 and
42 of Klima, which are reproduced below. See Ans. 3.
..
22
{\
• • • •
26
(
·..... .# .... ~
"'····•A.,,. - lt ....--·------. #" t1
FIG. 42
4
Appeal 2018-003886
Application 13/189,337
Figure 21 of Klima illustrates intracorneal ring 20 and its bridging
elements 24, which connect upper edge portion 26 to lower edge portion 28
and straight sloped side walls. Figure 42 of Klima illustrates transverse
cross sections of intracorneal rings that change the side shape and/or size
when treated with electromagnetic radiation. Klima, 8:57-9:5, 10:12-15.
The Examiner also finds that Barrett teaches a corneal implant with a
truncate dome shape and curved sides that may be implanted to change the
corneal curvature. Final Act. 6. The Examiner determines it would have
been obvious to a person of ordinary skill in the art to modify the corneal
implant of Klima so the connecting elements/outer walls are curved from the
upper ring to the lower ring (instead of straight) to form a truncate dome in
view of these teachings of Klima and Barrett to flatten and steepen central
regions of the cornea and to change the curvature of the cornea to correct
refractive errors as desired without adding further stress to the cornea. Id.
Appellant argues that Klima teaches a frusto-conical implant having
straight sides rather than a truncate dome with sides that are curved from top
to bottom by outwardly curved connecting elements as claimed. Appeal Br.
6-7. Appellant also argues that the bending of Klima' s connecting elements
is an in situ bending after the implant is in place, whereas the claims recite a
relaxed state in the shape of a truncate dome before implantation. Id. at 8.
This argument is not persuasive because Klima changes size, shape,
and/or configuration of all/part of the intracorneal implant by mechanical,
hydraulic, or pneumatic means, or by electromagnetic waves before or after
implantation so that Klima's intracorneal implant ring can be configured as a
truncate dome prior to implantation, as claimed, and corneal curvature can
be changed after implant. See Klima, 3:20-37; 4:39-49, 7:42-9:5; Ans. 3-5.
5
Appeal 2018-003886
Application 13/189,337
The Examiner correctly finds that Barrett uses a corneal implant with
outwardly curved sides as claimed to change the corneal curvature without
stressing the cornea. Final Act. 6; Barrett, 1:10-15, 2:60-68, 3:20-4:1. The
Examiner determines it would have been obvious to a skilled artisan to apply
this teaching to Klima's implant for similar benefits when Klima also alters
the size, shape, or configuration of an intracorneal implant to change corneal
curvature. Final Act. 5-6; see KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007) (holding that a technique that improves one device would be
recognized by skilled artisans as obvious to use to improve similar devices
in the same way unless its actual application is beyond their skill).
In response, Appellant argues that Barrett does not disclose a truncate
dome because the top is fully curved and has no truncation. Appeal Br. 8.
Appellant argues that Barrett teaches a frustoconical shape when implanted
and does not disclose a truncate dome. Id. at 9-10. Appellant also argues
that Barrett has a single ring rather than spaced rings as claimed. Id. at 10.
These arguments amount to individual attacks on the references where
the Examiner relies on Klima to teach a truncate dome shaped intracorneal
implant that may be formed with outwardly curved sides as a truncate dome
as claimed. The Examiner relies on Barrett to teach an intracorneal implant
that also has the outwardly curved sides of a truncate dome that can change
the shape of the cornea as claimed. Ans. 5-6; Final Act. 6.
Appellant responds that Klima and Barrett both teach frustoconical
implants that use a different principle of operation from the truncate dome
implants, which steepen a central region of the cornea and change the shape
of the cornea toward the peripheral shape of the truncate dome. Appeal Br.
10-11. Appellant cites declarations of Dr. Shiuey in support. Id. at 11.
6
Appeal 2018-003886
Application 13/189,337
Dr. Shiuey, named inventor of the present application, declares that
the claimed truncate dome shaped implants cause the central cornea to adopt
the shape of the truncate shaped implant thereby resulting in a flattening of
the central cornea in some cases by a relatively flat truncate dome and the
steepening of the central cornea in other cases by a relatively steep truncate
dome. Declaration ofYichieh Shiuey Under 37 C.F.R. § 1.132, dated Aug.
9, 2016, at 3 (First Shiuey Declaration). Dr. Shiuey also avers that conical
implants such as those disclosed in various embodiments of Klima result in a
deformation of the central cornea inversely proportional to the steepness of
the peripherally positioned implant. Id. at 4.
Dr. Shiuey further declares that Barrett teaches a corneal implant that
is "substantially dome shaped" and frustoconical in shape when implanted,
and Klima teaches an implant with straight (flat) sides having a frustoconical
shape. Declaration ofYichieh Shiuey Under 37 C.F.R. § 1.132, dated Jan.
17, 2017 iJiJ 13-17 (Second Shiuey Declaration).
Klima illustrates a frustoconical corneal implant as Dr. Shiuey states.
However, the Examiner modifies Figure 21 's shape based on other teachings
of Klima to curve the straight sides and Barrett's teachings discussed above.
See Final Act. 5-6; Ans. 3. As modified to include side segments that curve
outwardly, as taught by both Klima and Barrett, Klima teaches a truncate
dome shaped implant as claimed. Barrett's implant is substantially dome
shaped as well. See Barrett, Fig. 2. This teaching supports modification of
Klima's implant because it teaches that dome shaped and substantially dome
shaped implants (i.e., truncated domes) with outwardly curved sides change
the shape of a cornea. This shape provides corneal flattening and refractive
correction based on the slope of dome surface 7. Barrett, 1: 11-16, 3 :44-61.
7
Appeal 2018-003886
Application 13/189,337
Barrett teaches that its substantially dome shaped corneal ring implant
has a curved geometry that alters the anterior curvature of the optic zone of a
cornea without intrusion into the optic zone. Id. at 3 :20-61. Furthermore,
what Barrett characterizes as a frustoconical shaped implant is illustrated in
Figure 2 of Barrett as a substantially dome shaped implant or even a truncate
dome shape as claimed. When implanted, the flat, rear, posterior surface 8
may assume a "frustoconical shape," but dome shaped, anterior front surface
7 retains its dome or truncate dome shape. Id. at 3 :44-4: 1, see Figs. 1, 2.
The anterior peripheral corneal bulge caused by the ring and its substantially
dome shaped anterior surface 7 flattens the cornea. Id. at 3:20-61, 4:43-46.
Similarly, Klima teaches that its intracorneal implant is a refractive
correction device used with procedures for reshaping the cornea. Klima,
1 :5-58. More particularly, Klima teaches that the intracorneal ring can be
adjusted in its shape and/or size to compensate for changes to the eye by
aging and thereby adjust and fine tune vision to the fullest extent. Id. at
7:43-53. Such changes also can change the thickness of the intracorneal
implant, and this change in height can change the eye's diopter and axis of
astigmatism correction. Id. at 8:65-9:5. The Examiner correctly finds that
these teachings would be understood by a skilled artisan to teach that the
size and shape of the intracorneal ring can be changed to alter the shape and
refractivity and other optical qualities of the cornea and eye of a patient.
Ans. 6-7. The Examiner reasonably concludes that, because Klima and
Barrett provide these teachings and the modified Klima intracorneal implant
has the claimed truncate dome shape and segmented structure, the modified
Klima implant would steepen a central region of the cornea and reshape the
cornea to a peripheral shape of the truncate dome as claimed. Id.
8
Appeal 2018-003886
Application 13/189,337
Appellant's arguments and Dr. Shiuey's declarations do not persuade
us that the modified intracorneal implant of Klima is not capable inherently
of providing the claimed changes to the cornea. See In re Schreiber, 128
F.3d 1473, 1478 (Fed. Cir. 1997) (holding that patent applicants may recite
features of an apparatus structurally or functionally; however, if the PTO has
a reason to believe that the prior art possesses a functional feature as an
inherent characteristic, it has the authority to require the applicant to prove
that the subject matter does not possess the claimed functional feature).
Dr. Shiuey' s declarations are not persuasive primarily because they do
not address the prior art teachings as combined by the Examiner. Even if a
frustoconical shaped intracorneal implant lacks the capabilities of a truncate
dome shaped implant as Dr. Shiuey declares (First Shiuey Declaration, 3-4;
Second Shiuey Declaration ,i 18), the Examiner relies on the teachings of
Klima and Barrett to render obvious a truncate dome implant as discussed
above. As modified, Klima' s intracorneal implant is a truncate dome shape.
Neither Appellant nor Dr. Shiuey explains why Klima's modified truncate
dome implant would not provide the claimed cornea-shaping properties. See
Appeal Br. 12-13.
Indeed, Appellant recognizes that Klima teaches to treat the bridging
elements of intracorneal ring 20 in Figure 21 to change the height/thickness
of the ring. Reply Br. 5-6; Klima 8:65-9:5. Reducing the overall height of
ring 20 would change the shape of the sides to curve outwardly as claimed
and as illustrated by the Examiner. See Ans. 3. Klima illustrates this profile
change resulting from altering a transverse cross-section profile, shape, and
size of ring 20 via electromagnetic radiation such as a laser. Klima, 10:12-
15, Fig. 42; Ans. 3.
9
Appeal 2018-003886
Application 13/189,337
Neither Appellant's attorney arguments nor Dr. Shiuey's declarations
provide persuasive scientific or technical evidence to indicate that the sides
of Klima's intracorneal ring 20 would remain flat when the height of ring 20
is reduced as disclosed in Klima. Nor is the Examiner suggesting a toroidal
shape of Klima's ring as Appellant argues. Reply Br. 8-9. The Examiner
clearly indicates how Klima's teachings would yield a truncate dome shape
and these teachings are reinforced by Barrett's teaching of outwardly curved
sides of a substantially dome shaped implant as discussed above. In this
regard, the Examiner has not disregarded the declarations of Dr. Shiuey as
Appellant alleges. See Reply Br. 16-18. The Examiner finds them to be
inapposite because Klima and Barrett teach the principle of operation of the
claimed truncate dome cornea implant that changes the size, shape, and/or
configuration of the cornea to correct the vision of a patient as discussed
above. Ans. 6-7. The modified Klima corneal implant has the claimed
truncate dome shape as discussed above so that Dr. Shiuey' s analysis largely
is inapplicable to the rejection before us. The size, shape, and configuration
of a modified Klima corneal implant changes the shape of the cornea to
steepen a central region of the cornea or change the shape of the cornea
towards a peripheral shape of the implant as claimed. See Klima, 1: 10-67,
3:20-37, 7:43-53, 9:57-9:5, 10:12-15; Barrett, 2:60-68, 3:20-61.
Because the modified Klima intracorneal implant discloses all of the
limitations of independent claims 39 and 50 to include outwardly curved
connecting elements, Klima discloses a "quadrilateral comprising curved
sides." Claims 39 and 50 recite this feature as resulting from first and
second connecting elements connecting the upper and lower rings to form
segments of the upper and lower rings.
10
Appeal 2018-003886
Application 13/189,337
We appreciate that an ordinary meaning of quadrilateral includes "a
polygon of four sides." Definition of quadrilateral by Merriam-Webster at
http://www.merriam-webster.com/dictionary/quadrilateral (last viewed Apr.
24, 2019). This definition is inconsistent with the claims. Claims 63 and 64,
which depend from independent claims 39 and 50, respectively, recite that
the "quadrilateral comprises four curved sides." Appeal Br. 26 (Claims
App.). Thus, the quadrilateral of claims 39 and 50 requires only two curved
sides. The first and second connecting elements form two segments in the
upper and lower rings. The only sides claimed for the corneal implant are
the two outwardly curved connecting elements. Appellant's Figures 17 A-C
illustrate a truncate dome with four thin, curved, connecting elements as the
"sides." Appeal Br. 3 (Figs. 17 A-C illustrate the claimed subject matter).
As modified, Klima's corneal implant has two outwardly curved sides
that connect upper and lower rings 26 and 28 and divide those rings into two
segments of a quadrilateral as claimed. See Ans. 3 (illustrating modification
of straight sides of implant of Figure 21 of Klima to outwardly curved sides
of Figure 42). Appellant's arguments regarding the claimed quadrilateral
comprising four curved sides (Appeal Br. 14) are not commensurate with
claims 39 and 50 and therefore are not persuasive. Thus, we sustain the
rejection of claims 39 and 50.
Dependent Claims
Appellant argues that the limitations of dependent claims 48, 57, 59,
60-62, 63, and 64 are not taught. See Appeal Br. 18; Reply Br. 18-19. This
argument is not persuasive because Appellant merely recites the limitations
of these claims and asserts, without any further explanation, that the prior art
does not teach or suggest these limitations.
11
Appeal 2018-003886
Application 13/189,337
Reciting limitations of claims and asserting that the prior art does not
disclose the limitations does not provide effective argument for patentability
of those claims. See 37 C.F.R. § 41.37(c)(l)(iv); In re Lovin, 652 F.3d 1349,
1357 (Fed. Cir. 2011) (holding that the Board reasonably interpreted 37
C.F.R. § 41.37(c)(l)(vii) (predecessor to§ 41.37(c)(l)(iv)) to require "more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art."). Thus, we sustain the rejection of claims 40, 43, 44,
47-49, 51-53, 56-62, 63, and 64. See Appeal Br. 6-18.
Claims 45 and 54 I Claims 46 and 55
As Unpatentable Over Klima, Barrett, and Kirk/Shadduck
Appellant does not present arguments for these rejections. See Appeal
Br. 6-19. Therefore, we summarily sustain these rejections.
DECISION
We affirm the rejections of claims 39, 40, and 43-64.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED
12