Ex Parte Shiuey

Patent Trial and Appeal Board

Mar 15, 2018

12405900 (P.T.A.B. Mar. 15, 2018)

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.
12/405,900 03/17/2009 YICHIEH SHIUEY Keramed.Cornea.Gl 4415
28083 7590
Goldberg Cohen LLP
1350 Avenue of the Americas
3rd Floor
New York, NY 10019
03/19/2018 EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/19/2018 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
1 wigder @ goldbergcohen .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YICHIEH SHIUEY
Appeal 2016-003174
Application 12/405,900
Technology Center 3700
Before JOHN C. KERINS, STEVEN D.A. McCARTHY and
GEORGE R. HOSKINS, Administrative Patent Judges.
McCARTHY, Administrative Patent Judge.
DECISION ON APPEAL
1 STATEMENT OF THE CASE
2 The Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
3 decision finally rejecting claims 65-68, 70, 71 and 73-80 under pre-AIA 35
4 U.S.C. § 103(a) as being unpatentable over Marmo (US 2005/0080484 Al,
5 publ. Apr. 14, 2005) and Nigam (US 2005/0080485 Al, publ. Apr. 14,
6 2005); claim 69 under § 103(a) as being unpatentable over Marmo, Nigam,
7 Silvestrini (US 2002/0010510 Al, publ. Jan. 24, 2002) and Capecchi (US
8 5,292,514, issued Mar. 8, 1994); and claim 72 under § 103(a) as being
9 unpatentable over Marmo, Nigam and Barber (US 5,489,301, issued Feb. 6,
1 The Appellant identifies KeraMed, Inc., of Orange, California, as the
real party in interest.
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Application 12/405,900
1996). Claims 1-64 are cancelled. A hearing in the appeal was held on
March 6, 2018. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Claim 65 is the sole independent claim on appeal:
65. An article of manufacture, comprising:
(a) a corneal prosthesis for replacing corneal tissue;
(b) said corneal prosthesis being reversibly deformable,
with said corneal prosthesis comprising a relaxed state and a
deformed state;
(c) wherein said corneal prosthesis is capable of returning
to said relaxed state from said deformed state;
(d) wherein said corneal prosthesis in said deformed state
is capable of being implanted into a cornea through an opening
that is less than the width of said corneal prosthesis in said
relaxed state;
(e) said corneal prosthesis comprising a center optic
comprising an anterior surface, a posterior surface, and a
peripheral wall; and
(f) wherein said corneal prosthesis comprises as least one
rim circumscribing at least a portion of said peripheral wall, said
at least one rim having a thickness less than the thickness of said
center optic.
A human eye 10, as depicted in Figure 1 of Marmo, includes a cornea
20 that provides between approximately 60% to 70% of the focusing power
of the eye. (See Marmo, para. 5). Five layers of transparent tissue make up
a patient’s cornea. As depicted in Figure 2 of Marmo, these layers include
the corneal epithelium 22, which is the thin, outermost layer of tissue;
Bowman’s membrane 24, which lies immediately beneath the corneal
epithelium; the corneal stroma 26, which constitutes approximately 90% of
the thickness of the cornea; Descemet’s membrane 28, which lies
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Appeal 2016-003174
Application 12/405,900
immediately below the stroma; and an epithelium 30, which is the innermost
layer of tissue. (See Marmo, para. 60).
Marmo taught that there existed three types of corrective lenses that
might be placed in proximity to the cornea in order to improve a patient’s
eyesight. The first type, a corneal inlay, was placed within the patient’s
cornea. The second type, a corneal onlay, was placed over the cornea after
removing at least a portion of the corneal epithelium. The third type, a
contact lens, was placed over the corneal epithelium. (See Marmo, para. 5).
Marmo described corneal onlays. (See, e.g., Marmo, para. 62).
One of Marmo’s corneal onlays was designed to be positioned by
deforming the onlay; inserting the deformed onlay through an incision in the
corneal epithelium smaller than the width of the onlay; and then allowing the
onlay to resume the configuration the onlay had prior to deformation. (See
Marmo, para. 101). Nevertheless, such an onlay was positioned near the
corneal epithelium and did not to extend into interior tissue layers such as
the stroma. (See “Appellant’s Brief on Appeal,” dated July 7, 2015 (“App.
Br.”), at 7, citing Marmo, para. 111).
Figures 17-21 of Nigam depict corneal implants for correcting
presbyopia, that is, a loss of visual acuity due to a diminution in the
elasticity of the lens in the eye with age. Each of these implants has an
additional power section at the center of the implant to facilitate close-up
work. (See Nigam, paras. 62 & 63; see also id., para. 3). In particular, the
corneal implant 100 depicted in Figure 20b of Nigam includes a central
power add 98 surrounded by a sharp transition zone 96 to a relatively thin,
radially-outer portion. Nigam teaches that the sharp transition zone 96
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Application 12/405,900
further improves visual acuity by sharply defining the central power add 98.
(See Nigam, paras. 64 & 65).
Nigam teaches implanting the corneal implant 100 by dissecting the
cornea to form a corneal flap 102; placing the implant into the space below
the flap; and replacing the flap over the implant. (See Nigam, para. 65; &
Figs. 21a & 21b). Nigam teaches in connection with a method for
implanting corneal implants designed for the treatment of near-sightedness
or far-sightedness that the step of lamellar dissectomy is to be performed by
cutting through the corneal epithelium into Bowman’s membrane. (See
Nigam, paras. 57 & 58). According to Nigam, cutting into Bowman’s
membrane has the effect of relieving tension in the membrane so as to
reduce the likelihood that corneal tension would extrude the implant. (See
Nigam, paras. 10 & 58). Nigam does not teach cutting into the stroma.
The Examiner finds that the “corneal onlay of Marmo is clearly
dimensioned to fit within the eye and is capable of being placed into the
stroma.” (Examiner’s Answer, mailed Dec. 4, 2015 (“Ans.”), at 2). The
Examiner also finds that Nigam’s corneal implant 100 “has a thickness sized
capable of replacing corneal tissue.” (Final Office Action, mailed Mar. 4,
2015 (“Final Act.”), at 5). The Examiner cites no evidence to support either
finding. Instead, the Examiner supports these findings by reasoning that:
[B]oth the corneal implants of Marmo and Nigam are implanted
into tissue of the eye. Because the tissue is cut into a flap, the
implants are inserted into the tissue and the flap is replaced, a
corneal implant is left within the tissue of the eye. Therefore,
tissue has been replaced. The fact that Marmo and Nigam
provide additional capabilities of providing refractive correction
to a cornea does not refute that both Marmo and Nigam disclose
corneal prostheses capable of replacing corneal tissue.
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(Ans. 4 & 5; see also id. at 3 (“However, implantation of any three
dimensional device, such as the onlay of Marmo, would replace tissue. In
other words, where tissue once was (pre-implantation) a device now resides
(post-implantation). Thus, tissue has been replaced.”)).
Both Marmo and Nigam teach displacing (that is, reshaping) corneal
tissue. Neither teaches replacing such tissue. The fact that neither Marmo
nor Nigam teaches cutting further than the relatively thin corneal epithelium
and Bowman’s membrane belies the notion that either Marmo’s onlay or
Nigam’s implant is designed either to serve as a corneal prosthesis or to
replace corneal tissue. Considering the disclosure of each reference as a
whole, we are not persuaded that the Examiner has a sound basis for
believing that either Marmo’s onlay or Nigam’s implant is capable of
replacing corneal tissue.
Absent such a sound basis for belief, the Appellant is under no
obligation to produce evidence tending to disprove the Examiner’s findings.
Because we do not adopt the Examiner’s finding that Marmo and Nigam,
alone or in combination, teaches a corneal prosthesis for replacing corneal
tissue, we do not sustain the rejection of claims 65-68, 70, 71 and 73-80
under § 103(a) as being unpatentable over Marmo and Nigam.
With respect to claim 69, the Examiner cites Silvestrini and Capecchi
for teachings regarding desirable mechanical properties of materials for use
in fabricating corneal prostheses. {See Final Act. 5 & 6). The Examiner
cites neither Silvestrini nor Capecchi for a teaching that might remedy the
deficiencies in the combined teachings of Marmo and Nigam as applied to
parent claims 65-67. We do not sustain the rejection of claim 69 as being
unpatentable over Marmo, Nigam, Silvestrini and Capecchi.
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With respect to claim 72, the Examiner cites Barber as teaching “an
implant wherein the rim circumscribes the peripheral wall of the center optic
between the anterior edge and the posterior edge.” (Final Act. 6). The
Examiner does not cite Barber for a teaching that might remedy the
deficiencies in the combined teachings of Marmo and Nigam as applied to
parent claim 65. We do not sustain the rejection of claim 69 as being
unpatentable over Marmo, Nigam and Barber.
DECISION
We REVERSE the Examiner’s decision rejecting claims 65-80.
REVERSED
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