Ex Parte Boukhny et al

Patent Trial and Appeal Board

Mar 7, 2017

11584996 (P.T.A.B. Mar. 7, 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.
11/584,996 10/23/2006 Mikhail Boukhny PAT903106-US-NP 6704
26356
ALCON
IP LEGAL
7590 03/09/2017 EXAMINER
SZPIRA, JULIE ANN
6201 SOUTH FREEWAY
FORT WORTH, TX 76134 ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/09/2017 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):
patent, docketing @ alcon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MIKHAIL BOUKHNY, JAMES CHON,
DAVID DOWNER, and STEVE VAN NOY1
Appeal 2015-003495
Application 11/584,996
Technology Center 3700
Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and ERICA A.
FRANKLIN, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
intraocular lens delivery system. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1—29 are on appeal (App. Br. 9). Claims 1 and 8 are
illustrative and read as follows:
1. An intraocular lens delivery system comprising:
an injector body;
a plunger slidably movable within the injector body;
1 Appellants identify the real party in interest as Novartis AG (App. Br. 2).
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Application 11/584,996
a nozzle portion on a distal end of the injector body, the nozzle
portion having a hollow interior adapted for receiving an intraocular lens;
a heater integrated with the intraocular lens delivery system
adapted to heat the intraocular lens while the intraocular lens is external to
an eye; and
an indicator on the injector body operable to be illuminated to
display a visible indication to deliver the intraocular lens into the eye
while the intraocular lens is external to the eye when the heater has heated
the intraocular lens to a predetermined temperature range.
8. The intraocular lens delivery system of claim 1 further
comprising a controller for regulating the temperature of the intraocular
lens.
Claims 1—7, 11—22, and 26—28 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Van Gent (US 4,955,889, Sept. 11, 1990) in view
of Callahan et al. (US 2003/0033013 Al, Feb. 13, 2003) and Flom et al.
(US 4,053,953, Oct. 18, 1977) (Final Act. 2).
Claims 8—10, 23—25, and 29 stand rejected under 35 U.S.C. § 103(a)
as obvious over Van Gent in view of Callahan, Flom, and Ludin et al.
(US 6,193,683 Bl, Feb. 27, 2001) (Final Act. 5).
I
In rejecting claim 1, inter alia, the Examiner relies on Van Gent for
disclosing an intraocular lens (IOL) delivery system comprising:
an injector body (22) and a polymer plunger (26 ... ) slidably
movable within the injector body[;] ... a polymer nozzle portion
(34 . . . ) on a distal end of the injector body . . . , the nozzle
portion . . . having a hollow interior . . . adapted for receiving an
intraocular lens . . . ; a heater . . . integrated with the intraocular
lens delivery system, . . . adapted to heat the intraocular lens . . .
; [and] an indicator on the injector body operable to display a
visible indication when the heater has heated the intraocular lens
to a predetermined temperature range ( ... the shape change of
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Application 11/584,996
part 44 is the “indicator” since it is a visual indication of the
heater heating the lens to a predetermined temperature range).
(Final Act. 2—3.) The Examiner acknowledges that Van Gent “fails to
disclose the heating of the lens being external to the eye and the indicator
being illuminated” {id. at 3).
The Examiner relies on Callahan for teaching “heating ... a lens prior
to insertion of the device within the eye” {id.). The Examiner concludes that
it would have been obvious “to heat the lens prior to inserting the lens into
the eye to allow for the lens to deform to a small diameter configuration to
minimize the delivery profile of the lens, and thus reduce the size of the
corneal incision” {id. at 3 4).
The Examiner relies on Flom for teaching “a visual indicator being
illuminated to denote the correct positioning of an IOL” {id. at 4). The
Examiner concludes:
It would have been obvious to one having ordinary skill in the art
at the time the invention was made to use an illuminated signal
as taught by Flom et al. in combination with the IOL delivery
system disclosed by Van Gent in view of Callahan et al. as using
an illuminated signal would provide a reliable and less subjective
way to sense if a lens was in the correct position for delivery.
{Id.)
Findings of Fact
1. Van Gent discloses an apparatus for inserting an intraocular
lens into an eye, the apparatus including “[cjarrying element 44 . . . made of
a shape memory alloy which is programmed or has a composition to release
the IOL 12 at the temperature within eye” (Van Gent, col. 5,11. 54—56,
col. 6,11. 59-62, & Fig. 2).
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Application 11/584,996
2. In particular, Van Gent discloses:
The shape memory alloy from which carrying element 44 is
made is such that at the temperature within the eye 14, the
carrying chamber 44 reverts to its original shape and opens up,
i.e., side flaps 46 and 48 separate, to allow IOL 12 to be separated
or released from carrying element 44. A heating system 50 may
optionally be included to heat carrying element 44 to a
temperature equal to or greater than the transition temperature of
carrying element 44.
{Id. at col. 7,11. 12-20, & Figs. 1 & 4.)
3. Callahan discloses a “deformable artificial intraocular lens”
(Callahan | 8).
4. Callahan also discloses:
The lens 10 is warmed, or heated, prior to rolling or deforming.
. . . When the lens is cooled to about room temperature, or
dehydrates, the lens becomes brittle. In certain embodiments, the
temperature of the lens 10 [is] reduced prior to inserting the
lens 10 into an incision of the eye. When the lens 10 is re­
hydrated, or warmed, as it will be by the fluid present in the eye,
the lens 10 will unroll by itself.
(Id. 1114.)
5. In describing rolling the lens, Callahan states: “The lens 10
was just removed from a vial containing a balanced salt solution, BSS,
which was heated to approximately 100 degrees F. The lens 10 must be
rolled immediately after removal from the warm BSS, since the material
becomes stiff when cooled or dehydrated.” {Id. 140.)
6. Flom “relates to an artificial intraocular lens for implantation in
the posterior chamber of the eye to obviate aphakia, the lens including
retaining means” (Flom, col. 1,11. 16—18).
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Application 11/584,996
7. Flom discloses that “[pjrotruding from the bottom of the
retaining ring 320 are three posts 321 - 323, which serve to attach the
retaining ring 320 to the lens 300” {id. at col. 22,11. 30-32, & Fig. 35).
8. Flom also discloses that “lens 300 and retaining ring 320 . . .
are adapted to form part of an electrical circuit, the electrical circuit in turn
providing an extra-ocular confirmation signal to indicate that the posts and
lens are properly operatively engaged” {id. at col. 24,11. 21—26, & Fig. 36).
9. In particular, Flom discloses that, “[i]f both posts 321 and 322
are operatively engaged with the split ring 306 [of the lens], electrical
contact is established between them and the electrical circuit is completed
through the posts 321, 322 and split ring 306 to light light emitting
diode 345” {id. at col. 24,11. 27 & 60-64, & Figs. 36 & 40).
Analysis
Appellants argue that the applied references fail to teach or suggest
“an indicator on the injector body operable to be illuminated to display a
visible indication to deliver the intraocular lens into the eye while the
intraocular lens is external to the eye when the heater has heated the
intraocular lens to a predetermined temperature range,” as recited in claim 1
(App. Br. 9—11 & 38). We agree.
The Examiner relies on the shape change of Van Gent’s carrying
element 44 to be “an indicator [that is] operable to display a visible
indication when the heater has heated the intraocular lens to a predetermined
temperature range” (Final Act. 3). However, as acknowledged by the
Examiner, Van Gent does not disclose that this “indicator” is operable to be
illuminated to display the visible indication {id.).
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As noted by the Examiner, Callahan teaches “heating ... a lens prior
to insertion of the device within the eye” (Final Act. 3; see also Findings of
Fact (FF) 4—5). However, the Examiner does not rely on, nor did we find,
Callahan to disclose the claimed indicator.
Flom discloses an indicator that is operable to be illuminated to
display a visible indication (FF 9). However, as noted by Appellants (App.
Br. 10), Flom’s indicator provides “an extra-ocular confirmation signal to
indicate that the posts [of the retaining ring] and [the] lens are properly
operatively engaged” (FF 7—8). Flom does not disclose that the indicator
displays a visible indication “when the heater has heated the intraocular lens
to a predetermined temperature range” (App. Br. 10). As a result, we agree
with Appellants that incorporating Flom’s indicator into the apparatus of
Van Gent in view of Callahan would not result in an apparatus having the
claimed indicator (id. at 10 & 12).
The Examiner argues:
The combination of references is simply using Flom et al. to
disclose the visual indicator portion of the delivery device, rather
than implanting of the whole system. Given that Van Gent in
view of Callahan et al. teaches a visual indicator, the substitution
of the illuminated indicator disclosed by Flom et al. is an obvious
variant of a display and would be within ordinary knowledge of
one skilled in the art.
(Final Act. 9.) We are not persuaded.
Consistent with our prior Decision in this case,2 we agree with the
Examiner that Van Gent discloses a shape change, which provides a visible
2 Appeal No. 2011-005666, Decision dated August 10, 2012.
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indication when the heater has heated the intraocular lens to a predetermined
temperature (FF 1—2). However, the stated purpose of this shape change is
“to allow IOL 12 to be separated or released from carrying element 44”
(FF 2), not to act as an indicator. Therefore, we do not agree with the
Examiner that it would have been obvious to substitute Van Gent’s shape
change for Flom’s illuminated indicator. Instead, given that the Examiner
has not shown that Van Gent or Flom teaches or suggests the need for a
visible indication when the heater has heated the intraocular lens to a
predetermined temperature range, we conclude that the Examiner has not
adequately explained how the applied references teach or suggest the
indicator of claim 1.
Claim 14 also recites “an indicator . . . operable to be illuminated to
display a visible indication to deliver the intraocular lens into the eye while
the intraocular lens is external to the eye when the heater has heated the
intraocular lens to a predetermined temperature range” (App. Br. 40).
Therefore, for the reasons discussed above, we also conclude that the
Examiner has not adequately shown how the applied references teach or
suggest the indicator of claim 14.
Conclusion
The Examiner has not set forth a prima facie case that the combined
teachings of Van Gent, Callahan, and Flom suggest the systems of claims 1
and 14. We therefore reverse the obviousness rejection of claims 1 and 14
and of claims 2—7, 11—13, 15—22, and 26—28, which directly or indirectly
depend from either claim 1 or claim 14.
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II
In rejecting claim 8, inter alia, the Examiner relies on Van Gent,
Callahan, and Flom as discussed above (Final Act. 5). The Examiner finds
that “Van Gent strongly suggests that the temperature increase is
monitored[], but fails to explicitly teach it further comprising a controller”
{id.).
The Examiner relies on Ludin for teaching “a power level controller
(38, figure 1), an interface (32) between the heater (28) and the controller
(38), wherein the interface provides feedback to the controller ... so that the
controller can operate the heater to maintain the intraocular lens within a
desired temperature range” {id.). The Examiner concludes that it would
have been obvious “to provide the invention of Van Gent in view of
Callahan and Flom et al. with a controller as taught by Ludin et al. since
Ludin et al. state that such a modification would allow the user to control the
power supplied to the distal end” {id. at 5—6).
Analysis
Claims 8—10 and 23—25 directly or indirectly depend from claims 1 or
14 (App. Br. 39 & 41). The Examiner does not rely on Ludin for teaching or
suggesting the claimed indicator (Final Act. 5). Therefore, for at least the
reasons discussed above, the Examiner has not set forth a prima facie case
that Van Gent, Callahan, Flom, and Ludin suggest the systems of these
claims.
Similarly, we conclude that the Examiner had not adequately
explained why the applied references suggest modifying Van Gent’s device
to include a “controller [that] is adapted to . . . generate a signal to illuminate
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[an] indicator ... in response to the temperature of the intraocular lens
having been regulated such that the intraocular lens has been heated to a
predetermined temperature range,” as recited in claim 29.
Conclusion
The Examiner has not set forth a prima facie case that the combined
teachings of Van Gent, Callahan, Flom, and Ludin suggest the systems of
claims 8—10, 23—25, and 29. We therefore reverse the obviousness rejection
of these claims.
REVERSED
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