Ex Parte Dell

Patent Trial and Appeal Board

Apr 18, 2014

12129379 (P.T.A.B. Apr. 18, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEVEN J. DELL1
__________

Appeal 2012-001833
Application 12/129,379
Technology Center 3700
__________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
ULRIKE W. JENKS, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
accommodating intraocular lens. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 Appellant identifies the Real Party in Interest as Bausch & Lomb
Incorporated (App. Br. 3).
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Application 12/129,379

2
STATEMENT OF THE CASE
Claims 1-3, 5-11, 19-21, and 23-34 are on appeal (App. Br. 4).2
Claims 1 and 19 are illustrative and read as follows:
1. An accommodating intraocular lens (AIOL) comprising:
an optic; and
at least one haptic plate coupled to the optic by at least one connector,
the connector being less rigid than the haptic plate, the at least one haptic
plate surrounding the optic, and the optic and haptic plate having a combined
surface area between 70 mm2 and 100 mm2, and the at least one haptic plate
having a surface area of at least 65 mm2.
19. An accommodating intraocular lens (AIOL) comprising:
an optic; and
at least one haptic plate coupled to the optic by at least one connector,
the connector being less rigid than the haptic plate, the at least one haptic
plate surrounding the optic, and the at least one haptic plate has a width in a
radial dimension of 1.0 - 3.5 mm across its entire angular extent, wherein the
at least one haptic plate has an area of at least 60 mm2.
Claims 1-3, 5, 6, 8-11, 19-21, 23, 24, and 26-30 stand rejected under
35 U.S.C. § 103(a) as obvious over Blake (US 2006/0064161 A1, Mar. 23,
2006) in view of Smith (US 4,872,876, Oct. 10, 1989) (Ans. 5).
Claims 7 and 25 stand rejected under 35 U.S.C. § 103(a) as obvious
over Blake in view of Smith and Richardson (US 2008/0021550 A1, Jan. 24,
2008) (Ans. 7).
Claims 1, 5, 19, 23, and 31-34 stand rejected under 35 U.S.C. § 103(a)
as obvious over Ran (US 2006/0020339 A1, Jan. 26, 2006) in view of Smith
(Ans. 7).

2 Claims 12-18 are also pending but have been withdrawn from
consideration (App. Br. 3).
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Application 12/129,379

3
I
The Examiner relies on Blake for disclosing “an accommodating
intraocular lens (AIOL) comprising an optic (312); and at least one haptic
plate(314) coupled to the optic by at least one connector (flexible or resilient
arm portions, 316), the at least one haptic plate surrounding the optic
(Fig. 9)” (Ans. 5). The Examiner also finds that “Blake discloses that the
lens is designed to be placed in the capsular bag of the eye[,] . . . that the
device can be customized to take into account the interior of the eye of the
patient . . . , and that [the] plate haptic portion can be harder or softer than
the lens portion” (id.).
The Examiner relies on Smith for teaching an intraocular lens “where
the haptics are formed to any size desired by the surgeon, for the purpose of
providing a lens for various size eyes” (id. at 6). The Examiner concludes
that it would have been obvious “to modify the haptic plate of Blake to have
dimensions in the desired ranges, in order to fit in the eye with desired
dimensions” (id.). In particular, the Examiner finds that, “[w]here the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation”
(id.).
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Application 12/129,379

4
Findings of Fact
1. Specification Figure 1 is reproduced below:

[Specification] FIG. 1 illustrates a cross-sectional view of a
human eye 10 having an anterior chamber 12 and a posterior
chamber 14 separated by an iris 30. Within the posterior
chamber 14 is a capsular bag 16 which holds the eye’s natural
crystalline lens 17. The capsular bag comprises an anterior
capsule 16a and a posterior capsule 16b that meet at a capsular
rim 16c.
(Spec. 1: 16-19.)
2. The Specification “relates to accommodative intraocular lenses
(AIOLs), and more particularly to AIOLs having a haptic plate surrounding
an optic” (id. at 1: 12-13).
3. The Specification discloses that “the haptic plate and the optic
have a combined surface area that is sufficient to reduce or eliminate the
herniation that occurs around conventional lenses during accommodation”
(id. at 5: 20-22).
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Application 12/129,379

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4. The Specification also discloses:
Typical capsular bag diameters range from 10-13 mm with an
average of about 11.5 millimeters (i.e., an area of about
104 mm2). Assuming an optic having a diameter of 5 mm (i.e.,
an area of about 20 mm2), about 84 mm2 of posterior capsule is
not covered by the optic. The Applicant proposes that the area
of the one or more haptic plates surrounding the optic have a
combined area of at least 60 mm2 . . . and in some embodiments
at least 65 mm2.
(Id. at 6: 25-30.)
5. In addition, the Specification discloses:
It will also be appreciated that a given volume of vitreous fluid
is displaced by contraction of the ciliary muscle. By
appropriately controlling the relative rigidity of the plate and
the connectors, most of the forward displacement of the
vitreous can be caused to occur behind the optic thereby
enhancing the accommodative movement of the optic. In some
embodiments, the lens is relatively thin (i.e., the edge of the
optic is between 50-150 microns) so that, in addition to
accommodative translation of the optic as the connectors
extend, the optic can be deformed to alter the optical power of
the optic.
(Id. at 8: 26-32.)
6. Blake “is directed to an accommodating intraocular lens device,
preferably for use in the capsular bag after cataract lens removal” (Blake,
¶ [0001]).
7. Blake discloses:
The accommodating intraocular lens . . . includes a lens portion
connected to a haptic portion, preferably a plate haptic portion.
. . . The plate haptic portion is preferably made of a substantial
flexible or resilient material and configured to allow the plate
haptic to bow when an inwardly directed force is applied to the
edges or edge portions of the plate hap[t]ic portion.
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(Id. at ¶ [0012].)
8. Blake also discloses that the accommodating intraocular lens
“includes at least one arm, preferably a flexible or resilient arm connecting
the lens portion to the plate haptic portion” (id. at ¶ [0015]).
9. In addition, Blake discloses:
The outer periphery or edge portion of the plate haptic portion
is preferably configured and/or treated to facilitate or enhance
anchoring thereof within the eye. Specifically, the plate haptic
portion can be provided with one or more through holes to
allow tissue on either side of the plate haptic portion to adhere
together in the through hole. Alternatively, or in addition, the
outer edge of the plate haptic portion can be provided with
scallops, serrations and/or notches to facilitate tissue adherence
thereto.
(Id. at ¶ [0017] (emphasis added).)
10. Blake also discloses that the accommodating lens “can be made
of a material that varies in hardness or stiffness along its length (e.g. harder
lens portion and softer plate haptic portions or reverse)” (id. at ¶ [0053]).
11. Blake Figure 9 is reproduced below:

As depicted in Figure 9, Blake discloses:
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The accommodating intraocular lens 310 includes a
substantially round lens portion 312 connected to a round plate
haptic portion 314 by a pair of flexible or resilient arm
portions 316, 316. A pair of oblong or partial oval-shaped
openings 320, 320 are provided between the lens portion 312
and the plate haptic portion 314. A plurality of through
holes 322 are provided to facilitate anchoring of the perimeter
of the plate haptic portion 314.
(Id. at ¶ [0059].)
12. In addition, Blake discloses that “the accommodating
intraocular lens haptic portion . . . has a length preferably from 8 millimeters
to 13 millimeters, a width from 5 to 13 millimeters, and a thickness from
0.05 millimeters to 1 millimeter. The opening distance D is preferably 0.20
to 2.0 millimeters.” (Id. at ¶ [0085].)
13. Smith discloses “a one piece soft material lens capable of fitting
several different diameter eye openings. The haptics are formed so that the
surgeon can choose the size required at the time of surgery and trim from the
haptics the portions not required for the desired size.” (Smith, col. 2, ll. 49-
54.)
Principles of Law
“[I]t is not inventive to discover the optimum or workable ranges by
routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).
“Only if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a
patent be obtained for the claimed critical range.” In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620
(CCPA 1977)).
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Application 12/129,379

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Analysis
Appellant argues that, “even assuming arguendo that the embodiment
shown in [Blake] FIG. 9 has the maximum outer dimension mentioned in
Blake . . . , the haptic plate of Blake has an area of approximately 57.5 mm2
which is less than the surface area of 65 mm2 recited in claim 1” (App.
Br. 7). With regard to claim 19, Appellant argues that “the at least one
haptic plate would likely not have an area of at least 60 mm2” (id.). We are
not persuaded.
In Figure 9, Blake discloses a lens having a “pair of oblong or partial
oval-shaped openings 320, 320 . . . between the lens portion 312 and the
plate haptic portion 314” and a “plurality of through holes 322 . . . to
facilitate anchoring of the perimeter of the plate haptic portion 314” (Finding
of Fact (FF) 11). Blake also teaches that the “opening distance D is
preferably 0.20 to 2.0 millimeters” (FF 12). In addition, Appellant has not
pointed to any teaching in Blake indicating that through holes are required,
much less that their size and/or number is critical (see FF 9). Thus, even if
we assume that the haptic plate depicted in Blake Figure 9 has a surface area
of approximately 57.5 mm2, Appellant’s argument does not persuade us that
Blake and Smith fail to suggest a haptic plate having a larger surface area,
such as area of at least 60 mm2, as recited in claim 19, and of at least
65 mm2, as recited in claim 1.
Appellant also argues that “Blake does not disclose having an optic
and haptic plate having a combined surface area as large as is recited in
claim[] 1” (App. Br. 5). We are not persuaded.
Appeal 2012-001833
Application 12/129,379

9
As discussed above, we agree with the Examiner that Blake and Smith
suggest a haptic plate having a surface area of at least 65 mm2. In addition,
Appellant indicates that the typical diameter of an optic is 5-6 mm (App.
Br. 6). “Assuming an optic having a diameter of 5 mm (i.e., an area of about
20 mm2)” (FF 4), Blake therefore suggests a combined surface area of at
least 85 mm2, which overlaps with the claimed range of between 70 and
100 mm2.
In addition, Appellant argues:
There would be no reasonable expectation of success . . . if the
outer diameter of the lens of Blake were simply increased
(without further modification of the lens’s openings 320 and
holes 322) until the limitations as recited in claim 1 were
reached as proposed by the Examiner, because it would be
uncertain that sufficient accommodation (i.e., flexure of the
haptic plate) would be possible. Further, there is a limit to the
outer diameter of a lens, in that the lens must at least fit within a
capsular bag of an adult eye (i.e., one of ordinary skill in the art
would not make an IOL with an arbitrarily large outer
diameter).
(App. Br. 5-6.) We are not persuaded.
First, we do not agree that the Examiner is indicating that it would
have been obvious to modify Blake’s lens such that it could no longer be
expected to fit in the capsular bag of an adult eye. Instead, the Examiner
concludes that it would have been obvious “to modify the haptic plate of
Blake to have dimensions in the desired ranges, in order to fit in the eye with
desired dimensions” (Ans. 6 (emphasis added)). In addition, Appellant has
not adequately explained why there would not have been a reasonable
expectation of success in forming a haptic plate having a diameter of, for
example, 13 mm2 and having an opening distance at the low end of the range
Appeal 2012-001833
Application 12/129,379

10
of 0.20 to 2.0 millimeters recited in Blake (FF 12) and having no through
holes or through holes that together with the other dimensions provide a
surface area of at least 65 mm2, as required by claim 1, or an area of at least
60 mm2, as required by claim 19.
Appellant also argues:
[T]he claimed invention is not an optimization of the prior art.
Blake teaches a haptic whose primary purpose is to provide
flexibility to achieve accommodation by flexure of the haptic;
and Smith teaches a customizable non-accommodating lens.
By contrast, in the present claimed invention, the haptic is sized
to prevent herniation (page 5, lines 19-22 of the present
application) and to direct displacement of vitreous behind the
optic to cause accommodation (page 8, lines 26-32; also see
page 6, line 25 et seq. for a discussion of sizing). Thus, the
presently claimed apparatus is different in kind than the Blake
lens, and the Examiner’s stated rationale for modifying Blake in
view of Smith is improperly applied.
(Reply Br. 2.) We are not persuaded.
The Specification discloses that “the haptic plate and the optic have a
combined surface area that is sufficient to reduce or eliminate the herniation
that occurs around conventional lenses during accommodation” (FF 3). The
Specification also discloses that, “[b]y appropriately controlling the relative
rigidity of the plate and the connectors, most of the forward displacement of
the vitreous can be caused to occur behind the optic thereby enhancing the
accommodative movement of the optic” (FF 5). However, Appellant has not
pointed to sufficient evidence to demonstrate that the claimed features
provide an unexpectedly superior property. Thus, we do not agree with
Appellant that the evidence supports the conclusion that “the presently
claimed apparatus is different in kind than the Blake lens” (Reply Br. 2).
Appeal 2012-001833
Application 12/129,379

11
With regard to claims 7 and 25, the Examiner additionally relies on
Richardson for teaching the additional features recited in these dependent
claims (Ans. 7). Appellant argues that Richardson “does not cure the above-
identified deficiencies of Blake and Smith” (App. Br. 8). We are not
persuaded by this argument for the reasons discussed above.
Conclusion
The evidence supports the Examiner’s conclusion that Blake and
Smith suggest the accommodating intraocular lens of claims 1 and 19. We
therefore affirm the obviousness rejection of claims 1 and 19 over Blake and
Smith. Claims 2, 3, 5, 6, 8-11, 20, 21, 23, 24, and 26-30 have not been
argued separately and therefore fall with claims 1 and 19. 37 C.F.R.
§ 41.37(c)(1)(vii).
For the same reasons, we affirm the obviousness rejection of claims 7
and 25 over Blake, Smith, and Richardson.
II
The Examiner relies on Ran for disclosing “an accommodating
intraocular lens (AIOL) comprising an optic (12d); and at least one haptic
plate(14a) coupled to the optic by at least one connector (flexible
membrane 16b), the at least one haptic plate surrounding the optic (Fig. 1A
. . . )” (Ans. 7). The Examiner also finds that “Ran discloses that the lens is
designed to be placed in the capsular bag of the eye” and “that the flexible
membrane is more resilient than the haptics and optic” (id. at 7-8).
The Examiner relies on Smith for teaching an intraocular lens “where
the haptics are formed to any size desired by the surgeon, for the purpose of
providing a lens for various size eyes” (id. at 8). The Examiner concludes
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Appeal 2012-001833
Application 12/129,379

13
(Id.)
16. Ran also discloses:
The lens optic is secured to the haptic through flexible,
elastomeric membranes 16a. Membranes 16a together at least
substantially encircle optic 12a. Each membrane has a
flexibility greater than that of the surrounding materials. In
particular, each membrane 16a has a flexibility greater than that
of either lens optic 12a or haptic 14a.
(Id. at ¶ [0017].)
Analysis
Appellant argues that, “even assuming that the optic has a relatively
small dimension and that the haptic plates of Ran are configured to have a
large diameter, the relevant haptic plate surface area = 31.1 [mm2,] which is
far less than the area of the haptics 65 mm2 as recited in claim 1” and is also
“less than the recited surface area of 60 mm2 recited in claim 19” (App.
Br. 12). We conclude that the Examiner has not adequately addressed these
arguments.
Ran discloses an AIOL comprising optic 12a and at least one
haptic 14a coupled to the optic by at least one connector 16a, the connector
being less rigid than the haptic (FF 14-16). Ran also discloses that
“haptic 14a is a supporting structure for mounting the optic in the capsular
bag” and that “[h]aptic 14a includes mounting points 18a, which engage
against the capsular bag” (FF 15). Thus, we agree with the Examiner that it
would have been obvious “to dimension the haptic plate to fit the posterior
sac of the eye” (Ans. 9; see also FF 1 (“The capsular bag comprises an
anterior capsule 16a and a posterior capsule 16b that meet at a capsular
rim 16c.”)).
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Application 12/129,379

14
The Examiner notes that “the 'eye' could be that of an adult human,
child human, or various sized animals, and as such different dimensions of
the ocular implant(haptic) would be used depending on the patient that
receives the implant” (Ans. 9). However, the Examiner does not point to
any specific teaching of what these sizes would be.
As noted by Appellant (App. Br. 9), the Specification discloses that
“[t]ypical capsular bag diameters range from 10-13 mm” (FF 4). Thus, the
evidence that has been pointed to on this record suggests diameters as high
as 13 mm. We note that one of ordinary skill in the art may have had reason
to make AIOLs having a larger diameter to, for example, accommodate an
atypically large capsular bag. However, the Examiner has not pointed to any
evidence of what this would be. Thus, we find that Appellant has been
reasonable in providing calculations based on an AIOL having a diameter of
13 mm (App. Br. 12).
As noted by the Examiner, Appellant’s calculations are somewhat
arbitrary (Ans. 9). However, the Examiner has not pointed to any teachings
in Ran of the size of its components, nor did we find any. In addition, we
agree with Appellant that the calculations for the most part seem to favor the
Examiner’s position (Reply Br. 3). For example, Appellant states that the
typical diameter of an optic is 5-6 mm (App. Br. 6). The Examiner provides
no evidence that smaller optics were known in the art. Thus, we find that
Appellant has been reasonable in providing calculations based on an optic
having a diameter of 5 mm (id. at 12), given that, with a 13 mm AIOL, a
larger optic would only decrease the amount of surface area available for the
haptic.
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Application 12/129,379

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Where the calculations get more speculative is with the size of the
connector 16a. However, even if we do not account of the connector 16a,
which unreasonably favors the Examiner’s position, the surface area
between an optic having a 5 mm diameter and an outer diameter of 13 mm is
approximately 113 mm2. In addition, we agree with Appellant that the
embodiment of Ran that is relied up by the Examiner (Figure 1A) does not
cover even half of this area (56.5 mm2) with haptic plate(s) (App. Br. 10
(“the result is reduced by 50% because there are only two haptics; and . . .
the result is further reduced by 33% because the side edges of the haptic
plates do not extend radially”)). Thus, we agree with Appellant that the
Examiner has not set forth a prima facie case that Ran suggests at least one
haptic plate having a surface area of at least 65 mm2, as recited in claim 1, or
even an area of at least 60 mm2, as recited in claim 19.
In addition, the Examiner has not shown that Smith overcomes this
deficiency. As noted by the Examiner, Smith discloses “a one piece soft
material lens capable of fitting several different diameter eye openings. The
haptics are formed so that the surgeon can choose the size required at the
time of surgery and trim from the haptics the portions not required for the
desired size.” (FF 13.) However, the Examiner does not adequately explain
why Smith would suggest extending the haptic plates beyond the 13 mm
diameter already suggested by Ran. In addition, the Examiner has not
adequately explained why it would have been obvious to include Ran’s
haptic plates in areas of the 13 mm circle that are not covered by the AIOL
depicted in Ran’s Figure 1A.
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Conclusion
The Examiner has not set forth a prima facie case that Ran and Smith
suggest the accommodating intraocular lens of claims 1 and 19. We
therefore reverse the obviousness rejection over Ran and Smith of claims 1
and 19 and of claims 5, 23, and 31-34, which depend from claims 1 or 19.
SUMMARY
We affirm the obviousness rejections of claims 1-3, 5, 6, 8-11, 19-21,
23, 24, and 26-30 over Blake in view of Smith and of claims 7 and 25 over
Blake in view of Smith and Richardson.
However, we reverse the obviousness rejection of claims 1, 5, 19, 23,
and 31-34 over Ran in view of Smith. Thus, claims 31-34 are not currently
subject to a rejection.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

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