Ex Parte Peyman

Patent Trial and Appeal Board

May 25, 2016

13457568 (P.T.A.B. May. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/457,568 04/27/2012
27805 7590
THOMPSON HINE L.L.P.
10050 Innovation Drive
Suite 400
DAYTON, OH 45342-4934
05/27/2016
FIRST NAMED INVENTOR
Gholam A. Peyman
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.
075200.34 1200
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
05/27/2016 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):
ipdocket@thompsonhine.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GHOLAM A. PEYMAN
Appeal2014-006559
Application 13/457,568
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREYN. FREDMAN, and
RICHARD SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134(a) involving claims to a
method of providing a therapeutic agent to an eye of a patient. The
Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.
1 Appellant identifies the Real Party in Interest as the inventor,
Gholam A. Peyman (see App. Br. 3).
Appeal2014-006559
Application 13/457,568
Statement of the Case
Background
"Known methods of drug delivery to the eye have drawbacks .. .
Topical drug deliver[y] must be repeated many times on a daily basis .. .
Subconjunctival drug delivery can be painful and has slow drug penetration.
Intravitreal drug delivery has a short duration" (Spec. 1 ).
The claimed "method uses the capsular bag, obtained during or after
cataract extraction, as a polymeric slow release drug delivery system and
method" (Spec. 1 ).
The Claims
Claims 1, 3, 4, and 6-23 are on appeal. Claim 1 is representative and
reads as follows:
1. A method of providing a therapeutic agent to an eye of a
patient, the method comprising
providing to an eye of the patient a device that is 15 mm
to 60 mm in length, deformable, biodegradable and absorbable
and containing at least one of:
(i) a therapeutic agent selected from the group consisting
of a rho kinase inhibitor, a platelet-derived growth factor
inhibitor, and an integrin inhibitor; and
(ii) stem cells released upon injecting in the patient's eye,
a releasable neuronal cell protective and optionally other
agents, the device shaped to stably fit a suprachoroidal or
subretinal position in the eye choroid or on the lens zonules,
and sized to occupy the choroidal space inside the eye or the
space on the lens zonules to provide a relatively longer duration
of agent release over a relatively larger space-occupying area
inside the eye; and
implanting the device suprachoroidially between the
sclera and the choroid posteriorly with respect to the pars plana
of the eye or subretinally following the curvature of the retina
and subretinal space but not bulging the retina.
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Application 13/457,568
The Issues
A. The Examiner rejected claims 1, 3, 4, 6-13, and 15-1 7 under 3 5
U.S.C. § 103(a) as obvious over Nivaggioli,2 Furst,3 Huang,4 Mackool,5
Silvestrini,6 Cooper,7 Azuma,8 Jeannin, 9 and Bowman10 (Final Act. 5-11).
B. The Examiner rejected claims 1, 3, 4, and 6-17 under 35 U.S.C.
§ 103(a) as obvious over Nivaggioli, Furst, Huang, Mackool, Silvestrini,
Cooper, Jeannin, and Levitzki 11 (Final Act. 13-19).
C. The Examiner rejected claims 1, 3, 4, 6-8, and 10-17 under 35 U.S.C.
§ 103(a) as obvious over Nivaggioli, Furst, Huang, Mackool, Silvestrini,
Cooper, Jeannin, and van der Kooy12 (Final Act. 19-25).
D. The Examiner rejected claims 1, 6-13, and 18-23 under 35 U.S.C.
§ 103(a) as obvious over Nivaggioli, Furst, Huang, Mackool, Silvestrini,
Cooper, Azuma, Jeannin, and Pardo13 (Final Act. 26-32).
E. The Examiner rejected claims 1, 3, 4, 6-17, and 23 under 35 U.S.C.
§ 103(a) as obvious over Nivaggioli, Furst, Huang, Mackool, Silvestrini,
2 Nivaggioli et al., US 2004/0137059 Al, published July 15, 2004.
3 Furst et al., US 2006/0106455 Al, published May 18, 2006.
4 Huang et al., US 2007/0031472 Al, published Feb. 8, 2007.
5 Mackool, R., US 2007/0093892 Al, published Apr. 26, 2007.
6 Silvestrini, T., US 6,096,076, issued Aug. 1, 2000.
7 Cooper et al., US 2005/0064010 Al, published Mar. 24, 2005.
8 Azuma et al., US 6,649,625 B2, issued Nov. 18, 2003.
9 Jeannin et al., US 2005/0251236 Al, published Nov. 10, 2005.
10 Bowman et al., US 6,378,526 Bl, issued Apr. 30, 2002.
11 Levitzki et al., US 2004/0132725 Al, published July 8, 2004.
12 Van der Kooy et al., US 6, 117,675, issued Sept. 12, 2000.
13 Pardo et al., US 2008/0027304 Al, published Jan. 31, 2008.
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Application 13/457,568
Cooper, Azuma, Jeannin, Bowman, Vittitow, 14 Ambati, 15 and Loftsson16
(Final Act. 32-34).
Because the same issues are dispositive for all of these rejections, we
will consider them together.
The Examiner finds it obvious to
have treated an ocular disorder by injecting or placing with
forceps into either a suprachoroidal or subretinal location a
folded rod implant having either a monolithic solid or reservoir-
type containing a liquid/agent combination, made from flexible,
deformable, and foldable polymers such as PLGA and having a
diameter between 30um-3mm and a length of between 37-
44mm, with the rod configured in a c-shape of between 12-
14mm suitable for conforming to the ocular anatomy to deliver
a ROCK inhibitor to the posterior segment of the eye.
(Ans. 10).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the prior art suggests "a
device that is 15 mm to 60 mm in length" as required by claims 1 and 18?
Findings of Fact
1. Nivaggioli teaches that "bioerodible implants ... may be of any
size or shape compatible with the selected site of implantation, as long as the
implants have the desired release kinetics" (Nivaggioli iJ 61 ).
14 Vittitow et al., US 2009/0325959 Al, published Dec. 31, 2009.
15 Ambati et al., Age-Related Macular Degeneration: Etiology,
Pathogenesis, and Therapeutic Strategies, 48 SURVEY OF
OPHTHALMOLOGY 257-93 (2003).
16 Loftsson et al., US 2007/0020336 Al, published Jan. 25, 2007.
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Application 13/457,568
2. Nivaggioli teaches that "the vitreous chamber is able to
accommodate relatively large rod-shaped implants, generally having
diameters of about 0.05 mm to 3 mm and a length of about 0.5 to about 10
mm" (Nivaggioli ii 61 ).
3. Huang teaches that "intraocular implants disclosed herein may
have a size of between about 5 µm and about 10 mm" (Huang ii 122).
4. Huang teaches that the "vitreous chamber in humans is able to
accommodate relatively large implants of varying geometries, having
lengths of, for example, 1 to 10 mm" (Huang ii 122).
5. Mackool teaches that the "diameter of the capsular sac is
remarkably similar from patient to patient. Therefore, if a line were drawn
from the distal tip of one haptic to the distal tip of the other, it would
probably be desirable for this dimension to be approximately 12-14 mm"
(Mackool ii 35).
6. Mackool teaches that "endocapsular tension rings are horseshoe
shaped plastic rings that are used to prevent capsular contraction after
cataract surgery in eyes that are susceptible to this phenomenon. They are
available in diameters between 12-14 mm" (Mackool ii 36).
7. The Examiner calculates that a diameter of 12-14 mm
"corresponds to a circumference formed by such a ring of between 37-
44mm" (Ans. 5).
8. Cooper teaches that the "polymer implant may be shaped as a
suture, which may generally be of any dimensions including but not limited
to a length of less than about 10 cm and a diameter of less than about 2 mm"
(Cooper ii 34).
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Application 13/457,568
9. The Peyman17 Declaration states:
because the ocular space is relatively small and confined, the
site of the device is important. If the device is too large ( 15 mm
to 60 mm long) it cannot be placed in the vitreous cavity. It
will certainly injure the retina. If the device is too small (less
than 10 mm) it cannot be placed over the lens zonules because
it will fall through the zonular spaces, either in the vitreous
cavity or it will move through the pupil in the anterior chamber.
In both cases, the device moves in front of the visual axis and
obstructs the patient's vision.
(Peyman Dec. 2; emphasis omitted).
Principles of Law
A prima facie case for obviousness "requires a suggestion of all
limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed nevi invention does." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellant contends that:
Nivaggioli teaches smaller ocular implants that are placed
within the vitreous cavity, Huang teaches smaller ocular
implants that are placed intravitreally or subconjunctivially,
Mackool teaches smaller ocular implants that are permanently
and non-degradably placed as ocular lens supports, and Cooper
teaches transscleral, not intra-ocular, drug delivery with devices
implanted in subconjunctivial, subtenon, and intrascleral
locations. Furst, Azuma, and Jeannin do not teach ocular
implants effecting sustained treatment over a large area; they
17 Declaration of Dr. Gholam A. Peyman, dated July 7, 2013.
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Application 13/457,568
instead teach other treatment devices. Levitzki does not teach
any particular form or size of implanted device. Thus these
references, as asserted by the Examiner on the record, do not
suffice to establish a prima facie case of obviousness.
(App. Br. 13). Appellant contends that the "length of a C-shaped structure
50 ... cannot be simply be calculated as 'n' times a distance 'D' between
the tips of haptics, because the cited C-shaped structure 50 is both manifestly
smaller than the distance between the tips of haptics 54 and does not have
any specifically calculable length" (Reply Br. 5).
The Examiner responds that
Mackool and Silvestrini are relied upon to clearly show that
ocular implants having a length of 37-44mm comfortably fit
within the capsular bag of the eye to deliver active agents to the
eye (Mackool), and that given the relative dimensions of the
ocular anatomy and specifically the sclera and choroid of the
posterior segment in comparison to the capsular bag of the
anterior segment (Silvestrini), such as suggested by the broad
teachings ofNivaggioli and each of Cooper and Bowman,
could easily accept an implant, particularly a flexible implant of
this size, owing to the larger circumference of this area of the
ocular anatomy.
(Ans. 30-31 ). The Examiner finds that "while no single reference discloses
an implant of l 5-60mm, the art as a whole indeed supports the use of
precisely such an implant in precisely such a manner" (Ans. 34).
We find that Appellant has the better position. Other than Mackool
and Cooper, none of the cited prior art could be reasonably interpreted as
suggesting an implant size larger than 10 mm (FF 2, 4). As Appellant notes,
Cooper suggests "devices placed on the outer scleral surface at the rear of
the eye and anchored and/or adhered into place" (Reply Br. 6) but this
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Application 13/457,568
suggestion does not provide a reason for the implants in the size ranges
claimed in the locations claimed in claims 1 and 18.
We also agree with Appellant that the teaching in Mackool does not
establish implants with lengths sized from 37--44 mm because when
Mackool refers to the diameter, Mackool is not referring to a completely
circular device but rather to a device that is "horseshoe shaped" (FF 6) with
haptic dimension between the heels of the horseshoe (the haptic ends) of 12-
14 mm. Thus, the length of Mackool' s device cannot simply be calculated
as n times D, because the device is only part of a circle, not the entire circle,
and the Examiner does not establish the actual length of Mackool's device.
We also find unpersuasive the Examiner's finding that "[g]iven this
relative sizing, the skilled artisan would clearly recognize that the use of a
flexible C or ring-shaped implant having a length of between 37--44 mm
would advantageously fit within the vitreous or other posterior segment eye
structures" (Ans. 6). The Examiner provides insufficient evidence to
establish why the "skilled artisan would clearly recognize" that a 37--44 mm
sized implant would be desirable.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the prior art suggests "a device that is 15 mm to 60 mm in length" as
required by claims 1 and 18.
SUMMARY
In summary, we reverse the obviousness rejections.
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Appeal2014-006559
Application 13/457,568
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a).
REVERSED
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