Schieber, Andrew T. et al.

Patent Trials and Appeals Board

Sep 30, 2019

14440610 - (D) (P.T.A.B. Sep. 30, 2019)

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.
14/440,610 05/05/2015 Andrew T. Schieber 10502-715.US0 8829
66854 7590 09/30/2019
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
EXAMINER
LOUIS, RICHARD G
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
09/30/2019 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):
info@shayglenn.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW T. SCHIEBER and IQBAL K. AHMED
Appeal 2019-002295
Application 14/440,610
Technology Center 3700
Before JENNIFER D. BAHR, EDWARD A. BROWN, and
WILLIAM A. CAPP, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision (set forth in the Final Action dated April 16, 2018,
hereinafter “Final Act.”) rejecting claims 1–16 and 24–29. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as IVANTIS,
INC. Appeal Br. 2.
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Application 14/440,610

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CLAIMED SUBJECT MATTER
Appellant’s invention is directed to an apparatus “for delivering
ocular implants into the eye.” Spec. ¶ 3. Claims 1 and 9 are independent
and differ from each other in that claim 1 is directed to a cannula only, and
claim 9 is directed to an implant and delivery system comprising both the
cannula and an ocular implant. See Appeal Br. 8, 9 (Claims App.). Claim 1,
reproduced below with italics to highlight pertinent limitations, is illustrative
of the claimed subject matter.
1. A cannula for delivering an ocular implant into Schlemm’s
canal of an eye, comprising:
a rigid curved tube adapted to extend along a medial
plane through an anterior chamber of the eye to achieve
tangential entry into Schlemm’s canal;
a trough portion formed by an opening extending along a
distal portion of the rigid curved tube; and
an asymmetric tip disposed at a distal end of the trough
portion offset from, and asymmetric about, the medial plane,
the asymmetric tip being located at an intersection between an
upper camming surface and a lower camming surface, the
upper camming surface being configured to contact scleral
tissue of the eye to guide the trough portion into Schlemm’s
canal, the lower camming surface being configured to contact a
scleral spur of the eye to guide the trough portion into
Schlemm’s canal.
REFERENCES
The prior art relied upon by the Examiner is:
Villette
Schieber
US 2007/0021725 A1
US 2010/0121342 A1
Jan. 25, 2007
May 13, 2010
REJECTION
Claims 1–16 and 24–29 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Schieber and Villette.
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OPINION
Independent claims 1 and 9 each recite “a rigid curved tube [(claim 1)
or cannula (claim 9)] adapted to extend along a medial plane” and “an
asymmetric tip disposed at a distal end of the trough portion [of the curved
tube or cannula] offset from, and asymmetric about, the medial plane.”
Appeal Br. 8, 9 (Claims App.). Although the term “medial plane” is
typically used in the context of anatomy as referring to a vertical plane that
divides an organism into symmetrical halves, we understand “medial plane,”
as used in claims 1 and 9, to denote the plane that includes the central
longitudinal axis of the curved tube and divides the tube into symmetrical
halves. See, e.g., Figs. 11B, 11D (the medial plane extending into the page
and denoted by dashed line 122); Spec. ¶ 87 (describing “medial plane
122”).
The Examiner finds that Schieber discloses a cannula substantially as
recited in claims 1 and 9, except that:
Schieber fails to disclose the tip is offset from and
asymmetrical about the medial plane, the distal tip being in a
position offset from a central axis of the trough, the asymmetric
tip being asymmetric about the medial plane and the trough
portion being symmetric about the medial plane, wherein the
asymmetric tip is in a position offset from a central axis of the
trough, the asymmetric tip being asymmetric about the medial
plane and the trough portion being symmetric about the medial
plane.
Final Act. 3–4. In Figure 21 of Schieber, curvature plane 2172, which
passes through central axis 2164 of cannula 2108, is the medial plane of
Schieber’s cannula. See Schieber ¶ 106. As illustrated in Figure 21, distal
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Application 14/440,610

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end 2168 of Schieber’s cannula 2108 appears to be offset from central axis
2164, but in plane 2172.
The Examiner finds that Villette teaches a “similar cannula . . . used
for the related purpose of delivering a therapeutic wherein the tip is offset
from and asymmetrical about the medial plane . . . for the purpose of
configuring the cannula to be advanced through the body in a manner which
is less painful.” Final Act. 4 (citing Villette ¶ 25). The Examiner
determines it would have been obvious to modify Schieber’s cannula
such that the tip is offset from and asymmetrical about the
medial plane, the distal tip being in a position offset from a
central axis of the trough, the asymmetric tip being asymmetric
about the medial plane and the trough portion being symmetric
about the medial plane, wherein the asymmetric tip is in a
position offset from a central axis of the trough, the asymmetric
tip being asymmetric about the medial plane and the trough
portion being symmetric about the medial plan, in order to
configure it to move through soft tissue (such as the trabecular
meshwork) better.
Ans. 5.2
Appellant argues that “[n]othing in the record supports the Examiner’s
rationale.” Appeal Br. 6. Appellant submits that “Villette’s needle tip was
designed for a needle that is rotated during insertion” and not for a cannula,
such as Schieber’s cannula, which is not rotated during insertion. Id. Given
the differences in the manner in which the references operate, Appellant

2 The Final Action does not include a statement proposing to modify
Schieber in view of the teachings of Villette, much less articulate a rationale
for doing so. See Final Act. passim. Rather, the Examiner’s determination
that it would have been obvious to modify Schieber to dispose the distal tip
offset from and asymmetric about the medial plane, and supporting
rationale, appear for the first time in the Answer.
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argues that “a skilled artisan would not have been motivated to modify
Schieber’s cannula to include Villette’s needle tip.” Id. For the reasons that
follow, we agree with Appellant that the Examiner has not established a
sustainable case of obviousness of the subject matter of independent
claims 1 and 9, or their dependent claims.
Schieber’s cannula 2108, much like Appellant’s cannula, comprises a
curved distal portion (curved distal portion 2170) and is designed to be used
to deliver an ocular implant into Schlemm’s canal in an eye by first
advancing distal end 2168 of the cannula through the cornea of the eye so
the distal end is disposed in the anterior of the eye, and then accessing
Schlemm’s canal by, for example, piercing the wall of Schlemm’s canal with
the distal end of the cannula. Schieber ¶¶ 66, 107. Consistent with this
function, Schieber’s distal tip is “adapted to be inserted into an anterior
chamber of a human subject’s eye, through trabecular meshwork and into
Schlemm’s canal of the eye.” Id. ¶ 10. Schieber’s distal tip is neither
designed nor intended to pierce tissue by being rotated.
Villette’s perforating injection needle, on the other hand, has “a first
end intended to be connected to means for driving it in rotation.” Villette
¶ 13. Villette’s needle cuts “following a helical motion with a significant
circumferential component corresponding to the speed of rotation of the
needle and a much less significant axial component corresponding to the
speed of penetration—or axial speed—of the needle. Id. ¶ 16. Villette’s
cutting edge is designed with geometric characteristics specifically intended
“for perforation and incision, a task which involves a first incision for
starting a removal of tissue and then a cutting of the tissue in slices in order
to accomplish the removal of the tissue.” Id. ¶ 15. The distal end of
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Villette’s needle has main bevel 6 inclined at angle F and secondary bevel 8
arranged opposite main bevel 6 and forming with main bevel 6 cutting
edge 11 and needle point 10, which “may be moved laterally relative to the
axis in order to cause the angle of the point B, measured between the cutting
edge 11 and the tangent T to the edge of the main bevel 6 adjacent to the
cutting edge 11, to vary.” Id. ¶¶ 37–38 (boldface omitted). As illustrated in
Figures 4A, 5, and 6A, the distal end of Villette’s needle includes two
secondary bevels—first secondary bevel 8 and second secondary bevel 9.
Id. ¶ 39. The two secondary bevels are “arranged asymmetrically relative to
a median plane of the needle passing through a longitudinal axis L of the
needle” in such a way that “they rejoin uniquely to form the point 20 in the
form of a flat blade.” Id. ¶ 43 (boldface omitted). Villette teaches that,
“[t]hanks to the asymmetrical arrangement of the secondary bevels and more
particularly thanks to the fact that the perforating injection needle of the
invention has only a single cutting edge, the needle performs better in
perforating and cutting soft tissues, making it less painful.” Id. ¶ 25.
Given the significant differences in the way Schieber’s cannula and
Villette’s needle are designed to operate, it is not apparent, and the Examiner
does not adequately explain, why a person having ordinary skill in the art
would have considered Villette’s teachings regarding the asymmetrical
arrangement of the secondary bevels to be pertinent to Schieber’s cannula.
The Examiner fails to provide sufficient evidence or technical reasoning to
explain why a skilled artisan might have gleaned, from Villette’s teaching
that such an asymmetrical arrangement on Villette’s distal end may perform
better in perforating and cutting soft tissues using a rotating cutting motion,
that offsetting the distal tip of Schieber’s cannula from the medial plane
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would similarly improve the performance of Schieber’s cannula in piercing
the wall of Schlemm’s canal.
For the above reasons, the Examiner fails to articulate a reason with
some rational underpinnings to support the conclusion of obviousness of the
subject matter of claims 1 and 9. Accordingly, we do not sustain the
rejection of claims 1 and 9, or their dependent claims 2–8, 10–16, and 24–
29, as unpatentable over Schieber and Villette.
DECISION
The Examiner’s decision rejecting claim 1–16 and 24–29 is
REVERSED.
CONCLUSION
In summary:

Claims
Rejected
Basis  Affirmed Reversed
1–16, 24–29 § 103(a)
Schieber, Villette 
1–16, 24–29

REVERSED