Subramanian Venkatraman et al.

Patent Trials and Appeals Board

Sep 24, 2019

13816631 - (D) (P.T.A.B. Sep. 24, 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.
13/816,631 04/22/2013 Subramanian Venkatraman 055514/429902 9146
826 7590 09/24/2019
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
EXAMINER
MARCETICH, ADAM M
ART UNIT PAPER NUMBER
3781
NOTIFICATION DATE DELIVERY MODE
09/24/2019 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):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte SUBRAMANIAN VENKATRAMAN, LEI SHANG,
YIN CHIANG FREDDY BOEY, and TINA WONG
____________________

Appeal 2018-0068301
Application 13/816,631
Technology Center 3700
____________________

Before MURRIEL E. CRAWFORD, PHILIP J. HOFFMANN, and
BRADLEY B. BAYAT, Administrative Patent Judges.

CRAWFORD, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
This is an appeal from the final rejection of claims 1–5, 7–14, and 17.
The invention relates generally to a glaucoma valve, a casing for containing
a glaucoma valve, and a glaucoma drainage device comprising either the
valve, the casing, or both. Spec. ¶ 2.

1 The Appellants identify Nanyang Technological University and Singapore
Health Services Pte Ltd. as the real parties in interest. Appeal Br. 2.
Appeal 2018-006830
Application 13/816,631

2
Claim 1 is illustrative:
1. A glaucoma valve, the valve comprising
a) a flow channel having an inlet and an outlet; and
b) a valve member connected to the outlet of the flow channel,
wherein the valve member comprises a degradable
polymer and a steroid, wherein the valve member is
adapted to start degradation when a fibrous capsule is
developing around the valve, wherein the steroid is mixed
with the degradable polymer to form the valve member,
and wherein the degradable polymer is configured to
degrade during formation of the fibrous capsule so as to
release the steroid in therapeutic levels concurrently with
degradation of the degradable polymer.
The Examiner rejected claims 1–3, 14, and 17 under 35 U.S.C.
§ 103(a) as unpatentable over Brown et al., (US 2004/0162545 A1, pub.
Aug. 19, 2004) (“Brown”), Butuner (US 2009/0280158 A1, pub. Nov. 12,
2009), and E. I. Shishatskaya et al., “Tissue response to the implantation of
biodegradable polyhydroxyalkanoate sutures”, Journal Of Materials Science:
Materials In Medicine, Vol. 15, 2004, pp. 719-728 (“Shishatskaya”).
The Examiner rejected claims 4, 5, and 7–11 under 35 U.S.C. § 103(a)
as unpatentable over Brown, Butuner, Shishatskaya, and Pacetti et al.,
(US 2009/0004243 A1, pub. Jan. 1, 2009) (“Pacetti”).
The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as
unpatentable over Brown, Butuner, Shishatskaya, and Cuevas
(US 2011/0230963 A1, pub. Sept. 22, 2011).
The Examiner rejected claim 13 under 35 U.S.C. § 103(a) as
unpatentable over Brown, Butuner, Shishatskaya, and Ramzipoor et al.,
(US 2010/0004734 A1, pub. Jan. 7, 2010) (“Ramzipoor”).
We REVERSE.

Appeal 2018-006830
Application 13/816,631

3
ANALYSIS
We are persuaded by the Appellants’ arguments that the Examiner has
failed to establish a prima facie case of obviousness of the pending claims.
In rejecting claim 1, the Examiner finds that Brown, at Figure 13C
and paragraph 62, discloses “the degradable polymer is configured to
degrade,” but, rather than degrading “during formation of a fibrous capsule,”
as claimed, degrades “at some time after formation of the fibrous capsule.”
Answer 4 (emphasis added). The Examiner further finds that the
combination of Brown and Butuner is “silent” on the member starting
degradation “when a fibrous capsule is developing around the valve,” but
“Shishatskaya discloses a study of polyhydroxyalkanoate / PHA sutures”
that discloses the degrading during formation of the fibrous capsule.
Answer 4–5. The Examiner articulates that “Shishatskaya establishes . . .
that macrophages will begin eroding the implant even before the capsule
forms,” and that “Shishatskaya further describes a stage preceding this
capsule, and shows that circulating macrophages will degrade the implant
shortly after introducing it.” Answer 7.
The Appellants argue, citing evidence in Shishatskaya, that no
degradation while “a fibrous capsule is developing,” as claimed is disclosed
in Shishatskaya, because “there was no degradation of the implant in
Shishatskaya, thereby showing that mere presence of macrophages
surrounding a biodegradable polymer does not mean that degradation of the
biodegradable polymer is taking place. Instead, the increase in activity of
AcP relates to results obtained four weeks after the surgery, during which a
fibrous capsule has already formed around the sutures (i.e., from Week 2
onwards).” Appeal Br. 4 (emphasis omitted); see also id. at 3.
Appeal 2018-006830
Application 13/816,631

4
In response, the Examiner argues “the polymers of Brown can be
expected to degrade along the same timeframe as Appellant’s invention.”
Answer 15. In addition, the Examiner asserts that the “term ‘when a fibrous
capsule is developing’ is broad, since it does not narrowly select a specific
step of capsule development” (Appeal Br. 1), and that the “claims fail to set
forth a particular timeline in which the claimed events occur” (id.at 2).
We are persuaded by the Appellants’ arguments that the Examiner has
not shown the obviousness of a degradable polymer, mixed with a steroid,
adapted to start degradation when a fibrous capsule is developing around the
claimed valve, as claimed. First, the Examiner articulates, and Brown
discloses, that Brown’s biodegradable member dissolves or disintegrates
“after formation of the fibrous capsule,” rather than “when a fibrous capsule
is developing.” See Answer 3; Brown ¶ 62. Thus, we are unpersuaded by
the Examiner’s later statement, that “the polymers of Brown can be expected
to degrade along the same timeframe” as the claimed structure, as
establishing degradation during formation of a fibrous capsule, as claimed.
Answer 15.
Second, because the Examiner fails to rebut the Appellants’ argument,
that Shishatskaya fails to disclose degradation during formation of a fibrous
capsule, we accept the Appellants interpretation of Shishatskaya.
Third, because the claim specifically calls for a member, comprising a
mixture of degradable polymer and a steroid, which is both “adapted to start
degradation when a fibrous capsule is forming,” and “configured to degrade
during formation of the fibrous capsule,” the Examiner would need to
demonstrate that the polymer/steroid member in the art is specifically
adapted and configured to degrade at a particular time. However, the
Appeal 2018-006830
Application 13/816,631

5
Examiner has not shown a member comprising a mixture of degradable
polymer and steroid that was adapted or configured as claimed. Instead, in
the end, the Examiner relies on a combination of materials that might
degrade in the expected time during the claimed conditions. This
speculation about the possible behavior of materials, (materials which have
not been combined and configured as claimed in the art, but only in the
theoretical combination the Examiner advances), does not meet the claim
language, which requires a definitive adaption and configuration as claimed.
The claim language is thus not so broad as to encompass the Examiner’s
assertions about the theoretical combination of elements from the prior art
references.
Because the Examiner has not established a prima facie case of
obviousness of claim 1 over the cited art, for the three reasons above, we do
not sustain the rejection of claims under 35 U.S.C. § 103(a).

DECISION
We reverse the rejections under 35 U.S.C. § 103(a) of claims 1–5,
7–14, and 17.
REVERSED