Ex Parte Chern et al

Board of Patent Appeals and Interferences

Oct 24, 2011

11999637 (B.P.A.I. Oct. 24, 2011)

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.
11/999,637 12/06/2007 Yijuang Chern 4910-40CIP 9202
27799 7590 10/24/2011
Cozen O'Connor
277 Park Avenue, 20th floor
NEW YORK, NY 10172
EXAMINER
MI, QIUWEN
ART UNIT PAPER NUMBER
1655
MAIL DATE DELIVERY MODE
10/24/2011 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte YIJUANG CHERN, YUN-LIAN LIN,
NAI-KUEI HUANG, JUNG-HSING LIN,
JIM-MIN FANG, and CHIA-I LIN
__________

Appeal 2011-008489
Application 11/999,637
Technology Center 1600
__________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating Huntington‟s disease. The Examiner rejected the claims as
lacking written description. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

Appeal 2011-008489
Application 11/999,637

2
Statement of the Case
Background
The Specification teaches “that certain extracts of Gastrodia elata (a
traditional Chinese medicinal herb) and related compounds are surprisingly
effective in treating conditions such as Huntington‟s disease and
hyperglycemia” (Spec. 6 ¶ 0005).
The Claims
Claims 1, 3, 21, and 27 are on appeal. Claim 1 is representative and
reads as follows:
1. A method of ameliorating or treating
Huntington‟s disease in a mammalian subject in
need thereof comprising administering the subject
a pharmaceutical composition comprising an
effective amount of purified or chemically
synthesized N
6
-(4-hydroxybenzyl)adenosine or a
pharmaceutical salt or solvate thereof as a
pharmaceutical active agent.

The issue
The Examiner rejected claims 1, 3, 21, and 27 under 35 U.S.C. § 112,
first paragraph as failing to comply with the written description requirement
(Ans. 5-7).
The Examiner finds that the “the Specification does not disclose, to
which solvates of N6-(4-hydroxybenzyl) adenosine Appellants are referring.
. . . Appellants‟ specification does not disclose how to make any particular
solvate of N6-(4-hydroxybenzyl)adenosine, nor do Appellants depict
chemical structures of N6-(4-hydroxybenzyl)adenosine as any particular
solvate in their disclosure.” (Ans. 5.) The Examiner finds that “the
Appeal 2011-008489
Application 11/999,637

3
formation of a particular solvate, polymorph, or hydrate for a given
compound or series of compounds or the structure of a particular solvate is
unpredictable” (Ans. 6).
Appellants contend that “in the present application, the term „solvate‟
recited in the claims of the present application is not describing a desired
result; rather, it is a precise definition by chemical name. The Federal Circuit
has made it clear that using a chemical name is sufficient to distinguish a
genus from other materials” (App. Br. 7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that the claims fail to comply with the
written description requirement?
Findings of Fact
1. The Specification teaches that as “used herein, the term
„solvate‟ means a compound of the present invention or a salt thereof that
further includes a stoichiometric or non-stoichiometric amount of solvent,
e.g., water or organic solvent, bound by non-covalent intermolecular forces”
(Spec. 27 ¶ 0077).
2. Vippagunta
1
teaches that “[m]ost organic and inorganic
compounds of pharmaceutical relevance can exist in one or more crystalline
forms” (Vippagunta 4, col. 1).
3. Vippagunta teaches that “[p]redicting the formation of solvates
or hydrates of a compound and the number of molecules of water or solvent

1
Vippagunta et al., Crystalline solids, 48 ADVANCED DRUG
DELIVERY REVIEWS 3-26 (2001).
Appeal 2011-008489
Application 11/999,637

4
incorporated into the crystal lattice of a compound is complex and difficult.”
(Vippagunta 18, col. 1.)
4. Braga
2
teaches that
One can say that if the formation of polymorphs is a
nuisance for crystal engineers, solvate formation can be a
nightmare, because it is extremely difficult to predict
whether a new species may crystallizes from solution with
one or more molecules of solvent. However, while
serendipitous polymorphism and solvate formation are very
common (“it happens” to crystallize the same substance as
different crystals or solvates), intentional polymorphism is
more difficult, as it requires the purposed investigation of
the conditions to obtain different crystals for the same
species.

(Braga 3640, col. 2.)
5. Seddon
3
teaches that the “term „solvate‟ has been around for
centuries, is universally understood, and is a perfect descriptor for these
materials” (Seddon 1087).
Principles of Law
“[T]he determination of what is needed to support generic claims to
biological subject matter depends on a variety of factors, such as the existing
knowledge in the particular field, the extent and content of the prior art, the
maturity of the science or technology, the predictability of the aspect at

2
Braga, Dario and Grepioni, Fabrizia, Making crystals from
crystals: a green route to crystal engineering and polymorphism,
CHEM. COMMUNICATION 3635-3645 (2005).
3
Seddon, Kenneth, Pseudopolymorph: A Polemic, 4 CRYSTAL
GROWTH & DESIGN 1087 (2004).
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5
issue, and other considerations appropriate to the subject matter.” Capon v.
Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).
Analysis
The claimed invention is treating Huntington‟s disease by
administering an effective amount of N
6
-(4-hydroxybenzyl)adenosine (see
Claims 1 and 21). The inclusion of “pharmaceutical salt or solvate thereof”
is limited to salts or solvates of N
6
-(4-hydroxybenzyl)adenosine (see Claims
1 and 21).
In our opinion, the Examiner begins from the incorrect premise that
the touchstone of written description is predictability rather than possession
and that written description is lacking where “the formation of a particular
solvate, polymorph, or hydrate for a given compound or series of
compounds or the structure of a particular solvate is unpredictable” (Ans. 6).
While the Examiner‟s evidence shows that particular solvates may be
unpredictable (FF 2-5), the evidence also demonstrates that “serendipitous
polymorphism and solvate formation are very common” (Braga 3640, col. 2;
FF 4).
In Ariad, the court found that the written description “doctrine never
created a heightened requirement to provide a nucleotide-by-nucleotide
recitation of the entire genus of claimed genetic material; it has always
expressly permitted the disclosure of structural features common to the
members of the genus.” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010).
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Application 11/999,637

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Here, the structural feature common to all solvates of the genus is N
6
-
(4-hydroxybenzyl)adenosine. Whatever solvate is used must be a solvate of
N
6
-(4-hydroxybenzyl)adenosine.
As in Capon, Appellants do not claim their inventive contribution is to
provide solvates of N
6
-(4-hydroxybenzyl)adenosine. Instead, the inventive
contribution is asserted to be the use of N
6
-(4-hydroxybenzyl)adenosine to
treat Huntington‟s disease (see Claim 1). Capon teaches that the
The Board erred in holding that the specifications do not
meet the written description requirement because they do
not reiterate the structure or formula or chemical name for
the nucleotide sequences of the claimed chimeric genes.

Capon, 418 F.3d at 1358.
In our opinion, Capon and Ariad control the instant situation. The
claims are drawn to a specific pharmaceutical, N
6
-(4-hydroxybenzyl)
adenosine, to treat a specific disease, Huntington‟s disease, which may also
include solvates of the specific pharmaceutical, N
6
-(4-hydroxybenzyl)
adenosine. Thus, the instant situation is different than that in Ariad, for
example, where the invention was drawn to an NF- B inhibitor where no
chemical name or structure of the inhibitor was disclosed. See Ariad, 598
F.3d at 1356. Here, a specific chemical structure is required as the active
pharmaceutical agent, N
6
-(4-hydroxybenzyl) adenosine, and a particular
disease is identified. This is substantially different than the vague
discussions in Ariad of potential NF- B inhibitors where essentially no
structure was disclosed and no particular diseases were identified. See Ariad,
598 F.3d at 1353-1356.

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Application 11/999,637

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Conclusion of Law
The evidence of record does not support the Examiner‟s conclusion
that the claims fail to comply with the written description requirement.
SUMMARY
In summary, we reverse the rejection of claims 1, 3, 21, and 27 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.

REVERSED

cdc