Prism Pharma Co., Ltd. v. Choongwae Pharma Corp.,

Trials@uspto.gov Paper 14
571-272-7822 Entered: July 8, 2014
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________
PRISM PHARMA CO., LTD.
Petitioner
v.
CHOONGWAE PHARMA CORPORATION
Patent Owner
____________
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Patent 8,318,738 B2
____________
Before LORA M. GREEN, SHERIDAN K. SNEDDEN, and
ZHENYU YANG, Administrative Patent Judges.
YANG, Administrative Patent Judge.
DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. INTRODUCTION
Pursuant to 35 U.S.C. §§ 311-319, PRISM Pharma Co., Ltd.1
(“Petitioner”) filed a Petition for an inter partes review of claims 1-3 and 5-7
of U.S. Patent No. 8,318,738 (“the ’738 patent”). Paper 1 (“Pet.”).
Choongwae Pharma Corporation2 (“Patent Owner”) timely filed its
Preliminary Response. Paper 11 (“Prelim. Resp.”).
Petitioner contends that because the challenged claims are entitled to a
priority date of no earlier than July 29, 2011, they are anticipated by a
reference published on December 12, 2009. Patent Owner counters that the
challenge is a disguised written-description attack, a ground barred under
35 U.S.C. § 311(b). In addition, Patent Owner asks the Board to deny the
Petition under 35 U.S.C. § 325(d) because during prosecution, Petitioner
(through one of the co-inventors of the ’738 patent, who is also a cofounder
and outside board member of the Petitioner) presented, and the Examiner
considered, the same prior art and substantially the same arguments.
We have jurisdiction under 35 U.S.C. § 314. For the reasons provided
below, we exercise our discretion under 35 U.S.C. § 325(d), and deny the
Petition.
A. The Parties
Petitioner is a Japanese company cofounded in 2006 by Dr. Michael
Kahn, one of the co-inventors of the’738 patent. Ex. 2003, Further
Declaration of Dr. Michael Kahn ¶ 2; id., Curriculum Vitae. Dr. Kahn has
1 PRISM Pharma Co., Ltd. was formerly known as PRISM BioLab
Corporation. Pet. 1.
2 JW Pharmaceutical Corporation, formerly known as Choongwae Pharma
Corporation, is the real party in interest in this proceeding. Paper 6, 1.

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been an outside board member of Petitioner. Id., Further Declaration of
Dr. Michael Kahn ¶ 2. From 1999 to 2005, Dr. Kahn served as a consultant
to Patent Owner. Id., Curriculum Vitae. The parties appear to be engaged in
numerous lawsuits, which, although not strictly over the ’738 patent, relate
to the subject matter claimed therein. See, e.g., Pet. 4-5 n.1; Ex. 1011, 3-4.
According to Patent Owner,
Kahn secretly founded [Petitioner] Prism to develop competing
compounds. In 2008, Prism filed the U.S. provisional
application that served as the priority document for
WO 2009/148192 (hereinafter the “Prism PCT”). [Patent
Owner] believes that Prism is actively taking steps to
commercialize one or more compounds of the Prism PCT,
which compounds are encompassed within the scope of the
claims [of the ’738 patent].
Ex. 1011, 4. As a result, Patent Owner sued Petitioner and Dr. Kahn in the
U.S. District Court for the Central District of California, alleging “breach of
contract, fraud, breach of confidentiality[,] and trade secret
misappropriation.” Id. at 3.
According to Petitioner,
PRISM and the Patent Owner have filed suits against one
another in Japan and the U.S. alleging that the other has
misappropriated its confidential information. PRISM, for
example, is accusing Patent Owner of misuse of PRISM’s
confidential information. PRISM’s contention is that Patent
Owner obtained confidential information from PRISM
regarding the structure of its PRI-724 compound, which Patent
Owner then used to fashion claims (including the challenged
claims in this petition) in an attempt to cover PRISM’s
compound.
Pet. 4-5 n.1.

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B. The ’738 Patent
The ’738 patent “relates generally to reverse-turn mimetic structures
and to a chemical library relating thereto.” Ex. 1001, 1:40-41. It discloses
conformationally constrained compounds that mimic the secondary structure
of reverse-turn regions of biologically active peptides and proteins. Id. at
Abstract; see also id. at 4:38-43. It also relates to the use of such
compounds for inhibiting or treating disorders such as cancer. Id. at
Abstract; see also id. at 4:31-37.
Claim 1 is the sole independent challenged claim. It reads:
1. A compound having formula (VI)
wherein,
Ra is a phenyl group; a substituted phenyl group having one or
more substituents wherein the one or more substituents are
independently selected from one or more of amino, amidino,
guanidino, hydrazino, amidazonyl, C1-4alkylamino,
C1-4dialkylamino, halogen, perfluoro C1-4alkyl, C1-4alkyl,
C1-3alkoxy, nitro, carboxy, cyano, sulfuryl, and hydroxyl
groups; or a bicyclic aryl group having 8 to 11 ring
members, which may have 1 to 3 heteroatoms selected from
nitrogen, oxygen and sulfur;
Rb is a monocyclic aryl group having 5 to 7 ring members,
which may have 1 to 2 heteroatoms selected from nitrogen,
oxygen or sulfur, and aryl ring in the compound may have
one or more substituents selected from a group consisting of
halogen, hydroxy, cyano, lower alkyl, and lower alkoxy
groups;

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Rc is a saturated or unsaturated C1-6alkyl, C1-6alkoxy,
perfluoro C1-6alkyl group; and
X1, X2, and X3 may be the same or different and
independently selected from hydrogen, hydroxyl, and
halide;
and wherein the compound of formual [sic] (VI) is substituted
with hydrogen or methyl at the 9-position.
C. Asserted Ground of Unpatentability
Petitioner challenges the patentability of claims 1-3 and 5-7 based on
a single ground—anticipation under 35 U.S.C. § 102(b) by PCT Publication
No. WO 2009/148192 (“the ’192 publication,” Ex. 1004), published on
December 12, 2009.
II. BACKGROUND
A. Priority Chain
The ’738 patent issued from U.S. Patent Application No. 13/194,428
(“the ’428 application”), filed on July 29, 2011. Ex. 1001. The ’428
application is a continuation of U.S. Patent Application No. 12/553,858
(“the ’858 application”), filed on September 3, 2009. Id. at 1:7-8. The ’858
application claims priority, through a series of continuation, divisional, and
continuation-in-part applications, to an application filed in 2001. Id. at 1:9-
19; see also Ex. 1012, 1.
B. Prosecution of the ’858 Application
After filing the ’858 application (the parent of the ’428 application,
which matured into the patent-at-issue), Patent Owner canceled the original
claims, and added new claims 43-66 in a preliminary amendment. Ex. 1013,
5-15. New claims 59-66 were directed to compounds having C1-6alkyl at the
9-position of formula (VI) in claim 1 of the ’738 patent, as well as to
compositions comprising such compounds. Id. at 12-15. Specifically,

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claim 59, added in the preliminary amendment, recites a compound of
formula (VII):
wherein Ra, Rb, and Rc are as defined in claim 1 of the ’738 patent, and Rd is
C1-6alkyl. Id. at 12-13.
In the First Office Action, the Examiner objected to the abstract, and
rejected claims 43-66 on the ground of nonstatutory obviousness-type
double patenting. See Ex. 2005, 15. In response, Patent Owner revised the
abstract and filed a terminal disclaimer.3 Id. at 15-16. Patent Owner also
informed the Examiner of a related application that was being examined by a
different examiner:
USAN 12/541,388 (“the 388 application”) relates to the
present application in that it claims prodrugs of compounds that
are the same as or similar to the compounds of claims 59-63 of
the present application. During prosecution of the ‘388
application, Assignee received an unsolicited Declaration from
Dr. Michael Kahn, a co-inventor of the ‘388 application (and
the present application), asserting that the claims of the ‘388
application are not patentable for failing to meet the enablement
and written description requirements. Assignee submitted the
Declaration (including WO2009/148192 referenced therein) to
Examiner Venkataraman Balasubramanian in the ‘388
application on September 30, 2010. To ensure compliance with
Assignee’s duty of candor and good faith in dealing with the
3 Patent Owner amended certain claims to correct informalities related to
chemical structures and amended claim 59 to recite Rd as “C1-7alkyl” (as
opposed to “C1-6alkyl”). Ex. 2005, 3-13.

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U.S. Patent Office, a copy of this Declaration is submitted
herewith in a Supplemental Information Disclosure Statement
[Ex. 2002], along with the Amendment filed by the Assignee in
the ‘388 application addressing the same.
Id. at 16-17.
In his Declaration, Dr. Kahn stated that claims directed to prodrugs
reciting Rd at the 9-position as hydrogen or C1-6alkyl, or Rd of any type in the
context of an adjacent Ra bicyclic aryl group (1) lacked written support in
the Specification (Ex. 2001 ¶¶ 5-9), and (2) were anticipated by the ’192
publication, the same prior art that Petitioner asserts in the Petition in the
instant proceeding (id. ¶¶ 11-13).4
After the Patent Owner’s response, the Examiner allowed all the
claims pending in the ’858 application. But, on the same day Patent Owner
paid the issue fee, the examiner of the ’388 application rejected the claims
for failing to comply with the written-description requirement. Patent
Owner filed an Information Disclosure Statement (“IDS”) to bring this
rejection to the attention of the Examiner of the ’858 application, petitioned
to withdraw the ’858 application from issuance, and filed a Request for
Continued Examination (“RCE”). Ex. 3001.
Acknowledging the IDS, the Examiner of the ’858 application
rejected claims 59-66 for lack of written description. Ex. 1014, 2-3.
According to the Examiner, “[t]he compounds of formula (VII) with
new variable Rd (C1-7 alkyl) attached to the bicyclic 1,2,4-triazin-5-
one ring . . . ha[ve] no written description in this specification” or any
4 Dr. Kahn also stated that those claims did not comply with the enablement
requirement. Ex. 2001 ¶ 6.

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priority document. Id. at 3. In addition, even though Table 4 of the
’858 application disclosed several species with methyl as Rd, the
Examiner concluded that “Applicants are claiming Rd = C1-7 alkyl that
is broader than the scope of these species.” Id. at 4. The Examiner
allowed claims 43-58 because they have no variable Rd attached to the
bicyclic ring. Id. at 3, 5.
In response to the rejection, Patent Owner cancelled claims 59-
66 (see Ex. 3002), pursuing them in a continuation application, the
’428 application (Ex. 1002).
C. Prosecution of the ’428 Application
Upon filing the ’428 application, Patent Owner canceled original
claims 1-42 and added new claims 43-61 in a preliminary amendment.
Ex. 1005, 2-7. The new claims were directed to compounds having C1-7alkyl
at the 9-position of formula (VI). Id. Specifically, claim 43 was the same as
canceled claim 59 of the ’858 application, except that the 9-position shows
“substituted or unsubstituted C1-7alkyl” in the formula, instead of the “Rd”
substituent:

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In the First Office Action, the Examiner rejected all pending claims on
the grounds of nonstatutory obviousness-type double patenting,
indefiniteness of the term “substituted,” and certain defective chemical
structures. See Ex. 1006, 3-5. In response, Patent Owner filed a terminal
disclaimer, amended claim 43 by replacing “substituted or unsubstituted
C1-7alkyl” at the 9-position with “C1-7alkyl,” and cancelled the claims
directed to the unsubstituted C1-7alkyl embodiments, including those with
defective chemical structures. Ex. 1007, 2-7. The Examiner then allowed
all pending claims, and Patent Owner paid the issue fee.
Shortly thereafter, Dr. Kahn sent another Declaration to Patent
Owner’s prosecuting attorneys. Ex. 2003. He alleged that claims added in
the preliminary amendment, and later amended in Patent Owner’s response
to the first office action, lacked written description support.5 Id. at ¶¶ 6-10.
Specifically, according to Dr. Kahn, the Specification provided no support
for claims having C1-7alkyl as the Rd group, or C1-7alkyl as Rd in the context
of an adjacent bicyclic aryl group as Ra. Id. Dr. Kahn contended in his
Declaration that the ’192 publication, the same prior art that Petitioner
asserts in the Petition in the instant proceeding, anticipated those claims. Id.
at ¶¶ 15-17. Patent Owner submitted Dr. Kahn’s Second Declaration in an
IDS (Ex. 2006), withdrew the ’428 application from issuance, and filed an
RCE (Ex. 3003).
Acknowledging the IDS, the Examiner rejected the pending claims for
lack of written description. Ex. 1008, 3. Specifically, the Examiner stated:
5 Dr. Kahn also stated that those claims failed to comply with the
enablement requirement. Ex. 2003 ¶ 7.

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The scope of Rd at the position 9 attached to the bicyclic
ring as (C1-7 alkyl) []is now broader tha[n] the scope disclosed
in the specification of this application as well as its related
parent and grandparent applications.
In regard to the species 69, 78, 80, 83, 84 and 111 for
Rd = methyl disclosed in Table 4, the specification has no
written description. Applicants are claiming Rd = C1-7 alkyl
that is broader than the scope of these species.
Id. at 4.
In response, Patent Owner amended claim 43 to recite “H or –CH3” at
the 9-position of formula (VI):
Ex. 1009, 2.
Later, in a supplemental amendment, Patent Owner further amended
claim 43 by deleting “H or –CH3” at the 9-position and adding “wherein the
compound of formula (VI) is substituted with hydrogen or methyl at the 9-
position,” as currently recited in claim 1 of the ’738 patent. Ex. 1010, 3-4.
In addition, Patent Owner amended the Specification by inserting language
from PCT Publication No. WO 01/00210 (Ex. 1003). According to Patent
Owner,

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[T]he 2001 PCT was incorporated by reference in its entirety in
the specification as filed (see page 424, lines 1-6), as well as in
all the intervening priority applications going back to the
earliest priority document . . . . In order to further clarify that
the first component piece includes at least hydrogen and methyl
as amino acid side chain moieties, Applicants have amended the
specification by copying portions of the 2001 PCT into the
pending application; namely, the text from pages 16, line 30
through page 17, line 9, and from page 7, lines 26-27 and
page 8, lines 7-9.
Ex. 1010, 10.
Patent Owner also submitted an expert declaration in support of its
argument that “the specification conveys with a reasonable clarity to those
skilled in the art that Applicants were in possession of the invention as now
claimed at least by . . . 2004 . . . and as early as . . . 2001.” Id. at 11.
After an interview requested by Patent Owner (Ex. 2004), the
Examiner allowed all pending claims in the ’428 application, and they issued
as the currently challenged claims. Ex. 1011, 1. In the Reasons for
Allowance, the Examiner explained that “Applicants [have] overcome the
written description problem by incorporating WO 01/00210 A1 by reference
as disclosed on pages 3 and 424 of the specification” and that the claims
were “free from prior art.” Id. at 2.
The Examiner also noted the remarks submitted with the RCE, in
which Patent Owner explained the relationship between itself and Dr. Kahn.
Id. at 3-4. According to Patent Owner, Dr. Kahn, who served as a consultant
for Patent Owner, was a co-inventor of the ’428 application. Id. at 3. He
later founded Petitioner, which filed a patent application that published as
the ’192 publication. Id. at 4. Patent Owner also alleged that it had sued
Petitioner and Dr. Kahn for “breach of contract, fraud, breach of

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confidentiality and trade secret misappropriation on the part of Kahn.” Id. at
3. In view of these, the Examiner stated:
Due to the nature of the case, the examiner consulted with his
SPE for assistance in allowing this case. The examiner and his
supervisor (Mr. James Wilson) reviewed [Patent Owner’s
expert] declarations and applicant’s argument carefully and
decided that the claims are in condition for allowance.
Id. at 4.
III. ANALYSIS
Under 35 U.S.C. § 325(d),
In determining whether to institute or order a proceeding under
. . . chapter 31, the Director may take into account whether, and
reject the petition or request because, the same or substantially
the same prior art or arguments previously were presented to
the Office.
Here, Petitioner argues that the subject matter recited in the
challenged claims do not have written support in the parent ’858 application.
Pet. 32-51. Thus, according to Petitioner, those claims are not entitled to a
priority date earlier than July 29, 2011, the filing date of the ’428 application
that matured into the patent-at-issue. Id. Without the benefit of the earlier
priority date, Petitioner contends, claims 1-3 and 5-7 are anticipated by the
’192 publication, published on December 12, 2009. Id. at 51-59.
The same prior art (i.e., the ’192 publication) and arguments
substantially the same as Petitioner’s current contention (i.e., the ’192
publication is an invalidating prior art that anticipates the challenged
claims), were presented previously to the Office. Indeed, Dr. Kahn, one of
the named co-inventors of the ’738 patent, was a cofounder of Petitioner.
Ex. 2003, Further Declaration of Dr. Michael Kahn ¶ 2. Twice during the

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prosecution of the ’428 application and the parent ’858 application,
Dr. Kahn brought the ’192 publication to the Examiner’s attention, asserting
that it was anticipatory prior art. See supra Sections II.B, II.C. The ’192
publication is prior art only if the claims-at-issue lack written description
support in the parent ’858 application, and therefore, are not entitled to the
priority date of September 3, 2009, the filing date of the’858 application.
Thus, Dr. Kahn’s allegation of lack of written description support in his
Declarations must also serve as the basis for challenging the priority claim.
Aware of the ’192 publication, the Examiner, together with his supervisor,
reviewed the materials and determined that the challenged claims were “free
from prior art.” Ex. 1011, 2.
Based on these facts, we conclude that the same prior art and
substantially the same arguments were presented to the Office previously.
We exercise our discretion and deny the Petition under 35 U.S.C. § 325(d).
IV. ORDER
Accordingly, it is
ORDERED that Petitioner’s request for an inter partes review of
claims 1-3 and 5-7 of the ’738 patent is denied.

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For PETITIONER:
William James
wjames@kenyon.com
For PATENT OWNER:
Karl Hermanns
karlh@seedip.com
Qing Lin
beckyl@seedip.com