Ex Parte 7416848 et al

Patent Trial and Appeal Board

Sep 26, 2013

95001246 (P.T.A.B. Sep. 26, 2013)

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.
95/001,246 10/13/2009 7416848 12096-006-999 6125
20583 7590 09/27/2013
JONES DAY
222 EAST 41ST ST
NEW YORK, NY 10017
EXAMINER
CAMPELL, BRUCE R
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
09/27/2013 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 PATENT TRIAL AND APPEAL BOARD
____________

ARENA PHARMACEUTICALS, INC.
Requester and Appellant

v.

H. LUNDBECK A/S
Patent Owner and Respondent
____________

Appeal 2013-004841
Reexamination Control 95/001,246
Patent 7,416,848 B2
Technology Center 3900
____________

Before LORA M. GREEN, RICHARD M. LEBOVITZ,
RAE LYNN P. GUEST, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Third Party Requester in the
above-identified inter partes reexamination of US 7,416,848 B2. Requester
appeals the Examiner’s decision not to adopt rejections of claims 1-20 as
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anticipated under 35 U.S.C. § 102 and obvious under 35 U.S.C. § 103 over
prior art. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b),
134, and 315. We reverse the Examiner’s decision not to adopt the
rejections. A decision to reverse an examiner’s decision not to adopt a
rejection constitutes a new ground of rejection 37 C.F.R. § 41.77(b). We
therefore set forth new grounds of rejection based on the non-adopted
rejections.

I. STATEMENT OF THE CASE
The patent in dispute in this appeal is US 7,416,848 B2 (“the ‘848
patent”) which issued August 26, 2008. A request for inter partes
reexamination of the ‘848 patent was filed on October 13, 2009 by a Third
Party Requester under 35 U.S.C. §§ 311-318 and 37 C.F.R. §§ 1.902-1.997
(Request for Inter Partes Reexamination). The Requester and Appellant is
Arena Pharmaceutical, Inc. (TPR (Third Party Requester) Appeal Br. 1,
dated August 16, 2011). The Patent Owner and Respondent is H. Lundbeck
A/S (Resp’t Appeal Br. 1, dated September 16, 2001).
An oral hearing was held May 22, 2013. A transcript of the hearing
will be entered into the record in due course (“Oral Hearing Transcript”).
The claims of the ‘848 patent are directed to processes for
determining whether a chemical compound specifically binds and activates a
mammalian SNORF25 receptor. According to the ‘848 patent, SNORF25 is
a cell surface protein which comprises seven putative transmembrane
regions (‘848 patent, col. 12, ll. 23-27).
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Claims 1-20 are pending. Claims 1-8, 12 and 13 are original claims as
issued in the ‘848 patent. Claims 9-11 and 14 are claims issued in the ’848
patent and amended during reexamination. Claims 15-20 were added during
the reexamination proceeding. Claims 1 and 5 are independent claims, and
claims 2-4 and 6-20 depend upon them.

II. REPRESENTATIVE CLAIM
Representative claim 1 is reproduced below:
1. A process for determining whether a chemical compound
specifically binds to and activates a mammalian SNORF25 receptor, which
comprises contacting cells producing a second messenger response and
expressing on their cell surface the mammalian SNORF25 receptor, wherein
such cells do not normally express the mammalian SNORF25 receptor, with
the chemical compound under conditions suitable for activation of the
mammalian SNORF25 receptor, and measuring the second messenger
response in the presence of the chemical compound indicating that the
compound activates the mammalian SNORF25 receptor, wherein
(1) the mammalian SNORF25 receptor has an amino acid
sequence greater than 95% identical to the amino acid
sequence shown in SEQ ID NO: 2 or that encoded by the
plasmid pEXJT3T7-hSNORF25 (ATCC Accession No.
203495); or
2) the mammalian SNORF25 receptor has an amino acid
sequence greater than 95% identical to the amino acid
sequence shown in SEQ ID NO: 4 or that encoded by the
plasmid pcDNA3.1-rSNORF25 (ATCC Accession No.
203494); or
3) the mammalian SNORF25 receptor has an amino acid
sequence greater than 95% identical to the amino acid
sequence shown in SEQ ID NO: 25 or that encoded by
the plasmid pEXJ-mSNORF25-f (ATCC Patent
Depository No. 2263).

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III. NON-ADOPTED REJECTIONS
The Requester appeals the Examiner’s decision not to adopt rejections
2-20, 22, and 23 under 35 U.S.C. §§ 102 and 103 (TPR Appeal Br. 3-5). All
of the non-adopted rejections rely on Chen1 for its teaching of mammalian
RUP3 nucleic acid and protein, which is said to be identical to human
SNORF25 of SEQ ID NO: 2 as recited in claim 1 (TPR Appeal Br. 29).
Patent Owner filed a declaration under 37 C.F.R. § 1.131 to antedate Chen.
The declaration was executed by all of the inventors and is referred to herein
as “the 1.131 Declaration” or the “1.131 Decl.” (See TPR Appeal Br.,
App’x B2). The Examiner found the 1.131 Declaration sufficient to antedate
Chen (Right of Appeal Notice (“RAN”) 8-9). Requester contends that the
Examiner’s determination about the sufficiency of the 1.131 Declaration was
an error and that Patent Owner failed to antedate Chen (TPR Appeal Br. 6).
Consequently, Requester contends that claims 1-20 are not patentable over
the various prior art rejections based on Chen that were withdrawn or not
adopted by the Examiner (id.). The issue in this appeal is whether the
inventors’ 1.131 Declaration is sufficient to antedate Chen.

1 Chen is a family of related patent applications and patents, which are:
US2003/0017528, published January 23, 2003; US2003/0148450, published
August 7, 2003; US 7,108,991, issued September 19, 2006;
US2007/0122878, published May 31, 2007; US2008/0199889, published
August 21, 2008. All citations to Chen reference the column and line
number of US 7,108,991.
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IV. DISCUSSION
Chen describes the RUP3 protein and gene expressed in the human
pancreas (Chen, col. 5, ll. 62-65). It is undisputed that Chen’s RUP3 has the
same sequence as the claimed SNORF-25 (TPR Appeal Br. 29; Resp’t Br.
15). The inventors proffered a declaration under 37 C.F.R. § 1.131 in which
they assert to have “conceived of and reduced to practice the subject matter
of claim 1 of the ‘848 Patent and amended claims 9 and 11 to 14 prior to
May 28, 1999.” (1.131 Decl. ¶ 8.) The effective date of Chen is said by
both parties to be June 29, 1999 (TPR Appeal Br. 14 (fn. 4); Resp’t Br. 4 (fn.
6)). Thus, if the inventors are successful at showing that the subject matter
of claims 1, 9, and 11-14 was reduced to practice before May 28, 1999,
Chen is antedated and the rejections of the claims based on Chen are
overcome.
To antedate a reference under 37 C.F.R. § 1.131, an inventor is
required to show as much as the invention as the reference shows. In re
Stryker, 435 F.2d 1340 (CCPA 1971). When a practical utility has been
shown for a prior art publication, a 1.131 declaration must show the same.
As stated in In re Moore, 444 F.2d 572, 580 (CCPA 1971), “the third
inventive act, (i.e., the determination of a practical utility when one is not
obvious) need not have been accomplished prior to the date of a reference
unless the reference also teaches how to use the compound it describes.”

Utility
Both parties in the reexamination proceeding agree that Chen
demonstrated that the RUP3 (i.e., SNORF25) receptor has a role in insulin
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regulation (Oral Hearing Transcript, p. 5, l. 18 to p. 6, l. 13; Resp’t Br. 15;
see also Chen, col. 5, ll. 62-64 (“As the data below indicate, RUP3 is
expressed within the human pancreas, suggesting that RUP3 may play a role
in insulin regulation and/or glucagon regulation.”)). Requester takes the
position that, to antedate Chen, the inventors must provide evidence that this
same utility was appreciated prior to Chen’s filing date of June 29, 1999
(TPR Appeal Br. 15; TPR Rebuttal Br. 2). Patent Owner does not dispute
Requester’s position (Resp’t Br. 6 and 8). We also agree that Patent Owner
must demonstrate reduction to practice of the same utility described by
Chen. (See Moore, 444 F.2d 572 at 580; TPR Rebuttal Br. 2.)
We first begin with the ‘848 patent to determine what utility it
describes for SNORF-25. The ‘848 patent discloses: “The pharmacological
profile of SNORF25 and the localization of its mRNA in the pancreas
suggests that this receptor could play a role in insulin secretion.” (’848
patent, col. 54, ll. 57-59.) Thus, the inventors disclosed the same utility for
SNORF-25 as disclosed for RUP3 by Chen. In the 1.131 Declaration, the
inventors sought to show that this utility was reduced to practice prior to
May 28, 1999:
14. Prior to May 28, 1999, the high level of pancreatic expression
of human SNORF25 receptor in combination with the fact the rat
SNORF25 receptor was cloned from a rat insulinoma cell line
indicated to us a possible role of mammalian SNORF25 receptor in
metabolic functions, such as the regulation of insulin release.

37 C.F.R. § 1.131(b) sets for the requirements to establish a reduction
to practice:
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The showing of facts for an oath or declaration under paragraph
(a) of this section shall be such, in character and weight, as to
establish reduction to practice prior to the effective date of the
reference, . . . . Original exhibits of drawings or records, or
photocopies thereof, must accompany and form part of the
affidavit or declaration or their absence must be satisfactorily
explained.
In accordance with the rule, an inventor must make a “showing of
facts . . . to establish reduction to practice prior to the effective date of the
reference.” As held in In re NTP Inc., 654 F.3d 1279, 1291 (Fed. Cir. 2011):
A party seeking to antedate a reference based on reduction to
practice must present evidence of the actual reduction to
practice of the invention prior to the effective date of the
reference. 37 C.F.R. § 1.131(b). An inventor cannot rely on
uncorroborated testimony to establish a prior invention date. Id.
It has long been the case that an inventor's allegations of earlier
invention alone are insufficient — an alleged date of invention
must be corroborated. Medichem S.A. v. Rolabo, S.L., 437 F.3d
1157, 1170 (Fed. Cir. 2006); Woodland Trust v. Flowertree
Nursery, Inc., 148 F.3d 1368, 1371 (Fed. Cir. 1998).
“[E]vidence is assigned probative value and collectively
weighed to determine whether reduction to practice has been
achieved.” Medichem, 437 F.3d at 1170. “Sufficiency of
corroboration is determined by using a ‘rule of reason’ analysis,
under which all pertinent evidence is examined when
determining the credibility of an inventor's testimony.” Id.
Where a utility must be shown to antedate a publication under 37
C.F.R. § 1.131, the inventors must demonstrate that the utility was
appreciated and recognized prior to the date of the publication. 37 C.F.R.
§ 1.131(b) requires corroborating evidence (see NTP above). Accordingly,
the inventors’ statement in paragraph 14 of their Rule 1.131 declaration that
the “regulation of insulin release” utility had been appreciated prior to May
28, 1999 must be corroborated by evidence in the record. The Examiner’s
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statement to the contrary that “corroboration is not required” (RAN 9)
conflicts with the express language in 37 C.F.R. § 1.131(b) that a “showing
of facts . . . shall be such, in character and weight, as to establish reduction
to practice prior to the effective date of the reference.”
We thus turn to the facts set forth in the 1.131 declaration. There are
three key facts relied upon by the inventors to establish a reduction to
practice of the same utility shown in Chen: 1) cloning of SNORF from rat
insulinoma; 2) high level expression of SNORF-25 in pancreas; and 3)
appreciation (“indicated to us”) of “possible role of mammalian SNORF25
receptor in . . . regulation of insulin release” based on 1) and 2). We
address the sufficiency of each below.
It is stated in the declaration that the rat SNORF25 receptor was
cloned from a rat insulinoma line (1.131 Decl. ¶ 14). However, the
inventors did not present objective evidence in the declaration that the
source of the cloned rat receptor was a rat insulinoma cell line. Exhibit 1 is
a deposit receipt from the American Type Culture Collection (ATCC)
stating that the plasmid pcDNA3.1-rSNORF25 was deposited on November
24, 1998 (Exhibit 1), which comprises a nucleic acid coding for the rat
SNORF25 receptor (1.131 Decl. ¶ 10; ‘848 patent, col. 13, ll. 43-46).
Exhibit 1 does not indicate that the source of the rat SNORF25 receptor was
a rat insulinoma cell line. Indeed, neither the declaration nor ATCC Deposit
Form (Exhibit 1) indicate whether the clone SNORF25 is a genomic DNA,
which would be present in every cell, or a cDNA, which might be limited to
only those cells in which it is expressed.
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Exhibit 2, referenced in the declaration, shows the results of using
PCR to detect human SNORF25 mRNA in various tissues (1.131 Decl.
¶ 12). Notebook page 188 of Exhibit 2 shows the data obtained from the
PCR reaction (id. at ¶ 13). The inventors state that “[o]f all of the adult
tissues tested, the highest level of mRNA expression of human SNORF25
was detected in the pancreas.” (Id.) The data summarized on page 188 of
the notebook corroborates this statement.
These two facts are not sufficient to show that the inventors
recognized the insulin regulatory utility prior to May 28, 1999. The
inventors simply stated that these facts “indicated to us a possible role” in
“the regulation of insulin release” but did not provide corroborating
evidence that they recognized this function prior to May 28, 1999 (1.131
Decl. ¶ 14).
As to the expression levels, we note that page 188 of Exhibit 2 also
shows high levels of expression in adult stomach and fetal liver, facts
acknowledged in the ‘848 patent (col. 56, ll. 24-25 and 37-39). Based on the
change in expression during liver development, the inventors stated in the
‘848 patent that the “profound change of SNORF25 mRNA during [liver]
development implies a role in the maturation of the liver, or a role in the
regulation of glucose demands/levels during development.” (‘848 patent,
col. 56, ll. 40-44.) Consistently, in the 1.131 Declaration, the inventors
acknowledged a “possible role” more generally in “metabolic functions”
(1.131 ¶ Decl. 14).
In other words, there is more than one possible utility mentioned in
the ‘848 patent, depending upon which tissue is examined. As argued by
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Requester, the inventors did not provide adequate evidence that the data
relating to pancreas expression was recognized as more relevant or
significant than the data relating to expression in the fetal liver or other
tissues (TPR Appeal Br. 19). The inventors also did not explain why the
expression data indicated a utility related to insulin release, rather than
another function of the pancreas.
In addition to this, the inventors did not provide an adequate
explanation or corroborating evidence, as to what led the inventors to
appreciate a connection between expression of SNORF25 in the pancreas, its
cloning in an insulinoma cell line, and insulin release. In particular, the
inventors did not identify a characteristic or property of the insulinoma cell
line which led them to believe that cloning SNORF25 from it indicated a
role of SNORF25 in insulin release. The inventors simply did not explain
the nexus between high levels of expression of SNORF25 in the pancreas
and the function that SNORF25 protein is involved in insulin release, rather
than some other pancreatic activity.
The inventors described in the 1.131 Declaration evidence that all
trans retinoic acid (ATRA) stimulated cells transfected with SNORF25 had
higher cAMP responses (1.131 Decl. ¶ 18). However, they did not attribute
this activity in the declaration to a role in the regulation of insulin release.
As discussed in the ‘848 patent, ATRA affects numerous tissues (‘848
patent, col. 2, ll. 35-58). The inventors did not document or explain why
ATRA stimulation of SNORF25 led them to believe that SNORF25 is
involved in the regulation of insulin release, rather than one of the other
activities associated with ATRA stimulation.
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In the Respondent Brief, Patent Owner refers to page 69 of Exhibit 3
which states “BN2 [aka hSNORF25-R] may be [a] glucoreceptor.” (PO
Resp’t Br. 9.) However, the inventors did not refer to this statement in their
declaration as supporting the role of SNORF25 in insulin regulation. Patent
Owner also did not cite evidence in their brief that a glucoreceptor would
have been known prior to May 28, 1999 to reside in the pancreas, rather than
some other tissue, or that the receptor mediates insulin release.
In sum, there is inadequate objective evidence and explanatory
reasoning to establish that the inventors had recognized that SNORF25 had a
role in the regulation of insulin release prior to May 28, 1999 as asserted in
the 1.131 Declaration.

Assay
As mentioned, to antedate a publication, a 37 C.F.R. § 1.131
declaration much show as much as the invention as described in the
publication. Requester disputes that the claimed subject matter was reduced
to practice before May 28, 1999 because ATRA is not a ligand for
SNORF25. Ligand activity is described in Chen and also recited in the
method claims.
In particular, Requester raises doubt about the disclosure in the 1.131
declaration that ATRA stimulated human SNORF25 in cells into which the
receptor had been transfected (TPR App. Br. 6-7 and 23-26). Evidence was
cited to support their arguments, including data described in a declaration by
Dr. James N. Leonard and US 7,083,933 (id. at 24-25). Such aspersions on
the ability of ATRA to stimulate SNORF25 do not undermine the inventors’
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attempt at a reduction to practice because the objective evidence shows that
the claimed step of “measuring the second messenger response in the
presence and in the absence of the chemical compound” in cells “expressing
on their cell surface the mammalian SNORF25 receptor” had been carried
out (1.131 Decl. ¶ 18). To the extent it was subsequently learned that ATRA
does not stimulate SNORF25 as it had been believed by the inventors to,
subsequent experimentation showing that the invention does not work
doesn’t vitiate the facts that existed prior to May 28, 1999.
Summary
The Examiner did not adopt and withdrew rejections of claims 1-20
based on Chen because the inventors’ 37 C.F.R. § 1.131 Declaration was
accepted by the Examiner as antedating Chen as a prior art publication.
Because we conclude that this determination was erroneous and that the
1.131 Declaration is not sufficient to remove Chen as prior art, we reverse
the Examiner’s decision to not adopt and withdraw the rejections of claims
1-20 based on Chen as listed in 2-20, 22, and 23 on pages 3-5 of Requester’s
Appeal Brief. We designate such rejections as new grounds of rejection
under 37 C.F.R. § 41.77(b).

TIME PERIOD; NEW GROUNDS OF REJECTION
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.77(b) which provides that “[a]ny decision which includes a new ground
of rejection pursuant to this paragraph shall not be considered final for
judicial review.” Accordingly, no portion of the decision is final for
purposes of judicial review. A requester may also request rehearing under
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37 C.F.R. § 41.79, if appropriate, however, the Board may elect to defer
issuing any decision on such request for rehearing until such time that a final
decision on appeal has been issued by the Board.
For further guidance on new grounds of rejection, see 37 C.F.R.
§ 41.77(b)-(g). The decision may become final after it has returned to the
Board. 37 C.F.R. § 41.77(f).
37 C.F.R. § 41.77(b) also provides that the Patent Owner, WITHIN
ONE MONTH FROM THE DATE OF THE DECISION, must exercise one
of the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. The owner may file a response requesting
reopening of prosecution before the examiner. Such a response must be
either an amendment of the claims so rejected or new evidence relating to
the claims so rejected, or both.
(2) Request rehearing. The owner may request that the proceeding be
reheard under § 41.79 by the Board upon the same record. …
Any request to reopen prosecution before the examiner under 37
C.F.R. § 41.77(b)(1) shall be limited in scope to the “claims so rejected.”
Accordingly, a request to reopen prosecution is limited to issues raised by
the new ground(s) of rejection entered by the Board. A request to reopen
prosecution that includes issues other than those raised by the new ground(s)
is unlikely to be granted.
A requester may file comments in reply to a patent owner response.
37 C.F.R. § 41.77(c).
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Compliance with the page limits pursuant to 37 C.F.R. § 1.943(b), for
all patent owner responses and requester comments, is required.
The examiner, after the Board’s entry of a patent owner response and
requester comments, will issue a determination under 37 C.F.R. § 41.77(d)
as to whether the Board’s rejection is maintained or has been overcome.
The proceeding will then be returned to the Board together with any
comments and reply submitted by the owner and/or requester under
37 C.F.R. § 41.77(e) for reconsideration and issuance of a new decision by
the Board as provided by 37 C.F.R. § 41.77(f).

REVERSED; 41.77(b)

PATENT OWNER:

JONES DAY
222 East 41st Street
New York, NY 10017

THIRD PARTY REQUESTER:

James F. Haley, Jr.
ROPES & GRAY LLP, PATENT DOCKETING 39/361
1211 Avenue of the Americas
New York, NY 10036-8704