Ex Parte Mocikat

Board of Patent Appeals and Interferences

Oct 18, 2010

10716580 (B.P.A.I. Oct. 18, 2010)

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.
10/716,580 11/18/2003 Ralph Mocikat 080306-000100US 6256
20350 7590 10/18/2010
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO, CA 94111-3834
EXAMINER
WOODWARD, CHERIE MICHELLE
ART UNIT PAPER NUMBER
1647
MAIL DATE DELIVERY MODE
10/18/2010 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 RALPH MOCIKAT
__________

Appeal 2010-007342
Application 10/716,580
Technology Center 1600
__________

Before CAROL A. SPIEGEL, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
vector for the expression of immunoglobulin-cytokine fusion proteins in
malignant B cells. The Patent Examiner rejected the claims as failing to

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2010-007342
Application 10/716,580

2
comply with the written description requirement, as anticipated, and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1-5, 7-9, and 11-17 are on appeal. Claims 1 and 12 are
representative and read as follows:
1. A vector for the expression of immunoglobulin-cytokine fusion
proteins in malignant B cells, comprising the following components
operably linked to each other
(a) a continuous region of at least 1.5 kb which is homologous to an at
least 1.5 kb segment of the μ intron or the k intron;
(b) at least one DNA sequence encoding a constant region of an
immunoglobulin or a part of the constant region;
(c) a DNA sequence encoding a cytokine; and
(d) a marker gene which is selectable in eukaryotic B cells and
contains a functional enhancer region.

12. The vector according to claim 1, wherein the DNA sequence of
(b) encodes the constant region of a mouse, rat, goat, horse or sheep
immunoglobulin.

The Examiner rejected the claims as follows:
• claims 1-5, 7-9, and 11-17 under 35 U.S.C. § 112, first paragraph,
as failing to comply with the written description requirement;
• claims 1-5, 7-9, 11, and 13-17, and 29 under 35 U.S.C. §102(e) as
anticipated by Polack,2 as evidenced by Mucke;3
• claims 1-5, 7-9, 11-13, and 15-17 under 35 U.S.C. § 103(a) as
unpatentable over Polack, Levy4, and Gillies,5 as evidenced by Mucke;

2 US Patent No. 6,521,449 B1 issued to Axel Polack, et al., Feb. 18, 2003.
3 S. Mücke, et al., Suitability of Epstein-Barr virus-based episomal vectors
for expression of cytokine genes in human lymphoma cells, 4 GENE
THERAPY, 82-92 (1997).
4 US Patent No. 6,099,846 issued to Ronald Levy, et al., Aug. 8, 2000.
Appeal 2010-007342
Application 10/716,580

3
• claims 1-5, 7-9, 11-17 under 35 U.S.C. § 103(a) as unpatentable
over Mucke, Polack, and Mocikat.6
Claims 2-5, 7-9, and 11-17 have not been argued separately and
therefore stand or fall with claim 1 in each rejection. 37 C.F.R.
§ 41.37(c)(1)(vii).
WRITTEN DESCRIPTION
The Issue
The Examiner’s position is that the claims are drawn to multiple
genera of vectors. (Ans. 3). The Examiner found that apart from the
disclosure of one exemplary vector in the Specification and the vectors
disclosed in the prior art, a skilled artisan would have “to guess at the
multiple vector components from which to pick and choose in order to
construct vectors encompassed by the instant claims.” (Id. at 5). According
to the Examiner, “the instant claims and Specification do nothing more than
suggest various vector components in the form of generic lists or as a
laundry list of potential components that one of ordinary skill in the art could
piece together to obtain possession of the claimed genus of vectors.” (Id.,
citing Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir.
2004) and In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009)).
The Examiner also found that the prior art of record “shows that the
large size of the k locus makes it exceedingly difficult to determine which
homologous intron segments structurally constitute the claimed region of “at

5 US Patent No. 5,650,150 issued to Stephen D. Gillies, Jul 22, 1997.
6 R. Mocikat, et al., Unaltered immunoglobulin expression in hybridoma
cells modified by targeting of the heavy chain locus with an integration
vector, 84 IMMUNOLOGY 159-163 (1995).
Appeal 2010-007342
Application 10/716,580

4
least 1.5 kb which is homologous to an at least 1.5 kb segment of the μ
intron or the k intron.” (Id. at 6). The Examiner found that “[i]n the absence
of sufficient recitation of distinguishing characteristics, the specification
does not provide adequate written description of the claimed genera of
vectors to establish that Appellant was in possession of the vectors in their
full scope.” (Id. at 7).
Appellant contends that, in contrast to Rochester or Kubin, at the time
their application was filed all of the “components of the claimed vector-- μ
or k intron sequences, immunoglobulin constant region sequences, cytokine
sequences, selectable marker sequences, and enhancer sequences, were well
known and available to a person of ordinary skill in the art.” (App. Br. 6, 8).
Appellant asserts that the disclosure provides sufficient detail such that a
skilled artisan would reasonably conclude that the inventor had possession
of the claimed invention at the time of filing. (Id.).
The issue with respect to this rejection is whether the Examiner
established that a person of ordinary skill in the art would understand that
Appellant was in possession of the claimed invention.
Findings of Fact
1. The Examiner does not dispute that the μ or k intron sequences,
immunoglobulin constant region sequences, cytokine sequences, selectable
marker sequences, and enhancer sequences of the claimed invention were
well known to a person of ordinary skill in the art at the time of the
invention. (See Ans. 4-5, 18).
2. The Specification states, “The homologous sequence contained in said
vector must have a length of at least 1.5 kb to achieve a homologous
recombination event at all.” (Spec. 10).
Appeal 2010-007342
Application 10/716,580

5
Principles of Law
When an Applicant claims a class, the Applicant “must describe that
class in order to meet the description requirement of the statute.” In re
Lukach, 442 F.2d 967, 968 (CCPA 1971). “The adequate written description
requirement . . . serves ‘to ensure that the inventor had possession, as of the
filing date of the application relied on, of the specific subject matter later
claimed by him; how the specification accomplishes this is not material.’”
In re Alton, 76 F.3d 1168, 1172 (Fed. Cir. 1996) (citation omitted). The
amount of description needed to meet the requirement can vary with the
scientific and technologic knowledge already in existence. Capon v. Eshhar,
418 F.3d 1349, 1357 (Fed. Cir. 2005). “It is not necessary that every
permutation within a generally operable invention be effective in order for
an inventor to obtain a generic claim, provided that the effect is sufficiently
demonstrated to characterize a generic invention.” Id. at 1359.
It is well settled that “claims in an application are to be given their
broadest reasonable interpretation consistent with the specification and that
claim language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art.” In re Sneed, 710 F.2d 1544,
1548 (Fed. Cir. 1983).
Analysis
A. Claim Interpretation
We turn to the Specification for clarification as to the meaning and
scope of the claim phrase “homologous to an at least 1.5 kb segment of the μ
intron or the k intron” recited in claim 1. See Sneed, 710 F.2d at 1548.
The Examiner’s position is that “[s]imply knowing the nucleic acid code of a
μ intron or k intron is not sufficient to describe a representative number of
Appeal 2010-007342
Application 10/716,580

6
species or to adequately show possession when the claim limitations, as
written, recite ...a region which is homologous to an at least 1.5 kb segment
of the μ intron or the k intron.” (Ans. 6). According to the Examiner, a
skilled artisan would require knowing something more about the structure of
the homologous regions required for the vector to be apprised that Appellant
was in possession of a generic homologous region of a genus of k introns.
(Id.). However, the Specification describes the homologous sequence
contained in claimed vector as “hav[ing] a length of at least 1.5 kb to
achieve a homologous recombination event at all.” (Spec. 10, emphasis
added).
In light of the Specification, we interpret the claim phrase
“homologous to an at least 1.5 kb segment of the μ intron or the k intron”
broadly as referring to any homology to an at least 1.5 kb segment of the μ
intron or the k intron, both of which are known sequences (FF-1), that is
sufficient to achieve homologous recombination. There is no evidence to
support the Examiner’s finding that a person of ordinary skill in the art
would have needed more examples to recognize that Appellant had
possession of homologous regions.
B. Appellant’s Possession of the Claimed Invention
We agree with Appellant that a skilled artisan at the time of filing
would have understood that Appellant was in possession of the claimed
invention as the components of the claimed vector were known in the art.
(FF-1). This fact distinguishes this situation from the facts of Rochester and
Kubin, for the reasons asserted by Appellant. (See App. Br. 7-8). As the
Federal Circuit explained in Capon, “[t]he ‘written description’ requirement
must be applied in the context of the particular invention and the state of the
Appeal 2010-007342
Application 10/716,580

7
knowledge.” See Capon, 418 F.3d at 1358. A re-description of what was
already known in the art is not necessary to satisfy this requirement. Id. at
1357. Moreover, “every permutation within a generally operable invention”
does not have to be described. Id. at 1359. The written description
examination guidelines in the MANUAL OF PATENT EXAMINING PROCEDURE
apply those principles: “[g]enerally, there is an inverse correlation between
the level of skill and knowledge in the art and the specificity of disclosure
necessary to satisfy the written description requirement. Information which
is well known in the art need not be described in detail in the specification.”
(MPEP § 2163 II.A.2).
Here, similar to Capon, the invention is not in discovering the DNA
sequences which are the components of the claimed vector, for that is in the
prior art, but instead in the novel combination, i.e., operable linkage, of the
DNA sequences to achieve a novel result, i.e., a vector for the expression of
immunoglobulin-cytokine fusion proteins in malignant B cells. There are
likely a variety of ways to describe that invention, but how the Specification
accomplishes the description is not material. Alton, 76 F.3d at 1172. The
rejection demands one kind of description (more examples), rather than the
kind of description the Specification gave. That requirement has not been
shown to be supportable under the applicable precedent and the application
of the precedent by the written description examination guidelines in the
MPEP.
ANTICIPATION
The Issue
The Examiner’s position is that Polack disclosed each limitation of the
instant claims, including “a combination of kappa E3  and kappa Ei
Appeal 2010-007342
Application 10/716,580

8
enhancers … exceed[ing] the ‘at least 1.5 kb which is homologous to an at
least 1.5 kb segment of the μ intron or the k intron,’” recited in instant claim
1. (Ans. 8-10). The Examiner also found that Polack disclosed BC219-
TNFα vector integrated into BL60 cells capable of expressing TNFα. (Id. at
9; compare with instant claim 29). The Examiner referenced Mucke to
demonstrate the inherent features of Polack’s vector. (Id. at 9). Specifically,
the Examiner found that Mucke’s BC219 vector illustrated Polack’s vector
in detail and demonstrated that the kappa E3  and the kappa Ei of Polack’s
vector provided a combined length of approximately 2.64 kb. (Id.).
Appellant contends that “neither Polack nor Mucke provides the
limitation of ‘a continuous region of at least 1.5 kb which is homologous to
an at least 1.5 kb segment of the μ intron or the k intron’….” (App. Br. 9).
Appellant asserts that “Polack describes the combined use of two enhancer k
intron elements, which provide a combined length of over 1.5 kb but each is
less than 1.5 kb….” (Id.). According to Appellant (Reply Br. 5-6) the claim
phrase “continuous region” should be interpreted as requiring “an
uninterrupted or unbroken polynucleotide sequence having a defined
minimal length as well as a sequence homology” and not as comprising “a
multiplicity of segments,” as the Examiner asserted (Ans. 24).
The issues with respect to the anticipation rejection are:
whether the claimed “continuous region” should be interpreted as
requiring a single, “uninterrupted or unbroken polynucleotide sequence
having a defined minimal length as well as a sequence homology”; and
whether Polack disclosed “a continuous region of at least 1.5 kb
which is homologous to an at least 1.5 kb segment of the μ intron or the k
intron.”
Appeal 2010-007342
Application 10/716,580

9

Additional Findings of Fact
3. We agree with the Examiner’s explicit findings regarding the scope
and content of Polack and Mucke. (See Ans. 8-10).
4. Merriam-Webster Online Dictionary defines “continuous” as “marked
by uninterrupted extension in space, time, or sequence.” (Reply Br. 5, Ex.
A).
Principle of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
Analysis
The Specification does not define “continuous.” Appellant asserts
that the plain meaning of the word is “an uninterrupted or unbroken
polynucleotide sequence having a defined minimal length as well as a
sequence homology.” (Reply Br. 5). However, the plain meaning of the
term “continuous” is not so limiting. (See FF-2). The plain meaning of the
term is consistent with the Examiner’s reasoning (Ans. 21) that two
enhancer regions located adjacent to each other in a vector, as illustrated in
Mucke, “will innately be continuous with one another,” i.e., in an
uninterrupted extension in space, time, or sequence. We agree with the
Examiner that the placement of “continuous” “does not limit the
homologous region to being continuous segments from the μ intron or the k
intron that are each individually at least 1.5 kb in length.” (Id.). The
Specification does not require a narrower interpretation. Therefore, we
Appeal 2010-007342
Application 10/716,580

10
interpret the phrase “continuous region” to broadly include a region
comprising either one required gene segment or more than one of the
required gene segments positioned in a continuous, i.e., uninterrupted
sequence with each other. It is the Applicants’ burden to precisely define
the invention, not the PTO’s. In re Morris, 127 F.3d 1048, 1056 (Fed. Cir.
1997).
Giving the phrase “continuous region” its broadest reasonable
interpretation, it is reasonable to interpret the phrase to include Polack and
Mucke’s vector region comprising the kappa E3  and the kappa Ei. While
these are two separate enhancer elements, they are positioned adjacent to
each other in a continuous manner.
For these reasons, we do find that Appellant has not established that
the Examiner erred in determining that Polack and Mucke disclosed a vector
comprising “a continuous region of at least 1.5 kb which is homologous to
an at least 1.5 kb segment of the μ intron or the k intron.” Accordingly, we
affirm the anticipation rejection.
OBVIOUSNESS
The Issue
The Examiner’s position is that Polack and Mucke disclosed all of the
limitations of claim 1. (Ans. 11, 14-15). For the rejection over Polack,
Mucke, Levy and Gillies, the Examiner also found that Levy and Gillies
taught the limitations of the dependent claims that were not disclosed by
Polack and Mucke. (Id. at 12). According to the Examiner, it would have
been obvious to a person of ordinary skill in the art at the time the invention
was made to combine the prior art elements according to known methods to
yield predictable results. (Id. at 13).
Appeal 2010-007342
Application 10/716,580

11
For the rejection over Polack, Mucke and Mocikat, the Examiner
found that Mocikat disclosed the limitations of the dependent claims that
were not disclosed by Polack and Mucke. (Id. at 15). In particular,
regarding instant claim 12, the Examiner found that Mocikat disclosed a
vector for homologous recombination at the immunoglobulin (Ig) locus
comprising a murine IgH locus including a 5   homology flank. (Id.). The
Examiner also found that Mocikat’s vector comprised a 2.3 kb fragment
from the mouse µ intron. (Id.). According to the Examiner, it would have
been obvious to a person of ordinary skill in the art at the time the invention
was made to combine the prior art elements according to known methods to
yield predictable results. (Id. at 16). In particular, the Examiner reasoned
that it would have been obvious to a person of ordinary skill in the art at the
time the invention was made to create a vector capable of expressing an
immunoglobulin-cytokine fusion protein in malignant B cells, as taught by
Polack and Mucke, using at least one DNA sequence encoding part of a
mouse immunoglobulin constant region, such as the 5   homology flank from
the IgH locus taught by Mocikat, with predictable results. (Id. at 16-17).
According to the Examiner, combining or substituting “at least one DNA
sequence encoding a part of a mouse constant region in the vector construct
for the human constant region [would have provided] predictable results
because of similarities in mouse and human constant regions, which are old
and well known in the art.” (Id. at 17).
Appellant contends that claims are not obvious over the combination
including Polack and Mucke for the same reasons asserted regarding
anticipation rejection, i.e., Polack and Mucke fail to disclose “a continuous
Appeal 2010-007342
Application 10/716,580

12
region of at least 1.5 kb which is homologous to an at least 1.5 kb segment
of the μ intron or the k intron,” as recited in claim 1. (App. Br. 10).
Regarding the rejection over Polack, Mucke and Mocikat, Appellant
further contends that Mocikat’s use of a 2.3 kb fragment of the mouse μ
intron sequence in the recombination vector does not supplement the
missing claim limitation. (Id. at 10-11). According to Appellant, there
would not be any motivation to combine Polack and Mocikat “because of
fundamental differences in the purpose and mechanism of action between
expression vectors (e.g., the Polack vector) and integration vectors (e.g., the
Mocikat vector)….” (Id. at 11). Additionally, Appellant asserts that
replacing Polack’s expression vector enhancers with the 2.3 kb intron
sequence of Mocikat “would completely defeat the purpose of
enhancing/promoting expression.” (Id.).
The issues with respect to these rejections are:
whether the combination of Polack and Mucke taught or suggested “a
continuous region of at least 1.5 kb which is homologous to an at least 1.5
kb segment of the μ intron or the k intron;” and
whether the combination of Polack, Mucke and Mocikat taught or
suggested a vector according to instant claim 1, wherein at least one DNA
sequence encodes the constant region of a mouse immunoglobulin.
Additional Finding of Fact
5. We agree with the Examiner’s explicit findings regarding the scope
and content of Levy, Gillies, and Mocikat. (See Ans. 10-17).

Appeal 2010-007342
Application 10/716,580

13
Principle of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l. Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
To the extent that Appellant asserts that Polack and Mucke did not
disclose “a continuous region of at least 1.5 kb which is homologous to an at
least 1.5 kb segment of the μ intron or the k intron,” we remain unpersuaded
for the reasons discussed regarding the anticipation rejection.
Further, we disagree with Appellant that the Examiner’s combination
of Polack, Mucke and Mocikat was improper. (See App. Br. 10-11).
Appellant’s arguments are directed to the replacement of enhancers in
Polack’s expression vector with the 2.3 kb intron sequence of Mocikat as a
means of supplementing the asserted “missing claim limitation” of “a
continuous region of at least 1.5 kb which is homologous to an at least 1.5
kb segment of the μ intron or the k intron.” (Id.). However, as discussed,
this claim limitation is met by the disclosures of Polack and Mucke. As the
Examiner explained, “[t]he Mocikat reference was cited against the
limitations of claim 12, which … recites that the DNA sequence … encodes
the constant region of a mouse [immunoglobulin].” (Ans. 25). For this
limitation, the Examiner’s combination only involved substituting at least
one DNA sequence encoding a part of a mouse constant region in the vector
construct for the human constant region. (Id. at 17). By explaining that
mouse and human constant regions share similarities that were well known
in the art the Examiner provided sound reasoning that this substitution would
Appeal 2010-007342
Application 10/716,580

14
have been obvious to a skilled artisan at the time of the invention, and would
have provided predictable results.
For these reasons, we find that Examiner’s rejection involved
combining familiar elements according to known methods to yield a
predictable, i.e., disclosed, result. See KSR Int’l, 550 U.S. at 416-17.
CONCLUSIONS OF LAW
The Examiner did not establish that a person of ordinary skill in the
art would require additional descriptions of the recited vector or its
components to credit Appellant with possession of the claimed invention.
Polack disclosed “a continuous region of at least 1.5 kb which is
homologous to an at least 1.5 kb segment of the μ intron or the k intron.”
A person of ordinary skill in the art at the time the invention was
made would have found it obvious to combine the known elements of the
prior art to yield the claimed invention.
SUMMARY
We reverse the rejection of claims 1-5, 7-9, and 11-17 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement;
we affirm the rejection of claims 1-5, 7-9, 11, and 13-17, and 29 under
35 U.S.C. §102(e) as anticipated by Polack, as evidenced by Mucke;
we affirm the rejection of claims 1-5, 7-9, 11-13, and 15-17 under
35 U.S.C. § 103(a) as unpatentable over Polack, Levy, and Gillies, as
evidenced by Mucke;
we affirm the rejection of claims 1-5, 7-9, 11-17 under 35 U.S.C.
§ 103(a) as unpatentable over Mucke, Polack, and Mocikat.

Appeal 2010-007342
Application 10/716,580

15
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

lp

TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO CA 94111-3834