Robert Pytela et al.

Patent Trials and Appeals Board

Sep 26, 2019

14283093 - (D) (P.T.A.B. Sep. 26, 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.
14/283,093 05/20/2014 ROBERT PYTELA EPIT-016CON4 5026
93726 7590 09/26/2019
EPA - BOZICEVIC FIELD & FRANCIS LLP
BOZICEVIC, FIELD & FRANCIS
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
WEN, SHARON X
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
09/26/2019 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT PYTELA, WEIMIN ZHU,
YAOHUANG KE, QI QIAN, and HARRY C. AU1
____________

Appeal 2019-001619
Application 14/283,0932
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The claims in this appeal are directed to a rabbit-derived immortal B-
lymphocyte capable of fusing with a rabbit splenocyte. The Examiner
rejected the claims under the doctrine of obviousness-type double-patenting.
Pursuant to 35 U.S.C. § 134, Appellants appeal the Examiner’s
determination that the claims are unpatentable. We have jurisdiction for the
appeal under 35 U.S.C. § 6(b). The Examiner’s decision is AFFIRMED.

1 The Appeal Brief (“Appeal Br.” entered July 30, 2018) lists Epitomics,
Inc., which is a subsidiary of Abcam, as the real-party-in-interest. Appeal
Br. 3.
2 “The ’093 application.”
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STATEMENT OF THE CASE
The Examiner finally rejected the claims as follows:
Claims 16–21 on the ground of nonstatutory obviousness-type double
patenting as obvious in view of 1) claims 1–12 of U.S. Patent No. 8,062,867
B2 (issued Nov. 22, 2011) (“the ’867 patent”), 2) claims 1–6 of U.S. Patent
No. 7,429,487 B2 (issued Sept. 30, 2008) (“the ’487 patent”), and 3) claims
1–7 of U.S. Patent No. 8,367,408 B2 (Feb. 5, 2013) (“the ’408 patent”).
Ans. 4.
Claims 16–21 on the ground of nonstatutory obviousness-type double
patenting as being unpatentable over claims 16–23 of co-pending
Application No. 15/089,135 (“the ’135 application”).3 Ans. 4.

Rejected claims
Claim 16, the only independent claim on appeal, is reproduced below:
16. A rabbit-derived immortal B-lymphocyte capable of fusing
with a rabbit splenocytes [sic, splenocyte] to produce a hybrid
cell that produces an immunoglobulin, wherein the rabbit-
derived immortal B-lymphocyte fuses with rabbit splenocytes a
rate of at least 40%.
Dependent claim 21 recites “wherein the rabbit-derived immortal B-
lymphocyte fuses with rabbit splenocytes a rate of at least 64%.”

U.S. Patent No. 8,062,867
Claim 1 of the ’867 patent is reproduced below:
1. A method of making a hybrid cell that produces an antibody,
comprising:

3 This Application issued August 13, 2019 as US 10,377,814. Therefore,
this rejection is no longer provisional.
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fusing a first cell that produces an antibody with a rabbit
derived immortal B-lymphocyte, wherein immunoglobulin
heavy chain (IgH) mRNA expression of said rabbit-derived
immortal B-lymphocyte is not detectable by RT-PCR and said
rabbit derived immortal B-lymphocyte does not detectably
express IgH,
thereby producing an [sic, a] hybrid cell that produces
said antibody.

The claims of the ’867 patent are directed to making a hybrid cell that
makes an antibody. The hybrid cell is made by fusing 1) a first cell that
produces an antibody with 2) a rabbit derived immortal B-lymphocyte. The
“rabbit derived immortal B-lymphocyte” of the ’867 patent corresponds to
the “rabbit derived immortal B-lymphocyte” of rejected claim 16. Claim 1
of the ’867 patent does not recite a specific fusion rate for the immortal B-
lymphocyte as does claim 16 of the ’093 application. Claim 1 also requires
the cells not to produce immunoglobulin heavy chains, which is not a
requirement of rejected claim 16. The issue in the rejection is whether the
claimed fusion rate “of at least 40%” recited in claim 16 of the ’093
application, in cells which are not limited as to heavy chain immunoglobulin
expression, would have been obvious to one of ordinary skill in the art.
As mentioned above, the immortal B-lymphocyte of rejected claim 16
is not required by the claim to not produce a heavy chain as in claim 1 of the
’867 patent. However, the claim is unlimited as to heavy chain expression,
and thus the claim encompasses cells which do not produce heavy
immunoglobulin chains and therefore the patented ’867 claim falls with the
broader scope of claim 16 with respect to this limitation.
Appellants argue that “a fusion rate ‘of at least 40%’ cannot
necessarily flow from the claims of” the ’867 patent “because there are other
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examples of rabbit derived immortal B-lymphocytes that have a much lower
fusion rate.” Appeal Br. 5. As evidence of this, Appellants cite the Knight
patent (U.S. Pat. No, 5,675,063, issued Oct. 7, 1997) which Appellants state
describes “a rabbit-derived B-lymphocyte capable of fusing with rabbit
splenocytes to produce a hybrid cell, where the rabbit-derived B-lymphocyte
has a fusion rate of less than 1%.” Id.
This argument is not persuasive.
The Examiner stated that one of ordinary skill in the art would have
been motivated to elect a B-lymphocyte with a specific fusion rate, including
the claimed fusion rate of at least 40%. Ans. 9.
While it may be true that lower fusion rates are known in the prior art,
as established by Knight, Appellants did not provide a reason why it would
not have been obvious to obtain a cell with the claimed fusion rate of at least
40% using routine and conventional screening. The rejection is not based on
inherency as argued by Appellants (Appeal Br. 5), but rather on the
obviousness of obtaining cells with the desired fusion rate (Ans. 9). As held
in In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990):
[The] law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims…in such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
Thus, Appellants have the burden of showing that claimed fusion rate of
rejected claim 16 is critical and unexpected relative to claim 1 of the ’867
patent which is unlimited as to the fusion rate. This burden was not met.
Appellants also argue that “there is no biological connection between
heavy chain expression and high fusion rate. As such, there should be no
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obviousness between the present claims and the claims of the prior patents.”
Reply Br. 2. However, the claims of the ’093 application are not limited as
to the status of the heavy chain expression. Thus, a “connection” between
immunoglobulin expression and fusion rate is not required by claim 16.
Dependent claim 8 of the ’867 patent further recites “wherein said
immortal B-lymphocyte has a hybridization frequency of at least 80%.” The
“hybridization frequency” of at least 80% of claim 8 of the ’867 patent falls
within the broader scope of at least 40% of rejected claim 16 and at least
64% recited in rejected dependent claim 21 and thus meets the claimed
limitation. It is well established that, when there is a range disclosed in the
prior art, and the claimed invention overlaps or falls within that range, as
here, there is a presumption of obviousness. In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d
1317, 1322 (Fed. Cir. 2004). See also arguments above citing Woodruff.
Thus, claim 16 (“at least 40%”) and claim 21 (“at least 64%”) are also
obvious in view of claim 8 of the ’867 patent.
For the foregoing reasons, the obviousness-type double-patenting
rejection of claims 16 and 21 over the claims of the ’867 patent is affirmed.
Claims 17–20 were not separately argued and therefore fall with claim 16.
37 C.F.R. § 41.37(c)(1)(iv).

U.S. Patent No. 7,429,487
Claim 1 of the ’487 patent is reproduced below:
1. A rabbit-derived immortal B-lymphocyte capable of fusing
with a rabbit splenocyte to produce a hybrid cell that produces
an immunoglobulin, wherein immunoglobulin heavy chain
mRNA expression of said rabbit derived immortal B-
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lymphocyte is not detectable by RT-PCR and said rabbit-
derived immortal B-lymphocyte does not detectably express
immunoglobulin heavy chain.
Claim 1 of the ’487 patent is directed to “[a] rabbit-derived immortal
B-lymphocyte capable of fusing with a rabbit splenocyte to produce a hybrid
cell that produces an immunoglobulin, wherein immunoglobulin heavy chain
mRNA expression” is not detectable by RT-PCR and the heavy chain is not
expressed by the B-lymphocyte. Claim 3, which depends from claim 1,
further recites “wherein said immortal B-lymphocyte has a hybridization
frequency of at least 80%.”
Claim 1 of the ’487 patent does not recite a specific fusion rate for the
immortal B-lymphocyte. Thus, the issue in the rejection is whether the
claimed cells, which are unlimited as to immunoglobulin heavy chain
expression, and which recite a fusion rate “of at least 40%”, would have
been obvious to one of ordinary skill in the art in view of claims 1 and 3 of
the ’487 patent.
The immortal B-lymphocyte of rejected claim 16 is not required by
the claim to not produce a heavy chain as in claim 1 of the ’487 patent.
However, claim 16 encompasses cells which do not produce heavy
immunoglobulin chains and therefore the patented ’487 claim falls with the
broader scope of claim 16 with respect to this limitation.
Rejected claim 16 requires the fusion rate to be at least 40%. Claim 1
of the ’487 patent is not limited to a specific fusion rate. The Examiner
stated that one of ordinary skill in the art would have been motivated to
select a B-lymphocyte with a specific fusion rate, including the claimed
fusion rate. Ans. 9.
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Appellants contend that there are numerous examples of cells with
lower fusion rates, citing Knight as an example. Appeal Br. 5.
This argument is not persuasive. As discussed above for the ’867
patent, Appellants did not provide a reason why it would not have been
obvious to obtain a cell with the claimed fusion rate using routine and
conventional screening. As held in In re Woodruff, 919 F.2d at 1578:
[The] law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims…in such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
Thus, Appellants have the burden of showing that claimed fusion
frequency of rejected claim 16 is critical and unexpected relative to claim 1
of the ’487 patent. This burden was not met.
Claim 3 of the ’487 patent recites hybridization frequency of at least
80% which overlaps and is encompassed by the 40% value of claim 16 and
the 64% value of claim 21 of the ’093 application. Thus, claims 16 and 21
are also obvious in view of claim 8 of the ’487 patent for the same reasons
set forth above in the discussion of the ’867 patent.
For the foregoing reasons, the obviousness-type double-patenting
rejection of claims 16 and 21 over the claims of the ’487 patent is affirmed.
Claims 17–20 were not separately argued and therefore fall with claims 16
and 21. 37 C.F.R. § 41.37(c)(1)(iv).

U.S. Patent No. 8,367,408
Independent claim 1 of the ’408 patent is reproduced below:
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1. A hybrid cell made by fusing a rabbit spleen cell with a
myeloma cell, wherein:
said rabbit spleen cell produces an antibody;
said myeloma cell does not detectably express rabbit IgH
and immunoglobulin heavy chain (IgE) mRNA expression of
said myeloma cell is not detectable by RT-PCR; and
said hybrid cell produces said antibody.

Claim 1 of the ’408 patent comprises a “myeloma cell” which “does
not detectably express rabbit IgH and immunoglobulin heavy chain (IgE)
mRNA expression of said myeloma cell is not detectable by RT-PCR.” The
issue is whether the claimed “rabbit-derived immortal B-lymphocyte” that
“fuses with rabbit splenocytes a rate of at least 40%” of the ’093 application
would have been obvious to one of ordinary skill in view of claim 1 of the
’408 patent.
From the description in Appellants’ Specification that the disclosed
rabbit-derived immortal B-lymphocytes can be the myeloma-like 240E-1
cells, we find that the claimed “rabbit-derived immortal B-lymphocyte” can
be a myeloma cell as in claim 1 of the ’408 patent. Spec. 1:29–Spec. 2:10;
Spec. 14:9–10. The immortal B-lymphocyte of rejected claim 16 is not
required by the claim to not produce a heavy chain as in claim 1 of the ’4
08 patent. The heavy immunoglobulin chain expression limitation of claim
1 of the ’408 patent falls within the scope of rejected claim 16 because claim
16 is broader and thus a cell with this immunoglobulin characteristic meets
the claimed cell.
Claim 1 of the ’408 patent does not require a fusion rate of 40% as
recited in rejected claim 16. The Examiner stated that one of ordinary skill
in the art would have been motivated to select a B-lymphocyte with a
specific fusion rate, including the claimed fusion rate. Ans. 9.
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Appellants contend that there are numerous examples of cells with
lower fusion rates, citing Knight as an example. Appeal Br. 5. Appellants
also argue that “there is no biological connection between heavy chain
expression and high fusion rate. As such, there should be no obviousness
between the present claims and the claims of the prior patents.” Reply Br. 3.
This argument is not persuasive for the same reasons discussed above.
Appellants did not provide a reason why it would not have been obvious to
have obtained a cell with the claimed fusion rate using routine and
conventional screening nor establish that the claimed fusion rate is critical.
For the foregoing reasons, the obviousness-type double-patenting
rejection of claim 16 over the claims of the ’487 patent is affirmed. Claims
17–21 were not separately argued and therefore fall with claim 16. 37
C.F.R. § 41.37(c)(1)(iv).

Application No. 15/089,135
The claims of the ’135 application received an issue notification on
July 24, 2019.
Claim 16 of the ’135 application is reproduced below:
16. A hybrid cell produced by fusing: i. an antibody-producing
cell of a rabbit with ii. a rabbit-derived immortal B-lymphocyte,
wherein immunoglobulin heavy chain (IgH) mRNA expression
of the rabbit-derived immortal B-lymphocyte is not detectable
by RT-PCR and said rabbit derived immortal B-lymphocyte
does not detectably express immunoglobulin heavy chain.
Claim 16 of the ’135 application comprises a “rabbit-derived
immortal B-lymphocyte, wherein immunoglobulin heavy chain (IgH)
mRNA expression of the rabbit-derived immortal B-lymphocyte is not
detectable by RT-PCR and said rabbit derived immortal B-lymphocyte does
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not detectably express immunoglobulin heavy chain.” Claim 16 of the ’093
application is obvious view of the ’135 application claims for the same
reasons the claim is obvious over the claims of the ’867 patent, the ’487
patent, and the ’408 patent.
Claims 17–21 were not separately argued and therefore fall with claim
16. 37 C.F.R. § 41.37(c)(1)(iv).

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED