Ex Parte Palmer

Patent Trial and Appeal Board

Apr 30, 2014

12269967 (P.T.A.B. Apr. 30, 2014)

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.
12/269,967 11/13/2008 Michelle PALMER CELN-0001-CONT 1335
80308 7590 05/01/2014
Steven B. Kelber
Alchemy-Partners, PC
5885 Trinity Parkway
Suite 370
Centreville, VA 20120
EXAMINER
SCHNIZER, RICHARD A
ART UNIT PAPER NUMBER
1674
MAIL DATE DELIVERY MODE
05/01/2014 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
____________

Ex parte MICHELLE PALMER
____________

Appeal 2012-008736
Application 12/269,967
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, JOHN A. EVANS and
ANNETTE R. REIMERS, Administrative Patent Judges.

REIMERS, Administrative Patent Judge.

DECISION ON APPEAL

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Application 12/269,967

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STATEMENT OF THE CASE1
Michelle Palmer (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner’s decision to reject claims 11-44. Claims 1-10 have been
canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The claimed subject matter “relates generally to an assay system to
determine a drugs effect on a particular disease pathway, and methods of
using this assay system” (Spec. 1, ll. 12-13; figs. 2, 4A). Claims 11, 21, 29
and 37 are independent.
Claim 11 is illustrative of the claimed subject matter and recites:
11. A method of screening drugs for their
effectiveness for treating or preventing a disease
comprising: treating primary cells or cell lines in tissue
culture plate wells or vessels with a drug of interest,
wherein multiple primary cells or cell lines are treated,
each in their own tissue culture plate well or vessel;
optionally lysing the primary cells or cell lines; adding
the treated primary cells, cell lines or cell lysates to six or
more wells of a microarray plate, with the caveat that
only one primary cell, cell line or cell lysate is present in
any single well; adding six or more reagents to the wells
of said microarray plate occupied by a primary cell, cell
line or cell lysate, wherein at least one reagent is added to
each of the wells of said microarray plate occupied by a
primary cell, cell line or cell lysate; conducting an assay
reaction for each well of said microarray plate, wherein
each reagent and or assay is chosen to measure a
particular node in the disease pathway for the disease for
which drugs are being screened; and analyzing the effect

1 Appellant identifies the Real Party in Interest as Michelle Palmer, the sole
inventor of the instant application on appeal (App. Br. 2).
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the drug of interest has on each of the nodes of the
disease pathway, thereby determining whether the drug
of interest would be effective for treating or preventing
the disease.

THE EVIDENCE
The Examiner relies on the following references in rejecting the
appealed claims:
Wiley US 6,207,642 B1 Mar. 27, 2001
Michnick US 2004/0161787 A1 Aug. 19, 2004

THE REJECTIONS
The following rejections are before us for review:
1. Claims 11-17, 20-25, 28-33, 36-41 and 44 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Michnick.
2. Claims 18, 19, 26, 27, 34, 35, 42 and 43 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Michnick and Wiley.

ANALYSIS
Rejection 1 - Obviousness over Michnick - Claims 11-17, 20-25, 28-33, 36-
41 and 44
Appellant does not present separate arguments for independent claims
11, 21, 29 and 37 (App. Br. 13-18; Reply Br. 2-5). Appellant does not
present arguments for dependent claims 12-17, 20, 22-25, 28, 30-33, 36, 38-
41, and 44 separate from those presented for independent claims 11, 21, 29
and 37 (Id.). Accordingly, Appellant has argued claims 11-17, 20-25, 28-33,
36-41 and 44 as a group for purposes of the rejection of those claims under
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§ 103(a). Claim 11 is representative of the group and is selected for review,
with claims 12-17, 20-25, 28-33, 36-41 and 44 standing or falling with claim
11. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
The dispute between Appellant and the Examiner is rooted in claim
construction. We begin, therefore, by interpreting claim 11. Independent
claim 11 calls for a method of screening drugs including, inter alia, the steps
of (1) “treating primary cells or cell lines in tissue culture plate wells or
vessels with a drug of interest, wherein multiple primary cells or cell lines
are treated, each in their own tissue culture plate well or vessel”; (2) “adding
the treated primary cells, cell lines or cell lysates to six or more wells of a
micro array plate, with the caveat that only one primary cell, cell line or cell
lysate is present in any single well”; (3) “adding six or more reagents to the
wells of said micro array plate occupied by a primary cell, cell line or cell
lysate, wherein at least one reagent is added to each of the wells of said
micro array plate occupied by a primary cell, cell line or cell lysate”; (4)
“conducting an assay reaction for each well of said microarray plate”; and
(5) “analyzing the effect the drug of interest has on each of the nodes of the
disease pathway” (App. Br. 21, Clms. App’x) (emphases added).
Appellant contends that (1) “[Appellant’s] invention is directed to a
novel ‘side-by-side’ assay that permits the investigator to do a rapid but
meaningful assessment of the potential of a candidate drug or
therapeutic to be effective in the treatment of a disease or condition” (App.
Br. 13); (2) “[t]o provide directly comparable results - one MUST use the
identical cell in the at least six (6) different comparisons” (Id.); and (3) “the
reason for selecting a cell line for at least six (6) different wells, or test sites
- is to be able to compare the effects of changing the reagent or test
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conditions - all other variables are held constant” (Reply Br. 3). In other
words, Appellant appears to take the position that claim 11 requires the cells
of the same cell line be present in each of the six (6) wells. However, this is
not the case.
Although claim 11 recites that “only one primary cell, cell line or cell
lysate is present in any single well,” the claim also recites that “multiple
primary cells or cell lines are treated, each in their own tissue culture plate
well or vessel” and “adding six or more reagents to the wells of said micro
array plate occupied by a primary cell, cell line or cell lysate, wherein at
least one reagent is added to each of the wells of said micro array plate
occupied by a primary cell, cell line or cell lysate.” Emphases added. Claim
11 does not require that (1) “one primary cell or cell of a cell line is present
in each of at least six (6) wells for that given cell line”; or (2) “[r]eagents are
added to each of the at least six (6) wells occupied by each set of primary
cells or cell lines” (App. Br. 11).
We agree with the Examiner that
[claim 11 recites] a method of treating multiple
cell lines with a drug of interest; transferring the
treated cells to six or more wells of a microarray
plate, wherein no more than one cell line is present
in any single well; adding six or more reagents to
the wells of the plate occupied by any cell line,
wherein every well occupied by any cell line
receives at least one reagent; conducting an assay
to measure at least one node in a disease pathway,
and analyzing the effect of the drug at each
assayed node. Contrary to [Appellant’s]
arguments, the claims do not exclude assays of a
different cell line for each assayed node, nor do
they require testing of six different nodes in the
exact same cell line. In fact, they explicitly
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embrace assays of “multiple” cell lines. There is
no explicit or implied nexus between the identity
of anyone of the possible “multiple” cell lines and
the number of reagents that must be tested in that
one cell line

(Adv. Act. 32) (emphases added). We further agree with the Examiner that
(1) under the broadest reasonable interpretation, cells of different cell lines
can be present in each of the six (6) wells; and (2) “[a]ll that is required . . .
is that six or more reagents must be added to the microarray plate, and that
every well that comprises a cell line must also receive at least one reagent”
(see Adv. Act. 3).
Appellant contends that “Michnick teaches . . . away from what
[Appellant] claims - a method to test a drug at various nodes of the same
pathway using the same cell so that results can be meaningfully compared”
(App. Br. 17). Specifically, Appellant contends that
[w]hile it is true that, depending on what reagents and assays
are to be run, one might select a different cell line or primary
cell, pursuant to the extensive teaching in the specification,
nowhere does the Specification teach to change cell lines or [a]
primary cell source from one well to the next!
(Id. at 16). We disagree.
First, as discussed above, claim 11 does not require that cells of the
same cell line be present in each of the six (6) wells. Second, claim 11
merely requires “analyzing the effect the drug of interest has on each of the
nodes of the disease pathway,” it does not require “comparing results from
one well to another” (see App. Br. 21, Clms. App’x (emphases added);
Reply Br. 3). Third, Appellant’s Specification describes that (1) “multiple

2 Advisory Action, mailed October 13, 2011.
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treated primary cells, cell lines or cell lysates may be present in the wells of
the microarray plate, in any configuration, so long as each individual well
only has one treated primary cell, cell line or cell lysate” (Spec. 10, ll. 14-
17) (emphasis added); and (2) “the primary cells, cell lines, cell lysates and
reagents used in this method would change depending on what type of assay
is going to be performed in a particular well” (id. at 16, ll. 3-5 (emphasis
added); see also Adv. Act. 4). Consequently, contrary to Appellant’s
contention, the Specification does support changing cell lines or a primary
cell source from one well to the next. In this case, both the Examiner and
Appellant acknowledge that Michnick discloses that each well can have
different cells (see Ans. 8-9, 14-15; App. Br. 14-15, 19; Reply Br. 3).
Accordingly, Michnick does not teach away from the subject invention.
Appellant contends that Michnick fails to teach a number of the claim
recitations (App. Br. 17-18; Reply Br. 4-5). Appellant merely reiterates the
Examiner’s statements concerning what the Examiner regarded as not being
disclosed by Michnick (Id.). Appellant fails to point out how the
Examiner’s findings and conclusions of obviousness regarding the teachings
of Michnick lack rational underpinnings (see Ans. 7-10, 19-21). Such
arguments are insufficient to apprise us of error in the rejection. See In re
Lovin, 652 F.3d 1349 (Fed. Cir. 2011) (“we hold that the Board reasonably
interpreted Rule 41.37 to require more substantive arguments in an appeal
brief than a mere recitation of the claim elements and a naked assertion that
the corresponding elements were not found in the prior art.”).
Accordingly, for the foregoing reasons, we sustain the Examiner’s
rejection of claim 11 and of claim 12-17, 20-25, 28-33, 36-41 and 44, which
fall with claim 11, as being unpatentable over Michnick.
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Rejection 2 - Obviousness over Michnick and Wiley - Claims 18, 19, 26, 27,
34, 35, 42 and 433
Appellant contends that
if one of skill in the art were driven to use the
HMVEC or HUVEC cells of Wiley as the
“background” or “source” cells for the assay of
Michnick, one would still modify those cells to
express the exogenous genetic material - as
observed above, one of skill in the art would
recognize them as no longer HMVEC or HUVEC
cells - rather, they would be JMVEC cells
modified by each of six different genes in each of
the six different wells. . . .
The rejection advances the notion . . . that
somehow the claims do not require each well or
vessel out of six have the same primary cell or cell
of a cell line. The language is part of the
Specification and claims. The requirement is
central to the feature of the invention - a matrix
method that allows one of skill in the art to
compare the response of a set of cells to multiple
reagents/assays at various nodes of a disease
pathway. If each well has a different cell in it, as
required by the combination of Michnick and
Wiley - these results are not directly comparable.
It is true that the Specification teaches that
recombinant cells may be used in the invention.
But NOT a different recombinant cell in the six
wells of a given cell line or primary cell culture -
rather, recombinant cells may be selected to be the
tested cell in each of the six wells - they still have
the same cell

3 Claims 18 and 19 depend from claim 11. Claims 26 and 27 depend from
claim 21. Claims 34 and 35 depend from claim 29. Claims 42 and 43
depend from claim 37.
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(App. Br. 18-19; see also Reply Br. 6).
This argument assumes that the claims call for cells of the same cell
line to be present in each of the six (6) wells. For the reasons provided in
our analysis of claim 11 above, we disagree with Appellant’s premise that
claim 11 requires cells of the same cell line be present in each of the six (6)
wells. As discussed above, under the broadest reasonable interpretation,
claim 11 reads on cells of different cell lines being present in each of the six
(6) wells. Further, Appellant’s arguments do not address the Examiner’s
proposed modification of Michnick with the teachings of Wiley to meet the
subject matter of dependent claims 18, 19, 26, 27, 34, 35, 42 and 43 (see
Ans. 11-12). As such, based on the claim construction discussed above in
reference to claim 11 and claims 21, 29 and 37, which fall with claim 11, we
sustain the Examiner’s rejection of claims 18, 19, 26, 27, 34, 35, 42 and 43
as being unpatentable over Michnick and Wiley.

DECISION
We AFFIRM the decision of the Examiner to reject claims 11-44.
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

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