X-Body, Inc.

Patent Trials and Appeals Board

Nov 16, 2020

14849203 - (D) (P.T.A.B. Nov. 16, 2020)

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.
14/849,203 09/09/2015 Lance G. Laing 429468-000002 1005
128166 7590 11/16/2020
DLA Piper LLP (US) Boston
Attn: Patent Group
11911 Freedom Dr.
Suite 300
Reston, VA 20190
EXAMINER
PRIEST, AARON A
ART UNIT PAPER NUMBER
1637
NOTIFICATION DATE DELIVERY MODE
11/16/2020 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):
BostonIPDocketing@dlapiper.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte LANCE G. LAING, RICK WAGNER,
RAFAEL FERNANDEZ, and ALEXANDER YUZHAKOV
____________

Appeal 2020-002116
Application 14/849,203
Technology Center 1600
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 11, 12, and 15–19 (Appeal Br.2 1).3 We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “X-Body,
Inc., . . . a subsidiary of Juno Therapeutics, Inc., which is a subsidiary of
Bristol-Myers Squibb Company” (Appellant’s February 3, 2020 updated
Real Party in Interest 1).
2 Appellant’s February 18, 2019 Appeal Brief.
3 Claims 1–10, 13, 14, and 20–24 are canceled (see Appellant’s February 18,
2019 After-Final Amendment 5; see also Examiner’s March 5, 2019
Advisory Action (“Claims 1–10, 13–14 and 20–24 are canceled”)).
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STATEMENT OF THE CASE
Appellant’s disclosure relates to “a method of identifying an
antagonist or agonist of an ion channel” (Spec.4 2). Appellant’s only
independent claim, claim 11, is reproduced below:
11. A method of identifying a modulator of an ion channel
comprising:
(a) applying cells in a serum-free medium to a surface of a
colorimetric resonant reflectance optical biosensor,
wherein one or more extracellular matrix (ECM) ligands
are immobilized to the surface of the biosensor;
(b) detecting a colorimetric resonant reflectance optical first
peak wavelength value (PWV) for the cells;
(c) applying one or more test ion channel modulators to the
surface of the biosensor;
(d) effecting a change in the activity of one or more ion
channels of the cells;
(e) detecting a colorimetric resonant reflectance optical
second PWV for the cells; and
(f) determining if the one or more test ion channel
modulators modulated the one or more ion channels of
the cells.
(Appeal Br. 19.)

Grounds of rejection before this Panel for review:
Claims 11, 12, and 15–19 stand rejected under 35 U.S.C. § 112(b).

4 Appellant’s November 23, 2015 Specification.
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Claims 11, 12, and 15–19 stand rejected under 35 U.S.C. § 103 as
unpatentable over the combination of Picard,5 Lin,6 Cunningham,7 Priest,8
Dorn,9 Tang,10 Renner,11 and Streunker.12
Claims 11, 12, and 15–19 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–20 of Binder13 in view of Pichard, Linn, Cunningham, Priest, Tang,
Dorn, Renner, and Streunker.

DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that the term “colorimetric resonant reflectance optical biosensor,” is
indefinite?

5 Picard, US 2004/0091397 A1, published May 13, 2004.
6 Lin et al., US 2007/0054339 A1, published Mar. 8, 2007.
7 Cunningham et al., US 2003/0027327 A1, published Feb. 6, 2003.
8 Priest et al., Role of hERG potassium channel assays in drug development,
2 Channels 87–93 (2008).
9 Dorn et al., Evaluation of a High-Throughput Fluorescence Assay Method
for hERG Potassium Channel Inhibition, 10 J. Biomolecular Screening 339–
347 (2005).
10 Tang et al., Development and Evaluation of High Throughput Functional
Assay Methods for hERG Potassium Channel, 6 J. Biomolecular Screening
325–331 (2001).
11 Renner et al., US 5,811,299, issued Sept. 22, 1998.
12 Struenker et al., US 2008/0227819 A1, published Sept. 18, 2008.
13 Binder et al., US 9,778,267 B2, issued Oct. 3, 2017.
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ANALYSIS
Examiner finds that “[t]he metes and bounds of ‘colorimetric resonant
reflectance optical biosensor’ are unclear in light of the few examples in
[Appellant’s] Specification” (Final Act.14 8; see also Ans.15 3–7). We are
not persuaded.
Appellant discloses that Cunningham and Picard disclose colorimetric
resonant reflectance biosensors (see Spec. 11; see also id. at 11–16
(Appellant distinguishes colorimetric resonant reflectance biosensors from
other biosensors). Amplifying Appellant’s disclosure, Examiner’s
obviousness rejection, discussed below, relies on Cunningham and Picard, in
addition to Lin, to disclose colorimetric resonant reflectance biosensors (see
Final Act. 10–13; Ans. 7–11; see also Lin, Title (disclosing the use of a
colorimetric resonant reflectance optical biosensor)). Thus, we find that the
evidence of record supports a conclusion that, at the time of Appellant’s
claimed invention, those of ordinary skill in this art understood the scope of
the term colorimetric resonant reflectance biosensors. See In re Moore, 439
F.2d 1232, 1235 (CCPA 1971) (Claim language must be analyzed “not in a
vacuum, but always in light of the teachings of the prior art and of the
particular application disclosure as it would be interpreted by one possessing
the ordinary skill in the pertinent art.”).
In addition, we agree with Appellant’s contention that a “patent need
not teach, and preferably omits, what is well known in the art” (Reply Br.16
5). See Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384

14 Examiner’s June 22, 2018 Final Office Action.
15 Examiner’s November 21, 2019 Answer.
16 Appellant’s January 21, 2020 Reply Brief.
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(Fed. Cir. 1986). Therefore, we are not persuaded by Examiner’s assertions
regarding “essential material” (see Ans. 5 (internal quotations omitted)).
To the extent that Examiner is concerned with distinguishing the
scope of the term colorimetric resonant reflectance biosensors from other
biosensors (see Final Act. 8–10), we note that “breadth is not to be equated
with indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971).
To be complete, we recognize Examiner’s assertion that Appellant’s
May 7, 2018 Response to Examiner’s February 7, 2018 non-Final Office
Action contradicted Appellant’s Specification by asserting that “Picard does
not teach or suggest . . . colorimetric resonant reflectance optical biosensors”
(see Appellant’s May 7, 2018 Response 11; see also Final Act. 9; cf. Spec.
11 (“Biosensors of the invention can be colorimetric resonant reflectance
biosensors. See e.g., . . . [Picard,] U.S. Pat. Publ. No. 2004/0091397.”)).
We note, however, that Appellant subsequently corrected this misstatement
(see Reply Br. 2 (Appellant contends that Picard “cited at page 11, line 11,
of the specification teaches detailed structures of colorimetric resonant
reflectance biosensors”)).
CONCLUSION
The preponderance of evidence fails to support Examiner’s conclusion
that the term “colorimetric resonant reflectance optical biosensor,” is
indefinite. The rejection of claims 11, 12, and 15–19 under 35 U.S.C.
§ 112(b) is reversed.

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OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Initially we note Examiner’s reliance on Cunningham 200217 (see
Ans. 8–10; cf. Reply Br. 7 (Appellant contends that “Examiner’s Answer
appears to cite to two different references by Cunningham (designated
‘Cunningham’ and ‘CUNNINGHAM’”)). Examiner’s statement of the
rejection does not, however, rely on Cunningham 2002 (see Final Act. 10–
11).18 Examiner also does not designate the obviousness rejection, as set
forth in the Answer, as a new ground of rejection. Therefore, we do not
include Cunningham 2002 in our deliberations.
Based on the combination of Picard, Lin, Cunningham, Priest, Dorn,
Tang, Renner, and Streunker, Examiner concludes that, at the time
Appellant’s invention was made, it would have been prima facie obvious
to apply familiar ion channel screening assays to the familiar
“colorimetric resonant reflectance optical biosensors” of the
prior art in order to perform high-sensitivity assays without any
type of label in a format that is readily compatible with the
microtiter plate-based or microarray-based infrastructure that is

17 Cunningham et al., Colorimetric resonant reflection as a direct
biochemical assay technique, 81 Sensors and Actuators B 316–328 (2002).
18 In re Hoch, 428 F.2d 1341, 1342 n.3 (CCPA 1970) (“Where a reference is
relied on to support a rejection, whether or not in a ‘minor capacity,’ there
would appear to be no excuse for not positively including the reference in
the statement of the rejection.”).
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most often used for high-throughput biomolecular interaction
analysis with a reasonable expectation of success.
(Final Act. 11.) In this regard, Examiner finds that a person of ordinary skill
in this art
would have been motivated to apply non-label detection of ion
channel modulators using the familiar ‘colorimetric resonant
reflectance optical biosensor’ (CRROB) of . . . [(Picard,]
CUNNINGHAM and LIN) to the familiar ion channel assay
using hERG-transfected CHO cells of Priest, Tang, Dorn and
STREUNKER, as modified according to the teachings of
RENNER and STREUNKER . . . in order to simplify the ion
channel assay with a reasonable expectation of success.
(Ans. 8; see generally id. 7–11 (citing Cunningham ¶¶ 3, 5, 15, 44, 103, 175,
284 and claims 16, 18; Lin ¶¶ 11–14, 43, 44, 71, 76, 110, 139–145, 208–
214; Picard, Figs. 1–10 and ¶¶ 29, 45–50, 60; Renner 1:41–64, 6:63–10:29;
Struenker ¶¶ 53, 54, 74, 76, 96, 119–126); see also Final Act. 11–13 (citing
Picard, Figs. 1–10 and ¶¶ 29, 45–50, 60; Lin, Figs. 1–14 and ¶¶ 110, 115;
Cunningham, Figs. 1–18 and ¶¶ 5, 287; Priest, Abstract and 89; Dorn 341;
Tang 326; Renner 1:41–64, 6:63–10:29; Struenker ¶¶ 53, 54, 74, 76, 96,
119–126.) We are not persuaded.
As Appellant explains, “not all cell-based assays are alike” (Reply Br.
7). “Priest, Tang, and Dorn measure the amount of markers (Rb+ or
fluorescent dyes) that move into or out of cells in order to detect[] ion
channel modulation,” and “[t]he detection of mass changes on the surface of
a biosensor due to e.g., cell presence or absence as taught by Cunningham,
Lin, and Picard is different from detection of ion channel modulation
properties of a test reagent” (Appeal Br. 11; see also Reply Br. 8–10).
Stated differently, “[n]othing in the prior art teaches or suggests that changes
in ion channel modulation as taught by Priest, Tang, and Dorn could be
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detected by methods other than by measuring the amount of markers (Rb+ or
fluorescent dyes) that move into or out of cells,” and “Picard, Lin, and
Cunningham do not teach or suggest anything about measuring the amount
of markers (Rb+ or fluorescent dyes) that move into or out of cells, and do[]
not teach or suggest any methods of determining ion channel modulation by
test reagents” (id. (footnote omitted); see also id. at 13).
In addition, Appellant explains why “Renner and Struenker do not
remedy the deficiencies of Picard, Lin, Cunningham, Priest, Tang, and
Dorn”:
Renner teaches the production of recombinant proteins
using animal cells using serum-free and protein-free culture
media. Renner neither teaches nor suggests methods of
identifying a modulator of an ion channel comprising applying
cells in a serum-free medium to a surface of a colorimetric
resonant reflectance optical biosensor, wherein one or more
extracellular matrix (ECM) ligands are immobilized to the
surface of the biosensor. In fact, Renner never mentions any
type of biosensors.
Streunker teaches assays using voltage-sensitive
fluorescent dyes. Streunker neither teaches nor suggests a
method of identifying a modulator of an ion channel comprising
applying cells in a serum-free medium to a surface of a
colorimetric resonant reflectance optical biosensor, wherein one
or more extracellular matrix (ECM) ligands are immobilized to
the surface of the biosensor. In fact, Streunker never mentions
any type of biosensors, let alone label-free colorimetric
resonant reflectance biosensors.
(Appeal Br. 16.)
For the foregoing reasons, we agree with Appellant’s contention that
Examiner “has not provided a proper reasoning and motivation to combine
the references, a reasonable expectation of success has not been identified,
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and the cited art does not teach or suggest all elements of the claims”
(Appeal Br. 16).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 11, 12, and
15–19 under 35 U.S.C. § 103 as unpatentable over the combination of
Picard, Lin, Cunningham, Priest, Dorn, Tang, Renner, and Streunker is
reversed.

OBVIOUSNESS-TYPE DOUBLE PATENTING:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
ANALYSIS
Examiner finds that Binder claims “a method to identify a compound
that is a modulator of an ion channel using the same ‘colorimetric resonant
reflectance optical biosensor’,” but does “not explicitly teach ‘serum-free’
media or ECM ligands” (Final Act. 16). Examiner relies on Picard, Lin,
Cunningham, Priest, Dorn, Tang, Renner, and Streunker, as discussed above,
to make up for this deficiency in the claims of Binder (id.).
Appellant agrees that Binder’s claims “do not recite, inter alia,
applying cells in a serum-free medium to a surface of a colorimetric resonant
reflectance optical biosensor” and contends that “Picard, Lin, Cunningham,
Priest, Tang, Dorn, Renner, and Streunker do not teach or suggest that this
feature is merely an obvious variant” (Appeal Br. 17). Thus, Appellant
contends:
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None of the cited references, in combination, or alone, teach or
suggest methods of identifying a modulator of an ion channel
comprising applying cells in a serum-free medium to a surface
of a colorimetric resonant reflectance optical biosensor, wherein
one or more extracellular matrix (ECM) ligands are
immobilized to the surface of the biosensor.
(Id.)
Examiner does not address Appellant’s contentions. Thus, we find
that Examiner failed to carry the burden of maintaining the obviousness-type
double patenting on this record. See In re Hedges, 783 F.2d 1038, 1039
(Fed. Cir. 1986) (“If a prima facie case is made in the first instance, and if
the applicant comes forward with reasonable rebuttal, whether buttressed by
experiment, prior art references, or argument, the entire merits of the matter
are to be reweighed.”).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness-type double patenting. The rejection of
claims 11, 12, and 15–19 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–20
of Binder in view of Pichard, Linn, Cunningham, Priest, Tang, Dorn,
Renner, and Streunker is reversed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
11, 12, 15–19 112(b) Indefiniteness 11, 12, 15–
19
11, 12, 15–19 103 Picard, Lin,
Cunningham, Priest,
Dorn, Tang,
Renner, Streunker
11, 12, 15–
19
11, 12, 15–19 Nonstatutory
Double Patenting,
claims 1–20 of
Binder, in view of
Picard, Lin,
Cunningham, Priest,
Dorn, Tang,
Renner, Streunker
11, 12, 15–
19
Overall
Outcome
11, 12, 15–
19

REVERSED