Streck, Inc.

Patent Trials and Appeals Board

Oct 28, 2020

2020001944 (P.T.A.B. Oct. 28, 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.
15/010,549 01/29/2016 Wayne L. Ryan 1251-048C2 9087
25215 7590 10/28/2020
The Dobrusin Law Firm P.C.
29 W. Lawrence Street
Suite 210
Pontiac, MI 48342
EXAMINER
MCNEIL, STEPHANIE A N
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
10/28/2020 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):
dobrusin_PAIR@firsttofile.com
patmail@patentco.com
rmasquelier@patentco.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte WAYNE L. RYAN
__________

Appeal 2020-001944
Application 15/010,549
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2,3 under 35 U.S.C. § 134 involving claims to a method for
inhibiting cellular aggregation in a biological sample using diazolidinyl urea. The
Examiner rejected the claims as indefinite, as anticipated, and on the grounds of
obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

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 Streck Inc., (see Appeal Br. 2).
2 We have considered and refer to the Specification of Jan. 29, 2016 (“Spec.”); Final
Action of Mar. 7, 2017 (“Final Act.”); Appeal Brief of June 17, 2019 (“Appeal Br.”);
and Examiner’s Answer of Sept. 27, 2019 (“Ans.”).
3 We note that Appellant does not identify any related appeals (see Appeal Br. 3), but
Appeal 2020-000655, US application 10/605,669, with same inventor and assignee, is
drawn to a method of adding diazolidinyl urea in similar amounts to cells.
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Statement of the Case
Background
“In biological and biochemical analysis, and related arts, it is often necessary to
collect and preserve biological tissues (i.e., cells and cellular components), for useful
periods of time” (Spec. ¶ 1). “The primary objective of tissue preservation is to
provide as much structural detail of cells and components thereof as possible” (id. ¶
4). “Thus, it is desirable in the art to obtain a method and a collection device that
maintain the cells in their original unaltered morphology and preserve their antigenic
sites” (id.). However, the “usual formulations for preservation of cells contain one or
more agents, which react vigorously with the proteins of the cells to denature and
insolubilize the components of the cell” (id. ¶ 5). “[I]t is also desirable to develop a
method and a collection device that allow transportation (e.g., from the collection site
to the analysis site) of the cells in ambient temperature” (id. ¶ 6).
The Claims
Claims 28–43 are on appeal.4 Independent claim 28 is representative and reads
as follows:
28. A method of inhibiting cellular aggregation in a
biologically active sample comprising mixing an effective
amount of diazolidinyl urea with a sample of viable cells,
wherein the effective amount of diazolidinyl urea is in a
concentration that is less than about 2:100 upon mixing with the
sample of viable cells.

The Issues
A. The Examiner finds that the claims do not receive benefit of priority under 35
U.S.C. §§ 119(e) and 120 to US applications 60/418,978, 10/605,669, and 12/850,269

4 We rely on the claims as presented in the July 1, 2019 supplemental Appeal Brief.
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because these priority applications do not provide descriptive support under 35 U.S.C.
§ 112(a) (Ans. 3–5).
B. The Examiner rejected claims 28–35, 37, and 38 under 35 U.S.C. § 112(b) as
indefinite (Ans. 5–6).
C. The Examiner rejected claims 28–40 and 43 under 35 U.S.C. § 102(a)(1) as
anticipated by Tsinberg5 (Ans. 6–7).
D. The Examiner rejected claims 36, 37, 39, and 41–43 under 35 U.S.C.
§ 102(a)(1) as anticipated by Ryan6 (Ans. 7)
E. The Examiner rejected claims 28–40 and 43 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over: claims 1, 5, 6 of US
5,459,073 and Tsinberg; claims 1–34 of US 6,337,189 and Tsinberg; claims 1–9 of
US 7,767,460 and Tsinberg (Ans. 8–10, 11).
F. The Examiner rejected claims 36, 37, 39, and 41–43 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over claim 1 of
US 5,459,073 and Ryan; claims 1–34 of US 6,337,189 and Ryan; claims 1–9 of US
7,767,460 and Ryan (Ans. 10–11, 11–12).
G. The Examiner provisionally rejected claims 28–40 and 43 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over claims 1,
30, 37, 51–63 of copending US application 12/850,269 and Tsinberg; claims 1, 4, 8,
10, 27, 31, 40, and 45–47 of copending US 10/605,669 and Tsinberg (Ans. 12–14, 15–
17).
H. The Examiner provisionally rejected claims 36, 37, 39, 41–43 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over claims 1,

5 Tsinberg et al, US 2012/0164676 A1, published June 28, 2012.
6 Ryan, US 5,250,438, issued Oct. 5, 1993.
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30, 37, 51–63 of copending US application 12/850,269; claims 1, 4, 8, 10, 27, 31, 40,
and 45–47 of copending US 10/605,669 and Ryan (Ans. 14–15, 17–19).

A. Priority
The Examiner finds the instant claims “fail to provide adequate support”
because the priority applications are “silent as to inhibiting cellular aggregation ‘in a
biologically active sample’ or one containing ‘viable cells’” (Ans. 4). The Examiner
also finds the “prior-filed applications are all drawn to fixation methods and make no
reference to ‘a biologically active sample’; the only biological activity disclosed is
cells’ ability to present their antigens” (id.).
Appellant contends “whether viewed in the context of the ’255 Patent or the
Priority Applications, the same result occurs –- inherency principles dictate that the
claim construction of ‘biologically active sample’ and ‘viable cells’ inherently is
present in the teachings of each” (Appeal Br. 18). Appellant asserts they
filed the Declaration Under Rule 132 of Carissa Moore, Ph.D.
(which was provided as Exhibit 1 in the Amendment dated
November 21, 2016). The test results in that Declaration
demonstrate that there is a period (during which mixing
necessarily would occur under the claims) after collection of a
blood sample when blood cells remain viable when mixed with
DU in varying amounts.
(id. at 21).
We find that Appellant has the better position. Provisional US Application
60/418,978 teaches “collecting the cells 20 using art-disclosed methods (e.g.,
venipuncture, use of a lancet, etc.)” (’978 provisional. 11:23–24). The ’978
provisional explains that cells are collected in a “tube with compounds consisting
essentially of: an anticoagulant agent” and “a fixative agent selected from the group
consisting of: diazolidinyl urea” (id. at 4:25–27). The ’978 provisional teaches that
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when using this collection process “cell clumping is prevented” (id. at 12:20).
Therefore, the provisional provides express support that combining an anticoagulant,
diazolidinyl urea, and cells will prevent cell clumping, which is reasonably equated
with cellular aggregation.
As to the question of viability, we agree with Appellant that the broadest
reasonable interpretation of claim 28 does not require that the cells remain viable after
addition of the diazolidinyl urea, but rather requires the cells to be viable at the
moment of combination. White blood cells obtained by venipuncture are reasonably
understood to be viable at the moment of combination with diazolidinyl urea. Even if
we interpreted the claims to require some viability for a period of time after
combination with diazolidinyl urea, Dr. Moore7 evidences that “each sample exhibited
viable cells over the period commencing with blood draw through at least 24 hours
after draw” (Moore Decl. ¶ 11). Thus, we find that both the reasonable claim
interpretation and the evidence support Appellant’s position that the ’978 provisional
provides support for viable cells combined with diazolidinyl urea. We therefore agree
that the claims are entitled to priority to the filing date of the ’978 provisional of
October 16, 2002.

B. 35 U.S.C. § 112(b), indefiniteness
The Examiner finds
Claims 28 and 37 are drawn to “a method of inhibiting cellular
aggregation in a biologically active sample,” but its active steps
are carried out on “a sample of viable cells,” not a “biologically
active sample.” It is unclear whether the scope of the method is
limited to inhibiting cellular aggregation in samples of viable

7 Declaration of Dr. Carissa Moore, dated Nov. 21, 2016.
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cells or to all methods in which cellular aggregation is limited
in any sample with any biological activity.
(Ans. 5).
We do not agree with the Examiner.8 Claims 28 and 37 broadly teach the use
of viable cells as the biologically active sample, specifically reciting the step of
“mixing an effective amount of diazolidinyl urea with a sample of viable cells.” It is
therefore clear that the method inhibits cellular aggregation in samples of viable cells,
as required by the claims. The claim therefore does not reasonably include “any
sample with any biological activity” as argued by the Examiner, but is limited to
samples that include viable cells. To the extent that the claims encompass both viable
cells and other biologically active materials, “breadth is not to be equated with
indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971). We reverse the
indefiniteness rejection.
C. 35 U.S.C. § 102(a)(1) over Tsinberg
We found above that the claims were entitled to priority to the filing date of the
’978 provisional of October 16, 2002. Tsinberg was filed Sept. 23, 2011 with a
provisional application filed on Sept. 23, 2010. Thus, even if Tsinberg is entitled to
the provisional priority date, a determination we need not make, Tsinberg is not prior
art to the instant application. We therefore reverse the anticipation rejection over
Tsinberg.

D. 35 U.S.C. § 102(a)(1) over Ryan

8 We recognize that Appellant proffered an amendment in an After-Final Response
filed Mar. 6, 2018 that was not entered by the Examiner in the Advisory mailed May
2, 2018.
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The Examiner finds “Ryan teaches that the amount of DU added was between
0.5 and 2%, and that it was added to blood in an instrument (reads on collection
container)” (Ans. 7). The Examiner finds, as to “the requirement that the method
results in less aggregation compared to samples that have not been treated, this is an
inherent property” (id.). The Examiner finds that because “the claims do not require
an active step of carrying out any downstream applications, Ryan’s teachings of
stabilized cells reads on these limitations of cells suitable for downstream
applications” (id.).
We agree with and adopt the position of the Examiner. Ryan teaches they
“discovered that the compound diazolidinyl urea stabilizes white blood cells” (Ryan
2:49–50). Ryan teaches
the invention provides an improved blood diluent having a predetermined
pH and osmolality for diluting whole blood samples to be mixed with a
lysing agent for the volumetric differentiation of white blood cells,
comprising an aqueous solution of organic buffer and a white blood cell
stabilizer, the improvement comprising employing as said white cell
stabilizer diazolidinyl urea.
(Ryan 2:53–60). Example I of Ryan teaches “samples of whole blood and the diluent
system were fed into the counting bath of the instrument and the lysing reagent
introduced” (Ryan 6:35–37). Example II of Ryan teaches a method where the “diluent
employed was similar to that employed in Example I except that concentrations of
diazolidinyl urea was varied from 0%, 0.5%, 0.75%, 1.0%, 1.5% and 2.0%” (Ryan
6:50–53). Example II of Ryan teaches “the diazolidinyl urea stabilizes the white
blood cells” (Ryan 6:59–60).
Thus, Ryan teaches mixing amounts of diazolidinyl urea in concentrations less
than 2:100 as required by claims 36, 37, 39, and 41–43. We agree with the Examiner
that Ryan’s mixing with blood, identical to that claimed, will necessarily and
inherently result in inhibiting cellular aggregation. The Examiner has therefore
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reasonably established a prima facie case of unpatentability at least based on
inherency, thereby shifting to Appellant the burden of proving that Ryan’s process
will yield different results. See In re Best, 562 F.2d 1252, 1255 (CCPA
1977)(“Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on
‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the burden
of proof is the same, and its fairness is evidenced by the PTO’s inability to
manufacture products or to obtain and compare prior art products”) (footnote omitted).
On this record, Appellant has proffered no such proof.
Appellant contends that in Ryan, “[t]here is no direct an[d] unambiguous
inherent teaching that mixing occurs ‘upon collection of the whole blood sample’”
(Appeal Br. 29).
We find this argument unpersuasive because Ryan teaches that “samples of
whole blood and the diluent system were fed into the counting bath of the instrument”
(Ryan 6:35–37). This is an express teaching to combine blood and the diluent system,
which in Example II includes five concentrations of diazolidinyl urea in
concentrations equal to or less than 2:100 (see Ryan 6:51–53).
Appellant contends the rejection “has failed to show any teaching of this
combination of a temporal feature (‘upon collection’) and structural feature (‘into a
sample collection container’)” (Appeal Br. 29). Appellant contends that to the extent
“the claimed ‘collection container’ reads on a hematology analytical instrument, the
phrase ‘collection container’ has been construed overly broad and unreasonably in
light of the Appellant’s specification” (id. at 30).
We find these arguments unpersuasive because the term “sample collection
container” is reasonably understood as any container in which a sample is placed and
Ryan unambiguously describes mixing whole blood with diazolidinyl urea in Example
II (see Ryan 6:33–61). Our review of the Specification finds no special definition of
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the term “sample collection container” (see, e.g., Spec. ¶ 16: “it should be understood
that a wide range of changes and modifications can be made to the preferred
embodiment described above for the container 10”). Nor does Appellant include any
limitations which distinguish the instrument of Ryan from other containers capable of
holding collected samples. Claim 37 does not impose any specific requirements on
the “sample collection container” other than the ability to hold a sample of whole
blood, something that the instrument of Ryan performs (see Ryan 6:35–37).
Appellant contends the rejection “has failed to make any findings of where
[Ryan] teaches the claim requirement regarding a ‘biologically active sample’ and
‘viable cells’” (Appeal Br. 30).
As discussed above, we agree with Appellant that the instant application
inherently provides support for “viable cells.” We similarly find that Ryan’s teaching
of whole blood also provides inherent descriptive support for viable cells, since just as
Appellant’s cells would have been expected to be viable at the moment of
combination, so would the whole blood cells of Ryan (see Ryan 6:35–37).
We therefore affirm the anticipation rejection over Ryan.

E. Obviousness-type double patenting including Tsinberg
These rejections over the ’073, ’189, and ’460 patents rely upon the
combination with Tsinberg. As discussed above, Tsinberg is not prior art to the
instant application. As the ’189 and ’460 patents require disclosure from Tsinberg to
render the claims obvious, we reverse these obviousness type double patenting
rejections.
We address the rejection over the ’073 patent separately because that rejection
does not require teachings from Tsinberg. We note the Board may rely on less than
all of the references applied by the Examiner in an obviousness rationale without
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designating it as a new ground of rejection. In re Bush, 296 F.2d 491, 496 (CCPA
1961).
Claim 1 of the ’073 patent teaches “suspending cytological material having one
or more antigenic sites in a fixing amount of a fixative” where the fixative “is selected
from the group consisting of: i) diazolidinyl urea.” Claim 1 of the ’073 patent does
not discuss the nature of the cytological material nor the amounts of diazolidinyl urea
recited in claim 28. While we recognize that “the patent disclosure may not be used
as prior art . . . it may be used as a dictionary to learn the meaning of terms in a
claim.” In re Vogel, 422 F.2d 438, 441 (CCPA 1970); cf. Abbvie Inc. v. Mathilda &
Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1380 (Fed. Cir. 2014).
Here we use the Specification of the ’073 patent as a dictionary to determine
what constitutes cytological material and what constitutes a “fixing amount of a
fixative” of diazolidinyl urea. The Specification of the ’073 patent explains that
cytological material may be “derived from any source including normal blood, bone
marrow, lymph, or solid tissues, or may be derived from abnormal tissues such as
leukemias or solid tissue cancers” (’073 patent 5:22–25). The Specification of the
’073 patent also explains the “amount of the active agents in the formulation of the
invention is that effective to fix or stabilize the tissue . . . falls in the range of about
20 to 100 grams per liter” (’073 patent 6:15–18). The Specification of the ’073 patent
teaches exemplary amounts including “20-40 grams of diazolidinyl urea . . . per 1000
ml of solvent used” (’073 patent 6:23–26).
Therefore, claim 1 of the ’073 patent is reasonably understood to teach a
method of suspending materials including normal blood, reasonably understood to
include viable cells, in amounts of diazolidinyl urea of about 2:100. As to the
teaching of 2:100 in the ’073 patent and the recitation of “less than about 2:100” in
claim 28, we find these disclosures “so mathematically close that the examiner
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properly rejected the claims as prima facie obvious.” In re Brandt, 886 F.3d 1171,
1177 (Fed. Cir. 2018).
Appellant contends:
the claims of U.S. 5,459,073 are directed toward a control material. One
skilled in the art would be well aware of the distinction between a control
material (material that is designed to mimic a naturally occurring sample
but that must be permanently fixed to maintain long term shelf life for
continuous long term use in a flow cytometry device) and a composition
utilized so that a blood sample for use in diagnostic testing can be
transferred without freezing for testing. One skilled in the art would have
no motivation to combine one with the other.
(Appeal Br. 32).
We find this argument unpersuasive for two reasons. First, we do not rely upon
Tsinberg and therefore do not require a reason to combine the ’073 patent with
Tsinberg. Second, the issue is not whether the ’073 patent is drawn to a control
material but rather whether the ’073 patent teaches the performance of the active step
of the method of claim 28, “mixing an effective amount of diazolidinyl urea with a
sample of viable cells, wherein the effective amount of diazolidinyl urea is in a
concentration that is less than about 2:100.” As discussed above, claim 1 of the’073
patent, with terms properly defined by the Specification, teaches this step and
therefore suggests all of the limitations of claim 28.
We therefore affirm the obviousness-type double patenting rejection over the
’073 patent.

F. Obviousness-type double patenting including Ryan
The Examiner finds claims 36, 37, 39, and 41–43 obvious over claims of the
’073, ’189, and ’460 patents in view of Ryan, specifically finding the “artisan would
have further reasonably expected that the method of the’073 patent would yield a
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sample suitable for use in downstream applications because Ryan teaches these
concentrations of DU stabilize the cells” (Ans. 10; cf. Ans. 11–12 for the ’189 and
’460 patents).
Appellant contends that Ryan does not teach the use of viable cells and that
Ryan and these patents “are completely unrelated to the claimed composition for
stabilizing a blood sample for downstream diagnostic testing” (Appeal Br. 33).
We find this argument unpersuasive. As discussed above, Ryan teaches “that
the compound diazolidinyl urea stabilizes white blood cells” (Ryan 2:49–50) and
specifically teaches combining whole blood samples with diazolidinyl urea (see Ryan
2:55–60) in amounts within the claimed range (see Ryan 6:51–53). Thus, we find it
would have been obvious to employ the stabilization method of Ryan with the
“establishing a positive control” method of the ’073 patent for use in downstream
methods as noted by the Examiner (see Ans. 10). We also agree that such a
stabilization method would have been useful in the “method for preserving a
biological test specimen to screen for multiple assays” of the ’189 patent and in the
“blood sedimentation rate analysis” of the ’460 patent. Appellant provides no
evidence or other rebuttal arguments regarding these motivations.

G. and H. Provisional obviousness-type double patenting
We summarily affirm the provisional obviousness-type double patenting
rejections because Appellant does not dispute the merits of this rejection. See Manual
of Patent Examining Procedure § 1205.02 (“If a ground of rejection stated by the
examiner is not addressed in the appellant’s brief, that ground of rejection will be
summarily sustained by the Board.”)
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
28–35, 37, 38 112(b) Indefiniteness 28–35, 37,
38
28–40, 43 102(a)(1) Tsinberg 28–40, 43
36, 37, 39, 41–
43
102(a)(1) Ryan 36, 37,
39, 41–43

28–40, 43 Obviousness
-type Double
Patenting
US 5,459,073,
Tsinberg
28–40, 43
28–40, 43 Obviousness
-type Double
Patenting
US 6,337,189, US
7,767,460,
Tsinberg
28–40, 43
36, 37, 39, 41–
43
Obviousness
-type Double
Patenting
US 5,459,073, US
6,337,189, US
7,767,460, Ryan
36, 37,
39, 41–43

28–40, 43 Provisional
Obviousness
-type Double
Patenting
US 12/850,269,
US 10/605,669,
Tsinberg
28–40, 43
28–40, 43 Obviousness
-type Double
Patenting
US 12/850,269,
US 10/605,669,
Ryan
28–40, 43
Overall
Outcome
28–43

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