Wayne Ryan

Patent Trials and Appeals Board

Aug 21, 2020

10605669 - (D) (P.T.A.B. Aug. 21, 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.
10/605,669 10/16/2003 Wayne L. Ryan 1251-048 2668
25215 7590 08/21/2020
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
08/21/2020 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 2020-000655
Application 10/605,669
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
method for collecting mammalian blood cells. The Examiner rejected the
claims as obvious and on the grounds of obviousness-type double patenting.
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 Streck Inc.
(see App. Br. 2).
2 We have considered and refer to the Specification of Oct. 16, 2003
(“Spec.”); Final Action of Aug. 15, 2018 (“Final Act.”); Appeal Brief of
May 15, 2019 (“Appeal Br.”); and Examiner’s Answer of Sept. 3, 2019
(“Ans.”).
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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 1, 4, 8, 10, 27, 31, 40, 45–47 and 52–61 are on appeal.
Independent claim 1 is representative and reads as follows:
1. A method for collecting mammalian blood cells, comprising
steps of:
(a) providing a tube including preloaded compounds consisting
of
(i) ethylene diamine tetra acetic acid (EDTA) and
(ii) diazolidinyl urea, the tube having an open end and a
closed end that receives cells collected directly from a blood
draw and wherein a majority of an interior portion of the tube is
substantially free of contact with the preloaded components;
(b) drawing a blood sample containing a plurality of blood cells
into the tube whereby it contacts the preloaded compounds to yield a
final composition, wherein a ratio of a volume of the preloaded
compounds to a combined volume of the blood sample and the
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preloaded compounds is from about 1:100 to about 2:100, and so that
blood cells of the blood sample are stabilized directly and
immediately upon blood draw; and
(c) transporting the blood sample, wherein the blood sample is
drawn and transported in the same tube with no processing steps
between blood draw and transporting.

The Issues
A. The Examiner rejected claims 1, 4, 10, 27, 31, 40, 45–47, 53–58, 60,
and 61 under 35 U.S.C. § 103(a) as obvious over Ryan,3 Camiener,4
Zelmanovic,5 and Ames6 (Ans. 3–8).
B. The Examiner rejected claims 8, 52, and 59 under 35 U.S.C. § 103(a)
as obvious over Ryan, Camiener, Zelmanovic, Ames, and Deindoerfer7
(Ans. 8–9).
C. The Examiner rejected claims 1, 4, 10, 27, 31, 40, 45–47, 53–58, 60,
and 61 on the ground of nonstatutory obviousness-type double patenting as
being unpatentable over: claims 1, 5, 6 of US 5,459,073; claims 9, 11, 12 of
US 5,977,153; claims 1, 5 of US 7,419,832; claims 1–34 of US 6,337,189;
claims 1–9 of US 7,767,460; each separately in view of Ryan, Camiener,
Zelmanovic, and Ames (Ans. 9–17).
D. The Examiner rejected claims 8, 52, and 59 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 5, 6 of US 5,459,073; claims 9, 11, 12 of US 5,977,153; claims 1,
5 of US 7,419,832; claims 1–34 of US 6,337,189; claims 1–9 of US

3 Ryan, W., US 5,849,517, issued Dec. 15, 1998.
4 Camiener, G., US 5,977,153, issued Nov. 2, 1999.
5 Zelmanovic et al., US 5,817,519, issued Oct. 6, 1998.
6 Ames et al., An Appraisal of the “Vacutainer” System for Blood
Collection, 12 Ann. Clin. Biochem 151 (1975).
7 Deindoerfer et al., US 3,874,384, issued Apr. 1, 1975.
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7,767,460; each separately in view of Ryan, Camiener, Zelmanovic, Ames,
and Deindoerfer (Ans. 14–17).
E. The Examiner provisionally rejected claims 1, 8, 27, 40, 45–47, 52,
54, 55, 59, 60 on the ground of nonstatutory obviousness-type double
patenting as being unpatentable over claims 54, 57, 64–66, 70, and 72 of
copending US application 12/850,269 alone, or in combination with Ryan,
Camiener, Zelmanovic, and Ames (Ans. 17–18).

A–D Obviousness and Obviousness-type double patenting
We will consider rejections A–D together because these four
obviousness and obviousness-type double patenting rejections share the
same issues and substantially the same prior art.
The issues with respect to these rejections are:
(i) Does a preponderance of the evidence of record support the
Examiner’s conclusion that the combination of prior art renders claim 1
obvious?
(ii) If so, has Appellant provided evidence of commercial success that,
when considered with the prima facie case, results in a finding that the
evidence considered as a whole does not support the obviousness of claim 1?
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Findings of Fact
1. Ryan teaches:
Patient samples are treated by mixing them directly with a preferred
fixative solution of the present invention. The preferred ratio of sample
to reagent is 1:1 but a ratio as low as 1:4 or as high as 2:1 is acceptable.
For example, 1 ml peripheral blood is added to a vial containing 1 ml
fixative solution, mixed and stored at 4° C.
(Ryan 8:35–40).
2. Ryan teaches a “preferred fixative solution of the present
invention comprises imidazolidinyl urea (IDU), polyethylene glycol and
EDTA, preferably in a buffered physiological salt solution” (Ryan 4:23–26).
3. Ryan teaches: “In a preferred embodiment of the present
invention, the fixative solution comprises diazolidinyl urea (Du) and/or
imidazolidinyl urea (IDU) in a buffered physiological salt solution. In a
highly preferred embodiment, the fixative solution further comprises
polyethylene glycol and EDTA” (Ryan 7:9–14).
4. Ryan teaches the “preferred concentration of Du is from about 1
% to about 20% by weight” (Ryan 4:49–50).
5. The Examiner finds that in Ryan’s
preferred final composition containing both sample and fixative, DU
is present at about 0.5% to about 10% (that is, the 1–20% DU solution
is diluted 1:1 with the sample). “0.5%” is mathematically equivalent
to “0.5:100” and “1:200.” Regarding claims 31 and 53, Ryan teaches
fixative solutions containing 50g DU in 1 liter total, i.e. 0.05 g of DU
per ml of fixative solution.
(Final Act. 3).
6. Ryan teaches the “use of Du preserves the cell structure, nucleic
acids, and cell antigens. Thus, the sample can be transported or held in the
lab for several days” (Ryan 9:13–15).
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7. Camiener teaches a “solution was prepared using citric, alkane-
sulfonic, glycolic, and salicylic acids plus diazolidinyl urea at a molar ratio
of 1.8. The material was evaporated . . . The reactive group content and
fixative activity was found to be unchanged” (Camiener 9:9–15).
8. Camiener teaches blood may be preserved using the disclosed
compositions (see Caminer 7:42–47) and ingredients may include “chelating
agents (such as EDTA and its alkali metal or ammonium salts), all of which
are used in a conventional manner in fixative solutions” (Camiener 8:13–
15).
9. Zelmanovic teaches “solutions of sodium citrate or K3EDTA
can be mixed with a blood sample . . . about 7 to 14 mg of K3EDTA in
powder form are used per 7 cc tube” (Zelmanovic 18:27).
10. Ames teaches vacutainer tubes that may contain EDTA (see
Ames 151).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Claim Interpretation
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art or analyzed for
patent eligibility. We find two limitations that require interpretation. First,
independent claims 1, 27, and 40 each recite a step requiring a collection
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container/tube that is “preloaded” with or “contains preloaded” “compounds
consisting of: (i) ethylene diamine tetra acetic acid (EDTA); and (ii)
diazolidinyl urea.” Second, these claims also have a volumetric ratio
requirement: that “a ratio of a volume of the preloaded compounds to a
combined volume of the blood sample and the preloaded compounds is from
about 1:100 to about 2:100” (claim 1); “ratio of a volume of the preloaded
compounds to a volume of the final composition is from about 1:100 to
about 2:100” (claims 27 and 40).
“collection container preloaded compounds consisting of: (i)
ethylene diamine tetra acetic acid (EDTA); and (ii) diazolidinyl urea”
It is well settled that the transitional phrase “consisting of” excludes
any element, step, or ingredient not specified in the claim. In re Gray, 53
F.2d 520 (CCPA 1931). Thus, the use of the transitional phrase “consisting
of” suggests that the collection container contains solely EDTA and
diazolidinyl urea. This understanding is consistent with Appellant’s
amendment filed May 2, 2016, where Appellant contends “the preloaded
contents have been limited to IDU, EDTA, and glycine” and cites MPEP
2111.03 regarding the limiting effect of “consisting of” (see Amdt. 5/2/2016
at 5). The claims were further limited to only EDTA and diazolidinyl urea
in the Amendment filed April 12, 2018 (see Amdt 4/12/2018 at 2).
We therefore interpret the claim to require a collection container
containing compounds that are solely EDTA and diazolidinyl urea.
“ratio of a volume of the preloaded compounds to a combined
volume of the blood sample and the preloaded compounds is from
about 1:100 to about 2:100”
The Specification’s explains that the “preloading step 204 may
optionally include freeze drying the compounds in the tube 12” (Spec. ¶ 29).
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Thus, the Specification encompasses both liquid and dry formulations.
However, in the amendment filed January 3, 2012, Appellant deleted the
limitation “drying the compounds” (see Amdt 1/3/2012 at 2), suggesting that
the claim recites compounds in the tube in liquid form. The claim itself, by
using the phrase “volume of the preloaded compounds” also reasonably
supports a finding that the preloaded compounds are in liquid form.
Therefore, we interpret the claim to require a liquid volume of the
preloaded compounds that is between 1:100 to about 2:100 relative to the
liquid volume of the blood sample added in combination with the preloaded
compounds.
Obviousness
Appellant contends “Ryan does not teach preloading DU and EDTA
into the sample collection tube” and contends that even if “Camiener
suggests a composition comprising EDTA and DU
. . . . the Final Office Action has not established that Camiener teaches
compounds consisting of EDTA and DU” (Appeal Br. 22). Appellant also
contends “above, Ryan appears to teach away from a volume ratio of ‘about
1:100 to about 2:100’, as that is clearly not within the acceptable volume
range disclosed above in Ryan” (Appeal Br. 20; cf. FF 1).
The Examiner responds that “it is the primary reference Ryan who
teaches collecting the blood sample into an EDTA vacutainer, and that it is
useful to also combine a DU fixative with this blood EDTA mixture” (Ans.
19). The Examiner responds to the ratio issue by finding that
Ryan teaches contacting 1 ml of the biological sample with 1 ml of
DU solution, and that Ryan therefore teaches that in the preferred final
composition containing both sample and DU fixative, the DU is
present at about 0.5% to about 10% (that is, the 1–20% DU solution is
diluted 1: 1 with the sample). As explained above, “0.5%” is
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mathematically equivalent to “0.5:100” and “1:200.” Moreover, it is
noted that even Ryan’s teaching of amounts as low as 1%, before the
dilution, also read on the claimed amount. Furthermore, the rejection
above states that it is obvious to use preloaded dried DU with the
EDTA in Ryan’s method, not only a diluted DU as applicant alleges.
(Ans. 18–19).
We agree with Appellant on both issues. As to the recitation of
“consisting of,” the Examiner does not identify a teaching in Ryan,
Camiener, Zelmanovic, Ames, or Deindoerfer that teaches a solution
composed solely of EDTA and diazolidinyl urea. Ryan does teach a fixative
composed of “imidazolidinyl urea (IDU), polyethylene glycol and EDTA,
preferably in a buffered physiological salt solution” (FF 2; cf. FF 3), but this
fixative does not consist of the urea and EDTA compounds alone, but also
includes polyethylene glycol and a salt solution. The Examiner provides no
persuasive reasoning explaining why a fixative composition solely
composed of EDTA and diazolidinyl urea as required by all of the
independent claims would be obvious.
As to the limitation reciting a “a volume of the preloaded compounds
to a combined volume of the blood sample and the preloaded compounds is
from about 1:100 to about 2:100,” the Examiner interprets this as
encompassing the situation where equal volumes of fixative and blood may
be used, so long as the amount of diazolidinyl urea in the fixative solution is
only 1% of the total volume. Consistent with our claim interpretation above,
we understand the claims to require that the total volume of the preloaded
fixative solution itself is between 1% and 2% of the blood sample plus
preloaded fixative. Therefore, when a volume of blood sample is being
added to the tube such that the combined volume of the blood and preloaded
fixative is 1 ml, the volume of the preloaded fixative solution must be
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between about 10 µl and 20 µl, not a 1 ml fixative solution that only has
between about 10 µl and 20 µl of diazolidinyl urea and EDTA along with
solvents.
While we do not agree with Appellant that Ryan teaches away,
because Ryan does not discredit the use of volumes outside the preferred
ratios (FF 1), and we recognize that the volume of fixative solution is an
optimizable variable as argued by the Examiner (see Ans. 21), we find
“[m]issing from the . . . analysis is an explanation as to why it would have
been routine optimization to arrive at the claimed invention.” In re Stepan
Co., 868 F.3d 1342, 1346 (Fed. Cir. 2017). In this case, the Examiner
provides no explanation as to why the ordinary artisan would have had either
reason to modify Ryan’s ratio of 1:4 and optimize to a 1:100 or 2:100 ratio
as recited by the claims or a reasonable expectation of success in doing so.
We therefore conclude that the Examiner has not established a prima
facie case of obviousness.
Commercial success
We recognize the commercial success data submitted by Appellant in
the Owen Declarations dated Dec. 21, 2011 and Jan. 9, 2015. We do not
find the evidence particularly persuasive because the evidence only shows
an increase in sales of Cyto-Chex BCT product relative to the Streck Cell
Preservative product, but does not demonstrate growth relative to other
manufacturers. That is, the market is limited to “direct draw tubes for long
term stabilization” but evidence simply shows that the market itself grew,
not that there was any preference for the product at issue.
In any case, we need not rely upon the commercial success
information because the Examiner did not establish a prima facie case of
obviousness.
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Conclusion of Law
(i) A preponderance of the evidence of record does not support the
Examiner’s conclusion that the combination of references renders the claims
obvious.
(ii) Appellant has provided some evidence of commercial success but
we need not rely upon this evidence in view of the unpersuasive prima facie
case of obviousness.
E. Provisional Double Patenting
When application on appeal is provisionally rejected based on later-
filed application, and all other rejections on appeal are reversed, the proper
course is not to reach the provisional obviousness-type double patenting
rejection. Ex parte Moncla, 95 USPQ2d 1884 (BPAI 2010). Here, US
application 12/850,269 remains pending and an Appeal Brief was filed on
May 20, 2020. Thus, we do not reach the provisional double patenting
rejection over claims 54, 57, 64–66, 70, and 72 of that application.
(According to MPEP § 804, if the double-patenting rejection is the only one
remaining in the senior application, the Examiner should withdraw the ODP
rejection and require a TD in the junior application.)
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4, 10, 27,
31, 40, 45–47,
53–58, 60, 61
103 Ryan, Camiener,
Zelmanovic,
Ames,
1, 4, 10, 27,
31, 40, 45–
47, 53–58,
60, 61
8, 52, 59 103 Ryan, Camiener,
Zelmanovic,
8, 52, 59
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
Ames,
Deindoerfer
1, 4, 10, 27,
31, 40, 45–47,
53–58, 60, 61
Obviousnes
s-type
Double
Patenting
US 5,459,073,
Ryan, Camiener,
Zelmanovic,
Ames
1, 4, 10, 27,
31, 40, 45–
47, 53–58,
60, 61
1, 4, 10, 27,
31, 40, 45–47,
53–58, 60, 61
Obviousnes
s-type
Double
Patenting
US 5,977,153,
Ryan, Camiener,
Zelmanovic,
Ames
1, 4, 10, 27,
31, 40, 45–
47, 53–58,
60, 61
1, 4, 10, 27,
31, 40, 45–47,
53–58, 60, 61
Obviousnes
s-type
Double
Patenting
US 7,419,832,
Ryan, Camiener,
Zelmanovic,
Ames
1, 4, 10, 27,
31, 40, 45–
47, 53–58,
60, 61
1, 4, 10, 27,
31, 40, 45–47,
53–58, 60, 61
Obviousnes
s-type
Double
Patenting
US 6,337,189,
Ryan, Camiener,
Zelmanovic,
Ames
1, 4, 10, 27,
31, 40, 45–
47, 53–58,
60, 61
1, 4, 10, 27,
31, 40, 45–47,
53–58, 60, 61
Obviousnes
s-type
Double
Patenting
US 7,767,460,
Ryan, Camiener,
Zelmanovic,
Ames
1, 4, 10, 27,
31, 40, 45–
47, 53–58,
60, 61
8, 52, 59 Obviousnes
s-type
Double
Patenting
US 5,459,073,
Ryan, Camiener,
Zelmanovic,
Ames,
Deindoerfer
8, 52, 59
8, 52, 59 Obviousnes
s-type
Double
Patenting
US 5,977,153,
Ryan, Camiener,
Zelmanovic,
Ames,
Deindoerfer
8, 52, 59
8, 52, 59 Obviousnes
s-type
US 7,419,832,
Ryan, Camiener,
8, 52, 59
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
Double
Patenting
Zelmanovic,
Ames,
Deindoerfer
8, 52, 59 Obviousnes
s-type
Double
Patenting
US 6,337,189,
Ryan, Camiener,
Zelmanovic,
Ames,
Deindoerfer
8, 52, 59
8, 52, 59 Obviousnes
s-type
Double
Patenting
US 7,767,460,
Ryan, Camiener,
Zelmanovic,
Ames,
Deindoerfer
8, 52, 59
1, 8, 27, 40,
45–47, 52, 54,
55, 59, 60
Provisional
Obviousnes
s-type
Double
Patenting
US application
12/850,269

Overall
Outcome
1, 4, 8, 10,
27, 31, 40,
45–47, 52–
61

REVERSED