C A Casyso AG

Patent Trials and Appeals Board

Feb 22, 2021

2020003758 (P.T.A.B. Feb. 22, 2021)

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.
15/056,666 02/29/2016 Axel Schubert 102082-1003242-000810US 3114
20350 7590 02/22/2021
Kilpatrick Townsend & Stockton LLP - West Coast
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
EXAMINER
MARTIN, PAUL C
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
02/22/2021 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):
KTSDocketing2@kilpatrick.foundationip.com
ipefiling@kilpatricktownsend.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte AXEL SCHUBERT
____________

Appeal 2020-003758
Application 15/056,666
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, 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 23–30, 37–44, 52–61, and 63 (Final Act.2 2). 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 “C.A.
CASYSO AG” (Appellant’s December 30, 2019 Appeal Brief (Appeal Br.)
3).
2 Examiner’s July 29, 2019 Final Office Action.
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STATEMENT OF THE CASE
Appellant’s disclosure relates “to diagnostic compositions for use in
the viscoelastic analysis of a test liquid, and to a container comprising same.
The present invention further is directed to a method of performing a
viscoelastic analysis on a test liquid, and to the use of the diagnostic
composition in such a method” (Spec. 1). Claim 23 is reproduced below:
23. A method of performing a viscoelastic analysis on a test
liquid, comprising the steps of:
a) adding the test liquid into a container comprising a
diagnostic composition that comprises the following
constituents: a lipidated or recombinant Tissue Factor (TF); a
calcium salt; and optionally an inhibitor of heparin, wherein
each of the constituents is present in an essentially dry form and
in an amount sufficient for performing one single viscoelastic
analysis of a test liquid, and wherein the constituents are not
present in a substance mixture, but in a spatially separated
form, thereby dissolving the diagnostic composition contained
therein in the test liquid to form a mixture;
b) optionally transferring the mixture of said test liquid
and said diagnostic composition into an apparatus suitable for
performing a viscolelastic analysis; or putting the container into
an apparatus suitable for performing a viscolelastic analysis;
and
c) performing the viscoelastic analysis of said mixture.
(Appeal Br. 17.)

Grounds of rejection before this Panel for review:
Claims 23–25, 30, 37, 38, 53–58, 60, and 61 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Morrissey.3

3 Morrissey et al., US 7,148,067 B2, issued Dec. 12, 2006.
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Claims 23–30, 37–40, 52–61, and 63 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Morrissey and Calatzis
’216.4
Claims 23–25, 30, 37, 38, 41–44, 53–58, 60, and 61 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over the combination of Morrissey
and Klose.5
Claims 23–30, 37–40, 52–59, and 63 stand provisionally rejected
under the judicially created doctrine of obviousness-type double patenting as
being unpatentable over claims 2–4, 6, 9–11, 15, and 21–28 of Calatzis
’3646 in view of Morrissey.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that Morrissey discloses:
[A] method of performing a viscoelastic analysis (prothrombin
time clotting assay) on a liquid, comprising;
adding the test liquid (human blood plasma) into a
container comprising [a thromboplastin regent comprising]
relipidated, recombinant tissue factor, serum albumin and
CaCl2;

4 Calatzis et al., WO 2008/093216 A1, published Aug. 7, 2008.
5 Klose et al., US 4,515,889, issued May 7, 1985.
6 Calatzis et al., US 2010/0190193 A1, published July 29, 2010 (Application
12/522,364).
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transferring the mixture or performing the analysis using
a coagulometer; and performing the viscoelastic analysis
(determination of clotting time) of the mixture.
(Ans. 7 (citing Morrissey 13:48–67, 14:1–15, and 14:38–47); see also
Morrissey 3:49–53 (Morrissey defines a “[t]hromboplastin reagent” as “any
reagent which contains TF and that when 100 µL of the reagent pre-warmed
to 37° C. is mixed with 50 µL plasma pooled from normal individuals will
result in clotting within 1 minute; and when neat and warmed to 37° C. does
not clot within 2 minutes”).)
FF 2. Morrissey discloses that “the thromboplastin regent contains Ca2+, or
the Ca2+ may be added just prior to use of the reagent” (Morrissey 5:64–65;
id. at 6:1 (Morrissey discloses that “Ca2+ is preferably added as CaCl2”); see
Ans. 7).
FF 3. Morrissey discloses that “Ca2+ may be provided with the
thromboplastin reagent in a kit, with each part separately packed,
optional[ly] with each reagent [in] dry form” (Morrissey 5:66–6:1; id. at
6:61–62 (Morrissey discloses that “[s]ome or all of the components may be
provided in dried forms”); see Ans. 8).
FF 4. Examiner finds that Morrissey fails to disclose “a method wherein
each constituent is present in an amount sufficient for performing a single
viscoelastic analysis; or wherein the reagents are in a container to which the
test liquid is added thereby dissolving the diagnostic composition” (Ans. 8).
FF 5. Examiner finds that Morrissey fails to disclose:
[A] method wherein performing the viscoelastic analysis takes
about 1-60 seconds, or about 2-10 seconds or about 5 seconds,
as required by Claims 26, 39 and 40;
wherein the mixture is transferred by manually or
automatically pipetting the mixture from the container and
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transferring it to a viscoelastic analysis apparatus, as required
by Claim 27;
wherein the mixture is transferred to a measuring cup of
the apparatus, as required by Claim 28;
wherein the apparatus is a thromboelastometer or a
thromboelastograph, as required by Claim 29;
wherein the reagent mixture comprises an inhibitor of
heparin selected from heparinase, protamine or protamine-
related peptides, as required by Claims 52 and 63;
or wherein the container has an inner portion shaped in a
manner that it can be attached to a device for performing
viscoelastic measurements, as required by Claim 59,
and relies on Calatzis ’216 to make up for these deficiencies in Morrissey
(Ans. 10 (emphasis omitted); see also id. at 10–13).
FF 6. Examiner finds that Morrissey fails to disclose:
[A] method wherein the spatial separation of the constituents is
realized by incorporating each constituent into a separate carrier
material, as required by Claim 41;
or wherein the carrier material comprises the
carbohydrate cellulose which shows no significant influence on
clotting behavior, clot formation behavior, or clot lysis
behavior, as required by Claims 42, 43 and 44,
and relies on Klose to make up for these deficiencies in Morrissey (Ans. 14
(emphasis omitted); see also id. at 14–15).
FF 7. Examiner finds that Klose discloses:
[A] method for carrying out an analytical determination on a
liquid sample comprising an insert element wherein several
different analysis reagents are spatially separated from one
another and wherein the analysis reagents are dried for
example, by lyophilization or present in the form of a granulate,
in tableted form or the like (Column 5, Lines 55-68 and
Column 15, Claim 1);
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and wherein the reagents can be present as individual
components and can consist of individual paper carriers
(cellulose) each of which contains a definite amount of reagent
impregnated therein (Column 9, Lines 50-56).
(Ans. 14–15.)
ANALYSIS
The rejection over Morrissey:
Appellant’s claim 23, reproduced above, is representative.
Based on Morrissey, Examiner concludes that, at the time Appellant’s
invention was made, it would have been prima facie obvious to modify
Morrissey’s method “of performing a viscoelastic analysis (prothrombin
time clotting assay) on a blood plasma sample to have each component
present in an amount sufficient for performing a single viscoelastic analysis
because this would ensure that there was enough component for the
performance of the assay without extraneous wastage” (Ans. 8). Examiner
further finds that it would have been prima facie obvious, at the time of
Appellant’s claimed invention, to modify Morrissey’s method “so that the
reagents are in a container to which the test liquid is added thereby
dissolving the diagnostic composition because the selection of any order of
combining the test liquid and reagent composition is prima facie obvious”
(Ans. 9 (citing In re Burhans, 154 F.2d 690 (CCPA 1946) (selection of any
order of performing process steps is prima facie obvious in the absence of
new or unexpected results))). We find no error in Examiner’s prima facie
case of obviousness.
Disclosed examples and preferred embodiments do not constitute a
teaching away from a broader disclosure or non-preferred embodiments. In
re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971); see also In re Lamberti, 545
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F.2d 747, 750 (CCPA 1976) (A reference disclosure is not limited only to its
preferred embodiments, but is available for all that it discloses and suggests
to one of ordinary skill in the art.). Thus, we are not persuaded by
Appellant’s contention that, although, “Morrissey teaches a kit of a
thromboplastin reagent and a Ca2+ salt in dried form,” “Morrissey never
actually performed any clotting assay using dried and separately kept
thromboplastin reagent and Ca2+ salt. Morrissey performed only a liquid
format of clotting assay” (Appeal Br. 7).
Claim 23 requires that each of the TF and calcium salt are present in
essentially dry form and spatially separated. Because Morrissey discloses
the separate packaging of dry reagents (FF 3), we are not persuaded by
Appellant’s contention that Morrissey “fail[s] to provide a motivation to
keep the constituents of the diagnostic composition . . . in an essentially dry
form and spatially separate” (Appeal Br. 8; see also Reply Br. 2).
We are not persuaded by Appellant’s reliance on Leo Pharmaceutical
Products, Ltd. v. Rea, 726 F.3d 1346 (Fed. Cir. 2013) (see Appeal Br. 8–9;
Reply Br. 2–3). According to Appellant, the record before this Panel
presents “a very similar fact pattern” to that before our reviewing Court in
Leo, because:
[T]here was nothing in . . . [Morrissey] indicating any
recognition of a rapid decline in assay performance over the
time period the reagents were mixed, lyophilized, and stored
before being used in the assays, let alone any recognition of the
distinction between keeping the reagents together or separate
prior to use.
(Appeal Br. 9.) As discussed above, Morrissey describes both of the
components in dry and separate form, the same arrangement Appellant
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asserts. Thus, on this record, Appellant has, at best, discovered a new
benefit of an old process, which cannot render the old process patentable.
It is a general rule that merely discovering and claiming a
new benefit of an old process cannot render the process again
patentable. . . . While the processes encompassed by the claims
are not entirely old, the rule is applicable here to the extent that
the claims and the prior art overlap.
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Prindle, 297
F.2d 251, 254 (CCPA 1962) (“[M]ere recognition of . . . latent properties [in
the prior art] does not render the otherwise obvious [invention] unobvious”).
Although it is true that Morrissey does not appear to have recognized
the problem asserted to have been overcome by Appellant, unlike in Leo,
Appellant’s solution to the problem was not in devising an unknown
solution that was not predictable, but was instead, the mere recognition of
latent properties associated with an embodiment of Morrissey’s disclosure.
As stated in In re Baxter Travenol Labs., 952 F.2d 388 (Fed. Cir. 1991):
Baxter argues that the unexpected hemolysis-suppression
quality of DEHP rebuts any prima facie showing of
obviousness. However, when unexpected results are used
as . . . with the closest prior art. . . . Since the prior art bags
plasticized with DEHP were inherently suppressing hemolysis,
albeit unknown at the time of the Becker document, this
hemolysis-suppressing function is not a basis for rebutting a
prima facie finding of obviousness.
Id. at 392.
Because Morrissey alone makes obvious the method of Appellant’s
claim 23, we agree with Examiner’s finding that Morrissey is the closest
prior art on this record (see Ans. 17). See In re Baxter, 952 F.2d at 392
(“[W]hen unexpected results are used as evidence of nonobviousness, the
results must be shown to be unexpected compared with the closest prior
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art.”). As Appellant acknowledges, a comparison of the method of
Appellant’s claim 23 against the closed prior art, Morrissey, “is a demand
for Appellant to compare the claimed method against itself to show
surprising results” (Reply Br. 6).
For the foregoing reasons, we are not persuaded by Appellant’s
contention:
The closest prior art is already used as the comparison
basis (the viscoelastic assay method in the pre-mixed reagent
format) in Dr. Schwaiger’s [D]eclaration,[7] because the only
difference between the comparison basis and the claimed
invention is whether or not the assay reagents were kept
spatially separate until the time of assay.
(Reply Br. 6.)
Further, in order to be persuasive of non-obviousness, “[e]vidence of
secondary considerations must be reasonably commensurate with the scope
of the claims.” In re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
As Examiner explains, on this record, the comparative experiments set forth
in the Schwaiger Declaration are not comparative in scope with the claimed
invention (Ans. 17). Specifically, Schwaiger addresses a comparison of
compositions comprising “a [H]eparin inhibitor” which is not required, but
is instead an optional reagent, in the method of Appellant’s claim 23 (see
Schwaiger Decl. ¶¶ 5–7; cf. Ans. 17 (Examiner finds that the method of
Appellant’s claim 23 “recite[s] a composition comprising . . . the optional
presence of an inhibitor of Heparin, whereas the Declarant notes that the
reagents used include . . . a Heparin inhibitor.”)). Thus, we are not

7 Declaration of Martin Schwaiger, Ph.D., signed December 27, 2017 (“the
Schwaiger Declaration” or “Schwaiger Decl.”).
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persuaded by Appellant’s reliance on the Schwaiger Declaration to support a
finding of unexpected results on this record (see Appeal Br. 12–16).
Because, as discussed above, Morrissey makes obvious the method of
Appellant’s claim 23, we are not persuaded by Appellant’s contention that
“keeping reagents spatially separate requires additional effort and results in
additional cost” and, therefore, “it is not something one would be inclined to
do unless there is a definitive and pressing need” (Reply Br. 4–5).

The rejection over Morrissey and Calatzis ’216:
Appellant’s claim 23, reproduced above, is representative.
Based on the combination of Morrissey and Calatzis ’216, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious to combine Morrissey’s method “for performing a
viscoelastic analysis of blood plasma comprising . . . dried, spatially
separated reagent[s] with” Calatzis ’216’s method “of performing a
viscoelastic analysis on blood because this is no more than the combination
of prior art elements (methods for performing blood viscoelastic analysis)
according to known methods (same reagent composition) to yield
predictable results (blood viscoelastic analysis)” (Ans. 13; see FF 1–5). See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results.”).
Having found that Morrissey makes obvious the method of
Appellant’s claim 23, we find no error in Examiner’s prima facie case of
obviousness, as it relates to Appellant’s representative claim 23. The Board
may rely upon less than all the references cited by the Examiner. See In re
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May, 574 F.2d 1082, 1090 (CCPA 1978); In re Kronig, 539 F.2d 1300, 1304
(CCPA 1976).

The rejection over Morrissey and Klose:
Appellant’s claim 23, reproduced above, is representative.
Based on the combination of Morrissey and Klose, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious to combine Morrissey’s method “for performing a
viscoelastic analysis of blood plasma comprising a dried, spatially separated
reagent with” Klose’s disclosure of
reagents being present as individual components and can
consist of individual paper carriers (cellulose) each of which
contains a definite amount of reagent impregnated therein
because this is no more than the combination of prior art
elements (reagents for performing blood viscoelastic analysis)
according to known methods (combining reagents with blood
sample) to yield predictable results (blood viscoelastic
analysis).
(Ans. 15; see FF 1–4, 6, and 7). See KSR, 550 U.S. at 416 (“The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.”).
Having found that Morrissey makes obvious the method of
Appellant’s claim 23, we find no error in Examiner’s prima facie case of
obviousness, as it relates to Appellant’s representative claim 23. The Board
may rely upon less than all the references cited by the Examiner. See In re
May, 574 F.2d at 1090; In re Kronig, 539 F.2d at 1304.
In addition, we find that Klose’s disclosure of an analytical method,
wherein the method’s reagents are dry and spatially separated from one
another (FF 7) amplifies and supports Morrissey’s disclosure of maintaining
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separately packed dry reagents (FF 3). Thus, we find no error in Examiner’s
conclusion that the combination of Morrissey and Klose makes obvious the
method of Appellant’s claim 23 (cf. Reply Br. 4–5 (“Klose at best indicates a
general understanding of variable reagent stability during storage” and “does
not provide any specific motivation to keep reagents in dried and separate
form before performing viscoelastic analysis and therefore cannot
supplement the missing motivation in this obviousness analysis”)).
Because Morrissey and Klose both disclose the separation of dry
reagents (FF 3 and 6–7), we are not persuaded by Appellant’s contention
that Morrissey and Klose “viewed individually or together, fail to provide a
motivation to keep the constituents of the diagnostic composition . . . in an
essentially dry form and spatially separate” (Appeal Br. 8).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable
over Morrissey. Claims 24, 25, 30, 37, 38, 53–58, 60, and 61 are not
separately argued and fall with claim 23.
The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Morrissey and Calatzis ’216. Claims 24–30, 37–40,
52–61, and 63 are not separately argued and fall with claim 23.
The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Morrissey and Klose. Claims 24, 25, 30, 37, 38,
41–44, 53–58, 60, and 61 are not separately argued and fall with claim 23.

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Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
FACTUAL FINDINGS (FF)
FF 8. Calatzis ’364 claims:
21. A method of performing a viscoelastic analysis on a test
liquid, comprising:
a) obtaining a the test liquid;
b) providing a container according to comprising the
diagnostic composition of claim 1;
c) adding the test liquid into said container, thereby
dissolving the diagnostic composition contained therein;
d) optionally transferring a mixture of said test liquid and
said diagnostic composition so obtained into an apparatus
suitable for performing a viscoelastic analysis;
or
putting the container into an apparatus suitable for performing a
viscoelastic analysis; and
e) performing the viscoelastic analysis of said mixture.
(Calatzis ’364 6.)
FF 9. Calatzis ’364 claims:
1. A diagnostic composition for use in viscoelastic analysis of
a test liquid, comprising the following constituents:
a) at least one activator of coagulation;
b) optionally a calcium salt, preferably CaC12, in an
amount sufficient to ensure recalcification of the test liquid;
and,
c) optionally one or more inhibitors and/or other coagulation
components or factors;
wherein
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the composition is present as an essentially dry mixture of all
constituents and in an amount sufficient for performing one
single viscoelastic analysis of a specified test liquid.
(Id. (emphasis added).)
FF 10. Calatzis ’364 claims:
3. The diagnostic composition of claim 1, wherein the extrinsic
activator of coagulation is the Tissue Factor (TF).
(Id.)
FF 11. Calatzis ’364 claims:
4. The diagnostic composition of claim 3, wherein the Tissue
Factor is selected from lipidated TF or rTF.
(Id.)
FF 12. Examiner relies on Morrissey as discussed above (see Ans. 5–6; see
also FF 1–3).
ANALYSIS
Examiner finds that “[a]lthough the claims at issue are not identical,”
to those set forth in Calatzis ’364, “they are not patentably distinct from each
other because both methods are drawn to the performance of a viscoelastic
analysis on a test liquid involving the use of the same reagents” (Ans. 5; see
FF 8–12; cf. Appeal Br. 17). Examiner recognizes that the claims of
Calatzis ’364 relate to co-lyophilized reagents, as opposed to the unmixed
reagents, required by the method of Appellant’s claim 23, that are present in
a spatially separated form (Ans. 5). Examiner finds, however, that
Morrissey discloses a method of performing a viscoelastic analysis on a test
liquid, wherein the reagents required to perform the method are unmixed in a
spatially separated form (see Ans. 5; see also FF 12). Thus, Examiner
concludes that it would have been prima facie obvious to modify the method
claimed by Calatzis ’364 to use Morrissey’s unmixed spatially separated
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reagents (see Ans. 6)). We find no error in Examiner’s prima facie case of
obviousness-type double patenting.
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Calatzis ’364’s “pending claims . . . are drawn to a method of
performing a viscoelastic assay by mixing a test liquid with a co-lyophilized
composition” and “shows no recognition of any performance issues
associated with how the reagents are stored before assay time” (Appeal Br.
9–10; see also Reply Br. 3). Because Morrissey discloses that dry, unmixed
spatially separated reagents may be used in a viscoelastic analysis, we are
not persuaded by Appellant’s contention that Calatzis ’364’s preference for a
“pre-mixed reagent format” teaches away from the method of Appellant’s
claim 23 (see id.).
For the reasons set forth above, we are not persuaded by Appellant’s
contentions regarding Leo (see Appeal Br. 10–11).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The provisional rejection of claim 23 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 2–4, 6, 9–11, 15, and 21–28 of Calatzis ’364. Claims 24–30, 37–40,
52–59, and 63 are not separately argued and fall with claim 23.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
23–25,
30, 37, 38,
53–58, 60, 61
103(a) Morrissey 23–25,
30, 37, 38,
53–58, 60,
61

23–30,
37–40,
52–61, 63
103(a) Morrissey, Calatzis
’216
23–30,
37–40,
52–61, 63

23–25, 30,
37, 38,
41–44,
53–58, 60, 61
103(a) Morrissey, Klose 23–25, 30,
37, 38,
41–44,
53–58, 60,
61

23–30,
37–40,
52–59, 63
Provisional
Obviousness-type
Double Patenting,
Calatzis ’364,
Morrissey
23–30,
37–40,
52–59, 63

Overall
Outcome
23–30,
37–44,
52–61, 63

TIME PERIOD FOR RESPONSE
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