Saori Otsuka et al.

Patent Trials and Appeals Board

Sep 20, 2019

14061333 - (D) (P.T.A.B. Sep. 20, 2019)

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.
14/061,333 10/23/2013 Saori OTSUKA Q207547 6715
23373 7590 09/20/2019
SUGHRUE MION, PLLC
2000 PENNSYLVANIA AVENUE, N.W.
SUITE 900
WASHINGTON, DC 20006
EXAMINER
GOUGH, TIFFANY MAUREEN
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
09/20/2019 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):
PPROCESSING@SUGHRUE.COM
USPTO@sughrue.com
sughrue@sughrue.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SAORI OTSUKA, KAZUKI HATCHO,
TOSHIHIRO MIZUKAMI, and SHINICHIRO OGUNI

Appeal 2018-005485
Application 14/061,333
Technology Center 1600
____________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1,2 appeals from the
Examiner’s decision to reject claims 8–19 for obviousness and on the ground
of non-statutory 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(a). Appellant identifies the real party in interest as Sysmex
Corporation. Appeal Br. 2.
2 A hearing was held on August 28, 2019. See Transcript (“Tr.”).
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STATEMENT OF THE CASE
Claims 8–19 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. Claim 8 is representative of the claims on appeal, and
reads as follows:
8. A reagent kit for classifying leukocytes comprising
a first reagent containing a fluorescent dye capable of
staining nucleic acid; and
a second reagent containing cationic and nonionic
surfactants for lysing erythrocytes and damaging cell
membranes of leukocytes so as to be permeable to the
fluorescent dye and an aromatic organic acid at a concentration
of not less than 20 mM and not more than 50 mM,
wherein when the second reagent contains the aromatic
organic acid at a concentration of not less than 20 mM and less
than 30 mM, the second reagent has pH of not lower than 5.5
and not higher than 6.4, and when the second reagent contains
the aromatic organic acid at a concentration of not less than 30
mM and not more than 50 mM, the second reagent has pH of
not lower than 5.5 and not higher than 7.0.
Appeal Br. 21 (Claims Appendix). Claim 14, the only other independent
claim, recites a reagent composition containing a cationic and nonionic
surfactant in conjunction with an aromatic organic acid. See id. at 22.
The claims stand rejected as follows:
I. Claims 8–19 are rejected under pre- AIA § 35 U.S.C. § 103(a) over
Narikawa (EP 2202516 A1, published June 30, 2010)(“EP’516”) and
Mizukami (EP 0882983 A2, published Sept. 12, 1998)(“EP’983);
II. Claim 8 is rejected on the ground of non-statutory obviousness-type
double patenting over claim 9 of US 6,004,816 (issued Dec. 21, 1999).
III. Claim 8 is rejected on the ground of non-statutory obviousness-type
double patenting over claims 1, 2, 6−8, 16, and 18 of US 8,101,414 B2
(issued Jan. 24, 2012).
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IV. Claims 8 and 13 are rejected on the ground of non-statutory obviousness-
type double patenting over claim 8 of US 8,802,025 B2 (issued Aug. 12,
2014) in view of EP’516 and EP’983.
V. Claims 8 and 13 are rejected on the grounds of non-statutory
obviousness-type double patenting over claim 8 of US 8,445,209 B23
(issued May 21, 2013) in view of EP’516 and EP’983.
VI. Claims 8 and 13 are rejected on the grounds of non-statutory
obviousness-type double patenting over claim 8 of US 8,859,200 B2
(issued Oct. 14, 2014) in view of EP’516 and EP’983.

I. Obviousness over EP’516 and EP’983
Examiner finds that EP’516 teaches a kit for differentiating
leukocytes, the kit comprising a first reagent containing fluorescent dye and
a second reagent containing a cationic and a nonionic surfactant. Ans. 4
(citing EP’516 ¶¶ 12–15, 23–29, 32–46, 48, and 50–52). Examiner
acknowledges that EP’516 does not disclose the pH range as presently
claimed. Id. Examiner relies on the teaching of EP’983 for teaching a
similar leukocyte differentiating composition, and specifically relies on
EP’983 for teaching aromatic organic acids at a pH range between 5 to 10.
Id. at 5. EP’983 exemplifies a leukocyte differentiating formulation having
a pH of 7. Id. Based on this combination, Examiner concludes that “it
would have been obvious to one of ordinary skill in the art to combine the
claimed components together in a kit and as a reagent for classifying
leukocytes because they are known in the art to exist together as a reagent

3 We note that the patent number cited in the Final Office Action and
Answer appears to contain a typographical error. See Tr. 16:14–17:3.
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and combined in a kit with the fluorescent dye.” Id. Examiner further notes
that the teachings of the combined prior art includes the claimed organic
acid concentrations as well as the claimed pH. Id. Examiner finds “that
adjusting the concentrations [of organic acid] and pH are result effective
variables and it is well within the purview of one of ordinary skill in the art
to adjust such as a practice of routine optimization to achieve a desired
result.” Id., see also id. at 15 (EP’983 teaches “that if the pH is too low or
too high, separation [of cells] is poor and it becomes difficult to classify into
cell populations and can damage leukocytes.”).
Appellant contends that Examiner has not presented a prima facie case
but, and even if, the Board were to conclude that Examiner has met the
initial burden of presenting a prima case, their unexpected results merit a
reversal of the rejection. See Appeal Br. 11–19.
The issue is: (1) Does the preponderance of evidence of record
support Examiner’s conclusion that the combination of EP’516 and EP’983
renders the claimed kit for classifying leukocyte populations obvious; and
(2) if so has Appellant provided sufficient evidence of unexpected results?
A. Findings of Fact (FF)
FF1. EP’983 teaches “[w]hen the reagent[/kit] and method of the present
invention are used, not only can normal leukocytes be classified into
at least 1–5 populations and counted by the type of population, but []
the classification and counting of abnormal cells [can] be performed
simultaneously with their classification and counting.” EP’983, 6:24–
26. Example 6 of EP’983 discloses a formulation for differentiating
leukocytes comprising:
HEPES
10 mM Commercially available product
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BC30TX (polyoxyethylene (30) cetyf ether)
1500 ppm Nikko Chemicals
Lauryl trimethylammonium chloride
550 ppm Commercially available product
Dye Compound A
0.5 ppm
Acid [either citric acid or phthalic acid]
20 mM Commercially available product
pH adjusted to 7.0 with NaOH
Id. 10:36–46.
FF2. EP’983 teaches that “[w]hen phthalic acid (an organic acid having an
aromatic ring in the molecular structure) was used as the acid,
separation of neutrophils from eosinophils was improved compared
with the use of citric acid.” Id. 10:56–57. “[T]he incorporation into
the hemolytic agent of at least one organic acid having at least one
aromatic ring in a molecule or a salt thereof is preferred for the
purpose of adjusting the scattered light intensity distribution of
leukocytes so as to be more suitable for classification. For example,
benzoic acid, phthalic acid, . . . or a salt of any of these acids can be
used preferably as the organic acid or its salt.” Id. 4:25–29.
FF3. EP’983 teaches sample preparation by mixing blood with hemolytic
agent. “The purpose of this step is merely to form pores in the cell
membrane of a leukocyte cell to be measured, the pores being of a
sufficient size for at least dye molecules to pass through. The
hemolytic agent used for this purpose is an aqueous solution of pH 4.5
to 11.0, preferably 5.0 to 10.0, which contains at least one cationic
surfactant, at least one nonionic surfactant, and a buffer for
maintaining a constant pH.” Id. 3:40–44, see id. 4:32–33 (“The pH of
the hemolytic agent is 4.5 to 11.0, preferably 5.0 to 10.0. To maintain
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a constant pH, a buffer such as citrate, HEPES or phosphate is
contained in the hemolytic agent”).
FF4. EP’983 teaches that:
[i]f the pH is too low, eosinophils and basophils
are separated poorly, and it becomes difficult to
classify normal leukocytes into 5 populations [, i.e.
lymphocytes, monocytes, neutrophils, eosinophils,
and basophils]. However, it is possible to classify
normal leukocytes into 3 categories (lymphocytes,
monocytes, granulocytes) and to classify and count
immature leukocytes and abnormal leukocytes.
Too high a pH is [also] not preferred because it
will make leukocytes prone to damage.
Id. 4:34–38.
FF5. EP’516 teaches a reagent kit for classifying leukocytes containing
cationic surfactant a nonionic surfactant and an aromatic carboxylic
acid in conjunction with a fluorescent dye. EP’516, Abstract. EP’516
explains that cell membranes of blood cells must be damaged so that
the fluorescent dye can permeate into the cell. Id. ¶ 16.
FF6. EP’516 teaches that “[t]he concentration of the aromatic carboxylic
acid or a salt thereof in the first reagent is not specifically limited as
long as the pH of the first reagent is within the range described below,
and [the aromatic carboxylic acid] is preferably 0.1 to 100 mM and
more preferably 0.5 to 50 mM.” Id. ¶ 51. “[T]he pH of the first
reagent is preferably acidic, such as preferably 2.0 to 4.5, more
preferably 2.0 to 3.5. Within this pH range, granules of basophils are
stable. In addition, within this pH range, erythrocytes can be
efficiently lysed without excessively affecting leukocytes, nucleated
erythrocytes and the like.” Id. ¶ 54.
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B. Analysis
Appellant contends: (1) that “the pHs used in EP’516 and EP’983 are
incompatible with each other” (Appeal Br. 11); (2) that none of the cited
documents disclose pH as a result effective variable (id. at 11–12); (3) that
EP’516 teaches away from the presently recited pH (id. at 13); (4) that the
invention exhibits unexpected results (id. at 15–17); and (5) that there is no
reasonable expectation of success in the combination of references (id. at
17–19).
We have reviewed Appellant’s contentions and arguments that
Examiner erred in rejecting the claims. See Appeal Br. 11–19; see Reply Br.
4–7. We disagree with Appellant’s contentions and adopt the findings
concerning the scope and content of the prior art as well as conclusion as set
forth in Examiner’s Answer and the Final Office Action mailed June 22,
2017. The findings of fact reproduced above are referenced to highlight
certain pertinent evidence. We address Appellant’s arguments below:
1. Incompatible pH values
That “the pHs used in EP’516 and EP’983 are incompatible with each
other” does not persuade us that the Examiner erred in determining that the
cited references would have suggested a composition having the pH recited
in Appellant’s claim 1. Appeal Br. 10–11. Appellant contends that EP’516
is directed to separation of basophils from nucleated erythrocytes while
EP’983 is directed to separating eosinophils from basophils. Id. at 10.
In the appeal before us, the claims are directed to a product. See
Ans. 17. The claims do not recite the separation of a particular cell type;
instead, the claims generically recite “classifying leukocytes” that can
include lymphocytes, monocytes, neutrophils, eosinophils, and basophils.
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See Spec. ¶15 (“Normal leukocytes are generally classified into four types:
lymphocytes, monocytes, eosinophils and granulocytes other than
eosinophils, or five types: lymphocytes, monocytes, neutrophils, eosinophils
and basophils”). Therefore, even if we were to interpret the claims as
requiring separation between cell types, the claims would encompass
separation between any one of lymphocytes, monocytes, neutrophils,
eosinophils, and basophils.
EP’983 teaches differentiating leukocyte populations using a dye and
a hemolytic agent. FF1–FF4. EP’983 teaches that the hemolytic agent is
between pH 4.5 and pH 11. FF3. EP’983 also teaches that the use of
phthalic acid (an organic acid with aromatic ring) over citric acid improves
separation of neutrophils from eosinophils. FF2.
The pH range disclosed in EP’983 entirely overlaps the 5.5–6.4 and
5.5–7.0 ranges recited in Appellant’s claims. That overlap is sufficient to
establish a prima facie case of obviousness. See In re Peterson, 315 F.3d
1325, 1329 (Fed. Cir. 2003) (“[W]e and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.”). Such a prima facie case may be rebutted “by
establishing that the claimed range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior art range.”
Id. at 1330 (citations omitted). But, as explained further below (see I.B.4),
Appellant has not shown that the claimed pH and aromatic acid
concentration achieves unexpected results as compared to those taught in
EP’516 and EP’983 or otherwise established that the claimed range is
critical. Accordingly, the record supports Examiner’s obviousness
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determination and, as explained below, we are not persuaded by Appellant’s
arguments to the contrary.
2. Result effective variable
We are not persuaded by Appellant’s contention that none of the cited
documents disclose pH as a result effective variable. See Appeal Br. 11–12.
The claimed formulation is intended for classifying leukocytes but does not
further recite what particular leukocytes cell population to classify. EP’983
recognizes that the pH of the leukocyte differentiation formulation has an
effect on the ability to separate some leukocyte populations, for example
eosinophils and basophils. FF4; see also Ans. 16 (“depending on the cells to
be classified, the pH is a result effective variable which can be optimized to
provide for better separation of groups”), see id. at 5–6 (citing MPEP
2144.05). EP’983 recognizes that the inclusion of the organic acid in the
differentiation formulation helps improve the scattered light intensity
between cell populations. FF2. EP’983 also recognizes that in order to
improve the separation between eosinophils and basophils the pH of the
differentiation buffer should not be too low. FF4. These teachings would
lead one of ordinary skill in the art to adjust the pH of a differentiation
solution such that the separation between eosinophils and basophils is
improved, while at the same time warning not to adjust the pH to high
because it will lead to damage in another type leukocyte. FF4. Accordingly,
we are not persuaded by Appellant’s contention that EP’983, one of the cited
references, does not suggest pH as a result effective variable for
differentiation of a leukocyte population.
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3. Teaches away
We are not persuaded by Appellant’s contention that EP’516 teaches
away from the presently recited pH. Appeal Br. 13. A reference teaches
away when “a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Moreover, a teaching away
requires a reference to actually criticize, discredit, or otherwise discourage
the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)
(“The prior art’s mere disclosure of more than one alternative does not
constitute a teaching away from any of these alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed”). Finally, in an obviousness analysis, “all disclosures of the prior
art, including unpreferred embodiments, must be considered.” Merck & Co.,
Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(quoting In re Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)).
EP’516 teaches that leukocyte differentiation reagent is preferably in
a range from pH 2.0–4.5. FF5. A suggestion that some range is preferable
is not a teaching that one should not work outside the particular range or that
going outside the range is somehow detrimental to the assay. See Tr. 11–12.
This is true, especially when read in light of the teaching of EP’983, a
reference also directed at leukocyte differentiation but using reagents that
are preferably in a range from pH 4.5–11. FF3. Here, Appellant’s argument
attacking the EP’516 reference individually is not proper when the rejection
is based on the combination of EP’516 with EP’983. See In re Keller, 642
F.2d 413, 426 (CCPA 1981).
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4. Unexpected results
Appellant contends that the classification kit of the present claims
exhibit unexpected results. Appeal. Br. 15–17. Specifically, that the kit is
“capable of separating the region where the signal of the monocytes appears
on the scattergrams from the region where the signal of the lymphocytes
appears on the same scattergrams, in order to differentiate between the blast
cells and the atypical lymphocytes.” Id. at 16.
We are not persuaded by Appellant’s contention. Here, EP’983
teaches that the dye formulation allows for the classification of not only
normal leukocytes but also counts abnormal cells. FF1. This would indicate
that the prior art was interested in separating the various populations of cells
for the purpose of counting and identifying the blood components. EP’983
teaches that separation between basophils and eosinophils, both a type of
leukocyte, is improved when using phthalic acid instead of citric acid. FF2.
EP’983 teaches that the use of an aromatic organic acid containing at least
one aromatic ring in the molecule allows for improved classification of
leukocytes because of the different scattered light intensity in the different
populations. FF2. EP’983 also teaches that if the pH is too low then the
separation of the leukocytes into 5 populations becomes difficult, but also
cautions against having the pH to high because this causes more damage to
the leukocyte. FF4. EP’983 therefore recognizes that pH affects the ability
to separate various cell population for the purpose of classification. Thus,
the references already recognize that adjusting the pH and organic acid
affects the ability to separate various cell populations. The question before
is whether the organic acid concentration and the pH ranges as claimed
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provide results that are unexpectedly different from what is already
disclosed in the art.
During oral argument, Appellant directed our attention to the figures
and Table 5 of the Specification as allegedly providing evidence of
unexpected results based on the centroid distance measured between
monocytes and lymphocytes. See Tr. 5–6; see also Appeal Br. 18–19 (citing
“Examples of the present specification” and “Figs. 2–4”). Table 5 of the
Specification, which discusses certain of Appellant’s exemplified
compositions, is reproduced below:

Spec. ¶ 92. The Specification explains the leukocytes form clusters in the
scattergrams. The table measures the centroid distance between monocytes
and lymphocyte clusters. Spec. ¶ 93. “These clusters are analyzed with an
appropriate analysis software to identify the leukocyte clusters and calculate
the number of cells in the respective leukocyte clusters, . . . . From the
positions of the centroid of the respective leukocyte clusters, the distance
between the centroids (hereinafter referred to as the centroid distance) is
calculated.” Spec. ¶ 70.
We are not persuaded by Appellant’s unexpected results argument.
See Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997)
(“[A]rguments of counsel cannot take the place of evidence lacking in the
record.”). At best, Table 5 of the Specification shows that when the pH is
changed from pH 7.2 to pH 6.0 the centroid distance between the two
populations tested has changed. What is not clear is whether this change in
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distance is unexpected, especially given the teaching in the EP’983 that
already suggests that a change in pH can affect the separation of a different
type of leukocyte. FF2. Here, the claims are not limited to the separation
between monocytes and lymphocytes, both cells are a type of leukocyte, but
instead the claims are directed to a composition/kit for “classifying
leukocytes” that are known to contain at least 5 cell populations.
The centroid distances given in Table 5 for reagents G, R, and S are
numerically different; however, what has not been established on this record
is whether these differences are significant. “‘[D]ifferences in degree’ of a
known and expected property are not as persuasive in rebutting obviousness
as differences in ‘kind’—i.e., a new property dissimilar to the known
property.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d
967, 977 (Fed. Cir. 2014) (citation omitted). Here, the evidence presented in
Table 5 does not clearly “represent a ‘difference in kind’ that is required to
show unexpected results.” In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005); see also Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731,739
(Fed. Cir. 2013) (“Unexpected results that are probative of nonobviousness
are those that are different in kind and not merely in degree from the results
of the prior art.”) (internal quotations omitted). What is missing in Table 5
and the accompanying text in the Specification is an explanation of why the
small numerical differences in the table between reagents G, R, and S rise to
the level of being unexpected and thereby a difference in kind rather than a
difference in degree. The Specification explains that it is the software that
determines centroid distances but provides no further detail. Without
knowing how the boundaries are determined in order to calculate the
position of the centroid, from which to then calculate any distances between
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centroids associated with different cell populations, it is impossible to say
that any difference shown in the figures is significant. See Tr. 6–7. Would a
different software program place the centroids at the same position? If the
position of the centroid changes based on different software then the
question is whether the numerical differences shown in Table 5 is an
attribute of the software selection rather than an attribute to the reagent.
When balancing the totality of the evidence presented in support of the
unexpected results against the evidence of obviousness presented by
Examiner, we find that the balance of the evidence weighs in favor of
finding the claims unpatentable based on the teachings of EP’516 and
EP’983.
5. Reasonable expectation of success
We are also not persuaded by Appellant’s argument that there is no
reasonable expectation of success in the combination of references. Appeal
Br. 17–19. We agree with the Examiner that the claims are directed to a
kit/composition and are not directed to a method of separating a particular
cell population. As Examiner explains, “[t]he prior art references teach the
reagents for the purpose of adjusting the scattered light intensity distribution
of leukocytes to be more suitable for classification into different
populations.” Ans. 18.
Example 6 of EP’983 teaches a formulation for differentiating
leukocytes that contains HEPES a buffer, BC30TX (polyoxyethylene (30)
cetyl ether) an anionic surfactant, lauryl trimethylammonium chloride a
cationic surfactant, and 20 mM of an acid such as phthalic acid and organic
aromatic acid, with the pH of 7.0. FF1. The question presented is whether
the combination of references provides a reasonable expectation that the
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concentration of organic aromatic acid can be increased to 30 to 50 mM
while retaining the same pH?
EP’983 explains that the use of the organic acid is for the purpose of
adjusting the scattered light intensity and distribution of leukocytes. FF3.
EP’516 similarly teaches cell differentiation based on scattered light
information. EP’516 ¶¶ 12–15. EP’516 teaches that it is important to first
lyse erythrocytes in order to get a correct basophil count. Id. ¶ 49. EP’516
teaches that erythrocytes and other blood components have the same size
and shape of basophils and thereby could contribute to a high basophil count
if these other components are not properly removed from the samples. See
id. ¶¶ 48–52. EP’516 teaches that aromatic carboxylic acids effectively lyse
erythrocytes. Id. ¶ 48. There is nothing in the record that would suggest that
increasing the concentration of aromatic organic acid from 20 mM shown in
EP’983 up to 100 mM shown in EP’516 would be detrimental the leukocyte
cells of interest. See FF1, FF2, FF6. Here, the records suggests that the
inclusion of an aromatic acid is desirable for the removal of erythrocytes and
for improving the light scattering in the remaining cells. FF6; EP’983 4:25–
27 (“the incorporation into the hemolytic agent of at least one organic acid
having at least one aromatic ring in a molecule or a salt thereof is preferred
for the purpose of adjusting the scattered light intensity distribution of
leukocytes so as to be more suitable for classification”). Based on these
teachings, we determine that the combination of references provides a
reasonable expectation that the use of an organic aromatic acid contributes to
an improvement of the differentiation of the leukocyte population by at least
removing erythrocytes from the sample and improving light intensity.
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6. Hindsight
Finally, we are also not persuaded by Appellant’s contention that the
combination of references is a result of hindsight. See Reply Br. 5.
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.

In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, Appellant has
not explained what knowledge Examiner was relying on that could only be
gleaned from Appellant’s Specification in order to arrive at the conclusion of
obviousness.
C. Conclusion
We conclude that the evidence cited by Examiner supports a prima
facie case of obviousness with respect to claim 8, and Appellant has not
provided sufficient rebuttal evidence that outweighs the evidence supporting
the Examiner’s conclusion of obviousness. As Appellant does not argue the
claims separately, claims 9–19 fall with claim 8. 37 C.F.R. § 41.37
(c)(1)(iv).
II.–VI. Non-Statutory Obviousness Type Double Patenting
Appellant does not provide separate arguments with respect to the
nonstatutory obviousness type double patenting rejection instead relying on
the unexpected results arguments discussed in conjunction with the
obviousness rejection. See Appeal Br. 19. For the reasons discussed in
detail above (see I.B.4), we are not persuaded by Appellant’s unexpected
results argument. As Appellant does not provide any other arguments we
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affirm the non-statutory obviousness-type double patenting rejections for the
reasons set out by Examiner in the Final Office Action and Answer.

CONCLUSION
In summary:

Claims
Rejected
Basis Affirmed Reversed
8–19 § 35 U.S.C. 103 (a)
over EP’516 and
EP’983
8–19
8 Obviousness-type
double patenting
8
8 Obviousness-type
double patenting
8
8, 13 Obviousness-type
double patenting
8, 13
8, 13 Obviousness-type
double patenting
8, 13
8, 13 Obviousness-type
double patenting
8, 13
Outcome 8–19

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