Dragheim, Marianne et al.

Patent Trials and Appeals Board

Sep 25, 2020

13812073 - (D) (P.T.A.B. Sep. 25, 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.
13/812,073 03/22/2013 Marianne Dragheim 2205889.138-US2 7131
28089 7590 09/25/2020
WILMERHALE/NEW YORK
7 WORLD TRADE CENTER
250 GREENWICH STREET
NEW YORK, NY 10007
EXAMINER
WANG, SHENGJUN
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/25/2020 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):
scott.barrett@wilmerhale.com
whipusptopairs@wilmerhale.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIANNE DRAGHEIM and IOANA FLOREA
Appeal 2019-003984
Application 13/812,0731
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims related to
a method for the treatment of depression or anxiety in certain patients for
more than twelve weeks using vortioxetine. The Examiner rejected the
claims as obvious under 35 U.S.C. § 103(a) and for obviousness-type double
patenting. We heard oral argument on July 16, 2020. We have jurisdiction
under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real parties in interest as
H. Lundbeck A/S and Takeda Pharmaceuticals America, Inc. Appeal Br. 2.
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We affirm the obviousness rejection. However, because our
affirmance includes reasoning somewhat different from the Examiner’s, and
because we rely on additional evidence not specifically relied upon by the
Examiner, we designate our affirmance a New Ground of Rejection. We
also affirm the obviousness-type double patenting rejections.
CLAIMED SUBJECT MATTER
Claims 10, 34, 36–41, and 43–46 are on appeal. Non-Final Act.2 2.
Independent claim 10, reproduced below, is illustrative of the claimed
subject matter:
10. A method for the treatment of depression or anxiety, the
method comprising the administration of a therapeutically
effective amount of l-[2-(2,4-dimethyl-phenylsulfanyl)phenyl]
piperazine[3] or a pharmaceutically acceptable salt thereof to a
patient in need thereof for a treatment period of more than 12
weeks,
wherein the patient has previously received medication or
is still receiving medication for the treatment of depression or
anxiety, the medication is ceased or has to be ceased due to
weight gain, and the l-[2-(2,4-dimethyl-phenylsulfanyl)phenyl]
piperazine or a pharmaceutically acceptable salt thereof is
administered to the patient at a daily dose ranging from 2 mg to
40 mg.
Appeal Br. 29.

2 Non-Final Action dated June 28, 2018.
3 The claimed compound is also known as vortioxetine. See Appeal Br. 2.
For brevity, we use the term vortioxetine herein.
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REJECTIONS
The following rejections are before us for review:4
(1) claims 10, 34, 36–41, and 43–46 under 35 U.S.C. § 103 as
being unpatentable over Artigas5 and Moore6 (Non-Final Act. 15);
(2) claims 10, 34, 36–41, and 43–46 on the ground of nonstatutory
obviousness-type double patenting over claims 1, 6, 7, 9–11, 14 and 15 of
U.S. Patent No. 9,278,096 (the “’096 Patent”) in view of Artigas and Moore
(id. at 4); and
(3) claims 10, 34, 36–41, and 43–46 on the ground of nonstatutory
obviousness-type double patenting over claims 1, 5, and 7 of U.S. Patent No.
8,969,355 (the “’355 Patent”) in view of Artigas and Moore (id. at 7–8).
OPINION
Obviousness Over Artigas and Moore
Examiner’s Findings
The Examiner found that Artigas discloses a study wherein 5 mg or
10 mg vortioxetine HBr was administered to patients for six weeks, wherein
the treatment effectively treated depression, with no relevant changes in
weight. Non-Final Act. 15, 16. The Examiner further found that Moore

4 The Non-Final Action included a provisional rejection for nonstatutory
obviousness-type double patenting over claims of copending Application
No. 15/661,392 in view of Artigas and Moore. Non-Final Act. 11. Because
this copending Application has been abandoned, we do not further discuss
this rejection. See Application No. 15/661,392, Notice of Abandonment
(dated June 25, 2020).
5 Artigas et al., A randomised, double-blind, placebo-controlled, active-
referenced study of Lu AA21004 in patients with major depression, 19
European Neuropsychopharmacology S426–S427 (2009) (“Artigas”).
6 Moore et al., WO 2009/062517 A1, published May 22, 2009 (“Moore”).
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teaches that vortioxetine has a unique pharmacological profile with an
unexpectedly favorable safety profile, and is useful as a second line
treatment for patients who cannot use other antidepressants, such as selective
serotonin reuptake inhibitors (“SSRIs”), due to sleep- or sex-related adverse
events. Id.
The Examiner found that one of ordinary skill in the art at the time of
the invention would have been motivated to try providing vortioxetine to the
claimed patient population to treat depression for more than 12 weeks
because:
1) Artigas et al. teach that the HBr salt of the same compound
administered [at] 5 mg or 10 mg doses daily is effective in
treating depression wherein there is no relevant changes in
weight after 6 weeks; and 2) Moore et al. teach [that
vortioxetine] and salts thereof [are] useful for the treatment of
depression and obesity for example in patients previously
receiving treatment for depression and needed to stop due to the
adverse reaction such as reduced sleep or a sexually related
adverse event to an anti-depressant such as a
noradrenaline/serotonin reuptake inhibitors or SSRI (see page
11, lines 10, 13 and 30).
Id. at 16–17.
Analysis
Considering the totality of evidence of record, we determine that the
Examiner has presented a prima facie case of obviousness of the appealed
claims over the combination of Artigas and Moore. Specifically, Artigas
teaches a proof-of-concept study in patients with major depressive disorder.
Artigas S426. Patients were treated with vortioxetine HBr for six weeks,
and treatment was statistically significantly superior to placebo, with no
clinically relevant changes in the clinical laboratory results, vital signs, or
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weight. Id. Moore teaches that in clinical trials for depression, as compared
to placebo, vortioxetine showed a statistically significant improvement of
sleep pattern, and showed “that the sexual adverse effect of [vortioxetine] is
similar to placebo [and] is thus much better than what would normally be
expected from a[n] antidepressant, and in particular an SSRI.” Moore 9:9–
17, 10:7–8. Moore teaches that vortioxetine has a unique pharmacological
profile and unexpectedly favorable safety profile, making it useful for the
treatment of depression, including for long-term treatment and second line
treatment for patients who cannot use other antidepressants (including
SSRIs) due to sleep- or sex-related adverse events. Id. at 10:13–12:4.
We agree with the Examiner that in view of the teachings of Artigas
and Moore, a skilled artisan would have been motivated to try vortioxetine
as a second-line, long-term treatment of depression in the claimed patient
population. Non-Final Act. 17–18. Artigas and Moore provide a reasonable
expectation of success in meeting the limitations of the claimed invention,
i.e., treating depression or anxiety for more than twelve weeks in the claimed
patient population.7 For example, in a proof-of-concept study, Artigas
demonstrated the compound’s success in treating depression for six weeks,
and Moore teaches added benefits of the compound for long-term treatment
and second line treatment for patients who cannot use other antidepressants
(albeit due to unrelated side effects). We further discuss our reasoning and
address Appellant’s arguments below.

7 As will be discussed further below, because the claims do not require that
the claimed treatment be associated with lack of weight gain, there is no
requirement for a reasonable expectation of success with respect to this
attribute.
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Claims 10 and 34
Appellant argues that “the Office failed to show how all claim
limitations are taught or suggested by Artigas and Moore,” because these
references do not teach or suggest treatment for more than six weeks.
Appeal Br. 12–13, 14. We are not persuaded by this argument. Persons of
ordinary skill in the art understood that long-term treatment for depression is
often required. For example, Moore discusses long-term and chronic
treatments for depression, and the utility of vortioxetine for such extended
treatments. See, e.g., Moore 10:13–18 (“The absence of these adverse
effects [sleep and sexual activity disruptions] in treatments comprising the
administration of compound I makes compound I particular[ly] useful in
therapeutic interventions over an extended period of time, such as e.g.
depression relapse prevention.”). Additionally, Dr. Dragheim acknowledged
that “[m]ost patients require long-term treatment for depression.” Dragheim
Decl.8 ¶ 5 (quoting Baldwin9 31).
Appellant also argues that Artigas does not teach or suggest whether
“longer-term treatment . . . would be expected to show no clinically relevant
weight change.” Appeal Br. 13. We are not persuaded by this argument,
because the appealed claims do not recite any limitation requiring a lack of
clinically relevant weight change. Thus, there is no need for the asserted
prior art combination to teach such a limitation.

8 Declaration of Marianne Dragheim under 37 C.F.R. § 1.132, dated
September 4, 2015 (“Dragheim Decl.”).
9 Baldwin, D.S., The importance of long-term tolerability in achieving
recovery, 10 (Supp. 1) Int. J. Psychiatry in Clin. Prac. 31–37 (2006)
(attached as Ex. 3 to Dragheim Decl.) (“Baldwin”).
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Appellant further argues that neither Artigas nor Moore teaches or
suggests treating the claimed subpopulation, i.e., patients who stopped or
need to stop taking medication for the treatment of depression or anxiety due
to weight gain. Id. at 12, 15. We are not persuaded by this argument. First,
we agree with the Examiner that Moore indicates that “it is known in the art
to switch medications when adverse effects occur in patients to another
antidepressant, particularly the claimed compound.” Ans. 21. Second, as
acknowledged in the Specification and as is clear from the record, the
claimed patient population was known in the prior art. See Spec. 6:22–23
(indicating that “many patients who experience treatment emergent weight
gain are reluctant to take the drug as prescribed”); Zajecka10 61 (“[M]any
patients prematurely discontinue their medication as a result of increased
appetite or weight gain.”); Papakostas II11 ¶¶ 16, 19; see also Prometheus
Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1099–01 (Fed. Cir. 2015)
(finding that it would have been obvious to treat the claimed subpopulation
of irritable bowel syndrome patients based on common practices in the
field).
Appellant additionally argues that “there is no reasonable expectation
that treatment of depression with vortioxetine would be effective for more
than 12 weeks without significant weight gain” in the claimed
subpopulation, because one cannot predict which adverse effects a patient
will experience or the net side effect profile of a compound such as

10 Zajecka, J. M., Clinical Issues in Long-Term Treatment with
Antidepressants, 61 (Supp. 2) J. Clin. Psychiatry 20–25 (2000) (attached as
Ex. 2 to Dragheim Decl.) (“Zajecka”).
11 Supplemental Declaration of George Papakostas, M.D. Under 37 C.F.R.
§ 1.132, dated August 29, 2017 (“Papakostas II”).
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vortioxetine, which has multiple mechanisms of action. Appeal Br. 16–17;
see also id. at 17–18 (citing, e.g., Papakostas II ¶¶ 17, 24, 25; Dragheim
Decl. ¶¶ 5–8, 12). Appellant additionally argues that Moore’s teachings
regarding vortioxetine’s beneficial effects on sleep- and sex-related adverse
events do not translate to a reasonable expectation “that vortioxetine would
be useful to treat depression patients without long-term weight gain”
because “side-effects are not expected to be directionally correlated with one
another.” Id. at 19 (citing, e.g., Papakostas II ¶ 23; Papakostas I12 ¶ 16).
Appellant additionally argues that the claimed invention is not obvious to try
because the “impact on reducing long-term weight gain is not predictable.”
Appeal Br. 21; see also id. at 21–22 (citing, e.g., Papakostas II ¶¶ 17, 23–30;
Dragheim Decl. ¶¶ 5–8, 12, 13).
We are not persuaded by these arguments, because they are not tied to
the claimed method. “The reasonable expectation of success requirement
refers to the likelihood of success in combining references to meet the
limitations of the claimed invention.” Intelligent Bio-Systems, Inc. v.
Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (emphasis
added). Here, the appealed claims do not recite any requirements relating to
lack of weight gain from long-term vortioxetine treatment, and thus there is
no requirement to show a reasonable expectation of success related to lack
of weight gain. See id. (finding that, where the claim did not require
quantitative removal of protecting group, it was “of no moment” that prior
art did not provide a reasonable expectation of success of quantitative
removal); see also BTG Int’l Ltd. v. Amneal Pharms. LLC, 923 F.3d 1063,

12 Declaration of George Papakostas, M.D. Under 37 C.F.R. § 1.132, dated
October 23, 2016 (“Papakostas I”).
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1075, 1076 (Fed. Cir. 2019) (rejecting appellants’ arguments about a lack of
reasonable expectation of success of anti-cancer effect and survival
advantage where the subject claims did not require such attributes).
Appellant also argues that the claimed invention is not obvious to try
because given the large number of antidepressants, many of which result in
weight gain, there is no “‘finite number of identified’ solutions from which
to choose in order to treat depression without long-term weight gain.”
Appeal Br. 21 (citing Papakostas I ¶ 21; Papakostas II ¶¶ 13, 17). We are
not persuaded by this argument. First, we again note that the claim does not
require a lack of long-term weight gain. Second, even though there may
have been a large number of available antidepressants (see, e.g., Papakostas
I ¶ 21 (listing antidepressants)), the prior art gave direction on which were
more frequently associated with weight gain. See, e.g., Cassano13 17
(discussing weight gain observed in long-term clinical studies for various
antidepressants); Serretti14 1260 (presenting “quantitative review of the
literature regarding the effect on body weight potentially exerted by the most
common antidepressant drugs”).
Accordingly, we agree with the Examiner that “since Artigas
demonstrated the compound[’]s success in treating short-term depression
without weight gain” and, as will be further discussed below in connection
with unexpected results, the majority of patients do not experience weight

13 Cassano et al., Tolerability Issues During Long-Term Treatment with
Antidepressants, 16 Annals of Clinical Psychiatry 15–25, 17 (2004)
(“Cassano,” attached as Ex. 1 to Dragheim Decl.).
14 Serretti et al., Antidepressants and Body Weight: A Comprehensive
Review and Meta-Analysis, 71(10) J. Clin. Psychiatry 1259–1272 (2010)
(“Serretti,” attached as Ex. 5 to Dragheim Decl.).
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gain with long-term treatment with many serotonin reuptake inhibitors, a
skilled artisan would have been motivated to try vortioxetine for the
treatment of depression for more than twelve weeks. Ans. 21; see also id. at
20 (“[T]he majority of patients (77–75%) in long-term care for depression
with SSRIs do not have weight gain.”). We agree with the Examiner that
given “the fact that the majority of patients taking long term treatment for
depression with serotonin reuptake inhibitors do not experience weight gain,
and the special characteristics of the instantly claimed compound to be used
as a second line treatment for patients with depression who cannot use
antidepressants such as SSRls, one would have [had] a reasonable
expectation of success that the instantly claimed compound would provide
long-term treatment for depression to the patient population claimed.” Id. at
22.
Appellant argues several objective indicia of nonobviousness,
including unexpected results. Specifically, Appellant argues that although
clinicians would have expected vortioxetine to cause long-term weight gain,
the converse is true. Appeal Br. 23; see also Papakostas II ¶ 25; Dragheim
Decl. ¶¶ 5, 9, 12; Spec. 15:1–3, 16:5–7; see also Appeal Br. 19–20
(discussing unexpected results and additionally citing Dragheim Decl. ¶¶ 3,
9; Papakostas I at ¶¶ 13, 22; Papakostas II ¶¶ 17, 23, 27, 31). Appellant
additionally argues that “regulatory agencies in the U.S. and Europe
approved vortioxetine to treat depression and recognized that vortioxetine
has a low level of weight-related adverse events.” Appeal Br. 23 (citing
Dragheim Decl. ¶¶ 9–10).
We are not persuaded that Appellant has demonstrated unexpected
results. Appellant contends that vortioxetine’s “low level of weight-related
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adverse events” is unexpected because clinicians would have expected that
agents that inhibit serotonin reuptake (like vortioxetine) would cause long-
term weight gain. Id. We acknowledge the opinions offered by Drs.
Papakostas and Dragheim regarding this purported expectation (e.g.,
Papakostas II ¶ 25; Dragheim Decl. ¶ 5), but find that the totality of evidence
of record does not corroborate such an expectation. See, e.g., In re Am.
Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board
is entitled to weigh the declarations and conclude that the lack of factual
corroboration warrants discounting the opinions expressed in the
declarations.”).
Rather, we agree with the Examiner that the evidence of record
indicates that the majority of patients taking long term treatment for
depression with serotonin reuptake inhibitors do not experience weight gain.
Ans. 20–21. For example, Cassano indicates that within the SSRI class,
weight gain associated with long-term therapy affects a minority of patients,
and the rate of weight gain among patients varies from agent to agent.
Specifically, Cassano reports that after six months of therapy, the rate of
significant weight gain was approximately 25% for paroxetine, 8% for
fluoxetine, and 4% for sertraline. Cassano 17. Cassano also recognizes that
while weight gain is a “relatively common side effect[] of chronic treatment,
. . . in some studies the occurrence of these long-term side effects was
similar in placebo-treated patients.” Id. (indicating that “significant (i.e.,
≥7% of body weight) weight gain occurred in 4.8% of fluoxetine-treated
patients vs. 6.3% of placebo-treated patients in a 6-month study”) (citation
omitted). Additionally, Serretti reports that “no significant effect [on body
weight] could be observed for citalopram during maintenance treatment.”
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Serretti 1267; see also id. at 1263 (indicating that “maintenance” refers to
treatment periods greater than four months).
Thus, while the record reflects that weight gain is a possibility for
some patients on long-term SSRI therapy, we agree with the Examiner that
the record indicates that “the majority of patients administered serotonin
reuptake inhibitors for the treatment of long-term depression do not have
weight gain.” Ans. 26. Further, Cassano teaches that “intolerance to one
SSRI is not predictive of intolerance to other SSRIs.” Cassano 17.
Accordingly, on this record, Appellant has not persuasively established an
expectation that vortioxetine would cause long-term weight gain based on its
serotonin reuptake inhibitory action, such that vortioxetine’s lack of weight-
related adverse events is unexpected. See Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1371 (Fed. Cir. 2007) (“[B]y definition, any superior property
must be unexpected to be considered as evidence of non-obviousness.”).
Moreover, Appellant must prove a nexus between any proffered
unexpected results and the merits of the claimed invention. See In re GPAC
Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). Here, the claims are directed to
treatment with vortioxetine in a specific subpopulation, but on this record,
we have not been directed to information regarding whether any of the
participants in the vortioxetine studies that established the lack of weight-
related adverse events fell within the claimed subpopulation and experienced
the lack of weight-related adverse events. See, e.g., Spec. 13:12–19
(discussing study design but providing no details on whether subjects were
in the claimed subpopulation), 15:6–13 (same). Similarly, we have not been
directed to information regarding whether the regulatory approval or
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recognition by regulatory agencies of a low level of weight-related adverse
events was tied to the claimed subpopulation.
Appellant additionally argues that “clinicians recognized a long-felt
unmet need for anti-depressant therapies with reduced long-term weight
gain,” and that “SSRIs [have] failed to provide effective anti-depressant
therapy without long-term weight gain.” Appeal Br. 24 (citing Papakostas II
¶¶ 16–18; Dragheim Decl. ¶ 7). We are not persuaded by these arguments,
because as discussed above, the record indicates that not all SSRIs are
associated with significant long-term weight gain, and not all patients
experience long-term weight gain. Additionally, Appellant’s argument
regarding a long-felt, unmet need for anti-depressant therapies with reduced
long-term weight gain lacks a nexus with the appealed claims. As discussed
above, the appealed claims only require an effective treatment for depression
or anxiety in treatments greater than twelve weeks; they do not recite any
limitations related to lack of weight gain. Because other effective
antidepressants were available for long-term treatment, we are not persuaded
that Appellant has established a long-felt, unmet need that was solved by the
claimed invention. See BTG Int’l Ltd., 923 F.3d at 1076 (“The Asserted
Claims only require an effective treatment for prostate cancer. . . . [B]ecause
other treatments for prostate cancer were available, the evidence presented
here does not establish that there was a specific unsolved, long-felt need for
the treatment.”).
Claims 40 and 41
Independent claim 40 and dependent claim 41 recite that the patient
has ceased other anti-depressant or anti-anxiety medications due to weight
gain, and the ceased medication is a serotonin re-uptake inhibitor. See
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Appeal Br. 30 (Claims Appendix). For these claims, Appellant additionally
argues that because “long-term weight gain remains a problem with SSRIs,”
clinicians would expect other SSRIs to also cause long-term weight gain, but
vortioxetine is “weight neutral.” Id. at 25–26 (citing, e.g., Papakostas II
¶ 25; Dragheim Decl. ¶ 12). We are not persuaded by this argument,
because as discussed above, on this record Appellant has not persuasively
established that long-term weight gain is a problem with all SSRIs for all
patients.
Claims 36–39
Claims 36–39 indirectly depend from claim 40, and recite specific
daily doses of vortioxetine HBr. See Appeal Br. 29–30 (Claims Appendix).
For these claims, Appellant additionally argues that “it would require
extensive experimentation to arrive at the claimed doses” because “it would
take several months before a clinician can decide whether a given dose of
vortioxetine would cause long-term weight gain.” Id. at 26 (citing, e.g.,
Papakostas I ¶ 21; Papakostas II ¶ 30). We are not persuaded by this
argument, because as discussed above, the claims do not require a lack of
long-term weight gain.
Claims 43–46
Claims 43–46 indirectly depend from claim 40, and additionally recite
specific daily doses of vortioxetine HBr in patients for a treatment period of
more than 12 weeks, wherein the patients have ceased other anti-depressant
or anti-anxiety medications due to weight gain, and the ceased medication is
a serotonin re-uptake inhibitor. See Appeal Br. 30–31 (Claims Appendix).
With respect to these claims, Appellant essentially reiterates the arguments it
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made for claims 36–41. See id. at 27–28. We apply our analyses for claims
36–41 to claims 43–46.
Summary – Obviousness Over Artigas and Moore
In sum, we agree with the Examiner that the combination of Artigas
and Moore would have rendered claims 10, 34, 36–41, and 43–46 obvious.
However, because our reasoning differs somewhat from that of the
Examiner, we designate this rejection a New Ground under 37 C.F.R.
§ 41.50(b) to provide Appellant with a full and fair opportunity to respond to
the rejection.
Obviousness-Type Double Patenting
On appeal, Appellant does not address the Examiner’s nonstatutory
obviousness-type double patenting rejections. See generally Appeal Br.
Arguments not presented in a brief are waived. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2015) (“Except as provided for in §§ 41.41, 41.47 and
41.52, any arguments or authorities not included in the appeal brief will be
refused consideration by the Board for purposes of the present appeal.”).
Additionally, Appellant has not filed a terminal disclaimer that would moot
these rejections. Accordingly, we summarily affirm the uncontested
nonstatutory obviousness-type double patenting rejections.
CONCLUSION
We affirm the rejection of claims 10, 34, 36–41, and 43–46 under
35 U.S.C. § 103 as being unpatentable over Artigas and Moore, but
designate our affirmance a New Ground of Rejection because our conclusion
of obviousness includes reasoning and evidence not specifically relied upon
by the Examiner.
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We affirm the rejection of claims 10, 34, 36–41, and 43–46 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1, 6, 7, 9–11, 14, and 15 of the ’096 Patent in view
of Artigas and Moore.
We affirm the rejection of claims 10, 34, 36–41, and 43–46 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1, 5, and 7 of the ’355 Patent in view of Artigas
and Moore.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed New
Ground
10, 34,
36–41,
43–46
103 Artigas, Moore 10, 34,
36–41,
43–46
10, 34,
36–41,
43–46
10, 34,
36–41,
43–46
Obviousness-type
double patenting
over claims 1, 6,
7, 9–11, 14, 15 of
the ’096 Patent,
Artigas, Moore
10, 34,
36–41,
43–46

10, 34,
36–41,
43–46
Obviousness-type
double patenting
over claims 1, 5,
7 of the ’355
Patent, Artigas,
Moore
10, 34,
36–41,
43–46

Overall
Outcome:
10, 34,
36–41,
43–46
10, 34,
36–41,
43–46
TIME PERIOD FOR RESPONSE
This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of
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rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .
Should Appellant elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.

AFFIRMED
37 C.F.R. § 41.50(b)