Sharon Mates et al.

Patent Trials and Appeals Board

Jul 29, 2019

14394470 - (D) (P.T.A.B. Jul. 29, 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.
14/394,470 10/14/2014 Sharon Mates IT-74-US 6424
50446 7590 07/29/2019
HOXIE & ASSOCIATES LLC
75 MAIN STREET , SUITE 203
MILLBURN, NJ 07041
EXAMINER
KAROL, JODY LYNN
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
07/29/2019 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):
HoxiePatentMail@gmail.com
HoxiePatentMail@hoxpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SHARON MATES, ROBERT DAVIS, KIMBERLY VANOVER,
and LAWRENCE WENNOGLE1
__________

Appeal 2019-002729
Application 14/394,470
Technology Center 1600
__________

Before RYAN H. FLAX, RACHEL H. TOWNSEND, 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 to a
method for the treatment of one or more disorders associated with
Alzheimer’s disease comprising administering a specific compound. The
Examiner rejected the claims as obvious over the prior art and for
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.

1 Appellants identify “Intra-Cellular Therapies, Inc.” as the real party in
interest. Br. 2.
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STATEMENT OF THE CASE
According to the Specification, “[t]he present invention relates to use
of particular substituted heterocycle fused gamma-carbolines as described
herein, in free, pharmaceutically acceptable salt or prodrug form, and
pharmaceutical composition comprising the same, optionally in combination
with one or more agents, for the prophylaxis or treatment of one or more
disorders associated with dementia, particularly behavioral or mood
disturbances (e.g., agitation/aggression), psychosis, depression and/or sleep
disturbances among other disorders in patients suffering from dementia.”
Spec. ¶ 1.
Claims 1, 6–16, 23, and 24 are on appeal. Claim 1, the only
independent claim, reads as follows:
1. A method for the treatment of one or more disorders
associated with Alzheimer’s Disease selected from the group
consisting of (1) behavioral or mood disorders selected from
agitation/irritation, aggressive/assaultive behavior, anger,
physical and emotional outbursts; (2) psychosis; (3) depression;
and (4) sleep disorders, and said one or more disorders is caused
by Alzheimer’s disease, comprising administering to an
Alzheimer’s disease patient, a therapeutically effective amount
of a compound of Formula I:

wherein:
X is –N(CH3)– ; and
Y is –C(=O)– ;
in free or pharmaceutically acceptable salt form.
Br. 20 (Claims Appendix).
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The following rejections are before us on appeal:
Claims 1, 6–10, 23, and 24 are rejected under 35 U.S.C. § 103 as
being unpatentable over Robichaud2 and Lopez.3 Final Act. 16.
Claims 1, 6–16, 23,4 and 24 are rejected under 35 U.S.C. § 103 as
being unpatentable over Robichaud, Lopez, and Tariot.5 Id. at 18.
Claims 1, 7, 9, 10, 23, and 24 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1–29 of
US 8,598,119 B2 and Lopez. Id. at 8.
Claims 1, 7, 9, 10, 23, and 24 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1–20 of
US 9,168,258 B2 and Lopez. Id. at 10.
Claims 1, 7, 10, and 24 are rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1 and 2 of
US 9,586,960 B2 and Lopez.6 Id. at 11.

2 Robichaud et al., US 7,071,186 B2, issued July 4, 2006 (“Robichaud”).
3 Lopez et al., Psychiatric Symptoms Vary with the Severity of Dementia in
Probable Alzheimer’s Disease, 15(3) J. NEUROPSYCHIATRY CLIN. NEUROSCI.
346–53 (2003) (“Lopez”).
4 The Final Action contains an apparent typographical error, by identifying
claim 32 as among those included in this rejection. Final Act. 18. The
appealed claim set does not include a claim 32. The Examiner corrected the
error in the Answer, by including in the list of claims subject to this rejection
pending claim 23 instead of claim 32. Ans. 13.
5 Tariot et al., Memantine Treatment in Patients With Moderate to Severe
Alzheimer Disease Already Receiving Donepezil, 291(3) JAMA 317–24
(2004) (“Tariot”).
6 Although the Examiner and Appellants both refer to US 9,589,960, we
assume this is a typographical error, and that the intended citation is to US
9,586,960. Moreover, although the Examiner stated that Appellants’ claims
are “provisionally rejected” over claims 1 and 2 of US 9,586,960 B2 and
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Claims 1, 6–8, and 10 are provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1–23 and
27 of US App. No. 14/394,469 and Lopez. Id. at 12.
Claims 1, 7, 9, 10, 23, and 24 are rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1–29 of
US 9,616,061 B2 and Lopez.7 Id. at 14.
ANALYSIS
“[T]he examiner bears the initial burden . . . of presenting a prima
facie case of unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.” In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered those arguments
made by Appellants in the Appeal Brief; arguments not so presented in
Appellants’ brief are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015); see
also Ex Parte Borden IV, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) (“Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.”).
Appellants focus their arguments for each rejection on the limitations
in claim 1 and dependent claim 10, and did not provide any separate
arguments for dependent claims 6–9, 11–16, or 23–24. None of claims 6–9,
11–16, or 23–24 depend from claim 10, accordingly, dependent claims 6–9,

Lopez (Final Act. 11; Ans. 6), because US 9,586,960 is an issued patent, we
understand the rejection to be non-provisional.
7 Although the Examiner stated that Appellants’ claims are “provisionally
rejected” over claims 1–29 of US 9,616,061 B2 and Lopez (Final Act. 14;
Ans. 8–9), because US 9,616,061 is an issued patent, we construe the
rejection as non-provisional.
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11–16, and 23–24 stand or fall with independent claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
Obviousness
The Examiner rejected claims 1, 6–10, 23, and 24 as being obvious
over Robichaud and Lopez, and claims 1, 6–16, 23, and 24 as being obvious
over Robichaud, Lopez, and Tariot. Final Act. 16, 18. According to the
Examiner, Robichaud discloses the compound recited in Appellants’ claims,
and teaches that this compound has “therapeutic utility in disorders
involving mood or sleep, depression, psychosis, etc.,” and “potentially h[as]
utility in the treatment of Alzheimer’s disease.” Id. at 16–17. Robichaud
teaches dosages of about 1–100 mg of the active compound, which
“overlap[s] with the dosages as claimed in the instant claims 7 and 10.” Id.
at 17. The Examiner also found that Lopez teaches that “agitation,
aggression, psychosis, depression, [and] sleep disorders are common
psychiatric disorders commonly associated with Alzheimer’s disease.” Id.
The Examiner found that while Robichaud “do[es] not explicitly teach
treating . . . disorders involving mood or sleep, depression, psychosis, etc. in
a patient with Alzheimer’s disease,” in view of Lopez’s teaching of
disorders associated with Alzheimer’s disease that overlaps with
Robichaud’s discussion of the therapeutic utility for the claimed compound,
a person of ordinary skill in the art would have been motivated, with a
reasonable expectation of success, to use Robichaud’s compound to treat
those disorders associated with Alzheimer’s. Id. at 17–18.
The Examiner further found that “Robichaud et al. in view of Lopez
do not teach administering one or more therapeutic agents useful for the
treatment of dementia as claimed in the instant claim[s] 11–16.” Id. at 19.
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Accordingly the Examiner cited Tariot, which teaches “treating Alzheimer’s
disease by administering memantine (starting dose 5 mg/day) to patients
with probably Alzheimer’s disease receiving a stable dosage of donepezil of
5–10 mg/day as claimed in the instant claims 11–16.” Id.
We adopt the Examiners findings of fact with respect to obviousness
(Final Act. 2–7, 16–20; Ans. 15–29), and find that the Examiner has
established a prima facie case of obviousness of the appealed claims. We
address Appellants’ arguments below.
Appellants assert that a person of ordinary skill in the art would have
been “required to make a large number of unguided structural selections
before even narrowing down the genus of compounds disclosed by
Robichaud to that of hexahydropyrido[3',A':4,5]pyrrolo[l,2,3-
de]quinoxalines, much less [to] Appellant’s single compound claimed in
claim 1.” Br. 5. We are not persuaded by this argument because Robichaud
expressly discloses and claims the same compound recited in Appellants’
claims, such that a person of ordinary skill in the art would not have needed
to make any “structural selections” to arrive at the claimed compound for
use in the treatment claimed. See Robichaud, cols. 113–14, Table 1,
Compound 261; col. 143 (claim 1); col. 178 (claim 15, in particular lines
20–22).
Appellants further assert that Robichaud discloses “a[n] exceedingly
broad genus comprising millions of compounds, and over 500 particular
species,” and “submit[] that one skilled in the art would not possibly
consider Robichaud to suggest that every single one of the 500 or more
species disclosed therein [is] actually effective in the treatment of all of the
diseases recited, much less that they are effective in purely speculative
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therapeutic indications, such as Alzheimer’s.” Br. 4–5. To the extent
Appellants are arguing that Robichaud has not enabled the teaching that
compound 261 is useful to treat the diseases and disorders disclosed in
Robichaud, we are not persuaded. Robichaud is presumed to be enabled.
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir.
2003) (“[P]rior art patents are presumed enabled . . . .”). On this record,
Appellants have not pointed to any evidence demonstrating that compound
261 would not have been considered by one of ordinary skill in the art to
work in the diseases and disorders disclosed in Robichaud. Attorney
argument is “no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d
1574, 1581 (Fed. Cir. 1989).
Appellants further argue that “Robichaud does not specifically suggest
the use of compounds, such as Appellant’s claimed compound, in the
treatment of disorders associated with Alzheimer’s disease,” but rather
“affirmatively teaches that the broad genus of compounds disclosed therein
are effective for a variety of specific disorders which are known to be
associated with serotonin pathways.” Br. 5. Appellants further note that
Robichaud “speculates, without support, that the compounds may also
‘potentially’ have therapeutic utility in neurodegenerative diseases and
traumatic conditions, such as Alzheimer’s disease,” and argue that nothing
in Robichaud suggests that such conditions are associated with serotonin
signaling. Id. at 6.
We are not persuaded by these arguments. As noted by the Examiner,
Appellants’ claims are not directed to a method of treating Alzheimer’s
disease per se, but rather are directed to the treatment of one or more
disorders associated with and caused by Alzheimer’s disease. Ans. 18.
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Robichaud expressly teaches that its compounds are antagonists or agonists
of the 5-HT2A and 5-HT2C receptors (col. 107, lines 48–64), and that they
have therapeutic utility for illnesses and disorders involving serotonin, such
as depression, psychosis, and sleep disorders. See, e.g., Robichaud, col. 107,
lines 20–64; col. 1, lines 39–46; col. 2, lines 16–67; col. 3, line 40–col. 4,
line 2; col. 4, line 42–col. 5, line 6; col. 111, lines 37–46. These are the
same disorders recited in Appellants’ claims. As noted by the Examiner,
Appellants “ha[ve] not supplied any evidence that depression, sleep
disorders, psychosis, etc. do not ‘involve serotonin’ when they occur in a
patient with Alzheimer’s disease.” Final Act. 4; Ans. 20. Thus, even setting
aside Robichaud’s teaching that the claimed compounds have potential
therapeutic utility treating Alzheimer’s disease (Robichaud col. 107, lines
43–46), we agree with the Examiner that there is sufficient motivation from
Robichaud to treat “disorders known to be associated with Alzheimer’s
disease, such as sleep disorders.” Ans. 20.
Appellants argue that “the treatment of symptoms of psychosis and
altered behavior and mood in Alzheimer’s patients has been shown to be
very difficult to treat,” and thus one skilled in the art would not have had a
reasonable expectation of success of using Appellant’s claimed compound to
treat such disorders in Alzheimer’s patients. Br. 6–8.8 We are not

8 In support of this argument, Appellants cite Koppel & Greenwald, Optimal
Treatment of Alzheimer’s Disease Psychosis: Challenges and Solutions, 10
Neuropsychiatric Disease and Treatment 2253–62 (2014); Madhusoodanan
& Ting, Pharmacological Management of Behavioral Symptoms Associated
with Dementia, 4(4) World J. Psychiatry 72–79 (2014); and Lin et al.,
Dosage and Duration of Antipsychotic Treatment in Demented Outpatients
with Agitation or Psychosis, 114 J. Formosan Med. Assoc. 147–53 (2015).
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persuaded by this argument. We agree with the Examiner that the cited
references acknowledge challenges in treating psychosis and behavioral
disturbances, but still show that antipsychotic drugs provide improvements
in aggression and psychosis in Alzheimer’s patients. Ans. 18–19. Further,
the references cited by Appellants do not suggest any difficulties in treating
depression or sleep disorders (both of which are recited in Appellants’
claims) in such patients.
Appellants additionally assert that their claimed compound (ITI-007)
has a side effect profile that is “unexpectedly superior to both risperidone
and olanzapine, the two primary treatments for psychological symptoms of
Alzheimer’s disease.” Br. 8. We are not persuaded by this argument.
Appellants rely on a press release concerning a Phase III clinical trial of ITI-
007 in Alzheimer’s patients, but that press release is silent with respect to
the drug’s side effect profile. Appellants additionally cite a press release
regarding a Phase III trial of ITI-007 in schizophrenia patients, which states
that “ITI-007 was statistically significantly better than risperidone on all of
these tolerability parameters.” Br. 8 (quoting Intra-Cellular Therapies Press
Release, dated Sept. 28, 2016).9 The appealed claims, however, are directed
to use of ITI-007 in Alzheimer’s patients, not schizophrenia patients.
Accordingly there is no nexus between the alleged unexpected results and
the claimed subject matter. See, e.g., In re GPAC Inc., 57 F.3d 1573, 1580
(Fed. Cir. 1995).

9 Available at https://globenewswire.com/news-release/2016/09/28/875435/0
/en/Intra-Cellular-Therapies-Announces-Top-Line-Results-from-the-Second
-Phase-3-Trial-of-ITI-007-in-Patients-with-Schizophrenia-Study-302.html.
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Moreover, unexpected results “must be shown to be unexpected
compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991). Given that the prior art teaches use of
Appellants’ claimed drug in a method of treating sleep disorders and other
disorders recited in the appealed claims, uses of risperidone and olanzapine
do not represent the closest prior art. Finally, even assuming that ITI-007
showed better tolerability in schizophrenia patients compared to risperidone,
superiority alone is not sufficient. Rather, Appellants must also show that
the result is unexpected. See, e.g., 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.”). Here,
Appellants fail to point to any evidence of record establishing that the side
effect profile observed in the Phase III trial of ITI-007 in schizophrenia
patients was unexpected. See In re Geisler, 116 F.3d 1465, 1469–71 (Fed.
Cir. 1997) (attorney argument is insufficient to establish unexpected results).
Appellants additionally argue that “Robichaud’s entire patent
application is predicated on the conclusion that the Compounds of Formula I
are selective serotonin agonists or antagonists,” whereas WO 2009/145900
(the “’900 Publication”) instead indicates that Appellants’ claimed
compound is highly non-selective. Br. 8–11. Appellants assert that in view
of this “highly unique binding profile,” a person of ordinary skill in the art
would not have had a reasonable expectation of success that Appellants’
compound would be useful for the treatment of the diseases and disorders
discussed by Robichaud. Id. We are not persuaded by this argument,
because as indicated by the Examiner, the ’900 Publication, although
disclosing more information about the binding profile of Appellants’
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claimed compound, “also teaches its compounds may be used in diseases
involving the 5-HT2A receptor, such as depression, sleep disorders, and
mood disorders associated with psychosis (see [’900 Publication] abstract;
page 1, section [0001]), which are the same disorders taught by Robichaud.”
Final Act. 5; Ans. 21–22. To the extent Appellants are arguing that
Robichaud is not enabled as evidenced by the ’900 Publication, we agree
with the Examiner that “[a] teaching of the same compounds, for the
treatment of the same diseases, but with new information about the binding
profile, is not seen to provide evidence that the compounds disclosed by
Robichaud would not be effective for their stated purpose.” Ans. 23.
With regard to Lopez, Appellants assert that “nothing in Lopez
suggests that treatments that are effective for these associated conditions
[agitation, aggression, psychosis, etc.] in any other kind of patient, are also
effective in a patient having Alzheimer’s.” Br. 11. However, we agree with
the Examiner that Lopez is used for its teachings that agitation, aggression,
psychosis, depression, and sleep disorders are commonly associated with
Alzheimer’s disease, and it would have been obvious to use a drug known
for treating these conditions in Alzheimer’s patients, who are known to
suffer from these conditions. Final Act. 6–7; Ans. 24. Moreover, as noted
above, Appellants have not pointed to any evidence that depression, sleep
disorders, psychosis, etc., do not involve serotonin when they occur in a
patient with Alzheimer’s disease, such that they would not be treatable by
the same therapeutic regimens used to treat these diseases and disorders
when they occur in other types of patients. Final Act. 4, 6–7; Ans. 20, 24.
Appellants additionally argue that even if Robichaud taught that
Appellants’ claimed compound “was known to be a successful treatment for,
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e.g., depression, there still would not have been a motivation for the skilled
artisan to select that particular compound out of the myriad compounds
disclosed in Robichaud for use in a patient having Alzheimer’s,” such that
there is no finite number of identified, predictable solutions to choose from
and no reasonable expectation of success. Br. 11–12. We are not persuaded
by this argument, because as noted above, Robichaud expressly discloses
(and claims) Appellants’ claimed compound, and enables its use in a method
of treating sleep disorders, thus motivating the use of the compound to treat
such disorders when they occur in Alzheimer’s patients. Final Act. 4–7, 16–
20; Ans. 17–25.
Turning to dependent claim 10, this claim recites use of a dosage of
about 1–10 mg in the claimed method. Br. 21 (Claims Appendix).
Appellants argue that they have “unexpectedly found that the dose of
administration of the claimed compound can have an important impact on
the compound’s pharmacological profile.” Br. 13. Appellants further argue
that the claimed compound “results in greater than 80% receptor occupancy
for cortical 5-HT2A receptors with only about 12% receptor occupancy for
striatal D2 receptors when administered at a dose of 10 mg to human
subjects,” whereas “at a dose of 40 mg, receptor occupancy at striatal D2
receptor[s] rose to 39% and striatal serotonin transporters were occupied at
33%.” Id. (citing Spec. ¶ 7 and Davis et al., ITI-007 demonstrates brain
occupancy at serotonin 5-HT2A and dopamine D2 receptors and serotonin
transporters using positron emission tomography in healthy volunteers, 232
PSYCHOPHARMACOLOGY 2863 (2015)). Appellants argue that “[o]ne effect
of this is that at low doses, the claimed compound is associated with receptor
occupancies consistent with both effective sleep maintenance and impulse
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aggression (mediated by 5-HT2A), and anti-psychotic efficacy (mediated by
D2),” and the “particular relative occupancy of these receptors is expected to
result in minimal extrapyramidal side effects.” Id.
We agree with the Examiner that the data in Davis does not
reasonably evince “that the dosage range of 1–10 mg as claimed in the
instant claim 10 provides any unexpected benefit.” Ans. 28. Davis does not
appear to disclose the receptor occupancy for cortical 5-HT2A receptors
following a dose of 40 mg of ITI-007, making a comparison to the 10 mg
dose impossible with respect to occupancy of the 5-HT2A receptors. Further,
Appellants compare the “peak” D2 receptor occupancy observed for the 40
mg dose with the mean D2 receptor occupancy observed for the 10 mg dose.
See Davis Table 1 (disclosing ~39% striatal D2 receptor occupancy for one
subject dosed at 40 mg, and ~12% mean occupancy for two subjects dosed
at 10 mg). This is not an apples-to-apples comparison that permits drawing
a meaningful conclusion.
Even assuming Appellants had demonstrated a different binding
profile for a 10 mg dose compared to a 40 mg dose, on this record they have
not established the practical effect of such a difference with respect to the
full scope of the disorders recited in the claims. As noted by the Examiner,
Davis “specifically teaches that ‘the separation of pharmacological effects
provides an opportunity to treat different symptoms and/or different
neuropsychiatric disorders of different doses of ITI-007[,]’ which suggests
that 1 to 10 mg may not be effective for the full scope of the disorders as
instantly claimed.” Ans. 27 (citing Davis 2870). Accordingly, we determine
that on this record, Appellants have not demonstrated unexpected results for
claim 10.
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In sum, we affirm the rejections of claims 1, 6–10, 23, and 24 as being
obvious over Robichaud and Lopez, and claims 1, 6–16, 23, and 24 as being
obvious over Robichaud, Lopez, and Tariot. Final Act. 16, 18.
Double Patenting
We adopt the Examiner’s findings of fact and analysis regarding (i)
the rejection of claims 1, 7, 9, 10, 23, and 24 for nonstatutory double
patenting over claims 1–29 of US 8,598,119; and (ii) the provisional
rejection of claims 1, 6–8, and 10 over claims 1–23 and 27 of copending
Application No. 14/394,469. Final Act. 8, 12. In brief, we agree with the
Examiner that claims 1–29 of US 8,598,119 and claims 1–23 and 27 of
copending Application No. 14/394,469 are directed to methods of using
Appellants’ claimed compound for the treatment of one or more 5-HT2A-
related disorders, such as depression, psychosis, sleep disorders, etc., or for
disorders such as agitation, aggressive behavior, posttraumatic stress
disorder, and impulse control disorder. Id. at 9, 12–13. We further agree
with the Examiner that it would have been obvious to one of ordinary skill in
the art prior to the filing date of the invention to treat these diseases and
disorders using Appellants’ claimed compound, for the reasons explained by
the Examiner. Id. at 9–10; 13–15.
We also adopt the Examiner’s findings of fact and analysis regarding
nonstatutory double patenting of (i) appealed claims 1, 7, 9, 10, 23, and 24
over claims 1–29 of US 9,168,258; (ii) appealed claims 1, 7, 9, 10, and 24
over claims 1 and 2 of US 9,586,960; and (iii) appealed claims 1, 7, 9, 10,
23, and 24 over claims 1–20 of US 9,616,061. Final Act. 10, 11, 13–14. As
stated by the Examiner, each of the patented claims is directed to
Appellants’ claimed compound, or to a pharmaceutical composition
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comprising the compound, and the corresponding patent specifications
indicate that this compound has utility in the treatment of depression, sleep
disorders, and/or mood disorders associated with psychosis, etc. Id. at 8–15.
A proposed claim to a method of using a composition is not patentably
distinct from a patent claim to the identical composition, where the patent’s
specification discloses the same utility for the composition that is recited in
the proposed claim. See Geneva Pharms., Inc., v. GlaxoSmithKline, PLC,
349 F.3d 1373, 1385–86 (Fed. Cir. 2003); Sun Pharm. Indus., Ltd. v. Eli
Lilly and Co., 611 F.3d 1381, 1389 (Fed. Cir. 2010) (“In light of the earlier
’614 patent’s description of gemcitabine’s use in treating cancer, the asserted
claims of the later ’826 patent, which recite a method of using gemcitabine
to treat cancer, are not patentably distinct from the ’614 patent’s claim to
gemcitabine.”).
In response to each of the double patenting rejections, Appellants
argued that:
the Examiner has not pointed to any reason why there would be
a reasonable expectation of success in applying the methods of
the reference patent [or application] to the treatment of the
specific claimed disorders in a patient having Alzheimer’s
disease, wherein the disorder is caused by Alzheimer’s disease,
as recited in Appellant’s claim 1.
Br. 15–18. We are not persuaded by this argument, because the reference
patents and application teach use of Appellants’ claimed compounds for the
same underlying disorders recited in the appealed claims, and on this record,
Appellants have not pointed to any evidence that these very same conditions,
when they occur in Alzheimer’s patients, would not be treatable by the same
therapeutic regimen.

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SUMMARY
We affirm the rejection of claims 1, 6–10, 23, and 24 under 35 U.S.C.
§ 103 as being unpatentable over Robichaud and Lopez.
We affirm the rejection of claims 1, 6–16, 23, and 24 under 35 U.S.C.
§ 103 as being unpatentable over Robichaud, Lopez, and Tariot.
We affirm the rejection of claims 1, 7, 9, 10, 23, and 24 on the ground
of nonstatutory double patenting as being unpatentable over claims 1–29 of
US 8,598,119 B2 and Lopez.
We affirm the rejection of claims 1, 7, 9, 10, 23, and 24 on the ground
of nonstatutory double patenting as being unpatentable over claims 1–20 of
US 9,168,258 B2 and Lopez.
We affirm the rejection of claims 1, 7, 10, and 24 on the ground of
nonstatutory double patenting as being unpatentable over claims 1 and 2 of
US 9,586,960 B2 and Lopez.
We affirm the provisional rejection of claims 1, 6–8, and 10 on the
ground of nonstatutory double patenting as being unpatentable over claims
1–23 and 27 of US App. No. 14/394,469 and Lopez.
We affirm the rejection of claims 1, 7, 9, 10, 23, and 24 on the ground
of nonstatutory double patenting as being unpatentable over claims 1–29 of
US 9,616,061 B2 and Lopez.
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)(1)(iv).

AFFIRMED