Hansen, John Bondo. et al.

Patent Trials and Appeals Board

Sep 16, 2019

14937286 - (D) (P.T.A.B. Sep. 16, 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.
14/937,286 11/10/2015 John Bondo Hansen HAN-10003/16 5493
25006 7590 09/16/2019
DINSMORE & SHOHL LLP
900 Wilshire Drive
Suite 300
TROY, MI 48084
EXAMINER
IVANOVA, SVETLANA M
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/16/2019 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):
MichiganPatTM@dinsmore.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN BONDO HANSEN and MIKAEL S. THOMSEN1
__________

Appeal 2019-003393
Application 14/937,286
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC B. GRIMES, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating certain movement disorders, which have been rejected as
obvious, nonenabled, and lacking adequate written description. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
“Movement disorders are a group of diseases that affect the ability to
produce and control body movement, and are often associated with

1 Appellants identify the Real Party in Interest as Contera Pharma ApS.
Appeal Br. 1.
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neurological disorders.” Spec. ¶ 3. “Movement disorders are frequently
caused by impaired regulation of dopamine neurotransmission.” Id. ¶ 11.
“Dopamine release and re-uptake is regulated by a number of
neurotransmitters, including serotonin (5-HT).” Id. ¶ 13. “Serotonin acts by
binding to different serotonergic receptors. These include . . . 5-HT1A,
5-HT1B, 5-HT1D, 5-HT1E, 5-HT1F,” etc. Id. ¶ 14.
“The present invention relates to use of 5-HT1 agonists . . . in
methods for treatment of movement disorders related to neurological
dysfunctions.” Id. ¶ 2. Buspirone is a 5-HT1A agonist. Id. ¶ 30. “[A]
subgroup of 5-HT1B/5-HT1D receptor agonists are collectively called ‘the
triptans’. The triptans have been developed as medication for treatment of
migraine. . . . These compounds include sumatriptan, zolmitriptan,” etc. Id.
¶ 81.
Claims 54, 56, and 60 are on appeal. Claim 54 is the only independent
claim and reads as follows:
54. A method for treatment or alleviation of a movement
disorder selected from the group consisting of: ataxia, dystonia,
Huntington’s disease, Rett syndrome, Tourette syndrome,
Wilson’s disease, Machado-Joseph disease, restless leg
syndrome and spasmodic torticollis, comprising:
one or more steps of administration of a synergistically
effective amount of a pharmaceutical composition comprising
zolmitriptan or a pharmaceutically acceptable salt thereof, and
one or more steps of administration of a synergistically
effective amount of buspirone or a pharmaceutically acceptable
salt thereof, to an individual in need thereof.

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The claims stand rejected as follows:
Claims 54, 56, and 60 under 35 U.S.C. § 103(a) as obvious based on
Green,2 Barber,3 Byrne,4 and Bonelli5 (Ans. 15);
Claims 54, 56, and 60 under 35 U.S.C. § 112, first paragraph, as
lacking adequate written description (Ans. 19); and
Claims 54, 56, and 60 under 35 U.S.C. § 112, first paragraph, as
nonenabled (Ans. 22).
I
The Examiner has rejected claims 54, 56, and 60 as obvious based on
Green, Barber, Byrne, and Bonelli.6 The Examiner finds that “Green relates
to . . . a method of treating extrapyramidal motor disorders, comprising a
5-HT1A agonist, such as buspirone.” Ans. 16. “Green discloses that 5-HT1
agonists have been used in the treatment of Huntington’s disease.” Id.
“Example 10 . . . specifically discloses a composition with zolmitriptan as
the main ingredient.” Id.
The Examiner notes that “Green discloses a number of diseases,” but
finds that “Barber is directed to the treatment of neurodegenerative diseases
specifically, to include Huntington’s disease specifically,” and discloses

2 WO 98/42344, published October 1, 1998.
3 US 2008/0227813 A1, published September 18, 2008.
4 Alan Byrne et al., BENEFICIAL EFFECTS OF BUSPIRONE THERAPY IN
HUNTINGTON’S DISEASE, 151 Am. J. of Psychiatry 1097 (1994).
5 Raphael M. Bonelli & Peter Hofmann, A SYSTEMATIC REVIEW OF THE
TREATMENT STUDIES IN HUNTINGTON’S DISEASE SINCE 1990, 8 Expert Opin.
Pharmacotherapy 141–153 (2007).
6 The Examiner cites Bonelli only in response to Appellants’ declaratory
evidence, not as part of the prima facie case of obviousness. See Ans. 17–18.
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treatment with a specific compound (I) “in combination with additional
agents, which include buspirone and zolmitriptan.” Id. The Examiner cites
Byrne as evidence that “use of buspirone specifically for the treatment of
Huntington’s disease specifically, is also known in the art.” Id.
The Examiner concludes that the method of claim 54 would have been
obvious based on Green, Barber, and Byrne,
because the art clearly discloses both compounds as beneficial
for the treatment of neurodegenerative diseases, to include
Huntington’s disease specifically. Based on the disclosure of
Green alone, or in combination with Barber and Byrne, the
skilled artisan would have been motivated to combine the two
agents in order to enhance the therapeutic effect of each drug
alone.
Id. at 17.
Appellants argue, among other things, that Green discloses
“[z]olmitriptan is . . . mentioned in an example separately from buspirone.
No teaching or suggestion of a combination of buspirone and zolmitriptan is
found in the Green reference.” Appeal Br. 2.
Appellants also argue that Barber does not disclose treatment with its
compound (I), combined with both buspirone and zolmitriptan, because “the
Barber reference . . . merely provides a ‘laundry list’ of more than 230
compounds. Appellant submits that Barber merely lists ‘buspirone’ and
‘zolmitriptan’ as examples of suitable anxiolytic agents and neurotransmitter
agonists, respectively.” Id. Appellants argue that “no teaching or suggestion
of a combination of buspirone and zolmitriptan is found in the Barber
reference.” Id. at 4.
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Appellants argue that “Byrne only states that buspirone could have an
effect on aggression and irritability associated with Huntington’s disease.
Byrne makes no reference to effects on abnormal movements.” Id. at 4.
Appellant submits that it is incorrect that “[bas]ed on the
disclosure of Green alone, or in combination with Barber and
Byrne, the skilled artisan would have been motivated to
combine the two agents in order to enhance the therapeutic
effect of each drug alone.” There simply is no support at all for
this assertion and Appellant submits that no prima facie case of
obviousness is established.
Id. (quoting Office Action mailed July 2, 2018, alteration in original).
We agree with Appellants that the cited references do not provide “a
reason that would have prompted a person of ordinary skill in the relevant
field to combine the elements in the way the claimed new invention does.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418–19 (2007).
Claim 54 defines a method of treating one of nine specific movement
disorders by administering a synergistically effective amount of zolmitriptan
and buspirone to an individual in need thereof. Thus, claim 54 requires
treating a movement disorder, which is one of “a group of diseases that
affect the ability to produce and control body movement, and are often
associated with neurological disorders.” Spec. ¶ 3. Claim 54 specifies which
neurological disorders affect the treated individual.
As a whole, therefore, claim 54 requires treating an individual whose
ability to produce and control body movement has been affected by one of
nine specific conditions, with amounts of both zolmitriptan and buspirone
that are effective to treat or ameliorate the body movement effects. Claim 54
also requires that zolmitriptan and buspirone are administered in
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“synergistically effective” amounts; i.e., amounts that in combination
produce an effect that is greater than the additive effect of each drug alone.
Green discloses
a pharmaceutical composition . . . and the use of such a
composition for the treatment of anxiety, depression, attention
deficit disorder and/or panic disorders, sleep apnoea and/or
related respiratory disorders and/or substance addiction,
especially alcohol abuse, the treatment and/or prophylaxis of
incontinence disorders, inducing immunosuppression and/or
treating immune disorders, the alleviation of extrapyramidal
motor disorders and/or as a memory enhancer.
Green 1:4–13. More specifically, Green discloses “a pharmaceutical
composition for oral administration comprising a carrier and, as an active
ingredient, a 5-HT1 agonist, characterised in that the composition is
formulated to reduce pre-systemic metabolism of the 5-HT1 agonist.” Id. at
5:21–25.
Green discloses that “buspirone is a 5-HT1 agonist.” Id. at 1:18–19.
“Buspirone is an example from a class of compounds known as the
azapirones which have been shown to be effective in the treatment of
anxiety.” Id. at 2:23–26. Green lists other azapirones. Id. at 2:25 to 3:9. “All
these compounds act as agonists at 5-HT1 receptors.” Id. at 3:10–11. Green
also lists other 5-HT1 agonists, including zolmitriptan. Id. at 3:13 to 5:13; in
particular 5:3.
Green discloses the use of its compositions “in the treatment of
anxiety” (id. at 14:24–25); “in the treatment of depression, attention deficit
disorder and panic disorders and as memory enhancers” (id. at 14:30–32);
“in the treatment and/or prophylaxis of incontinence disorders” (id. at
14:33–34); “for inducing immunosuppression and/or treating immune
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disorders” (id. at 14:37 to 15:1); “in the treatment of sleep apnoea” (id. at
15:9–10); and “in the treatment of substance addiction” (id. at 15:15).
As relevant specifically to the instant claims, Green discloses that
“[a]zapirones, particularly buspirone, are also useful for the alleviation of
extrapyramidal motor disorders and can therefore be used to treat such
conditions as Parkinson’s disease, neuroleptic-induced extrapyramidal
symptoms and tardive dyskinesia.” Id. at 15:35 to 16:2. Green discloses that,
[i]n addition to the above conditions, 5-HT1 agonists
have also been used in the treatment of social phobia,
obsessive-compulsive disorder, migraine, cerebellar ataxia,
levodopa-induced dyskinesias, Huntington’s disease, central
and peripheral neurodegenerative disorders, emesis,
hypertension, hayfever, asthma and pruritis and to assist
smokers in giving up smoking.
Id. at 16:3–10.
Green provides working examples of dosage forms comprising either
buspirone or zolmitriptan, but not both. Id. at 16:28 to 18:13, 21:1–27
(buspirone); 23:14–25 (zolmitriptan).
Barber discloses methods of treating diseases associated with
neurodegeneration in the central nervous system using its compound (I)
“alone or in combination with at least one additional therapeutic agent.”
Barber ¶ 25. The diseases include ALS, Huntington’s disease, Parkinson’s
disease (PD), stroke, and cystic fibrosis. Id. ¶ 27. The additional therapeutic
agents include anxiolytic agents and neurotransmitter agonists, among others.
Id. ¶ 81. “Suitable anxiolytic agents include . . . buspirone.” Id. ¶ 82.
“Suitable neurotransmitter agonists include . . . zolmitriptan.” Id.
Byrne “report[s] the successful use of buspirone in the treatment of
two aggressive patients with Huntington’s disease.” Byrne 1097. Byrne
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concludes that buspirone has a potential role “in the management of
aggression and irritability in Huntington’s disease.” Id. Byrne does not
disclose any effect of buspirone in treating a movement disorder.
We conclude that the above disclosures would not have directed a
skilled artisan to the method of claim 54 without the benefit of hindsight
gleaned from Appellants’ Specification. Green discloses treating many
different disorders, ranging from psychiatric conditions like anxiety,
depression, and addiction, to incontinence, immune disorders, and
extrapyramidal motor disorders. Green’s only disclosure of treating a
condition listed in claim 54 is within a list of thirteen conditions, and even
then Green does not specify that its method treats a movement disorder
associated with Huntington’s disease. See Green 16:3–10.
In addition, while Green exemplifies dosage forms comprising either
buspirone or zolmitriptan, it does not exemplify or specifically suggest
combining either of those active agents with other 5-HT1 agonists, nor does
it suggest combining them with each other.
Barber discloses treating diseases associated with neurodegeneration,
rather than movement disorders. Barber’s invention is treatment with its
Compound (I), which can be combined with other therapeutic agents within
a variety of different classes. Those classes include anxiolytic agents, of
which buspirone is one example, and neurotransmitter agonists, of which
zolmitriptan is one example, but Barber does not suggest combining both an
anxiolytic agent and a neurotransmitter agonist, much less buspirone and
zolmitriptan specifically, with its Compound (I) to treat a movement
disorder.
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Byrne, for its part, discloses treatment of aggression, not a movement
disorder, with buspirone alone, and does not suggest combining buspirone
with another agent.
“Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination.” Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352,
1360 (Fed. Cir. 2011). “Rather, obviousness requires the additional showing
that a person of ordinary skill at the time of the invention would have
selected and combined those prior art elements in the normal course of
research and development to yield the claimed invention.” Id.
In our view, the cited references do not show that a person of ordinary
skill in the art would have selected buspirone and zolmitriptan in the normal
course of research and development of a treatment for a movement disorder
associated with Huntington’s disease (or any of the other disorders listed in
claim 54), and therefore the references do not support a prima facie case of
obviousness. We reverse the rejection of claim 54, and dependent claims 56
and 60, under 35 U.S.C. § 103(a).
II
The Examiner has rejected claims 54, 56, and 60 on the basis that they
lack adequate written description in the Specification. The Examiner reasons
that, “[t]o provide adequate written description and evidence of possession
of a claimed genus, the specification must provide sufficient distinguishing
characteristics of the genus,” which “may be achieved by means of a
recitation of a representative number of species falling within the scope of
the genus or of a recitation of structural features common to the members of
the genus.” Ans. 20–21.
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The Examiner finds that the Specification
provides no description of the broadly claimed method of
treatment of the various movement disorders claimed. To the
extent that there is any description of treating, it is for treating
Parkinson’s disease, LID, akinesia and tardive dyskinesia.
There is nothing in the specification to provide a link that
treating Parkinson’s disease, LID, akinesia and tardive
dyskinesia with the claimed combination can also treat vastly
different movement disorders as the ones currently claimed.
Id. at 21. The Examiner concludes that “[o]ne of skill in the art would not
recognize from the disclosure that the applicant was in possession of the
genus.” Id.
Appellants argue that “the claims list ataxia, dystonia, Huntington’s
disease, Rett syndrome, Tourette syndrome, Wilson’s disease, Machado-
Joseph disease, restless leg syndrome and spasmodic torticollis, all of which
are well-known to be ‘movement disorders’ and to be associated with
‘altered dopamine levels.’” Appeal Br. 8–9. Appellants argue that the
Examiner’s concern about Parkinson’s disease versus Huntington’s disease
is misplaced. Id. at 9–10. Appellants cite portions of the Specification to
show that “modulators of serotonin receptors can affect dopamine
neurotransmitter activity in a complex manner.” Id. at 11. Appellants
conclude that
one of skill in the art, having reviewed the present specification,
would recognize that treatment of the movement disorders
listed in claim 1 [sic, 54] would be beneficial and thus, a person
skilled in the art at the time the application was filed would
have recognized that the inventor was in possession of the
invention as claimed.
Id. at 12.
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“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). “Insofar as the written
description requirement is concerned, that burden is discharged by
‘presenting evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.’” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (citation omitted).
“If . . . the specification contains a description of the claimed invention,
albeit not in ipsis verbis (in the identical words), then the examiner . . . must
provide reasons why one of ordinary skill in the art would not consider the
description sufficient.” Id.
Here, the Specification describes the “use of 5-HT1 agonists for the
treatment of movement disorders. The combined activation of different
serotonergic receptors can lead to a synergic effect which more effectively
influences the dopamine levels in the synapse and lead to efficacious
treatment of the movement disorders described herein.” Spec. ¶ 22. The
Specification exemplifies the combination of zolmitriptan and buspirone to
treat a rat model of a movement disorder. Id. ¶¶ 239–246. And the
Specification states that
[m]ovement disorders according to the present invention may
be selected from the group of disorders comprising ataxia,
akathisia, dystonia, essential tremor, Huntington’s disease,
myoclonus, Parkinson’s disease, Rett syndrome, tardive
dyskinesia, Tourette syndrome, Wilson’s disease, dyskinesia,
chorea, Machado-Joseph disease, restless leg syndrome,
spasmodic torticollis, geniospasm, or movement disorders
associated therewith.
Id. ¶ 103 (emphases added).
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Thus, the Specification describes the invention as a method of treating
movement disorders, specifically lists the disorders recited in claim 54 as
among the disorders that can be treated, and exemplifies the combination of
the two drugs recited in claim 54 in treating a rat model of a movement
disorder. We agree with Appellants that the Specification describes the
claimed method adequately to demonstrate possession to a person of
ordinary skill in the art.
With respect to the Examiner’s concern about describing a genus, we
note that claim 54 recites treatment of specific disorders with specific
compounds. Because claim 54 does not recite a genus, of either disorders or
compounds, no genus needs to be described in order to describe the claimed
method.
We reverse the rejection of claims 54, 56, and 60 under 35 U.S.C.
§ 112, first paragraph, based on lack of adequate written description.
III
The Examiner has rejected claims 54, 56, and 60 as nonenabled, on
the basis that, “although the specification is enabling for treating of
Parkinson’s disease, LID, akinesia and tardive dyskinesia, it is not broadly
enabling for treating the broad number of other movement disorders
claimed.” Ans. 22.
The Examiner cites Bonelli as evidence of “the state of the prior art as
it relates to movements disorders as currently claimed, to take Huntington’s
disease as one non-limiting example.” Id. at 24. The Examiner finds that
Bonelli discloses that one class of drugs used to treat Huntington’s disease is
antidopaminergics, and “this strategy of using antidopaminergics is the exact
opposite of what needs to be achieved with respect to Parkinson’s disease
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and the related diseases- i.e. enhancement of dopamine levels or activity, for
which Applicant has support in the specification.” Id. at 25.
The Examiner cites Kandel & Schwartz7 as evidence that, although
“Parkinson’s disease and Huntington’s disease are both movement disorders,
and . . . dopamine has been implicated in both, [that] in no way makes them
akin in pathology, and treatment means.” Id. at 26. That is, “Parkinson’s
disease is a hypokinetic disorder characterized by akinesia and bradykinesia,
whereas Huntington’s disease, on the other end of the spectrum, is [a]
hyperkinetic disorder, characterized by dyskinesia and hypotonia.” Id. The
Examiner finds that Kandel & Schwartz also discloses that “the circuitry
involved in both [Parkinson’s disease and Huntington’s disease] in the basal
ganglia is balanced in a completely different manner,” with “frequently
completely opposite activity of increased v. decreased signaling in
Parkinson’s disease, as compared to Huntington’s chorea,” relative to a
normal brain. Id.
The Examiner finds that “the only Examples in Applicant’s
specification pertain to testing in only Parkinson’s disease, LID, akinesia
and tardive dyskinesia.” Id. at 29. The Examiner also finds that “a broad
search of the art indicates that there is no silver bullet for any and every
movement disorder across the spectrum,” with “different treatment methods
from one movement disorder to another,” and “there is no existing
prevention regimen for movement disorders.” Id.

7 Mahlon R. DeLong, “The Basal Ganglia,” in PRINCIPLES OF NEURAL
SCIENCE, 4th Edition, Kandel et al. (eds.), McGraw-Hill Health Profs. Div.,
New York (2000), pp. 853–867.
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The Examiner concludes that, even though the “skill of one in the art
is expected to be high,” “the specification does not provide support for
treatment of all movement disorders as currently claimed, with the claimed
combination of buspirone and zolmitriptan” and “[o]ne of ordinary skill in
the art would be burdened with undue experimentation to practice the
invention commensurate in the scope of the claims.” Id. at 30.
Appellants argue that, “as noted in the specification, the listed
disorders are all movement disorders and are all associated with altered
synaptic dopamine levels, commonalities shared with L-DOPA induced
dyskinesia.” Appeal Br. 5.8 With respect to the Examiner’s statement that
Parkinson’s disease and Huntington’s disease are treated with opposite
strategies, Appellants argue that “the idea that Parkinson’s disease is treated
directly with dopamine receptor agonists only and that Huntington’s disease
is treated directly only with dopamine receptor antagonists is inappropriately
reductive.” Id. at 6. Appellants point to the discussion in the Specification of
treating different movement disorders with serotonin receptor modulators
and conclude that “the specification indicates that modulators of serotonin
receptors can affect dopamine neurotransmitter activity in a complex manner
and that effects on both increased and decreased dopamine neurotransmitter
activity are possible.” Id. at 6–8.

8 Appellants’ arguments regarding the nonenablement rejection refer to “the
remarks above.” Appeal Br. 12. Appellants, earlier in the brief, argued that
evidence presented in the Specification and in two declarations demonstrated
unexpected results with respect to the claimed invention. Id. at 4–8.
Accordingly, we have considered those arguments and that evidence as they
pertain to the issue of enablement.
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“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
When rejecting a claim under the enablement
requirement of section 112, the PTO bears an initial burden of
setting forth a reasonable explanation as to why it believes that
the scope of protection provided by that claim is not adequately
enabled by the description of the invention provided in the
specification of the application; this includes, of course,
providing sufficient reasons for doubting any assertions in the
specification as to the scope of enablement.
Id. at 1561–62.
In this case, the Examiner has not established that the Specification
does not enable practicing the claimed method without undue
experimentation. The Specification describes the invention as “relat[ing] to
use of 5-HT1 agonists . . . in methods for treatment of movement disorders
related to neurological dysfunctions.” Spec. ¶ 2. The Specification states that
one “example of a movement disorder is dyskinesia which [is] characterized
by various involuntary movements, which can affect discrete body parts or
can become generalized and severely disabling. Tardive dyskinesia is one
example of dyskinesia.” Id. ¶ 4.
The Specification also states that
the treatment of PD [Parkinson’s disease] with L-DOPA often
gives rise to dyskinesia (diminished voluntary movements and
presence of involuntary movements) in advanced PD patients
with impaired regulations of [dopamine] levels. This specific
type of dyskinesia is called L-DOPA Induced Dyskinesia (LID)
and is caused by excessive dopamine levels in the synapses.
Id. ¶ 7.
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The Specification provides working examples of “the evaluation of
zolmitriptan and buspirone in the 6-OHDA rat model.” Id. ¶ 239. “The
results . . . showed that buspirone (1 mg/kg/day i.p.) in combination with
zolmitriptan (3 mg/kg/day i.p. or 10 mg/kg/day) significantly reduced
L-DOPA-induced dyskinesia.” Id. ¶ 246.
The Examiner concludes that the Specification is enabling for
treatment of LID, among other movement disorders. Ans. 22. LID is a
“dyskinesia . . . caused by excessive dopamine levels in the synapses.” Spec.
¶ 7. The movement disorder caused by Huntington’s disease (a.k.a.
Huntington’s chorea9) is also a dyskinesia. Ans. 26 (citing Kandel &
Schwartz at 861).
The Examiner also cites the disclosure in Kandel & Schwartz that:
“Drug-induced dyskinesias [e.g., LID], which closely resemble chorea, are a
side effect of dopamine replacement therapy for Parkinson disease. The
pathophysiology of those pharmacologically induced dyskinesias may be in
part similar to that of chorea in Huntington disease.” Id. at 28 (quoting
Kandel & Schwartz at 865).
Thus, both LID and the movement disorder of Huntington’s disease
are dyskinesias; i.e., movement disorders characterized by abnormal
involuntary movement. Spec. ¶¶ 4, 7; Ans. 26, 28. LID “is caused by
excessive dopamine levels in the synapses.” Spec. ¶ 7. The movement
disorder of Huntington’s disease has been treated with, among other things,
“dopamine blocking, or dopamine depleting” agents. Ans. 29. Thus, the

9 See Ans. 35 (“(Huntington’s) chorea (i.e. Huntington’s disease)”).
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movement disorder of Huntington’s disease is also characterized by
excessive dopamine.
The Specification’s working examples use a rat model of LID, and the
Examiner has concluded that the Specification is enabling for treatment of
both Parkinson’s disease and LID, among other movement disorders. The
Examiner concludes that the Specification does not enable treating the
movement disorder of Huntington’s disease because the underlying causes
of Parkinson’s disease and Huntington’s disease differ. However, those
differences also apply to LID; both LID and the movement disorder of
Huntington’s disease are caused by excessive dopamine.
In our view, the Examiner has not persuasively explained why the
Specification’s evidence showing treatment of an animal model of LID
enables treatment of Parkinson’s disease, but does not enable treatment of
the movement disorder of Huntington’s disease. The Examiner cites Kandel
& Schwartz as evidence that Parkinson’s disease and Huntington’s disease
(“chorea”) have different effects on “the circuitry involved in . . . the basal
ganglia.” Ans. 26. However, the reproduced text and figure do not
adequately explain why the Specification’s results using an animal model of
LID—a movement disorder caused by excessive dopamine—would not be
enabling for Huntington’s disease.
In summary, the Examiner has not presented sufficient evidence or
technical reasoning to support a conclusion that the Specification is not
enabling for treatment of Huntington’s disease. The Examiner does not
specifically address any of the other movement disorders recited in claim 54.
We therefore reverse the rejection of claims 54, 56, and 60 under 35 U.S.C.
§ 112, first paragraph, for lack of enablement.
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SUMMARY
We reverse all of the rejections on appeal.

REVERSED