PROTHENA BIOSCIENCES LIMITED

Patent Trials and Appeals Board

Jun 4, 2021

2019006505 (P.T.A.B. Jun. 4, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/037,978 05/19/2016 Gene G. Kinney 057450-477900 3021
826 7590 06/04/2021
ALSTON & BIRD LLP
ONE SOUTH AT THE PLAZA
101 SOUTH TRYON STREET
SUITE 4000
CHARLOTTE, NC 28280-4000
EXAMINER
ULM, JOHN D
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
06/04/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
usptomail@alston.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte
GENE G. KINNEY, THERESA ANNE NEUMANN, and
DANIEL KEITH NESS1

Appeal 2019-006505
Application 15/037,978
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and JOHN G. NEW,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of assessing the efficacy of an immunotherapy for a Lewy Body
disease, which have been rejected as obvious and as being directed to patent
ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as Prothena Biosciences
Limited. Appeal Br. 2. We use the word “Appellant” to refer to “applicant”
as defined in 37 C.F.R. § 1.42.
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STATEMENT OF THE CASE
“Lewy Body disease[s] include Parkinson’s disease . . . and Lewy
Body dementia.” Spec. ¶ 2. “Alpha-synuclein is . . . implicated with a central
role in pathogenesis of Lewy body disease. The protein can aggregate to
form insoluble fibrils in pathological conditions.” Id. ¶ 3.
“Immunotherapy directed against alpha-synuclein has been reported
to reduce alpha-synuclein deposits and behavioral symptoms in mouse
models of Lewy body disease. . . . However, effects of immunotherapy on
alpha-synuclein deposits are not easy to monitor in human subjects.” Id. ¶ 4.
The Specification discloses a method of assessing the efficacy of
immunotherapy against alpha-synuclein in Lewy Body disease patients
based on improvement in constipation symptoms, and treating the patient
accordingly. Id. ¶¶ 5, 28.
Claims 1–21 and 25–30 are on appeal. Claim 1, reproduced below, is
illustrative:
1. A method of assessing the efficacy of immunotherapy
against alpha-synuclein in subjects diagnosed with a Lewy
Body disease and having one or more constipation symptoms,
comprising:
(a) evaluating the subjects’ constipation symptoms before
administration of an immunotherapeutic agent in a first regime;
(b) administering the immunotherapeutic agent to the
subjects in the first regime;
(c) evaluating the subjects’ constipation symptoms after
administering the iummunotherapeutic [sic] agent in the first
regime,
(d) comparing the subjects’ constipation symptoms
before and after administering the immunotherapeutic agent in
the first regime;
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(e) administering a second regime to subjects whose
symptoms improve and a third regime to subjects whose
symptoms deteriorate, the second and third regimes being
different.

The claims stand rejected as follows:
Claims 1–21 and 25–30 under 35 U.S.C. § 101 as being directed to
subject matter that is ineligible for patenting (Ans. 3) and
Claims 1–21 and 25–30 under 35 U.S.C. § 103 as obvious based on
Schenk,2 Saldanha,3 and Abbott4 (Ans. 4).
OPINION
Eligibility
Claims 1–21 and 25–30 stand rejected under 35 U.S.C. § 101
“because the relationship between bowel movement frequency and the
progression of Lewy Body diseases is a natural phenomen[on].” Ans. 3. The
Examiner reasons that “[t]he instant claims are directly analogous to those
that were held to be patent ineligible by the courts in the decision Mayo
Collaborative Services v. Prometheus Laboratories Inc., 132 S. Ct. 1289,
101 USPQ2d 1961 (2012).” Id.
The Examiner finds that “steps (a) and (c) of claim 1 simply tell[] a
practitioner to engage in well-understood, routine, conventional activity
previously engaged in by scientists in the field.” Id. at 5. The Examiner also
finds that “[s]teps (d) and (e) of claim 1 merely advise[] the practitioner to

2 US 2010/0278814 A1, published November 4, 2010.
3 US 2013/0108546 A1, published May 2, 2013.
4 Bowel Movement Frequency in Late-Life and Incidental Lewy Bodies,
MOVEMENT DISORDERS 22(11):1581–86 (2007).
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continue a treatment regimen if it produces a positive effect upon bowel
movement frequency, and essentially to try something else if it does not,
making these steps analogous to, but less specific than the ‘wherein’ clause
recited in the claim that was the subject of the Mayo decision.” Id.
The Examiner concludes that, “the instant claims do nothing more
than attempt to apply, to a known method of treating Lewy Body diseases[,]
a natural relationship between the frequency of bowel movements in a
subject and the presence or progression of Lewy Body disease,” and
therefore “they do not reflect a distinguishing patent eligible inventive
contribution.” Id. at 4.
Appellant argues that “claim 1 is directed to administering different
treatment regimes to a patient receiving immunotherapy against alpha-
synuclein depending on the monitoring of constipation levels, which are
used as a marker of the success of treatment.” Appeal Br. 5. Appellant
argues that “claim 1 (and its dependents) is closely analogous to the claim
found patent-eligible in Vanda [Pharm. Inc. v. West-Ward Pharm. Int’l Ltd.,
887 F.3d 1117 (Fed. Cir. 2018)]” because “[t]he administration of different
treatment regimes depending on the resulting of monitoring is a practical
application of the monitoring, as found in Vanda.” Id.
Appellant argues that the claimed invention in Mayo is distinguished
from the present claims because “the claims at issue in Mayo v. Prometheus
merely informed the operator of the consequences of a measurement without
requiring any specific action integrating the measurement into a practical
application.” Id. at 5–6.
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Principles of Law
A. Section 101
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Alice, 573 U.S. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
we first determine what concept the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
If the claim is “directed to” a judicial exception—a law of nature, a
natural phenomenon, or an abstract idea—we turn to the second step of the
Alice and Mayo framework, where “we must examine the elements of the
claim to determine whether it contains an ‘inventive concept’ sufficient to
‘transform’ the claimed abstract idea into a patent-eligible application.”
Alice, 573 U.S. at 221 (quotation marks omitted). “If a law of nature is not
patentable, then neither is a process reciting a law of nature, unless that
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process has additional features that provide practical assurance that the process
is more than a drafting effort designed to monopolize the law of nature itself.”
Mayo, 566 U.S. at 77.
B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“2019 Revised Guidance”).5 “All USPTO personnel are, as a matter of
internal agency management, expected to follow the guidance.” Id. at 51; see
also October 2019 Update at 1.
Under the 2019 Revised Guidance and the October 2019 Update, we
first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th
ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).6

5 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
6 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
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2019 Revised Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
2019 Revised Guidance, 84 Fed. Reg. at 52–56.

Revised Guidance Step 1
Appellant’s claim 1 recites: “A method of assessing the efficacy of
immunotherapy against alpha-synuclein in subjects diagnosed with a Lewy
Body disease.” Following the first step of the Mayo analysis, we find that the
claims are directed to a process, or method, and therefore fall into one of the
broad statutory categories of patent-eligible subject matter under 35 U.S.C. §
101.
Revised Guidance Step 2A, Prong 1
Following the Revised Guidance, we next consider whether the claims
recite a judicial exception. Independent claim 1 recites a method of treating
subjects with a Lewy Body disease and having constipation symptoms by
evaluating subjects’ constipation symptoms before and after treatment, and

practical application. See 2019 Revised Guidance — Section III(A)(2), 84
Fed. Reg. at 54–55.
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potentially adjusting treatment if the constipation symptoms do not improve.
Independent claims 27 and 29 recite the same steps. Independent claim 25 recites
treating a transgenic animal model and monitoring symptoms of constipation.
The Revised Guidance identifies “a law of nature, or a natural
phenomenon” as being among the judicial exceptions to patentability. 84 Fed.
Reg. at 54. We conclude, however, that claim 25 does not recite a natural
phenomenon. The recited transgenic animal model is not naturally occurring,
so any association between the occurrence of Lewy bodies and symptoms of
constipation in such a man-made animal model cannot be characterized as “a
law of nature, or a natural phenomenon.” Revised Guidance, 84 Fed. Reg. at
54. We therefore reverse the rejection of claim 25, and dependent claim 26,
under 35 U.S.C. § 101.
On the other hand, we conclude that independent claims 1, 27, and 29
do recite a judicial exception to patentability. In Mayo, the Court held that
“Prometheus’ patents set forth laws of nature—namely, relationships
between concentrations of certain metabolites in the blood and the likelihood
that a dosage of a thiopurine drug will prove ineffective or cause harm.” 566
U.S. at 77. Similarly here, claims 1, 27, and 29 set forth laws of nature—
namely, a natural association between a Lewy Body disease and
constipation.
Revised Guidance Step 2A, Prong 2
Even though claims 1, 27, and 29 recite a natural phenomenon, they
would still be patent-eligible if “the claim as a whole integrates the recited
judicial exception into a practical application of the exception.” Revised
Guidance, 84 Fed. Reg. at 54. The analysis of determining whether the claim
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integrates the judicial exception into a practical application includes
“[i]dentifying whether there are any additional elements recited in the claim
beyond the judicial exception(s)” and “evaluating those additional elements
individually and in combination to determine whether they integrate the
exception into a practical application.” Id. at 54–55. “[R]evised Step 2A
specifically excludes consideration of whether the additional elements
represent well-understood, routine, conventional activity.” Id. at 55.
Among the “exemplary considerations [that] are indicative that an
additional element . . . may have integrated the exception into a practical
application” is “an additional element that applies or uses a judicial
exception to effect a particular treatment or prophylaxis for a disease or
medical condition.” Id.
Here, in addition to the naturally occurring association between a
Lewy Body disease and constipation, claim 1 recites “administering a
second regime to subjects whose [constipation] symptoms improve and a
third regime to subjects whose [constipation] symptoms deteriorate, the
second and third regimes being different.”
Similarly, claim 27 recites “comparing the subject’s constipation
symptoms before and after administering the immunotherapeutic agent in the
first regime; wherein the subject’s symptoms improve,” and “administering
a second regime, which is the same as the first regime, or which administers
the same immunotherapeutic agent as the first regime at a reduced dose or
frequency.”
Claim 29 recites the alternative outcome to that of claim 27:
“comparing the subject’s constipation symptoms before and after
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administering the immunotherapeutic agent in the first regime; wherein the
subject’s symptoms remain the same or deteriorate,” and “administering a
second regime, which administers the same immunotherapeutic agent as the
first regime at an increased dose or frequency or which administers a
different immunotherapeutic agent or which administers a non-
immunotherapeutic agent effective for treatment of Lewy body disease.”
What all of claims 1, 27, and 29 share, however, is a requirement for a
subsequent treatment administration to be based on the effect of the first
treatment regime on the subject’s constipation symptoms. We agree with
Appellant that this aspect of the claims distinguishes them from the claimed
invention in Mayo, where “the ‘wherein’ clauses simply [told] a doctor
about the relevant natural laws, at most adding a suggestion that he should
take those laws into account when treating his patient.” Mayo, 566 U.S. at
78.
We agree with Appellant that, instead, the claims on appeal are more
similar to those at issue in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l
Ltd., 887 F.3d 1117 (Fed. Cir. 2018), where “[u]nlike the claim at issue in
Mayo, the claims . . . require[d] a treating doctor to administer iloperidone in
the amount of either (1) 12 mg/day or less or (2) between 12 mg/day to 24
mg/day, depending on the result of a genotyping assay.” Vanda, 887 F.3d at
1135. The Vanda court explained the distinction from Mayo: “The claim in
Mayo did not go beyond recognizing (i.e., ‘indicates’) a need to increase or
decrease a dose. . . . Thus, the claim in Mayo did not involve doctors using
the natural relationship between the metabolite level and lessening ‘the
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likelihood that a dosage of a thiopurine drug will prove ineffective or cause
harm.’” Id.
Similar to Vanda, the claims on appeal are directed to an application
of the association between constipation symptoms and a Lewy Body disease,
because they require treating a patient according to a second or third
treatment regime, depending on the effect of a first treatment regime on a
subject’s constipation symptoms. Thus, as in Vanda, the instant claims recite
“treatment steps,” in contrast to Mayo, where “the metabolite level in blood
simply ‘indicate[d]’ a need to increase or decrease dosage.” Vanda, 887 F.3d
at 1135.
Also on point is Endo Pharms. Inc. v. Teva Pharms. USA, Inc., 919
F.3d 1347 (Fed. Cir. 2019). The claims at issue in Endo were directed to a
“method of treating pain” by administering oxymorphone, then measuring a
creatinine clearance rate and “orally administering to said patient, in
dependence on which creatinine clearance rate is found, a lower dosage of
the dosage form to provide pain relief.” Endo, 919 F.3d at 1350–51
(emphasis omitted). The court concluded that “the asserted claims are not
directed to patent-ineligible subject matter. On the contrary, the claims are
directed to a patent-eligible method of using oxymorphone or a
pharmaceutically acceptable salt thereof to treat pain in a renally impaired
patient.” Id. at 1353 (footnote omitted).
The Endo court reasoned that, similar to Vanda,
the inventor [in Endo] recognized the relationship between
oxymorphone and patients with renal impairment, but that is
not what he claimed. Rather, he claimed an application of that
relationship—specifically, a method of treatment including
specific steps to adjust or lower the oxymorphone dose for
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patients with renal impairment. The claims are thus directed to
more than just reciting the natural relationship.
Id. at 1354.
Just as in Endo, Appellant has recognized the relationship between
constipation symptoms and a Lewy Body disease, but that is not what they
claimed. Rather, they claimed an application of that relationship—a method
of treatment that includes administering a second or third immuno-
therapeutic regime in which the specific treatment regime depends on the
effect of a first immunotherapeutic treatment regime on a subject’s
constipation symptoms.
In summary, we conclude that claims 1, 27, and 29 are directed to a
practical application of the recited judicial exception. We therefore reverse
the rejection of claims 1, 27, and 29, as well as dependent claims 2–21, 28,
and 30, under 35 U.S.C. § 101. The rejection of claims 25 and 26 was
reversed above. Thus, the rejection under 35 U.S.C. § 101 is reversed as to
all of the claims.
Obviousness
Claims 1–21 and 25–30 stand rejected as obvious based on Schenk,
Saldanha, and Abbott. The Examiner finds that Schenk teaches “the
treatment of a Lewy Body disease, including PD [Parkinson’s Disease], by
the administration of the antibody 9E4, or a humanized derivative thereof, to
a subject afflicted therewith.” Ans. 5–6. The Examiner finds that Saldanha
“adds to Schenk et al. by describing the reduction to practice of a humanized
form of the 9E4 antibody discussed in Schenk et al.” Id. at 6.
The Examiner finds that Saldanha states that
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[p]atients amenable to treatment include individuals at risk of
disease of a LBD [Lewy Body disease] but not showing
symptoms, as well as patients presently showing symptoms or
the early warning signs of synucleinopathies, for example, EEG
slowing, neuropsychiatric manifestations (depression, dementia,
hallucinations, anxiety, apathy, anhedonia), autonomic changes
(orthostatic hypotension, bladder disturbances, constipation, . . .
Id. at 6–7 (quoting Saldanha ¶ 111). The Examiner finds that the quoted
passage “shows that constipation was a known symptom of the early stages
of Lewy Body disease.” Id. at 7.
The Examiner finds that Abbott “shows that there was an established
correlation between bowel movement frequency and the presence of
incidental Lewy Bodies (ILB) in the brain of a subject.” Id. The Examiner
quotes Abbott’s finding that, “[a]fter age-adjustment, the percent of brains
with ILB declined with increasing bowel movement frequency,” and its
conclusion that “[a]ssuming that ILB represents an early phase of PD, an
association between ILB and constipation provides evidence that
constipation could be one of the earliest markers of the beginning of the PD
process.” Id. at 7–8.
The Examiner concludes that it would have been obvious “to have
employed bowel movement frequency as a measurable parameter when
evaluating the effectiveness of a therapeutic protocol, such as those
described in the Schenk et al. and Saldanha et al. publications, in the
treatment or prevention of a Lewy Body disease such as Parkinson’s
disease.” Id. at 8.
Appellant argues that
[a]lthough Abbott or Saldanha may report that constipation is an
early marker of Parkinson’s disease, they do not propose or
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otherwise provide sufficient reason to use constipation to monitor
immunotherapy directed against alpha-synuclein in treatment of a
Lewy body disease, nor to administer a subsequent treatment of
such a patient based on the outcome of the monitoring.
Appeal Br. 9–10.
Appellant argues that “[t]he present specification discloses that
indicators of Lewy body disease have been subdivided into at least three
classes: core indicators, suggestive clinical features and early warning
indicators (see paragraphs 79–82)” and “[c]onstipation is but one of many
early warning indicators.” Id. at 10.
Appellant also argues that “[i]n selecting signs and symptoms of a
disease with which to monitor a treatment, one would most naturally choose
the signs and symptoms that are most strongly and specifically associated
with the disease, namely the core features.” Id. Appellant argues that “[i]t
has not been shown that a skilled person would necessarily also determine
all of the many non-diagnostic and nonspecific signs or symptoms of Lewy
body disease in monitoring a treatment, or select constipation from among
these many signs and symptoms.” Id. at 11.
We agree with Appellant that the Examiner has not persuasively
shown that the claimed method would have been obvious based on the cited
references. Schenk suggests immunotherapy against alpha-synuclein to treat
a subject with a Lewy Body disease. See Schenk ¶ 51: “The invention
provides methods of effecting prophylaxis or treating a disease characterized
by Lewy bodies or alpha-synuclein aggregation in the brain, the method
comprising administering to a patient having or at risk of the disease an
effective regime of an antibody that specifically binds . . . alpha-synuclein.”
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Schenk states that, “[o]ptionally, the antibody is monoclonal antibody 9E4.”
Id.
As the Examiner has found, Saldanha discloses “humanized 9E4
antibodies.” Saldanha, abstract. Saldanha discloses “[t]he antibodies bind to
human alpha synuclein and can be used for immunotherapy of Lewy body
disease.” Id.
As the Examiner also found, Saldanha discloses that constipation is
one of many possible early warning signs of Lewy Body disease. The entire
list of symptoms cited by the Examiner states:
Patients amenable to treatment include individuals at risk of
disease of a LBD but not showing symptoms, as well as
patients presently showing symptoms or the early warning signs
of synucleinopathies, for example, EEG slowing,
neuropsychiatric manifestations (depression, dementia,
hallucinations, anxiety, apathy, anhedonia), autonomic changes
(orthostatic hypotension, bladder disturbances, constipation,
fecal incontinence, sialorrhea, dysphagia, sexual dysfunction,
changes in cerebral blood flow), sensory changes (olfactory,
pain, color discrimination abnormal sensations), sleep disorders
(REM sleep behavior disorder (RBD), restless legs syndrome/
periodic extremity movements, hypersomnia, insomnia) and
miscellaneous other signs and symptoms (fatigue, diplopia,
blurred vision, seborrhea, weight loss/gain).
Id. ¶ 111. True, the list includes constipation but it appears without emphasis
in a much longer list of “symptoms or the early warning signs of
synucleinopathies.” See id. Saldanha does not suggest monitoring
constipation symptoms as a way of monitoring the efficacy of treatment of
the underlying Lewy Body disease, or disclose that effective treatment of a
Lewy Body disease will also effectively treat associated constipation
symptoms.
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Abbott states that “[t]he purpose of this report is to examine the
association between late-life bowel movement frequency and ILB
[incidental Lewy bodies]. Bowel movement frequency was assessed from
1991 to 1993 in 245 men aged 71 to 93 years . . . who later received
postmortem examinations.” Abbott 1581, Abstract. Abbott reports that,
“[a]fter age-adjustment, the percent of brains with ILB declined with
increasing bowel movement frequency.” Id. at 1584, left col. Abbott states
that, “[a]ssuming that ILB represents an early phase of PD [Parkinson’s
disease], an association between ILB and constipation provides evidence
that constipation could be one of the earliest markers of the beginning of the
PD process.” Id. at 1584, right col.
Again, however, Abbott does not suggest monitoring the efficacy of
treatment of the underlying Lewy Body disease by monitoring constipation
symptoms, nor does it state that effectively treating a Lewy Body disease
will also effectively treat associated constipation symptoms. In summary,
although the cited references disclose that constipation can be an early
symptom of a Lewy Body disease such as Parkinson’s disease, none of the
references suggest monitoring constipation symptoms in order to track the
efficacy of treatment of the Lewy Body disease itself.
On the contrary, Saldanha states that
[a]ntibodies can be used for treating or effecting prophylaxis of
Lewy Body disease in patients by administration under
conditions that generate a beneficial therapeutic response in a
patient (e.g., reduction of neuritic and/or axonal alpha
synuclein aggregates, reduction of neuritic dystrophy,
improving cognitive function, and/or reversing, treating or
preventing cognitive decline) in the patient.
Saldanha ¶ 113 (emphasis added). Saldanha also states:
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Cognitive impairment, progressive decline in cognitive
function, changes in brain morphology, and changes in
cerebrovascular function are commonly observed in patients
suffering from or at risk of Lewy Body disease. Administration
of the present antibodies can inhibit or delay decline of
cognitive function in such patients.
Id. ¶ 114 (emphasis added).
Thus, when the prior art suggests determining the efficacy of
immunotherapy for a Lewy Body disease, it suggests evaluating the primary
symptoms of the disease: reduction of neuritic or axonal alpha synuclein
aggregates, reduction of neuritic dystrophy, improving cognitive function,
treating cognitive decline, or delaying decline of cognitive function. Id.
¶¶ 113–114. It does not suggest monitoring any of the “early warning signs”
of Lewy Body disease such as constipation.
In summary, we conclude that the Examiner has not shown that the
cited references would have provided a skilled artisan with sufficient reason
to compare a Lewy Body disease subject’s constipation symptoms before
and after a treatment regime, and then to administer either a second or third
treatment regime depending on whether the constipation symptoms improve.
We therefore reverse the rejection under 35 U.S.C. § 103 of independent
claims 1, 27, and 29, and dependent claims 2–21, 28, and 30.
With regard to claim 25, Saldanha discloses treatment of an animal
model with the anti-alpha-synuclein antibody 9E4. Saldanha ¶ 138. Saldanha
does not, however, discloses monitoring constipation symptoms in the
treated animals. Rather, Saldanha carried out “[b]ehavioral assays [that]
include Morris Water Maze test (MWW [sic, MWM?]) and horizontal beam
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test” and states that “[t]he following neuropathology measurements were
taken: alpha synuclein aggregation, synaptophysin, and MAP2.” Id. ¶ 141.
Saldanha reports that the antibodies “produced significant reduction in
α-syn accumulation and preservation of synaptic and dendritic densities, as
well as positive outcomes in MWM performance,” and “[t]he 9E4 antibody
improved water maze performance in α-synuclein transgenic mice.” Id.
¶¶ 142, 144.
Again, therefore, the cited references do not disclose monitoring
constipation symptoms in an animal model of Lewy Body disease, as a
means of evaluating efficacy of immunotherapy. We therefore reverse the
rejection of claim 25 and dependent claim 26 under 35 U.S.C. § 103.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–21, 25–
30
101 Eligibility 1–21, 25–
30
1–21, 25–
30
103 Schenk, Saldanha,
Abbott
1–21, 25–
30
Overall
Outcome
1–21, 25–
30

REVERSED