Ex Parte CUNNINGHAM et al

Patent Trial and Appeal Board

Sep 25, 2017

12626085 (P.T.A.B. Sep. 25, 2017)

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.
12/626,085 11/25/2009 Sean CUNNINGHAM 34074.01062 1474
61214 7590
Fox Rothschild, LLP
Alkermes PLC
997 Lenox Drive, Bldg. #3
Lawrenceville, NJ 08648
09/27/2017 EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/27/2017 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):
ipdocket @ foxrothschild. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SEAN CUNNINGHAM, SEAMUS MULLIGAN,
and MICHAEL MYERS1
Appeal 2016-001845
Application 12/626,085
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and TAWEN CHANG,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Alkermes Pharma Ireland
Limited. App. Br. 2.
Appeal 2016-001845
Application 12/626,085
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 42—62 and 82—114.2 Specifically,
claims 42, 49, 58—60, 88, and 104—106 stand rejected as unpatentable under
35 U.S.C. § 102(b) as anticipated by S.R. Schwid et al., Quantitative
Assessment of Sustained Release 4-Aminopyridine for Symptomatic
Treatment of Multiple Sclerosis, 48 Neurology 817—21 (1997)
(“Schwid”).
Claims 42, 43, 47^19, 51, 52, 56, 58-60, 62, 83, 88, 89, 93-95, 97,
98, 102, 104—106, and 108 stand rejected as unpatentable under 35 U.S.C. §
102(b) as being anticipated by P.J. Potter et al., Randomized Double-blind
Crossover Trial of Fampridine-SR (Sustained Release 4-Aminopyridine) in
Patients with Incomplete Spinal Cord Injury, 15(10) J. Neurotrauma 837—
49 (1998) (“Potter”).
Claims 42, 43, 49, 58—60, 88, 89, 95, and 104—106 stand rejected as
unpatentable under 35 U.S.C. § 102(b) as being anticipated by J.L. Segal et
al., Absorption Characteristics of Sustained-release 4-Aminopyridine
(Fampridine SR) in Patients with Chronic Spinal Cord Injury, 40(4) J.
Clin. Pharmacol. 402-A09 (2000) (“Segal”).
Claims 43^16, 51-57, 62, 82-87, 89-92, 95, 97-103, and 109-114
stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious
over Schwid, as evidenced by the Declaration of Mairead Fogarty,
December 21, 2012 (the “Fogarty Declaration”), as applied to claims 42,
49, 58-60, 88, and 10^U106.
2 Claims 1—41 and 63—81 are canceled. App. Br. 20-21.
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Application 12/626,085
Claims 4A46, 53-55, 57, 82, 8^87, 90-92, 99-101, 103, and 109—
114 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being
obvious over Potter, as evidenced by the Fogarty Declaration, as applied to
claims 42, 43, 47^19, 51, 52, 56, 58-60, 62, 83, 88, 89, 93-95, 97, 98, 102,
104—106, and 108.
Claims 4A46, 51-57, 62, 82-87, 90-92, 97-103, and 109-114 stand
rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over
Segal, as evidenced by the Fogarty Declaration, as applied to claims 42, 43,
49, 58-60, 88, 89, 95, and 10^U106.
Claims 47, 48, 50, 61, 93, 94, 96, 107, and 108 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over Schwid and
Potter, as evidenced by the Fogarty Declaration, as applied to claims 42^46,
49, 51-60, 62, 82-92, 95, 97-106, and 109-114.
Claims 50, 61, 96, and 107 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over Potter, as evidenced by the Fogarty
Declaration, as applied to claims 42-49, 51—60, 62, 82—95, 97—106, and
108-114.
Claims 47, 48, 50, 61, 93, 94, 96, 107, and 108 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over Segal, as
applied to claims 42^46, 49, 51—60, 62, 82—92, 95, 97—106, and 109-114 in
view of Potter.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
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Application 12/626,085
NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to a pharmaceutical composition
which comprises a therapeutically effective amount of an aminopyridine
dispersed in a release matrix, including, for example, a composition that can
be formulated into a stable, sustained-release oral dosage formulation, such
as a tablet which provides, upon administration to a patient, a
therapeutically effective plasma level of the aminopyridine for a period of
at least 12 hours, preferably 24 hours or more, and the use of the
composition to treat various neurological diseases. Abstract.
REPRESENTATIVE CLAIM
Claim 42 is representative of the claims on appeal and recites:
42. A sustained release aminopyridine composition
comprising: 4-aminopyridine particles; dispersed in a sustained
release matrix, wherein the 4-aminopyridine particles have a
particle size distribution such that 90% of the 4-aminopyridine
particles are smaller than 1.5 mm, 50% of the 4-aminopyridine
particles are smaller than 1 mm, and 10% of the 4-
aminopyridine particles are smaller than 500 pm.
App. Br. 20.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner’s reasoning and conclusion
that the claims are anticipated and obvious over the cited prior art
references and the Fogarty Declaration. We address Appellants’ arguments
below.
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Application 12/626,085
A. Rejections under 35 U.S.C. $ 102(b)
Issue 1
Appellants argue all of the Section 102 rejections together.
Appellants argue that the Examiner erred because none of the respective
cited prior art discloses the limitation reciting: “wherein the 4-
aminopyridine particles have a particle size distribution such that 90% of
the 4-aminopyridine particles are smaller than 1.5 mm, 50% of the 4-
aminopyridine particles are smaller than 1 mm, and 10% of the 4-
aminopyridine particles are smaller than 500 pm,” and because the
Examiner improperly relies upon the Fogarty Declaration to cure this
alleged deficiency. App. Br. 7—8.
Analysis
Appellants argue the Examiner improperly relied on the Appellants’
Fogarty Declaration as extrinsic evidence to fill the acknowledged gap in
the teachings of Schwid, Potter, and Segal. App. Br. 8. According to
Appellants, the Examiner acknowledges that none of the cited prior art
references discloses anything about the claimed particle size distribution.
Id. (citing Office Act., filed October 9, 2012).
The Examiner finds, and Appellants do not dispute, that Schwid,
Potter, and Segal each teach 4-aminopyridine, in a sustained-release
formulation, and that the formulation employed in each reference was
supplied to the respective investigators by Elan Pharmaceutical Research
Corporation (“Elan”), the predecessor in title to the real party-in-interest in
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Application 12/626,085
the present appeal.3 See Final Act. 8—10, App. Br. 5—6, Schwid 8, Potter
838, Segal 405. Appellants contend, however, that none of the cited prior
art references expressly disclose the particle size distribution recited in the
claims. App. Br. 6.
The Examiner relies on the Fogarty Declaration4 as demonstrating
that the claimed particle size distribution was inherently present in the
sustained release formulations employed in each of the cited prior art
references. Final Act. 2-4 (citing Fogarty Decl. 14), App. Br. 6. Paragraph
4 of the Fogarty Declaration expressly states that the batches of 4-
aminopyridine sustained-release formulation supplied to the investigators of
Schwid, Potter, and Segal were composed of particles conforming to the
size distribution recited in the claims. Fogarty Decl. 14.
Appellants argue the Examiner improperly relies upon the Fogarty
Declaration to demonstrate that the cited prior art inherently discloses the
claimed particle size distribution, contrary to the holding of the predecessor
to our reviewing court in In re Oelrich, 666 F.2d 578 (C.C.P.A. 1981).
App. Br. 8. According to Appellants, Oelrich stands for the proposition
that the prior art must first expressly disclose all structural limitations of a
claimed product, before extrinsic evidence can be relied to demonstrate that
a function is “necessarily present.” Id. (citing 666 F.2d at 581).
Appellants argue that because the cited prior art does not teach a structural
limitation of the claim, i.e., the particle size distribution of the sustained-
release 4-aminopyridine composition, the Examiner’s reliance upon the
3 See Fogarty Declaration 11.
4 Mairead Fogarty, the Declarant, avers that she is “Senior Director, Process
Development at Alkermes Pharma Ireland Limited.” Fogarty Decl. 11.
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Fogarty Declaration to demonstrate that the particle size distribution was
inherently disclosed by the cited prior art is therefore improper.
Appellants further point to the Fogarty Declaration’s assertion that
the claimed particle size distribution was not publicly known or available.
App. Br. 9 (citing Fogarty Decl. Tflf 2, 3). Appellants therefore contend that
the Fogarty Declaration speaks neither to a functional limitation that makes
clear the missing descriptive matter as being “necessarily present” in
Schwid, Potter, and Segal, nor would it have provided any insight to
persons of ordinary skill that, at the time the invention was made, the
structure of compositions was described in the cited references. Id.
Consequently, Appellants argue, the Fogarty Declaration is not competent
extrinsic evidence under Oelrich. Id.
We are not persuaded by Appellants’ arguments. The Fogarty
Declaration expressly states that Elan provided the 4-aminopyridine
sustained-release compositions used in Schwid, Potter, and Segal, and that:
The relevant batch records indicate that each of the test
articles used in the 0295-001 [Potter, Segal] and 0995-001
[Schwid] studies were manufactured using 4-aminopyridine drug
substance which was subjected to a milling process prior to
incorporation into the final dosage form, as a result of which, the
test articles each comprised 4-aminopyridine particles dispersed
in a sustained release matrix, wherein the 4-aminopyridine
particles had a particle size distribution such that 90% of the 4-
aminopyridine particles were smaller than 1.5 mm, 50% of the
4-aminopyridine particles were smaller than 1 mm, and 10% of
the 4-aminopyridine particles were smaller than 500 pm.
Fogarty Decl. 14. Appellants thus admit that Elan supplied the claimed
composition, with the recited particle size distribution, that was employed
in each of the cited prior art references. We consequently agree with the
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Examiner that, because the claimed composition was admittedly used in the
studies disclosed by Schwid, Potter, and Segal, the particle size distribution
of that composition was necessarily, and therefore inherently, disclosed by
each of the prior art references.
Nor are we persuaded by Appellants’ reliance upon Oelrich. In
Oelrich, the property that was argued to be inherently disclosed was a
functional property, viz., “a ... carrier frequency [in an apparatus for
moving fins in a missile guidance system] ... less than the minimum system
resonant frequency,” as Appellants state. Oelrich, 666 F.2d at 582.
However, we do not interpret this to mean, as Appellants suggest, that the
structural limitations of a claim must all be expressly disclosed by an
anticipatory reference before a functional property can be found to be
inherently disclosed. See, e.g., Reply Br. 5 (“Therefore, an inherent
anticipation is warranted where there are [sic] no dispute that the prior art
teaches the structural limitations of the pending claim”). Indeed, Oelrich
expressly states: “[M]ere recitation of a newly discovered function or
property, inherently possessed by things in the prior art, does not
distinguish a claim drawn to those things from the prior art.” 666 F.2d at
581 (emphasis added) (citing In re Swinehart, 439 F.2d 210, 212—13,
(C.C.P.A. 1971). Oelrich thus expressly states that a property of a claimed
invention, i.e., a structural limitation, can be inherently possessed, and
disclosed, by a prior art reference.
A subsequent decision by the Federal Circuit, Continental Can Co.
USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991), reinforces this
point. In Continental Can, the limitation that was argued to be inherently
disclosed was the hollow rib forming a portion of the structure of the base
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Application 12/626,085
of a plastic beverage bottle, i.e., a structural limitation. 948 F.2d at 1268.
The court held that:
To serve as an anticipation when the reference is silent about the
asserted inherent characteristic, such gap in the reference may be
filled with recourse to extrinsic evidence. Such evidence must
make clear that the missing descriptive matter is necessarily
present in the thing described in the reference, and that it would
be so recognized by persons of ordinary skill.
Id. (citing Oelrich, 666 F.2d at 581). We are not persuaded by Appellants
that an inherent “characteristic” that may be inherently characterized by
missing “descriptive matter” is limited only to a functional property and is
exclusive of structural limitations. Indeed, an allegedly inherent structural
limitation was the very limitation at issue in Continental Can.
Nor are we persuaded by Appellants’ argument that Continental Can
holds that extrinsic evidence may be used only to educate the decision­
maker as to what the teachings of a reference may mean to persons of
ordinary skill in the art in the field of the invention, and not to fill gaps in
the reference. See Reply Br. 11. Rather, the Federal Circuit has explicitly
and consistently held “that a reference may anticipate even when the
relevant properties of the thing disclosed were not appreciated at the time.”
Abbott Labs. v. Baxter Pharm. Prods., Inc., 471 F.3d 1363, 1367 (2006).
Moreover, “a prior art reference may anticipate without disclosing a feature
of the claimed invention if that missing characteristic is necessarily present,
or inherent, in the single anticipating reference.” Id. at 1368 (quoting
Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed. Cir.
2003)). It is not disputed that the claimed particle size distribution was
necessarily present in the studies disclosed by Schwid, Potter, and Segal,
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even if unknown to the investigators in those references. We are therefore
not persuaded in this instance to accept Appellants’ argument that
inherency may only be used as a “gap-filling” function with respect to
knowledge that is commonly known in the art.
We consequently reject Appellants’ argument that the Examiner
improperly relied upon the Fogarty Declaration to find that the disputed
limitation reciting the claimed particle size distribution was inherently
disclosed by the cited prior art.
Issue 2
Appellants argue that the cited prior art references are not sufficiently
enabling to render the present claims anticipated in view of the Fogarty
Declaration. App. Br. 10.
Analysis
Appellants contend that the Examiner erroneously finds that “when
the claimed composition or machine is disclosed identically by the
reference, an additional reference may be relied on to show that the primary
reference has an ‘enabled disclosure.’” App. Br. 10 (citing Final Act. 3—5,
citing In re Samour, 571 F.2d 559 (C.C.P.A. 1978) and In re Donohue, 766
F.2d 531 (Fed. Cir. 1985)). Appellants repeat their assertion that none of
the cited prior art references discloses the recited particle size distribution.
Id. at 10-11. Therefore, argue Appellants, the prior art references are
devoid of any specifics about the compositions they employed, and are
therefore non-enabling. Id. at 11.
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Appellants next point to the Federal Circuit’s decision in In re
Morsa, 713 F.3d 104 (Fed. Cir. 2013), in which the court reversed an
anticipation rejection where an applicant had challenged the enabling
quality of the cited prior art reference, even though the applicant had not
submitted evidence in support of its position. App. Br. 12. Appellants
argue that, in Morsa, the Federal Circuit held that: “an examiner must
determine if prior art is enabling by asking whether a person of ordinary
skill in the art could make or use the claimed invention without undue
experimentation based on the disclosure of that particular document....” Id.
(quoting 713 F.3d at 110).
Appellants repeat their argument supra that the Fogarty Declaration
does not cure the alleged deficiencies of Schwid, Potter, and Segal; rather,
Appellants argue, the Fogarty Declaration merely confirms that the
investigators and authors of those references were kept blind as to the
nature and design of the test composition. App. Br. 13. Appellants contend
that the Examiner has not engaged in any analysis with respect to how the
references are enabling for the particle size distribution recited in the
claims; instead, Appellants argue, the Examiner improperly relies upon the
Fogarty Declaration and Donohue to dismiss Appellants’ arguments. Id.
The Examiner responds that Appellants have put on record via the
Fogarty Declaration that the sustained-release 4-aminopyridine composition
disclosed severally by the cited prior art inherently has the particle size
distribution recited by the claims. The Examiner repeats the prior
conclusion that when the claimed composition or machine is disclosed
identically by the reference, an additional reference may be relied on to
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show that the primary reference has an “enabled disclosure.” Ans. 13
(citing Samour, 571 F.2d 559, 563; Donohue, 766 F.2d 531, 534).
We are not persuaded by Appellants’ arguments. It is undisputed that
the compositions provided by Elan to the investigators of Schwid, Potter,
and Segal were formulated by Elan and conformed to the particle size
distribution recited in the claims. It is therefore indisputable that both Elan
and the investigators were in possession of the claimed invention prior to
Appellants’ filing date, even if the Schwid, Potter, and Segal investigators
were unaware of the precise properties of the 4-aminopyridine formulation
provided by Elan. We agree with the Examiner that, under these
circumstances additional evidence, i.e., the Fogarty Declaration, may be
relied on to show that the primary reference has an enabled disclosure.
Furthermore, each of the prior art references cited by the Examiner
expressly recites the provenance of the 4-aminopyridine formulation
employed in their respective studies. See Schwid 818; Potter 838; Segal
405 (“The study was sponsored by Elan Pharmaceutical Research
Corporation, Gainesville, Georgia. Elan provided the fampridine SR [i.e.,
4-aminopyridine], prepared the randomization schedule, maintained the
double-blind code, conducted the plasma analyses, and provided monitoring
for quality control and adverse event reporting to FDA and HPB”). An
individual seeking to use the claimed sustained-release 4-aminopyridine
compound would therefore have been enabled to obtain the recited
compound by knowing precisely where to obtain it.
We therefore affirm the Examiner’s rejection of the claims on this
ground.
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B. Rejection of the claims under 35 U.S.C. $ 103(a)
Appellants argue further that the Examiner erred in finding the claims
on appeal are obvious over the cited prior art as evidenced by the Fogarty
Declaration. App. Br. 16—17. Appellants repeat their argument supra that
the Examiner has impermissibly employed the disclosures of the Fogarty
Declaration and that, therefore, the cited prior art references neither teach
nor suggest the recited particle size distribution.
We are not persuaded. We have explained why we agree with the
Examiner’s conclusion that the claims are anticipated by the cited prior art
references as evidenced by the Fogarty Declaration. Having so concluded,
we incorporate the same reasoning here, noting additionally that, because
the claims are anticipated by the prior art references, they are also obvious
over them. See In re Kalm, 378 F.2d 959, 962 (C.C.P.A. 1967)
(Anticipation is the epitome of obviousness). We consequently affirm the
Examiner’s rejection of the claims on this ground.
DECISION
The Examiner’s rejection of claims 42, 43, 47-49, 51, 52, 56 58—60,
83, 88, 89, 93-95, 97, 98, 102, 10^106, and 108 under 35 U.S.C. § 102(b)
is affirmed.
The Examiner’s rejection of claims 43—48, 50-57, 61, 62, 82—87, 89-
103, and 107—114 under 35 U.S.C. § 103(a) is affirmed.
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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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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