Ex Parte Herrmann et al

Patent Trial and Appeal Board

Sep 6, 2016

13480227 (P.T.A.B. Sep. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/480,227 05/24/2012
121974 7590 09/08/2016
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Robert A. Herrmann
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
03-544US03(4010/94Cl) 4138
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
09/08/2016 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):
kddocketing@cpaglobal.com
Docketing@kdbfirm.com
bbonneville@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT A. HERRMANN, JOHN J. DAMARATI,
SEPIDEH HASHEM!, WENDY NAIMARK,
BARRY N. GELLMAN, ROBERT RIOUX,
ALEXANDRA ROUSSEAU, and RAYMOND LAREAU 1
Appeal2015-000997
Application 13/480,227
Technology Center 1600
Before JOHN G. NEW, RICHARD J. SMITH, and KRISTI L. R. SA WERT,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Boston Scientific Scimed, Inc.
App. Br. 2.
Appeal2015-000997
Application 13/480,227
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 8, 9, 11, 12, 27, 30, and 50-58. 2
Specifically, claims 1, 8, 9, 11, 12, 27, 30, and 50-54 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Jackson et al. (US 2003/0134811 Al, July 17, 2003)
("Jackson") and M. Lawrence et al., Efficacy of Inhaled Fluticasone
Propionate in Asthma Results from Topical and not from Systemic Activity,
156 (3 Pt. 1) AM. J. RESPIR. CRIT. CARE MED. 744--51 (1997) ("Lawrence").
Claims 1, 8, 9, 11, 12, 27, 30, and 50-58 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over Shenoy (US
2010/0021519 Al, January 28, 2010) ("Shenoy").
Claims 1, 8, 9, 11, 12, 27, 30, 50, 55, and 56 stand rejected as
unpatentable under 35 U.S.C. § 103(a) as being obvious over Mollison et al.
(US 2004/0234573 Al, November 25, 2004) ("Mollison"). 3
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to methods for the treatment of
asthma, which comprise: (a) providing an implantable or insertable medical
device that comprises an asthma treatment agent; and (b) inserting or
2 Claims 2-7, 10, 13-15, 17, 18, 23-25, 28, 29, 31, and 33--49 have been
canceled and claims 16, 19-22, 26, and 32 have been withdrawn.
3 The rejection of claims 51-54, 57, and 58 as being unpatentable as obvious
over Mollison has been withdrawn by the Examiner on this ground only.
Ans. 7.
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implanting the medical device within the lungs (e.g., the trachea or the
bronchial tree) of a patient, whereupon the therapeutic agent is delivered to
the patient in an amount effective to reduce or eliminate the symptoms of
asthma. Also disclosed are medical devices and kits for carrying out such
methods. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is the sole independent claim on appeal and is representative
of the remaining claims. App. Br. 3. Claim 1 recites:
1. A method for the treatment of asthma, comprising:
providing an implantable or insertable medical device that
comprises a steroidal anti-inflammatory agent as an asthma
treatment agent; and
inserting or implanting the medical device within the
trachea or the bronchial tree of a patient, whereupon the
therapeutic agent is delivered to the patient in an amount
effective to reduce or eliminate the symptoms of asthma.
App. Br. 13.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are obvious over the cited prior art references. We
address the arguments raised by Appellants on appeal below.
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A. Rejection of claims 1, 8, 9, 11, 12, 27, 30, and 50-54 over Jackson and
Lawrence
Issue
Appellants argue the Examiner impermissibly used hindsight
analysis to reach the conclusion that the claims are obvious over Jackson and
Lawrence. App. Br. 5.
Analysis
Appellants argue Jackson is directed to"[ c ]ompositions and methods
for in vivo delivery of pharmaceutically active agents associated with
hydroxyapatite (HAP)" and, specifically, to "compositions, systems,
methods, etc .... that provide controlled release formulations comprising
hydroxyapatite (HAP) complexed with negatively-charged therapeutics such
as ASOs [antisense agents] and other oligonucleotide therapeutics." App.
Br. 3 (emphasis omitted) (quoting Jackson Abstr.; i-f 6). Appellants assert
that Jackson teaches treatment of a large number of diseases or conditions,
including asthma. Id. (citing, e.g., Jackson i-fi-1144; 147; 149).
Appellants contend further that Jackson teaches that, in some
embodiments, the composition may further comprise at least one second
pharmacologically active agent, which may be at least one of an anti-
diabetic, antimicrobial, anesthetic, vasoconstrictor, vasodilator, cardiotonic,
enzyme, anti-inflammatory, hormone, bone metabolism controlling agent,
hypotensive, sedative, anti-cancer agent, antihistamine, antitussive, vaccine,
and asthma treatment. App. Br. 4 (citing, e.g., Jackson claim 6; i-fi-1 1 O; 87).
Appellants note that anti-inflammatory drugs are discussed in conjunction
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with the second pharmacologically active agent. Id. (citing, e.g., Jackson
claims 2; 6; 26; 36; 53; 68; 72; i-fi-16; 8; 10; 14; 15; 19; 20; 21; 28).
Appellants also argue that, although Jackson teaches the potential use
of steroidal anti-inflammatory agents, these are described as being used in
current drug therapies and as having a wide range of toxicities. Id. (citing
Jackson i-f 144). According to Appellants, Jackson thus associates steroidal
anti-inflammatory agents, such a prednisone, with a number of undesirable
toxicities and thereby teaches away from using such substances.
Appellants contend, therefore, that the Examiner could have arrived at
a conclusion of obviousness only with the hindsight gained from Appellants'
Specification. App, Br. 5. Appellants admit that Jackson teaches
tracheal/bronchial stents; however, Appellants argue a person of ordinary
skill in the art would have had to select tracheal/bronchial stents from the
large group of devices recited in paragraphs [0092]-[0095] of Jackson to
treat asthma, which is similarly listed among a very large number of diseases
or conditions in recited in paragraphs [0096]-[0150] of Jackson. Id.
Moreover, Appellants argue, Jackson makes no connection between
tracheal/bronchial stents and asthma. Id.
Finally, Appellants argue, Jackson does not teach the use of the
steroidal anti-inflammatory agent fluticasone for use in treating asthma.
App. Br. 5.
With respect to Lawrence, Appellants argue Lawrence teaches the use
of only inhaled fluticasone for the treatment of asthma. App. Br. 5.
Appellants disagree with the Examiner's finding that one of ordinary skill in
the art would have been motivated to use such an anti-inflammatory drug in
a drug-delivering polymer-coated stent in the bronchial tree. Id. Appellants
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contend that administration via a device implanted in the bronchial tree is
very different from treatment by inhalation. Id. Appellants also argue that
Jackson's teaching that the complex ofhydroxyapatite and a
pharmacologically active agent can be formulated as a powder suitable for
administration by the method taught by Lawrence, would reduce a person of
ordinary skill's motivation to use an agent taught as being administered by
inhalation. Id.
The Examiner responds that the instant claims on appeal employ open
language, and the inclusion of other active agents (e.g., hydroxyapatite, etc.)
are therefore within the scope of the claims. Ans. 8. The Examiner finds
Jackson expressly teaches the treatment of inflammatory diseases, including
chronic lung diseases such as asthma, with a composition for controlled
delivery having at least two active agents, of which the second active agent
includes anti-inflammatory and anti-asthma treatments. Id. (citing, e.g.,
Jackson claims 6; 75; i-fi-f 144; 147; 149; 10; 87). The Examiner finds
Jackson teaches that the composition can be a stent such as a bronchial or
trachea stent. Id.
The Examiner further finds Jackson does not teach away from the use
of current drug therapies, but rather addresses the then-current state of the art
of the recited drug therapies. Ans. 8. The Examiner finds Jackson teaches
only what was well-known to those skilled in the art: that drug therapies
often have side effects and toxicities, which is why patients are monitored by
their doctor as they are treated. Id. at 8-9. The Examiner finds that
disclosing possible side effects of currently known treatments does not teach
away, but only addresses what was well-known in the contemporary art. Id.
at 9.
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The Examiner asserts Lawrence was cited as teaching that tluticasone
propionate is useful in the treatment of asthma and has fewer side effects
when administered by inhalation than when administered orally. Ans. 9.
The Examiner concludes it would be obvious to a person of ordinary
skill to incorporate the teachings of Jackson, which include using a
tracheal/bronchial stent and a steroidal inflammatory agent for the treatment
of asthma, with the teachings of Lawrence that fluticasone is an effective
steroidal anti-inflammatory agent for the treatment of asthma.
Upon review of the entire record, we are not persuaded by Appellants'
arguments. As an initial matter, we agree with Appellants that Jackson does
not teach use of the particular steroidal anti-inflammatory agent fluticasone.
However, Jackson does teach the use of steroidal anti-inflammatory agents
in the treatment of asthma generally (see Jackson i-f 144) and Lawrence
explicitly teaches the topical use of fluticasone proprionate in the treatment
of asthma, and the claims are rejected over the combination of Jackson and
Lawrence. Appellants "cannot show non-obviousness by attacking
references individually where ... the rejections are based on combinations of
references." In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981).
Jackson explicitly teaches that it is well-known in the art that chronic
inflammatory lung diseases include asthma and that current drug therapies
for such diseases "include the use of steroidal anti-inflammatory agents such
as prednisone (Deltasone®)." Jackson i-fi-187; 135; 144; 147; 149. Jackson
also teaches that its compositions, which include a pharmaceutically active
agent can be applied to implantable stents, including tracheal and bronchial
stents. Jackson claims 41--43; i-fi-192; 94. We agree with the Examiner that
Jackson thus teaches all of the limitations of claim 1.
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Appellants argue that the clams are not obvious over Jackson because
Jackson teaches a large variety of treatments and diseases to which its
claimed compositions can be applied. We disagree. Jackson explicitly
describes diseases (including asthma) and treatments, including applying
active agents such as steroidal anti-inflammatory agents used to treat asthma,
via implantation of tracheal or bronchial stents. See, e.g., Jackson i-f 16.
Moreover, Jackson teaches that all of these treatments for diseases would
have been well-known in the art to a person of ordinary skill at the time of
invention.
Lawrence teaches topical application of fluticasone, as required by
dependent claims 51 and 52. Appellant argues that it would not have been
obvious to combine the teachings of Jackson and Lawrence, because
Lawrence teaches administration of inhaled fluticasone. However,
Lawrence explicitly teaches: "The results of this study suggest that the
therapeutic benefits of inhaled fluticasone propionate are mediated through
topical effects in the lungs and not through systemic effects." Lawrence
Abstr. (emphasis added). We find a person of ordinary skill would realize
that application of fluticasone to an implanted bronchial or tracheal stent
would be an alternate means of topically applying fluticasone to the surfaces
of the tracheal and bronchial tissues, and superior in its effects to oral
administration. Id. We therefore agree with the Examiner that it would have
been obvious to use fluticasone (a steroidal anti-inflammatory agent), taught
by Lawrence as a topical application for the treatment of asthma, as the
steroidal anti-inflammatory agent topically applied via an implantable
tracheal or bronchial stent for the treatment of asthma, as taught by Jackson.
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Appellants allege the Examiner improperly used hindsight analysis in
arriving at the conclusion that the claims are obvious over the prior art. See
App. Br. 5. However:
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). Appellants adduce
no evidence to show that the Examiner's conclusion could only have come
from Appellants' Specification or would have been outside the knowledge of
a person of ordinary skill in the art. As such, Appellants' contentions
constitute merely attorney argument. Attorney arguments and conclusory
statements that are unsupported by factual evidence are entitled to little
probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Finally, Appellants argue Jackson teaches away from the claims on
appeal. See App. Br. 5. We are not persuaded. A reference teaches away
when "a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken by the applicant." In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We agree with Appellants that
Jackson teaches that it was well-known in the contemporary art that
treatment with steroidal anti-inflammatory drugs may have toxic side
effects. See Jackson i-f 144. But, as the Examiner finds, potentially adverse
side effects are common in drug therapies and Appellants point to no
teaching in Jackson that would discourage or divert a person of ordinary
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skill from using them in the treatment of diseases such as asthma beyond a
warning of possible adverse effects. We are therefore not persuaded by
Appellants' argument that Jackson "teaches away" from Appellants' claims.
We consequently affirm the Examiner's rejection of claims 1, 8, 9, 11,
12, 27, 30, and 50-54.
B. Rejection of claims 1, 8, 9, 11, 12, 27, 30, and 50-58 over Shenoy
Issue
Appellants argue the Examiner impermissibly used hindsight analysis
to reach the conclusion that the claims would have been obvious over
Shenoy. App. Br. 8.
Analysis
Appellants contend that paragraph [O 157] of Shenoy teaches treatment
of asthma only in conjunction with a large number of other anti-
inflammatory diseases. App. Br. 7. However, Appellants argue, there is no
discussion in that paragraph of what drugs would be suitable for the
treatment of asthma or by what vehicle such a drug might be delivered. Id.
Appellants admit anti-asthmatic agents are taught in paragraph [0099]
of Shenoy, but again argue there is no discussion in that paragraph as to
what drugs are included in the genus or what vehicles would be employed
for delivery. Id.
Appellants also admit that tracheal and bronchial stents are discussed
among various other stents in paragraphs [O 108]-[0109] of Shenoy, but
Appellants assert such stents are taught only in the context of treating
malignant obstructions. App. Br. 8 (citing Shenoy i-fi-f 161; 169; Examples).
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Consequently, Appellants conclude, it could only be by impermissible
hindsight, gained from Appellant's Specification, that the Examiner selected
steroidal anti-inflammatory agents from the large number of drugs listed in
Shenoy to treat asthma and a large number of other diseases or conditions, as
well as the use of a bronchial or tracheal stent, which is not taught by
Shenoy for the treatment of asthma.
The Examiner responds that Shenoy teaches a method of treating
diseases, including asthma, with an implanted stent with a polymer matrix
coating and an active agent. Ans. 11 (citing Shenoy i-f 157; Abstr.). The
Examiner finds Shenoy teaches anti-asthmatic agents, and in so teaching,
implicitly teaches the treatment asthma with the anti-asthmatic agent.
The Examiner further finds Shenoy teaches steroidal anti-
inflammatory agents, such as beclomethasone and fluticasone, which can be
dispersed in the polymer and formed as a homogeneous layer on the stent.
Id. (citing Shenoy i-fi-128; 93; 115-116; 50). The Examiner finds the polymer
matrix can be a coating for tracheal and bronchial stents (i.e., the stent can
be place in the trachea, bronchus, and bronchioles), and the polymers can
include nonbiodegradable polymers, e.g., biostable, acrylic polymers and
polyurethanes, silicones. Id. (citing Shenoy i-fi-1 109-111 ).
The Examiner also finds Shenoy teaches that, because the stent is
locally delivering the active agent, systemic and unwanted side effects can
be avoided. Ans. 11 (citing Shenoy i-f 69). The Examiner therefore
concludes, based upon the express teachings of Shenoy, that it would have
been obvious to use the polymer coated stents in the trachea and bronchial
tree to treat asthma with steroidal anti-inflammatories, such as fluticasone,
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and that a person of ordinary skill would therefore have a reasonable
expectation of success in so doing. Id.
Upon review of the entire record, we are not persuaded by Appellants'
arguments. We agree with the Examiner's factual findings that Shenoy
teaches all of the limitations of the claims. Appellants do not dispute these
findings, but claim that there are too many other diseases and active agents
taught by Shenoy that it is only by hindsight that the Examiner could have
arrived at Appellants' invention. We disagree. As we have related supra,
for Appellants to prevail in their allegation of impermissible hindsight
analysis, they need to adduce evidence of a teaching or suggestion that could
only have been gleaned from Appellants' Specification, or which would
necessarily have been outside of the knowledge of a person of ordinary skill.
McLaughlin, 443 F.2d at 1395. Appellants have not pointed to any such
evidence; in fact, Shenoy, like Jackson, teaches that tracheal and bronchial
stents, and the use of anti-inflammatory agents, such as fluticasone, for the
treatment of asthma, were all well-known in the contemporary art. We
consequently affirm the Examiner's rejection of claims 1, 8, 9, 11, 12, 27,
30, and 50-58.
Appellants additionally argue claims 52, 54, and 58 would not have
been obvious over Shenoy because they require that the steroidal anti-
inflammatory agent be fluticasone. App. Br. 9. Appellants contend that a
person of ordinary skill would not have been motivated to select fluticasone
from the large numbers of active agents recited by Shenoy. Id. (citing
Shenoy iii! 28, 30, 44, 93).
We disagree. Claims 51-54 and 57-58 require fluticasone.
Fluticasone is recited, as Appellants admit, a number of times as being well-
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known in the art as a steroid used in the treatment of inflammatory diseases.
See Shenoy i-fi-1 28, 30, 44, 93. Moreover, Shenoy teaches that it was well-
known in the art that asthma is an inflammatory disease of the respiratory
system. See Shenoy i-fi-f 14, 99, 157. We agree with the Examiner that using
fluticasone to treat asthma would have been well-known in the art at the time
of invention. We consequently uphold the Examiner's rejection of the
claims.
C. Rejection of claims 1, 8, 9, 11, 12, 27, 30, 50, 55, and 56 over Mollison
Issue
Appellants argue the Examiner impermissibly used hindsight analysis
to reach the conclusion that the claims would have been obvious over
Mollison.
Analysis
Appellants argue that treatment of asthma is disclosed only as part of
a large list of diseases or conditions in paragraph [0055] of Mollison. App.
Br. 9. Appellants also contend that topical administration of compositions to
the lungs is described in Mollison only in conjunction with compositions for
inhalation. Id. at 10. Appellants assert there is no description of a method in
which a medical device is inserted or implanted within the trachea or the
bronchial tree of a patient. Id. Specifically, Appellants contend Mollison
neither teaches nor suggests placing a stent in the trachea or a bronchial tree.
Id. at 11. Consequently, Appellants allege, the Examiner must have
impermissibly relied upon hindsight analysis in concluding the claims would
have been obvious over Mollison. Id.
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The Examiner responds that Mollison teaches treating bronchial
asthma with implanted devices, such as a polymer coated stent with drugs
such as prednisone and dexamethasone, and local drug delivery from the
stent. Ans. 12.
Upon review of the entire record, we are not persuaded by Appellants'
arguments. Mollison explicitly teaches "A medical device comprising a
supporting structure capable of containing or supporting a pharmaceutically
acceptable carrier or excipient, which carrier or excipient may contain one or
more therapeutic agents or substances." Mollison Abstr. Moreover,
Mollison teaches that such a device can include stents. Id. Mollison also
teaches compounds that can be used with the device include those for the
treatment of reversible obstructive airway disease, which includes conditions
such as asthma (for example, bronchial asthma, allergic asthma, intrinsic
asthma, extrinsic asthma and dust asthma), particularly chronic or inveterate
asthma (for example, late asthma and airway hyper-responsiveness).
Mollison i-f 55. Mollison teaches that such conditions may be treated with
topical application of steroidal anti-inflammatory agents such as prednisone.
Mollison i-fi-159; 76. Moreover, Mollison teaches:
The pharmaceutical compositions of the present invention
comprise a compound of the invention and a pharmaceutically
acceptable carrier or excipient, which may be administered
orally, rectally, parenterally, intracistemally, intravaginally,
intraperitoneally, topically (as by powders, ointments, drops or
transdermal patch), bucally, as an oral or nasal spray, or locally,
as in a stent placed within the vasculature.
Mollison i-f 76. Although Mollison does not explicitly teach a tracheal or
bronchial stent, we agree with the Examiner that a person of ordinary skill
would have realized that a steroidal anti-inflammatory agent could be
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applied to stent, as taught by Mollison, and used for the topical application
of the agent in the treatment of asthma.
Moreover, Appellants do not point to a limitation of the claim that
could be gleaned only from Appellants' Specification or that would be
outside of the knowledge of an artisan of ordinary skill. We consequently
affirm the Examiner's rejection of claims 1, 8, 9, 11, 12, 27, 30, 50, 55, and
56.
DECISION
The Examiner's rejection of claims 1, 8, 9, 11, 12, 27, 30, and 50-58
as unpatentable as obvious under 35 U.S.C. § 103 is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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