Ex Parte Knauer

Patent Trial and Appeal Board

Oct 30, 2017

12445113 (P.T.A.B. Oct. 30, 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.
12/445,113 04/10/2009 Kent A. Knauer CWR-8199US PCT 5088
68705 7590 11/01/2017
TAROLLI, SUNDHEIM, COVELL & TUMMINO, LLP
1300 EAST NINTH STREET
SUITE 1700
CLEVELAND, OH 44114
EXAMINER
COLEMAN, BRENDA LIBBY
ART UNIT PAPER NUMBER
1624
NOTIFICATION DATE DELIVERY MODE
11/01/2017 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):
rkline @ tarolli. com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENT A KNAUER1
Appeal 2016-005748
Application 12/445,113
Technology Center 1600
Before ULRIKE W. JENKS, RYAN H. FLAX, and DAVID COTTA,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for treating mucosal inflammation. Claims 13
and 14 are on appeal as rejected under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies the Real Party in Interest as “Case Western Reserve
University.” Br. 2.
Appeal 2016-005748
Application 12/445,113
STATEMENT OF THE CASE
The Specification explains, “the term ‘rhinitis’ refers to inflammation
of the nasal mucous membranes resulting from, e.g., a cold, flu, or allergies”
and “the term ‘sinusitis’ refers to inflammation of the paranasal sinuses,
which can be the result of infection (e.g., bacterial, fungal or viral), allergic
or autoimmune causes.” Spec. ^ 19-20. The Specification further states:
The present invention generally relates to a pharmaceutical
composition and method for treating mucosal inflammation, and
more particularly to a non-habituating nasal spray composition
and method for intranasally treating rhinitis and/or sinusitis. The
present invention is based on the discovery that a nasal spray
composition comprising a decongestant and at least one
therapeutic agent can effectively reduce or eliminate symptoms
associated with inflammation of the nasal mucosa, i.e., rhinitis,
sinusitis, or both.
Spec. If 11.
Claim 13, the sole independent claim, is representative,2 and is
reproduced below:
13. A method for treating mucosal inflammation of the paranasal
sinus tissue associated with sinusitis in a subject, the method
comprising intranasally administering to the subject a
therapeutically effective amount of a non-habituating nasal spray
composition to treat the mucosal inflammation of the paranasal
sinus tissue associated with sinusitis in the subject, the nasal
spray composition comprising oxymetazoline hydrochloride and
triamcinolone acetonide.
Br. 16 (Claims App’x).
2 Appellant argues that claim 14 is patentable only because claim 13, from
which it depends, is patentable. Br. 11.
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Appeal 2016-005748
Application 12/445,113
The following rejection is on appeal:
Claims 13 and 14 stand rejected under 35 U.S.C. § 103(a) over
Sudsakom3 and Meltzer.4 Final Action 3.
FINDINGS OF FACT
We agree with and adopt the Examiner’s findings of fact and
determinations as to the scope and content of the prior art. We identify the
following findings of fact to highlight certain evidence.
FF1. Sudsakom discloses, “[tjriamcinolone acetonide (TAA)
(Fig. 1) is a glucocorticosteroid that is widely administered topically as
a nasal spray for the treatment of allergic rhinitis. Oxymetazoline
hydrochloride (OXY) (Fig. 1) is an ai-agonist agent that is also widely
used in nasal spray preparations as nasal decongestant.” Sudsakom
1273; see also Final Action 3—4, 6, and Ans. 2, 4-7 (discussing
Sudsakom).
FF2. Sudsakom further discloses, “a nasal spray formulation
that combined both the decongestant property of OXY [oxymetazoline
hydrochloride] with the allergic rhinitis properties of TAA
[triamcinolone acetonide] was developed with the expectation that the
decongestant properties of OXY [oxymetazoline hydrochloride]
would enhance the penetration of TAA [triamcinolone acetonide]
3 Sirimas Sudsakom et al., Simultaneous Determination of Triamcinolone
Acetonide and Oxymetazoline Hydrochloride in Nasal Spray Formulations
by HPLC, 40 J. Pharma. & Biomed. Anal. 1273-80 (2006 (“Sudsakom”).
4 Eli O. Meltzer et al., Allergic Rhinitis, Asthma, and Rhinosinusitis:
Diseases of the Integrated Airway, 10 J. Managed Care Pharmacy 310-17
(2004) (“Meltzer”).
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Appeal 2016-005748
Application 12/445,113
deeper into the nasal sinuses.” Sudsakom 1273; see also Final Action
3—4, 6, and Ans. 2, 4-7 (discussing Sudsakom).
FF3. Sudsakom discloses two commercial nasal spray
formulations, Tri-Nasal® and Nasacort AQ®, each being a
triamcinolone acetonide containing product, to which oxymetazoline
hydrochloride was added to provide formulations that were stable
when stored under controlled room temperatures (20-25°C).
Sudsakom 1274, 1279; see also Final Action 3—4, 6, and Ans. 2, 4-7
(discussing Sudsakom).
FF4. Meltzer discloses allergic rhinitis and rhinosinusitis are
common conditions and that “recent studies have suggested that
allergic rhinitis, rhinosinusitis, and asthma may be manifestations of a
common underlying pathology, but there are many unanswered
questions.” Meltzer 310, 311; see also Final Action 3-6, and Ans. 2-
7 (discussing Meltzer).
FF5. Meltzer discloses “[ajllergic rhinitis, rhinosinusitis, and
asthma are frequently comorbid conditions, and this association has
been recognized since the early 1900s. Recent studies have
strengthened the concept that allergic rhinitis, rhinosinusitis, and
asthma are manifestations of an inflammatory process within a
continuous airway.” Meltzer 310; see also Final Action 3-6, and Ans.
2-7 (discussing Meltzer).
FF6. Meltzer discloses “[ajllergic rhinitis also may be a
contributing factor in 25% to 30% of patients with acute maxillary
sinusitis and in as many as 60% to 80% of patients with chronic
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Appeal 2016-005748
Application 12/445,113
sinusitis. At the least, allergic rhinitis is associated with, and probably
a predisposing factor in the development of, rhinosinusitis.” Meltzer
311; see also Final Action 3-6, and Ans. 2-7 (discussing Meltzer).
FF7. The Specification states that “[rjhinitis, an inflammation
of the nasal mucosal membrane, is characterized by sneezing,
rhinorrhea, nasal congestion, and increased nasal secretion,” that
“[f]ailure to effectively treatment rhinitis may lead to other disorders
including infection of the ears, lower respiratory tract, and sinuses,”
and “[inflammation of the sinuses, known as rhinosinusitis or
sinusitis, is difficult to treat successfully,” but “steroid nasal sprays
are commonly used to reduce inflammation.” Spec. 3^1 and 19,
20; see also Final Action 7, and Ans. 3—4, 6 (discussing
Specification).
FF8. Gawchick confirms that it was well know that “[i]n
addition to seasonal and perennial rhinitis, intranasal corticosteroids
[e.g., aqueous triamcinolone acetonide at dosages of 110^440 gg once
or twice a day] have additional benefits when used to reduce
inflammation in the treatment of sinusitis.” Gawchick 309, 310;5 see
also Ans. 4, 6 (discussing Gawchick).
5 Sandra M. Gawchick & Consuelo L. Saccar, A Risk-Benefit Assessment of
Intranasal Trimcinolone Acetonide in Allergic Rhinitis, 23 Drug Safety
309-22 (2000) (“Gawchick”) (cited by Examiner as evidence supporting,
but not the basis for rejection).
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Appeal 2016-005748
Application 12/445,113
DISCUSSION
“[W]hen a patent claims a structure [or method] already known in the
prior art that is altered by the mere substitution of one element for another
known in the field, the combination must do more than yield a predictable
result.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (citing U.S.
v. Adams, 383 U.S. 39, 50-51 (1966)). “The combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” Id.
We find that in view of the findings of fact, under the above
precedent, the Examiner has established a prima facie case that claim 13
would have been obvious over Sudsakom and Meltzer, as evidenced by the
Specification and Gawchick. FF1-FF8. Appellant has not produced
evidence showing, or persuasively argued, that the Examiner’s
determinations are incorrect. Only those arguments made by Appellant in
the Brief have been considered in this Decision. Arguments not presented in
the Brief are waived. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellant argues Sudsakom and Meltzer do not teach or suggest
treating sinusitis-associated inflammation by administering the claimed
formulation of triamcinolone acetonide and oxymetazoline hydrochloride in
a nasal spray. Br. 6. Appellant contends that Sudsakom is directed only to
treating rhinitis and not sinusitis, or any inflammation outside the nasal
cavity. Id. Appellant also contends that, while Sudsakom discloses adding
oxymetazoline hydrochloride to triamcinolone acetonide because the former
allows the later to penetrate deeper into the nasal sinuses, this does not mean
that the reference teaches that such access equates to the composition being
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Application 12/445,113
therapeutically effective in treating sinusitis. Id. at 6-7. Finally, Appellant
argues that, even though Meltzer discloses that it is believed that rhinitis and
sinusitis are related, comorbid conditions (the integrated airway hypothesis),
this does not mean that the reference suggests that treating rhinitis will also
treat sinusitis. Id. at 7. These arguments are not persuasive.
The evidence shows it was well known that rhinitis and sinusitis are
closely related conditions and that the former causes or leads to the later.
FF4-FF6, FF8. The evidence also shows it was well known that a primary
symptom of each condition is inflammation. FF7. The evidence also shows
it was well known that triamcinolone acetonide was useful to treat both
rhinitis and sinusitis. FF1, FF8. Therefore, when Sudsakom discloses that
oxymetazoline hydrochloride should be added to triamcinolone acetonide to
create a formulation where a nasal spray can penetrate to the nasal sinuses,
this teaches and suggests treatment of sinusitis using this formulation. See
FF2. We conclude there is ample evidence that the claimed method would
have been obvious in view of the cited prior art combination.
SUMMARY
The obviousness rejection is affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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