Ex Parte Patel et al

Patent Trial and Appeal Board

Feb 10, 2016

11450786 (P.T.A.B. Feb. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111450,786 0610912006
1059 7590 02/11/2016
BERESKIN & PARR LLP/SEN,CRL, s,LL
40 KING STREET WEST
40th Floor
TORONTO, ON MSH 3Y2
CANADA
FIRST NAMED INVENTOR
Piyush Ranchodbhai Patel
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.
057092/394252 8701
EXAMINER
ROONEY, NORA MAUREEN
ART UNIT PAPER NUMBER
1644
MAILDATE DELIVERY MODE
02/11/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PIYUSH RANCHODBHAI PATEL
and ANNE MARIE SALAP A TEK
Appeal2013-007041
Application 11/450,786
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for exposing an asthma patient to allergens for investigating asthma in the
asthma patient. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as PRACS Institute
Management, LLC (see Br. 1).
Appeal2013-007041
Application 11/450,786
Statement of the Case
Background
"Asthma is a chronic inflammatory disease of the airways
characterized by variable airflow obstruction and airway hyper-
responsiveness" (Spec. 1 ). "Investigation of the disease via the introduction
of allergen to an allergenic patient can enable the determination of the
efficacy of treatment options" (Spec. 5).
The Claims
Claims 1-8 and 10-17 are on appeal. Claim 1 is representative and
reads as follows:
1. A method for exposing an asthma patient to allergens for
investigating asthma in the asthma patient, comprising:
(a) placing the asthma patient into an environmentally
controlled chamber;
(b) preparing a dust mite allergen preparation, the dust
mite allergen preparation comprising dust mite particles having
an average diameter of 1 to 25 microns; and
( c) introducing a predetermined amount of the dust mite
allergen preparation into the environmentally controlled chamber
by aerosolizing a powder comprising the prepared dust mite
allergen particles inside the environmentally controlled chamber
thereby exposing the asthma patient to a controlled level of the
dust mite allergen preparation.
The Issues
A. The Examiner rejected claims 1-8 and 10-17 under 35 U.S.C.
§ 103(a) as obvious over Ronborg2 and Shoseyov3 (Ans. 3-7).
2 Ronborg et al., Exposure chamber for allergen challenge, 51
ALLERGY 82-88 (1996).
3 Shoseyov, 0., US 2009/0246287 Al, published Oct. 1, 2009.
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Application 11/450,786
B. The Examiner rejected claims 1, 4--8, 10-13 and 15-17 under 35
U.S.C. § 103(a) as obvious over Temelkovski,4 Gu,5 Kumar, 6 and Ronborg
(Ans. 7-10).
C. The Examiner rejected claims 1 and 2 under 35 U.S.C. § 103(a) as
obvious over Ronborg and Horak7 (Ans. 10-11).
A. 35 U.S.C. § 103(a) over Ronborg and Shoseyov
The Examiner finds that Ronborg teaches "exposing volunteer
asthmatic subjects with proven allergy to house-dust mite to Der p 1 in an
exposure chamber" (Ans. 3). The Examiner finds that Ronborg teaches the
"aerosols used in the system were generated by a standard Porta· Neb® 50
medical air compression" and that the "mean mass diameter of the aerosol
particles produced in comparable set ups was 4.1 µm" (Ans. 4).
The Examiner relied upon Shoseyov to teach that "microparticles and
nanoparticles of oxidized cellulose can be milled to be of the correct size for
optimal administration including to treat allergic diseases" (Ans. 6)
The Examiner finds it obvious to "physically alter the allergen
preparation by milling to make the particle size smaller to reach the
4 Temelkovski et al., An improved murine model of asthma:
selective airway inflammation, epithelial lesions and increased
methacholine responsiveness following chronic exposure to
aerosolised allergen, 53 THORAX 849-856 (1998).
5 Gu, US 2008/0213248 Al, published Sept. 4, 2008.
6 Kumar et al., Reversibility of airway inflammation and
remodelling following cessation of antigenic challenge in a model
of chronic asthma, 34 CLIN. EXP. ALLERGY 1796-1802 (2004).
7 Horak, F., US 2004/0054262 Al, published Mar. 18, 2004.
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Application 11/450,786
bronchial tree to investigate the effect on asthma of the allergen" and "to
aerosolize the particles in powder form, as opposed to in liquid form because
[Shoseyov] teaches inhalation administration by an aerosol" (Ans. 6-7).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that Ronborg and Shoseyov render
claims 1 and 13 obvious?
Findings of Fact
1. The Specification teaches that "' aerosolization' refers to any
method of converting a powder to a spray or suspension in air. In this
regard, the present invention is not limited to anyone aerosolization method
but contemplates any means to aerosolize the particles into the air of the
chamber" (Spec. 14).
2. Ronborg teaches a "pilot trial involved three volunteer
asthmatic subjects with proven allergy to house-dust mite" and that "trials
in the exposure chamber were performed twice after a stable period of at
least 14 days" (Ronborg 84, col. 2).
3. Ronborg teaches that the "allergen extract used in the study was
a purified intermediary product made from a culture of the house-dust mite
Dermatophgoides pternyssinus (Der p)" and that "[a]erosols were made
with an amount of allergen equivalent to a total of 600-1800 ng of the major
allergen Der p I, i.e., concentrations of 150-450 ng/ml of fill in the
nebulizer" (Ronborg 83, col. 1 to 84, col. 2).
4. Ronborg teaches that the "mean mass diameter of the aerosol
particles produced in comparable setups was 4.1 µm" (Ronborg 83, col. 1 ).
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Application 11/450,786
5. Shoseyov teaches that "the microparticles and/ or nanoparticles
of oxidized cellulose are prepared by milling the already oxidized cellulose
to a desired particle size, typically in the range of about 0. 01 and 100
microns." (Shoseyov i-f 65).
6. Shoseyov teaches that "the composition comprising
microparticles and/or nanoparticles of oxidized cellulose is suitable for the
treatment and/or prophylaxis of at least one disease or disorder. ... In
another embodiment, said disease or disorder is associated with or mediated
by at least one allergen" (Shoseyov i-fi-155-56). Shoseyov specifically
teaches that the "disease or disorder is asthma and the condition or symptom
is any one symptom associated with asthma" (Shoseyov i-f 135).
7. Shoseyov teaches that the "term 'allergen' refers to all foreign
agents capable of inducing, promoting, or stimulating allergy . . . The term
encompasses ... house dust mite" (Shoseyov i-f 91 ).
8. Shoseyov teaches that the "compounds of the present invention,
alone or in combination with other suitable components, can be made into
aerosol formulations to be administered via inhalation or intranasally"
(Shoseyov i-f 107).
Principles of Law
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) ("[D]uring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.").
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Application 11/450,786
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The limitation in
dispute is the phrase "aerosolizing a powder" in claims 1 and 13.
Appellants contend that the "Ronborg reference only teaches
nebulizing a liquid. The Ronborg reference does not teach or suggest
aerosolizing a dry powder comprising a controlled preparation of dust mite
allergen particles" (Br. 4).
The Examiner responds that "aerosols comprising fine solid particles
or liquid are both encompassed by the term 'aerosol'" (Ans. 12).
Where, as here, Appellants have specifically defined a term in the
Specification, that definition controls claim interpretation. See Phillips v.
AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) ("[O]ur cases recognize
that the specification may reveal a special definition given to a claim term by
the patentee that differs from the meaning it would otherwise possess. In
such cases, the inventor's lexicography governs.")
The Specification teaches that "'aerosolization' refers to any method
of converting a powder to a spray or suspension in air" (FF 1 ). The
Specification therefore defines the term "aerosolization" as encompassing
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Application 11/450,786
any method of converting a powder to a spray or suspension in air, including
liquid nebulizer methods of generating aerosols taught by Ronborg (FF 3).
We therefore are not persuaded by Appellants' argument that "[a]s
clearly recited by independent Claims 1 and 13, the present invention
'aerosolizes' a dry power comprising a controlled preparation of dust
mite allergen particles" (Br. 4). We agree with the Examiner that "the
invention is not directed aerosolizing a 'dry powder' contrary to Applicant's
assertion in their argument. The claims are directed to 'aerosolizing a
powder"' (Ans. 12). Consistent with the Specification, any aerosolization
method will reasonably satisfy the claims including the method of Ronborg
(FF 3) because Appellants did not include a limitation to aerosolizing a "dry
powder" in claims 1 or 13 or so define the term "aerosolizing" in the
Specification.
We recognize, but find unpersuasive, Appellants argument that "any
references to 'aerosols' (and the like) in the Ronborg reference necessarily
refers only to liquid aerosols. Thus, the discussion in the Ronborg reference
of particle sizes (e.g., 'mean diameter of particles') necessarily refers to
liquid droplet sizes" (Br. 5). As already noted, claims 1 and 13 do not
exclude the use of powders mixed with liquids to form the aerosols as in
Ronborg (FF 1, 3).
Moreover, the Examiner has cited Shoseyov, who teaches that the
drug particle size is a routinely optimizable variable with a range of 0.01 to
100 microns (FF 5) that can be administered by inhalation (FF 8) for
treatment of diseases including asthma (FF 6). "[W]here the general
conditions of a claim are disclosed in the prior art, it is not inventive to
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Application 11/450,786
discover the optimum or workable ranges by routine experimentation." In re
Aller, 220 F.2d 454, 456 (CCPA 1955). Appellants have provided no
evidence that the overlapping range of Shoseyov does not render the claimed
range obvious. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)
("In cases involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.")
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Ronborg and Shoseyov render claims 1 and 13 obvious.
B. and C. 35U.S.C.§103(a)
Appellants do not separately argue the rejections of Ronborg in
combination with (B) Temelkovski, Gu, and Kumar or (C) Horak, relying
instead upon their arguments concerning Ronborg to overcome the
rejections. The Examiner provides sound fact-based reasoning for
combining Ronborg with (B) Temelkovski, Gu, and Kumar and (C) Horak
(see Ans. 7-11 ). Having affirmed the obviousness rejection of claims 1 and
13 over Ronborg and Shoseyov for the reasons given above, we also find
that the further rejections relying upon Ronborg render the rejected claims
obvious for the reasons given by the Examiner.
SUMMARY
In summary, we affirm the rejection of claims 1 and 13 under 35
U.S.C. § 103(a) as obvious over Ronborg and Shoseyov. Claims 2-8, 10-
12, and 14--17 fall with claims 1and13. 37 C.F.R. § 41.37(c)(l)(iv).
We affirm the rejection of claims 1, 4--8, 10-13 and 15-17 under 35
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U.S.C. § 103(a) as obvious over Temelkovski, Gu, Kumar, and Ronborg.
We affirm the rejection of claims 1 and 2 under 35 U.S.C. § 103(a) as
obvious over Ronborg and Horak.
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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