Ex Parte Weers et al

Board of Patent Appeals and Interferences

Dec 15, 2011

10751342 (B.P.A.I. Dec. 15, 2011)

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.
10/751,342 12/31/2003 Jeffry G. Weers PAT053311-US-CNT 7605
1095 7590 12/15/2011
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080
EXAMINER
CARTER, KENDRA D
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
12/15/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JEFFRY G. WEERS, THOMAS E. TARARA,
MICHAEL A. ELDON, and RANGACHARI NARASIMHAN
__________

Appeal 2011-008158
Application 10/751,342
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) from the Patent
Examiner’s rejection of claims 1-15, 18-20, 23-25, 28-31, 38-40, 63-78, 98,
99, and 101. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 1 and 23 are representative and read as follows:
1. A method of providing therapy against a pulmonary fungal infection,
the method comprising:
determining a minimum inhibitory concentration of an antifungal
agent for inhibiting a specific pulmonary fungal infection; and
administering by inhalation directly to the lungs of a patient a powder
aerosolized pharmaceutical formulation comprising an antifungal agent
having efficacy against said pulmonary fungal infection, wherein the powder
comprises porous particles and has a mass median aerodynamic diameter of
less than about 5 microns and a bulk density of less than about 0.5 g/cm
3
, the
powder formulation being administered in a first dosage, followed after a
predetermined time interval by a second dosage, said first dosage being
greater than the second dosage;
wherein a sufficient amount of the pharmaceutical formulation is
administered to maintain for at least one week a target antifungal lung
concentration of at least two times the determined minimum inhibitory
concentration.

23. A method of providing therapy against a pulmonary fungal infection
comprising an aspergillosis, the method comprising:
administering by inhalation directly to the lungs of a patient an
aerosolized pharmaceutical formulation comprising amphotericin B, wherein
the formulation comprises porous particles having a mass median
aerodynamic diameter of less than about 5 microns and a bulk density of less
than about 0.5 g/cm
3
, and
wherein a sufficient amount of the pharmaceutical formulation is
administered to maintain for at least two weeks a target amphotericin lung
concentration of at least 9 μg/g, and wherein the administration comprises a
first administration period and a second administration period and wherein
the amphotericin B is administered more frequently or at a higher dosage
during the first administration period than during the second administration
period.

The claims stand rejected as follows:

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 claims 1-15, 18-20, 23-25, 28-31, 38-40, 63-78,1 98, 99, and 101
under 35 U.S.C. §103(a) as unpatentable over Weickert
2
and Straub.
3

 claims 1-15, 18-20, 23-25, 28-31, 38-40, 98, and 99 provisionally
on the ground of nonstatutory obviousness-type double patenting over
claims 23-25,27-30 and 35-44 of copending Patent Application No.
11/187,757, Straub, and Schmitt.
4

OBVIOUSNESS
The Issue
Appellants contend that the rejection should be reversed because it
fails to properly account for at least three claim limitations:
(i) maintaining for at least one week an antifungal lung concentration
of a least two times the minimum inhibitory concentration;
(ii) a treatment regimen[] where a first dosage is administered for a
predetermined time interval followed by second smaller dosage; and

1
Appellants state that claims 77 and 78 were rejected “for unknown
reasons” (App. Br. 4) and that the Examiner did not provide reasons for
rejecting those claims (id. at 11). The Final Rejection had a typo in the
heading statement of rejection that omitted claims 77 and 78 (Final Rej. 8),
but it specifically addressed both claims in the body of the rejection (id. at
9). The Answer repeated the typo (Ans. 7), but it retained the explicit
reasons for rejecting claims 77 and 78 (id. at 8), and additionally responded
to Appellants by reiterating the reasoning from the body of the rejection (id.
at 15). The Reply Brief maintains that the reasons for rejection are unknown
but also alleges that new grounds of rejection for claims 77 and 78 were
added. (Reply Br. 3.) While it is unfortunate that the typo was made, the
Final Rejection stated explicit reasons for rejecting claims 77 and 78, so the
reasons were not unknown, and their reiteration in the Answer was not a
new ground of rejection.
2
Weickert et al., US 2002/0177562 A1, published November 28, 2002.
3
Straub et al., US 6,395,300 B1, issued May 28, 2002.
4
Schmitt et al., US 4,950,477, issued August 21, 1990.
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(iii) the use of porous particles that have a mass median aerodynamic
diameter of less than about 5 microns and a bulk density of less than
about 0.5 g/cm
3
.

(App. Br. 5.)
Findings of Fact
1. We adopt the Examiner’s findings concerning the scope and content
of the prior art (Ans. 7-15), and repeat the following findings for
reference purposes.
2. Weickert described particles having a density “most preferably from
about 0.17 to 0.75 gram/cubic centimeter.” (Weickert 10, [0113].)
3. Weickert described powders containing “aerosol particle sizes below
3.3 μm to about 0.5 μm.” (Id., [0114].)
4. Weickert taught:
For treating a subject suffering from a pulmonary fungal
infection, the amount per dose of antifungal agent administered by
oral inhalation is that amount which is effective to treat the infection.
The amount of antifungal agent for the treatment of infection will
generally be higher than that used for prevention. . . . In one
exemplary treatment regimen, an antifungal powder in accordance
with the invention is administered 1 to 8 times daily, preferably from
2-6 times daily, over a course of from about 7 to about 183 days.

(Id. at 11, [0127].)
5. Weickert taught:
In treating these respiratory fungal conditions, the powders of
the invention are typically administered in doses that are 3-10 or more
times the MIC90 of the causative fungal pathogens; these levels are
safely achievable by inhalation. Generally, the dose of antifungal
compound delivered to a subject will be from about 2 mg to about 400
mg daily, preferably from about 10 to 200 milligrams daily,
depending upon the particular antifungal compound, the condition
being treated, the age and weight of the subject, and the like.
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(Id., [0128].)

Principles of Law
“[W]hile an analysis of obviousness always depends on evidence that
supports the required Graham factual findings, it also may include recourse
to logic, judgment, and common sense available to the person of ordinary
skill that do not necessarily require explication in any reference or expert
opinion.” Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587 F.3d 1324,
1329 (Fed. Cir. 2009).
“[W]here there is a range disclosed in the prior art, and the claimed
invention falls within that range, there is a presumption of obviousness. Iron
Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir.
2004) (citations omitted). “[A] prima facie case of obviousness arises when
the ranges of a claimed composition overlap the ranges disclosed in the prior
art.” In re Harris, 409 F.3d 1339, 1341 (Fed. Cir. 2005) (citations omitted).
Analysis
Appellants’ first contention is that the prior art did not teach or
suggest the limitation “maintaining for at least one week an antifungal lung
concentration of at least two times the minimum inhibitory concentration
[MIC].” (App. Br. 5.) We find the Examiner has the more reasonable
interpretation of the prior art. First, Weickert explicitly taught administering
a dose from three to ten times the MIC by inhalation, (FF 5), and explicitly
provided an example regimen administering that dose 1 to 8 times daily over
a course of from about 7 to about 183 days (FF 4). We also agree with the
Examiner’s reliance on the principle that “[W]here the general conditions of
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a claim are disclosed in the prior art, it is not inventive to discover the
optimum or workable ranges by routine experimentation.” (Ans. 11, citing
In re Aller, 220 F.2d 454, 456 (CCPA 1955).) In light of Weickert’s
teachings of multiple daily administration of a dose up to ten times the MIC
for periods much greater than a week, we conclude that there was sufficient
evidence to support the Examiner’s reasoning.
Appellants’ second contention is that the prior art did not teach or
suggest “a treatment regimen[] where a first dosage is administered for a
predetermined time interval followed by second smaller dosage.” (App. Br.
5.) The Examiner acknowledged that the references did not explicitly teach
this feature of Appellants’ method. However, the Examiner reasoned that
because Weickert taught adjusting dosages “depending upon the particular
antifungal compound, the condition being treated, the age and weight of the
subject, and the like” (FF 5), adjusting over time to a later, smaller dosage
would have been within the skill in the art. Appellants contend that
Weickert’s disclosure did not suggest a lower second dose, but this reading
would deny the person of ordinary skill in the ability to adjust depending on
“the condition being treated” as Weickert instructed. We see no reason to
assume that a physician starting a patient on a dose ten times MIC would not
reasonably be expected to lower the dose over the course of weeks as the
condition being treated improves. In this regard, we again agree with the
Examiner’s continued reliance on the principle that where the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.
Appellant’s third contention is that the prior art did not teach or
suggest “the use of porous particles that have a mass median aerodynamic
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diameter of less than about 5 microns and a bulk density of less than about
0.5 g/cm
3
.” (App. Br. 5.) Weickert’s 3.3 micron diameter (FF 3) meets the
limitation less than 5 microns, and Appellants’ density is within Weickert’s
density range of 0.17 to 0.75 (FF 2). See Iron Grip, 392 F.3d at 1322;
Harris, 409 F.3d at 1341. Appellants provide no evidence that particles
within the same ranges would not have been readily produced even if made
as porous particles as suggested by Straub. We are also unpersuaded by
Appellants’ contention that a person of ordinary skill in the art would not
have wanted an antifungal drug to dissolve too quickly and would therefore
not have wanted to use porous particles as taught by Straub. As noted by the
Examiner, Straub explicitly taught using its invention for antifungals such as
amphotericin B to be administered to the lungs by inhalation. (Ans. 9-10.)
Against that evidence we conclude that Appellants’ attorney argument is
unpersuasive.

In sum, we find the evidence supports the Examiner’s findings and
reasoning and conclude that the rejection of claim 1 should be affirmed.
Independent claim 23 is separately argued, with Appellants
contending that the prior art did not suggest the limitations “wherein a
sufficient amount of the pharmaceutical formulation is administered to
maintain for at least two weeks a target amphotericin lung concentration of
at least 9 μg/g, and wherein the administration comprises a first
administration period and a second administration period and wherein the
amphotericin B is administered more frequently or at a higher dosage during
the first administration period than during the second administration period.”
(App. Br. 15-16.) Like the arguments for claim 1, this argument gives too
little weight to the ability of the person of ordinary skill in the art to apply
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Weickert’s teachings to patient conditions. We again find the evidence
supports the Examiner’s findings and reasoning and conclude that the
rejection of claim 23 should be affirmed.
Claims 2-15, 18-20, 24, 25, 28-31, 38-40, 63-78, 98, 99, and 101 have
not been argued separately and therefore stand or fall with claims 1 and 23.
37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS-TYPE DOUBLE PATENTING
Appellants’ claims were rejected over claims 23-25, 27-30 and 35-44
of copending Patent Application No. 11/187,757. The file of the copending
Application shows that the conflicting claims have since been cancelled.
Given the cancellation, the rejection cannot be affirmed as it stands. We
therefore reverse the rejection without further consideration.

SUMMARY
We affirm/reverse the rejection of claims 1-15, 18-20, 23-25, 28-31,
38-40, 63-78, 98, 99, and 101 under 35 U.S.C. §103(a) as unpatentable over
Weickert and Straub.
We reverse the provisional rejection of claims 1-15, 18-20, 23-25, 28-
31, 38-40, 98, and 99 on the ground of nonstatutory obviousness-type double
patenting.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

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AFFIRMED

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