Ex Parte Platz et al

Board of Patent Appeals and Interferences

Oct 24, 2011

11536348 (B.P.A.I. Oct. 24, 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.
11/536,348 09/28/2006 Robert M. Platz 53216-US-CNT [ 5 ] 8906
1095 7590 10/24/2011
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
10/24/2011 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 ROBERT M. PLATZ, THOMAS K. BREWER,
and TERENCE D. BOARDMAN
____________

Appeal 2011-001127
Application 11/536,348
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-4, 6-10, 12-24,
26-30, 32-40, 57-95, 142-145, 147-160, 162-171, and 183-185 (App. Br. 2;
Reply Br. 2).
1
We have jurisdiction under 35 U.S.C. § 6(b).

1
Appellants‟ statement that “[t]he rejection of each of claims 1-40 and 55-
58 is hereby appealed” appears to contain a typographical error (App. Br. 2;
Reply Br. 2). Appellants‟ arguments account for all rejected claims (see,
e.g., App. Br. 8: 2-4). Accordingly, we find that this Appeal involves claims
1-4, 6-10, 12-24, 26-30, 32-40, 57-95, 142-145, 147-160, 162-171, and 183-
Appeal 2011-001127
Application 11/536,348

2
STATEMENT OF THE CASE
The claims are directed to a composition (claims 1-4, 6-10, 12-15, 21-
24, 26-30, 32-35; 57-95); a unit dosage (claims 16-19, 36-39); an inhalation
device (claims 20, 40); a method of treating diabetes (claims 142-145, 147-
160, and 162-171); and a method of delivery of a composition to the lungs of
a subject (claims 183-185). Claim 1 is representative and is reproduced in
the “Claims Appendix” of Appellants‟ Brief (App. Br. 30).
Claims 1-4, 6-10, 12-24, 26-30, 32-40, 57-95, 142-145, 147-160, 162-
171, and 183-185 stand rejected under 35 U.S.C. § 103 as unpatentable over
the combination of Ganderton
2
and either Suzuki
3
or Sakon.
4

Claims 6, 7, 14, 26, 27, 34, 62, 64, 70, 72, 76-85, 89, 90, 95, 147, 148,
155, 162, 163, and 170 stand rejected under 35 U.S.C. § 103 as unpatentable
over the combination of Ganderton, Desai,
5
and either Suzuki or Sakon.
Claims 11, 12, 31, 32, 66, 67, 74, 75, 93, 94, 152, 153, 167, and 168
stand rejected under 35 U.S.C. § 103 as unpatentable over the combination
of Ganderton and at least one of Robertson,
6
Bellm,
7
and Boiarski,
8
with or
without Suzuki.

185. “Claims 5, 11, 25, 31, 41-56, 96-141, 146, 161, 172-182, and 186 have
been cancelled” (id.).
2
Ganderton et al., US 5,254,330, issued October 19, 1993.
3
Suzuki et al., US 4,613,500, issued September 23, 1986.
4
Sakon et al., EP 0 611 567 A1, published August 24, 1994. Appellants
refer to this document as “Teijin” (see App. Br. 11).
5
Desai, US 5,206,219, issued April 27, 1993.
6
Robertson et al., US 5,487,378, issued January 30, 1996.
7
Bellm, US 5,235,969, issued August 17, 1993.
8
Boiarski et al., US 4,268,460, issued May 19, 1981.
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Application 11/536,348

3
Claims 28, 149, and 164 stand rejected under 35 U.S.C. § 103 as
unpatentable over the combination of Ganderton and Moses,
9
with or
without Suzuki.
We reverse.
ISSUE
Does the preponderance of evidence on this record support a
conclusion that it would have been prima facie obvious to a person of
ordinary skill in this art to prepare an inhalable particle composition
comprising insulin and a carrier, wherein the inhalable particles have a
rugosity of at least 2?
FACTUAL FINDINGS (FF)
FF 1. Appellants define the term “rugosity” as “a measure of surface
convolution, with a higher number indicating a higher degree of surface
irregularity” (Spec. 8: ¶ [0016]).
FF 2. Appellants disclose that “it is presently believed that the increase in
surface irregularity as measured by rugosity results in a decrease in
cohesiveness between adjacent particles. Such decrease in surface
interactions, in turn, improves the dispersibility of the resulting powders”
(id.).
FF 3. Ganderton suggests that “[t]he rugosity of conventional excipients
measured by air permeametry has been found to be at least 1.96 and
generally greater than 2.0” (Ganderton, col. 1, ll. 57-59).

9
Moses, et al., Insulin Administered Intranasally as an Insulin-Bile Salt
Aerosol Effectiveness and Reproducibility in Normal and Diabetic Subjects,
32 DIABETES 1040-1047 (1983).
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4
FF 4. Ganderton suggests that a difficulty with conventional drug
formulations for delivery to the lungs
is caused by the tendency of the drug particles which are
necessarily of a relatively small size to agglomerate either with
themselves or more usually with particles of the carrier
materials with which they are admixed. The difficulties
inherent in redispersion of these agglomerates means that only a
small proportion of the drug, may be as little as 5% is actually
injested [sic] via the lungs.

(Ganderton, col. 1, ll. 33-40; Ans. 5.)
FF 5. Ganderton “discovered that the redisperson of drug particles from
compositions comprising carriers is facilitated if the rugosity of the carrier
particles is reduced” (Ganderton, col. 1, ll. 43-46; Ans. 5).
FF 6. Ganderton suggests “a particulate carrier suitable for use in the
preparation of pharmaceutical compositions having an average particle size
of from 5.0 to 1000 microns and a rugosity [as determined by air
permeametry] of less than 1.75” (Ganderton, col. 1, ll. 46-51; see generally
Ans. 6).
FF 7. Ganderton prefers the carrier particles‟ rugosity to be “no more than
1.5 and most preferably no more than 1.3” (Ganderton, col. 3, ll. 18-19).
FF 8. Ganderton suggests that (1) “the carrier comprises a particulate
crystalline sugar . . . most preferably lactose” and (2) “[t]he conditions under
which crystallisation occurs should be controlled so as to favour the
production of crystals having a desired low degree of rugosity” (Ganderton,
col. 2, ll. 3-5 and ll. 16-19).
FF 9. Ganderton exemplifies a lactose particle wherein “[t]he rugosity
before crystallization was found to be 2.36 whilst the rugosity after
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Application 11/536,348

5
recrystallization was found to be 1.16” (Ganderton, col. 5, ll. 25-27; see
generally Ans. 5).
FF 10. Ganderton fails to suggest a “homogeneous distribution of insulin in
the carrier” (Ans. 5).
FF 11. Suzuki suggests powdery preparations of insulin and excipient for
nasal administration (id. at 6).
FF 12. Sakon suggests powdery preparations for inhalation prepared by
mixing insulin and excipient, wherein “[t]he particle sizes are 0.5 to 10
microns” (id.).
FF 13. The Examiner relies on Desai to suggest “the use of citrate buffer
with a pH at or around 2.5 for insulin” (id. at 7).
FF 14. The Examiner relies on Robertson, Bellm, and Boiarski to suggest
particle sizes for the delivery of medicaments to the alveoli of the lungs (id.
at 8).
FF 15. The Examiner relies on Moses to suggest “that bile salts enhance . . .
serum insulin levels when administered intravasally as an aerosol” (id. at 9).
ANALYSIS
Each of Appellants‟ claims require, inter alia, an inhalable particle
having a rugosity of at least 2. Based on the combined teachings of
Ganderton, and either Suzuki or Sakon the Examiner concludes that “it
would have been obvious to one of ordinary skill in the art to vary the
rugosity of the particles and perhaps increase the rugosity if the efficient re-
dispersion of drug is not desired” (Ans. 6 (emphasis added)). We are not
persuaded.
The Examiner failed to identify a suggestion in either Suzuki or Sakon
of a rugosity of at least 2 (see e.g., Ans. 12 (“Suzuki is silent with regard to
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Application 11/536,348

6
this property”); see also App. Br. 13 (Suzuki and Sakon “fail to teach
particles that comprise insulin and a carrier that have a rugosity of at least
2”)). Further, the Examiner fails to articulate a persuasive rationale as to
why a person of ordinary skill in this art would have expected either Suzuki
or Sakon to have a rugosity of at least 2. Accordingly, while “rugosity is a
property of a particle,” the Examiner failed to establish an evidentiary basis
on this record to suggest that either Suzuki or Sakon‟s particles exhibit, or
would have been expected to exhibit, the same property/rugosity as required
by Appellants‟ claimed invention (see Ans. 12). The same is true of the
Examiner‟s reliance on Desai, Robertson, Bellm, Boiarski, and Moses (FF
13-15; see also App. Br. 25, 26, and 27).
Ganderton expressly suggests reducing the rugosity of carrier particles
below that of conventional drug formulations to avoid the problems
associated with redispersion of inhaled drugs, which results in the injection
of a small percentage of the drug in the lungs (FF 4-5). Notwithstanding
Ganderton‟s express suggestion to the contrary, the Examiner concludes that
“perhaps” a person of ordinary skill in this art would have found it obvious
to “increase the rugosity if the efficient re-dispersion of drug is not desired”
is contrary to teachings of Ganderton (see Ans. 6 (emphasis added)). The
Examiner failed to identify an evidentiary basis on this record to support this
conjecture. Specifically, the Examiner fails to provide persuasive reasoning
or evidence to support a conclusion that a person of ordinary skill in this art
would not want the efficient redispersion and efficient uptake of an insulin
based drug formulation as required by Appellants‟ claimed invention.
We recognize the Examiner‟s assertion that Ganderton suggests that
“particles of different rugosity can be prepared” and exemplifies a lactose
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7
particle wherein “[t]he rugosity before crystallization was found to be 2.36
whilst the rugosity after recrystallization was found to be 1.16” (see
generally Ans. 10; FF 9; see also Ans. 9). However, when Ganderton is
read as a whole, we disagree with the Examiner‟s assertion that this example
of the preparation of a lactose particle within the scope of Ganderton would
have motivated a person of ordinary skill in this art to prepare particles
having the rugosity required by Appellants‟ claimed invention (Ans. 10; see
also FF 8-9; App. Br. 12 (“the particles referred to by the Examiner . . . are
the raw material particles prior to treatment according to the teachings of
Ganderton”)).
We also recognize, but are not persuaded by, the Examiner‟s citation
of Kodas
10
(Ans. 10). Since Kodas is not relied upon in the statement of the
rejection, it is not properly before this panel for review. Accordingly, we
have not included the Kodas reference in our deliberations. In re Hoch, 428
F.2d 1341, 1342 n.3 (CCPA 1970) (“[w]here a reference is relied on to
support a rejection, whether or not in a „minor capacity,‟ there would appear
to be no excuse for not positively including the reference in the statement of
the rejection.”).
In sum, Ganderton is the only reference relied upon by the Examiner
that suggests a rugosity value and in doing so Ganderton expressly directs a
person away from formulations with a carrier particle rugosity above 1.75
(FF 5-7). Accordingly, we are compelled to find that the Examiner failed to
establish the requisite evidentiary basis required to support a prima facie
case of obviousness.

10
Kodas et al., US 6,051,257, issued April 18, 2000.
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Application 11/536,348

8
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support a
conclusion that it would have been prima facie obvious to a person of
ordinary skill in this art to prepare an inhalable particle composition
comprising insulin and a carrier, wherein the inhalable particles have a
rugosity of at least 2.
The rejection of claims 1-4, 6-10, 12-24, 26-30, 32-40, 57-95, 142-
145, 147-160, 162-171, and 183-185 under 35 U.S.C. § 103 as unpatentable
over the combination of Ganderton and either Suzuki or Sakon

is reversed.
The rejection of claims 6, 7, 14, 26, 27, 34, 62, 64, 70, 72, 76-85, 89,
90, 95, 147, 148, 155, 162, 163, and 170 under 35 U.S.C. § 103 as
unpatentable over the combination of Ganderton, Desai, and either Suzuki or
Sakon is reversed.
The rejection of claims 11, 12, 31, 32, 66, 67, 74, 75, 93, 94, 152, 153,
167, and 168 under 35 U.S.C. § 103 as unpatentable over the combination of
Ganderton and at least one of Robertson, Bellm, and Boiarski, with or
without Suzuki is reversed.
The rejection of claims 28, 149, and 164 under 35 U.S.C. § 103 as
unpatentable over the combination of Ganderton and Moses, with or without
Suzuki is reversed.
REVERSED

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