James D. Pipkin et al.

Patent Trials and Appeals Board

Oct 9, 2019

13335780 - (D) (P.T.A.B. Oct. 9, 2019)

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.
13/335,780 12/22/2011 James D. Pipkin LIGAN4.011C2 4792
20995 7590 10/09/2019
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
LIU, SUE XU
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
10/09/2019 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):
efiling@knobbe.com
jayna.cartee@knobbe.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JAMES D. PIPKIN, GEROLD L. MOSHER, and
DOUGLAS B. HECKER
____________

Appeal 2018-007526
Application 13/335,7801
Technology Center 1600
____________

Before FRANCISCO C. PRATS, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a
composition comprising agglomerated particles comprising sulfoalkyl ether
cyclodextrin. The Examiner rejected the claims on appeal as obvious under
35 U.S.C. § 103(a).
We reverse.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. According to Appellant, the real party in interest is CyDex
Pharmaceuticals, Inc. App. Br. 4.

Appeal 2018-007526
Application 13/335,780

2
STATEMENT OF THE CASE
The Specification discloses “a dry powder formulation for
administering an inhalable active agent by inhalation with a dry powder
inhaler (DPI) using sulfoalkyl ether cyclodextrin as a carrier there[of].”
Spec. 1.
Claims 12, 16–23, and 29–33 are on appeal. Claim 12 is
representative and reads as follows:
12. A composition comprising agglomerated particles
comprising sulfoalkyl ether cyclodextrin, wherein the
composition comprises less than 10% by weight moisture and
has a bulk density of 0.34 g/cc to 0.55 g/cc, a CARR’s index of
about 10% to about 40%, and a median particle diameter of
about 10 microns to about 300 microns, and wherein the
agglomerated particles have a rough surface.
App. Br. 22.
The Examiner rejected claims 12, 16–23, and 29–33 under 35 U.S.C.
§ 103(a) as being obvious over the combination of Stella ’418,2 Stella ’878,3
Platz,4 Staniforth,5 Edwards,6 and Assmann.7

2 Stella et al., US 5,874,418, issued Feb. 23, 1999 (“Stella ’418”).
3 Stella et al., US 7,625,878 B2, issued Dec. 1, 2009 (“Stella ’878”).
4 Platz et al., US 6,051,256, issued Apr. 18, 2000 (“Platz”).
5 Staniforth et al., US 8,182,791 B2, issued May 22, 2012 (“Staniforth”).
6 Edwards et al., US 2002/0035993 A1, published Mar. 28, 2002
(“Edwards”).
7 Assmann et al., US 2002/0022584 A1, published Feb. 21, 2002
(“Assmann”).
Appeal 2018-007526
Application 13/335,780

3
ANALYSIS
In rejecting claims 12, 16–23, and 29–33 as obvious over the cited art,
the Examiner found, inter alia, that it would have been obvious “to produce
the formulations of Stella ’418 as an inhalation formulation as taught by
Stella ’878 in order to produce the instant invention.” Final Act.8 6. The
Examiner explained that the ordinary artisan would have been “motivated to
do this because both references are drawn to pharmaceuticals comprising
SAE-CD compounds, Stella ’418 teach[es] a plurality of product
formulations including powder[,] and Stella ’878 teach[es] SAE-CD
formulations may be administered as dry inhalation powders.” Id.
Appellant argues that Stella ’878 does not disclose sulfoalkyl ether
cyclodextrin (“SAE-CD”) as recited in the claims, and as disclosed in Stella
’418. Rather, according to Appellant, Stella ’878 discloses sulfoalkyl ether-
alkyl ether cyclodextrin (“SAE-AE-CD”). App. Br. 6. Thus, according to
Appellant, there would have been “no reason for a person of ordinary skill in
the art to combine it with the disclosure [of] Stella ’418.” Id.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
“[T]he examiner bears the initial burden . . . of presenting a prima facie case
of unpatentability.” Appellant has persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
Each of the pending claims requires a composition comprising SAE-
CD. Stella ’418 teaches a composition comprising SAE-CD, but does not
teach that it has the properties recited in the claims. To arrive at the claimed
properties, the Examiner concludes that it would have been obvious to

8 Office Action mailed May 12, 2017 (“Final Act.”).
Appeal 2018-007526
Application 13/335,780

4
produce the composition of Stella ’418 as a dry inhalable powder, “as taught
by Stella ’878.” Final Act. 6–10. The problem with this conclusion is that
Stella ’878 does not teach a dry inhalable powder comprising SAE-CD.
Rather, Stella ’878 discloses an inhalable powder composition comprising
an SAE-AE-CD. Stella ’878 Abstract, 31:13–17.
When Appellant raised this problem in its Appeal Brief, the Examiner
responded that this argument was not persuasive because “both references
are drawn to cyclodextrin compounds with sulfoalkyl ether functionality in
drug delivery systems” and both references relate to “the same active agents
such as prednisolone.” Ans. 3. We do not find this argument persuasive
because SAE-CD and SAE-AE-CD are different compounds and the
Examiner does not provide a persuasive explanation of why the ordinary
artisan would expect the teaching of Stella ’878 with respect to SAE-AE-CD
to apply to SAE-CD. See id.
Accordingly, we reverse the Examiner’s rejection of claims 12, 16–
23, and 29–33.
SUMMARY
In summary:
Claims
Rejected
Basis Affirmed Reversed
12, 16–23, and
29–33
§ 103(a), Stella ’418,
Stella ’878, Platz,
Staniforth, Edwards,
and Assmann.

12, 16–23, and
29–33
Overall Outcome 12, 16–23, and
29–33

REVERSED