Ex Parte Sarna

Patent Trial and Appeal Board

Apr 11, 2013

11817220 (P.T.A.B. Apr. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SUSHIL K. SARNA
____________

Appeal 2012-002470
Application 11/817,220
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC GRIMES, and ERICA A.
FRANKLIN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 3, 5-8, 22, and
24 (App. Br. 2; Ans. 3). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method for treating constipation. Claims
1, 3, 8, 22, and 24 are representative and are reproduced in the Claims
Appendix of Appellants’ Brief.
Appeal 2012-002470
Application 11/817,220

2
Claims 1, 5, and 6 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Onyuksel.1
Claims 3 and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Onyuksel and Foldvari.2
Claim 8 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Onyuksel, Foldvari, Mercer,3 and Bevec.4
Claim 22 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Onyuksel and Warren.5
Claim 24 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Onyuksel and Gandhi.6
We affirm.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Onyuksel teaches Appellant’s claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Onyuksel teaches sterically stabilized liposomes comprising a
biologically active amphipathic compound such as vasoactive intestinal

1 Onyuksel et al., US 6,197,333 B1, issued March 6, 2001.
2 Foldvari, US 5,718,914, issued February 17, 1998.
3 Mercer et al., US 2004/0038888 A1, published February 26, 2004.
4 Bevec, WO 03/103702 A1, published December 18, 2003.
5 J.B. Warren et al., Pituitary adenylate cyclase activating polypeptide is a
potent vasodilator and oedema potentiator in rabbit skin in vivo, 106 Br. J.
Pharmacol. 331-334 (1992).
6 Gandhi, US 6,911,430 B2, issued June 28, 2005.
Appeal 2012-002470
Application 11/817,220

3
peptide (VIP) or pituitary adenylate cyclase activating peptide (PACAP)
(Onyuksel, col. 5, ll. 10-44; Ans. 4-5).
FF 2. Onyuksel teaches the use of a “biologically active liposome product
comprising a biologically active amphipathic compound … for the treatment
of … chronic constipation” (Onyuksel, col. 9, ll. 44-49; Ans. 4-5).
FF 3. Onyuksel teaches that the “liposome products of the invention may
be administered intravenously, …orally, [and] transdermally” (Onyuksel,
col. 8, ll. 44-51; see generally Ans. 5).
FF 4. Gandhi suggests the administration of a VIP or PACAP receptor
antagonist for the treatment of ileus, which Gandhi suggests is distinguished
from constipation (Gandhi, col. 1, ll. 28-29; Ans. 9-10).
ANALYSIS
Onyuksel teaches the administration of a liposome comprising VIP or
PACAP for the treatment of constipation (FF 1-3). Therefore, we are not
persuaded by Appellant’s unsupported contention that Onyuksel fails to
enable a method of treating constipation (App. Br. 5-7; Cf. Ans. 9-14).
To the extent that Appellant contends that Onyuksel fails to teach
delivery to gut smooth muscle cells, Appellant failed to provide persuasive
evidence or reasoning the support a finding that intravenous, oral, or
transdermal administration of Onyuksel’s biologically active liposome
comprising VIP or PACAP would not inherently result in delivery of the
biologically active liposome to gut smooth muscle cells (FF 1-3; Cf.
Appellant’s claim 6 (VIP or PACAP is formulated for transdermal,
intravenous, or oral administration); see generally App. Br. 5-7).
We are also not persuaded by Appellant’s reliance on Gandhi’s
suggestion of the administration of a VIP or PACAP antagonist for the
Appeal 2012-002470
Application 11/817,220

4
treatment of ileus, which Gandhi suggests “should be distinguished from
constipation” (FF 4).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Onyuksel teaches Appellant’s claimed invention. The rejection
of claim 1 under 35 U.S.C. § 102(b) as being anticipated by Onyuksel is
affirmed. Claims 5 and 67 are not separately argued and fall with claim 1.

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 5. Examiner relies on Onyuksel as set forth above (Ans. 5).
FF 6. Examiner finds that “Onyuksel does not expressly disclose
transdermal administration using a patch over a time period of at least 3
hours” (id.).
FF 7. Foldvari suggests “a patch for delivery of … [a therapeutic
liposome] for a period of time of up to 6 hours” (id.).

7 To be complete, we recognize Appellant’s recognition of “the pending
objection of claim 6 for containing the word ‘transdermally’ instead of
‘transdermal’” and contention that “[i]f [A]ppellant[] prevail[s] in this
appeal Appellant[] will gladly submit an appropriate amendment correcting
this objection by replacing ‘transdermally’ with ‘transdermal’” (App. Br.
10).
Appeal 2012-002470
Application 11/817,220

5
FF 8. Examiner finds that the combination of Onyuksel and Foldvari fails
to “suggest a dosage of VIP or PACAP less than 25 ng/kg/day for treatment
of chronic constipation” (id.).
FF 9. Onyuksel suggests that it is “merely routine to determine the
minimum dosage required to achieve a desired biological effect” (Onyuksel,
col. 9, ll. 5-7; Ans. 15).
FF 10. Mercer suggests “a therapeutic dosage of VIP or PACAP as being
0.1 ng/kg/day … and Bevec discloses a therapeutic dosage of VIP or
PACAP as being 5 ng/kg/day, preferably 20 ng/kg/day” (Ans. 7).
FF 11. Examiner finds that Onyuksel fails to suggest the administration of
PACAP38 (id. at 8).
FF 12. Warren suggests that “PACAP38 was well known as being a
PACAP polypeptide” (id.; see Warren 331: col. 1, ll. 9-10 (“A 38 amino acid
and a 27 amino acid form of PACAP have been described”)).
FF 13. Examiner finds that Onyuksel fails to suggest “administering a
combination of VIP and PACAP” (Ans. 8 (emphasis removed)).
FF 14. Gandhi suggests the delivery of dosage forms comprising VIP and
PACAP (id. at 9).
ANALYSIS
Claim 3:
Based on the combination of Onyuksel and Foldvari, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to transdermally administer the liposomal product
comprising VIP of Onyuksel using the patch of Foldvari over a period of at
least 3 hours ”(Ans. 6).
Appeal 2012-002470
Application 11/817,220

6
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Onyuksel fails to suggest “the treatment of constipation …
by delivering to gut smooth muscle VIP or PACAP” (App. Br. 8; Cf. FF 1-
2). Therefore, we are not persuaded by Appellant’s contention that Foldvari
fails to make up for this alleged deficiency in Onyuksel (id.).

Claim 8:
Based on the combination of Onyuksel, Foldvari, Mercer, and Bevec,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious “to administer VIP or PACAP at the
dosages of Mercer or Bevec to a subject having chronic constipation” (Ans.
7).
Appellant contends that Mercer and Bevec fail to suggest VIP or
PACAP dosages for the treatment of constipation and therefore, Mercer and
Bevec in combination with Onyuksel and Foldvari fails to suggest
Appellant’s claimed invention. We are not persuaded. Onyuksel suggests
that the determination of an effective dosage is routine in the art (FF 9). “[I]t
is not inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955)). In this
regard, as Examiner explains, it is not unreasonable to have expected that
VIP or PACAP dosages less than 25 ng/kg/day would have a therapeutic
effect since VIP or PACAP were recognized as having a therapeutic effect at
those dosages (see Ans. 15; see generally FF 10).

Appeal 2012-002470
Application 11/817,220

7
Claim 22:
Based on the combination of Onyuksel and Warren, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to use PACAP38 in the method of Onyuksel”
(Ans. 8). Because Onyuksel suggests a method of treating constipation by
administering VIP or PACAP, we are not persuaded by Appellant’s
contention that the combination of Onyuksel and Warren fails to suggest
Appellant’s claimed invention because Warren “only describe[s] VIP,
PACAP and PACAP38 as vasodilators” (App. Br. 8; Cf. FF 2).
Claim 24:8
Based on the combination of Onyuksel and Gandhi, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to practice the method of Onyuksel using a
combination of VIP and PACAP” (Ans. 9).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Onyuksel fails to suggest “the treatment of constipation …
by delivering to gut smooth muscle VIP or PACAP” (App. Br. 10; Cf. FF 1-
2). Therefore, we are not persuaded by Appellant’s contention that Gandhi
fails to make up for this alleged deficiency in Onyuksel (id.). As Examiner
explains, it was recognized in the art that VIP and PACAP may be used in
combination (Ans. 17; FF 14). Further, Onyuksel suggests a composition
comprising either VIP or PACAP for the treatment of constipation (FF 1-2).

8 Appellant recognizes that claim 24 depends from a canceled claim and
asserts that “[i]f Appellant[] prevail[s] in this appeal Appellant[] will gladly
submit the appropriate amendment to correct the dependency of claim 24
(see App. Br. 10). For the purposes of this Appeal, we considered claim 24
as if it depended from claim 1 (see Fin. Rej. 4).
Appeal 2012-002470
Application 11/817,220

8
“[I]t is prima facie obvious to combine two compositions each of which is
taught by the prior art to be useful for the same purpose, in order to form a
third composition which is to be used for the very same purpose.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980); see Ans. 17.
CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Onyuksel and Foldvari is affirmed. Claim 7 is not
separately argued and falls with claim 3.
The rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Onyuksel, Foldvari, Mercer, and Bevec is affirmed.
The rejection of claim 22 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Onyuksel and Warren is affirmed.
The rejection of claim 24 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Onyuksel and Gandhi 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
lp