Ex Parte Modi

Board of Patent Appeals and Interferences

Sep 15, 2009

10378371 (B.P.A.I. Sep. 15, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte PANKAJ MODI
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Appeal 2009-005323
Application 10/378,371
Technology Center 1600
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Decided: September 15, 2009
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Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of administering insulin or heparin. The Examiner has rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

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Application 10/378,371

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STATEMENT OF THE CASE
Claims 26-50 are pending and on appeal. Claims 26 and 37, the only
independent claims, read as follows:
Claim 26: A method for administering insulin to the buccal mucosa
comprising spraying an effective amount of said insulin to the buccal
mucosa, using an atomizer, while resisting inhalation.

Claim 37: A method for administering heparin to the buccal mucosa
comprising spraying an effective amount of said heparin to the buccal
mucosa, using a metered dose dispenser, while resisting inhalation.

The claims stand rejected as follows:
• claims 26 and 27 under 35 U.S.C. § 102(b) in view of Campfield;1
• claims 26-50 under 35 U.S.C. § 103(a) in view of Campfield,
Gertner,2 Cho,3 Modi,4 and Ekwuribe.5
ANTICIPATION
Issue
The Examiner has rejected claims 26 and 27 under 35 U.S.C. § 102(b)
as being anticipated by Campfield. The Examiner finds that Campfield
discloses administering insulin and that “[s]uitable methods of
administration comprises buccal” (Answer 3). The Examiner also finds that
Campfield discloses “the dosage forms as a spray (non-aerosol)” (id.).

1 Campfield et al., EP 0414080 A2, Aug. 21, 1989
2 Gertner et al., US 5,707,641, Jan. 13, 1998
3 Cho, US 5,858,398, Jan. 12, 1999
4 Modi et al., WO 96/36352, Nov. 21, 1996
5 Ekwuribe et al., US 6,191,105 B1, Feb. 20, 2001
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Appellant contends that the Examiner erred in finding that Campfield
anticipates because “there is no disclosure or teaching of administering
insulin to the buccal cavity (a) by spraying, (b) while resisting inhalation, (c)
using an atomizer” (Appeal Br. 5).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Campfield discloses a method of
“spraying an effective amount of said insulin to the buccal mucosa,” as
required by the claims?
Findings of Fact
1. Campfield discloses that “alkali metal salts of coconut oil are
highly effective in promoting the absorption and bioavailability of insulin
via routes of administration other than parenteral injection” (Campfield,
2: 1-3).
2. Campfield discloses that “[s]uitable dosage forms comprise oral,
rectal, buccal, sublingual and intranasal” (id. at 2: 5).
3. Campfield discloses that “buccal film administration is the
preferred route of administration. . . . To produce such a buccal film, for
example, crystalline insulin is dissolved in an absorption enhancer to form a
solution. A polymeric material … is added to the mixture, dry or in solution.
The resulting solution is cast into a film.” (Id. at 2: 44-49.)
4. Campfield discloses that:
For the other types of non-parenteral administration
contemplated for use with this invention, suitable dosage forms
can be prepared utilizing appropriate techniques well known to
those skilled in the art. Such dosage forms for buccal and
sublingual administration include tablets, capsules, gels, films,
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patches and solutions, as well as aerosol sprays and drops for
intranasal delivery.
(Id. at 7: 11-14)
Principles of Law
An anticipatory reference under 35 U.S.C. § 102 “must clearly and
unequivocally disclose the claimed compound or direct those skilled in the
art to the compound without any need for picking, choosing, and combining
various disclosures not directly related to each other by the teachings of the
cited reference.” In re Arkley, 455 F.2d 586, 587 (CCPA 1972).
Analysis
Claim 26 recites spraying an effective amount of insulin to the buccal
mucosa. The Examiner finds that “Campfield teaches administering insulin
to the buccal cavity as … an aerosol spray (inherently by sprayer). … Note
that the buccal administration using a dosage form of aerosol sprays is a
clear disclosure of administration to the buccal mucosa.” (Answer 7.)
Appellant contends that Campfield teaches certain dosage forms for
buccal administration, but does not disclose buccal administration via spray
(Appeal Br. 4-5).
Appellant’s arguments are persuasive. Campfield discloses that
dosage forms for buccal and sublingual administration include tablets,
capsules, gels, films, patches and solutions. Campfield also discloses
aerosol sprays, but only for intranasal delivery. Thus, Campfield does not
disclose a spray for buccal delivery and therefore does not implicitly
disclose the step of “spraying … to the buccal mucosa,” as recited in claim
26.
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The Examiner's finding that Campfield discloses a spray for buccal
delivery relies on the type of picking, choosing, and combining various
disclosures that is foreclosed by Arkley. Thus, the Examiner has not
adequately shown that Campfield discloses an embodiment meeting all the
limitations of claim 26. The rejection of claim 26, and dependent claim 27,
as anticipated by Campfield is reversed.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Campfield discloses the claimed method of “spraying an effective amount of
said insulin to the buccal mucosa.”
OBVIOUSNESS
The Examiner has rejected claims 26-50 under 35 U.S.C. § 103(a) as
being obvious in view of Campfield, Gertner, Cho, Modi, and Ekwuribe.
The Examiner’s conclusion that the claims would have been obvious
relies on the Examiner’s finding that Campfield discloses a spray for the
buccal administration of insulin. That finding is not supported by the
evidence of record. Therefore, the rejection of claims 26-50 under 35 U.S.C.
§ 103(a) is reversed for the reason discussed above.
SUMMARY
We reverse the rejection of claims 26 and 27 under 35 U.S.C. § 102(b)
in view of Campfield, and the rejection of claims 26-50 under 35 U.S.C. §
103(a) in view of Campfield, Gertner, Cho, Modi, and Ekwuribe.

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Application 10/378,371

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REVERSED

alw

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