Ex Parte Ong et al

Board of Patent Appeals and Interferences

Feb 18, 2011

10559595 (B.P.A.I. Feb. 18, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN ONG, ROBERT JENNINGS, and GREGG STETSKO
__________

Appeal 2010-010477
Application 10/559,595
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, or for filing a request
for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from
the “MAIL DATE” (paper delivery mode) or the
“NOTIFICATION DATE” (electronic delivery mode) shown on
the PTOL-90A cover letter attached to this decision.
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Statement of the Case
The Specification teaches “the design of novel pharmaceutical
compositions for the transmucosal delivery of bioactive peptides and
proteins. The novel compositions of the invention may be used to effectively
deliver bioactive peptides and proteins systemically to the blood subsequent
to transmucosal administration” (Spec. 6, l. 30 – Spec. 7, l. 2).
The Claims
Claims 1-10 and 15-34 are on appeal. Claim 1 is representative, and
the remaining claims have not been argued separately and therefore stand or
fall together with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 reads as
follows:
1. A pharmaceutical composition for
transmucosal administration of a bioactive peptide
or protein of interest comprising said bioactive
peptide or protein of interest, a cationic polyamino
acid, and a compatible buffer, wherein at the pH of
the composition said compatible buffer does not
cause precipitation of the cationic polyamino acid,
and has a mono-anionic or neutral net charge; and
wherein the bioactive peptide or protein of
interest has the same net charge as the cationic
polyamino acid at the pH of the composition; and
wherein the transmucosal absorption of said
bioactive peptide or protein is increased relative
the absorption of said bioactive peptide or protein
in the absence of said cationic polyamino acid.

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The issues
A. The Examiner rejected claims 1-10 and 15-34 under 35 U.S.C. § 112,
second paragraph as indefinite (Ans. 11-13).
B. The Examiner rejected claim 1 under 35 U.S.C. § 102(b) as
anticipated by Rothbard2 (Ans. 4).
C. The Examiner rejected claims 1-4, 6, 7, 9, 10, 15, 16, and 18-21 under
35 U.S.C. § 102(a) and (e) as anticipated by Defelippis3 (Ans. 4-5).
D. The Examiner rejected claims 1-10 and 15-26 under 35 U.S.C. §
103(a) as obvious over Young,4 Baichwal,5 and Ryser6 (Ans. 6-11).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds that it “is unclear how a bioactive peptide or
protein of interest will have the same net charge as the cationic polyamino
acid” (Ans. 11). The Examiner finds that “if the poly-arginine is a 13mer,
this would give a net charge of +13. It is unclear how a bioactive peptide or
protein, exendin-4, having a 39 amino acid would have a net charge of +13”
(id.). The Examiner finds that the “sequence of exendin-4 is
HGEGTFTSDLSKQMEEEAVRLFIEWLKNGGPSSGAPPPS. There are
not enough positively charged amino acids (K, R and H) to get the same net
charge of +13 as the cationic polyamino acid” (id. at 11-12).
Appellants contend that “Claim 1 recites that the bioactive peptide or
protein of interest has the ‘same net charge’ as the cationic polyamino acid

2 Rothbard et al., US 2002/0009491 A1, published Jan. 24, 2002.
3 Defelippis et al., WO 02/098348 A2, published Dec. 12, 2002.
4 Young et al., US 2003/0087820 A1, published May 8, 2003.
5 Baichwal, Anand R., US 5,330,761, issued Jul. 19, 1994.
6 Ryser et al., US 4,847,240, issued Jul. 11, 1989.
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at the pH of the composition. It appears that the rejection is not based on a
proper interpretation of this claim term” (App. Br. 7). Appellants point to
the Specification, which states “at the pH of the composition both the protein
and the polyamino acid have a net positive charge. In this situation, it is not
necessary that the magnitude of the charge be identical, but only that the net
charge be the same” (Spec. 8, ll. 15-18).
Appellants contend that it “is clear that the claim language means that
the protein or peptide and the polyamino acid both have a net positive charge
or a net negative charge, and that the magnitude of that charge is not referred
to in the claim” (Reply Br. 2).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the phrase “wherein the bioactive
peptide or protein of interest has the same net charge as the cationic
polyamino acid at the pH of the composition” renders claim 1 indefinite?
Findings of Fact
1. The Specification teaches that “at the pH of the composition
both the protein and the polyamino acid have a net positive charge. In this
situation, it is not necessary that the magnitude of the charge be identical,
but only that the net charge be the same” (Spec. 8, ll. 17-20).
Principles of Law
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986).

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Analysis
We agree with Appellants that the claims must be read in light of the
Specification (see App. Br. 7). We also agree that the Specification makes
clear that it is the “net charge” of the peptides and protein that must be the
same, not the magnitude of that charge (FF 1). Additionally, we agree with
Appellants that “as noted in the Examiner’s Answer, the pI of exendin-4 is
5.3. Therefore, persons of ordinary skill in the art readily understand that at
a pH of 4.5, exendin-4 will be positively charged” (Reply Br. 2).
We are therefore not persuaded by the Examiner’s argument, which
does not interpret the claim term “same net charge” in light of the
Specification, as required.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the phrase “wherein the bioactive peptide or protein of interest has the
same net charge as the cationic polyamino acid at the pH of the
composition” renders claim 1 indefinite.
B. 35 U.S.C. § 102(b) over Rothbard
The Examiner finds that “Rothbard et al teach a pharmaceutical
composition comprising components (delivery-enhancing transporter (poly-
arginine) and biologically active agents (such as peptide or protein)) in a
suitable medium, such as water or a buffered aqueous solution” (Ans. 4).
The Examiner finds that since “the bioactive peptide and cationic polyamino
acid are formed in water or aqueous buffer, this would inherently have the
functionality and the characteristics of the instantly claimed invention” (id.).
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Appellants contend that “Rothbard does not disclose or suggest a
composition where the bioactive peptide or protein of interest has the same
net charge as the cationic polyamino acid at the pH of the composition”
(App. Br. 8). Appellants contend that
Rothbard explains at paragraph 44 (and 45) that the
components of the composition (delivery-enhancing
transporters such as poly-Arg (paragraph 48), and the
biologically active agent (paragraph 26)) “are held in an
ionic association, typically viewed as an ion pair.” Thus,
these components of an ion pair necessarily have opposite
net charges at the pH of the composition, one net positive
and the other net negative.

(Id.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Rothbard anticipates claim 1?
Findings of Fact
2. Rothbard teaches that therapeutic agents “refer, without
limitation, to any composition that can be used to the benefit of a
mammalian species. Such agents may take the form of ions, small organic
molecules, peptides, proteins or polypeptides” (Rothbard 2 ¶ 0026).
3. Rothbard teaches that “delivery enhancing transporters are
poly-Arg transporters consisting of heptamers, octamers, nonamers and the
like of arginine. Similarly, polymers of homoarginine are useful” (Rothbard
4 ¶ 0048).
4. Rothbard teaches that the compositions “can be prepared by
combining the components (delivery-enhancing transporter and biologically
active agents) in a suitable medium and concentrating the composition to
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dryness. In many embodiments, the compositions are formed in water or a
buffered aqueous solution, lyophilized and packaged for reconstitution and
use by the clinician” (Rothbard 9 ¶ 0123).
5. Rothbard teaches that “[r]ather than a covalent composition, the
components are held in an ionic association, typically viewed as an ion pair.
Despite the term ‘ion pair,’ the invention will, in some embodiments,
include compositions of one or more biologically active agents in
association with one delivery-enhancing transporter” (Rothbard 4 ¶ 0044)
6. Rothbard teaches that “[e]ach of the composition components
will posses an ionic charge at physiologic pH. More particularly, the
transporter will be positively charged and the biologically active agent will
be negatively charged” (Rothbard 4 ¶ 0045).
Principles of Law
“Inherency … may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999) (quoting In re Oelrich, 666 F.2d 578,
581 (CCPA 1981)).
Analysis
The Examiner argues that Rothbard inherently teaches the claim
limitation that “the bioactive peptide or protein of interest has the same net
charge as the cationic polyamino acid at the pH of the composition” (see
Ans. 4).
We are not persuaded. Rothbard teaches that the “components are
held in an ionic association, typically viewed as an ion pair” (Rothbard 4 ¶
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0044; FF 5). Rothbard further explains that “[e]ach of the composition
components will posses an ionic charge at physiologic pH. More
particularly, the transporter will be positively charged and the biologically
active agent will be negatively charged” (Rothbard 4 ¶ 0045; FF 6). The
only reasonable interpretation of these teachings of Rothbard is that the
transporter and biologically active agent will not have the same net charge
(FF 5-6).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Rothbard anticipates claim 1.
C. 35 U.S.C. § 102(a) and (e) over Defelippis
The Examiner finds that “Defelippis teaches a composition
comprising a GLP-1 compound and a basic polypeptide (see claim 1).
Defelippis specifically teaches the use of exendin-4 (see claim 8, page 12,
lines 6-21) as the GLP-1 compound. Defelippis teaches polyarginine as the
basic polypeptide (see claim 13)” (Ans. 4). The Examiner finds that
“Defelippis teaches that the composition is in a buffered solution . . .
Defelippis teaches the use of a zinc solution at pH of between about 5 and
about 6 (see page 29, lines 29-32) and also teaches pH adjustments to less
than 5” (id.).
The Examiner finds that “[s]ince the reference teaches the
composition comprising poly-arginine peptide, exendin-4, and buffer at pH
of the instant claims, the composition would inherently have the same
functionality and characteristics as the instant composition” (id. at 5).
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Appellants contend that the “present claims recite that the bioactive
peptide or protein of interest has the same net charge as the cationic
polyamino acid at the pH of the composition” (App. Br. 9). Appellants
contend that the “disclosure of Defelippis makes it clear that the bioactive
peptide or protein of interest and the cationic polyamino acid disclosed have
opposite charges, and cannot have the same net charge” (id.).
Appellants also contend that the “present claims recite that the
pharmaceutical composition has a pH at which the compatible buffer does
not cause precipitation of the cationic polyamino acid. Defelippis discloses a
composition at a pH where the GLP-1 and polyamino acid is precipitated,
since it is disclosed as being in particle form” (id. at 10).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Defelippis anticipates claim 1?
Findings of Fact
7. Defelippis teaches that the “present invention encompasses
particles formed from a GLP-1 compound and a basic polypeptide added
together at a ratio between about 4: 1 and about 10: 1” (Defelippis 24, ll. 23-
25).
8. Defelippis teaches that “[a]mino acids 38-45 of an extended
GLP-1 compound are preferably the same as or a conservative substitution
of the amino acid at the corresponding position of Exendin-3 or Exendin-4”
(Defelippis 12, ll. 3-6).
9. Defelippis teaches that the “basic polypeptide is selected from
the group consisting of polyarginine, protamine” (Defelippis 8, ll. 1-2).
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10. Defelippis teaches that the “particles of the present invention
are prepared by mixing a buffered GLP-1 compound solution with a
buffered basic polypeptide solution” (Defelippis 27, ll. 18-20).
11. Defelippis teaches that
Alternatively the suspension can be manipulated to
form a solution which can then be administered as an
injectable composition or as an aerosol or spray-dried to a
dry powder composition of particles. If a solution is desired,
the suspension of particles can be dissolved by adjusting the
pH of the suspension. Typically the pH is decreased until the
particles dissolve. Generally, adjustment of the pH to less
than 6 will result in dissolution of the particles. More
preferred is a pH of less than 5. Most preferred is a pH less
than 4. The result is a solution formulation that precipitates
upon administration.

(Defelippis 31, ll. 7-16.)
12. Defelippis teaches, in Example 24, the dissolution of particles,
specifically teaching that “[o]ne part Val8-GLP-1 (7-37) OH solution was
combined with one part protamine solution. A precipitate formed and the pH
was adjusted to 4.0. The result was a clear solution” (Defelippis 55, ll. 13-
15).
13. Defelippis teaches that:
A glycine solution was prepared by dissolving glycine
in sterile water to achieve a final concentration of 1M. 8
mLs of the glycine solution was combined with 4 mLs of
Val8- GLP-1 (7-37) OH solution prepared as described in
example 24 and 20 mLs of protamine solution prepared as
described in example 24. The final concentration of glycine
was 100mM and the final concentration of Val8-GLP-1 (7-
37) OH was about 1 mg/mL. The resulting pH of the
mixture was 6.6. Precipitates formed immediately upon
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mixing. The pH was adjusted to 4.2 with 5N HCl resulting
in a clear solution.

(Defelippis 55, l. 19 to 56, l. 4.)
Analysis
Defelippis teaches pharmaceutical compositions which may comprise
exendin-4 (FF 8) and that the “basic polypeptide is selected from the group
consisting of polyarginine, protamine” (Defelippis 8, ll. 1-2; FF 9).
Defelippis teaches that
If a solution is desired, the suspension of particles can be
dissolved by adjusting the pH of the suspension. Typically
the pH is decreased until the particles dissolve. Generally,
adjustment of the pH to less than 6 will result in dissolution
of the particles. More preferred is a pH of less than 5. Most
preferred is a pH less than 4. The result is a solution
formulation that precipitates upon administration.

(Defelippis 31, ll. 7-16; FF 11.)
The Examiner finds that “[s]ince the reference teaches the
composition comprising poly-arginine peptide, exendin-4, and buffer at pH
of the instant claims, the composition would inherently have the same
functionality and characteristics as the instant composition” (Ans. 5).
We agree with the Examiner. The composition taught by Defelippis is
a mixture of an exendin-4 bioactive protein and polyarginine compound at
pH 4, at which pH Defelippis teaches the particles will not precipitate (FF 8-
11). Consistent with Appellants’ own claims, where the preferred pH is
between 4 and 5 (see Claim 3), a preferred cationic polyamino acid is
polyarginine (see Claim 7) and a preferred bioactive peptide is exendin-4
(see Claim 10), the Examiner has reasonably provided evidence supporting
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the inherent identity of the composition of Defelippis with the composition
being claimed, thereby shifting the burden to Appellant to prove that the
prior art product does not necessarily or inherently possess the
characteristics of the claimed product. See In re Best, 562 F.2d 1252, 1255
(CCPA 1977) (“Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an applicant to prove
that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product.”).
Appellants contend that the “present claims recite that the bioactive
peptide or protein of interest has the same net charge as the cationic
polyamino acid at the pH of the composition” (App. Br. 9). Appellants
contend that the “disclosure of Defelippis makes it clear that the bioactive
peptide or protein of interest and the cationic polyamino acid disclosed have
opposite charges, and cannot have the same net charge” (id.).
We are not persuaded. The net charge depends, as Appellants note in
response to the indefiniteness rejection, upon the pI of the molecule (see
App. Br. 8). Appellants teach that the pI of exendin-4 is 5.3, so it will have
a positive charge at pH 4, the preferred pH of Defelippis (FF 11).
Appellants also contend that the “present claims recite that the
pharmaceutical composition has a pH at which the compatible buffer does
not cause precipitation of the cationic polyamino acid. Defelippis discloses a
composition at a pH where the GLP-1 and polyamino acid is precipitated,
since it is disclosed as being in particle form” (App. Br. 10).
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We are not persuaded. While Appellants are correct that Example 4
demonstrates a situation where the GLP-1 and polyamino acid were
precipitated, Examples 24 and 25 of Defelippis demonstrate situations where
the precipitated GLP and polyamino acid solutions were pH adjusted to pH
4.0 and the precipitate dissolved (FF 12-13). That is, Defelippis teaches
compositions of GLP-1 and polyamino acids at pH 4.0 where the polyamino
acid is not precipitated and at a pH where the GLP and polyamino acid will
have the same net charge (FF 12-13), inherently satisfying the requirements
of Claim 1.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Defelippis anticipates claim 1.
D. 35 U.S.C. § 103(a) over Young, Baichwal, and Ryser
The Examiner finds that “Young discloses a pharmaceutical
composition for using exendin-4 for transmucosal administration (see
paragraph [0188]) using an acetate/glutamate buffer (comprises acetic
acid/glutamic acid), with a pH in the range of 3-7” (Ans. 7). The Examiner
finds that “Baichwal AR teaches that a bioadhesive controlled-release solid
dosage forms adhere to mucosa” (id.). The Examiner finds that “Ryser
teaches that cationic polypeptides, and in particular polyarginine effect or
enhance cellular uptake of molecules which are either excluded from or are
poorly taken up by cells” (id. at 8).
The Examiner finds it obvious to “combine the teachings of Young,
Baichwal and Ryser for the express benefits for enhancing cellular uptake of
polypeptide hormones across membranes, for controlled release, and for the
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adhesion of the bioactive agents to the mucosa of the patient population”
(Ans. 9).
Appellants contend that “Young functions according to a principle of
utilizing a formulation to provide exendins to the blood plasma. Baichwal
functions according to a principle of providing a solid tablet that is
compressible (Col. 3, lines 21-24) and that is not absorbed into the body, but
rather provides a localized effect” (App. Br. 12). Appellants contend that
“modifying Young according to Baichwal changes the principle of operation
of Young, and the two references are not properly combinable” (id.).
Appellants contend that “Ryser is not combinable with Young either,
because no motivation exists for doing so” (id.).
Appellants contend that “Ryser is not relevant to the present
invention, which recites a composition for transmucosal administration of a
bioactive peptide or protein . . . This is distinct from merely achieving a
cellular uptake of a molecule as in Ryser” (id. at 12-13). Appellants also
contend that “Ryser is not properly combinable with Young for the
additional reason that combining Ryser with Young changes the principle of
operation of Young” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Young, Baichwal, and Ryser render
claim 1 obvious?
Findings of Fact
14. Young teaches that “[e]xendins, exendin agonists and
antagonists, exendin analogs, formulations and dosages of the invention are
useful in view of their exendin-like or anti-exendin effects . . . Also
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described herein are formulations and dosages useful in alternative delivery
routes, including . . . transmucosal” (Young 7 ¶ 0188).
15. Young teaches that for
compounds having exendin-4-like potency, these dosage
forms preferably include approximately 0.005 to about 5% .
. . of the active ingredient in an aqueous system along with
approximately 0.02 to 0.5% (w/v) of an acetate, phosphate,
citrate or glutamate or similar buffer either alone or in
combination to obtain a pH of the final composition of
approximately 3.0 to 7.0, more specifically from about pH
4.0 to about 6.0, or from about 4.0 to 5.0

(Young 9 ¶ 0203).
16. Young teaches that “[p]assage of exendin-4 has been
investigated across several surfaces, the respiratory tract (nasal, tracheal, and
pulmonary routes) and the gut (sublingual, gavage and intraduodenal routes).
Biological effect and appearance of exendin-4 in blood have been observed
with each route of administration via the respiratory tract” (Young 12 ¶
0232).
17. Baichwal teaches “a controlled release bioadhesive tablet which
includes a locally active agent, a heterodisperse gum matrix, and a
pharmaceutically acceptable diluent. . . . The final product adheres to
mucous membranes and releases the locally active agent over a desired
period of time” (Baichwal abstract).
18. Ryser teaches that “many molecules of a wide variety are not
transported, or are poorly transported, into living cells. Macromolecules, for
example, such as proteins, nucleic acids, and polysaccharides, are not suited
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for diffusion or active transport through cell membranes simply because of
their size” (Ryser, col. 1, ll. 22-27).
19. Ryser teaches that “it was found that cellular uptake of some
molecules could be improved by the simple presence in the experimental
medium of such cationic polymers, especially homopolymers of positively
charged amino acids such as poly-L-lysines, poly-D-lysines and poly-L-
ornithines” (Ryser, col. 1, ll. 51-56).
20. Ryser teaches that this “method can be used to enhance cellular
uptake of macromolecules which normally are not effectively transported
into cells. These macromolecules include proteins, such as enzymes, growth
factors or other regulatory proteins, peptides, polypeptide hormones” (Ryser,
col. 4, ll. 12-16).
21. Ryser teaches that “[s]pecific poly(amino acids) which are
suitable include, but are not limited to . . . poly-L-arginine” (Ryser, col. 6, ll.
54-56).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
Young teaches that for
compounds having exendin-4-like potency, these dosage
forms preferably include approximately 0.005 to about 5% .
. . of the active ingredient in an aqueous system along with
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approximately 0.02 to 0.5% (w/v) of an acetate, phosphate,
citrate or glutamate or similar buffer either alone or in
combination to obtain a pH of the final composition of
approximately 3.0 to 7.0, more specifically from about pH
4.0 to about 6.0, or from about 4.0 to 5.0

(Young 9 ¶ 0203; FF 15).
Ryser teaches that “it was found that cellular uptake of some
molecules could be improved by the simple presence in the experimental
medium of such cationic polymers, especially homopolymers of positively
charged amino acids such as poly-L-lysines, poly-D-lysines and poly-L-
ornithines” (Ryser, col. 1, ll. 51-56; FF 19). Ryser teaches that “[s]pecific
poly(amino acids) which are suitable include, but are not limited to . . . poly-
L-arginine” (Ryser, col. 6, ll. 54-56; FF 21).
Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that it would have been obvious to add a cationic
polymer as taught by Ryser to the exendin-4 compound of Young since
Ryser teaches that this “method can be used to enhance cellular uptake of
macromolecules which normally are not effectively transported into cells.
These macromolecules include proteins, such as enzymes, growth factors or
other regulatory proteins, peptides, polypeptide hormones” (Ryser, col. 4, ll.
12-16; FF 20). Such a combination is merely a “predictable use of prior art
elements according to their established functions.” KSR, 550 U.S. at 417.
Appellants contend that “Ryser is not combinable with Young either,
because no motivation exists for doing so” (App. Br. 12). Appellants
contend that “Ryser is not relevant to the present invention, which recites a
composition for transmucosal administration of a bioactive peptide or
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protein . . . This is distinct from merely achieving a cellular uptake of a
molecule as in Ryser” (App. Br. 12-13; see also Reply Br. 6). The Examiner
responds that, “since Young teaches a transmucosal administration, one of
ordinary skill in the art would have been motivated to combine the teachings
of Young and Ryser for enhancing the cellular uptake of the therapeutic
agent via transmucosal administration” (Ans. 21).
We agree with the Examiner that an ordinary artisan would have
reasoned that Ryser’s technique for increasing cellular drug uptake would be
advantageous in transmucosal drug delivery methods, given that the
epithelial cells in the mucosa would be expected to increase their uptake of
the peptide drug, based on Ryser’s teachings (FF 20). While it might be true
that Appellants’ purpose for forming the claimed composition is different
than the reason suggested by Young and Ryser, that fact does not undermine
the Examiner’s prima facie case. See KSR, 550 U.S. at 419 (“In determining
whether the subject matter of a patent claim is obvious, neither the particular
motivation nor the avowed purpose of the patentee controls. What matters is
the objective reach of the claim. If the claim extends to what is obvious, it is
invalid under § 103.”).
Appellants also contend that “Ryser is not properly combinable with
Young for the additional reason that combining Ryser with Young changes
the principle of operation of Young” (App. Br. 13).
We are not persuaded. Young teaches that “[p]assage of exendin-4
has been investigated across several surfaces, the respiratory tract (nasal,
tracheal, and pulmonary routes) and the gut (sublingual, gavage and
intraduodenal routes). Biological effect and appearance of exendin-4 in
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blood have been observed with each route of administration via the
respiratory tract” (Young 12 ¶ 0232; FF 16). Each of the transmucosal routes
of Young requires entry into cells in order for the exendin-4 compound to
reach the blood and plasma, and Ryser teaches that the use of cationic
peptides assists in cellular entry (FF 20). Thus, Ryser is consistent with the
principle of operation of Young (FF 16, 20).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Young, Baichwal, and Ryser render claim 1 obvious.
SUMMARY
In summary, we reverse the rejection of claims 1-10 and 15-34 under
35 U.S.C. § 112, second paragraph as indefinite.
We reverse the rejection of claim 1 under 35 U.S.C. § 102(b) as
anticipated by Rothbard.
We affirm the rejection of claim 1 under 35 U.S.C. § 102(a) and (e) as
anticipated by Defelippis. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006),
we also affirm the rejection of claims 2-4, 6, 7, 9, 10, 15, 16, and 18-21, as
these claims were not argued separately.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Young, Baichwal, and Ryser. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2-10 and 15-
26, as these claims were not argued separately.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1).
Appeal 2010-010477
Application 10/559,595

20

AFFIRMED-IN-PART

cdc

INTELLECTUAL PROPERTY DEPARTMENT
AMYLIN PHARMACEUTICALS, INC.
9360 TOWNE CENTRE DRIVE
SAN DIEGO, CA 92121