Ex Parte Bodmer et al

Patent Trial and Appeal Board

Jul 30, 2013

10356860 (P.T.A.B. Jul. 30, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID BODMER, JONES W. FONG, ANN Y. FONG,
THOMAS KISSEL, HAWKINS V. MAULDING, OSKAR NAGELE,
JANE E. PEARSON, and CHARLOTTE AGNE
____________

Appeal 2013-006078
Application 10/356,860
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
1

This appeal under 35 U.S.C. § 134 involves claim 2 (App. Br. 12; Reply
Br. 1). Examiner entered rejections 35 U.S.C. § 103(a) and the judicially
created doctrine of obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.

1
The Real Party in Interest is Novartis AG (App. Br. 1).
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2
STATEMENT OF THE CASE
2

Claim 2 is directed to “[a] microsphere comprising the pamoate salt of
octreotide in a biodegradable, biocompatible polymeric matrix” (Claim 2).
Claim 2 stands rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1, 2,
and 9 of US 5,639,480 and claims 1 and 12 of US 5,538,739.
Claim 2 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
the combination of Bauer,
3
Schally,
4
Berge,
5
and Orsolini.
6

Obviousness-type Double Patenting:
ISSUE
Should the obviousness-type double patenting rejections of record be
summarily affirmed?
ANALYSIS
“If a ground of rejection stated by the examiner is not addressed in the
appellant‟s brief, that ground of rejection will be summarily sustained by the
Board.” Manual of Patent Examining Procedure § 1205.02 (Rev. 8, July
2010). Appellants do not address the obviousness-type double patenting

2
Examiner‟s objection under 37 C.F.R. § 3.73(b) is a petitionable rather
than appealable issue and will not be addressed further on this record (See
Ans. 2). We recognize Examiner‟s statement that Appellants‟ request that
the objection be held in abeyance until all other issues have been resolved
(Ans. 3).
3
Bauer et al., US 4,395,403, issued July 26, 1983.
4
Schally et al., US 4,650,787, issued March 17, 1987.
5
Stephen M. Berge, et al., Pharmaceutical Salts, 66(1) JOURNAL OF
PHARMACEUTICAL SCIENCES 1-19 (1977).
6
Orsolini et al., US 5,192,741, issued March 9, 1993.

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rejections, therefore they are summarily affirmed (see generally Ans. 10
(“The double patenting rejections remain in force”)).
CONCLUSION OF LAW
The rejection of claim 2 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1, 2,
and 9 of US 5,639,480 and claims 1 and 12 of US 5,538,739 are summarily
affirmed.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose that “Generic name Octreotide” refers to
“(D)Phe-Cys-Phe-(D)Trp-Lys-Thr-Cys-Thr-ol” (Spec., col. 5, ll. 16-17).
FF 2. Bauer suggests a sustained release form of the pharmaceutically
acceptable salt of the compound having the following structure:

(Bauer, col. 6, ll. 18-39; see also Final Rej. 4.)
FF 3. Bauer suggests that “[t]he polypeptides of the invention may exist in
salt form … include[ing] … acetates” (id. at col. 4, ll. 45-49; see also Final
Rej. 4).
FF 4. Examiner finds that Bauer does “not teach the pamoate salt of …
octreotide delivered in a biodegradable, biocompatible polymeric matrix”
and relies on Schally, Berge, and Orsolini to make up for this deficiency
(Final Rej. 5).
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FF 5. Schally suggests “[s]low release poly (lactide-co-glycolide)
microcapsules” of the “[a]cetate and pamoate salts” of the compound having
the following structure:

wherein: A may be (D)Phe, C‟ and C” may be Cys, X may be Phe, Z may be
(D)-Trp, Y may be Thr, and B may be Thr NH2 (Schally, col. 1, l. 37 - col. 2,
l. 4; col. 3, ll. 3-11; and col. 13, ll. 19-26; see also Final Rej. 4) .
FF 6. Berge suggests that acetate and pamoate are “FDA approved
commercially marketed salts” (Final Rej. 5; see Berge 2: Table 1).
FF 7. Orsolini suggests that “polypeptides which are normally water
soluble in nature or when prepared by synthesis, can be advantageously
rendered water insoluble by forming insoluble addition salts, such as with
pamoic acid … prior to their microencapsulation or dispersion in a
biodegradable polymeric matrix” (Orsolini, col. 1, ll. 43-50; see generally
Ans. 5).
FF 8. Orsolini suggests “the concept of sterilizing pamoate somatostatin
analogues in biodegradable biocompatible lactide-co-glycolide microspheres
with gamma radiation” (Final Rej. 5 (emphasis omitted); see also Orsolini,
col. 2, ll. 36-59; col. 3, ll. 31-39; and col. 3, l. 53 - col. 4, l. 46).
FF 9. Examiner finds that “microcapsules read[] on … [Appellants‟]
claimed microspheres” and the term “„slow release‟ is the equivalent … [of]
„sustained release‟” (Final Rej. 5).
ANALYSIS
Based on the combination of Bauer, Schally, Berge, and Orsolini,
Examiner concludes that, at the time Appellants‟ invention was made, it
would have been prima facie obvious to make a pamoate salt of Bauer‟s
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octreotide as suggested by Berge and Orsolini, in a slow release
biodegradable biocompatible microsphere as suggested by Schally and
Orsolini (Final Rej. 6).
Appellants contend that “Schally‟s disclosure should be strictly
limited to octapeptides which terminate in an amino acid amide” and,
therefore, “Schally cannot be readily applied … to octreotide as disclosed by
Bauer,” which Appellants contend is the “closest art of record” (App. Br. 4-
5; Reply Br. 2). In this regard, Appellants‟ contend that “the combination of
Bauer and Schally provides no reasonable expectation of achieving a
microsphere comprising the pamoate salt of octreotide, as is presently
claimed” and “that Berge and Orsolini do not remedy the deficiencies of
Bauer and Schally” (id. at 5-6; Reply Br. 2-3). We are not persuaded.
Bauer suggests the acetate salt of octreotide (FF 1-3). Berge suggests
that pamoate and acetate are both “FDA approved commercially marketed
salts” (FF 6). Orsolini suggests that water soluble polypeptides, such as
octreotide, can be rendered water insoluble by forming an insoluble addition
with pamoic acid prior to their microencapsulation or dispersion in a
biodegradable polymeric matrix (FF 7). Therefore, it would have been
prima facie obvious to prepare a pamoate salt of the water soluble octreotide
prior to microencapsulation or dispersion in a biodegradable polymeric
matrix (FF 1-3, 6, and 7). Schally exemplifies the foregoing with a
compound that differs from Bauer‟s octreotide only in that it contains a
carboxy-terminal amide instead of an alcohol (FF 5; Cf. FF 2). As Examiner
explains, “there is no evidence of record that replacing the amino acid amide
group with a terminal Thr-ol would render the sustained release
biocompatible, biodegradable poly(d,l-lactide-co-glycolide) somatostatin
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analog delivery matrix of Schally inoperative” (Ans. 4). Stated differently,
the evidence of record fails to support Appellants‟ contention that Orsolini
should be limited to its exemplified embodiments (see App. Br. 7 (“Orsolini
is … limited by its failure to disclose or suggest octreotide, disclosing
instead one of the terminal amino acid amide analogs of Schally”); Cf. FF 7).
Upon consideration of both Bodmer Declarations
7
we find a
discussion of the results obtained from undisclosed experimental protocols
(see Bodmer Declarations; see generally App. Br. 8-11; Reply Br. 4). As
Examiner explains “it is unknown what compositions were used for any of
these experiments” (Ans. 8; see also id. at 10 (“the constitution of the
microsphere(s) is/are unknown and left to conjecture”)). In this regard, we
find no error in Examiner‟s rationale (see Ans. 8-10).
In sum, we agree with Examiner‟s statement that “Examiner has
established a sound prima facie case of obviousness and Appellant‟s
arguments and Declarations are insufficient to overcome the Examiner‟s
rejection for the reasons of record” (Ans. 10).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 2 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Bauer, Schally, Berge, and
Orsolini is affirmed.

7
Declarations of David Bodmer executed February 6, 2008 and September
27, 2011.
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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

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