Ex Parte Janjic et al

Board of Patent Appeals and Interferences

Jun 27, 2008

10832941 (B.P.A.I. Jun. 27, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte
NEBOJSA JANJIC, LARRY GOLD, PAUL SCHMIDT,
CHANDRA VARGEESE, and MICHAEL WILLIS
__________

Appeal 2008-2252
Application 10/832,941
Technology Center 1600
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Decided: June 27, 2008
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Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a
composition for treating macular degeneration. The Examiner has rejected
the claims under the doctrine of obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-2252
Application 10/832,941

We agree with the Examiner that certain claims in the conflicting
patent render the appealed claims obvious. However, because the
Examiner’s rejection is based on an improper rationale, we reverse the
Examiner’s rejection and enter a new ground of rejection for
obviousness-type double patenting.
STATEMENT OF THE CASE
Claims 1-7 are pending and on appeal (App. Br. 2), and read as
follows:
1. A pharmaceutically effective composition for
treating macular degeneration comprising:
a RNA ligand to VEGF comprising the sequence
fCmGmGrArAfUfCmAmGfUmGmAmAfUmGfCfUfU
mAfUmAfCmAfUfCfCmG-3'3'-dT (SEQ ID NO:8; wherein
f=2'-fluoro and m=2'-O-methyl and
a pharmaceutically acceptable carrier suitable for
administration via intravitreal injection.

2. The composition of claim 1 wherein said RNA
ligand is complexed with a Non-Immunogenic, High Molecular
Weight Compound.

3. The composition of claim 2 wherein said Non-
Immunogenic, High Molecular Weight Compound is
Polyalkylene Glycol.

4. The composition of claim 3 wherein said
Polyalkylene Glycol is polyethylene glycol.

5. The composition of claim 4 wherein said
polyethylene glycol has a molecular weight of about between
10-80 K.

6. The composition of claim 5 wherein said
polyethylene glycol has a molecular weight of about 20-45 K.
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7. The composition of claim 6 wherein said complex
has the structure:

fCmGmGrArAfUfCmAmGfUmGmAmAfUmGfCfUfU
mAfUmAfCmAfUfCfCmG-3'3'-dT (SEQ ID NO:8), wherein
f=2'-fluoro and m=2'-O-methyl.

The Examiner applies the following patent in rejecting the claims:
Janjic et al. US 6,168,778 B1 Jan. 2, 2001

THE APPEALED REJECTION
ISSUE
Claims 1-7 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 23 and
27-31 of Janjic (Ans. 3).
The Examiner states that, while the appealed claims are not identical
to the patented claims, “they are not patentably distinct from each other
because the claims of the patent are directed to methods of making
complexes of VEGF ligands while the instant claims are directed to
compositions comprising such a VEGF ligand and a pharmaceutically
acceptable carrier” (id.). The Examiner contends that it would have been
obvious to combine a pharmaceutically acceptable carrier with the VEGF
ligands made by the patented process “because the disclosure of the patent
provides support for such compositions for the purpose of treating macular
degeneration at column 9, lines 38-45” (id.).
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Appellants contend that the Examiner’s rejection is improper because
“only those portions of the specification which provide support for the patent
claims may be considered when addressing the issue of whether a claim in
the application defines an obvious variation of an invention claimed in the
patent” (App. Br. 6).
The issue with respect to this rejection, then, is whether the
Examiner’s prima facie case of obviousness-type double patenting is
improperly based on disclosure from the conflicting patent’s specification.
PRINCIPLES OF LAW
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Thus, in obviousness-type
double patenting rejections, the Examiner must establish, in an analysis
comparable to that under 35 U.S.C. § 103, that one of ordinary skill would
have considered the rejected claims obvious over the conflicting claims. See
In re Braat, 937 F.2d 589, 592-93 (Fed. Cir. 1991).
To show that a claimed invention is “a mere variation . . . which
would have been obvious to those of ordinary skill in the relevant art . . .
there must be some clear evidence to establish why the variation would have
been obvious which can properly qualify as ‘prior art.’” In re Kaplan, 789
F.2d 1574, 1580 (Fed. Cir. 1986). Therefore, unless the conflicting patent
qualifies as prior art, that patent’s specification cannot be used as evidence
that the claims under examination would have been obvious. See id.; see
also In re Vogel, 422 F.2d 438, 441 (CCPA 1970) (“[T]he patent disclosure
may not be used as prior art.”)
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However, while the conflicting patent’s specification cannot be used
as prior art, it can nonetheless be used in certain circumstances “as a
dictionary to learn the meaning of terms in a claim.” Vogel, 422 F.2d at 441.
The conflicting patent’s disclosure may also be consulted to clarify the
patented claims’ scope, by referring to tangible embodiments of the patented
claims that are disclosed in the specification. See id. at 442. Nonetheless,
“only the disclosure of the invention claimed in the patent may be
examined.” Id.
FINDINGS OF FACT (“FF”)
1. Claims 23 and 27-31 of Janjic reads as follows:
23. A method for the preparation of a Complex
comprised of a VEGF Nucleic Acid Ligand comprising 2'-F-
modified nucleotides and a Non-Immunogenic, High Molecular
Weight Com-pound [sic] of Lipophilic Compound, said method
comprising:
a) identifying a VEGF Nucleic Acid Ligand from a
Candidate Mixture of Nucleic Acids by the method
comprising:
(i) contacting the Candidate Mixture with
VEGF, wherein Nucleic Acids having
increased affinity to VEGF relative to the
Candidate Mixture may be partitioned from
the remainder of the Candidate Mixture;
(ii) partitioning the increased affinity VEGF
Nucleic Acids from the remainder of the
Candidate Mixture;
(iii) amplifying the increased affinity VEGF
Nucleic Acids to yield a ligand-enriched
mixture of Nucleic Acids; and
b) forming a covalent bond between said identified
VEGF Nucleic Acid Ligand and a Non-
Immunogenic, High Molecular Weight Compound
of Lipophilic Compound.

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27. The method of claim 23 wherein said Non-
Immunogenic, High Molecular Weight Compound is
Polyalkylene Glycol.

28. The method of claim 27 wherein said Polyalkylene
Glycol is polyethylene glycol.

29. The method of claim 28 wherein said polyethylene
glycol has a molecular weight of about between 10-80 K.

30. The method of claim 29 wherein said polyethylene
glycol has a molecular weight of about 20-45 K.

31. The method of claim 30 wherein said Complex has
the structure

Ligand Component=
fCmGmGrArAfUfCmAmGfUmGmAmAfUmGfCfUfUmAfU
mAfCmAfUfCfCmG-3'3'-dT (VEGF ligand) (SEQ ID NO: 8).

(Janjic, col. 99, l. 24 through col. 100, l. 56.)
2. Thus, Janjic’s claim 31 recites a process of producing a complex
having a VEGF ligand encoded by SEQ ID NO: 8, the same VEGF ligand
present in the composition recited in appealed claims 1-7. Moreover, the
complex recited in Janjic’s claim 31 has the same structure as the complex in
the composition recited in appealed claim 7.
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3. None of Janjic’s claims 23 and 27-31 recites combining the VEGF
ligand with “a pharmaceutically acceptable carrier suitable for
administration via intravitreal injection,” as recited in the appealed claims.
4. Janjic discloses that it is one “object of the invention to provide a
method for inhibiting macular degeneration by the administration of a VEGF
Nucleic Acid Ligand or Complex comprising a VEGF Nucleic Acid Ligand
and Non-Immunogenic, High Molecular Weight Compound or Lipophilic
Compound or a Lipid Construct comprising a Complex of the present
invention” (Janjic, col. 9, ll. 39-45).
ANALYSIS
We agree with Appellants that the Examiner improperly relied on
Janjic’s disclosure as evidence of what one of ordinary skill would have
considered obvious at the time the claimed invention was made.
We note that Janjic discloses that its VEGF ligands are suitable for
treating macular degeneration (FF 4). However, in an obviousness-type
double patenting analysis, one may only consult those portions of the
conflicting patent’s disclosure that support the subject matter recited in the
conflicting claims. See In re Vogel, 422 F.2d at 442.
In the instant case, the claims in Janjic cited by the Examiner as
conflicting with the appealed claims are all directed to methods of making a
VEGF ligand complex. In contrast, the cited portion of Janjic explains how
the VEGF ligand can be used (see FF 4).
Thus, the cited portion Janjic is not directed to the patented claims’
methods of making the VEGF ligand complex, nor does that portion of
Janjic explain terms in the patented claims, or provide an illustrative tangible
embodiment of the patented claims’ method. We therefore do not agree with
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the Examiner that the cited portion of Janjic was properly used as evidence
to show that it would have been obvious to combine the VEGF ligand in the
patented claims with “a pharmaceutically acceptable carrier suitable for
administration via intravitreal injection,” as recited in appealed claim 1.
The Examiner argues that the pharmaceutical composition recited in
the appealed claims is “an obvious species of the genus of compounds”
prepared in the patented claims (Ans. 5), as evidenced by Janjic’s
specification, which the Examiner cited “in lieu of using a secondary
reference in order to demonstrate why one of ordinary skill in the art would
conclude that the formulation of a complex into a pharmaceutical
composition is an obvious variation of the patented invention” (id. at 6).
We are not persuaded by this argument. Claims 23 and 27-31 of
Janjic are directed to methods of preparing VEGF ligands by the steps of
(a) identifying a VEGF-binding nucleic acid ligand from a mixture of
candidate nucleic acids, and (b) covalently binding the ligand to a non-
immunogenic, high molecular weight compound (see FF 1). Thus, Janjic’s
disclosure may be consulted only to the extent that it relates to the process
recited in the patented claims. See Vogel, 422 F.2d at 442. Because claims
23 and 27-31 do not recite any step of using the produced compounds, the
Examiner’s reliance on Janjic’s specification for that teaching was clearly
improper.
Therefore, because the Examiner improperly applied the disclosure of
the conflicting patent as evidence of obviousness, we reverse the Examiner’s
obviousness-type double patenting rejection of claims 1-7 over claims 23
and 27-31 of Janjic.
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NEW GROUND OF REJECTION
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection:
Claims 1-7 are rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 23-25
and 27-31 of Janjic (Ans. 3).
As discussed above, Janjic’s claim 31, which depends on claims 23
and 27-30, recites a process of producing a complex having the same VEGF
ligand present in the composition of all of appealed claims 1-7 (see FF 1, 2).
None of Janjic’s claims 23 and 27-31, however, recites combining the VEGF
ligand-containing complex with “a pharmaceutically acceptable carrier
suitable for administration via intravitreal injection,” as recited in the
appealed claims (see FF 3).
However, claims 24 and 25 of Janjic read as follows:
24. The method of claim 23 wherein said Complex is
further associated with a Lipid Construct.

25. The method of claim 24 wherein said Lipid
Construct is a Liposome.

Thus, taken together, Janjic’s claims 24 and 25 recite a process of
making a VEGF ligand-containing complex associated with a lipid carrier
which can be a liposome. One of ordinary skill in the art viewing claims 23-
25 and 27-31 of Janjic as a whole would therefore have reasoned that it
would be desirable to formulate the complex of claim 31 with the lipid
construct of claim 24, or the liposome carrier recited in claim 25.
As admitted in Appellants’ Specification, liposomes were known as
useful for systemic delivery of therapeutic drugs (see, e.g., Spec. 32), and
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lipid constructs were suitable carriers for delivering the claimed complexes
in methods of treating eye disorders including macular degeneration and
diabetic retinopathy (id. at 15-16). Thus, proper reference to Appellants’
Specification to determine which carriers were “suitable for administration
via intravitreal injection” would have led one of ordinary skill to conclude
that the lipid construct of claim 24 and liposome of claim 25 would be
carriers suitable for intravitreal delivery.
Because Janjic’s claims 24 and 25 would have prompted one of
ordinary skill in the art to combine the complex of Janjic’s claim 31 with
lipid carriers suitable for intravitreal administration, appealed claims 1-7
would therefore have been obvious to a person of ordinary skill in the art in
view of the cited claims of Janjic.
SUMMARY
We reverse the Examiner’s obviousness-type double patenting
rejection of claims 1-7 over claims 23 and 27-31 of Janjic.
We enter a new ground of rejection of claims 1-7 for
obviousness-type double patenting over claims 23-25 and 27-31 of Janjic.
See 37 C.F.R. § 41.50(b).

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
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MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner . . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record . . . .

REVERSED, 37 C.F.R. § 41.50(b)

cdc

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