Ex Parte Wightman et al

Board of Patent Appeals and Interferences

Sep 13, 2010

10821335 (B.P.A.I. Sep. 13, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL D. WIGHTMAN, ISIDRO ANGELO E. ZARRAGA,
NAIYONG JING, and JIE J. LIU
__________

Appeal 2010-005037
Application 10/821,335
Technology Center 1600
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
immune response modifier-support complex. The Patent Examiner rejected

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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the claims as obvious and on the ground of non-statutory obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-
in-part.

STATEMENT OF THE CASE
The invention concerns immune response modifiers (IRMs) which
“appear to act through basic immune system mechanisms known as toll-like
receptors to induce selected cytokine biosynthesis and may be used to treat a
wide variety of diseases and conditions.” (Spec. 1, ll. 17-20). The IRM is
covalently bonded to a macromolecular support material to form an IRM-
support complex. (Id. at 1-2). The Specification explains that “the IRMs are
still biologically active when attached to a support complex” and that such
attachment “provides for the localized biological activity of the IRM….”
(Id. at 2, ll. 17-26).
Claims 1, 3, 11, 12 and 14 are on appeal. Claims 1 and 11 are
representative and read as follows:
1. An IRM-support complex comprising an IRM compound that is a
TLR agonist selected from the group consisting of TLR6, TLR7, TLR8, and
combinations thereof, and selected from the group consisting of
imidazoquinoline amines; tetrahydroimidazoquinoline amines; and
imidazopyridine amines; 1,2-bridged imidazoquinoline amines; 6,7-fused
cycloalkylimidazopyridine amines; imidazonaphthyridine amines;
tetrahydroimidazonaphthyridine amines; oxazoloquinoline amines;
thiazoloquinoline amines; oxazolopyridine amines; thiazolopyridine amines;
oxazolonaphthyridine amines; thiazolonaphthyridine amines; 1H-imidazo
dimers fused to pyridine amines, quinoline amines, tetrahydroquinoline
amines, naphthyridine amines, or tetrahydronaphthyridine amines; and
combinations thereof; covalently bonded to a macromolecular support
material.

11. The IRM-support complex of claim 1, wherein the macromolecular
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support material has an average largest dimension of at least 1 nm.

The Examiner rejected the claims as follows:
• claims 1, 3, 11, 12 and 14 under 35 U.S.C. § 103(a) over Miller,2
Gerster,3 Slade4 and Langer;5 and
• claim 1 on the ground of non-statutory obviousness-type double
patenting as unpatentable over claim 1 of Kedl.6
Claims 3, 12 and 14 have not been argued separately and therefore
stand or fall with the claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is Miller, Gerster and Slade each disclosed
forms of IRMs that fell within the scope of claim 1. (Ans. 4). The Examiner
found that the references disclosed using the IRMs for cytokine induction
and to treat viral and neoplastic conditions. (Id.).
The Examiner found that Langer disclosed drugs, e.g., antitumor
agents, covalently bonded to macromolecules for improved drug delivery.
(Id.). The Examiner found that Langer taught that the drug complexes
provided controlled release of the drug, localized delivery of the drug,

2 US Patent No. 7,030,129 B2 issued to Richard L. Miller et al., Apr. 18,
2006.
3 US Patent No. 4,689,338 issued to John F. Gerster, Aug. 25, 1987.
4 US Patent No. 6,894,060 B2 issued to Herbert B. Slade, May 17, 2005.
5 Robert Langer, New Methods of Drug Delivery, 249 SCIENCE, no. 4976,
1527-33 (1990).
6 US Patent No. 7,427,629 B2 issued to Ross M. Kedl, Sep. 23, 2008.

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increased comfort for the patient receiving the drug, improved compliance
by the patient, and reduced need for follow-up care. (Id. at 5-6).
Additionally, the Examiner found that Langer taught that the drug complex
preserved the drug from being rapidly destroyed by the body. (Id.).
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to improve the
drug delivery of the compounds of Miller, Gerster and Slade by using
Langer’s technique of covalently bonding the drug to a macromolecular
support. (Id. at 8). The Examiner explained that the skilled artisan would
have been motivated by Langer’s teaching that forming a covalently bonded
drug-support complex allows delivery of the drug to a specific location in a
controlled manner while providing the patient increased comfort and
improving patient compliance. (Id.).
Appellants do not dispute that Miller, Gerster and Slade each
disclosed IRMs that fall within the scope of claim 1. Nor do Appellants
dispute that Langer disclosed drugs covalently bonded to a macromolecular
support material. Rather, Appellants contend that “none of the cited
references teach or suggest (i) covalently attaching the IRM compounds of
the current invention to a macromolecule or polymer or (ii) the surprising
result that the presently claimed IRM compounds can remain functionally
active while they are attached to a macromolecule or polymer.” (Id. at. 8).
According to Appellants, the prior art provided “no motivation or
expectation of success in attaching IRMs to a solid support, or how to
covalently attach the claimed IRMs to a solid support, or that one can
preserve the activity of the IRM when attached to a solid support.” (Id. at
10). Further, Appellants assert that the cited references do not disclose a
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“macromolecular support material having an average largest dimension of at
least 1 nm,” as recited in dependent claim 11. (Id. at 9).
The issues with respect to this rejection are:
whether it would have been obvious to a person of ordinary skill in
the art at the time the invention was made to prepare the drug-support
complex disclosed by Langer using the IRM of Miller, Gerster or Slade as
the drug;
whether Appellants have established that the claimed invention
provided unexpected results sufficient to rebut a prima facie case of
obviousness; and
whether the combined prior art taught or suggested using a
macromolecular support material having an average largest dimension of at
least 1 nm, as recited in claim 11.

Findings of Fact
1. We adopt the Examiner’s specific findings of facts regarding the
scope and content of Miller, Gerster, Slade, and Langer as set forth in the
Answer. (See Ans. 4-7).

Principles of Law
The question of obviousness cannot be approached on the basis that
an artisan having ordinary skill would have known only what was read in the
references, because such artisan must be presumed to know something about
the art apart from what the references disclose. See In re Jacoby, 309 F.2d
513, 516 (CCPA 1962). Moreover, the law presumes skill on the part of the
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artisan rather than the converse. See In re Sovish, 769 F.2d 738, 742-43
(Fed. Cir. 1985).
“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.
It is well settled that unexpected results must be established by factual
evidence. Mere argument or conclusory statements in the specification does
not suffice. In re Lindner, 457 F.2d 506, 508 (CCPA 1972). A showing of
unexpected results must be commensurate in scope with the breadth of the
claims. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983).

Analysis
We agree with the Examiner that it would have been obvious to a
skilled artisan at the time of the invention to prepare a drug-support complex
as disclosed in Langer using the IRM drugs disclosed in Miller, Gerster and
Slade. The artisan would have been motivated by Langer’s teaching that this
drug complex advantageously improves drug delivery along with the
ordinary skill in the chemical and pharmaceutical arts to attach a known
IRM to a known macromolecular support according to a Langer’s disclosed
method, i.e., covalent bonding. Appellants have not established with
persuasive evidence that doing so was beyond the skill of the ordinary
artisan at the time of the invention. See Jacoby, 309 F.2d at 516; see also
Sovish, 769 F.2d at 742-43.
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Nor have Appellants established with persuasive evidence that the
prior art IRMs would have been inactivated when covalently attached to a
macromolecular support, or that Langer’s disclosure would have suggested
to an artisan at the time of the invention that such a result would have been
expected. Indeed, Langer stated that “[p]olymers, such as polyethylene
glycol (PEG), can be attached to drugs to either lengthen their lifetime or
alter their immunogenicity.” (See Ans. 5). Moreover, Langer did not limit
its disclosure to any particular class or category of drugs such that a skilled
artisan would not have been motivated or had a reasonable expectation of
successfully applying Langer’s teaching to an IRM.
For these reasons, we find that Examiner’s rejection involved
combining familiar elements according to known methods to yield a
predictable, i.e., disclosed, result. See KSR Int’l, 550 U.S. at 416-17.
We find that Appellants have not established that the claimed
invention provided unexpected results sufficient to rebut prima facie
obviousness. According to Appellants, “the surprising result [is] that the
claimed IRMs are able to remain active while covalently attached to a
macromolecular support complex (claims 1, 3, and 11) or polymer (claims
12 and 14).” (App. Br. 6-7). Appellants support this contention with
attorney argument and reference to Specification pages which simply state
that “the IRM is biologically active during use while it is attached to the
support.” (See App. Br. 7 n. 10, citing Spec. 21). Conclusory statements are
not the factual evidence required to establish unexpected results. Lindner,
457 F.2d at 508.
Moreover, as the Examiner explained, the claims do not recite any
limitation requiring the IRM compound to be active or to remain active in
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the complex. (Ans. 15). Thus, Appellants’ asserted unexpected results are
not commensurate in scope with the breadth of the claims. See Grasselli,
713 F.2d at 743.
Regarding claim 11, we agree with Appellants (App. Br. 9) that the
Examiner has not established that the cited references taught or suggested
that “the macromolecular support material has an average largest diameter of
at least 1 nm.” (See Claim 11). Consequently, we reverse the obviousness
rejection of claim 11.
Accordingly, we affirm the obviousness rejections of claims 1, 3, 12
and 14, and we reverse the obviousness rejection of claim 11.

DOUBLE PATENTING
The Issue
The Examiner’s position is that instant claim 1 and claim 1 of Kedl
are not patentably distinct from each other. (Ans. 11). Specifically, the
Examiner found that the instant claim is drawn to a complex of an IRM
compound which is covalently bonded to a macromolecule and Kedl’s claim
1 is also drawn to the same IRM compound which is bonded to an antigen,
i.e., a macromolecule. (Ans. 11).
Appellants contend that the Examiner erroneously referenced US
Patent No. 5,078,978 in the rejection, which patent “is not owned by 3M and
is not drawn to the same subject material.” (App. Br. 10). Further,
Appellants assert that “the Examiner may have meant to cite to claim 1 of
US Patent No. 7,427,629 [issued to Ross M. Kedl]. If such a rejection is
made, applicants can then consider whether filing a terminal disclaimer is
appropriate or not.” (Id.).
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The issue with respect to this rejection is whether the Examiner
established that instant claim 1 is patentably distinct from Kedl claim 1.

Principle of Law
An obviousness-type double patenting analysis entails two steps:
(1) construction of the claims of the patent and the claim in the application
to identify any differences, and (2) determination of whether the differences
in subject matter between the claims render the claims patentably distinct.
See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed Cir. 2001).

Analysis
In the Answer, the Examiner acknowledged mistakenly referencing
US Patent No. 5,078,978 instead of US Patent No. 7,427,629 B2. (See Ans.
17). The Examiner also mistakenly referenced a claim from what appears to
be an application rather than an issued patent. (See Ans. 12). Of greater
consequence, the Examiner failed to conduct an obviousness-type double
patenting analysis on the record. In particular, the Examiner has neither
identified the differences between the Kedl patent claim 1and Appellants’
claim 1, nor discussed whether any differences in the subject matter between
the claims render the claims patentably distinct. See Lilly, 251 F.3d at 968.
Consequently, we do not find that the Examiner has properly supported the
rejection.
Accordingly, we reverse the obviousness-type double patenting
rejection.

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CONCLUSIONS OF LAW
It would have been obvious to a person of ordinary skill in the art at
the time the invention was made to prepare the drug-support complex
disclosed by Langer using the IRM of Miller, Gerster or Slade as the drug.
Appellants have not established that the claimed invention provided
unexpected results sufficient to rebut a prima facie case of obviousness.
The Examiner did not show that the combined prior art taught or
suggested using a macromolecular support material having an average
largest dimension of at least 1 nm.
The Examiner has not established on the record that instant claim 1 is
patentably indistinct from Kedl claim 1.

SUMMARY
We affirm the rejection of claims 1, 3, 12 and 14 under 35 U.S.C.
§ 103(a) over Miller, Gerster, Slade and Langer;
we reverse the rejection of claim 11 under 35 U.S.C. § 103(a) over
Miller, Gerster, Slade and Langer; and
we reverse the rejection of claim 1 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claim 1 of Kedl.
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-IN-PART

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