Tuesday, March 04, 2008

Eleven easy pieces for obviousness under 103?

Patent Docs noted that Bruce Kisliuk (Group Director of Technology Center 1600 (Biotechnology and Organic Chemisry)) stated that TC 1600 examiners were being taught to analyze the issue obviousness using eleven key cases as tools. The eleven cases are:

1. Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007)
2. Pfizer, Inc. v. Apotex, Inc. (Fed. Cir. 2007)
3. Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. 2007)
4. McNeil-PPC, Inc. v. Perrigo, Co. (S.D.N.Y. 2007);
5. In re Omeprazole Patent Litigation (S.D.N.Y. 2007);
6. Ex parte Kubin (B.P.A.I. 2007)
7. In re Sullivan (Fed. Cir. 2007)
8. Daiichi Sankyo Co. v. Apotex, Inc. (Fed. Cir. 2007)
9. Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007)
10. Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007)
11. Syngenta Seeds, Inc. v. Monsanto Co. (D. Del. 2004)

Patent Docs also noted: When asked when he [Kisliuk] expected the Court to reach a decision [in Tafas v. Dudas on continuing applications], Mr. Kisliuk conceded that he knew little more than the conference attendees, but stated that "insiders" were thinking the Court would announce its decision in about a month from the date of the hearing (February 8th). If his prediction holds true, patent attorneys and applicants could see a decision by the end of this week.

**Separately, Patently-O notes that the BPAI affirmance rate [between Feb. 07 and Feb. 08] for TC 1600 was 59% but for TC 1700 (Chemical and Materials Engineering) was 68%. Patently-O also noted: Almost 80% of [BPAI] decisions involved a discussion of nonobviousness and 30 U.S.C. 103(a). Unfortunately for patent applicants, nonobviousness decisions were also the most difficult for applicants to win. In my study, decisions involving Section 103(a) were affirmed 63% of the time.


Of Ex Parte Kubin, note some relevant text:

A single, obvious species within a claimed genus renders the claimed genus
unpatentable under § 103. Thus, an obvious method of obtaining a single
nucleic acid molecule encoding NAIL may be all that is required to show
that the presently claimed genus of nucleic acid molecules is unpatentable
under § 103. (...) See University of California
v. Eli Lilly & Co., 119 F.3d 1559, 1567, 43 USPQ2d 1398, 1405 (Fed. Cir.
1997) (noting the court earlier held “a description which renders obvious a
claimed invention is not sufficient to satisfy the written description
requirement of that invention” and in this case holding disclosure of a
species did not provide adequate written description of a genus).
[IPBiz note: a description "not good enough" to support a genus claim may be
sufficient to render that genus claim obvious. Note that the BPAI also cited
Lizardtech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d
1336, 1345, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005). ]

The Kubin decision had text about the CAFC decision In re Deuel:

Appellants heavily rely on Deuel. (See, e.g., Br. 19.) To the extent
Deuel is considered relevant to this case, we note the Supreme Court
recently cast doubt on the viability of Deuel to the extent the Federal Circuit
rejected an “obvious to try” test. See KSR Int’l Co. v. Teleflex Inc., 127
S.Ct. 1727, ___, 82 USPQ2d 1385, 1394, 1396 (2007) (citing Deuel, 51 F.3d
at 1559). Under KSR, it’s now apparent “obvious to try” may be an
appropriate test in more situations than we previously contemplated

When there is motivation
to solve a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her
technical grasp. If this leads to anticipated success, it is
likely the product not of innovation but of ordinary skill and
common sense. In that instance the fact that a combination
was obvious to try might show that it was obvious under
§ 103.
KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, ___, 82 USPQ2d 1385, 1397
(2007). This reasoning is applicable here. The “problem” facing those in
the art was to isolate NAIL cDNA, and there were a limited number of
methodologies available to do so. The skilled artisan would have had reason
to try these methodologies with the reasonable expectation that at least one
would be successful. Thus, isolating NAIL cDNA was “the product not of
innovation but of ordinary skill and common sense,” leading us to conclude
NAIL cDNA is not patentable as it would have been obvious to isolate it.

**Separately, of written description and enablement -->

“Although there is often significant overlap” between the enablement
and written description requirements, “they are nonetheless independent of
each other.” University of Rochester, 358 F.3d at 921, 69 USPQ2d at 1891.
An “invention may be enabled even though it has not been described.” Id.
Such is the situation here.
While we conclude one skilled in the art would
have been able to make and use the full scope of claim 73 through routine
experimentation, we find Appellants did not describe the invention of claim
73 sufficiently to show they had possession of the claimed genus of nucleic
acids. See, e.g., Noelle v. Lederman, 355 F.3d 1343, 1348, 69 USPQ2d
1508, 1513 (Fed. Cir. 2004) (“invention is, for purposes of the ‘written
description’ inquiry, whatever is now claimed”).

The particular problem -->

Claim 73 is to a genus of polynucleotides encoding polypeptides “at
least 80% identical to amino acids 22-221 of SEQ ID NO:2” which bind to
CD48. Sufficient description to show possession of such a genus “may be
achieved by means of a recitation of a representative number of cDNAs,
defined by nucleotide sequence, falling within the scope of the genus or of a
recitation of structural features common to members of the genus, which
features constitute a substantial portion of the genus.” Eli Lilly, 119 F.3d at
1568, 43 USPQ2d at 1406. Possession may not be shown by merely
describing how to obtain possession of members of the claimed genus or
how to identify their common structural features. See University of
Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. (...)
Appellants also have described how to make and test other sequences
within claim 73 sufficiently to satisfy the enablement requirement.
However, they have not described what domains of those sequences are
correlated with the required binding to CD48
, and thus have not described
which of NAIL’s amino acids can be varied and still maintain binding.
Thus, under Lilly and its progeny, their Specification would not have shown
possession of a sufficient number of sequences falling within their
potentially large genus to establish possession of their claimed genus.

**The punchline -->

Without a correlation between structure and function, the claim does
little more than define the claimed invention by function. That is not
sufficient to satisfy the written description requirement. See Eli Lilly, 119
F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not
suffice to define the genus because it is only an indication of what the gene
does, rather than what it is”).

[The opinion was by ALJ Nancy J. Linck.]

Gene Quinn talked (unfavorably) about the discussion of Deuel by the BPAI.


see IPFrontline on Deuel and Kubin.


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