Transcript Overcoming Prior Art Rejections

Overcoming Prior Art References
Non-Enabling Prior Art References
Gary Kunz
SPE Art Unit 1616
Prior Art Reference is Presumed
to be Enabled
• When the reference relied on expressly anticipates
or makes obvious all of the elements of the
claimed invention, the reference is presumed to be
operable. Once such a reference is found, the
burden shifts to the applicant to provide facts
rebutting the presumption of operability. In re
Sasse, 629 F.2d 675, 681 (Fed. Cir. 1980)
• See also MPEP 716.07
Meaning of “Enabling
Disclosure” is Independent of the
Type of Disclosure
• Level of disclosure required for a prior art
reference to be an “enabling disclosure” is the
same no matter what type of art is at issue
• It does not matter whether the prior art is a U.S.
patent, foreign patent, or printed publication
• No basis in 35 USC 102 or 103 for discrimination
either in favor of or against prior art references on
the basis of nationality
• In re Moreton, 288 F.2d 708, 711, (CCPA 1961)
35 U.S.C 102 Reference Must
Enable Without Undue
Experimentation
• Elan Pharm., Inc. v. Mayo Foundation for
Medical and Education Research, 346 F.3d 1051,
1054, (Fed. Cir. 2003)
• CAFC remanded the case back to the district court
for determination of whether the prior art
reference enabled persons of ordinary skill in the
field to make the desired mutated mouse without
undue experimentation,
Reference is Enabling if . . . .
• Public was in possession of the claimed invention
• “Such possession is effected if one of ordinary
skill in the art could have combined the
publication’s description of the invention with his
[or her] own knowledge to make the claimed
invention.” In re Donohue, 766 F.2d 531, 533
(Fed. Cir. 1985)
35 U.S.C. 102 Rejections with
Additional References
Establishing Enablement
• An examiner may make a 35 U.S.C. 102 rejection
over a reference which teaches every element of
the invention but not does enable how to make or
use.
• Secondary references may be used to establish
public possession of the method of making and/or
using.
• In re Donohue, 766 F.2d 531, 534 (Fed. Cir. 1985)
When the Reference Only
Discloses the Structure of the
Compound
• Lack of enabling disclosure may be
established by evidence that attempts to
make the compound were unsuccessful. In
re Wiggins, 488 F.2d 538, 542 – 543 (CCPA
1973)
When the Reference Only
Discloses the Structure of the
Compound
• It is not necessary that an invention disclose
under 35 U.S.C. 102 shall have actually
been made in order to satisfy the
enablement requirement. In re Donohue,
766 F.2d 531, 533 (Fed. Cir. 1985)
When the Reference Only
Discloses the Structure of the
Compound
• In Donohue the examiner made a rejection 35
U.S.C. 102 over a publication which disclosed the
compound along with two patents which taught a
general process of preparing the specific class of
compounds.
• Applicant provided an affidavit stating that the
publication did not actually show the synthesis of
the compound—deemed insufficient evidence to
overcome rejection under 35 U.S.C. 102
35 U.S.C 103 Rejection Over
Obvious Homologs
• In re Hoeksema, 399 F.2d 269 (CCPA 1968)
• The examiner rejected a claim to a compound
using a patent (De Boer) which disclosed
homologs and process of making them.
• Applicant overcame rejection with affidavit by
expert who stated that the process disclosed in the
patent could not be used to make the claimed
compound.
What Constitutes Enabling Prior
Art for Plants?
• When the claims are directed to plants, the
reference combined with the knowledge in the
prior art, must enable one of ordinary skill in the
art to reproduce the plant. In re LeGrice, 301 F.2d
929 (CCPA 1962)
• The examiner rejected the claimed rose on the
basis of a catalogue which only disclosed pictures
of the plant and stated that the person had raised
the roses.
What Constitutes Enabling Prior
Art for Plants? (cont’d)
• In LeGrice there was no evidence of
commercial availability in enabling form
since the asexually reproduced rose could
not be reproduced from seed.
• In contrast in Ex parte Thompson, 24
USPQ2d 1618 (Bd. Pat. App. & Inter. 1992)
seeds were commercially available to grow
the cotton cultivar.
Pictures May be Enabling Prior
Art References
• Pictures and drawings may be enabling to
put the public in the possession of the
article pictured.
• However, the picture must show all of the
claimed structural features and how they are
put together.
• Jockmus v. Leviton, 28 F.2d 812 (2d Cir.
1928)
35 U.S.C. 102 Reference does
not Require a Patentable Utility
• “[N]o utility need be disclosed for a
reference to be anticipatory of a claim to an
old compound.” In re Schoenwald, F.2d
1122, 1124 (Fed. Cir. 1992).
• It is enough that the claimed compound is
taught by the reference.
Summary of Ways to Attack
Prior Art References as Nonenabling
• Establish that the prior art tried and failed to
make the compound
• Provide declaration by an expert that the
disclosure of the reference, even with the
knowledge in the art, was insufficient to
permit the artisan to make the compound.