Conceptus, Inc. v. Hologic, Inc.

Filing 534

APPENDIX RE JURY INSTRUCTIONS ON ENABLEMENT re 533 Order on Motion for Judgment as a Matter of Law. Signed by Judge Alsup on January 9, 2012. (whalc1, COURT STAFF) (Filed on 1/9/2012)

APPENDIX
Excerpt From Jury Instructions Regarding Enablement
(Dkt. No. 475 ¶¶ 40–46)

40.
The next defense is called lack of enablement. This relates to whether the patent
specification and figures, as originally filed, disclosed the claimed inventions in a way that
enabled those skilled in the art to make and use them.
41.

With respect to the question of enablement, the Patent Act provides:
The specification shall contain a written description
of the invention, and of the manner and process of
making and using it, in such full, clear, concise, and
exact terms as to enable any person skilled in the art
to which it pertains, or with which it is most nearly
connected, to make and use the same.

42.
To prove invalidity by reason of non-enablement, defendant Hologic must prove that the
asserted claims are invalid by showing that the patent specification and figures, as originally
filed, failed to contain a description of the claimed invention sufficiently full and clear to enable
a person of ordinary skill in the field to make and use the full scope of the asserted claims
without undue experimentation. The purpose of the enablement requirement is to make sure that
a patent specification and figures, as originally filed, disclosed how to practice the full invention
in return for the limited monopoly granted by the government to the inventor. The question of
whether a patent is enabling is judged as of the date the original application for the patent was
first filed. It is presumed that all relevant prior art was already known to those practicing in the
field.
43.
Even disclosure of a single example in a specification can sometimes support the full
scope of a claim. On the other hand, disclosure of one example for carrying out a claimed
method does not necessarily entitle an inventor to a broad generic claim covering any and all
means for achieving its objective. Whether or not claims 37 and 38 were enabled is a question
for you the jury to decide based on the trial evidence, the critical question being whether the
specification and drawings, when combined with all prior art known to those skilled in the art,
disclosed how to practice the full scope of the asserted inventions as claimed without having to
undertake excessive experimentation.
44.
In determining whether excessive experimentation would have been required, you may
consider the following factors:
1. the scope of the claimed invention;
2. the amount of guidance presented in the patent;
3. the amount of experimentation necessary;
4. the time and cost of any necessary experimentation;

5. how routine any necessary experimentation was in the field;
6. whether the patent disclosed specific working examples of the claimed invention;
7. the nature and predictability of experimentation and variations of the field; and
8. the level of ordinary skill in the field.
45.
I will now elaborate on some of these factors. With respect to the first factor, the scope
of the claimed invention, a patentee who chooses broad claim language must make sure the
broad claims are fully enabled. The scope of the claims must be less than or equal to the scope
of the enablement to ensure that public knowledge is enriched by the patent specification to a
degree at least commensurate with the scope of the claims. Put differently, the narrower the
claims, the easier it is to sustain enablement.
As stated, you may consider the predictability of experiments and variations in the field.
You may consider whether the invention pertains to an art where the results of variations and/or
experiments were predictable, such that variations on the embodiments disclosed in the
specification would have been predictable.
46.
By analogy, suppose that an inventor created a particular method for fuel efficiency and
described the method in such detail in the specification that a person of ordinary skill in the art
would be able to achieve fuel efficiency. Although the specification would meet the
requirements of enablement with respect to a claim directed to that particular method, it would
not necessarily support a broad claim to every possible type of method to achieve fuel efficiency
no matter how different in operation from the claimed invention. A single embodiment would
support such a generic claim only if the specification would enable a person skilled in the art to
use the full scope of the claimed invention at the time of application without undue
experimentation.
In our case, a question for you is whether defendant Hologic has proven that the
specification and figures failed to enable the full scope of claims 37 and 38 asserted by plaintiff
Conceptus.