Patent Reform - Conference Material

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American Conference Institute
Patent Reform …The Leahy-Smith America Invents Act

PATENT DRAFTING CHALLENGES UNDER
THE NEW FIRST-TO-FILE LAW
Harold C. Wegner
Foley & Lardner LLP
New York, New York
January 23-24, 2013

The Conference Paper
• Section headings in this presentation are
keyed to the identically styled headings in the
Conference paper, Patent Drafting Challenges
under the New First-To-File Law.
• The contents of the Conference paper are as
follows (pagination is to the conference
paper):

The Conference Paper
I.
II.
III.
IV.
V.
VI.
VII.
VIII.

OVERVIEW
THE PROBLEMATIC GRACE PERIOD
ENABLED EMBODIMENT, DRAFTING STARTING POINT
FOOLS GOLD, THE 24 MONTH “PROVISIONAL”
FORMAL ELEMENTS OF THE REGULAR APPLICATION
ESSENTIAL INTEGERS IN THE DRAFTING PROCESS
MPEP-SUGGESTED NON-STATUTORY INTEGERS
CONCLUSION

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About the Author

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§ II. THE PROBLEMATIC GRACE PERIOD
• The one year grace period that continues
under the new law is problematic, given the
various loopholes that can destroy meaningful
patent rights.
• The grace period is problematic: It should
never be prospectively relied upon by a patent
applicant.

• But, when one is faced with the problem of an
existing publication of the invention then it
will, of course, be necessary to attempt to rely
upon the grace period.
• The grace period provides no protection for
rights in the major countries of Asia and
Europe where there is a publication or other
prior art event before the effective filing date.

• The new grace period is not anything like the
original American provision.
• The new grace period only applies in the case
of the inventor’s own prior work or prior
commonly owned work or work published by
a third party that is derived from an inventor.

• There are serious burdens placed on relying
upon the grace period to avoid a third party’s
publication which include the requirement for
an oath or declaration for many situations to
establish a right to the grace period.

• The initial Patent Office interpretation of the
grace period excludes a third party’s derived
disclosure obtained from the true inventor
seeking reliance on the grace period if the
third party’s derived disclosure is not to the
“same” subject matter:

• Thus, the grace period does not apply under
the Patent Office interpretation if the derived
disclosure also includes “mere insubstantial
changes, or only trivial or obvious variations”.
• It is also unclear what proof will be needed to
establish a right to the grace period. The
initial Patent Office guidance published in the
Federal Register:

• “Specifically, the inventor or joint inventor
must establish the date and content of their
earlier public disclosure. If the earlier
disclosure was a printed publication, the
affidavit or declaration must be accompanied
by a copy of the printed publication.”

• “ If the earlier disclosure was not a printed
publication, the affidavit or declaration must
describe the earlier disclosure with sufficient
detail and particularity to determine that the
earlier disclosure is a public disclosure of the
subject matter.”

“The affidavit or declaration must specifically
show that the inventor or a joint inventor is
the inventor of the subject matter of the
earlier public disclosure and indicate the
communication of the subject matter to
another who disclosed the subject matter.”

§ III. ENABLED EMBODIMENT…
Whether one files a provisional application as
the first filing, it is essential that the priority
application include an enabled embodiment
of the invention and meet all the
requirements of what will be 35 USC § 112(a),
currently § 112, ¶ 1.

“Claims deserve the provisional application's
earlier filing date so long as that application
contains adequate written description under
35 U.S.C. § 112.… [T]he written description of
the provisional application must enable one of
ordinary skill in the art to practice the
invention claimed in the non-provisional
application.”

The Invention Submission Form:
The normal route to filing a complete patent
application starts with an Invention
Submission form which, ideally, should include
the full text of an enabled embodiment of the
invention.

• Effort should be made to identify, say, five recent
patents drafted by quality corporate patent
departments or law firms in the exact area of
technology of the specific units of research.
• Then, the enabled embodiment should be
highlighted in yellow, as should the generic
claims.
• This will provide the inventors with practical
guidance as to how to draft an enabled
embodiment.

• The Invention Submission form should permit the
inventor to provide a Word document that
includes an enabled embodiment that can be
electronically directly cut and pasted into a new
application with only minimal editing.
• The experiments should read like a “cook book”
recipe, showing the order and amounts of adding
ingredients, much like instructions to the chef
show how to make a bouillabaisse or other dish.

• The starting point should be the use of known
and available materials. (It does little good to
have an example which starts from a
heretofore unknown material: How is a
person reading an example to carry out the
invention if the starting material is unknown?)
• The finishing point is to show how the product
is to be used. What is the specific utility?

• Actual or Prophetic Enabled Embodiment:
In highly competitive areas it may be possible
to prophetically foresee an embodiment
without actually making the invention in
practice, yet a prophetic example may be all
that is needed to obtain a patent.
•

Time is of the essence:

• Beyond whatever offensive patent protection
that is gained by filing immediately, the ultimate
publication of an application claiming priority to
the early filing will have a patent defeating right.
• This defensive right will bar an applicant with a
junior filing date from obtaining a claim that
reads on that enabled embodiment or which
reads on obvious modifications of that enabled
embodiment.

• Generic Disclosure for Later Claims: For the
“upstream” pioneer invention from universities
and startups that opens the door to a new field of
research but where there is no specific product
ready for commercialization, generic protection is
the entire patenting exercise.
• Conversely, for a “downstream” product that will
go through the regulatory approval process which
is an adjacent homolog of a compound for the
same usefulness, here, the patentee is limited to
species protection.

• For “downstream” products, species protection
may be all that is needed: The epitome of the
value of species protection is found in terms of
commercial pharmaceutical patents such as the
Plavix® patent which was worth many billions of
dollars in terms of profits for a blockbuster drug,
Badorc et al., U.S. Patent 4,847,265. The
recently expired patent on Lipitor® generated
revenues of $ 13 billion for the last year before
expiration of the patent.

Rings of Generic Protection in the First Filing
• Several generic definitions of decreasing scope
should be included in the provisional
application.
• The broadest definition should correspond to
the broadest definition compatible with the
already known prior art.

Rings of Generic Protection (con’d)
• Like concentric circles of waves formed on a
pond after a pebble is thrown into the center,
decreasing scope generic definitions should be
provided.
• At least some of these definitions should focus
upon what is likely to be exploited in the
industry and then what is likely to be
exploited by the applicant company itself:

Rings of Generic Protection (con’d)
• The regular (nonprovisional) application filed a
year later can then include any or all the
definitions of the provisional application if it
turns out that the applicant’s understanding
of the state of the art at the time of the
provisional is unchanged at the time of the
regular application.

Late Genus Disclosure Lacks Priority Basis:
• It is important to include the generic definition in
the original application.
• Having a species disclosure in an original
application together with a broad genus is
generally insufficient to provide basis for a
narrower generic definition even though reading
on the originally disclosed species and within the
scope of the original generic invention.

Late Genus Disclosure (con’d):
“It is well settled that ‘the description of a
single embodiment of broadly claimed subject
matter constitutes a description of the
invention for anticipation purposes ...,
whereas the same information in a
specification might not alone be enough to
provide a description of that invention for
purposes of adequate disclosure....’”

• Late Genus Disclosure (con’d):
• The concept that the narrow disclosure of a
parent application, repeated in a published
application 18 months later, defeats a later
application filed after the critical bar date is
nothing more than a restatement of the the
Ruscetta line of case law:
• “It is now well settled law that disclosure of a
species is insufficient to provide descriptive
support for a generic or sub-generic claim[.]”

Defensive Patent Right without Generic
Protection:
• While offensive patent protection may be
problematic with a species patent, a strong
defensive patent right may be obtained
through earliest filing.

Defensive Patent Right … (con’d):
• Provided the species disclosure is carried
forward into a regular (nonprovisional)
application, upon publication the patentee
gains a patent-defeating right retroactive to
the filing date to defeat a junior applicant’s
claim to either the same invention or to
subject matter obvious from the species.

§ IV. FOOLS GOLD, 24 MONTH “PROVISIONAL”

•

On January 10, 2013, the Patent Office
published a Federal Register notice, Extension
of the Extended Missing Parts Pilot Program,
that extends through the end of this year the
“24 month provisional” scheme that is
designed to permit early commercialization
efforts after the provisional is filed without the
expense of a detailed drafting of the
application by a patent attorney:


• Then, at 24 months from the provisional filing,
the full effort is provided with a regular
application.
• Presumably, deficiencies through the
minimalistic drafting of the provisional will be
cured at this stage (under the theory of this
practice).


• To the extent that an applicant wants to have
generic coverage based upon a limited
disclosure in an application filed 24 months
from the date of the provisional, this may be
problematic.


• The probability is that (a) some of the
commercialization efforts in the first 12 months
will constitute “prior art” under the Leahy Smith
America Invents Act; and (b) a generic claim
broader than the original disclosure created
24 months after the provisional will not meet the
strict disclosure standards of Ruscetta and New
Railhead.


• The confluence of the two factors
will necessarily lead to invalidity
of any generic claim that may
result in the eventual patent.

§ V. FORMAL ELEMENTS OF THE REGULAR APPLICATION

Adding but not Deleting Definitions when Refiling
•
If there is a new preferred definition such as a
generic numerical range, that range should be
added as such but the original disclosure should
be maintained. Separate claims to both ranges
should be included in the application.


Adding … when Refiling (con’d)
• If there is no intervening prior art, then the
added range may be important for enforcement
purposes.
• But if it develops that there is intervening prior
art and that the new range is not entitled to
priority, then at least a claim to the old range will
remain in the case and can be relied upon.


The Summary of the Invention
• The Summary of the Invention should be the
first section appearing after the title. Drafting
the Summary… should take place immediately
after drafting the claims..
•
The following steps should be taken in
drafting the Summary…:


• The Summary of the Invention (con’d)
• First, create an electronic copy of all the
claims which should be the guts of the
Summary….
• Identical wording should be maintained
wherever possible.


The Summary of the Invention (con’d)
• Second, grammatical changes should be made
to transform the wording of the claim (which
is the object to “We claim” or “I claim” or “It is
claimed that:”) into a sentence.


Abstract of the Disclosure
•
The broadest generic claim should be used
as a template for the Abstract which should
then be rewritten with no change in the
definition of the invention, as any difference in
definitions may be used against the applicant
in enforcement proceedings.


Duty of Disclosure
• The provisional application should never include
prior art.
• The regular (nonprovisional) application generally
should not include a prior art discussion.
• Preferably, prior art should be cited, but in a
separate Information Disclosure Statement to
identify but not characterize prior art known to
the inventor that falls under the duty of
disclosure of 37 CFR §§1.56, 57, 98.

§ VI. ESSENTIAL INTEGERS IN THE DRAFTING PROCESS

Claim Drafting:
• Claim drafting is the heart and soul of the
patent drafting process and for most
applications in predictable technologies is the
only important part of the process where the
patent attorney adds value to the process.


Claim Drafting (con’d):
Claim drafting is the heart and soul of the
patent drafting process and for most
applications in predictable technologies is the
only important part of the process where the
patent attorney adds value to the process.


Claim Drafting: A Limited Number of Claims
• One of the most serious mistakes made in
patent drafting is to provide countless claims,
perhaps dozens or scores of claims.


Claim Drafting : A Limited Number of Claims (con’d)
• Creating a mindless maze of claims without
thought as to commercial realities will only make
it more difficult for the Examiner to go through
the examination process, creating an
unnecessarily hostile environment for the “judge”
who decides the fate of the application.
• The chance for inconsistent definitions and
ambiguities under 35 USC § 112(b) also are
greatly increased, proportional to the number of
claims that are presented.


Claim Drafting (con’d):Disclosure versus Claiming
• A handful of claims will receive far better
attention and treatment by the Examiner
than, say, thirty or forty claims (or more).
• Where a patent-defeating disclosure is the
goal of some of the possible claims, the
answer, here, is to provide such disclosure,
without claims.


Avoiding “Means” Claiming
•
“Means” claiming, if properly crafted, takes
an enormous amount of time which only adds
expense and delay in filing the application. This
claim form should be avoided altogether, given
the fact that a “means”-defined element is
always narrower than the same element defined
in traditional terms coupled with the highly
unfavorable reception such claims have had in
the case law of the Federal Circuit.


Claims to Stimulate a Restriction Requirement
• It is understandable that alternate forms of
claiming protection may be desirable.
• Thus, if there is a new product and also a new
use for that product, two sets of claims may
be desirable with the understanding this may
stimulate a restriction requirement.


Supporting Disclosure -- Alternate Enabled
Embodiments
• Some of the case law of the Federal Circuit has given a
negative reception to the idea of a broad interpretation of
generic claims supported by only a single example.
• Whether this is a trend in the law or not, the patent attorney
can mitigate the problem by providing alternate prophetic
examples to complement a limited disclosure of actual
working examples.


Defensive Patent Matrix: A prime value for early
disclosure of a species is that this will create a
patent-defeating effect against a junior
applicant’s generic claim inclusive of that species.
• But, this often is insufficient because the road
may be clear for the competitor to gain a claim to
an important subgeneric definition mutually
exclusive from this one species.


Defensive Patent Matrix (con’d): Here, a defensive
matrix should be set forth in the disclosure:
• Imagine a genus as being comparable to the nine
squares of a tic-tac-toe board, and the enabled species
occupies a space within one of these squares.
• If a competitor files a subgeneric claim to any of the
unoccupied squares and establishes a patentable
difference versus the disclosed species, then that
competitor may gain a dominant claim to that tic-tactoe square.


Defensive Patent Matrix (con’d):
• A goal of defensive patenting should be to block
the entire tic-tac-toe board: An enabled species
should be specifically named for each square.
• In this way, a patent-defeating right is established
to block all squares of the tic-tac-toe board.


IDS to Cite Prior Art
• Prior art should never be cited in a provisional
application and generally should not be cited
in a patent application. But, an Information
Disclosure Statement should be filed at the
time of the regular (nonprovisional)
application or shortly thereafter.


IDS to Cite Prior Art (con’d)
• The object of the IDS is to identify prior art
known to the inventor that falls under the
duty of disclosure of 37 CFR §§1.56, 57, 98.
• The IDS need only identify the prior art; it
should not characterize the prior art.’

§ VII. MPEP-SUGGESTED NON-STATUTORY INTEGERS

• A great deal of wasted effort goes into drafting a
patent application by following the guidance of the
Manual of Patent Examining Procedure.
• The statutorily unnecessary bells and whistles of the
Manual of Patent Examining Procedure are costly in
terms of the greatly increased time it takes to draft the
patent application both which adds greater costs and
delays filing.
• This is an untenable proposition in an era of first-tofile, but, just as important, creates technical traps in
terms of claim interpretation and arguments for
unpatentability or invalidity based upon KSR.


Summary of the Invention
• The proper drafting of a Summary… is a formal
matter that should never deviate from the
definition in the claims.
• The Manual says otherwise:


Summary of the Invention (con’d)
• “The summary may point out the advantages of the
invention or how it solves problems previously existent
in the prior art (and preferably indicated in the
Background of the Invention). In chemical cases it
should point out in general terms the utility of the
invention. If possible, the nature and gist of the
invention or the inventive concept should be set forth.
Objects of the invention should be treated briefly and
only to the extent that they contribute to an
understanding of the invention.”


Background of the Invention
• The Manual states that the Background of
the Invention should include “[a] description
of the related art known to the applicant and
[ ], if applicable, references to specific related
art and problems involved in the prior art
which are solved by the applicant's invention.
…”


Background of the Invention (con’d):
•
But, beyond the additional time and
expense needed to craft such a Background of
the Invention, under KSR it is also very
dangerous to make “references to specific
related art and problems involved in the prior
art which are solved by the applicant's
invention.”


• “Most Attorneys Follow the Manual” This is
not true as to some non-statutory provisions
of the MPEP.
• While the MPEP says that an “object” or “gist”
of the invention should be recited, fewer than
20 % percent set forth an “object” of the
invention and only 0.25 % express a “gist” of
the invention.

Thank you for your attention!
~

Questions?

hwegner@foley.com

HAROLD C. WEGNER
continues his patent practice as a partner at Foley & Lardner
LLP. Prof. Wegner retains his affiliation with the George
Washington University Law School where he had been
Director of the Intellectual Property Law Program and
Professor of Law. His involvement with other academic
institutions has included service as a Visiting Professor at
Tokyo University.
Prof. Wegner’s patent career commenced with service at the
U.S. Department of Commerce as a Patent Examiner. He
spent three years at the Max-Planck-Institut für Geistiges
Eigentum in Munich where he was a Wissenschaftliche
Mitarbeiter. He then became a Kenshuin at the Kyoto
University Law Faculty under Dr. Kitagawa.
contact: hwegner@foley.com

hwegner@foley.com

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