Building and Maintaining BioPharma Patent
Portfolios After KSR v. Teleflex:
Strategies Addressing Higher Standards for Patentability
Bruce D. Sunstein
Barbara J. Carter, Ph.D.
Bromberg & Sunstein LLP
Boston
www.bromsun.com
© 2007 Bromberg & Sunstein LLP
KSR v. Teleflex
KSR Intern. Co. v. Teleflex Inc., 127 S. Ct. 1727 (April 30, 2007)
Why it matters to Biopharma
Issued patents are now more readily
attacked.
Patents applied for may be harder to get.
Evaluating or managing a patent portfolio
requires new approaches.
2
Dealing with KSR v. Teleflex
The basic rules for determining whether
patentable invention is present
 How the rules were implemented: TSM
What did KSR v. Teleflex hold?
 What did KSR v. Teleflex say?
 What did KSR v. Teleflex do?
Who are the losers and winners under KSR v.
Teleflex?
Strategic implications of KSR v. Teleflex
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Spotting and strengthening weak patents
USPTO Examination Procedure: Post-KSR Impact, Draft Guidelines
Writing and prosecuting patents
Combination drugs
Portfolio management
The heightened position of prior art searching
Take Home Lessons
3
The basic rules for determining whether a
patentable invention is present
Patent Act, law since 1952, requires an
invention to be non-obvious.
“Obviousness” was drafted to be an
objective standard.
4
The obviousness standard of the law
A patent will be denied for an invention “if
the differences between the subject matter
sought to be patented and the prior art are
such that the subject matter as a whole
would have been obvious at the time the
invention was made to a person having
ordinary skill in the art.”
35 U.S.C. § 103(a).
5
How the obviousness standard has
been applied
Before KSR v. Teleflex, the Supreme Court
last spoke about obviousness in 1966.
 The 1952 law was intended by Congress to ban the
“flash of creative genius” test for patentable
invention articulated by the Supreme Court in 1941.
 Graham v. John Deere Co., 383 U.S. 1 (1966)
Over recent decades the Federal Circuit has
refined the obviousness standard.
6
The Federal Circuit’s standard for
obviousness
An invention would have been obvious only
“if ‘some motivation or suggestion to
combine the prior art teachings’ can be
found in the prior art, the nature of the
problem, or the knowledge of a person
having ordinary skill in the art.”
Called the “teaching, suggestion or
motivation test” (“TSM test”).
7
The beef in KSR v. Teleflex
Teleflex had exclusive rights to a patent for a gas
pedal and throttle control device which
incorporates an electronic pedal position sensor
attached to a fixed pivot point of the pedal
assembly.
KSR made a pedal assembly having features like
those patented, and Teleflex sued KSR for patent
infringement.
 KSR defended on ground that patent was invalid for
obviousness
 The patent licensed to Teleflex was invalidated on basis of
prior art not considered by the PTO when the patent was
granted.
8
What did KSR v. Teleflex hold?
The TSM test of the Federal Circuit was
applied erroneously.
 “There is no necessary inconsistency between the
idea underlying the TSM test” and the standard for
non-obviousness
 “But a court errs where, as here, it transforms
general principle into a rigid rule limiting the
obviousness inquiry.”
9
Pathways to Obviousness:
what KSR v. Teleflex said
Issue:
 How may prior art teachings be permissibly
combined to justify obviousness?
Supreme Court:
 Prior art in different fields may be combined.
 If work available in one field, design incentives, other market
forces prompt variations in same or different field.
 If a person of ordinary skill can implement a predictable
variation, § 103 likely bars patentability.
 If technique used to improve one device, and recognized by
person of ordinary skill in the art that it could improve
similar device in same way, using technique is obvious
unless actual application is beyond person’s skill.”
10
KSR v. Teleflex:
More ways to combine prior art
I. Combining Prior Art Elements according to Known
Methods to Yield Predictable Results
II. Simple Substitution of one Known Element for
Another to Obtain Predicable Results
 “A person of ordinary skill is also a person of ordinary creativity,
not an automaton.”
III. Use of Known Techniques to Improve Similar
Devices in Same Way
 “… familiar items may have obvious uses beyond their primary
purposes, and in many cases a person of ordinary skill will be
able to fit the teachings of multiple patents together like pieces
of a puzzle.”
IV. Applying Known Technique to Known Device
Ready for Improvement to Yield Predictable Results
11
KSR v. Teleflex:
More ways to combine prior art, cont.
V. Obvious to Try
 When design need or market pressure exists to solve problem
 And finite number of identified, predictable solutions
 Then a person of ordinary skill has good reason to pursue known
options within technical grasp
 If anticipated success achieved, success likely not innovative but
merely ordinary skill and common sense.
 Then, combination that was “obvious to try” might show
invention was obvious.
VI. Teaching, Suggestion, Motivation (TSM)
 Motivation may be implicit
 Motivation may be found in any number of sources, including
common knowledge, the prior art as a whole, or the nature of
the problem itself
12
Before KSR v. Teleflex, factual complexity
of obviousness commonly required a trial
Obviousness a legal question.
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
can be decided by a judge in summary judgment
but factual complexity often required a trial to
resolve the question
In KSR itself, Federal Circuit said trial was
necessary to resolve conflicting testimony of
expert witnesses bearing on question of
obviousness.
13
What did KSR v. Teleflex do?
Summary judgment in favor of defendant
KSR on the question of obviousness was
appropriate, so a trial is not necessary.
“Where, as here, the content of the prior art,
the scope of the patent claim, and the level
of ordinary skill in the art are not in material
dispute, and the obviousness of the claim is
apparent in light of these factors, summary
judgment is appropriate.”
14
Who are the losers under KSR v.
Teleflex?
Those holding patents with close prior art, not
considered by the PTO, are at risk in:
 Litigation, whether pending, threatened, or unasserted
 License negotiations
 Other business transactions, including equity financing
Those seeking patents
 Higher standards for non-obviousness = more difficulty
obtaining a patent
15
Who are the winners under KSR v.
Teleflex?
The Supreme Court decision benefits
companies on the receiving end of
infringement risk, in:
 Litigation, whether pending, threatened, or
unasserted
 License negotiations
 Other business transactions, including equity
financing
16
What to expect in the future of the
obviousness standard — I
Because the Supreme Court has sanctioned
additional ways of combining prior art references
in reaching a determination that a claimed
invention “would have been obvious”, it has
raised the standard for non-obviousness.
 Patents are easier to invalidate for obviousness.
 Patents are harder to get.
The notion of “common sense” now in the
obviousness standard adds subjectivity and
therefore unpredictability to obviousness
determinations.
17
The future of the obviousness
standard—II
Recent Federal Circuit cases in wake of KSR v. Teleflex
suggest Federal Circuit using modified TSM test.
 DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick
Co., 464 F.3d 1356, 1367 (2006)
Modified TSM means motivation to combine references
may be found implicitly in the prior art or nature of
problem to be solved.
 Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286, 1291 (2006)
Not a return to the good old days.
 The modified TSM test is more generous in finding obviousness.
 Summary judgment permits obviousness evaluation without a
trial in many cases.
Expect more obviousness rejections from the Patent
and Trademark Office on pending applications.
18
The future of the obviousness
standard—III
Post-KSR Fed. Cir. Decisions:
 Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed.Cir. (Ill.)
2007)
 Obviousness of a patent claim cannot be avoided simply by a
showing of some degree of unpredictability in the art so long
as there was a reasonable (i.e. not absolute) probability of
success
 Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157
(Fed.Cir. (Del.),2007)
 Even substantial evidence of secondary factors commercial
success, praise, and long-felt need inadequate to overcome
a final conclusion that claimed invention would have been
obvious given strength of the prima facie obviousness
showing
19
Strategic implications of KSR v.
Teleflex: Spotting weak patents
In KSR, the patent was invalidated on basis of
prior art not considered by the PTO
Patents most vulnerable after KSR are those
with close prior art, not considered by the
PTO.
 Sometimes the close prior art becomes known to patent
owner after issuance of the patent.
 Otherwise, conduct a thorough search to identify any
close prior art not considered by the PTO.
 Conversely, if closest prior art has been considered by
PTO, the presumption of validity is strengthened.
20
Strategic implications of KSR v.
Teleflex: Strengthening weak patents - I
Since weakness arises from prior art not
considered, patents may be strengthened
by getting prior art considered, through:
 Reexamination proceedings
 Requires prior art raising substantial new question of
patentability
 Reissue proceedings
 Requires showing, typically, that
• the patent claims more or less than patentee had
right to claim in the patent, and
• the error arose without deceptive intent
21
Strategic implications of KSR v.
Teleflex: Strengthening weak patents - II
Risk is unavoidable that claims will be
narrowed or rejected in such proceedings.
 91% of Reexamination requests granted
 71% result in narrowed/cancelled claims
 12% result in all claims cancelled
 29% result in all claims intact
22
USPTO Examination Procedure to Date
Current USPTO Guidelines for Prima Facie Case
of Obviousness: TSM
 Suggestion or motivation, either in the references
themselves or in the knowledge generally available
to one of ordinary skill in the art, to modify the
reference or to combine reference teachings
 Reasonable Expectation of Success
 Prior Art Reference (or references when combined)
must teach or suggest all the claim limitations
23
Post-KSR Impact
USPTO Draft Guidelines: Implementation Imminent
More Rationales for Finding Obviousness
 I. Combining Prior Art Elements according to
Known Methods to Yield Predictable Results
 II. Simple Substitution of one Known Element for
Another to Obtain Predicable Results
 III. Use of Known Techniques to Improve Similar
Devices in Same Way
 IV. Applying Known Technique to Known Device
Ready for Improvement to Yield Predictable Results
 V. Obvious to Try
 Precedential Opinion: Ex Parte Kubin, Appeal 2007-0819, Appln
No. 09/667,859, Technology Center 1600 (May 31, 2007)
 VI. Teaching, Suggestion, Motivation (TSM)
24
Post-KSR Impact
I. Known Methods = Predictable Results
Prior art teaches all claimed elements
 Elements need not be in same reference
One of ordinary skill could have combined the
elements, by known methods, and each element
performs same function in combination as did
before separately
 Suggestion not needed?
 Is this element optional?
One of skill would have recognized that results of
combination were predictable
 Suggests this is hindsight (even though official USPTO position is
that hindsight is still impermissible)
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Post-KSR Impact
II. Simple Substitution of one known element for
another = predictable results
Must have been obvious to person of ordinary
skill to replace known elements, and that
exchanged elements would give predictable
results, at time of invention
26
Post-KSR Impact
III. Use of Known Techniques to Improve Similar
Devices in Same Way
Prior art contained “base”
device/method/product
Invention is improvement of “base” device
One of ordinary skill could have applied the
known improvement technique in same way to
“base” device
Results of improvement would have been
predictable to one of ordinary skill
Additional Graham factors Examiner finds, as
needed
27
Post-KSR Impact
IV. Applying Known Technique to Known Device
for Improvement = Predictable Results
Criteria Presumably similar to III
Post-KSR Impact
V. Obvious to Try
Finite number of identified predictable
solutions
Reasonable expectation of success
28
Post-KSR Impact
VI. Teaching, Suggestion, Motivation (TSM)
(Still a rationale for obviousness)
Must find some teaching, suggestion, motivation
in references, knowledge generally available to
one of ordinary skill, or nature of problem, to
modify or combine reference teachings
Reasonable expectation of success
Additional Graham factors needed to support
rationale
29
Strategic implications of KSR v. Teleflex:
Writing and prosecuting patents—some principles
remain intact - I
Graham Factors Still the Legal Basis for
Obviousness
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Scope and Content of Prior art
Differences between claimed invention and Prior Art
Level of Skill
Secondary Considerations
Examiner must still articulate reason/rationale
to support obviousness rejection
Rebuttal Evidence must still be considered
30
Strategic implications of KSR v. Teleflex:
Writing and prosecuting patents—some principles
remain intact - II
Rebuttal Evidence Explicitly Mentioned by
USPTO Draft Guidelines as Still Valid
Commercial Success
Long-felt but unsolved needs
Failure of others
Unexpected Results
Elements could not have been combined – i.e., for
technological difficulties (a teaching away type
rebuttal)
 Elements in Combination do not perform same
function each did individually (an In re Gordon type
rebuttal)
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Strategic implications of KSR v. Teleflex:
Writing and prosecuting patents—some principles
are new - III
Examiner fulfills critical role of Fact finder in
Graham Inquiries!
 Ultimate determination is Legal, but Graham
Inquiries are Factual
 Precedential Opinion: Ex Parte Kubin, Appeal 2007-0819,
Appln No. 09/667,859, Technology Center 1600 (May 31,
2007)
 Written record must include findings of fact by
Examiner concerning teachings of references and
state of the art.
 Examiner may also need:
 Explicit findings as to how person of ordinary skill would
have understood prior art teachings
 What a person of ordinary skill would have known
 What a person of ordinary skill could have done
32
Strategic implications of KSR v. Teleflex:
Writing and prosecuting patents—some principles
are new - IV
New Rebuttal Evidence Explicitly Mentioned by
USPTO Draft Guidelines
 Actual application of known technique (to improvement of
“base” device) was beyond one of ordinary skill
Major Impact will be at Level of Appeal
Reversal Rate at BPAI Decreased Dramatically
since KSR
 Pre-KSR Reversal Rate – 70-80%
 Post-KSR Reversal Rate – 30-40%
33
Strategic implications of KSR v. Teleflex:
Combination drugs particularly vulnerable - I
When each component of a combination drug
contributes properties to the combination that
are expected, then the combination will be
attacked as obvious.
To resist the attack for obviousness, it is
important to show synergistic or unexpected
results.
34
Strategic implications of KSR v. Teleflex:
Combination drugs—II
Even when the prior art looks overwhelming,
sometimes special claim strategies can make a
difference.
 When the basic combination may be taught,
consider claims to a unit dosage of the combination
with specific ranges or ratios that may be novel and
unexpected.
 Consider method claims that address use of the
composition under specific conditions or with
specific types of administration that may be novel
and unexpected.
35
Limited Court Decisions:
FDC Patents at High Risk?
McNeil-PPC, Inc. v. L. Perrigo Co.
(207 F.Supp.2d 356 (E.D.Pa.2002))
 Extremely hostile decision
Facts:
 Near expiration of patent for Immodium (loperamide) , McNeil
obtained:
 two new FDC patents for loperamide w/ simethicone to treat
diarrhea/ gas; AND
 two new formulation patents for polymer-coated FDCs
 Perrigo filed para. IV certification that McNeil patents invalid and
that their products/use would not infringe
 McNeil sued Perrigo for infringement
All McNeil patents invalid for obviousness
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
36
Fed. Cir. Affirmed: 2003, 337 F.3d 1362 (Fed.Cir.(Pa.) Aug 01, 2003)
US Supreme Court Denied Certiorari: 540 U.S. 1107 (U.S. Jan 12, 2004)
Strategic implications of KSR v. Teleflex:
Portfolio management
A good-looking patent portfolio before KSR v.
Teleflex may not be a good-looking patent
portfolio after KSR v. Teleflex.
Portfolio managers should evaluate each U.S.
patent property (applications and issued
patents) in the portfolio for invalidity risk based
on obvious combinations of prior art.
 Weak patent properties should be evaluated for possible
 Rehabilitation through reexamination or reissue
 Pruning from the portfolio
 Licensing out
37
Strategic implications of KSR v. Teleflex:
Portfolio management—II
Clearance problems—infringement risks—should
be revisited in light of KSR v. Teleflex.
 Heretofore nearly invulnerable patents may be vulnerable
to prior art attacks under KSR v. Teleflex.
 For such newly vulnerable patents consider the following
approaches:
 Renewed licensing negotiations
 Reexamination proceedings, particularly inter partes
(contested) reexamination proceedings, which have often
produced outcomes favorable to the attacking party
 Litigation - declaratory judgment actions are much easier to
maintain after Medimmune v. Genentech (127 S.Ct. 764
(January 9, 2007))
38
Prior art searching now critically important
Helps reduce risk of KSR v. Teleflex attack for
obviousness on applications in portfolio
Helps efficient claiming of subject matter under
new compact prosecution rules
 Without knowledge of prior art, one risks needlessly
extending prosecution by claiming more broadly than
warranted by prior art, thereby potentially wasting the
limited number of continuations and requests for
continued examination available under the new rules
Helps identify vulnerabilities in competitors’
patents
39
The new regime under KSR v. Teleflex
Issued patents are at greater risk of attack for
obviousness, which may be found in summary
judgment without trial.
Pending applications must contend with the higher
and more subjective bar of the new obviousness
standard.
Strategy is more important in drafting and prosecuting
applications and in handling properties in patent
portfolios.
Early and deep knowledge of prior art is of critical
importance in formulating and implementing strategy.
40
Strategic implications of KSR v. Teleflex:
Writing and prosecuting patents—
further strategic principles
Draft applications bearing in mind prospective
downstream rejections based on obviousness.
 Knowing prior art in detail when drafting application is
critical!
Tell a story that includes a convincing showing
of unexpected or synergistic results.
 The story should make good sense in relation to the prior
art.
 Questions of judgment and advocacy affect the extent to
which prior art is discussed explicitly.
41
KSR v. Teleflex: Take Home Lessons
“obvious to try” may show obviousness
“When there is a design need or market pressure
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 the 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.”
Query: what does this language mean for new
compounds?!
42
KSR v. Teleflex: Take Home Lessons
Writing and prosecuting patents—some principles
remain intact - I
Prior art references can be distinguished on the
basis (when available) that they “teach away”
from the combination being urged to reject or
invalidate the patent claim.
 It is critical to study cited prior art references with great
care to understand what they teach.
 Prior art references do not always actually teach what
they seem to teach.
 Sometimes they are misconstrued by examiners.
 Sometimes they are not enabling; that is, they fail to contain
information sufficient to permit a person of ordinary skill to
practice the subject matter for which the reference is cited.
Unexpected results can be urged as showing
non-obviousness.
43
KSR v. Teleflex: Take Home Lessons
Writing and prosecuting patents—some principles
remain intact—II
Often the combination of prior art references
does not extend to all the limitations of the
patent claim being considered.
 When that is the case, it can be shown that a prima facie case
for rejection or invalidation has not been established.
 It is critical to make a rigorous analysis of the rejection to
determine whether all limitations of the claim have been
accounted for by the examiner in the rejection.
More patent claims – and creative ones – can make a
difference.
 Prior art attacks on claims must be mounted separately for each
claim.
 A well crafted claim that captures the inventor’s creativity may
be just the one for which a “common sense” combination of prior
art references simply does not exist.
44