American Intellectual Property Law Association
Post Therasense Decisions and
Practical Tips
DONALD STUDEBAKER
AIPLA IP PRACTICE IN JAPAN COMMITTEE
SPRING MEETING
TOKYO AND OSAKA
JAPAN
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APRIL 2013
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Table of Contents
 Summary of the Therasense Decision (May 2011)
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UPDATE: District Court Decision (N.D. Cal. March 2012)
 Post Therasense Decisions
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Powel v. Home Depot (Fed Cir: Nov. 2011)
Aventis Pharma v. Hospira (Fed Cir: April 2012)
1st Media v. Electronic Arts (Fed Cir: Sep. 2012)
Parker Vision v. Qualcomm (M.D. Fla., Jan. 2013)
 Summary
 Practical
Tips
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Therasense v. Becton (Fed. Cir. May 2011)
SUMMARY OF THE THERASENSE DECISION
 To prevail on the defense of Inequitable Conduct (IC), the
accused infringer must prove that the applicant
misrepresented or omitted material information with the
specific intent to deceive the USPTO.
 The accused infringer must prove both elements “intent
and materiality” by clear and convincing evidence.
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Therasense v. Becton (Fed. Cir. May 2011)
Summary of the Therasense decision: (cont’d)
 EXCEPTION:
 The court held that in cases involving Affirmative Egregious
Misconduct, “but for materiality” need NOT be proven.
 Example of Affirmative Egregious Misconduct – the submission
of an unmistakably false affidavit.
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Therasense v. Becton (N.D. Cal. March 2012)
Summary of the Therasense District Court decision
 The district court found by clear and convincing evidence that the lawyer and
expert had actual knowledge of the withheld EPO briefs,
 That the lawyer and expert had actual knowledge of the materiality of the briefs,
and
 That they made a deliberate decision to withhold the evidence.
 The district court found that these three elements together were sufficient by
themselves to establish a threshold case of specific intent to defraud.
 The district court went on to find that based on the overall evidence "intent to
deceive is the single most reasonable inference."
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Powell v. Home Depot (Fed. Cir. Nov. 2011) *
Aventis Pharma v. Hospira (Fed. Cir. April 2012) **
1st Media v. Electronic Arts (Fed. Cir. Sep. 2012) *
Parker Vision v. Qualcomm (M.D. Fla., Jan. 2013) *
* No finding of Inequitable conduct
** Finding of Inequitable conduct
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Powell v. Home Depot (Fed. Cir. Nov. 2011)
Background:
Powell sued Home Depot for willful patent infringement of U.S.
Patent No. 7,044,039, directed to a safety guard for a radial arm saw.
While prosecuting his patent, Powell filed a Petition to Make
Special in accordance with MPEP §708.02, seeking expedited review on
the grounds that he was obligated to manufacture and supply, to Home
Depot, devices as claimed in his application. "Mr. Powell believed that -based on his ongoing negotiations and long-term business relationship
with Home Depot -- he was obligated to supply it with saw guards for radial
arm saws located in each Home Depot store."
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Powell v. Home Depot (Fed. Cir. Nov. 2011)
Background cont.:
Ultimately the Patent Office granted Powell's Petition to Make Special
and his patent application received expedited review.
The negotiations with Home Depot had failed and Powell did not
inform the USPTO that he no longer qualified for the Special status
under the prospective manufacture exception.
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Powell v. Home Depot (Fed. Cir. Nov. 2011)
District Court:
 The district court determine that Mr. Powell, with intent to deceive,
failed to inform the Patent Office that he was no longer obligated to
manufacture products for Home Depot.
 The court also determined that this intentional omission was material to
the USPTO examination procedure.
 However, the district court concluded that Home Depot failed to
establish, by clear and convincing evidence, that Powell's patent was
unenforceable based in part on the balance of equities.
 Specifically, while the district court (before Therasense en banc
decision) held that the failure to inform the USPTO was done with the
intent to
deceive
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information was not material to the patentability of the claim.
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Powell v. Home Depot (Fed. Cir. Nov. 2011)
Federal Circuit
 During the pendency of Home Depot's appeal, the CAFC decided
Therasence.
 The Federal Circuit, affirmed the district court decision, and held that
Powell’s failure to inform the USPTO “that the condition which supports
a Petition to Make Special no longer exist” does not constitute
inequitable conduct, because Powell’s conduct (improper omission)
fails the but-for materiality standard of Therasense.
 The court further noted that this improper omission is not the type of act
which rises to the level of “affirmative egregious misconduct” and
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not an exception to the standard.
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Aventis Pharma v. Hospira (Fed. Cir. April 2012)
Background:
 The two patents-in-suit, U.S. Patent Nos. 5,750,561 and 5,714,512,
relate to an Aventis chemotherapy cancer drug, which is administered
in an aqueous solution called a “perfusion”.
 The prior art surfactant used to form the solution triggered allergic
reactions, including anaphylactic shock, in patients.
 To overcome the problem, the patented formulation uses a different
surfactant and limits the amount of ethanol in the solution, as compared
to prior art formulation.
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Aventis Pharma v. Hospira (Fed. Cir. April 2012)
District Court:
 In their pre-Therasense decision, the district court made separate and
distinct findings on intent and materiality.
 The district court found that the inventors had cited a prior art reference
which identified the problem they sought to solve, but did not cite two
other references which revealed the solution to the problem.
 Consequently, the court found that the withheld references were
material to patentability of the claimed invention and that the inventor
intentionally withheld them in order to deceive the USPTO.
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Aventis Pharma v. Hospira (Fed. Cir. April 2012)
Federal Circuit:
 Affirming the Pre-Therasense judgment of inequitable conduct, the court
held that the references were but-for-material because the district court
properly found that the claims were invalid over the references, and
 The court held that the inventor’s withheld the references with the
specific intent to deceive the USPTO and rejected the inventor’s
contentions that there was more than one inference that could be drawn
from his conduct and found that the inventor’s testimony, explaining why
he withheld the prior art, was not credible.
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Aventis Pharma v. Hospira (Fed. Cir. April 2012)
Federal Circuit (continued)
 Regarding inequitable conduct, the Court initially noted that “although
the district court did not have the benefit of our Therasense opinion . . . ,
the court nevertheless found that the withheld references were but-for
material to patentability and made distinct intent and materiality findings”
 The Federal Circuit concluded that “the court’s inequitable conduct
determination withstands even the more rigorous standard adopted in
Therasense.”
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Aventis Pharma v. Hospira (Fed. Cir. April 2012)
Federal Circuit (continued)
 Specifically, the Federal Circuit concluded that in view of a totality of the
inventor’s testimony, which included his testimony that his prior
experiments (recorded in the withheld reference) was one of the main
factors that shaped his thinking in choosing a surfactant for the claimed
invention, the district court was justified in finding the inventor’s
explanation non-credible, especially because the inventor disclosed to
the USPTO other prior art that shows the problem to be solved without
disclosing those indicating a possible solution.
 This case marks the first time that the appellate court has upheld an
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inequitable
Therasense.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Background:
 Dr. Scott Lewis was the inventor of US Patent No. 5,464,946 and
Joseph Sawyer acted as Lewis' attorney during prosecution. Sawyer
filed an application for the '946 Patent on November 13, 1992. The
Examiner initially rejected all claims in the application as anticipated or
obvious in view of certain prior art references. After Sawyer amended
the application, the Examiner issued a Notice of Allowance.
 While the '946 Patent was pending, Sawyer also prosecuted other
related patent applications for Lewis.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Background:
 The applications included:
 International Patent Application No. PCT/US93/10930, which was
identical to the '946 Patent application;
 US Patent Application No. 07/975,824, which became US Patent No.
5,325,423 ('423 Patent); and
 US Patent Application No. 08/265,391, which became US Patent No.
5,564,001 ('001 Patent).
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Background:
 After receiving the Notice of Allowance, but before payment of the
issue fee, Sawyer received:
 A Supplemental International Search Report for the PCT Application from
the European Patent Office with a “Y” reference (particularly relevant if
combined with another reference); and
 Office Actions for the related US Applications with two additional references
(allegedly disclosing features similar to those of the patent at issue).
 None of the 3 references were submitted to the USPTO for consideration
in connection with the ‘946 Patent.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
District Court:
 The district court found that their (Sawyer and Lewis) explanations for
non-disclosure, that they did not recognize the materiality of any of the
references and the failure to disclose these references was due to an
oversight, were not credible and that it was appropriate to infer that they
intended to deceive the USPTO.
 The district court, before the Therasense decision, concluded that
Sawyer and Lewis had committed inequitable conduct and held that the
patent was unenforceable given such inequitable conduct.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Federal Circuit
 The court reviews a district court’s determination of inequitable conduct
under a two-tiered standard:
 The court reviews the underlying factual determinations of materiality
and intent for clear error; and
 The court reviews the ultimate decision as to inequitable conduct for
an abuse of discretion.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Federal Circuit (continued)
 The court found that ultimately, for all of the references, the evidence
supports only that Lewis & Sawyer:
 (1) knew of the references,
 (2) may have known they were material, and
 (3) did not inform the USPTO of the references.
 That is not enough to support a finding of inequitable conduct!
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Federal Circuit (continued)
 The court noted that in order to show that the patentee acted with the
specific intent to deceive the USPTO, a defendant must prove “that the
applicant knew of the reference, knew that it was material, and made a
deliberate decision to withhold it.”
 A failure to prove any one of these elements precludes a finding of
inequitable conduct.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Federal Circuit (Continued)
 The defendant failed to prove that the applicant (1) knew of the
reference, (2) knew it was material, and (3) made a deliberate
decision to withhold it.
 In this case, the last element (3) is missing.
 The court did not decide whether any of the references were but-for
material, because court concluded that the defendant failed to prove
that Sawyer and Lewis made a deliberate decision to withhold any of
the references from the USPTO.
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1st Media v. Electronic Arts (Fed. Cir. Sep. 2012)
Federal Circuit (Continued)
 The panel distinguished Aventis v. Hospira, (Fed. Cir. 2012) noting an
“affirmative conduct by the applicants showing not only specific
awareness of materiality [but-for materiality had been established at
trial], but careful and selective manipulation of where, when and
how much of the most material information to disclose….” was
present.
 The court went on to state that “Evidence of such selective disclosure is
not present here.”
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Parker Vision v. Qualcomm (M.D. Fla., Jan. 2013)
Background
 ParkerVision brought suit against Qualcomm for infringement of U.S.
Patent 6,061,551 and five related patents and Qualcomm
counterclaimed that the ‘551 patent is unenforceable for inequitable
conduct.
 Qualcomm alleged that the inventor and the prosecuting patent attorney
“buried” the PTO with references. The ‘551 patent lists over 580 cited
references; 340 US patents, 36 foreign patent documents, over 150
literature references, and 55 press releases.
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Parker Vision v. Qualcomm (M.D. Fla., Jan. 2013)
District Court
 The court looked to the Therasense decision to dispose of the question of
intent to deceive.
 The court noted that “With inequitable conduct casting the shadow of a
hangman’s noose, it is unsurprising that patent prosecutors regularly bury
PTO examiners with a deluge of references, most of which have marginal
value.”
 Qualcomm’s assertions that Parker Vision provided voluminous references
to the USPTO in order to “distract” the examiner was not, the single most
reasonable inference to be drawn from the record.
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Parker Vision v. Qualcomm (M.D. Fla., Jan. 2013)
District Court
 The court noted, “taking into account the practice of bringing inequitable
conduct charges against a patentee for under-disclosing references, an
equally if not more reasonable inference is that ParkerVision aimed to
insulate itself from such claims by over-disclosing references.”
 Accordingly, there may be little risk in over-disclosing references to the
USPTO.
*
Remember, this District Court decision may be subject to appeal.
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SUMMARY
 Therasense decision significantly raised the bar of proving inequitable
conduct by a defendant.
 1st Media clarified just how high the bar has been raised.
 The defense of unenforceability based on Inequitable Conduct is still
very much alive as seen from the Aventis decision.
 If you need to think about whether or not to submit the information for
more than a minute, you probably should submit it.
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PRACTICAL TIPS
 Do not relax your existing IDS submission rules in view of Therasense
and 1st Media, because a defense, based on inequitable conduct, is still
often asserted during litigation. While the plaintiff may ultimately prevail
at trial or on appeal, dealing with the inequitable conduct related
defense at the trial court level and at the appellate court level will be
burdensome (time and cost).
 Create a set of rules for the submission of information to the USPTO
and routinely follow these rules.
 Particularly, since a “deliberate intent to deceive” the USPTO is very
difficult for the accused infringer to prove, as noted from 1st Media,
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submission rules and following the rules as routine practice
virtually eliminates the “intent to deceive” factor.
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PRACTICAL TIPS
 It is best to remain diligent in efforts to comply with existing rules to
reduce possible issues that may likely be the subject of an inequitable
conduct defense.
 Supplemental Examination provides the patent holder the ability to
correct errors and cure IDS related problems, especially nonsubmission of the relevant references cited during the examination.
 A thorough review of any patents to be asserted should be conducted
and the submission of a Request for Supplemental Examination should
be considered to cure as many problems as possible before asserting
the patent.
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Thank You For Your Attention
DON STUDEBAKER
STUDEBAKER BRACKETT PC
12700 SUNRISE VALLEY DRIVE
SUITE 102
RESTON, VIRGINIA 20191
Don.studebaker@sbpatentlaw.com
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SEE ADDITIONAL ATTACHMENTS
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PRACTICAL TIPS FOR IDS SUBMISSION
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Rule 1.97 (e) the Certification Statement
(1) That each item of information contained in the information disclosure
statement was first cited in any communication from a foreign patent office
in a counterpart foreign application not more than three months prior to
the filing of the information disclosure statement; or
(2) That no item of information contained in the information disclosure
statement was cited in a communication from a foreign patent office in a
counterpart foreign application, and, to the knowledge of the person
signing the certification after making reasonable inquiry, no item of
information contained in the information disclosure statement was known
to any individual designated in §1.56(c) more than three months prior to
the filing ofFirm
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information disclosure statement.
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SAMPLE IDS SUMISSION ROUTINE
During 1st STAGE:
 Before mailing of a First Official Action or within three months of initial
filing:
 Without in-depth review of the information to be submitted,
 No Certification Statement or fee necessary.
 Follow the submission routine described below with respect to
translations.
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SAMPLE IDS SUMISSION ROUTINE
During 2nd STAGE:
 After mailing of a First Official Action and before mailing of a Final
Official Action or Notice of Allowance:
 Without in-depth review of the information to be submitted,
 Submit along with Certification Statement or fee if certification is not
possible.
 Follow the submission routine described below.
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SAMPLE IDS SUMISSION ROUTINE
During 3rd STAGE:
 After mailing of a Final Official Action or Notice of Allowance and during time
period between mailing of the Notice of Allowance and Payment of Issue Fee:
 Review the information and determine if the information is “material to
patentability” under Rule1.56(b).
 May submit IDS only with Certification Statement and payment of fee.
 If Certification Statement can not be made filing of an RCE may be necessary
to have the references fully considered.
 Follow the procedures described below.
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SAMPLE IDS SUMISSION ROUTINE
During 4th STAGE:
 During a time period between payment of I/F and issuance of US
Patent:
 Review the information and determine if the information is “material to
patentability (‘non-cumulative’ and/or ‘more relevant’ than those
already submitted)” under Rule 1.56(b).
 If the information is found “material”, then consult with client and obtain
their approval for the ids submission; client must be informed that it will
be necessary to request withdrawal from issuance and the filing of an
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necessary.
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 Follow the procedures described below.
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SAMPLE IDS SUMISSION ROUTINE
During 4th STAGE: QPIDS PILOT PROGRAM
 The Quick Path Information Disclosure Statement (QPIDS) pilot program is part
of the USPTO's on-going efforts towards compact prosecution and pendency
reduction. Extended to September 30, 2013.
 The QPIDS pilot program eliminates the requirement for processing of a request
for continued examination (RCE) with an information disclosure statement (IDS)
filed after payment of the issue fee in order for the IDS to be considered by the
Examiner.
 Where the Examiner determines that no item of information in the IDS
necessitates reopening prosecution, the USPTO will issue a corrected notice of
allowability.
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 See http://www.uspto.gov/patents/init_events/qpids.jsp
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SAMPLE IDS SUMISSION ROUTINE
Office Action received from counterpart Patent Office(s):
In the case where the OA is written in English (EPO’s Search Report)：

Simply submit a copy of the English language document as an IDS.
In the case where the OA is NOT in English (such as JPO’s OA)：

Ideally an English translation including all the substantive grounds of
rejection should be submitted.
Oftentimes a full translation is too costly, particularly a translation of Chinese
Office Action (costing $600 or more). In this case, an English translation of at least
the portions that indicate which claims are rejected, under what provisions and by
which references,
should be submitted.
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SAMPLE IDS SUMISSION ROUTINE
TRANSLATION EXAMPLE
 Claims 1 and 2 are ejected under (Chinese patent law section XX) as
being anticipated by Ref A. Claims 3-5 are rejected under (Chinese
patent law section YY) as being unpatentable over Ref A in view of Ref
B. (see MPEP 609.04(a) III)
 Submit copy of both the original non-English language Office Action
together with the translation (whole or partial translation) as an IDS.
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SAMPLE IDS SUMISSION ROUTINE
CITED REFERENCES from counterpart Patent Office(s):
When the Cited Reference is in the English Language:
 If the reference is US Patent or Patent Publication, then only an
identification of the US Patent or Patent Publication needs to be
submitted as an IDS (however, in order to avoid the error, a copy of its
cover page is preferably submitted also).
 If the reference is in English language, but none-US Patent or Patent
Publication, then a copy of entire reference must be submitted as an
IDS.
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SAMPLE IDS SUMISSION ROUTINE
CITED REFERENCES from counterpart Patent Office(s): continued.
When the Cited Reference is in a Non- English Language:
Patent Publication
 First, try to locate an English language counterpart, such as a US
Publication, EPO Publication or GB Patent Publication. If such English
counterpart exits, submit the Non-English reference with the English
counterpart.
 If no English counterpart is available, try to obtain an English abstract
through esp@cenet (EPO), if available, then submit the English Abstract
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the copy of Non-English reference.
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SAMPLE IDS SUMISSION ROUTINE
CITED REFERENCES from counterpart Patent Office(s): continued.
When the Cited Reference is in a Non- English Language:
Patent Publication: cont.
 If no English language Abstract is available, then translate the portion of
the reference corresponding to its Abstract or Claim 1 and submit
human English translation of the Abstract together with the copy of NonEnglish reference.
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SAMPLE IDS SUMISSION ROUTINE
CITED REFERENCES from counterpart Patent Office(s): continued.
When the Cited Reference is in a Non- English Language:
Other Non-Patent Literature:
 Review and locate the relevant portion in the non-patent article,
translate the portions in English and submit the partial English
translation of the relevant portions of the non-patent article together with
the copy of original article.
 NOTE: Beneficial to submit the information to the USPTO within 30
days from the date that the information was known to the person in
charge Firm
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application in order not lose any period of Patent Term
Adjustment.
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MPEP §609.04
III. CONCISE EXPLANATION OF RELEVANCEFOR NON-ENGLISH
LANGUAGE INFORMATION
Each information disclosure statement must further include a concise explanation
of the relevance, as it is presently understood by the individual designated in
37CFR 1.56(c) most knowledgeable about the content of the information listed that
is not in the English language. The concise explanation may be either separate
from the specification or part of the specification. If the concise explanation is part
of the specification, the IDS listing should include the page(s) or line(s) numbers
where the concise explanation is located in the specification.
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MPEP §609.04
III. CONCISE EXPLANATION OF RELEVANCEFOR NON-ENGLISH
LANGUAGE INFORMATION: continued
Submission of an English language abstract of a reference may fulfill the
requirement for a concise explanation. Where the information listed is not in the
English language, but was cited in a search report or other action by a foreign
patent office in a counterpart foreign application, the requirement for a concise
explanation of relevance can be satisfied by submitting an English-language
version of the search report or action which indicates the degree of relevance
found by the foreign office. This may be an explanation of which portion of the
reference is particularly relevant, to which claims it applies, or merely an “X”, “Y”,
or “A” indication on a search report. The requirement for a concise explanation of
non-English language information would not be satisfied by a statement that a
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reference was
in the prosecution of a United States application which is not
relied on under 35 U.S.C. 120.
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