Making Sense of Therasense: New Law of
Inequitable Conduct & Post-Therasense
Strategies to Avoid Charges of Inequitable
Conduct in US Patent Practice
Hung H. Bui, Esq.
Bui Garcia-Zamor
1250 Connecticut Ave., Suite 200
Washington DC, 20036
Tel: 202-374-1966
Email: [email protected]
Website: www.buigarcia.com
Presented:
Ryuka IP Law Firm
Tokyo, Japan
July 22, 2011
1
Table of Content
I.
BACKGROUND




Duty of Candor (DC) under 37 CFR §1.56
Inequitable Conduct (IC)
Differences between Inequitable Conduct (IC) and
Duty of Candor (DC)
History of Inequitable Conduct (IC) before the
Supreme Court – Clear Case of Fraud and Deceitful
Conduct
1.
2.
3.

Keystone Driller Co. v. General Excavator Co., 290 U.S. 240
(1933)
Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238
(1944)
Precision Instrument Mfg. Co. v. Automotive Maint. Mach. Co.,
324 U.S. 806 (1945)
The Plague – Proliferation of Inequitable Conduct (IC)
Charges
2
Table of Content
II.
Therasense, Inc., v. Becton Dickinson & Co., 2011 WL
2028255 (Fed. Cir. May 25, 2011)




En banc Decision – May 25, 2011
USPTO Response to Therasense - May 26, 2011
Future of Inequitable Conduct
Implications to Patent Practitioners
Post-Therasense Strategies To Comply With Duty of
Candor and Avoid Charges of Inequitable Conduct
III.



“Egregious Misconduct” Avoidance
Safe Harbor Disclosure
Selective Disclosure
3
I. BACKGROUND – USPTO Duty of Candor


“Duty of Candor” is an issue for the USPTO
37 C.F.R. §1.56 Today (as revised in 1992):
–
“Each individual associated with the filing and prosecution of
a patent application has a duty of candor and good faith in
dealing with the Office, which includes a duty to disclose to the
Office all information known to that individual to be material to
patentability as defined in this section.”
–
“The duty to disclose all information known to be material to
patentability is deemed to be satisfied if all information known to
be material to patentability of any claim issued in a patent was
cited by the Office or submitted to the Office in the manner
prescribed by §§1.97(b)-(d) and 1.98.”
4
I. BACKGROUND – USPTO Duty of Candor

Those individuals associated with the filing or prosecution within
the meaning of Rule 1.56 include:
–
–
–


Each inventor named in the application
Each attorney or agent who prepares or prosecutes the application
Every other person who is substantially involved in the preparation or
prosecution of the application and who is associated with the inventor, with
the assignee or with anyone to whom there is an obligation to assign the
application
Thus, inventors, managers, attorneys and even foreign agents
involved with corresponding foreign applications are subject to
the Duty of Candor
The Duty of Candor exists throughout the prosecution of a patent
until the application is issued or becomes abandoned; however,
the duty is reactivated in further proceedings, such as reissue or
reexamination proceedings
5
Duty of Candor vs. Inequitable Conduct

Failure to comply with the duty of candor and
good faith under 37 C.F.R. §1.56:
–
–

Inequitable Conduct  Patent Unenforceability
Rationale: To prevent “Fraud on the Patent Office”
Inequitable conduct (IC) is a question of equity,
and not a question of law
–
As such, district court has the discretion to determine
inequitable conduct (IC) based on the facts of the case
6
Pre-Therasense: Law of Inequitable Conduct


Standard of Proof: Clear and convincing evidence
Two Separate and Distinct Elements: (1) Materiality, and (2)
Intent to Deceive
(1) Materiality is determined based on a reasonable examiner standard
 Failure to disclose material information (Rule 1.56)
 Misrepresentation of material fact, or
 Submission of false material information.
(2) Intent to deceive the Patent Office
 May be proven by the facts and circumstances surrounding the
patentee’s conduct.
Only after (1) and (2) are met, the district court then balances the equities to
determine whether the patentee’s conduct was egregious to warrant the
holding of inequitable conduct.
7
Pre-Therasense: Law of Inequitable Conduct

Standard of Review: Abuse of Discretion
–
–
To prevail on appeal, must prove the district court’s
ruling was based on:
 Clear erroneous findings of facts
 Clear misapplication or misinterpretation of law
 Clear error of judgment by the district court
Difficult to overturn the district court’s ruling of
inequitable conduct (IC) at the Federal Circuit
8
Differences between Inequitable
Conduct (IC) and Duty of Candor (DC)

Information that is not material under Rule 1.56 can be
material for purposes of determining inequitable conduct (IC).
–

Dayco Prods. Inc. v. Total Containment Inc., 329 F.3d 1358
(Fed. Cir. 2003)
Inequitable Conduct (IC) > Duty of Candor (DC)
9
History of Inequitable Conduct (IC) before the
Supreme Court – Clear Case of Fraud, Bribery,
Perjury and Deceitful Conduct

Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933)
–
–

Hazel-Atlas Glass Co. v. Hartford-Empire Co., 322 U.S. 238 (1944)
–
–

Falsified trade publications to falsely praise the achievements of an
invention in order to secure allowance by the Patent Office
Not merely perjury, but “a deliberately planned and carefully executed
scheme to defraud not only the PTO, but the Court”
Precision Instrument Mfg. Co. v. Automotive Maint. Mach. Co.,
324 U.S. 806 (1945)
–

Submitted false affidavit and deposition testimony
Secured promise by prior user to keep details of invalidating prior use
secret
Submitted false affidavits, including “false dates as to the conception,
disclosure, drawing, description and reduction to practice of the claimed
invention,” which were fabricated to predate certain activities during an
interference
These cases involved intentional conduct (direct evidence) meant
to mislead or deceive the Patent Office
10
Previous Problem: The “Plague” – Proliferation of
Inequitable Conduct (IC) Charges


However, direct evidence of “intent to deceive” such as outlined
in Keystone Driller (1933), Hazel-Atlas Glass (1944), and
Precision Instrument (1945), is VERY RARE
District courts began to infer “deceptive intent” based on the
facts and circumstances surrounding patentee’s conduct
–
–
Some courts inferred “deceptive intent” from materiality alone
Other courts utilized a “sliding scale” when evaluating the evidence
of “materiality” and “intent”

–
High degree of materiality  lesser showing of “intent” or vice versa
Yet other courts inferred “deceptive intent” based on a lower
threshold of “materiality” or even patentee’s lack of a credible
explanation

“Should-have-known” standard of materiality where simple
negligence may justify an inference of “deceptive intent”
11
Previous Problem: The “Plague” – Proliferation of
Inequitable Conduct (IC) Charges


Over last 25 years, the Federal Circuit embraced reduced
standards for “intent” and “materiality” to foster full disclosure to
the USPTO
However, the low standards for “intent” and “materiality” have
inadvertently led to many unintended consequences:
–
–
–
–

Increased adjudication cost and complexity
Reduced likelihood of settlement
Burdened courts
Strained USPTO resources, Increased USPTO backlog, and Impaired
patent quality
The IC doctrine has plagued not only the courts but also the
entire patent system because allegations of inequitable conduct
are routinely raised in every patent litigation
II. Therasense, Inc., v. Becton Dickinson & Co., No.
2008-1511, 2008-1512, 2008-1513, 2008-1514, 20081595, 2011 WL 2028255 (Fed. Cir. May 25, 2011)



Facts
Patentee (Abbott Diabetes Care, successor of Therasense
Inc.) holds multiple patents, including 5,820,551 patent directed
to a glucose home testing kit for diabetics, including disposable
blood glucose test strips
During 14 years of complex prosecution before USPTO, patent
attorney submitted a declaration with certain representations
of a prior art (Patent No. 4, 545,382) to overcome §102 & §103
rejections
During prosecution of a counterpart patent application filed in
EPO, patentee made contradictory representations to the EPO
concerning the teaching of the same prior art (‘382 patent);
however, patentee had not disclosed those contradictory
representations to the USPTO
12
II. Therasense, Inc., v. Becton Dickinson & Co., No.
2008-1511, 2008-1512, 2008-1513, 2008-1514, 20081595, 2011 WL 2028255 (Fed. Cir. May 25, 2011)

District Court
Declared the patent unenforceable due to
inequitable conduct
–
Applicant had described in a prior art patent in a way that
“contradicted” the applicant’s description of same patent in
a European application. That contradiction made the EPO
arguments “material information” in the US application.

–
“To deprive an examiner of the EPO statements – statement
directly contrary to representations to the PTO – on the
grounds that they are not material would be to eviscerate the
duty of disclosure.”
Sworn declaration submitted to the PTO – higher standard
13
II. Therasense, Inc., v. Becton Dickinson & Co., No.
2008-1511, 2008-1512, 2008-1513, 2008-1514, 20081595, 2011 WL 2028255 (Fed. Cir. May 25, 2011)
Federal Circuit panel (2-1)

Affirmed the district court’s ruling  Inequitable Conduct (IC)
–
–
“An applicant’s earlier statement about prior art, especially one’s
own prior art, are material to the PTO when those statements
directly contradicted the applicant’s position regarding the prior art
in the PTO”
“Because the district court’s findings that the EPO submissions are
highly material to the prosecution of the ‘551 patent and that
[patent attorney] and Dr. Sanghera intended to deceive the PTO
by withholding those submissions were not clearly erroneous, the
district court did not abuse its discretion in holding the ‘551 patent
unenforceable due to inequitable conduct.”
14
15
En Banc Review Granted on April 26, 2010
1.
2.
3.
4.
5.
6.
En Banc Questions
Should the materiality-intent-balancing framework for inequitable
conduct be modified or replaced?
If so, how? In particular, should the standard be tied directly to fraud
or unclean hands? If so, what is the appropriate standard for fraud or
unclean hands?
What is the proper standard for materiality? What role should the US
PTO’s rules play in defining materiality? Should a finding of materiality
require that but for the alleged misconduct, one or more claims would
not have issued?
Under what circumstances is it proper to infer intent from materiality?
Should the balancing inquiry (balancing materiality and intent) be
abandoned?
Whether the standards for materiality and intent in other federal
agency contexts or at common law shed light on the appropriate
standards to be applied in the patent context?
16
Over 30 Amicus Briefs Filed Asking for
Consistency

AIPLA; ABA; Dolby; Verizon; University of Kentucky IP Law
Association; Professor Hricik; IPO; 22 Patent Prosecution
Firms; Acacia and 1st Media; Apotex; Aventis and Microsoft; IP
Law Professors; Nilssen and Geo Foundation; Washington
State Patent Law Association; BIO; Boston Patent Law
Association; Chicago IP Law Association; Conejo Valley Patent
Law Association; Ecore Int’l; Eisai; Eli Lilly; Federal Circuit Bar
Association; Houston IP Law Association; Johnson & Johnson
and Proctor & Gamble; PhRma; San Diego IP Law Association;
SAP; USPTO
17
Therasense En Banc
Oral Hearing: November 9, 2010
Appellants’ Positions




IC standard should be limited to clear cases of fraud and deceitful
conduct Supreme Court precedent Federal Circuit’s own en banc
decision in Kingsdown Medical Consultants Ltd. v. Hollister Inc.,
863 F.2d 867, 9 U.S.P.Q.2d 1384 (Fed. Cir. 1988) which requires high
Standard of Proofs of Inequitable Conduct
Kingsdown requires a showing of specific deceptive intent and such
deceptive intent can not be inferred from materiality
A “but-for” causation standard should apply to the “materiality” prong of
the analysis
Court’s subsequent “sliding-scale” balancing after a finding of
“materiality” and “intent” dilutes both, and should be eliminated from
the analysis.
18
Therasense En Banc
Oral Hearing: November 9, 2010


AIPLA Positions
Inequitable conduct should be fraud on the PTO,
provable only with specific intent to deceive.
In addition, materiality should be found only where at
least one claim would not have issued “But For" the
alleged misconduct, and that limits on inequitable
conduct are justified by the severe penalty of
unenforceability.
19
Therasense En Banc
Oral Hearing: November 9, 2010
USPTO Positions




Proper standard for “materiality” should be Rule 56
– “But For” standard advocated by AIPLA is too narrow
Proper standard for “intent” should be a specific intent to
deceive
Intent should not be inferred from “materiality” along but
evidence of “materiality” may be used to show intent
“Materiality-Intent” Balancing should be clarified
20
Federal Circuit en banc (6-4-1) Decision in
Therasense – May 25, 2011

6-Member Majority (Judges Rader, Newman,
Lourie, Linn, More and Reyna):
–
–
–
Tightened the standards for finding both (1) the specific
“intent” to deceive the USPTO, and (2) “materiality” by “clear
and convincing” evidence
Expressly rejected the use of a “sliding scale” between
these two elements in order to redirect a doctrine that has
been overused to the detriment of the public
Confirmed that (1) the specific “intent” to deceive the
USPTO and (2) “materiality” are separate requirement
21
Federal Circuit en banc Decision in
Therasense – May 25, 2011

First, specific “intent” to deceive the USPTO can not
be based on evidence of:
–
–

Gross negligence, or
Negligence under a “should have known” standard
In a case involving nondisclosure of information,
clear and convincing evidence must show that
Applicant (patentee):
–
–
–
(1) knew of the reference,
(2) knew that it was material, and
(3) made a deliberate decision to withhold a known material
reference from the USPTO.
22
Federal Circuit en banc Decision in
Therasense – May 25, 2011

Specific “intent” to deceive the USPTO must be:
–


“the single most reasonable inference able to drawn
from the evidence” in light of all the circumstances.
Thus, where there are multiple reasonable
inferences that may be drawn from the facts and
circumstances of the case, intent to deceive can not
be found.
As such, even if an omitted material reference was
withheld from the USPTO, the specific “intent” to
deceive the USPTO may not be met if Applicant has
other reasonable explanations as to why the material
reference was withheld from the USPTO.
23
Federal Circuit en banc Decision in
Therasense – May 25, 2011



Second, as a general matter, the “materiality”
required to establish inequitable conduct must be
“but-for” materiality, as advocated by the AIPLA.
In a case involving nondisclosure of information
(prior art), that prior art must be “but-for” material if
the USPTO would not have allowed a claim had it
been aware of the undisclosed prior art.
Thus, in assessing the materiality of a withheld
reference, the court must determine whether the
USPTO would have allowed the claim if it had been
aware of the undisclosed reference.
24
Federal Circuit en banc Decision in
Therasense – May 25, 2011

The en banc Court rejected the definition of
“materiality” currently outlined in USPTO Rule 56, as
advocated by the USPTO, because:
–
“Rule 56 sets such a low bar for materiality” and
“adopting this standard would inevitably result in patent
prosecutors continuing the existing practice of disclosing too
much prior art of marginal relevance and patent litigators
continuing to charge inequitable conduct in nearly every
case as a litigation strategy”
25
Federal Circuit en banc Decision in
Therasense – May 25, 2011


However, cognizant of this high standard of
“materiality” and, perhaps, to avoid review by the US
Supreme Court, the en banc Court has created an
exception to the “but-for” materiality standard
Thus, even if “but-for” materiality standard is not
met, “egregious misconduct” may still be punished
–
Examples of “egregious misconduct” include old Supreme
Court cases of Keystone Driller Co. v. General Excavator
Co., 290 U.S. 240 (1933) (where patentee committed
perjury), Hazel-Atlas Glass Co. v. Hartford-Empire Co.,
322 U.S. 238 (1944) (where patentee manufactured false
evidence) and Precision Instruments Manufacturing Co.
v. Automotive Maintenance Machinery Co., 324 U.S. 806
(1945) (where patentee suppressed evidence of perjury)).
26
Federal Circuit en banc Decision in
Therasense – May 25, 2011

4-Member Dissent (Judges Bryson, Gajarsa, Dyk,
and Prost) disagreed with the majority on the
question of the “but-for” standard of materiality
–
Would continue to apply the lower standard of materiality
based on USPTO’s Rule 56 because new tightened
standards for finding both (1) the specific “intent” to deceive
the USPTO, and (2) materiality do not merely reform the
doctrine of inequitable conduct, but come close to
abolishing it altogether
27
Federal Circuit en banc Decision in
Therasense – May 25, 2011

According to the Dissent, there are less Draconian means of
addressing the abuse of inequitable conduct. For example:
(1) the refinements to the specific “intent” to deceive the
USPTO would significantly reduce the frequency with which
the defense is raised
(2) the Federal Circuit has recently held that the strict pleading
requirements of Federal Rules of Civil Procedure, Rule 9(b)
apply to counterclaims of inequitable conduct which would
discourage baseless counterclaims; see Exergen, Corp., v.
Wal-Mart Stores, Inc., 575 F.3d 1312 (Fed. Cir. 2009)
(3) the doctrine of inequitable conduct is an equitable doctrine,
and, even when the elements of “intent” and “materiality”
are satisfied, the district court still has discretion to exercise
its equitable judgment
28
USPTO Response to Therasense - May 26,
2011

On May 26, 2011, the USPTO issued a statement
that:
–

“[USPTO is] now studying the potential impact of
Therasense v. Becton, Dickinson on Office practice, and
[they] expect to soon issue guidance to applicants regarding
the materials they must submit to the Office under their duty
of disclosure.” USPTO Director David Kappos
USPTO Options:
–
–
Appeal to US Supreme Court to preserve the Duty of
Disclosure (Rule 56) and MPEP §2000, or
Revise Rule 56 and MPEP §2000 to require IDS
submission of only potentially “but-for” material information
29
USPTO Response to Therasense - May 26,
2011

Prediction: Duty of Disclosure (Rule 56) and MPEP
§2000 will remain largely intact
–
Why?
Difficult to determine “but-for” material information since
claims change during prosecution  Still safest to submit all
material information and let the Examiner decides
 USPTO still fosters full disclosure to assist examination 
More disclosure  Better presumption of validity
Previous Federal Circuit’s panel decisions regarding IDS in Dayco
Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358 (Fed. Cir.
2003); McKesson Information Solutions, Inc. v. Bridge Medical,
Inc., 487 F.3d 897 (Fed. Cir. 2007); and Larson Mfg. Co. v.
Aluminart Products Ltd., No. 2008-1096 (Fed. Cir. Mar. 18, 2009)
will remain largely intact  controlling law


30
Previous Federal Circuit’s Panel Decisions
Regarding IDS Submission to Avoid Inequitable
Conduct Allegations

Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358
(Fed. Cir. 2003)
–
Reversed the district court’s ruling of IC but only because the trial
record lacked sufficient evidence. However, “deceptive intent” can
be established based on the failure to disclose:


Adverse PTO Office Actions issued in co-pending application on
related subject matter
McKesson Information Solutions, Inc. v. Bridge Medical,
Inc., 487 F.3d 897 (Fed. Cir. 2007)
–
–
Affirmed the district court’s ruling of IC
Established “deceptive intent” based on the failure to disclose:



Prior art reference used to reject claims in unrelated application with
similar subject matter
PTO’s rejection of broad claims in that unrelated application
PTO’s Notice of Allowance in another related application
31
Previous Federal Circuit’s Panel Decisions
Regarding IDS Submission to Avoid Inequitable
Conduct Allegations

Larson Mfg. Co. v. Aluminart Products Ltd., No. 2008-1096
(Fed. Cir. Mar. 18, 2009)
–
Vacated the district court’s holding of IC based on patentee failure
to disclose:

–
Remanded for further consideration of “intent” w/ instructions that:



–
Prior art references and PTO Office Actions issued in related, copending application, i.e., parallel re-examination proceeding
Material does not presume intent
Nondisclosure, by itself, cannot satisfy the deceptive intent element
Even if deceptive intent is established by clear and convincing
evidence, evidence of good faith must be considered to mitigate
against a finding of deceptive intent
On remand, the district found “materiality” and “intent” but on
balance of equities, found IC was improper
32
Future of Inequitable Conduct (IC)

Aftermath of Therasense:
–
–
Easier to defend against charges of inequitable conduct
Deter those who would bring such charges when defending
patent cases



Difficult to prove specific “intent to deceive”
Difficult to establish “but-for” material information
Next battleground for inequitable conduct cases will
likely center on:
–
–
The “exception” created for cases of “egregious
misconduct”
Why?


No need to establish “but-for” material information
The only question remains whether a misconduct is an
“egregious misconduct”
33
Future of Inequitable Conduct (IC)


As a practical matter, inequitable conduct (IC) will no
longer serve as an effective defense to patent
infringement actions
Rather, re-examination and/or post-grant review
(PGR) as introduced in the Patent Reform Act of
2011 will likely serve as a better and more effective
defense to such patent infringement actions
34
Implications for Patent Practitioners

For Patent Litigators
–
–
Harder to plead inequitable conduct before discovery
because the burdens outlined in Exergen, Corp., v. WalMart Stores, Inc., 575 F.3d 1312 (Fed. Cir. 2009)  must
plead with particularity of WHO, WHAT, WHEN, WHERE,
and HOW under Federal Rule of Civil Procedure 9(b), and
must also plead facts from which a reasonable inference of
“intent to deceive" can be drawn
Harder to prove:
(1) Specific intent to deceive the PTO when there are reasonable
explanations as to why the material reference was withheld
from the USPTO
(2) “But-for” material information  PTO would not have
allowed claims had it been aware of such information
35
Implications for Patent Practitioners

For Patent Prosecutors
–
Dayco, McKesson and Larson will still be
controlling law

–
Absent of USPTO’s final Therasense guidelines
Duty of Disclosure (Rule 56) and MPEP §2000
will remain largely intact
36
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  AVOID EGREGIOUS MISCONDUCT

“Exception” created for cases of “Egregious Misconduct”
–

“But-for” material information is not necessary
Examples of “Egregious Misconduct”  Inequitable Conduct
–
–
–
–
–
–
–
–
–
–
Withholding best mode
Seeking to patent subject matter invented by another
Fabrication of an article praising the invention (see Hazel-Atlas)
Corruption of a witness as to prior public use (see Keystone Driller)
Perjury in an interference proceeding (see Precision Instruments)
Inconsistent arguments in the PTO and a District Court (see Therasense)
Problems with the affidavits concerning date of invention (see Precision
Instruments)
Factual misrepresentation of evidence of patentability (see Hazel-Atlas)
Material errors in the oath of inventorship
False claims of small entity status
37
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  Safe Harbor Disclosure

SAFE HARBOR: What Must Applicant Disclose?
– All "related” US applications whether or not the priority
lineage is the same (see Dayco Prods & MPEP
§2001.06(b))

–
–
CONs & CIPs
All unrelated applications with similar subject matter (see
McKesson)
All Office Actions issued in unrelated applications with
similar subject matter, or "related" US applications,
including:

All references cited by Applicant or Examiner, whether U.S. or
foreign applications (see McKesson & Larson)
38
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  Safe Harbor Disclosure

SAFE HARBOR: What Must Applicant Disclose?
–
All Office actions issued in Related Proceedings (see Larson)
including:





–
Simply disclose co-pendency is not enough

–
–
Re-examination (see MPEP §2014, §2280 and §2684)
Appeals
Reissues (see MPEP §2012)
3rd Party Submissions
Interferences (see MPEP §2001.06(d))
Must disclose all Office Actions even where the Examiner is aware of
the co-pendency (see Larson)
Foreign Search Reports and references in related foreign
applications (see MPEP §2001.06(a))
Contradictory statements made in another forum (see
Therasense)
39
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  Safe Harbor Disclosure

Safe Harbor: When To Disclose?
40
37 CFR §1.97(e)(1)



37 CFR §1.97(e)(1):
(e) A statement under this section must state either:
(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
Issues:
– US associate generally does not know about all related foreign
applications and their prosecution when filing foreign origin
applications
Recommendations:
– Pay fee OR request statement from foreign associate that §
1.97(e)(1) requirement has been met
41
37 CFR §1.97(e)(2)

37 CFR §1.97(e)(2):
(e) A statement under this section must state either:
(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
of the information disclosure statement
42
Problems with 37 CFR §1.97(e)(2)

WHEN USED:
–
–

WHO CERTIFIES:
–
–

US associate makes the certification, BUT may not know all the cases with
substantially similar claims in order to make the certification
US associate has to certify for everyone subject to the duty of candor
PROBLEM:
–

§ 1.97(e)(2) applies to applications with substantially similar claims
§ 1.97(e)(2) can be used for reporting USPTO Office Actions and
Applicant responses
Certification can place an unreasonable burden on the person certifying
RECOMMENDATIONS:
–
–
Have foreign associate indicate that the (e)(2) certification can be made,
OR
Pay the fee, because the $180 fee is cheaper than (1) determining whether
all cases with substantially similar claims, and (2) all people subject with a
duty of candor (3) who may be in other countries have met their duty.
43
Remember Timing


If filed after final rejection and certification is
to be avoided, then an RCE must be filed
If issued fees are paid, then file Petition to
withdraw from issuance along with an RCE
44
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  Selective Disclosure

For Applicants who seek cost-saving measures & selective
IDS disclosure
–
Must have clear internal policy & guidelines to classify different
types of information. This is necessary to provide reasonable
explanations as to why [material] information was withheld from
the USPTO
 No need to disclose: Information that is relevant to the
invention, but not material to the patentability of the invention
 Need to disclose: Information that is material to the
patentability of the invention (Rule 56). For example:
– Invention is a combination invention having A+B+C
– Any disclosure of individual A, B or C, or combination
thereof is material and must be disclosed to USPTO
– Such material information could be considered as “butfor” material information (in subsequent litigation)
45
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  Selective Disclosure

Examples of relevant information that does not need to be
disclosed to the USPTO
–
–
–
–
–
PCT Search Report with Category “A”
Foreign (JP) Office Action with formality requirement only
Foreign (JP) Office Action with lack of unity of invention rejection
only
Office Action issued in related US applications with no art rejection
Pre-filing prior art search with references that show the general
state of the art but less relevant

Note: submission of these references is cost free when combined and
filed with the new application in the USPTO
46
III. Post-Therasense Strategies to Comply with Duty
of Candor and Avoid Charges of Inequitable
Conduct  Selective Disclosure

Examples of material information that still needs to be
disclosed to the USPTO  SAFE HARBOR
–
PCT Search Report with


–
–
Category “X” (reference defeats novelty) and
Category “Y” (reference is said to defeat novelty when combined with
other references)
Foreign (JP) Office Action with art rejections & prior art references
cited
Office Action issued in related US applications with art rejections &
prior art references cited
47
QUESTIONS
Contact Information:
Hung H. Bui, Esq
Bui Garcia-Zamor
1250 Connecticut Ave., Suite 200
Washington DC 20036
Tel: 202-374-1966
Email: [email protected]
Website: www.buigarcia.com
©2011 Bui Garcia-Zamor
48
ありがとうございました

ご質問等ございましたら、下記までお気軽にお
問い合わせください
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