Massachusetts Association of Technology
Transfer Offices (MATTO)
Seminar
January 22, 2008
Faculty Room, Gordon Hall (1st Floor)
Harvard Medical School,
25 Shattuck Street, Boston
SUBMIT LESS, SAY MORE:
THE PROPOSED NEW
IDS RULES
Presented by
Isabelle Clauss
Massachusetts Association of Technology
Transfer Offices (MATTO)
January 22, 2008
© 2007 Foley Hoag LLP. All Rights Reserved.
Important Note: These materials have been prepared solely
for educational purposes. The presentation of these
materials does not establish any form of attorney-client
relationship with the authors or Foley Hoag LLP. Specific
legal issues should be addressed through consultation with
your own counsel, not by reliance on this presentation or
these materials. These materials may constitute attorney
advertising under some states’ laws. Prior results do not
guarantee a similar outcome. © Foley Hoag LLP 2008.
© 2008 Foley Hoag LLP. All Rights Reserved.
3
Proposed New IDS Rules
 Rule 1.56:
Each individual associated with the filing
and prosecution of a patent application has a duty to
disclose to the Office all information known to that
individual to be material to patentability of the pending
claims.
 The failure to disclose material information may render
a patent unenforceable.
 Under current rules: no limit as to the volume of
information.
 Too burdensome for the PTO: New IDS rules.
 The New IDS Rules are expected to publish any day.
 Expected to have at least one month to take effect.
© 2008 Foley Hoag LLP. All Rights Reserved.
4
Time Periods 1- 4
Application Prosecution Timeline
and corresponding IDS requirements
Application
Filed
First Office Action
on the Merits (FAOM)
Allowance of
Application
Payment of
Issue Fee
Time Sufficient for
Consideration
Patent
First Period
Up to 20 citations permitted
w/o any explanation req’d.
• Explanations req’d for:
all refs when more than 20;
each ref. >25 pages; or in
non-English language.
Second Period
• Explanation;
• Non-cumulative
description
© 2008 Foley Hoag LLP. All Rights Reserved.
Third Period
• Timeliness cert. (<3 mo);
•Explanation;
•Non-cumulative description;
•Patentability Justification
which includes either:
(A) Patentability reasons
for unamended claims; or
(B)(1) Statement of
unpatentable claims,
(B)(2) Amendment, and
(B)(3) Patentability reasons for
amended claim(s)
•
•
•
•
•
Fourth Period
Timeliness cert. (<3 mo);
Explanation;
Non-cumulative description;
Patentability Justification which
includes;
Statement of unpatentable claims,
Amendment, and
Patentability reasons for amended
claim(s);
Petition to w/d from issue
5
Time Period 1:
IDS Submission Requirements
Ends - later of {3 months after filing, or 1st Office action}
Exceptions
A. General rule:
IDSs filed during this time period may be submitted without
triggering an “explanation” requirement
Documents resulting from
a foreign search or
examination report in a
counterpart foreign
application where the
report is submitted
B. An “explanation” is required for each of the following:
Documents submitted in
reply to a requirement for
information (§ 1.105)
1. ALL documents when their cumulative number exceeds 20 in all
IDSs filed in this time period;
2. Any English-language document over 25 pages; and
3. Any non-English language document and any submitted translation if
the translation exceeds 25 pages.
An “explanation” requires identification of the specific teaching(s) that
caused the document to be cited, and correlation of the specific teaching(s) to
corresponding specific claim language, or to a specific portion(s) of the
supporting specification, where the document is cited for that purpose
© 2008 Foley Hoag LLP. All Rights Reserved.
6
“Explanation” Example
Facts:
Patent A teaches a rotary pump, as element 32 in Figure 3; and
Claim 1 of the application being examined recites a rotary pump
(as taught in Patent A)
Explanation:
Patent A teaches a rotary pump as element 32 in Figure 3, which
correlates to the recitation of a rotary pump in claim 1
© 2008 Foley Hoag LLP. All Rights Reserved.
7
Time Period 1:
IDS Submission Requirements (continued)
Ends - later of {3 months after filing, or 1st Office action}
Exceptions
C. Update of previously filed “explanations”:
With each amendment to the claims or the specification affecting
the scope of the claims filed after an information disclosure
statement, applicant must either:
See previous slide
1. Update each “explanation” for all previous information disclosure
statements, where necessary, in view of the amendment(s); or
2. Submit a statement to the effect that updating of the previous
explanation(s) submitted with information disclosure statement(s)
is not needed
© 2008 Foley Hoag LLP. All Rights Reserved.
8
Time Period 2:
IDS Submission Requirements
Starts - After First Office Action; Ends - Notice of Allowance
Exceptions
A. An “explanation” for each cited document (see time
period 1)
Documents from a foreign
search or examination
report for a counterpart
foreign application < 3
months
B. A “non-cumulative description” for each cited document
A “non-cumulative description” is a description how each
document is not merely cumulative of any other document cited
in any prior or current IDS, or any information cited by the
examiner
C. Update of previously filed “explanations” (see time
period 1)
© 2008 Foley Hoag LLP. All Rights Reserved.
Documents filed in
response to a requirement
for information (§ 1.105)
9
Time Period 3:
IDS Submission Requirements
Starts - after Notice of Allowance; Ends - at payment of Issue Fee
Exceptions
A. An “explanation” for each cited document
None
B. A “non-cumulative description” for each cited document
C. A timeliness “certification” to certify:
1. That each item of information is from a foreign patent office in a counterpart
foreign application having a date < 3 months prior to the filing of the IDS; or
2. That no item of information was known to any individual associated with the
filing or prosecution > 3 months prior to the filing of the IDS.
D. One of two “patentability justifications”:
1. When no claim amendment is made: Reasons why the independent claims are
patentable over the information in the IDS being submitted; and
2. When claim amendment(s) are made:
a. An unequivocal statement that one or more claims are “unpatentable” in view
of at least the cited information, and
b. An amendment to the claims admitted to be “unpatentable”, and
c. Reasons why the amendment causes the claims to be patentable.
E. Update of previously filed “explanations”
© 2008 Foley Hoag LLP. All Rights Reserved.
10
Time Period 4:
IDS Submission Requirements
Starts - at payment of issue fee; Ends – lack of sufficient time for the
examiner to consider the IDS prior to issuance
Exceptions
A. An “explanation” for each cited document
None
B. A “non-cumulative description” for each cited document
C. A timeliness “certification” (< 3 months)
D. A petition to withdraw an application from issue
E. Claim amendment(s)
F. A “patentability justification”: Statement of unpatentable claims, and
patentability reasons for amended claim(s);
G. Update of previously filed “explanations”
© 2008 Foley Hoag LLP. All Rights Reserved.
11
Reasonable Inquiry Required for Each
IDS Submission
 The reasonable inquiry mandated by §§ 10.18(b)(2) and
10.18(b)(2)(i) requires that information in any IDS
submitted during any of time periods 1-4 be reviewed
before submission to the Office to assure that it will not:
– (1) Cause unnecessary delay or needlessly increase
the cost of examination, or
–(2) Result in the obscuring of material information
© 2008 Foley Hoag LLP. All Rights Reserved.
12
Cons and Pros
Cons:
 IDSes will be more time consuming, thus more
expensive; and
 More statements will be made, which may be more
“dangerous.”
Pros:
 An IDS can be submitted after a final Office Action
without filing an RCE; and
 No fee for any IDS.
© 2008 Foley Hoag LLP. All Rights Reserved.
13
Conclusions
 Consider submitting all IDSes prior to the date that the
new IDS rules take effect;
 Consider whether to file an application early to use
current IDS rules; and
 Make sure that the inventors and anyone else
associated with the application know their duty of
disclosure and communicate the information early on.
© 2008 Foley Hoag LLP. All Rights Reserved.
14
Isabelle Clauss
Counsel
Boston
617 832 1177
[email protected]
© 2007 Foley Hoag LLP. All Rights Reserved.
Beyond KSR:
What is Obvious Today?
J. Peter Fasse
KSR International Co. v. Teleflex Inc.
550 U.S. ____ , 127 S.Ct. 1727 (2007)
What is Obvious to the Court?
– (1) Combinations of familiar elements according to known methods
– (2) Predictable variations based on design incentives and market
forces
– (3) Use of a known technique to improve a device in a known way
– (4) Predictable uses of prior elements according to their established
functions
17
KSR International Co. v. Teleflex Inc.
The Supreme Court’s New Guidelines
– (1) Any need or problem known in the field can provide a reason for
combining the elements as claimed
– (2) Common sense teaches that familiar items may have obvious
uses beyond their primary purposes
– (3) Design needs or market pressure and a finite number of
predictable solutions can make “obvious to try” a sufficient reason
for obvious
– (4) Avoid hindsight, but apply “common sense”
18
KSR International Co. v. Teleflex Inc.
The “Bright Side”
The Court suggested a few ways to show non-obviousness
(1) when the prior art teaches away
(2) unexpected results
The Court still requires an explicit showing of a reason to
combine the cited elements as in the claimed invention
19
Federal Circuit Cases Since KSR
Takeda Chemical Industries, Ltd. v. Alphapharm
Pty., Ltd.
492 F.3d 1350, 83 U.S.P.Q.2d 1169 (Fed. Cir. 2007)
PharmaStem v. Viacell
491 F.3d 1342, 83 U.S.P.Q.2d 1289 (Fed. Cir. 2007)
20
Takeda v. Alphapharm – Invention
Pioglitazone, for type II diabetes
21
Takeda v. Alphapharm - Result
District Court – New Type II diabetes drug NOT obvious
Federal Circuit – AFFIRMED
– No motivation to select drug from class of drugs
– Takeda took 17 years to get to market
– Teaching away due to toxicity of class of drugs
– Unexpected non-toxicity of claimed drug
22
PharmaStem v. Viacell
Claims to cord blood containing a number of stem cells
sufficient for hematopoietic reconstitution in an adult
District Court – NOT obvious
Federal Circuit – REVERSED
– Patent admitted that prior art described “progenitor cells” and “stem
cells”
– Federal Circuit thus did not believe Patentee expert’s testimony that
the prior art did not describe “stem cells”
– No unexpected results or teaching away in the prior art
23
USPTO Board of Appeals Decisions
Ex Parte Kubin, 83 U.S.P.Q.2d 1410 (Bd. Pat. App. & Int. 2007
Ex parte Kelm, Bd. Pat. App. & Int. 2006-1223, May 23, 2007
Ex Parte Lee, Bd. Pat. App. & Int. 2007-1033, June 19, 2007
Ex Parte Chen, Bd. Pat. App. & Int. 2007-1073, May 23, 2007
Ex parte Bunger, Bd. Pat. App. & Int. 2007-2308, July 12, 2007
24
Ex parte Kubin
Invention – polypeptide and gene sequences to human NAIL
(NK cell activation-inducing ligand)
Prior Art – mouse NAIL homolog + article re human NAIL
and antibody (but no sequence information) + Sambrook et
al., The Laboratory Manual
Isolating the human NAIL was a product of ordinary skill
and common sense
Contradicts In re Deuel (51 F.3d 1552, (Fed. Cir. 1995)) as not
controlling!
25
Ex parte Kelm
It would have been OBVIOUS to combine short-chain fatty
acids, which previously had been used to reduce body
weight, with long-chain fatty acids and fiber, which
previously had been used to treat obesity
There was no evidence of synergy (which could have
provided unexpected results) between the components of the
composition
26
Ex parte Lee
It would NOT HAVE BEEN OBVIOUS to treat cancer by
administering capecitabine (an anti-proliferative agent) and
compound 1
Broadest claim required synergy
Examiner held claims to have been obvious over prior art =
(1) compound 1 used as cancer drug with 5-fluorouracil; and
(2) capecitabine safer than 5-FU for treating cancer
Board held “...when an applicant demonstrates substantially
improved results…and states that the results were
unexpected, this should suffice to establish unexpected
results in the absence of evidence to the contrary”
27
Ex parte Chen
Composition that consisted essentially of particular amounts
of five ingredients would NOT HAVE BEEN OBVIOUS
Prior art = (1) composition with essentially same
components, but not in the particular amounts claimed, + (2)
last ingredient
Board found no teaching in either reference that would have
led one of ordinary skill in the art to substitute the last
ingredient
Board also stated that the examiner had not provided
“evidence of a sufficient reason, suggestion or motivation to
combine the cited references
28
Ex parte Bunger
A skin care composition including vitamin K, antioxidant,
and UV filter would NOT HAVE BEEN OBVIOUS
Prior art = (1) a skin care composition with antioxidant + UV
filter and (2) use of vitamin K in sunscreen.
Examiner said that one would have been motivated to
combine references
Board found “nothing in the combination of references relied
upon to suggest the use of more than one counterirritant”
KSR requires Examiner to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements as claimed
29
Keys to Rebut Obviousness Rejections
Show Examiner failed to establish an explicit reason
supported by some rational basis to combine the references
Find teaching away in cited (or other) prior art
Demonstrate unexpected (synergistic or surprising) results
30
What has become of the rules?
Faustino Lichauco
Commerce
PTO
Executive
Rule 78
Judiciary
Legislature
32
Complaint
-Irrep. Harm
Halloween 2007
-Likelihood of success
-Balance of harms
-Public policy
Preliminary
Injunction?
Yes
Suspend
enforcement
No genuine issue of
material fact
Yes
Summary
Judgment
You Are Here
No
Trial
In favor of
PTO?
No
Permanent
injunction
PTO Appeals to
CAFC
Yes
Unsuspend
rules?
GSK
Appeals to
CAFC
33
Arguments Raised
PTO
GSK
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
SCORE
34
SECTION 120 v. Rule 78
35 USC 120
– An application for patent for an invention disclosed [as required by
statute] in an application previously filed in the United States by the
same inventor shall have the same effect, as to such invention, as
though filed on the date of the prior application if . . .
GSK cites In re Henriksen (CCPA 1968)
PTO cites In re Bogese (CAFC 2001)
35
Case Citations
In re Henriksen (CCPA 1968)
– “there is no statutory basis for fixing an arbitrary limit to the number
of prior applications through which a chain of copendency may be
traced to obtain the benefit of the filing date of the earliest of a chain
of copending applications, provided applicant meets all the other
conditions of the statute”
In re Bogese (CAFC 2001)
– “Like other administrative agencies, the PTO may impose
reasonable deadlines and requirements on parties that appear before
it. The PTO has inherent authority to govern procedure before the
PTO, and that authority allows it to set reasonable deadlines and
requirements for the prosecution of applications.”
36
Case Citations (cont.)
But Bogese dissent refers back…
– “The PTO does not have the right to adopt administratively a
position that has been expressly denied by binding precedent. In In
re Henriksen, the court held that [quoted above]. The patent
examining process is a creature of statute, and operates on the
premise that the inventor is entitled to a patent if the statutory
requirements are met. 35 U.S.C. § 102 ("A person shall be entitled
to a patent unless--...."). The court today extends to patent
examiners a new power to deny a patent on the ground that the
applicant dawdled too long in prosecution.”
37
Arguments Raised
PTO
GSK
0
1
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
SCORE
38
Arguments Raised
PTO
GSK
0
1
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
SCORE
39
SECTION 132 v. Rule 114
35 USC 132 (b)
– The Director shall prescribe regulations to provide for the continued
examination of applications for patent at the request of the applicant.
GSK says no grant of power to restrict
PTO says opportunity for a showing is good enough
Limited briefing
Court says nobody wins yet
40
Arguments Raised
PTO
GSK
0
0
1
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
SCORE
41
Arguments Raised
PTO
GSK
0
0
1
1
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
SCORE
42
Claim Limits/ESD
35 USC 112
– “The specification shall conclude with one or more claims…”
Battle is over Chevron deference
Limited briefing
Court says nobody wins yet
43
Arguments Raised
PTO
GSK
0
0
1
0
0
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
SCORE
44
Arguments Raised
PTO
GSK
0
0
1
0
0
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
35 USC 2 (b)
Rules are
procedural only
PTO lacks substantive
rulemaking power
SCORE
45
PTO Lacks Substantive Rule Making
Authority
35 USC 2(b)
– The office may establish regulations not inconsistent with the law,
which
•
•
•
•
(a) shall govern the conduct of proceedings in the Office;
.
.
(c) shall facilitate the processing of patent applications
PTO: Our rules are procedural, they don’t impact rights under
sections 101, 102, 103
GSK: But they certainly impact rights under sections 120, 132,
111, and 112.
Court says GSK wins because of win on section 120
46
Arguments Raised
PTO
GSK
0
0
1
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
0
0
35 USC 2 (b)
Rules are
procedural only
0
1
PTO lacks substantive
rulemaking power
SCORE
47
Arguments Raised
PTO
GSK
0
0
1
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule
114
Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
0
0
PTO lacks substantive
rulemaking power
35 USC 2 (b)
Rules are
procedural only
0
1
Arbitrary & capricious
State Farm Mutual
Not explained,
ignores
alternatives
SCORE
48
Arbitrary and Capricious
GSK:
– (1) no explanation
– (2) no consideration of alternatives
PTO: State Farm deference: Court “is not to substitute its
judgment for that of the agency” but must “consider whether
the decision was based on a consideration of the relevant
facts and whether there has been a clear error of judgment”
GSK: No good comeback
PTO wins easily
49
Arguments Raised
PTO
GSK
0
0
0
1
0
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
Loophole
RCE
35 USC 132 v. Rule 114 Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
PTO lacks substantive
rulemaking power
35 USC 2 (b)
Rules are
procedural only
0
1
Arbitrary & capricious
State Farm Mutual
Not explained,
ignores
alternatives
1
0
Retroactivity
Landgraf
Landgraf
SCORE
50
Retroactivity
Rule is “retroactive” if it:
– Impairs rights party possessed when he acted;
– Increases party’s liability for past conduct
– Imposes new duties on a completed transaction
Landgraf v. USI Film Products (S. Ct. 1994)
51
Retroactivity (cont…)
PTO:
- No vested property right until issuance.
- No transaction completed until patent issues.
GSK
- Landgraf not limited to vested rights.
- Requirements for “showing” are new duties
- ESD requirement is a new duty.
- Changes terms of bargain between trade secret
(a property right) and disclosure.
Court: GSK likely to prevail
52
Arguments Raised
PTO
GSK
0
0
0
1
0
0
Rules contrary to statute
Continuation
35 USC 120 v. Rule 78
RCE
35 USC 132 v. Rule 114 Loophole
Claim limit/ESD
35 USC 111, 112 v.
Rules 75, 265
Chevron
deference
PTO lacks substantive
rulemaking power
35 USC 2 (b)
Rules are
procedural only
0
1
Arbitrary & capricious
State Farm Mutual
Not explained,
ignores
alternatives
1
0
Retroactivity
Landgraf
Landgraf
0
1
1
3
SCORE
Loophole
53
THANK YOU
J. Peter Fasse
617-521-7802
Faustino Lichauco
617-521-7034
www.fr.com
Note: These materials are for general informational purposes
only and should not be construed as legal advice. This
presentation is not intended to create an attorney-client
relationship between you and Fish & Richardson. This
material may be considered advertising in certain states. Prior
results do not guarantee a similar outcome. The FR Logo and
FISH & RICHARDSON are registered trademarks of Fish &
Richardson P.C.
55