Life Science Patent Prosecution in View of the Final AIA Rules

Patent Prosecution in view of the Final
AIA Rules February 21, 2013

Mike Fuller, Kerry Taylor, Ryan Melnick, and Brenden Gingrich

Orange County San Diego San Francisco Silicon Valley Los Angeles Riverside Seattle Washington DC

knobbe.com

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© 2013 Knobbe, Martens, Olson & Bear, LLP all rights reserved. 2

Prior Art under the AIA

© 2013 Knobbe, Martens, Olson & Bear, rights reserved.
©2012 Knobbe Martens, Olson & Bear, LLP all LLP all rights reserved. 3

New §102(a)(1) – Public Prior Art
Old 102(a)-102(g) replaced by new 102(a):
102(a)(1) parallels old
102(a): Novelty; Prior Art- A person shall be entitled to a 102(a) and (b)
patent unless--

102(a)(1): the claimed invention was patented, described in a
printed publication, or in public use, on sale, or otherwise
available to the public before the effective filing date of the
claimed invention; or


102(a)(1) parallels old
102(a): Novelty; Prior Art- A person shall be entitled to a 102(a) and (b)
patent unless--

printed publication, or in public use, on sale, or otherwise USPTO: use or sale under
available to the public before the effective filing date of the NDA not prior art
claimed invention; or

no longer an ―in this
country‖ requirement –
public use/sale anywhere
now counts as prior art


USPTO: example--public
102(a): Novelty; Prior Art- A person shall be entitled to a oral presentation and slides
patent unless--

available to the public before the effective filing date of
the claimed invention; or


USPTO: example--public
102(a): Novelty; Prior Art- A person shall be entitled to a oral presentation and slides
patent unless--

available to the public before the effective filing date of
the claimed invention; or

―effective filing date‖ also
―before the invention‖ and can mean a foreign priority
―more than one year prior‖ date
to US filing now replaced
with ―before the effective
filing date of‖


Summary of Key “First-to-File” Changes

 Public prior art is effective as prior art even if only one day
prior to filing the patent application
 Public presentations anywhere in the world are prior art
(USPTO interpretation)
 Foreign activities can be prior art (public sales, public use,
etc.)


New § 102(a)(2) – Application Prior Art
102(a): Novelty; Prior Art- A person shall be entitled to a
patent unless-- 102(a)(2) parallels old
102(e)
102(a)(2): the claimed invention was described in a
patent issued under section 151, or in an application for
patent published or deemed published under section
122(b), in which the patent or application, as the case may
be, names another inventor and was effectively filed
before the effective filing date of the claimed invention.


patent unless-- 102(a)(2) parallels old
102(e)
102(a)(2): the claimed invention was described in a
patent issued under section 151, or in an application
for patent published or deemed published under
section 122(b), in which the patent or application, as the
case may be, names another inventor and was effectively
filed before the effective filing date of the claimed
invention.
A published PCT app that
designates the US counts as
prior art – even if it wasn’t
published in English


patent unless-- ―names another inventor‖
is same as ―by another‖ in
102(a)(2): the claimed invention was described in a old 102(e) – means a
patent issued under section 151, or in an application for different inventive entity
before the effective filing date of the claimed invention.


patent unless-- ―names another inventor‖
is same as ―by another‖ in
102(a)(2): the claimed invention was described in a old 102(e) – means a
patent issued under section 151, or in an application for different inventive entity
before the effective filing date of the claimed
invention.
―effectively filed‖ can mean
a foreign priority date

―effectively filed‖ can mean
a foreign priority date


Summary of Key “First-to-File” Changes

 Prior filed application is effective as prior art even if only one
day prior to filing the patent application
 Foreign filing date can be effective prior art date
 PCT applications need not be in English

 102(c), 102(d), 102(f), and 102(g) eliminated
– But USPTO will police 102(f) using 101 and 115
– 102(g) applies to some transitional applications


Exceptions to Prior Art under the AIA


Exceptions to 102(a)(1) Prior Art

 102(b)(1) A disclosure made 1 year or less before the
effective filing date of a claimed invention shall not be
prior art to the claimed invention under subsection (a)(1)
if:
– (A) the disclosure was made by the inventor or
joint inventor or by another who obtained the
subject matter disclosed directly or indirectly from
the inventor or a joint inventor; or
– (B) the subject matter disclosed had, before such
disclosure, been publicly disclosed by the inventor
or a joint inventor or another who obtained the
the inventor or a joint inventor.



 102(b)(1) A disclosure made 1 year or less before
the effective filing date of a claimed invention shall
not be prior art to the claimed invention under
subsection (a)(1) if: PTO Position:
―disclosure‖ is a generic
joint inventor or by another who obtained the expression
subject matter disclosed directly or indirectly from encompassing all the
the inventor or a joint inventor; or documents and activities
– (B) the subject matter disclosed had, before such of 102(a)(1)



1) ―Grace Period Inventor
if: Disclosure‖
the inventor or a joint inventor; or



if: Disclosure‖
the inventor or a joint inventor; or 2) ―Grace Period Inventor-
– (B) the subject matter disclosed had, before such Originated Disclosure‖



if: Disclosure‖
the inventor or a joint inventor; or 2) ―Grace Period Inventor-
– (B) the subject matter disclosed had, before Originated Disclosure‖
such disclosure, been publicly disclosed by the
inventor or a joint inventor or another who
obtained the subject matter disclosed directly or
indirectly from the inventor or a joint inventor.
3) ―Inventor or Inventor-
Originated Prior Public
Disclosure‖


PTO Interpretation
Comparison is between the
prior art to the claimed invention under subsection (a)(1) subject matter of the two
if: disclosures—the claimed
– (A) the disclosure was made by the inventor or invention is irrelevant
the inventor or a joint inventor; or Modes of disclosure can be
– (B) the subject matter disclosed had, before different
such disclosure, been publicly disclosed by the
inventor or a joint inventor or another who obtained
Disclosures do not need to be
the subject matter disclosed directly or indirectly
from the inventor or a joint inventor.
verbatim the same

Intervening disclosure can
be more general than
inventor disclosure

Examples of Inventor Prior Public Disclosures

Inventor Prior Public Disclosure Intervening Disclosure

1 2
2 1
Genus A
3
3

PTO: NOT PRIOR ART




4
1 2
2 1
Genus A
3
3

PTO: SPECIES 4 IS PRIOR ART




1 2
Genus A
3

PTO: SPECIES ARE PRIOR ART




A+B +C A+B +C + D

PTO: ONLY ELEMENT D IS PRIOR ART



 102(b)(2) A disclosure shall not be prior art to a claimed
invention under subsection (a)(2) if :
– (A) the subject matter disclosed was obtained
directly or indirectly from the inventor or a joint
inventor;
subject matter was effectively filed under
subsection (a)(2), been publicly disclosed by the
from the inventor or a joint inventor; or
– (C) the subject matter disclosed and the claimed
invention, not later than the effective filing date of
the claimed invention, were owned by the same
person or subject to an obligation of assignment to
the same person.



1) ―Inventor-Originated
Disclosure‖
directly or indirectly from the inventor or a
joint inventor;
from the inventor or a joint inventor; or
the same person.



Disclosure‖
joint inventor;
– (B) the subject matter disclosed had, before
such subject matter was effectively filed under 2) ―Inventor or Inventor-
subsection (a)(2), been publicly disclosed by the Originated Prior Public
inventor or a joint inventor or another who Disclosure‖
indirectly from the inventor or a joint inventor; or
the same person.



Disclosure‖
joint inventor;
– (B) the subject matter disclosed had, before
such subject matter was effectively filed under 2) ―Inventor or Inventor-
subsection (a)(2), been publicly disclosed by the Originated Prior Public
inventor or a joint inventor or another who Disclosure‖
indirectly from the inventor or a joint inventor; or
– (C) the subject matter disclosed and the
claimed invention, not later than the effective
filing date of the claimed invention, were owned 3) ―Common Ownership or
by the same person or subject to an obligation Obligation of Assignment‖
of assignment to the same person.



Similar in scope to old
103(c), but removes both
directly or indirectly from the inventor or a joint anticipatory and
inventor; obviousness references
102(c) considers ―joint
research agreement‖ as
from the inventor or a joint inventor; or common ownership
Joint research agreement
the same person. must be in effect before the
effective filing date


Prior Art Exceptions - Summary

Exceptions to 102(a)(1) Prior Art Exceptions to 102(a)(2) Prior Art
Grace Period Inventor Disclosure
Grace Period Inventor-Originated Inventor-Originated Disclosure
Disclosure
Inventor or Inventor-Originated Prior Inventor or Inventor-Originated Prior
Public Disclosure Public Disclosure
Common Ownership or Obligation of
Assignment



Disclosure
Assignment


Removing Grace Period Inventor Disclosure

 If prior disclosure does not include additional authors, simple
argument should remove the reference
 e.g., disclosure = authors A and B
inventors = A, B, and C
 Can include statement regarding prior disclosures in
specification (37 CFR 1.77(b)(6))
 Affidavit or declaration of attribution (37 CFR 1.130(a))
– “Unequivocal statement” that the inventor invented the
subject matter
– Reasonable explanation of the presence of additional
authors on prior disclosure
– Additional evidence may be required


Disclosure
Assignment


Removing Inventor-Originated Disclosures

 Affidavit or declaration of attribution (37 CFR 1.130(a))
– Establish that the subject matter originated with the
inventor
– Establish that the subject matter was communicated by the
inventor, directly or indirectly
– Include documentation evidencing the communication


Removing Inventor-Originated Disclosures

 Derivation
– Cannot use 1.130 declaration to remove prior patents or
applications as inventor-originated if the patent or
application claims the same or substantially same invention
(37 CFR 1.130(c))
– Can file petition for derivation proceeding



Disclosure
Assignment


Removing Intervening Disclosures

 Affidavit or declaration of prior public disclosure (37 CFR
1.130(b))
– Identify subject matter publically disclosed by inventor
 If printed publication, include copy
 If not printed publication, describe with sufficient detail
– Identify date of disclosure
– If based on inventor-originated disclosure, need to also
make showings of origination and communication



Disclosure
Assignment


Removing Commonly Owned Patents and Applications

 Clear and conspicuous statement (37 CFR 1.104(c)(4)(i))
– common ownership or obligation of assignment to common
owner
– as of effective filing date of claimed invention
 Can be submitted by representative of record


Removing Joint Research Agreement Patents and
Applications
 Application must disclose or be amended to disclose the names
of the parties to the agreement
 Submission of statement (37 CFR 1.104(c)(4)(ii))
– Prior disclosure and claimed invention made on behalf of
one or more parties to a joint research agreement
– Agreement was in effect prior to the effective filing date
– Claimed invention was made as a result of the activities
undertaken within the scope of the agreement
 Can be submitted by representative of record


Filing Strategies in view of the AIA


Three Possible Examination Regimes

 Pure Pre-AIA
– Only pre-AIA §102(a)-(g) and §103(a)-(c)
– Advantages: swearing behind §102(a)/(e) art
 Pure AIA
– Only AIA§102 and §103 apply
– No pre-AIA §102(a)-(g)
– Advantages: common ownership removes §102(a)(2) art
for §102 and §103
 Mixed Pre-AIA and AIA
– AIA§102 and §103 apply, and
– Pre-AIA§102(g) applies

Three Possible Examination Regimes

 The AIA applies to an application or patent issuing thereon
“that contains or contained at any time”
– A claim that is not supported by a pre-AIA application, or
– A priority claim to an application that “contains or
contained at any time such a claim”
 Examination regimes are applied to all claims in an
application, not on a claim-by-claim basis


What does “contained at any time” mean?

 PTO’s position on unsupported claim amendments
– Claim amendments constituting “new matter” are not
permitted under 35 U.S.C. §132(a)
– Claim amendments entered and rejected as “new matter”
for examination purposes are not “contained” in the
application
– Therefore, claim amendments containing “new matter” do
not trigger the AIA, and can be canceled
 PTO may be wrong
– If so, cannot fix by canceling or amending claim to
overcome rejection

What does “contained at any time” mean?

 PTO’s position – open questions:
– Claim amendments lacking enabling support?
 No “new matter” lack of enablement rejection
 Presumably converts application to AIA
– Original claims / filing date preliminary amendment
lacking written description or enablement?
 “Contained” in the application
 Presumably converts application to AIA
– Cannot fix by canceling or amending claim


Identification of Transition Applications

 Applications that fall under AIA and claim priority to a pre-
AIA application must be identified as such
 Revised ADS will include check box
– No need to identify which claims are at issue
 Must file within the later of
– 4 months from filing / national stage entry
– 16 months from filing date of the pre-AIA application
– The date a claim with an effective filing date on or after
March 16, 2013 is added to the application


Selecting a Mixed Examination Regime

 A claim wholly supported by a pre-AIA application and a
claim not supported by pre-AIA application
 “At any time” in priority chain rule applies
– Easy to get into mixed regime, can never leave while
maintaining priority claim

March 16, 2013

Claim A Claim A Claim A
Claim A
Disclose B Claim B Disclose B


Selecting a Pre-AIA Examination Regime

 All claims must be supported by a pre-AIA application
 No priority application can be under AIA regime
– This includes a parent application that “flips” to AIA after
child application is filed
March 16, 2013

Disclose A
Disclose B Disclose B Disclose B



 All claims must be supported by a pre-AIA application
 No priority application can be under AIA regime
– This includes a parent application that “flips” to AIA after
child application is filed
March 16, 2013

Disclose A
Claim B Disclose B Disclose B



 Keep a pre-AIA line pending, with prosecution “branches” to
avoid mixed examination regime

March 16, 2013

Disclose A Disclose B Disclose B Disclose B

Disclose A Claim A
Claim B Claim B



 Or file separate pre-AIA and mixed applications to avoid
inadvertently entering mixed regime

March 16, 2013

Disclose A Claim A Claim A Claim A’

Claim A Disclose A
Claim B Claim B


Selecting a Pure AIA Examination Regime

 No claim wholly supported by a pre-AIA application
– Presence of claim wholly supported by pre-AIA application
results in mixed examination regime
– “At any time” rule applies, will “flip” family
March 16, 2013

Disclose A Disclose A Claim A
Disclose A
Claim B Claim B Disclose B


Selecting a Pure AIA Examination Regime

 No claim wholly supported by a pre-AIA application
– Presence of claim wholly supported by pre-AIA application
results in mixed examination regime
– “At any time” rule applies, will “flip” family
March 16, 2013

Claim A Disclose A Claim A
Disclose A
Claim B Claim B Disclose B


What to do before March 16, 2013

 If you want pure AIA regime
– If so, patent family with no pre-AIA claims is required
– Can let March 16 date pass
 If you want mixed AIA regime
– Application with pre- and post-AIA claims gets mixed
– Can let March 16 date pass


What to do before March 16, 2013

 If you want pre-AIA regime
– Option #1: file non-provisional prior to March 16
 Avoid §112 rejection “flip” of original claim
– Option #2: file provisional prior to March 16
 #2(a): file non-provisional carbon copy at 1-year
– Protects against claiming post-March 16 matter
 #2(b): file non-provisional with post-March 16 matter at
1-year
– Allows for pre-AIA and mixed family lines


Keeping All Options Open Strategy
March 16, 2013 1-Year Date

App. #1 App. #2

Claim A AND / OR Claim A Claim A

App. #3

Disclose A Disclose A Disclose A
Disclose A
Disclose B Claim B Claim B

Claim A Disclose A
Disclose B Claim B


California CLE Credit
 For CLE Credit, we have your bar number if you entered it during registration.
 If you did not enter it you bar number, please send an email to
 If you watched the webinar in a group, please send your name and bar number to


Disclaimer
 This presentation and our discussion constitute an educational and informational
presentation of the AIA and should not be construed as individualized legal advice
or representation.
 The presentation of these materials does not establish an attorney-client
relationship. Representation can be initiated only upon completion of our standard
new client/new matter process, including completion of a conflicts check, execution
of an engagement agreement and payment of any applicable retainer.
 Any discussions are based solely upon non-confidential information you may
provide. It is our understanding that you will not provide us with any confidential
information and will not do so until representation is initiated.


 mike.fuller@knobbe.com
 kerry.taylor@knobbe.com
Thank You!  ryan.melnick@knobbe.com
 brenden.gingrich@knobbe.com


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