Transcript CLOZARIL MASTER 2

Strategic Intellectual Property
Protection
Hsiu-Ming Saunders, Ph.D, J.D.
Attorney at Law
U.S. Tel: (650) 610-9136
[email protected]
Aug. 2007
Table of Contents
• What is a Patent?
• Patent Value Proposition
• Two Prongs of Patent Strategy
• Patent Process
• Budgeting
• Overcoming Examiner Rejections – Real cases
• Problems encountered by Asian inventors in
Applying for U.S. Patent Applications
2
What is a Patent?
• Patent types
- Utility
- Design
- Plant
3
Patentable Subject matter
• “machine” - apparatus, e.g., a medical device
• “process” – e.g., a method for treating diabetes or
making a chemical compound
• “article of manufacture” – e.g., an isolated DNA,
Protein, or peptide, or a chemical compound.
• “composition” – e.g., a pharmaceutical composition
4
Patentability
• New
• Nonobvious
• Utility
5
Patent Rights and Remedies for
Infringement
• Right to exclude others from making, using, selling,
offering for sale, or importing the patented
technology
• Injunction, damages in form of lost profits or
reasonable royalty, tripled for willful infringement,
attorneys’ fees, prejudgment interest, costs
6
Patent Value Proposition
• Defensive use of portfolio
– Counter infringement charges
– Prevent others from patenting
• Offensive use of portfolio
– Derive Revenue
– Prevent others from engaging in company’s
business
• Increase Valuation of Your Company
• Attract investors
7
Contents of U.S. Patent Application
• Title of the Invention
• Background of the Invention
• Field of the Invention
• Summary of the Invention
• Brief Description of Drawings
• Detailed Description of the Invention
• Claims
• Abstract
• Drawings
8
Two Prongs of Patent Strategy
• Defensive Use
• Patent Portfolio Building - create value for the
company
9
Patent Portfolio Philosophy
• Obtain strong, enforceable patents
• Build the highest quality patent portfolio
10
Obtaining Valuable Patents
• Pioneer technology or major improvement
– Invention creates new industry
– Invention is so new
• Roadblocks
– competitors must infringe patent to carry out their
enterprises
• Widespread applications
– across many different industries
• Easy to Detect Infringement
– claims that are easy to read on competitors’
device or process
11
Patent Process Overview
Phase 1: Set Up Company Infrastructure for Patenting
Phase 2: Invention Discovery - Patenting Decision
Phase 3: Patent Preparation and Filing Phase
Phase 4: Patent Prosecution Phase
Phase 5: Patent Maintenance and Exploitation Phase
12
Who is involved in the patent process?
• Patent Coordinator
• Patent Committee
• Company Development Team
• Patent Legal Counsel
• Patent Examiners
13
PHASE I PHASE II PHASE III
Implementation Discovery of
Strategy
Patentable
Technology
Most countries
other than U.S.
do not have
grace period
ì
Patent
Application
Preparation
Non-U.S.
ApplicationsPCT Applications to
preserve foreign
rights
Must file for
patent protection
before first public
disclosure, public
use or certain
commercial
activity.
Public disclosure/public use/
commercial activity involving
invention
PHASE IV
PHASE V
Patent
Prosecution
Patent
Issuance
& Exploitation
PATENT TIMELINE
U.S.
provisional/nonprovisional
application filing date
to preserve U.S. rights
One-year
U.S.
grace
period
1 year
Deadline for
filing in many
countries
Patent Prosecution
2 - 3 years
Deadline
for
filing U.S.
patent
application
Patent
Issuance
Patent
Exploitation
17 -18 years
Publication
ì 18 months after earliest filing date,
either U.S. provisional, U.S.
nonprovisional, or non-U.S. patent
application filing
ì If no non-U.S. patent filings will be
made, may request non-publication in
U.S. until patent issuance)
Budgeting for Patents
(U.S. Dollars, estimated)
1. U.S. Application Budgeting
• Patent search cost
$500-1,000
• Search report and analysis
$2,500-5,000
• Prepare patent application,
specification, claims, drawings,
assignment of patent rights, information
disclosure statement and cited
documents (costs dependent on
complexity of subject matter,
number of different inventions, bar dates,
closeness of art)
$10,000-40,000
• Patent prosecution (per application)
$5,000-15,000
15
Budgeting for Patents
(U.S. Dollars, estimated)
2. International Application Budgeting
– Filing costs, per additional country (costs per
country vary greatly)
$2,000 - 30,000
– Prosecution costs
$5,000 - 15,000
– Annuity fees (yearly)
$200 - 1,000
16
Practical Considerations
of Patent Portfolio Development
• Disclosure – must fully disclose the invention to the
public in return for monopoly (is trade secret
protection more effective?)
• Cost – patents can be expensive to procure and
maintain and are even expensive to enforce
• Time – inventors and others in company must invest
time in process to obtain and enforce patents
• Process – patents generally require 2 - 4 years to
obtain
• Possible Loss of Patent Rights – company must
monitor sales efforts, publications, or other events
that might result in loss of patent rights
17
Overcoming Examiner’s Rejections –
Real case illustrations
• Restriction Requirement
• Obviousness Rejection
• Enablement Rejection
• Written Description Rejection
18
Restriction Requirement
• What is it? (group election, species election)
• Examiner’s position
• Applicant’s position
• Patent Attorney’s position
• Response:
– Elect
– without traverse
– with traverse
19
Restriction Requirement: Real Case
illustration
U.S. Application No. 10/893,551
Title: “Compositions of Protein Mimetics and
Methods of Using Same Against HIV-1,
Sars-Cov and the Like”
Claim:
A protein mimetic for preventing HIV
entry into a host cell comprising:
a.
b.
at lest two peptide strands, and
an interstrand linker coupling the
peptide strands
20
Peptide strand:
T1249
WMEWYTSLIHSLIEESQNQQEKNEQELLELDK
WASLWNWF
C34
ELL
WMEWDREINNYTSLIHSLIEESQNQQEKNEQ
DP178
YTSLIHSLIEESQNQQEKNEQELLELDKWASL
WNWF
21
Interstrand linker structure I
22
Interstrand linker structure II
23
Restriction Requirement from the
Examiner:
“[r]estriction to one of the following inventions
is required . . . :
I. Claims 1-15, 23-29, 30-37 and 45-51 are
drawn to a protein mimetic comprised of
two peptides covalently linked together
and capable of inhibiting fusion of two
separate membranes, classified in class
530, subclass 332.
II. Claims 16-22 and 38-44, drawn to a
method for preventing or treating HIV-1
using the pharmacological composition of
Group I, classified in class 514, subclass
2.”
24
Restriction Requirement
The Examiner also stated that:
“[n]o matter which group is elected, a further
election of species is required. This
application contains claims directed to the
following patentably distinct species: Various
peptidomimetics (see for example claims 35).”
25
Arguments:
These peptide strands are not patentably
distinct species
T1249
WMEWYTSLIHSLIEESQNQQEKNEQELLE
LDKWASLWNWF
C34
WMEWDREINNYTSLIHSLIEESQNQQEKN
EQELL
DP178
YTSLIHSLIEESQNQQEKNEQELLELDKWA
SLWNWF
• Contain the same amino acid fragment 638662; and
• DP178 is a partial fragment of T1249
26
Arguments: Interstrand linkers of Formula
I and II are not patentably distinct
because
They belong to the same genus of the compound
of the formula depicted below:
X
Formula III
X
C=O
C=O Gly
X
C
ßAla
Lys
(Lys)n
R
O
27
Successful Outcome
• The arguments overcame the species election
requirement.
“Applicant’s election with traverse of
invention I . . . is acknowledged. The
traversal is on the ground(s) that peptide
T1249 and C34 are not patentably distinct
from the elected peptide DP179; linker I and
II are not patentably distinct. This is found
persuasive because of applicants’
arguments.”
28
Overcoming Rejections under
Enablement, written description, obviousness
U.S. Application No. 10/999,393
“Anti-Thrombotic Thrombin Variants”
Invention: (claim 1 as illustration)
1. A variant thrombin comprising an amino acid
sequence having the substitutions W215A and
E217A, wherein the amino acid sequence is at
least 80% identical to the sequence set forth in
SEQ ID NO: 3.
29
In Office Action Feb. 21, 2006,
Examiner rejected all claims
• Enablement Rejection
– while being enabling for the thrombin variant of SEQ
ID NO:3, does not reasonably provide enablement for
a thrombin variant that has substitutions W215 and
E217 and is at least 80% identical to SEQ ID NO:3.
• Written Description Rejection
– The specification does not contain any disclosure of
the function of all said polypeptides.
• Obviousness Rejection
– rejected as being unpatentable over Gibbs et al., 1995
in view of Arosio et al., 2000 (IDS) or Ayala et al.,
2001.
– Examiner asserted: suggestion and motivation to
combine is based on skilled artisan’s desire to provide
a thrombin variant with enhanced protein C activity
and decreased fibrinogen cleavage.
30
Argued in June 20, 2006 Response:
• Enablement
One of ordinary skilled in the art could practice
the invention without undue experimentation
(1)
(2)
(3)
(4)
(5)
(6)
Nature of the invention
Breadth of claims
Guidance
Working Examples
Quantity of experimentation necessary
Relative skill of those in the art
31
Argued in June 20, 2006 Response
Insufficient Written Description:
The working examples disclosed in the
specification are representative to the function
of the claimed thrombin variants. Further, the
specification has detail descriptions of making
and testing WE thrombin variants. Thus,
Applicants had contemplated and possessed
the claimed invention at the time when the
application was filed.
32
Argued in June 20, 2006 Response
Obviousness
– Neither reference provides any suggestion or
motivation for making a thrombin variant that has two
substitutions, let alone two substitutions W215A and
E217A.
– Claimed invention is non-obvious because of the
unexpected properties.
– The combination product WE has an synergy
effect on reducing the release of fibrinopeptides
A and B. See Tables 1 and 2
» (Fibrinogen: E217A: W215A:WE =
0.27:0.034:0.00089; Fibrin: E217A:
W215A:WE = 0.15:0.053:0.0021)
– Contrary to the examiner’s assertion, the combination
of E217 and W215A produces a dramatically
decreased, rather than enhanced, protein C activity.
See Table 2 data for Protein C + TM
(E217A:W215A:WE = 140:75:33).
33
Final Office Action Aug. 24, 2006:
Examiner maintained rejections
• Enablement
– “determining which of all polypeptides having at least
80% homology to SEQ ID NO: 3 have the desired
activity would require undue experimentation.”
• Insufficient written description
– Claim 1 fails to provide any functional limitations for
the recited thrombin variants. Therefore, the
polypeptides encompassed by the recited genus have
any or no activity.
34
In Final Office Action Aug. 24, 2006,
Examiner maintained rejections
• Obviousness
– The “synergistic effect is not unexpected” and
that “many enzymes have allosteric sites that
act synergistically in both the activation and
inhibition of the enzyme.” Citing Metzler et al
(2001).
– “The skilled artisan would know that it is the
ratio of protein C activity to fibrinogen
clotting activity (PA/FC), not the absolute
protein C activity, that determines whether the
action of thrombin will be primarily anticoagulation, via the activation of protein C, or
procoagulation, via cleavage of thrombin*.”
(*: fibrinogen)
35
Response to the Final Office Action:
Vigorously Refuted Examiner’s points
• Enablement and written description:
– Amended claim 1 to require the variant thrombin
W215A/E217A having the amino acid sequence set
forth in SEQ ID No: 3
• Obviousness:
– The invention E217A/W215A possesses unexpected
synergistic properties as shown in the attached Exhibit
A.
– addressed and Refuted Examiner’s each point by
citing scientific authority
36
Exhibit A
The invention Shows Synergistic Results
(From Tables 1 and 2, see Specification, pages 48 and 50)
Property
E217A
W215A
WE
PA/FC *
40.06
170
2865
Fibrinogen
kcat/Km (µM-1s-1)
0.27
0.034
0.00089
Fibrin
kcat/Km (µM-1s-1)
0.15
0.053
0.0021
Protein C + TM
kcat/Km (µM-1s-1)
0.14
0.075
0.033
PAR1
kcat/Km (µM-1s-1)
0.66
1
0.026
Antithrombin III
kon (µM-1s-1)d
1
0.56
0.0040
37
Comparative Data Between Cited
References and the Invention (Exhibit A
continued)
Property
PA/FC *
Primary
Reference
Secondary
Reference
Invention
E229A (E217A)
W215A
WE
19.1
170
2865
*PA/FC here are calculated from the data shown in Tables 1 and 2. The term
"PA/FC ratio" as used herein refers to the ratio of the percent of wild-type
protein C activation (PA) activity remaining in a thrombin variant relative to
the percent of wild-type fibrinogen clotting (FC) activity remaining in the
thrombin variant. A value of PA/FC greater than 1.0 indicates that the
thrombin variant has reduced procoagulant fibrinogen cleavage activity
relative to the residual anticoagulant activity resulting from protein C
activation.
38
Response to the Final Office Action:
Vigorously Refuted Examiner’s points
• The life science/Biotechnology being in the area of
unpredictable art, a synergistic effect cannot
reasonably or necessarily be expected from
allosteric sites.
– McLennan reported that Hemoglobin has three
allosteric sites, and their interactions are nonsynergistic but are simply additive. See attached
Abstract (Biochemistry and Molecular Biology
International, Vol. 44, No. 1, pages 175-183,
1998).
– Rao G.S. reported that Ascaris
suumphosphofructokinase has two allosteric
sites, one for fructose 2,6-biphosphate and one
for AMP, and that their effects on the enzyme are
additive and not synergistic. See attached
Abstract (Archives of Biochemistry and
Biophysics, Vol. 365, No. 2, pages 335-343(9),
1999.)
39
Vigorously Refuted Examiner’s points in
Response to the Final Office Action
• Examiner shifted the basis of motivation after
Applicants had responded by pointing out that
the combination of E217A and W215A
produced a decreased, rather than enhanced
protein C activity.
• if the motivation to combine the two references
were really that obvious as the Examiner
alleged, the Examiner would have asserted the
motivation based on the skilled artisan's desire
to provide an enhanced PC/PF ratio at the first
place, rather than alleged “the skilled artisan's
desire to provide a thrombin variant with
enhanced protein C activation.
40
Successful Outcome
• Enablement and written description rejection
were withdrawn for the following reasons.
“The means by which the function of thrombin
is regulated by its structure has been well
characterized (Tsiang et al, 1995; Richardson
et al, 2000). Therefore, it would not be
undue experimentatikon for the skilled
artisan to make and use the full scope of the
recited thrombin variants; Applicants were in
possession of their recited invention.”
41
Successful Outcome
• Overcame obviousness rejection
– “The extent of synergy resulting from the double
W215A+E217A mutation is far greater than
expected. As disclosed by Applicant’s analysis in
Exhibit A, filed Jan. 18, 2007, the single mutation
E217A gives a PA/FC of 19.1 (Gibbs et al; Table
1), the single mutation W215A gives a PA/FC of
170 (Arosio et al; Table 1), while Applicants’
W215A_E217A thrombin variant has a PA/FC of
2865. Such dramatic synergy is far greater than
expected and, as such, the unexpected results
overcome the prior obviousness rejection (MPEP
716.02(c)). For these reasons, rejections of
Claims 1, 2, 6, 7, 16-18, 44 and 45 under 35
USC 103(a). . . is withdrawn.
42
Successful Outcome
Patent granted and issued May 29, 2007
U.S. 7,223,583
“Antithrombotic thrombin variants”
Claim 1. A protein comprising a variant
thrombin, wherein the variant thrombin is at
least 80% identical to the sequence set forth
by SEQ ID NO: 3 and comprises the residues
corresponding to Ala263 and Ala265 of SEQ ID
NO: 3, and wherein the variant thrombin has
a PA/FC ratio greater than 1.0.
43
Asian Inventors Applying for U.S.
Patents
• Problems Asian Clients Have in Finding a Good
U.S. Patent Lawyer
44
Intellectual Property Protections
in the U.S.: Problems Asian Clients Have in
Finding a Good Patent Lawyer
• Disparity with American Clients in the Quality
and Amount of Attention Obtained
• Language and Cultural Barriers Obstruct the
Flow of Communications
• Mistakenly Hiring a Poor or Incompetent Patent
Counsel
• Inadequacy- Counsel fails to help the client to
make an informed decision.
• Incompetence: Counsel fails to understand the
invention, lacks the technical background to
prosecute the patent application.
45
Problems Asian Clients Have in Finding a
Good Patent Lawyer – Real Examples
• Counsel asks clients what to do without telling
them what the options are and their
implications.
• Counsel misses essential information in writing
patent applications.
• Counsel fails to be a zealous advocate for
clients, causing loss of patent coverage or
potential invalidation.
46
Taiwanese Invention
1. A heat sink, comprising:
a substrate (12) having a predetermined shape and having a
first pivoting portion (20) on a predetermined portion thereof;
a heat scattering member (14) provided on the substrate . . .
; and
a clip member (16) for securing the heat scattering member on
the substrate . . . , wherein the clip member is moved between a
47
fist positiona first position and a second position . . ..
Prior Art (Brownell)
Taiwanese Invention
Examiner’s Novelty Rejection:
48
Poor Patent Strategy: Surrender scope of the
invention without Any Fight (1st Office Action)
1.
(Currently amended): A heat sink,
comprising:
a substrate having a predetermined shape and
having a first pivoting portion on a predetermined
portion thereof;
a heat scattering member . . .; and
a clip member for . . .,
and wherein the substrate is made of a ductile
material and the first pivoting portion is mold by
pressing at bottoms of opposite sides of the
substrate.
*The patent application states: “The substrate 12 has two pairs of
first pivoting portions 20 on bottom of
the opposite sides respectively.” ---- (problem: Chinese English)
49
IPC
INTELLECTUAL PROPERTY CONNECTIONS
Hsiu-Ming Saunders, Ph.D.
Telephone:
Mobile:
Facsimile:
E-Mail:
404-504-7688
651-235-7129
404.365.9532
[email protected]
[email protected]
Address:
299 Old County Road, Suite 28,
San Carlos, CA 94070