Biotech Patents and Section 101 Rejections: Meeting Patent Eligibility Requirements Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections Today’s faculty features: 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10. THURSDAY, JUNE 8, 2017 Presenting a live 90-minute webinar with interactive Q&A Denise M. Kettelberger, Ph.D., Boston Katherine M. Kowalchyk, Ph.D., Partner, Merchant & Gould, Minneapolis
Transcript
Biotech Patents and Section 101 Rejections:
Meeting Patent Eligibility Requirements Leveraging Recent Decisions and USPTO Guidance to Overcome Rejections
The audio portion of the conference may be accessed via the telephone or by using your computer's
speakers. Please refer to the instructions emailed to registrants for additional information. If you
have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.
THURSDAY, JUNE 8, 2017
Presenting a live 90-minute webinar with interactive Q&A
Denise M. Kettelberger, Ph.D., Boston
Katherine M. Kowalchyk, Ph.D., Partner, Merchant & Gould, Minneapolis
Tips for Optimal Quality
Sound Quality
If you are listening via your computer speakers, please note that the quality
of your sound will vary depending on the speed and quality of your internet
connection.
If the sound quality is not satisfactory, you may listen via the phone: dial
1-866-819-0113 and enter your PIN when prompted. Otherwise, please
send us a chat or e-mail [email protected] immediately so we can address
the problem.
If you dialed in and have any difficulties during the call, press *0 for assistance.
Viewing Quality
To maximize your screen, press the F11 key on your keyboard. To exit full screen,
press the F11 key again.
FOR LIVE EVENT ONLY
Continuing Education Credits
In order for us to process your continuing education credit, you must confirm your
participation in this webinar by completing and submitting the Attendance
Affirmation/Evaluation after the webinar.
A link to the Attendance Affirmation/Evaluation will be in the thank you email
that you will receive immediately following the program.
For additional information about continuing education, call us at 1-800-926-7926
ext. 35.
FOR LIVE EVENT ONLY
2017 PATENT ELIGIBILITY
IS THE TIDE CHANGING?
JUNE 8, 2017
Denise M. Kettelberger, PhD, JD
Patterson Thuente Pedersen, PA
Minneapolis, MN
RECENT DECISIONS QUESTION ALICE &
MAYO 2-STEP TEST
5
Alice/Mayo Statistics - Ineligible
■ More than 16,000 claims invalidated
■ 68% of Federal Court Decisions ineligible
■ 92% of Federal Circuit Decisions ineligible
■ 61% of District Court Decisions ineligible
■ 60% of US Patents invalidated
■ 63% decided by motion on pleadings
■ 85% of CBM institutions
■ 98% of CBM final decisions
■ 43% of PGR decisions
■ 36% of ITC decisions
6
Bilski Blog, Robert Sachs
Supreme Court Decisions Applying the Alice/Mayo 2-step Test - Deficient ■ Lacks an objective standard for judging patent-eligibility,
■ Fails to define key terms of the Alice/Mayo test, such as “abstract idea”
and “something more”, other than by analogy to patents in prior cases;
■ Fails to provide meaningful and logical guidance for how to reach patent-
eligibility,” especially for systems/methods involving these so-called
“business methods”;
■ Provides conflicting patent-eligibility standards with respect to their own
precedents, particularly of Diamond v. Diehr and Diamond v. Chakrabarty;
■ Ignores Congressional intent by overreaching its constitutional authority to
interpret (not make) law, including asserting “policy” considerations to
support the two-part Alice test that are the province of Congress (not the
Supreme Court).
■ Providing no support in the factual record before it; and
■ Focuses on an “inventive concept,” improperly comingling patent-eligibility
under 35 U.S.C. § 101 with patentability under 35 U.S.C. § 102 and/or 35
U.S.C. § 103.
7
Can the Federal Circuit Stem the Tide? ■ Enfish LLC v. Microsoft Corp
■ TLI Communications LLC v. AV Automotive LLC
■ Rapid Litigation Management v. Cellz Direct
■ Sequenom v. Ariosa
■ McRO, Inc. v. Bandai Nanco Gaming, Inc.
■ Bascom Global Internet Services v. AT&T Mobility
■ Amdocs LTD v Opennet Telecom Inc
■ Thales v U.S.
8
Enfish v Microsoft (822 F3d 1327,Fed Cir 2016) ■ Model for a computer database
– All data entries stored in a single, self-referential table with column definitions by rows
– Conventional systems store data entries in multiple table
– Benefit in faster searching, more effective storage, flexablility
■ CDCA on Summary Judgement, all claims ineligible under §101
– Innovative logical claims held ineligible, anticipated, and non-infringed
■ Federal Circuit disagreed:
– Supreme Court did not foreclose the possibility that claims to improvements in computer existing architecture or software may survive Step 1 of the eligibility inquiry
– All claims directed to improvements in computer technology, hardware or software, need not be analyzed under the Step 2 inquiry.
9
Rapid Litigation Mgmt v. Cellz Direct (Fed Cir 2016) ■ …the "inventors certainly discovered the cells' ability to
survive multiple freeze-thaw cycles ... that is not where they stopped, nor is it what they patented.“
■ Instead, the inventors "employed their natural discovery to create a new and improved way of preserving hepatocyte cells for later use."
■ The court held the claims eligible under the first step of the Mayo/Alice framework
■ the "directed to" analysis requires more than "merely identifying a patent-ineligible concept underlying the claim" and instead requires an analysis of whether "the end result of the process, the essence of the whole was a patent-ineligible concept."
■ these claims that apply a law of nature are distinguishable from the claims in Mayo and Sequenom that were found to be directed to a patent-ineligible concept when they "amounted to nothing more than observing or identifying the ineligible concept itself 10
McRO, Inc. v. Bandai Namco Games America Inc. (Fed. Cir. 2016)
■ A method for automatically animating lip synchronization and facial expression of three-dimensional characters using sets of rules
■ The claimed invention relates to generating automated lip-synchronization and associated facial expression for 3D animated characters.
■ The inventive rule sets aim to produce more realistic speech by taking into consideration the differences in mouth positions for similar phonemes based on context."
■ Federal Circuit: "the claimed improvement here is allowing computers to produce accurate and realistic lip synchronization and facial expressions in animated characters that previously could only be produced by human animators."
■ "[d]efendants provided no evidence that the process previously used by animators is the same as the process required by the claims."
■ Judges Reyna, Taranto, and Stoll 11
Bascom Global Internet Services v. AT&T Mobility (Fed Cir 2016)
■ Method and system for content filtering information retrieved from an Internet computer network
– the claimed invention is able to provide individually customizable filtering at the remote ISP server by taking advantage of the technical capability of certain communication networks.
– no court – not the Supreme Court and not the Federal Circuit – has ever defined the term “abstract idea” or the term “significantly more.”
– “The district court’s analysis in this case, however, looks similar to an obviousness analysis, explained Judge Chen
■ The inventive concept …“is the installation of a filtering tool at a specific location, remote from the end-users, with customizable filtering features specific to each end user.”
12
Thales v. US (Fed Cir 2017)
■ Claims an inertial tracking system for tracking the motion of an object relative to a moving reference frame
■ Small errors in measuring acceleration and angular velocity translate to large errors in position over time; Known inertial systems include at least one other type of sensor, to correct these errors; The disclosed system can operate independently
■ The equations—dictated by the placement of the inertial sensors and application of laws of physics—serve only to tabulate the position and orientation information in this configuration. This arrangement is analogous to the claims in Diehr.
■ Far from claiming the equations themselves, the claims seek to protect only the application of physics to the unconventional configuration of sensors as disclosed. As such, these claims are not directed to an abstract idea and thus the claims survive Alice step one. Because we find the claims are not directed to an abstract idea, we need not proceed to step two 13
Sequenom v Ariosa (Fed Cir 2015)
■ Federal Circuit applied the two-step framework set out in Mayo and Alice
– Steps 2A and 2B in the USPTO's subject matter eligibility guidance
– Determined the claims were directed to a natural phenomenon (the presence of cffDNA in maternal serum or plasma),
– not recite an inventive concept that transforms cffDNA into a patentable invention because the amplifying and detecting steps are routine and conventional (788 F.3d at 1377).
■ Supreme Court denied cert, leaving Federal Circuit opinion in place.
■ Question – why wasn’t the application of the discovery of cffDNA in maternal blood not held to be an improvement over the only known method for obtaining fetal DNA samples, the invasive procedure of amniocentesis?
14
Federal Circuit embraces “improvement” inventions as not “abstract”
■ All but one of the Federal Circuit § 101 cases discussed above were found to be eligible for patenting as “improvements”
■ Many life science patents are invalidated as lacking an inventive concept at step 2. Going forward, applicants should stress the improvements made and distinguish the invention from well known products or processes.
– Consider if the game-changing inventions of Myriad Genetics, Sequenom, and others would have been eligible for patenting had the Federal Circuit stepped up to defend their patent claims?
15
Steps to Potentially Aid Patent Eligibility
■ DO
– Problem/Solution
– Compare Product or Process to Prior Known
– Specific method steps
– Detailed disclosure
– Discuss improvements
– Identify Gamechangers
■ DON’T
– Use General Claim Terms
– Claim as Routine & Conventional
– Disclose invention generally
– Use vague claim terms
– Hide new virtues of invention
16
Patentable Subject Matter
for Life Sciences
Katherine M. Kowalchyk
Merchant and Gould
2017
Agenda
• Review 101 analysis
• Review PTO guidelines and training
materials
• Analyze issued claims/Tips
• Summary of legislative proposals
18
101 Life science court cases
• Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 132 S. Ct. 1289,
1297 (2012): law of nature
• Ass'n for Molecular Pathology v. Myriad
Genetics, Inc., 133 S. Ct. 2107, 2117
(2013): natural product
• Ariosa Diagnostics, Inc. v. Sequenom,
Inc., 788 F.3d 1371 (Fed. Cir. 2015):
natural law
19
101 Lessons
• Does the subject matter of the claim include
new and useful process, machine,
manufacture, or composition of matter
• Is the claim directed to an exception
natural law, product, or abstract idea
• Compare application of the natural law or
product to that which occurs in nature to
find differences
• Something More :Inventive Concept
new steps, new result, new
technology, new characteristics
• Preemption: Are there alternatives 20
Challenges for All: Significant Differences
• Not Patentable Subject Matter: based on case
law
primers, methods of comparing sequences not
tied to a purpose or a specific set of mutations,
identification of a dosage, diagnostic methods (list
natural law and apply it- conventional techniques)
• Markedly Different: structure or function or both
• Inventive concept:102/103 analysis
combination of ordered steps, combination of
products or product that lends new features, changes
in structure, specifically identified changes that are
tied to a purpose(genetic mutations)
21
PTO Guidelines for the Life Sciences
• Promulgated in December 2014/Updated
examples 28-33 dated May 2016
• “Laws of Nature” and “Natural Phenomena”
include natural principles, naturally occurring
relations or correlations that occur without a
hand of man,
• Natural product: a substance found or derived
from nature
• Examples:
– The law of gravity
– The disinfectant qualities of ultraviolet light
– blood glucose levels and diabetes 22
Examples
• Gunpowder-combination of three
naturally occurring chemicals-eligible
• Pomelo juice plus preservative-
eligible(different properties)
• Amazonic acid and methods of
treatment eligible as long as amazonic
acid has a structural difference or is
combined with another component
• Purified protein having a different
crystal structure or different
glycosylation-eligible
23
Examples
• Genetically engineered bacterium with
new function-eligible
• Bacterial mixture with new properties-
eligible
• Nucleic acid with 1 change, a label, or a
vector-eligible
• Antibodies that are human or
humanized, claimed by CDRs, with
variants-eligible
• Stem cells with unique marker-eligible
• Food product with different property
24
Updates Examples 28-33
• Example 28- vaccine attenuated, killed, or with
adjuvant (resulting in a change in property-
enhanced seropositivity), or in device
• Example 29-diagnosing and treating julitis-
method of detecting or claiming specific reagents
• Example 30- dietary sweetener with additional
compounds resulting in new properties
• Example 31-Screening for gene alterations-
adding a specific device or cool melt PCR
• Example 32-Paper Making machine improves
process
• Example 33- Hydrolysis of Fat-chemical
transformation
25
New Example 28
• Vaccines attenuated, killed, or with
adjuvant, or in device are eligible
• Not eligible: peptide from virus not
altered other than isolated from virus:
3. A vaccine comprising: Peptide F; and a
pharmaceutically acceptable carrier.
26
PTO training on claim 28
• What was invented in each claim? BRI
Claim 3 is a vaccine with isolated peptide
F (not altered) in a carrier
• Does it fit in statutory category? Yes
• Is it a nature based product and/or
similar to court cases?
Use markedly different
characteristics(MDC) compare to natural
product in natural state-identify whether
the natural product is changed in
structure or function
27
PTO training on claim 28
• If no MDC then claim is directed to
judicial exception- peptide F and
water no change to structure or
function of peptide F so no MDC
• Is there something significantly more?
Inventive concept
Significantly more: unconventional
material or steps, transformation,
combination of elements e.g. use of
adjuvant and increase in seropositivity 28
Example 29 PTO analysis
• Diagnosing/treating julitis-diagnosing using
unconventional reagents- porcine abs or specific
ab or adding a treating step
• Ineligible: A method of diagnosing julitis in a
patient, said method comprising:
• a. obtaining a plasma sample from a human
patient; b. detecting whether JUL-1 is present in
the plasma sample by contacting the plasma
sample with an anti-JUL-1 antibody and detecting
binding between JUL-1 and the antibody; and
• c. diagnosing the patient with julitis when the
presence of JUL-1 in the plasma sample is
detected.
29
PTO analysis Example 29
• What is invention claimed using BRI?
method of diagnosing julitis
• Is it a statutory category?
Yes-process so no MDC needed
• Is claim directed to an exception?
Yes- like Mayo directed to correlation
between presence of Jul-1 and julitis
• Is there significantly more?
Only if unconventional steps or reagents-
porcine abs or specific monoclonal or
method of treating 30
Tips based on review of PTO analysis
• Consider structuring claims as close as
possible to the examples of eligible claims-
avoid claims similar to those found
ineligible by the Courts
• Argue that natural product is markedly
different in structure and/or function
• Argue process uses unconventional steps or
reagents or that the combination is unique
because of change in property or
improvement
• Change to “method of detecting”
• Avoid appeal-likely will lose 31
Issued Claims
• Nucleic acid claims-specific
sequences in claims have issued
• Polypeptide variant claims have
issued
• Polypeptide conjugated with
heterologous moieties
• Dimers of monomers-different forms
32
101 Rejections
• Detailed diagnostic method claims are issuing
• Need to interview because may be art unit
dependent-most success is interview and RCE
• Appeals not likely to succeed
• Statistics show that art units 1630, 1640,
1650, and 1660 have 20-50% OA with 101
rejections
• Art unit 1634-personalized medicine 101
rejections increased to 85% after Mayo
• Highest in bioinformatics, primers,
amplification, haplotyping 33
Claim of 14/750201 allowed (1678) 12. A method for diagnosing metabolic syndrome in a subject
comprising:
a. detecting and quantitating the level of arginine vasopressin pro-
hormone copeptin fragment in a sample from said patient,
wherein said detection and quantitation comprises contacting the sample
with a diagnostic assay reagent comprising at least one monoclonal
antibody or fragment thereof that specifically binds to the arginine
vasopressin pro-hormone copeptin fragment at the epitope corresponding
to amino acids 132-147 of pre-pro-vasopressin of SEQ ID NO: 1, and
detecting and quantitating thus-formed complexes of the antibody or
fragment thereof and arginine vasopressin pro-hormone copeptin
fragment,
b. detecting and quantitating at least one other clinical and/or laboratory
parameter associated with the diagnosis of metabolic syndrome, and
c. correlating the level of the arginine vasopressin pro-hormone copeptin
fragment in conjunction with the at least one other clinical and/or
laboratory parameter associated with the diagnosis of metabolic
syndrome, with the diagnosis of metabolic syndrome.
34
Arguments in response to 101
• Correlation of combined parameters-copeptin
fragment and one other parameter- is not a
natural phenomenon
• Significantly more-improvements to a
technological field-improves diagnosis
• Also combination of measuring the two
parameters not conventional-not known in the
art so not conventional
• No preemption-specific combination of
parameters
• Case law not meant to exclude all biomarkers
35
Issued Claims: US 9611511(AU1674)
• A method for detecting a decreased level of at least one
miRNA in a human patient having, or suspected of having, an
acute coronary syndrome comprising the steps of: (i)
providing a blood cell sample from a human, wherein the
blood cell sample is a blood cellular fraction consisting of a
mixture of erythrocytes, leukocytes and thrombocytes, and (ii)
detecting whether there is a decreased level of the at least one
miRNA in the blood cell sample as compared to a control
level of a healthy human subject, or a human subject not
having or not being suspected of having an acute coronary
syndrome, by contacting the sample with at least one probe
for at least one down-regulated miRNA and detecting binding
between the probe and the down-regulated miRNA; wherein
the nucleotide sequence of said at least one down-regulated
miRNA is miR-455-3p having SEQ ID NO: 16, or sequence
having at least 95% sequence identity thereto.
36
101 arguments • Argued that claim was amended to similar to
Example 29-amended claim to refer to
detecting rather than determining status, also
amended to add a specific sequence, other
claims as well were amended to specific
sequences
• Previous arguments not successful-blood
sample not natural and not used by others in
the field-unconventional –examiner cited art
to show methods of measuring miRNA in
blood cells were known
37
Issued Claims:US9606122(AU1636) An in vitro method for identifying a human subject having a poor prognosis of 5-
year survival of oesophageal and/or gastro-oesophageal junctional (GOJ)
adenocarcinoma, the method comprising the steps of: (a) obtaining a tumor tissue
sample from said human subject; (b) determining by RT-PCR assay the quantitative
expression level of a combination of target genes in said in vitro tumor tissue
sample obtained in step (a), wherein the combination of target genes consists of
TRIM44, SIRT2, EGFR, and WT1, and the RT-PCR assay utilizes at least one
primer selected from the group consisting of SEQ ID NO.1, SEQ ID NO.2, SEQ ID
NO.4, SEQ ID NO.5, SEQ ID NO.6, and SEQ ID NO.8; (c) comparing the
expression level of each target gene in said combination determined in step (b) with
a reference standard for each target gene; (d) detecting an at least 1.3 fold higher
level of expression of TRIM44, SIRT2 or EGFR, or an at least 1.3 fold lower level
of expression of WT1 as compared with said reference standards in step (c),
wherein detecting an at least 1.3 fold higher level of expression of at least one of
TRIM44, SIRT2 and EGFR as compared with said reference standards indicates a
dysregulated TRIM44, SIRT2 and/or EGFR target gene, and an at least 1.3 fold
lower level of expression of WT1 as compared with said reference standard
indicates a dysregulated WT1 target gene; and (e) identifying said human subject as
having a poor prognosis of 5-year survival of oesophageal and/or GOJ
adenocarcinoma based on the dysregulation of at least two of said target genes in
said combination consisting of TRIM44, SIRT2, EGFR, and WT1 as detected in
step (d).
38
101 Arguments
• Amended the claims to add the specific
primer sequences
• Examiner said adding the specific
sequences to claim overcame the 101
rejection because specificity of claim
prevents preemption
• Argued unsuccessfully detecting in vitro
not a natural phenomenon and a limited set
of specific genes
39
Issued Claims: US9605048 (1647)
• A composition comprising human soluble CD146
protein consisting of SEQ ID NO: 7, wherein said
human soluble CD146 protein is acetylated,
methylated, phosphorylated or fused to another
polypeptide and a pharmaceutically acceptable
carrier.
40
101 Arguments
• Amended claim to add the protein was
acetylated, methylated, phosphorylated to
add a markedly different characteristic
• 101 rejection without amendment- no
markedly different characteristics
• Most issued claims of proteins are modified
from natural and note the use of term
“consisting”
41
US 9274128(AU 1674) A method to diagnose Parkinson's disease in a subject comprising the
steps of: extracting nucleic acid from a test sample obtained from the
subject; measuring an amount of a component in a test sample
obtained from the subject, wherein the component is selected from the
group consisting of Parkin Interacting Substrate (PARIS), a
metabolite of Parkin interacting Substrate (PARIS), an mRNA coding
for Parkin Interacting Substrate (PARIS), peroxisome proliferator-
activated receptor gamma coactivator 1-.alpha., (PGC-1.alpha.), and
an mRNA coding for PGC-1.alpha., using at least one primer pair
selected from the group consisting of: (a) a first primer pair consisting
of a reverse primer consisting of SEQ ID NO: 120 and a forward
primer consisting of SEQ ID NO: 119; (b) a second primer pair
consisting of a reverse primer consisting of SEQ ID NO: 32 and a
forward primer consisting of SEQ ID NO: 31; and (c) a third primer
pair consisting of a reverse primer consisting of SEQ ID NO: 76 and
a forward primer consisting of SEQ ID NO: 75; determining the
expression of the component; and comparing the amount of the
component against a baseline expression value to determine whether
the levels of ….. are reduced as compared to levels of a healthy
