Post on 27-Jan-2021
Obviousness Standard:
Leveraging Latest PTO and Court Guidance Overcoming Challenges of Obviousness and Attacks on Patent Validity
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THURSDAY, JUNE 1, 2017
Presenting a live 90-minute webinar with interactive Q&A
Barry J. Herman, Partner, Womble Carlyle Sandridge & Rice, Baltimore
Jon L. Schuchardt, Ph.D., Partner, Dilworth IP, Trumbull, Conn.
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FOR LIVE EVENT ONLY
Obviousness Standard 2016-2017
A Strafford Publications Webinar
Barry J. Herman
June 1, 2017
Overview
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
5
6
Inter Partes Review – Lessons for Litigators
6
7 Source: www.uspto.gov, May 9, 2017
Statistics – Monthly AIA Filings
7
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
8
“Teaching Away”: a Thin Reed
Meiresonne v. Google Fed. Cir., March 7, 2017
Inter partes review initiated by Google challenging US 8,156,096
Invention: supplier identification locator system/method
Features a rollover view area that displays more information about an identified website than normally provided by a search engine
Fed. Cir.: affirms
9
“Teaching Away”: a Thin Reed
Meiresonne v. Google Fed. Cir., March 7, 2017
10
“Teaching Away”: a Thin Reed
Meiresonne v. Google Fed. Cir., March 7, 2017
Meiresonne’s theory:
References “teach away” from the claimed use of a rollover viewing area to display the additional information because both criticize use of descriptive text
Ref H: describes hit results as “gibberish” and recommends visiting the site
Ref F: abandons text in favor of graphical depiction (thumbnails)
Board: No teaching away
Fed. Cir.:
Substantial evidence supports Board; Ref F uses graphics to supplement—not replace—text
Ref H also says that other search results “can prove more useful” and encourages supplementing by visiting the site
11
Takeaways
Meiresonne v. Google Fed. Cir., March 7, 2017
Reinforces the challenge of winning when the Board only needs to show “substantial evidence”
“Teaching away” confirmed as a presumptively weak argument. If you use it, be sure there is no counter-argument that the reference does not truly teach away
Rely on other better arguments (No motivation to combine?)
12
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
13
KSR Predictability
In re Warsaw Orthopedic Fed. Cir., August 9, 2016
Inter Partes review sought by NuVasive
Invention: method of performing spinal fusion surgery
Perform implant insertion from side
Warsaw argues the implant “extends beyond the endplate portion of the vertebral body to include the apophyseal seal portion”
Board: Obvious from combination of 3 references (B, J, and L)
Fed. Cir.: Affirms almost in full; substantial evidence supports Board findings of adequate motivation to combine teachings with a reasonable expectation of success
14
Figures from US 8,251,997
In re Warsaw Orthopedic Fed. Cir., August 9, 2016
15
KSR Predictability
In re Warsaw Orthopedic Fed. Cir., August 9, 2016
Prior Art: Ref J – lateral insertion of implants; Ref B – implants designed to be recessed within the vertebrae
Issue: Did the claims cover implants that extended beyond the endplate portion of the vertebral body?
Warsaw Argues: “full transverse width” includes the apophyseal seal portion (outer ring), not taught by Ref B
Board: W’s disclosure is silent on “apophyseal seal”; W cannot demonstrate its intention to extend the implant length to cover more than the central portion
16
KSR Predictability
In re Warsaw Orthopedic Fed. Cir., August 9, 2016
Fed. Cir:
Substantial evidence supports the Board’s findings
Law does not require reference to teach the identical thing
Ref B does not “teach away” by suggesting implants that can be rotated or reversed (would not elevate one aspect of Ref B over another)
W argues “obvious to try” only, but Board gave adequate reasons for why skilled person “would” use Ref J’s lateral insertion with Ref B’s implants to get predictable results
One claim deemed allowable where Board did not explain why the instrument should have “elongated portions”
17
Takeaways
In re Warsaw Orthopedic Fed. Cir., August 9, 2016
Difficult to overcome predictability argument, particularly on appeal
At Federal Circuit, arguing “findings of fact” is dangerous; standard of review is “substantial evidence”
“Teaching away” = tough burden, particularly with conflicting portions within same prior art reference
Substantial evidence standard allows for reasonable minds to differ, particularly when the Board does a reasonably good enough job
Remember to present all arguments to Board if could present good arguments on appeal; appellate court found many arguments waived
18
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
19
Secondary Considerations and Nexus
Novartis v. Torrent Pharms Fed. Cir., April 12, 2017
IPR Petition: Torrent identified 3 grounds for invalidation
1st – Combination of Chiba and Aulton
2nd and 3rd – relied on Sakai
Institution decision: only review of 1st combination – not 2nd or 3rd, so no reliance on Sakai
Board: Found claims invalid over Chiba and Aulton but held that Sakai provided motivation to combine
Appeal: Novartis argued Sakai had been removed from scope of IPR and it didn’t have notice that it would be considered. Federal Circuit disagreed.
20
Secondary Considerations and Nexus
Novartis v. Torrent Pharms Fed. Cir., April 12, 2017
Fed. Cir.:
Also addressed secondary considerations
• Novartis claimed commercial success, industry praise, long-felt need
• Federal Circuit said there must be a causal nexus between patented invention and secondary considerations
• Must stem from “what was not known in the prior art”
Held that success stemmed from being the only FDA – approved drug of this type – not features from patented invention
21
Takeaways
Novartis v. Torrent Pharms Fed. Cir., April 12, 2017
Challengers in IPR proceedings can try to rely on prior art from rejected grounds
Patent owners should distinguish . . . but language from decision is tough
Reference that is found not anticipatory or a primary obviousness reference – still can be relevant to motivation to combine because “not contrary to Board’s” institution decision????
In ANDA cases, generic challengers have potential silver bullet
If drug is only one of its type approved by FDA, argue that is why it is successful
22
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
23
“Common Sense” Caveats
Arendi v. Apple Fed. Cir., August 10, 2016
Inter partes review of US 7,917,843
Invention: embedded program that allows user to conduct a search for information while staying in the first program
E.g., while in program 1, search for name/address in a database, return & display search results for confirmation or selection by user of program 1
PTAB: institutes review, finds claims obvious based on a single prior art reference
24
Claim 1
Arendi v. Apple Fed. Cir., August 10, 2016
25
“Common Sense” Caveats
Arendi v. Apple Fed. Cir., August 10, 2016
The more you explain it, the more I don’t understand it.
-- Mark Twain
26
“Common Sense” Caveats
Arendi v. Apple Fed. Cir., August 10, 2016
Prior Art: Ref P – Program identifies phone # information in a document, then prompts user to call, fax, or “add # to address book”
Arendi: Missing claim element – use of “first” information in a second program to find “second” information – cannot be supplied with “common sense”
PTAB:
“Common sense” dictates that the program in Ref P would search for info other than the phone # before adding the # to address book
Obviousness inquiry requires consideration of common knowledge and common sense 27
“Common Sense” Caveats
Arendi v. Apple Fed. Cir., August 10, 2016
Fed. Cir.:
Caveats to “common sense” apply:
• Not used to supply a missing claim element unless the element is simple and not critical
• Is the missing element peripheral or indisputably in the prior art?
• Common sense cannot substitute for reasoned analysis and evidentiary support
Board erred by accepting challengers’ conclusory assertion of common sense unsupported by evidence
“Data is data” argument from challengers fails to meet the required burden
28
Takeaways
Arendi v. Apple Fed. Cir., August 10, 2016
As challenger / petitioner, be very wary of relying on 1 prior art reference for obviousness assertion
2 pronged approach – common knowledge (based on expert testimony) AND secondary references
As patent owner, attack!
Missing claim limitation (and not a peripheral one) – do not allow challenger to plug a gap by relying on common sense
“Common sense” impermissibly used as a crutch—must demonstrate reasoned analysis
29
IPR “War Story”
Inline v. GPI PTAB, January 10, 2017
Inline asserted obviousness against 53 claims on GPI’s patent that covers the packaging for Hot Pockets
30
IPR “War Story”
Inline v. GPI PTAB, January 10, 2017
Battle of experts
Importance of depositions – will Board weigh credibility?
Common sense / common knowledge vs. application of secondary references
Secondary considerations
Best way to combat hindsight
Nexus, nexus, nexus!
Factual testimony from GPI employees – Bias???
Board: all claims invalid as obvious
Currently on appeal to Federal Circuit
31
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
32
District Courts – Lessons for Litigators
33
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
34
Reasonable Expectation of Success
Cumberland Pharma v. Mylan Fed. Cir., January 26, 2017
ANDA bench trial on validity only (infringement stipulated to) of patent related to administration of IV for suspected acetaminophen overdoses
Claims required stable composition that is free of chelating agents
Mylan asserted obviousness based on prior-art communications from FDA
District Court (N.D. Ill.): no reasonable expectation that a formulation without any chelating agents would be successful
Prevailing skilled-artisan view that chelating agents were necessary to prevent degradation of the main drug ingredient 35
Reasonable Expectation of Success
Cumberland Pharma v. Mylan Fed. Cir., January 26, 2017
36
Reasonable Expectation of Success
Cumberland Pharma v. Mylan Fed. Cir., January 26, 2017
Fed. Cir.: affirmed
Reasonable expectation of success = question of fact (clearly erroneous standard)
Likelihood of success in combining references to meet claim limitations
Battle of experts
Question of “sufficient evidence”
Lesson – for bench trials, you better win the expert battle or chances of success on appeal are small . . .
37
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
38
One Prior Art Reference + Common Knowledge = Enough?
WBIP v. Kohler Fed. Cir., July 19, 2016
2 patents on marine engine exhaust systems for houseboats
District Court (D. Mass.): jury found for patentee; Kohler moved for JMOL on obviousness of asserted claims; district court denied
On appeal – obvious over P reference + standard elements known to ordinary artisan
Evidence of secondary considerations should be discounted – no nexus
Federal Circuit standard:
For “black box” jury verdict – we presume jury resolved underlying factual disputes in favor of verdict winner and leave presumed findings
undisturbed if “supported by substantial evidence” 39
One Prior Art Reference + Common Knowledge = Enough?
WBIP v. Kohler Fed. Cir., July 19, 2016
40
One Prior Art Reference + Common Knowledge = Enough?
WBIP v. Kohler Fed. Cir., July 19, 2016
Undisputed that Phipps teaches every element of claims except for “B” and “D”
Undisputed that “B” and “D” existed in other prior art – “conventional cooling features”
Dispute centered on whether POSITA would take exhaust controls from automotive engines and apply them in marine environment
Battle of experts on motivation to modify or convert Phipps
Secondary considerations come into play
Federal Circuit affirmed district court
41
Takeaways
WBIP v. Kohler Fed. Cir., July 19, 2016
Use more than one reference for obviousness assertions!
If a battle of experts occurs, secondary considerations very likely will control
Nexus may be the key – presumption applies where it is shown that objective evidence is tied to specific product and that product is the invention disclosed and claimed
“Claimed invention as a whole”
Jury verdict + secondary considerations = tough to overturn on appeal
42
I. Lessons from IPR Decisions on Obviousness
i. Teaching Away
ii. KSR Predictability
iii. Secondary Considerations and Nexus
iv. Common Sense
II. Lessons from District Court Litigation on Obviousness
i. Reasonable Expectation of Success
ii. Reliance on One Prior Art Reference + Common
Knowledge = Enough?
iii. Hindsight
Overview
43
Hindsight
Zoltek v. United States Fed. Cir., February 19, 2016
Court of Federal Claims
Zoltek sought compensation from Air Force and Navy for use of patent
Lawsuit began in 1996 and appealed to Federal Circuit 3 times!
U.S. Reissue Patent No. Re 34,162
Method of manufacturing carbon fiber sheet products whose electrical resistivity is pre-selected and value-controlled
Based on inventor’s discovery of a non-linear relationship among heat treatment conditions, partial carbonization, and surface resistivity
44
Hindsight
Zoltek v. United States Fed. Cir., February 19, 2016
45
Hindsight
Zoltek v. United States Fed. Cir., February 19, 2016
Unusual assertion of obviousness
4 references – none mention “surface resistivity” or pre-selection
Gov’t expert constructed mathematical methodology for purposes of litigation
Court of Federal Claims found claims invalid
Federal Circuit found no teaching or suggestion in prior art to:
Select data that expert chose
Plug data into mathematical equation that the expert devised
Reversed – “no evidence of obviousness” 46
Hindsight
Zoltek v. United States Fed. Cir., February 19, 2016
47
"War Story"
GeoDynamics v. DynaEnergetics E.D. TX March 2017
Patent covers method for using reactive shaped charges to perforate oil and gas wells
Key limitation is negative – “without changing the pressure conditions to a more underbalanced condition”
4 day jury trial
Competing expert testimony
Dyna also had compelling fact testimony
“Black box” verdict for Defendant – all claims invalid
Anticipation, obviousness, and on-sale bar
48
"War Story"
GeoDynamics v. DynaEnergetics E.D. TX March 2017
Method for perforating
Loading reactive charge
Positioning the charge carrier in a
wellbore with a pressure condition
Without changing the pressure
condition to a more underbalanced
condition
Detonating
First explosive event creates a
tunnel surrounded by crushed zone
Second explosive event created by
exothermic intermetallic reaction
substantially eliminates the crushed
zone and clears debris from the
perforation tunnel
‘431 Patent – Claim 1
49
"War Story"
GeoDynamics v. DynaEnergetics E.D. TX March 2017
The thrill of convincing lay people that patent claims are obvious – and the differences between arguments to a judge and to jurors
50
Disclaimer
These materials are public information and have been
prepared solely for educational (and entertainment) purposes
to contribute to the understanding of U.S. intellectual property
law. These materials reflect only the personal views of the
speaker and are not individualized legal advice and do not
necessarily reflect the views of Womble Carlyle or Strafford
Publications. It is understood that each case is fact-specific,
and that the appropriate solution in any case will vary.
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made to insure that these materials are accurate, there may
be errors or omissions.
51
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52
Obviousness Standard 2016-2017
A Strafford Publications Webinar
Jonathan L. Schuchardt
June 1, 2017
Disclaimer:
The opinions expressed here are the author’s alone and are not
necessarily shared by Dilworth IP.
Any errors in the presentation are mine alone.
Information contained herein is presented to inform and perhaps
entertain. It is not intended as legal advice.
-- J.L. Schuchardt
54
Procedural posture matters
• Keep in mind how we got to the Fed. Cir.:
– Applicant’s appeal from final rejection affirmed,
then appealed to Fed. Cir.
– Ex parte reexamination: patentee challenges
obviousness ruling or challenger contests
patentability confirmation
– Inter partes reexamination: loser challenges
– Loser at district court appeals
– Inter partes review (“IPR”); loser challenges
55
• Substantial evidence hurdle
• The thin reed of “teaching away”
• Physical combinability not needed
• KSR predictability
• Unexpected results
• Problem and solution
• Motivation to combine and the need to explain
56
Themes 2017
High hurdle of substantial evidence
• Board’s obviousness decision reviewed de novo, but its
factual determinations need only be supported by
“substantial evidence”
• “Less than the weight of the evidence but more than a mere
scintilla” (Consol. Edison v. NLRB, 305 U.S. at 229-230)
• “Reasonable mind might accept as adequate”
• Agency may favor one reasonable conclusion over another
from two different, inconsistent ones
57
58
Substantial Evidence
Kennametal v. Ingersoll Cutting Tool Fed. Cir., March 25, 2015
• Inter partes reexamination of US 7,244,519
• Invention: cutting tools containing Co/Ru binder coated by
physical vapor deposition (PVD)
– Co/Ru binders known, but not with PVD
• Reexamination unit finds all claims obvious
• Board affirms, finding some claims anticipated, the rest obvious
• Fed. Cir. affirms
59
• Kennametal’s theory:
1. Skilled person would not have used Co/Ru and PVD because
coatings applied by PVD are too thin and do not adhere well to
binders that produce Co capping
2. Unexpected results: prolonged tool lifetime
• Ingersoll’s response:
• Any unexpected results were inherent in known compositions of
prior art
• No nexus between the prolonged tool lifetime and the claimed
novel features
Substantial Evidence
Kennametal v. Ingersoll Cutting Tool
60
Substantial Evidence
Kennametal v. Ingersoll Cutting Tool
• Fed. Cir.:
– Substantial evidence supports the Board’s determination
– Skilled person had a reasonable expectation of success in
combining Ru/Co binders in a PVD process
– Ref. L taught production of cutting tools with 9 metals, including
Ru, and taught that inserts could be coated using PVD.
– Ref. G disclosed all elements, taught 15 combinations, one of
which anticipated some claims. “Actual performance” of the
claimed combo wasn’t necessary.
– Because G taught the “precise combination” of Ru/Co and PVD,
any unexpected lifetime improvement came from something other
than the claimed novel feature
61
Kennametal -- Take-aways
• High hurdle to challenge obviousness determination when
Board’s decision only needs to be supported by substantial
evidence
• The skilled person can “envisage” the invention (even if the
reference examples show different combinations) when there
are relatively few ways to combine the elements
• Unexpected results need to be linked to both what is claimed
and what is novel in the claim.
62
“Teaching Away”: a Thin Fiber
In re Urbanski
• Ex parte appeal
• Invention: enzymatic hydrolysis of
soy fiber
– Limit reaction time to 1-2 hours, use
acidic pH to give a product having
limited water-holding capacity and
free simple sugar content < 1%
• Examiner: claims obvious from refs
G and W
• Board: affirms
• Fed. Cir.: affirms
Fed. Cir., January 8, 2016
“Magic Circle” John William Waterhouse
1886
63
Urbanski claim 43
64
“Teaching Away”
In re Urbanski • Prior art:
– Ref G: 5-72 hour reaction time to give stable dispersion of
soluble fiber
– Ref W: 1-2 hours for high-fiber product with good mouthfeel
• Examiner: Degree of hydrolysis = “result-effective variable”
• Urbanski argues:
1. G “teaches away” from partial hydrolysis; the claimed method
does not produce a stable dispersion
2. Different benefits of the references were mutually exclusive
• PTAB: Fiber properties are altered in a predictable manner
by degree of hydrolysis. Irrelevant that G and W had different
objectives
65
In re Urbanski
Fed. Cir.:
• “Substantial evidence” supports Board’s finding of motivation to
modify G’s teachings with W to use a shorter reaction time
• Motivation = favorable dietary properties
• Result-effective variable applies to predictable result
• Nothing in the references suggests that the claimed method would be
undesirable, thus no “teaching away”
• References must discredit or criticize the shorter reaction time;
teaching a longer time is not enough to “teach away”
66
In re Urbanski -- Take-aways
• Holding further illustrates the “high hurdle” of winning
when the Board only needs to show “substantial
evidence”
• “Result-effective variable” is a four-letter word; can
you show an element of unpredictability?
• “Teaching away” is narrowly interpreted and rarely
adopted as a viable argument by the court
67
Physical Combinability, cont.
ClassCo v. Apple Fed. Cir., September 22, 2016
• Inter partes reexamination of US
6,970,695
• Invention: identification of incoming
phone calls with alert to called party
about caller identity
– Announcing circuit uses identity info
to produce audio using a speaker at
the called station
• Reexam unit: claims are obvious
from combining refs F and G
• Board: affirms
• Fed. Cir.: affirms
Alexander Graham Bell places the first New York to Chicago telephone call (1892)
68
ClassCo’s claim 1
69
The minute you read something and you can't understand it you can almost be sure that it was drawn up by a lawyer.
Then if you give it to another lawyer to read and he don't know just what it means, why then you can be sure it was drawn up by a lawyer.
If it's in a few words and is plain and understandable only one way, it was written by a non-lawyer. --Will Rogers
70
• Prior art:
– Ref F: Disclosed all claim elements except use of phone’s
internal speaker to announce the caller identity
– Ref G: Missing element taught in a hands-free phone
• ClassCo argues:
1. KSR v. Teleflex requires combinations of known elements with
“no change in their respective functions”
2. Secondary considerations were ignored: industry praise,
commercial success, licensees
Physical Combinability
ClassCo v. Apple
71
Physical Combinability
ClassCo v. Apple • Fed. Cir.:
– No need for references to be physically combinable
– Skilled person is not a robot but uses “ordinary creativity”
and would have used a single speaker to deliver sound
from multiple kinds of data captured in a phone system
– Obviousness does not require “perfectly fitting puzzle
pieces”
– Board error not to consider the secondary considerations,
but on balance, strong prima facie case outweighs
evidence offered by ClassCo
– See also: Allied Erecting v. Genesis Attachments, decided
6-15-16 (multiple tool attachment system having “quick
change” feature obvious from references describing similar
individual features)
72
Post-KSR Obviousness:
Adds “Predictability” tests to TSM test
• Combine prior art elements with known methods for predictable results
• Simple substitution of known elements for predictable results
• Known technique to improve similar device, method, product in the same way
• Design need or market pressure leading to predictable variations
• Finite number of identified predictable solutions with reasonable expectation of success (obvious to try)
• Teaching, suggestion, motivation to modify art to arrive at claimed invention (“TSM” test)
See: MPEP 2143
73
You’ve Been KSR’d!
ABT Systems v. Emerson Electric Fed. Cir., August 19, 2015
• ABT owns US 5,547,017, with claims drawn to an HVAC
thermostat with recycle control for periodic operation when no
heating or cooling is needed
• Emerson’s “Big Blue” thermostat copies the feature; ABT sues
and wins in MO E.D. JMOL motion denied.
– Damages awarded: $300K based on sales of about 140,000
infringing thermostats
• Fed. Cir. reverses; patent invalid under § 103 based on
combined teachings of 4 references
74
ABT Systems v. Emerson
75
ABT Systems v. Emerson
• Cited art:
– Ref C: a circulating fan, intermittent start/stop, but not tied to fan H/C
deactivation
– Ref Y: periodic operation of fan without H/C and not tied to H/C
deactivation
– Ref P: single-shot fan operation to drain the coil
– Ref N: single-shot fan operation to drain coil or improve comfort
• D. Ct.: Jury could reasonably conclude that prior art did not
suggest periodic fan operation dependent upon deactivation of
the heating/cooling function. Evidence of long-felt need found.
76
ABT Systems v. Emerson
Fed. Cir.:
• KSR requires more than predictable results from substitution of
known elements
• “Recognizing that nonobviousness was determined by a jury, we
assign due deference to the jury’s verdict”
– Few if any relevant facts are in dispute. Ref. N also discussed
periodic fan operation, not just one-shot operation to drain the coil.
• Dismisses ABT’s argument that the refs were non-enabling and
taught away from the claimed invention
• Grant of licenses failed to demonstrate commercial success
“without a clear showing of nexus to the claimed invention.”
77
• KSR v. Teleflex raised the bar for many electro-mechanical
inventions, where unpredictability is more difficult to establish
• Fed. Cir. will give “due deference” to jury verdicts when it
suits the panel
• “Teaching away” is a thin reed
• “Secondary” considerations were just that
• Fed. Cir. dismissed the clear evidence of copying and grant of
licenses that—given the single key feature of the improved
thermostat—proved the value of the claimed invention to
competitors.
• Compare Cadence Pharm. v. Exela (evidence of licensing program considered persuasive).
ABT Systems – Take-aways
78
“Unexpected Results”
In re Efthymiopoulos Fed. Cir., October 18, 2016
• Ex parte appeal
• Invention: method of administering influenza
drug by oral inhalation alone
– Relenza® = zanamivir, normally taught for use by
nasal inhalation
• Examiner: obvious from art teaching nasal
inhalation; only two ways to inhale
• Board: Affirms
• Fed. Cir. (2:1): Affirms; “substantial
evidence” supports Board findings of
adequate motivation to use oral inhalation
• Dissent: (Newman): Obvious only to the
court
Inhaler, John Mudge (1778)
79
• Examiner: V1 teaches to use zanamivir and nasal inhalation;
V2 generically teaches inhalation of a similar drug. Only 2
ways to inhale, therefore obvious
• Applicant: Prior art believed nasal inhalation was needed to
treat influenza
• PTAB: affirms
• CAFC (2:1): Substantial evidence supports Board
– Oral administration only is obvious; inhalers taught by V1, V2
– Reasonable expectation of success from reference combo; nothing
unexpected about this drug working by oral inhalation
– Kaiser study criticized: related to prevention, not treatment
“Unexpected Results”
In re Efthymiopoulos
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In re Efthymiopoulos
Newman, dissenting:
• No art or expert suggests oral inhalation only;
obvious only to the tribunal
• Effectiveness of oral-only administration was
unexpected
• Kaiser study: nasal + oral administration worked
much better than nasal only
• Board’s argument is “obvious to try”
• V2 mentioned many ways to administer the drug,
but oral inhalation was not listed, so it can’t be
obvious as an “identified, predictable” solution
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In re Efthymiopoulos -- Take-aways
• PTO, Board will continue to hammer on KSR predictability
when the claims relate to a process that can only be practiced
a limited number of ways
• Applicant victimized by Board’s need to show only “substantial
evidence”
• The devil is often in the details: the dissent’s willingness to
investigate specifics reveals distinctions that the “high level”
views of the Board and majority overlook
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Unexpected Results—Where’s the Beef?
Prometheus Labs v. Roxane Labs Fed. Cir., November 10, 2015
• Prometheus owns ‘770 patent on use of alosetron to treat
females with non-constipating irritable bowel syndrome (“IBS-D”)
• Roxane files ANDA; Prometheus sues
• NJ D. Ct. holds ‘770 patent invalid over P’s own expired ‘800
patent on use of alosetron to treat IBS
– “Insubstantial differences” between ‘770 claims and prior art
– No unexpected results or other helpful secondary considerations
• Fed. Cir.: affirms
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Prometheus v. Roxane
Claims of the ‘770 patent (after ex parte reexam by P):
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Fed. Cir.:
• ‘770 claims are an obvious species of ‘800 patent
– 75-80% of IBS-D patients are women, moderate pain is a
known common symptom, and 6+ months of symptoms provide
confidence in the diagnosis
• D. Ct. correctly evaluated/resolved secondary considerations
in Roxane’s favor
– Not unexpected for alosetron to exhibit greater efficacy in IBS-D
patients
– Known elements combined in a known way to achieve expected
results
– Obvious to treat this subset of patients in this way
Prometheus v. Roxane
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Prometheus – Take-aways
• When a later-expiring patent is an obvious variation of
an invention disclosed in a reference, the later-expiring
patent is invalid
• Easy case for the Fed. Cir. absent the “beef” of
unexpected benefits from treating this subset of the
original target group
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Problem and Solution
Purdue Pharma v. Epic Pharma Fed. Cir., February 1, 2016
• A complex case, history related to
OxyContin® opiod pain reliever
– Need to reduce levels of toxic 14-
hydroxycodeinone impurity from 1500 to
< 10 ppm
• Generic producers file ANDAs, Purdue
sues.
• District court (NY, S.D.): Patents are
invalid; recognizing where the 14-
hydroxy isomer came from doesn’t
matter if the way to eliminate it is obvious
• Fed. Cir.: affirms
oxycodone
14-hydroxy “ABUK”
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Problem: an oxidation side product survives the initial hydrogenation, then dehydrates to generate more unsaturated ketone
Purdue Pharma
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US 7,683,072
Purdue Pharma
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Purdue Pharma
Purdue’s theory:
• No one understood the origin of the ABUK impurity, so
identifying the source of the problem results in an invention
Fed. Cir.:
• District court correctly concluded that the solution to the
problem--another hydrogenation step to convert the
unsaturated ketone to the desired product--was obvious
• Eibel Process (261 U.S. 45, 68 (1923)) is distinguishable
(process for making wrinkle-free paper at high speed required adjustment of machine parameters; held not obvious)
• Solving the problem only required adding another
hydrogenation step; it did not require the source of the
impurity to be identified
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Purdue Pharma – Take-aways
• Identification of the problem may not impart patentability if the
solution to the problem is obvious
• Fed. Cir. will be alert to pharma companies seeking to extend
patent lifetime based on a relatively minor improvement
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The Burden to Explain, Part 1
Intelligent Bio-Systems v. Illumina Cambridge
Fed. Cir., May 9, 2016
• Illumina owns US 7,566,537 to a method of labeling
nucleosides in a DNA strand
• IBS petitions for inter partes review, alleging obviousness
from combined teachings of T or J plus Z
• Board: Claims are patentable; no reasonable expectation of
success from prior art combination
• Fed. Cir.: Affirms the judgment but criticizes the Board’s
rationale: the motivation to combine was missing
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Illumina’s Claim 1 Refs T and J: Both teach “sequencing by synthesis” approach used by Illumina. Protection of the 3’ OH group is desirable; other protecting groups described Ref Z: Azidomethyl group for protection of hydroxyl groups IBS’s theory: Obvious to use a different
protecting group, including azido group
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IBS’s theory: Obvious to use a different protecting group, including azido group taught by Z, in combination with the SBS method taught by T and J because the protecting group is known
Illumina’s response: T and J teach that protection/deprotection must be near quantitative and rapid removal, and Ref L shows low efficiency with this protecting group (60-80%)
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The Burden to Explain
Intelligent Bio-Systems, cont.
Board:
– Challenger did not show a reasonable expectation of
success from prior art in quantitative removal of the
azido protecting group
Fed Cir:
– Substantial evidence supports Board decision, but . . .
– Board “conflates” motivation to combine and
reasonable expectation of success requirements
– Absent a way to satisfy the requirement of quantitative
deprotection from the combination of references, there
can be no “motivation to combine”
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The Burden to Explain
Intelligent Bio-Systems, cont.
Judge O’Malley: Accordingly, it is of no moment that Zavgorodny’s protecting group would not be removed quantitatively in Tsien or Ju’s sequencing method—removal is simply not required by the claim of the ‘537 patent. The Board seemed to believe that the “reasonable expectation of success” inquiry looked to whether one would reasonably expect the prior art references to operate as those references intended once combined. That is not the correct inquiry—one must have a motivation to combine accompanied by a reasonable expectation of achieving what is claimed in the patent-at issue. The Board’s reliance on the absence of a reasonable expectation of success was, thus, improper.
Intelligent Bio-Systems – Take-aways
• Examiners routinely summarize many facts from
references and then skimp on reasons for “motivation to
combine”
• Typical argument for motivation is a single sentence or
phrase
• Don’t settle for “conflation”: Insist on a thorough
explanation of why there is both motivation to combine
and a reasonable expectation of success
• Little said re the azido protecting group in application as
filed; just one among many other possibilities
• See also: Cutsforth v. Motivepower (22-Jan-2016) and
Black & Decker v. Positec USA (18-May-2016), both
non-precedential (insufficient reasoning from Board)
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Burden to Explain, part 2
In re NuVasive, Inc.
• NuVasive owns US 8,361,156, covering a spinal fusion implant
having “radiopaque markers” extended into sidewalls near the
middle of the implant
• Medtronic challenges with IPR proceeding
• Board: obvious from Refs T and Ref B
• Fed. Cir.: reverses; Board failed to adequately support its
obviousness conclusion
Fed. Cir., December 7, 2016
NuVasive’s claim 1
Burden to Explain, part 2
In re NuVasive, Inc.
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Implant with “radiopaque markers” US 8,361,156
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Fed. Cir.:
• NuVasive was correct that Board failed to explain why a skilled
person was motivated to combine references and place
radiopaque markers on the medial plane
• “Thorough and searching” factual inquiries required with “need for
specificity”
• Reviewing court can’t do its job without understanding basis for
Board decisions
• Motivation to combine analysis must be explicit
• Rejects Board’s adoption of expert’s “common sense” argument
Burden to Explain, part 2
In re NuVasive, cont.
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In re NuVasive – Take-aways
• Has the PTO provided “adequate evidentiary basis” for
arguments that there is motivation to combine reference
teachings?
• Reliance on conclusory statements instead of “reasoned
explanation”?
• “The Board knows how to do its job”
– Referring to Allied Erecting v. Genesis Attachments
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Need to Explain, part 3
In re Van Os Fed. Cir., January 3, 2017
• Ex parte appeal
• Invention: touchscreen interface that
allows users to rearrange icons
– First touch to open; longer touch to
enter interface reconfiguration mode
– Examiner: Obvious from
combination of Ref H (“edit faves”
button on menu) and Ref G
(computer touch pad with
rearrangeable icons)
• Board: We agree, the longer touch
feature is “intuitive”
• Fed. Cir.: Vacates/remands
In re Van Os
Fed. Cir.:
• We consider “common sense,” but KSR still requires explicit,
reasoned analysis of whether motivation to combine exists
• To conclude “it’s intuitive” or “common sense,” without more, is
conclusory—like saying “it’s obvious”
• Neither Examiner nor Board provided reasoning for why the
skilled person would have combined the teachings, so we punt it
back to the Board
Dissent-in-part (Newman):
• Proper remedy is reversal. PTO failed to meet its burden to show
why applicant was not “entitled to a patent.” (see also: Icon
Health and Fitness v. Strava, Judge O’Malley’s similar dissent-in-part)
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In re Van Os
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In re Van Os – Take-aways
• More of the same: Board is often too comfortable in simply
ratifying an Examiner’s conclusory viewpoint
– To err is human, to provide reasoned analysis is divine . . . ?
• Invocation of “common sense” by the PTO should set off
alarm bells
• Yet another case where the Fed. Cir. corrects the Board for
not articulating why there was motivation to combine
references
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Need to Explain, part 4
Personal Web Technologies v. Apple Fed. Cir., February 14, 2017
• PWT owns US 7,802,310
– Invention: method of tagging files with a “true name” based on file
contents to control access to files
– Got flowcharts?
• Apple’s IPR petition asserts obviousness based on 2 refs
• PTAB: Claims are obvious
• Fed. Cir.: Vacates/remands: PTAB failed to support its findings
that all elements were in the prior art and that there was motivation to combine with a reasonable expectation of success
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US 7,802,310 claim 1
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• Prior Art:
– Ref W: System for backing up/restoring data with content-
based identifiers
– Ref S: System for managing rights to access data. Control
access to digital works stored in a repository; ticket holder paid
for access
• Board:
– Mostly adopts Apple’s arguments
– Incomplete, inaccurate analysis criticized by Fed. Cir.
Need to Explain, part 4
Personal Web Technologies
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Personal Web Technologies
Fed. Cir.:
• PTAB decision inadequate for failure to find all claim elements
and provide reasoned explanation for why a skilled person had
motivation to combine them
• Complex/obscure technologies may require more than a brief
explanation
• Agency’s duty to provide a record of evidence upon which it
relies to allow for judicial review
• “Would have allowed for” = “could,” not the same as “would”
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Personal Web Technologies –
Take-aways
• Yet another example of the Fed. Cir.’s apparent new-found
willingness to “get into the weeds” to dissect faulty reasoning
from the PTAB (or examiner as adopted by PTAB)
• “Could combine” is not the standard
• Is there a “missing element” in the claim not found in the cited
art?
• Thorough, reasoned explanations are needed for motivation to
combine reference teachings and reasonable expectation of
success, especially when the technology is not “self-explanatory”
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Need to Explain, part 5
Icon Health & Fitness v. Strava Fed. Cir., February 27, 2017
• Inter partes reexam of US 7,789,800
sought by Strava
• Invention: method/system for
controlling exercise equipment using
a USB-compatible, portable remote
device
• Examiner finds some claims obvious
• Icon appeals, PTAB affirms
• On appeal, Fed. Cir. vacates-in-part,
remands
• Dissent (O’Malley): proper remedy is
reversal
Need to Explain, part 5
Icon Health & Fitness
• Icon’s theory: No substantial evidence to support PTAB findings
where the Board adopted legal conclusions of challenger’s expert
and failed to supply its own reasoning
Fed. Cir.:
• For some claims, finds PTAB’s explanation “sparse but adequate”
• For others, the multi-layered incorporation-by-reference of
arguments was insufficient
• PTAB may adopt examiner position as its own when the reasoning
is thorough and well explained, but PTAB must explain why it
accepts an argument
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Icon Health & Fitness
– Take-aways
• Court analysis of multiple claims demonstrates that it is
watching the PTAB closely
• Watch for inadequate explanations by examiners
• Watch for Board’s “rubber stamping” of examiner
positions without adequate explanation
• Add another one to the pile of helpful cases to cite
• No end in sight?
– Rovalma v. Bohler-Edelstahl GmbH, decided May 11, 2017
(Court vacated/remanded when Board failed to set forth
sufficient reasoning to allow court to determine what inferences
it drew from patent challenger’s submission)
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Final thoughts
• Convincing the court that the Board’s decision was not based
on “substantial evidence” is a challenge, but the hurdle may be
eroding
• Forget “teaching away” unless it is really there
• Arguing physical non-combinability is difficult
• Can you make the case for “unexpected” results?
• Patrol your Office actions and Board decisions for the
“reasoned explanation” of both motivation to combine/modify
and reasonable expectation of success
• Is this a mere rash of bad PTAB decisions, or is it a revolution
in the making?
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The obscure we see eventually. The completely obvious, it seems, takes longer.
--Ed Murrow
Thanks for your attention!
Jonathan L. Schuchardt, Ph.D. Partner Dilworth IP Intellectual Property Law 2 Corporate Dr., Suite 206 Trumbull, CT 06611 (203) 220-8496 jschuchardt@dilworthip.com
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