section 102 prior art and section 103 obviousness
TRANSCRIPT
Section 102 Prior Art and Section 103 Obviousness:
Leveraging CCPA and Early Federal Circuit
DecisionsWithstanding Rejections and Attacks on Patent Validity and Patentability
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THURSDAY, JANUARY 7, 2021
Presenting a live 90-minute webinar with interactive Q&A
Arpita Bhattacharyya, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Palo Alto, Calif.
Adriana L. Burgy, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Aliza G. Carrano, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
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South Corp. v. U.S., 690 F.2d 1368, 1369
(Fed. Cir. 1982)
“The court sits in banc to consider what case law, if any, may appropriately
serve as established precedent. We hold that the holdings of our predecessor
courts, the United States Court of Claims and the United States Court of
Customs and Patent Appeals (CCPA), announced by those courts before the
close of business September 30, 1982, shall be binding as precedent in this
court.”
And all of those CCPA cases were en banc.
Many, many are relied on in the MPEP.
Can district courts, the Federal Circuit, and PTAB ignore those en banc cases,
particularly just because they are old?
5
EVALUATION OF
ANTICIPATION
▪ AIA §102 applies to patents and applications where all claims
have an effective filing date (“EFD”) after March 15, 2013.
▪ Pre-AIA §102 applies to patents and application where all claims
have an EFD before March 16, 2013.
▪ AIA §102 and Pre-AIA §102(g)/§135/§291 apply to patents and
applications containing at least one claim with an EFD before
March 16, 2013, and at least one claim with an EFD after March
15, 2013.
▪ Until at least 2034, will have to carefully consider which law
applies to claims you are analyzing!
6
7
ANTICIPATING RANGE LIMITATIONS
Prior art that either teaches species or discloses embodiments falling within the claimed range anticipates that claimed range.
• Titanium Metals Corp. of America v. Banner, 778 F.2d 775 (Fed. Cir. 1985)
― Claimed titanium alloy having titanium with 0.6% to 0.9% nickel, 0.2% to 0.4% molybdenum, and up to 0.2% iron.
― Anticipated by prior art showed titanium alloy containing 0.25% molybdenum and 0.75% nickel (no requirement to show iron because the claim read “up to 0.2% iron”).
• Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990)
― Claimed zeolites with a silica/alumina ratio “of at least 12.”
― Anticipated by prior art zeolites having a silica/alumina ratio “up to about 60” because that teaching fell within the claim range from “at least 12” to “about 60.”
Overlapping ranges/endpoints anticipated.
8
INHERENCY REJECTIONS
To support an anticipation rejection based on inherency, examiner must
provide factual and technical grounds establishing that the inherent
feature necessarily flows from the teachings of the prior art.
• Possibility or even probability insufficient (Glaxo Inc. v. Novopharm Ltd., 52 F.3d
1043 (Fed. Cir. 1995))
Examiner may rely on additional references to substantiate or explain the
inherency of the characteristic at issue.
Once Examiner establishes prima facie case of inherency, burden shifts to
applicant to show that the prior art does not inherently possess the recited
features of the claimed invention.
• Show that prior art does not “inevitably” or “invariably” result in claimed
invention.
9
“necessarily and inevitably”
Property does not have to be recognized at date of
allegedly anticipating reference.
• Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1378
(Fed. Cir. 2005)
― “when considering a prior art method, the anticipation
doctrine examines the natural and inherent results in that
method without regard to the full recognition of those
benefits or characteristics within the art field at the time of
the prior art disclosure.”
INHERENCY REJECTIONS
INHERENCY REJECTIONS
MPEP 2112
“The fact that a certain result or characteristic may occur or be present in the prior art is not
sufficient to establish the inherency of that result or characteristic. In re Rijckaert, 9 F.3d
1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993) (reversed rejection because inherency was
based on what would result due to optimization of conditions, not what was necessarily
present in the prior art); In re Oelrich, 666 F.2d 578, 581-82, 212 USPQ 323, 326 (CCPA 1981).
Also, "[a]n invitation to investigate is not an inherent disclosure" where a prior art reference
"discloses no more than a broad genus of potential applications of its discoveries." Metabolite
Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367, 71 USPQ2d 1081, 1091 (Fed.
Cir. 2004) (explaining that "[a] prior art reference that discloses a genus still does not
inherently disclose all species within that broad category" but must be examined to see if a
disclosure of the claimed species has been made or whether the prior art reference merely
invites further experimentation to find the species).”
“… the prima facie case can be rebutted by evidence showing that the prior art products do
not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d 1252,
1255 (CCPA 1977).
10
IN RE OELRICH,666 F.2d 578 (CCPA 1981)
• Apparatus Claim 1. A time modulated fluid actuated control apparatus comprising:
― … a system having a range of resonant frequencies; … means for generating a
signal at a carrier frequency, said carrier frequency being greater than the
maximum dynamic command signal frequency and less than the minimum system
resonant frequency; …
• Board upheld examiner rejection for anticipation.
― Reference patent’s “signal generator does in fact inherently produce frequencies
which would be sub-critical when used with a low-inertia system, and therefore,
inherently supplies a carries frequency range which is usable in applicant’s
system[.]”
• CCPA: Reversed.― The “less than the minimum system resonant frequency” phrase is a claim limitation.
― “The relationship between the carrier frequency and the system critical frequency –
the former below the latter…-cannot be said to be ‘the natural result flowing from the
operation as taught’…[in the reference patent which] instructs that the device is
‘adapted to receive a carrier frequency substantially in excess of the particular system
critical or resonant frequency’[.] Given this express teaching, [the claim limitation] is
not inevitably present.”
11
INHERENCY
• In re Shetty, 566 F.2d 81, 86 (CCPA 1977)
• That which is inherent in the prior art, if not known at the time of the
invention, cannot form a proper basis for rejecting the claimed invention as
obvious under §103.
• Shetty claimed a composition of certain adamantane compounds and a
method of using them to curb appetite in animals. The prior art taught
structurally similar compounds for use as antiviral agents, with
recommended dosages that corresponded to those claimed by appellant.
• CCPA affirmed the rejection of the composition claims, but did not affirm
the USPTO position of unpatentability regarding the method claims.
― “Before Shetty had discovered an appetite curbing effect for the claimed
adamantane compounds, nothing in the art suggested using the structurally
similar prior art adamantanes to curb appetite, much less the claimed dosage
amount.”
12
INHERENCY
• In re Spormann, 363 F.2d 444 (CCPA 1966)
― Claim 7. A process for the production of solid alkali metal sulfite which comprises…
― Claimed process includes immediate drying after reaction and result in a product low in
sulfate content.
― CCPA: Reversed.
― Basic chemical reaction of appellants’ process is old.
― “The board apparently thought that the minimizing of sulfate production would be
inherent in the [prior art processes]. However, [the prior art references] make no
mention of it…Their process is not appallants’ process.”
― “[T]he inherency of an advantage and its obviousness are entirely different
questions. That which may be inherent is not necessarily known. Obviousness
cannot be predicated on what is unknown.”
― Prior art reference disclosure: “There is no objection to introducing the gases…at a
temperature of between 400 and 550 C.” – “What effect this would have by way of
vaporizing water is speculative” and would depend on many other variables.
13
INHERENCY• In re Naylor, 369 F.2d 765 (CCPA 1966)
• Claim 2. A process for preparing a rubbery polybutadiene containing at least
80 per cent of 1,2-addition…
• Solicitor: “Although the references do not specifically indicate that the
addition of a promotor to the [prior art] process would necessarily result in
a rubbery polymer having a high 1,2-addition, apparently this is an inherent
result which would flow naturally from combining the teachings of the prior
art.”
• CCPA: Reversed.
―“appellant is not claiming simply a process for preparing
polybutadiene. Rather it is a process for preparing a particular
polybutadiene having a particular microstructure and particular
properties.”
―“[Inherency] is quite immaterial if . . . one of ordinary skill in the
art would not appreciate or recognize the inherent result."
• See also, In re Rijckaert, 9 F.3d 1531, 1533 (Fed. Cir. 1993).
14
EVALUATION OF OBVIOUSNESS
Look for objective evidence of non-obviousness and tie it (show nexus)
to the claimed invention, such as unexpected benefit or result
(e.g., synergism), long felt need, failure of others, commercial
success .
Obviousness to try: finite v. very large number of possibilities.
Look for teachings away or disincentive to make a modification to arrive
at claimed invention.
KSR addressed motivation. • “[A]ny need or problem known in the field and addressed by the patent can
provide a reason for combining the elements in the manner claimed.”
• Try to establish there is not a finite number of predictable solutions with
anticipated success.
15
KSR Intern. Co. v. Teleflex, Inc., 127
S.Ct. 1727 (2007)
District court: summary judgment of obviousness under
Graham and teaching-suggestion-motivation (“T-S-M”) test.
FC: Reversed obviousness. “T-S-M” analysis was not strict
enough by the district court.
USSC: Reinstated obviousness. Reversed and remanded.
• Graham analysis reaffirmed.
• No secondary considerations dislodged the conclusion of
obviousness.
16
Graham v. John Deere Co.,
383 U.S. 1 (U.S. 1966)
“[if] the difference between the subject matter sought to
be patented and the prior art… would have been obvious at
the time to a person skilled in the art, then the subject
matter cannot be patented.”
Satisfying §103 is legal question with factual underpinnings:
• the scope and content of the prior art;
• differences between the prior art and the claims at issue; and
• the level of ordinary skill in the pertinent art.
• And “[s]uch secondary considerations as commercial
success, long felt but unsolved needs, failure of others,
etc., … may have relevancy.”― When do those factors have relevancy?
17
All of the USPTO post-KSR guidelines are based on Federal Circuit Cases from 2007
forward for a limited time period
Is that all there is?
The PTO Guidelines are very helpful but let’s not overlook lessons from the CCPA and
early Federal Circuit decisions
18
https://www.gpo.gov/fdsys/pkg/FR-2010-09-01/pdf/2010-21646.pdf
18
In re Papesch, 315 F.2d 381
(CCPA 1963)
Board affirmed examiner’s obviousness rejection of claims to compound
structurally similar to the prior art compound that differed by only
three -CH2 groups and was presumed to share many common properties.
CCPA: Reversed.
• Representative compound unexpectedly possessed anti-inflammatory
properties not possessed by the prior art compound; supported by affidavit
and comparative data.
• “If that which appears, at first blush, to be obvious though new is shown by
evidence not to be obvious, then the evidence prevails over surmise or
unsupported contention and a rejection based on obviousness must fall.”
• “a compound and all of its properties are inseparable; they are one and the
same thing.”
19
In re Lunsford, 357 F.2d 380
(CCPA 1966)
Board affirmed rejection of obviousness where claimed
compounds were structurally similar to the prior art compound
and each possessed anti-convulsant activity.
CCPA: Reversed.
• Claimed compounds had a “significant, advantageous, unexpected
difference” of 4.4 and 7 times the potency of the prior art compound.
• “Appellant has here proved his compounds to possess anti-convulsant
activity substantially greater than the prior art compound. We find
this to have been unpredictable from the prior art . . . .”
20
In re Chupp, 816 F.2d 643
(Fed. Cir. 1987)
Early Federal Circuit application of Papesch and Lunsford
Board affirmed obviousness of claim to compound that differed from the closest
prior art compound by a single methylene group; both claimed and prior art
compounds were selective herbicides.
Federal Circuit: Reversed.
• “It is undisputed that the claimed compound gave superior results [in only two crops,
corn and soybean], exhibiting selectivity factors (crop safety combined with weed-
killing activity) at least five times greater than those of the closest prior art
compounds.”
• Applying Papesch, held evidence of nonobviousness “may include data showing that a
compound is unexpectedly superior in a property it shares with prior art compounds.”
21
Chupp (con’t)
MPEP 716.02(a) II: Superiority of a property shared with the prior
art is evidence of nonobviousness.• “Evidence that a compound is unexpectedly superior in one of a
spectrum of common properties . . . can be enough to rebut a prima
facie case of obviousness.” No set number of examples of superiority
is required. In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987).
MPEP 2145: Consideration of Applicant’s Rebuttal Arguments.• Evidence that the compound or composition possesses superior and
unexpected properties in one of a spectrum of common properties
can be sufficient to rebut a prima facie case of obviousness. Id.
22
In re May, 574 F.2d 1082
(CCPA 1978)
Board affirmed obviousness rejection of composition and method-of-
use claims involving N-methyl benzomorphans having expected
analgesic potency, notwithstanding their unexpected nonaddictiveness
CCPA: Reversed.
• “Appellants have admitted . . . that one of ordinary skill in the art would have
expected that their compounds would be potent analgesics.”
• “Considering the entire record, including the fact that not a single reference relied
upon by the PTO suggests that any N-methyl benzomorphan exhibits the combined
properties of analgesic potency comparable to morphine coupled with
nonaddictiveness, we are led to the inescapable conclusion that it was totally
unexpected that appellants’ levo and alpha-levo N-methyl benzomorphans would
have exhibited such a combination of properties and, concommitantly, could be
used to effect nonaddictive analgesia.”
23
May (con’t)
Regarding the method-of-use claims:
• “[T]he raison d’ etre for research by those skilled in this art was, and still
is, not simply to produce another analgesic compound, but to produce one
which would exert this therapeutic value while at the same time being
nonaddictive. This, in our view, diminishes the significance that should be
attached to the expected beneficial result of potent analgesia, i. e., it
diminishes its evidentiary value that one skilled in the art would have
been motivated to make appellants’ compounds and to use them to effect
analgesia, and enhances the significance that should be attached to
appellants’ unexpected result of nonaddictive, potent analgesia, i. e., it
enhances its evidentiary value as an objective indicium of
nonobviousness.”
24
May (con’t)
Regarding the composition claims:
• “[T]he basis of the prima facie case of obviousness, at least to a major extent, is based
on the presumed expectation that compounds which are similar in structure will have
similar properties . . . . [A] showing of actual difference in properties between the
claimed compound and the structurally similar prior art compound . . . is not the only
manner of rebutting this presumption. . . . [A]n applicant may rebut the aforementioned
presumption by producing sufficient evidence which demonstrates a substantial degree of
unpredictability in the pertinent art area.”
• “[A]ppellants’ evidence establishes that a single prior art homologue . . . inherently
possessed, unbeknownst to the prior art, the combination of properties of appellants’
compound.”
• Appellants “established a substantial record of unpredictability vis-à-vis a highly
significant combination of properties” and “satisfactorily rebutted the presumed
expectation that structurally similar compounds have similar properties.”
25
Modern Application of May
Balance predictable and unpredictable
results• Sanofi-Synthelabo v. Apotex Inc., 550 F.3d 1075 (Fed. Cir. 2008) A claimed isolated
stereoisomer would not have been obvious where the claimed stereoisomer
exhibits unexpectedly strong therapeutic advantages over the prior art racemic
mixture without the correspondingly expected toxicity, and the resulting
properties of the enantiomers separated from the racemic mixture were
unpredictable.
• Relied on May.
MPEP 2143 E, ex. 7
26
In re Ruschig, 343 F.2d 965 (CCPA
1965)
Board affirmed obviousness rejection of claims for substituted
benzenesulfonyl ureas based on structural similarities to prior art
compounds despite the claimed compounds having superior oral
antidiabetic properties.
CCPA: Reversed.
• “What appellants invented . . . is a group of particular substituted benzenesulfonyl ureas having
hypoglycemic activity without antibacterial activity and which are non-toxic, so they have superior
properties as oral antidiabetic drugs.”
• No prior art reference disclosed blood sugar lowering action, treatment of diabetes, or a specific
utility.
• “What is important is the fact that the utility discovered by appellants is not disclosed in the prior
art.”
• “Notwithstanding its structural similarities to the claimed compounds, . . . [another prior art
compound] proved to have no hypoglycemic activity at all.”
27
Ruschig (con’t)
Regarding toxicity:
• “As to compounds identical except that [the claimed] one has N’-
cyclohexyl and the [prior art] other N’-phenyl . . .[,] the latter has
very high toxicity so as to be wholly unusable as a drug whereas
the former has hypoglycemic activity and is non-toxic.”
• “While the evidence does show that the compound had a blood
sugar level lowering property, it also disclosed that it was lethal.. .
Very high toxicity, in our view, cancels out any notion of anti-
diabetic ‘utility.’ Furthermore, it was appellants who disclosed the
property to which the solicitor refers. It was not known to the
prior art.”
28
In re Albrecht, 514 F.2d 1389
(CCPA 1975)
Board affirmed obviousness rejection of claims for esters and amides of
carbazole over structurally similar prior art compounds also possessing
anesthetic properties, despite the claimed compounds’ unexpected
antiviral activity.
CCPA: Reversed.
• “[T]he discovery of new and unobvious properties in the claimed compounds rebuts even
a prima facie case of obviousness where the art is silent on that property or the prior art
is shown not to possess that property.”
• “[T]he additional advantageous activity disclosed for the claimed compounds, namely
antiviral activity, is not in fact possessed by the prior art analog . . . [and] is itself
evidence of the nonobviousness of the subject matter as a whole.”
• “[T]he antiviral activity discovered . . . is totally dissimilar to any activity previously
disclosed for the prior art analogs . . . [and] is further evidence . . . of nonobviousness
of the claimed invention.”
29
Albrecht (con’t)
Regarding irritating side effects of prior art compounds:
• “With respect to the compounds studied, the [prior art] reference states: . . .
All of these compounds were more or less irritating to the rabbit’s eye and to
human skin, so that they cannot be regarded as useful anesthetics.”
• “[A] novel compound can be nonobvious to one having ordinary skill in the art
notwithstanding that it may possess a known property in common with a
known structurally similar compound. Where, as in this case, it is disclosed
that the prior art compounds ‘cannot be regarded as useful’ for the sole use
disclosed, as an anesthetic, . . . a person having ordinary skill in the art would
lack the ‘necessary impetus’ to make the claimed compounds.”
30
Albrecht (con’t)
Regarding irritating side effects of prior art compounds:
• MPEP 2144.08(II)(A)(4)(d): “[L]ack of any known useful properties weighs against a
finding of motivation to make or select a species or subgenus.” In re Albrecht, 514 F.2d
1389, 1392, 1395-96, 185 USPQ 585, 587, 590 (CCPA 1975) (The prior art compound so
irritated the skin that it could not be regarded as useful for the disclosed anesthetic
purpose, and therefore a person skilled in the art would not have been motivated to
make related compounds.)
• MPEP 2144.09(VI): “prior art reference studied the local anesthetic activity of various
compounds, and taught that compounds structurally similar to those claimed were
irritating to human skin and therefore “cannot be regarded as useful anesthetics.” In
re Albrecht, 514 F.2d 1389, 1393, 185 USPQ 585, 587 (CCPA 1975).― See also, In re Stemniski, 444 F.2d 581, 170 USPQ 343 (CCPA 1971): “If the prior art does not teach any
specific or significant utility for the disclosed compounds, then the prior art is unlikely to render
structurally similar claims prima facie obvious in the absence of any reason for one of ordinary skill in
the art to make the reference compounds or any structurally related compounds.”
• MPEP 2145: “Usually, a showing of unexpected results is sufficient to overcome a
prima facie case of obviousness. See, e.g., In re Albrecht, 514 F.2d 1389, 1396, 185
USPQ 585, 590 (CCPA 1975).”
31
Objective Evidence Must Be Considered if Submitted, But May
or May Not be Entitled to Weight
MPEP 2145:… “Consideration of rebuttal evidence and arguments requires
Office personnel to weigh the proffered evidence and arguments. Office
personnel should avoid giving evidence no weight, except in rare
circumstances. …However, to be entitled to substantial weight, the
applicant should establish a nexus between the rebuttal evidence and the
claimed invention, i.e., objective evidence of nonobviousness must be
attributable to the claimed invention…. Evidence pertaining to secondary
considerations must be taken into account whenever present; however, it
does not necessarily control the obviousness conclusion. …Office personnel
should not evaluate rebuttal evidence for its “knockdown” value against
the prima facie case, Piasecki, 745 F.2d at 1473, 223 USPQ at 788 [Fed. Cir.
1984], or summarily dismiss it as not compelling or insufficient. If the
evidence is deemed insufficient to rebut the prima facie case of
obviousness, Office personnel should specifically set forth the facts and
reasoning that justify this conclusion. See MPEP § 716 - § 716.10 for
additional information pertaining to the evaluation of rebuttal evidence
submitted under 37 CFR 1.132.
32
Guard Against Hindsight
In re Oelrich, 579 F.2d 86 (CCPA 1978)
Board affirmed rejection for obviousness of claims to a fin control
mechanism using sub-critical frequencies. • Selecting frequency to optimize system performance was mere design
choice.
• Expert testimony failed to establish that sub-critical-frequency operation
was thought not possible.
CCPA: Reversed.• “The question under §103, …is not whether one skilled in the art doing
what appellants did would have discovered what appellants discovered,
but whether it would have been obvious to one of ordinary skill in the
art to do what appellants did.”
33
Is weighing the objective evidence
against the other evidence
considering the invention “as a
whole”?
34
Patentability Over Intermediates
MPEP 2144.09(VI): “Similarly, if the prior art
merely discloses compounds as intermediates
in the production of a final product, one of
ordinary skill in the art would not ordinarily
stop the reference synthesis and investigate
the intermediate compounds with an
expectation of arriving at claimed compounds
which have different uses. In re Lalu, 747 F.2d
703, 223 USPQ 1257 (Fed. Cir. 1984).”
35
Taking Advantage of
Ruschig and Albrecht
Consider negative properties of prior art
• Stability
• Toxicity
• Bioavailability
• Metabolism
• Solubility
• Selectivity
• Target/receptor
• Site of action
36
Example of Proving a Negative
MPEP 2144.08 (4)(3): • In re Schechter, 205 F.2d 185, 191 (CCPA 1953):
Unpredictability in the insecticide field, with homologs, isomers and analogs of known effective insecticides having proven ineffective as insecticides, was considered as a factor weighing against a conclusion of obviousness of the claimed compounds.
• MPEP 2144.08 also cites Ruschig.
37
Gore v. Garlock, 721 F.2d 1540 (Fed. Cir. 1983):
Alive and Well in Current MPEP
Consider claimed invention “as a whole”.
• MPEP 2141.02 II: Distilling an invention down to the “gist” or
“thrust” of an invention disregards the requirement of analyzing
the subject matter “as a whole.” W.L. Gore & Assoc., Inc. v.
Garlock, Inc., 721 F.2d 1540 (Fed. Cir. 1983), cert. denied, 469
U.S. 851 (1984)
Consider prior art “as a whole,” including teaching away.
• MPEP 2141.02 IV: A prior art reference must be considered in its
entirety, i.e., as a whole, including portions that would lead
away from the claimed invention. Id.
38
In re Dillon, 919 F.2d 688
(Fed. Cir. 1990) (en banc)
Board affirmed a claimed tetra-orthoester fuel composition as obvious in
light of a prior art tri-orthoester fuel composition based on their
structural and chemical similarity and similar use as fuel additives.
En Banc Federal Circuit: Affirmed.
• “The art provided the motivation to make the claimed compositions in the
expectation that they would have similar properties . . . [Appellant] did not
present any showing of data to the effect that her compositions had
properties not possessed by the prior art compositions or that they possessed
them to an unexpectedly greater degree.”
39
Dillon (en banc) (con’t)
• “For example, she produced no evidence that her compositions
possessed properties not possessed by the prior art
compositions. Nor did she show that the prior art compositions
and use were so lacking in significance that there was no
motivation for others to make obvious variants. There was no
attempt to argue the relative importance of the claimed
compositions compared with the prior art.”
MPEP 2144.08 II: A determination of patentability under 35 U.S.C.
103 should be made upon the facts of the particular case in view
of the totality of the circumstances. See, e.g., In re Dillon, 919
F.2d 688, 692-93, (Fed. Cir. 1990) (en banc).
40
Avoiding the Result of Dillon
• Daiichi Sankyo Co., Ltd. v. Matrix Laboratories, Ltd., 619 F.3d 1346 (Fed. Cir. 2010):
• “Accordingly, proving a reason to select a compound as a lead compound depends on more than just structural similarity, but also knowledge in the art of the functional properties and limitations of the prior art compounds. See Eli Lilly, 471 F.3d at 1377-79. Potent and promising activity in the prior art trumps mere structural relationships.”
41
Federal Circuit in Daiichi: “These cases illustrate that it is the possession of promising useful
properties in a lead compound that motivates a chemist to make structurally similar compounds. Yet the attribution of a compound as a lead compound after the fact must avoid hindsight bias; it must look at the state of the art at the time the invention was made to find a motivation to select and then modify a lead compound to arrive at the claimed invention.”
“While the lead compound analysis must, in keeping with KSR, not rigidly focus on the selection of a single, best lead compound, …the analysis still requires the challenger to demonstrate by clear and convincing evidence that one of ordinary skill in the art would have had a reason to select a proposed lead compound or compounds over other compounds in the prior art. ”
Avoiding the Result of Dillon (con’t)
42
In re Rinehart, 531 F.2d 1048
(CCPA 1976)
Board affirmed obviousness rejection of claimed process
for preparing resin on a commercial scale.
CCPA: Reversed.
• Cited in MPEP 2143.02 II: No reasonable expectation that a process
combining the prior art steps could be successfully scaled up in
view of unchallenged evidence showing that the prior art processes
individually could not be commercially scaled up successfully.
43
Rinehart (con’t)
“As in In re Naylor, 369 F.2d 765, 54 CCPA 902 (1966), we find nothing in the
record which would lead one of ordinary skill to anticipate successful
production on a commercial scale from a combination of such elements,
without increase in glycol-acid ratio. The record in fact reflects the contrary.
The view that success would have been ‘inherent’ cannot, in this case,
substitute for a showing of reasonable expectation of success. Inherency and
obviousness are entirely different concepts. In re Spormann, 363 F.2d 444, 53
CCPA 1375 (1966); In re Adams, 356 F.2d 998, 53 CCPA 996 (1966).”
MPEP 2143.02 II: “Obviousness does not require absolute predictability,
however, at least some degree of predictability is required. Evidence
showing there was no reasonable expectation of success may support a
conclusion of nonobviousness.”
44
Practice Tips from Rinehart
Consider loading the prosecution with
substantiated and uncontroverted facts
establishing unpredictability, unexpected
results, teaching away, etc.
Make sure those facts are not inconsistent
with other facts known to the group of
inventors, counsel, etc. substantially
involved in the prosecution.
45
Rinehart (con’t)
Consider all evidence anew before final finding of
obviousness:
• “When prima facie obviousness is established and evidence is submitted in rebuttal, the
decision-maker must start over. Though the burden of going forward to rebut the prima facie
case remains with the applicant, the question of whether that burden has been successfully
carried requires that the entire path to decision be retraced. An earlier decision should not,
as it was here, be considered as set in concrete, and applicant’s rebuttal evidence then be
evaluated only on its knockdown ability. Analytical fixation on an earlier decision can tend to
provide that decision with an undeservedly broadened umbrella effect. Prima facie
obviousness is a legal conclusion, not a fact. Facts established by rebuttal evidence must be
evaluated along with the facts on which the earlier conclusion was reached, not against the
conclusion itself. Though the tribunal must begin anew, a final finding of obviousness may of
course be reached, but such finding will reset upon evaluation of all facts in evidence,
uninfluenced by an earlier conclusion reached by an earlier board upon a different record.”
46
Lessons From Rinehart
Use facts as a 1-2 punch against obviousness1. showing no prima facie case
2. rebutting an assumed arguendo prima facie case
Provides litigation or post-grant proceeding counsel the opportunity to use the
same evidence, but of course, it better be good.
K-40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6 (P.T.A.B. Aug. 29,
2013) – Instituted based on defective declaration submitted during prosecution.
Patent Owner lost at PTAB.
Intellect Wireless v. HTC Corp., 732 F.3d 1339 (Fed. Cir. 2013) and Apotex, Inc.
v. UCB, Inc., 7634 F.3d 1354 (Fed. Cir. 2014)• Inequitable conduct for submitting false declarations.
• Don’t even think it, much less do it!
47
Modern Application of In re Wilson, 424 F.2d
1382 (CCPA 1970) and In re Fine, 837 F.2d
1071 (Fed. Cir. 1988)
MPEP 2143.03: All Claim Limitations Must Be Considered
• “All words in a claim must be considered in judging the patentability
of that claim against the prior art.” In re Wilson, 424 F.2d 1382, 1385
(CCPA 1970).
• If an independent claim is nonobvious under 35 U.S.C. 103, then any
claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071
(Fed. Cir. 1988).
48
In re Baird, 16 F.3d 380 (Fed. Cir. 1994) and
In re Jones, 958 F.2d 347 (Fed. Cir. 1992): The Predicate for the
Modern-day Ortho-McNeil Federal Circuit Case
MPEP 2144.08 II: Obviousness of Species When Prior Art
Teaches Genus
• “The fact that a claimed compound may be encompassed by a disclosed
generic formula does not by itself render that compound obvious.” In re Baird,
16 F.3d 380 (Fed. Cir. 1994).
• Federal Circuit has “decline[d] to extract from Merck [& Co. v. Biocraft
Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the rule
that... regardless of how broad, a disclosure of a chemical genus renders
obvious any species that happens to fall within it.” In re Jones, 958 F.2d 347,
(Fed. Cir. 1992).
• Cases also cited in MPEP 2144.05 I.
49
“Small and Finite”
Ortho-McNeil Pharms. Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir.
2008)
• “Beyond that step, however, the ordinarily skilled artisan would have to have some
reason to select (among several unpredictable alternatives) the exact route that
produced topiramate as an intermediate.”
• “this clearly is not the easily traversed, small and finite number of alternatives that KSR
suggested might support an inference of obviousness.”
• “Mylan's expert… simply retraced the path of the inventor with hindsight, discounted
the number and complexity of the alternatives, and concluded that the invention of
topiramate was obvious. Of course, this reasoning is always inappropriate for an
obviousness test[.]”
50
In re Tiffin,
448 F.2d 791 (CCPA 1971)
MPEP 716.03(a) Commercial Success Commensurate in Scope With Claimed
Invention
• I. EVIDENCE OF COMMERCIAL SUCCESS MUST BE COMMENSURATE IN SCOPE WITH THE
CLAIMS
― Objective evidence of nonobviousness including commercial success must be
commensurate in scope with the claims. In re Tiffin, 448 F.2d 791, 171 USPQ
294 (CCPA 1971) (evidence showing commercial success of thermoplastic foam
“cups” used in vending machines was not commensurate in scope with claims
directed to thermoplastic foam “containers” broadly). In order to be
commensurate in scope with the claims, the commercial success must be due
to claimed features, and not due to unclaimed features.
Tiffin, FN 3: “affidavit is sufficient to establish that the subject matter of this application enjoyed
great commercial success which was not due to advertising or other extraneous factors.”
51
52
Proving Commensurate in Scope:
In re Hollingsworth, 253 F.2d 238 (CCPA 1958)
From Response:
In addition, In re Hollingsworth, 253 F.2d 238 (CCPA 1958), cited in MPEP
716.03(a)(II), also shows that one embodiment having commercial success
within the scope of new claims 27 and 28 can be sufficient to show non-
obviousness over the claims of the _____ patent:
If a particular range is claimed, applicant does not need to show
commercial success at every point in the range. “Where, as here, the
claims are directed to a combination of ranges and procedures not
shown by the prior art, and where substantial commercial success is
achieved at an apparently typical point within those ranges, and the
affidavits definitely indicate that the operation throughout the
claimed ranges approximates that at the particular points involved in
the commercial operation, we think the evidence as to commercial
success is persuasive.” In re Hollingsworth.
52
Antonie and Boesch:
One Way to Defeat Optimization Arguments
• MPEP 2144.05(II)(B): Only Result-Effective Variables Can Be Optimized
• A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) (The claimed wastewater treatment device had a tank volume to contractor area of 0.12 gal./sq. ft. The prior art did not recognize that treatment capacity is a function of the tank volume to contractor ratio, and therefore the parameter optimized was not recognized in the art to be a result- effective variable.).
• See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (prior art suggested proportional balancing to achieve desired results in the formation of an alloy).
53
Whalen: A Modern-Day Application of Antonie to Defeat
Optimization Arguments
• See also, Ex parte Whalen II, App. No.2007-4423 (BPAI July 23, 2008):
• “While ‘the discovery of an optimum value of a variable in a known process is normally obvious,’ In re Antonie,… this is not always the case. One exception to the rule is where the parameter optimized was not recognized in the prior art as one that would affect the results. Id.”
• “Here, the Examiner has not pointed to any teaching in the cited references, or provided any explanation based on scientific reasoning, that would support the conclusion that those skilled in the art would have considered it obvious to “optimize” the prior art compositions by increasing their viscosity to the level recited in the claims.”
54
Did KSR overrule Antonie?
KSR: “Under the correct analysis, any need or
problem known in the field and addressed by the
patent can provide a reason for combining the
elements in the manner claimed.”
55
56
Early Federal Circuit Case Regarding
Commensurate in Scope
From Response:
As explained at the interview, Federal Circuit case law
binding on the USPTO establishes that commercial
success establishes the patentability of a claim broader
in scope than the single embodiment of commercial
success shown within the claim. See In re Glatt, 630 F.3d
1026, 1030 (Fed. Cir. 2011) and Applied Materials, Inc. v.
Adv. Semiconductor Materials Am., Inc., 98 F.3d 1563,
1570 (Fed. Cir. 1996).
56
• In re Piasecki, 745 F.2d 1468 (Fed. Cir. 1984):• “As competent evidence tending to show the nonobviousness of appellants’
invention to one of ordinary skill in the art at the time the invention was made,
the . . . affidavits must be accorded fair weight in the company of all other
competent rebuttal evidence.” Citing In re Oelrich.
• In re Oelrich, 579 F.2d 86 (CCPA 1978):• “In our opinion, the affidavits were sufficient to shift the burden of going
forward with the evidence back to the PTO, and that burden has not been
sustained. In other words, the prima facie case of obviousness has been
overcome.”
57
PTO Must Consider Declarations When
Determining Obviousness
57
Applying CCPA decisions and early Federal
Circuit decisions to avoid untoward 103
results
58
Allergan v. Sandoz,
726 F.3d 1286 (Fed. Cir. 2013)
Allergan’s Combigan® is a combination product containing 0.2%
brimonidine and 0.5% timolol dosed twice a day approximately 12
hours apart to treat glaucoma.
’149 Claim 4. A method of reducing the number of daily topical
ophthalmic doses of brimondine administered topically to an eye of a
person in need thereof for the treatment of glaucoma or ocular
hypertension from 3 to 2 times a day without loss of efficacy, wherein
the concentration of brimonidine is 0.2% by weight, said method
comprising administering said 0.2% brimonidine by weight and 0.5%
timolol by weight in a single composition.
’463 Claim 1. A composition comprising about 0.2% brimonidine by
weight and about 0.5% timolol by weight as the sole active agents, in a
single composition.
59
Allergan v. Sandoz (cont.)
Dist. Ct.: Method and composition claims nonobvious
Fed. Cir.: Affirmed-in-part (method was nonobvious) and reversed-
in-part (composition was obvious)
District Court Federal Circuit
No motivation to develop fixed combinations based on FDA criteria
Motivation to combine - prior art taughtfixed combinations of ophthalmic drugs
Formulation arts are unpredictable Reasonable expectation of success in formulating combination
Some teaching away in the prior art, including potential side effects, etc.
Accepted Dist. Ct. factual findings
long-felt need Accepted Dist. Ct. factual findings
Twice per day dosage regimenunexpectedly no afternoon trough
Accepted Dist. Ct. factual findings
60
Allergan v. Sandoz (cont.)
Fed. Cir. on unexpected results regarding afternoon trough:
• “While the unexpected benefits of twice a day dosing of the combination
formula are relevant to . . . the validity of the method claims, we do not find
it similarly meaningful to our analysis of the formulation claims. There is
extensive evidence in the prior art showing the concomitant administration
of brimonidine and timolol multiple times per day, that the combination had
benefits over the administration of either alone, and that there was a
motivation to combine the two to achieve better patient compliance. . . .
Whether or not that combination also solved problems associated with the
afternoon trough, we find the motivation to make the combination was real.
Accordingly, we conclude that the claims of the ’463 patent are invalid as
obvious.”
See in re Dillon.
61
Allergan v. Sandoz (cont.)
Fed. Cir. on unexpected results regarding afternoon trough:
• “The record firmly establishes that when brimonidine is dosed twice per day as opposed to three
times per day, there is a loss of efficacy in the afternoon—the so called, afternoon trough.
[Challenger] has [f]ailed to point to evidence in the prior art that would allow us to conclude that
the addition of timolol to brimonidine dosed twice per day would eliminate the afternoon trough
issue.”
• “The evidence of record does not establish that the dose reduction ‘from 3 to 2 times a day
without loss of efficacy’ limitation is an inherent property or a necessary result of the
administration of 0.2% brimonidine and 0.5% timolol in a single composition. Of course, it may be
true that the mere administration of 0.2% brimonidine and 0.5% timolol twice daily in any fixed
combination formulation inherently produces the claimed result. Alternatively, it may also be true
that only certain fixed-combination formulations produce this result. On the present record, we
cannot draw a conclusion in favor of either proposition.”
Was the rationale of Papesch, that a compound and its unexpected properties are
inseparable and thus relevant to the nonobviousness of the composition, lost here?
62
Novo Nordisk A/S v. Caraco Pharm. Labs, Ltd., 719 F.3d 1346 (Fed. Cir. 2013)
Novo Nordisk markets Prandin® (repaglininde tablet) and
PrandiMet® (fixed-dose repaglinide/metformin tablet) for the
treatment of Type 2 diabetes mellitus (also known as non-insulin
dependent diabetes mellitus or NIDDM).
’358 Claim 4. A method for treating non-insulin dependent
diabetes mellitus (NIDDM) comprising administering to a patient in
need of such treatment repaglinide in combination with
metformin.
63
Novo v. Caraco (con’t)
Orally administered antidiabetic drugs (OADs)
• Monotherapy or combination therapy
• Several classes of OADs
― Different chemistry
― Different mechanisms of action
• This case only concerns 2 classes of OADs:
― Insulin sensitizers (e.g., metformin)
― Insulin secretagogues (2 subclasses)
― sulfonylureas (e.g., long-acting glyburide)
― meglitinides (e.g., short-acting repaglinide)
64
Novo v. Caraco (con’t)
PTO: Allowed claim “[b]ased solely upon the Declaration .
. . and reconsideration of the synergistic effects . . .”
• “In the Moses Study, patients failing on metformin alone were given
repaglinide/metformin combination therapy. . . . Although
repaglinide was previously thought to have no effect upon FPG
[fasting plasma glucose] due to its short-acting tendencies, the
Moses Study found that repaglinide/metformin reduced FPG to
levels more than eight times lower than what was typically
achieved by metformin alone.”
• Thus, synergism was shown.
65
Novo v. Caraco (con’t)
Dist. Ct.: Found claim obvious.• Determined that POSITA would have expected repaglinide/metformin
would yield some synergy and that results were entirely expected in
view of the state of the art at that time.
Fed. Cir (divided panel): Affirmed.• “[T]he parties did not dispute . . . a prima facie case . . .”
• Dispute regarding closest prior art and expectation regarding
synergism.
Adduce evidence to demonstrate unexpected nature of synergism and no finite
number of easily-traversed solutions.
66
Closest prior art to claimed metformin/repaglinide combination?
• Dist. Ct. and Fed. Cir.: metformin/sulfonylurea combo
― “earlier metformin/sulfonylurea combinations were generally understood
to yield synergy”
― Dissent: “a combination of metformin and a sulfonylurea . . . may or may
not have a synergistic effect . . ., for only some sulfonylureas showed
such effect.”
• Novo Nordisk: repaglinide alone
― “a short-acting insulin secretagogue, different from the longer-acting
sulfonylureas”
― “repaglinide in monotherapy had no impact on patient FPG.”
Adduce evidence to compel a conclusion that the active ingredient alone is your lead
compound.
67
Novo v. Caraco (con’t)
Is this the finite number of predictable solutions of
the sort envisioned by Jones and Baird and endorsed
in KSR?
Has the need for reasonable predictability in
obviousness been overlooked here?
• Novo v. Caraco Dissent: “The existence of synergy in some metformin-
sulfonylurea combinations is not predictive of synergy in the combination of
metformin with repaglinide.”
68
Galderma Laboratories, L.P. v. Tolmar, Inc., 737
F.3d 731 (Fed. Cir. 2013)
Galderma’s Differin® Gel 0.3% for the topical treatment of acne.
Dist. Ct.: Method and composition claims directed to 0.3% adapalene
were nonobvious.
• Held for Galderma, relying heavily on evidence showing that
― increasing the dose of adapalene was likely to increase the incidence
of certain side effects and
― evidence that 0.1% was considered the optimal adapalene
concentration for the treatment of acne,
― at least two secondary considerations,
― unexpected results and
― commercial success
69
Galderma v. Tolmar (con’t)
Fed. Cir.: Reversed
• “[P]rior art . . . patents disclose topical adapalene compositions for the purpose of treating acne
in the preferred range of 0.01%-1%, . . . Thus, the . . . patents disclose all of the limitations of
the asserted claims, except for a precise teaching of 0.3% adapalene . . . .”
• Majority: “[T]he dispute is whether there was motivation to select the claimed 0.3% adapalene
composition in the disclosed range. . . . [W]here there is a range disclosed in the prior art, and
the claimed invention falls within that range, the burden of production falls upon the patentee .
. . .”
• Dissent: “[M]y colleagues announce their rule whereby a broad teaching that includes the
patented invention removes the statutory presumption of validity, and without more establishes
obviousness. . . . and places on the patentee the burden of establishing patentability based on
‘secondary considerations.’”
Have to somehow establish the separate patentability, to the satisfaction of a district
court, a Federal Circuit panel, and possibly PTAB, of a claimed value falling within a
prior art range, perhaps by using real-world objective evidence of the type discussed
above.
70
Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
752 F.3d 967 (Fed. Cir. 2014)
BMS’s hepatitis B drug, Baraclude® contains entecavir.
Dist. Ct.: compound claim directed to entecavir was obvious
despite unexpectedly superior therapeutic properties.• “[I]ts high potency, high barrier to resistance and the size of its
therapeutic window” were “beyond what was expected at the time of
the invention.”
• “more potent in vitro than every other compound”
Fed. Cir.: Affirmed.
71
BMS v. Teva (con’t)
What about unexpected avoidance of side effects?
• Courts considered 2’-CDG as the lead compound
• Fed. Cir.: “2’-CDG showed ‘excellent activity’ against the hepatitis B
virus” and “was generally understood to be safe and nontoxic, and other
researchers were already using it as a lead compound.”
• But 2’-CDG and Madhavan 30 (another prior art compound relied on by the
courts) are toxic.― Dist. Ct.:
― “The most significant difference between 2’-CDG and entecavir is
that the former is toxic while the latter is not.”
― “Of the analogs made by the Madhavan group, they found that
Madhavan 30 was the most potent, but also the most toxic.”
72
• Such unexpectedly superior efficacy would
have sufficed historically under cases like
Lunsford to establish nonobviousness.
The lessons of Ruschig (“very high toxicity so
as to be wholly unusable as a drug”) and
Albrecht; have they been lost?
73
Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc.,
894 F.3d 1374 (Fed. Cir. 2018)
Endo holds the approved New Drug Application for Aveed®, a testosterone undecanoate
(TU) intramuscular injection.
Bayer owns the two patents listed in the Orange Book for Aveed®, U.S. Patent Nos.
7,718,640 (the '640 patent) and 8,338,395 (the '395 patent).
The Federal Circuit affirmed the district court’s ruling
that the asserted patent claims were not obvious.
74
Endo Formulation Claims
Claim 2 of the '640 patent: A composition formulated for intramuscular injection in a form
for single injection according to claim 1, which contains 750 mg testosterone
undecanoate.
Claim 1. A composition formulated for intramuscular injection in a form for single
injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a
mixture of castor oil and benzyl benzoate wherein the vehicle contains castor oil in a
concentration of 40 to 42 vol %.
75
Custopharm: the references inherently disclosed the formulation, because they recited the
TU injection’s pharmacokinetic performance, from which a skilled artisan could derive that
the vehicle contained 40% castor oil and 60% benzyl benzoate.
FC: No, the pharmacokinetic profiles in the clinical references did not necessarily point to
the use of the claimed vehicle or bar the possibility of alternatives.
• Custopharm had not shown that a POSITA could extrapolate the vehicle formulation used in
the clinical study references from the pharmacokinetic performance data.
• The prior art disclosed many potential co-solvents such that skilled artisans reviewing the
clinical studies would not have necessarily recognized that the references’ authors used
benzyl benzoate as a co-solvent for their reported clinical studies.
― Credited Endo’s expert’s testimony that, based on the references’ disclosures, a
POSITA would not have recognized that a co-solvent was necessary, and even if one
was necessary, many were available.
― Custopharm’s expert conceded that even knowing the co-solvent’s identity would
not necessarily lead a skilled artisan to the ratio claimed in the asserted patents.
76
Endo (con’t)
Custompharm: A POSITA would have turned to Proluton when formulating a long-acting,
injectable testosterone therapy.
• Proluton is a commercially available injectable composition of hydroxyprogesterone
in a mixture of 40% castor oil and 60% benzyl benzoate administered weekly to
pregnant women to prevent miscarriage.
FC rejected argument.
• Unlike Aveed®, Proluton is not a testosterone product for men.
• Proluton is not an injectable steroid with prolonged activity. Consequently, the
Federal Circuit was not persuaded that a skilled artisan would have turned to
Proluton when formulating a long-acting, injectable testosterone therapy.
Endo (con’t)
Side note re related MOT claims, which were also upheld by the Federal Circuit: Endo presented evidence that injections like TU
injections behave in unpredictable ways and that dose and regimen changes would require more than routine experimentation.
Specifically, the clinical study references did not disclose a linear relationship between dose amount and amount of TU in the
patient’s body.
77
• Claim 49. A topical formulation consisting essentially of: 1-2% w/w diclofenac
sodium; 40-50% w/w DMSO; 23-29% w/w ethanol; 10-12% w/w propylene glycol;
hydroxypropyl cellulose; and water to make 100% w/w, wherein the topical
formulation has a viscosity of 500-5000 centipoise.
• Actavis argued that modifying PENNSAID® 1.5% to get the PENNSAID® 2% formulation would have
been obvious to a POSITA because “the drawbacks to PENNSAID® 1.5%—frequent application and
vulnerability to run-off—were known, and that “all the changes were obvious optimizations of
result-effective variables that produced a predictable result in relation to absorption, thickness,
and drying times.”
• Horizon argued the prior art reflected that the field of topical pharmaceutical formulations is
complex and unpredictable.
• DC: Not invalid for obviousness.• “not a result of routine optimization of PENNSAID® 1.5% . . . because general principles and ranges of
permissible concentrations would not have predicted the exact formulation and dosing frequency that
resulted in PENNSAID® 2%.”
• “the variables involved in this case, including the components of the inventive formulation, interact in an
unpredictable or unexpected way, such that the results emanating into PENNSAID® 2% were not obvious.
• Nothing in the prior art allowed a POSITA to find "the schematic or roadmap to a diclofenac gel effective
at two doses a day."
• "the combination of adjustments needed to change PENNSAID® 1.5% into PENNSAID® 2% was not
predictable from the prior art."
HZNP Meds. LLC v. Actavis Labs.,
940 F.3d 680 (Fed. Cir. 2019)
78
• HZNP (con’t)
• Actavis: “the district court erred by requiring that the prior art
predict the exact formulation of the asserted claim.”
• FC: Affirmed nonobvious holding.
• “While a drug formulator could be inspired by general knowledge
and the prior art to adjust a certain variable, the district court
found that the variables here interacted with each other in
unpredictable ways.”
• “the inventive formulation was complex and that a POSITA would
be challenged to predict relative ratios in order to achieve the
desired goal of PENNSAID® 2%.”
Federal Circuit: Affirmed Nonobvious
79
Reasonable Expectation Of Success
In Unpredictable Arts
OSI Pharms., LLC v. Apotex Inc., 939 F.3d 1375 (Fed. Cir. 2019) (
• N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazo-linamine, also known as
erlotinib.
― OSI markets as Tarceva®.
• IPR2016-01284 FWD claims 44-46 and 53 of U.S. 6,900,221 unpatentable.
• FC: Reversed.
― Finding of reasonable expectation of success not supported by substantial
evidence.
80
Background
Non-small cell lung cancer (NSCLC).
Most therapies for NSCLC failed in clinical trials, even ones
that seemed promising in vitro.
• 1631 new drugs studied in phase II.
• 7 gained FDA approval (.04%).
“Cancer treatment is highly unpredictable.”
81
OSI Claim
44. A method for the treatment of NSCLC (non small cell lung
cancer), pediatric malignancies, cervical and other tumors caused
or promoted by human papilloma virus (H[P]V), Barrett's
esophagus (pre-malignant syndrome), or neoplastic cutaneous
diseases in a mammal comprising administering to said mammal a
therapeutically effective amount of a pharmaceutical composition
comprised of at least one of N-(3-ethynylphenyl)-6,7-bis(2-
methoxyeth-oxy)-4-quinazolinamine, or pharmaceutically
acceptable salts thereof in anhydrous or hydrate forms, and a
carrier.
82
References
Schnur: discloses 105 compounds, including erlotinib and method of
making, and discloses lung cancer as condition that could be treated.
Gibbs: discusses studies including one on erlotinib; “appear to have good
anti-cancer activity in preclinical models, with an acceptable therapeutic
index, particularly in patients with non-small cell lung cancer.”• No data regarding the use of erlotinib to treat NSCLC in Gibbs or in any of the
references cited in Gibbs.
• Patent Owner submitted reference by Gibbs (spoiler for Case Studies!)
OSI’s 10-K: “[Erlotinib] is a potent, selective and orally active inhibitor of
the epidermal growth factor receptor, a key oncogene in these cancers.• No data on erlotinib on NSCLC.
83
PTAB Decision
A POSITA “would have combined Gibbs or OSI 10-K with Schnur and had a
reasonable expectation of success of achieving the invention of
challenged claims 44 and 53.”
Schnur discloses all of the limitations of claims 44 and 53 except for the
treatment of NSCLC.
OSI’s 10-K would have provided a person of ordinary skill with a
reasonable expectation of success in light of Schnur’s teachings.
Credited Gibb’s “good anti-cancer” activity comment even though
unsupported with data.
Discounted Gibb’s testimony.
84
Federal Circuit Decision
PTAB’s conclusion “not supported by substantial evidence.”
• “Board misinterpreted the asserted references to teach more than substantial
evidence supports.”
• “the claims require only treatment of a mammal with erlotinib—efficacy in
humans is not required. But the asserted references do not disclose any data
or other information about erlotinib’s efficacy in treating NSCLC. The record
does not contain any clinical (human) data or pre-clinical (animal) data. It
does not even include in vitro (test tube) data regarding erlotinib’s effect on
NSCLC.”
• “At the same time, it is undisputed that NSCLC treatment was highly
unpredictable with an over 99.5% rate of failure for drugs entering Phase II
clinical studies.”
85
Federal Circuit (con’t)
Gibb’s “anti-cancer” comment only supported by references 12, which does not
mention erlotinib, and 13, which does not mention NSCLC.
“no evidence that a publication discussing erlotinib’s effect on NSCLC existed at
the time Gibbs was published.”
“asserted references do not disclose any information about erlotinib’s efficacy in
treating NSCLC in a mammal.”
86
Federal Circuit (con’t)
“The lack of erlotinib-NSCLC efficacy data or other indication of success
here is significant because of the highly unpredictable nature of treating
NSCLC, which is illustrated by the over 99.5% failure rate of drugs
entering Phase II. ... Indeed, this failure rate includes only drug
candidates that were promising enough to make it to Phase II trials, and
does not even take into account all of the drug candidates that failed in
the preclinical stage and in Phase I studies. Further, it is undisputed that
a drug’s success in treating one type of cancer does not necessarily
translate to success in treating a different type of cancer, which
underscores the unpredictability in cancer treatment generally.”
“there is not only a complete absence of data regarding the effect of
erlotinib on NSCLC, but also a complete absence of an indicator or
mechanism on which a person of ordinary skill could rely to reasonably
expect success. “
87
Federal Circuit (con’t)
“There is nothing in OSI’s 10-K suggesting the existence of erlotinib
preclinical efficacy data that is specific to NSCLC. Even if a skilled
artisan could presume that some preclinical data exists, there is no basis
for assuming that the data pertains to NSCLC as opposed to other
cancers. And just because the EGFR is targeted by a drug does not
necessarily mean that the drug will treat NSCLC. …(Dr. Bunn testifying
that several EGFR inhibitors that showed promising in vitro activity failed
later in the drug development process).”
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Federal Circuit (con’t)
“Moreover, between 1990 and 2005, a period that includes the time of the invention,
there were 1,630 other new drug compounds that, like erlotinib, targeted NSCLC and
were studied in Phase II trials. The failure rate for these compounds was 99.5%. The
Board did not properly consider OSI’s 10-K statement in light of the 99.5% failure rate of
the other 1,630 drugs entering Phase II trials for the treatment of NSCLC. Given this
high failure rate, a fact finder could not reasonably find that the 10-K statement
combined with Schnur would have been sufficient to create a reasonable expectation of
success. These references provide no more than hope—and hope that a potentially
promising drug will treat a particular cancer is not enough to create a reasonable
expectation of success in a highly un-predictable art such as this. Indeed, given a 99.5%
failure rate and no efficacy data or any other reliable indicator of success, the only
reasonable expectation at the time of the invention was failure, not success. It is only
with the benefit of hindsight that a person of skill in the art would have had a
reasonable expectation of success in view of the asserted references.”
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Take-Aways
• Remember Rinehart. Martial evidence to show unpredictability
to support arguments of no motivation to combine/modify and
no reasonable expectation of success.
• Caution on claim scope: OSI may work best for single species
and single method of treatment on the theory that
unpredictability can limit the scope of enablement.
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Polling Question 1
As we have seen, South Corp. made all CCPA
decisions en banc authority with the Federal
Circuit. The CCPA ceased to be on September
30, 1982, over 38 years ago. Will you rely on
CCPA cases before PTAB?
Yes or No?
91
Polling Question 2
As mentioned in Polling Question 1, the
CCPA ceased to be on September 30,
1982, over 38 years ago. Will you rely on
CCPA cases before a United States
District Court?
Yes or No
92
Polling Question 3
The current version of the MPEP cites both CCPA decisions and
appellate court decisions arising from district court litigation.
E.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94
USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc) and n re Fout, 675
F.2d 297, 213 USPQ 532 (CCPA 1982). During prosecution it is
better to rely on a Federal Circuit decision arising from district
court litigation than on an ancient CCPA decision (they are all
ancient at this point).
Yes or No
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Thank You!
Contact Information:
Arpita Bhattacharyya, [email protected]
Adriana L. [email protected]
Aliza [email protected]
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USPTO GUIDELINES:
COMBINING PRIOR ART ELEMENTSPost-KSR cases have held such combinations to be nonobvious “when the combination
requires a greater expenditure of time, effort, or resources than the prior art teachings.”
Case Cite Notes
In re Omeprazole Patent Litigation
536 F.3d 1361 (Fed. Cir. 2008)
Even where a general method that could have been applied to make the claimed product was known and within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown.
Crocs Inc. v. International Trade Commission
598 F.3d 1294 (Fed. Cir. 2010)
“[M]erely pointing to the presence of all claim elements in the prior art is not a complete statement of a rejection for obviousness.”
Sundance Inc. v. DeMonte Fabricating Ltd.
550 F.3d 1356 (Fed. Cir. 2008)
A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results.
Ecolab Inc. v. FMC Corp. 569 F.3d 1335 (Fed Cir. 2009)
A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so.
Wyers v. Master Lock Co.
No. 2009-1412—F.3d-- (Fed. Cir. July 22, 2010)
The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.
DePuy Spine Inc. v. Medtronic Sofamor Danek Inc.
567 F.3d 1314 (Fed. Cir. 2009)
Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements.
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USPTO GUIDELINES: SUBSTITUTING ONE KNOWN
ELEMENT FOR ANOTHER
“applies when the claimed invention can be viewed as resulting from substituting a known
element for an element of a prior art invention”
Case Cite Notes
In re ICON Health & Fitness Inc.,
496 F.3d 1374(Fed. Cir. 2007)
When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved.
Agrizap v. Woodstream
520 F.3d 1337(Fed. Cir. 2008)
Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for applicant’s purpose.
Muniauction Inc. v. Thomson Corp.
532 F.3d 1318 (Fed. Cir. 2008)
Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions.
Aventis Pharma Deutschland v. Lupin Ltd.
499 F.3d 1293(Fed. Cir. 2007)
A chemical compound would have been obvious over a mixture containing that compound as well as other compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art.
Eisai Co. Ltd. v. Dr. Reddy's Laboratories Ltd.
533 F.3d 1353(Fed. Cir. 2008)
A claimed compound would not have been obvious where there was no reason to modify the closest prior art leadcompound to obtain the claimed compound and the prior art taught that modifying the lead compound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound.
Procter & Gamble Co. v. Teva Pharmaceuticals USA Inc.
566 F.3d 989 (Fed. Cir. 2009)
It is not necessary to select a single compound as a ‘‘lead compound’’ in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious.
Altana Pharma AG v. Teva Pharmaceuticals USA Inc.
566 F.3d 999 (Fed. Cir. 2009)
Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound.
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USPTO GUIDELINES: OBVIOUS TO TRYApplies when “there is a recognized problem or need in the art; there are a finite number of identified,
predictable solutions to the recognized need or problem; and one of ordinary skill in the art could have
pursued these known potential solutions with a reasonable expectation of success.”
Case Cite Notes
In re Kubin 561 F.3d 1351 (Fed. Cir. 2009)
A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ‘‘predictable’’ arts.
Takeda Chemical Industries Ltd. v. Alphapharm Pty. Ltd.
492 F.3d 1350(Fed. Cir. 2007)
A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound.
Ortho-McNeil Pharmaceutical Inc. v. Mylan Laboratories Inc.,
520 F.3d 1358(Fed. Cir. 2008)
Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives.
Bayer Schering Pharma A.G. v. Barr Laboratories Inc.
575 F.3d 1341(Fed. Cir. 2009)
A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable.
Sanofi-Synthelabo v. Apotex Inc.
550 F.3d 1075(Fed. Cir. 2008)
A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable.
Rolls-Royce PLC v. United Technologies Corp.
603 F.3d 1325 (Fed. Cir. 2010)
An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness.
Perfect Web Technologies Inc. v. InfoUSA Inc.
587 F.3d 1324, 1328-29 (Fed. Cir. 2009)
Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning.
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USPTO GUIDELINES:
CONSIDERATION OF EVIDENCE Case Cite Notes
PharmaStem Therapeutics Inc. v. Viacell Inc.
491 F.3d 1342(Fed. Cir. 2007)
Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required.
In re Sullivan 498 F.3d 1345 (Fed. Cir. 2007)
All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.
Hearing Components Inc. v. Shure Inc.
600 F.3d 1357(Fed. Cir. 2010)
Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated.
Asyst Technologies Inc. v. Emtrak Inc.
544 F.3d 1310(Fed. Cir. 2008)
Evidence of secondary considerations of obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art.
98