Section 102 Prior Art and Section 103 Obviousness ...

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.”



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


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


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


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


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


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


“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


“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).”

88


“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

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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]

Tom [email protected]

94

mailto:[email protected]




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.

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