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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices(8) Narrow woven ribbons comprised
at least 85 percent by weight of threads
having a denier of 225 or higher;(9) Narrow woven ribbons constructedfrom pile fabrics (i.e., fabrics with asurface effect formed by tufts or loops ofyarn that stand up from the body of thefabric);(10) Narrow woven ribbon affixed(including by tying) as a decorative
detail to non-subject merchandise, suchas a gift bag, gift box, gift tin, greetingcard or plush toy, or affixed (including
by tying) as a decorative detail topackaging containing non-subject
merchandise;(11) Narrow woven ribbon that is (a)affixed to non-subject merchandise as aworking component of such non-subject
merchandise, such as where narrow
woven ribbon comprises an appareltrimming, book marker, bag cinch, orpart of an identity card holder, or (b)affixed (including by tying) to nonsubject merchandise as a working
component that holds or packages suchnon-subject merchandise or attaches
packaging or labeling to such nonsubject merchandise, such as a ‘‘belly
band’’ around a pair of pajamas, a pairof socks or a blanket;(12) Narrow woven ribbon(s)comprising a belt attached to andimported with an item of wearing
apparel, whether or not such belt isremovable from such item of wearing
apparel; and(13) Narrow woven ribbon(s) included
with non-subject merchandise in kits,such as a holiday ornament craft kit ora scrapbook kit, in which the individual
lengths of narrow woven ribbon(s)included in the kit are each no greaterthan eight inches, the aggregate amountof narrow woven ribbon(s) included in
the kit does not exceed 48 linear inches,none of the narrow woven ribbon(s)included in the kit is on a spool, and thenarrow woven ribbon(s) is only one ofmultiple items included in the kit.
The merchandise subject to this orderis classifiable under the HTSUS
statistical categories 5806.32.1020;
5806.32.1030; 5806.32.1050 and
5806.32.1060. Subject merchandise also
may enter under subheadings
5806.31.00; 5806.32.20; 5806.39.20;
5806.39.30; 5808.90.00; 5810.91.00;
5810.99.90; 5903.90.10; 5903.90.25;
5907.00.60; and 5907.00.80 and under
statistical categories 5806.32.1080;
5810.92.9080; 5903.90.3090; and6307.90.9889. The HTSUS statisticalcategories and subheadings are provided
for convenience and customs purposes;
however, the written description of themerchandise under the order isdispositive.

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Countervailing Duty Order
According to section 706(b)(2) of theAct, duties shall be assessed on subject
merchandise entered, or withdrawn
from warehouse, for consumption on orafter the date of publication of the ITC’s
notice of final determination if that
determination is based upon the threatof material injury. Section 706(b)(1) of
the Act states, ‘‘If the Commission, in its
final determination under section
705(b), finds material injury or threat ofmaterial injury which, but for thesuspension of liquidation under section
703(d)(2), would have led to a findingof material injury, then entries of themerchandise subject to thecountervailing duty order, theliquidation of which has beensuspended under section 703(d)(2),shall be subject to the imposition ofcountervailing duties under section
701(a).’’ In addition, section 706(b)(2) ofthe Act requires CBP to refund any cash
deposits or bonds of estimatedcountervailing duties posted since theDepartment’s preliminary
countervailing duty determination, if
the ITC’s final determination is threatbased. Because the ITC’s final
determination in this case is based on
the threat of material injury and is notaccompanied by a finding that injury
would have resulted but for theimposition of suspension of liquidationof entries since the Department’s
Preliminary Determination 1 waspublished in the Federal Register,
section 706(b)(2) of the Act isapplicable.
As a result of the ITC’s determination,and in accordance with section 706(a)(1)of the Act, the Department will direct
U.S. Customs and Border Protection(‘‘CBP’’) to assess, upon further
instruction by the Department,
countervailing duties equal to theamount of the net countervailable
subsidy for all relevant entries of narrow
woven ribbons from the PRC. In
accordance with section 706 of the Act,
the Department will direct CBP toreinstitute suspension of liquidation 2
effective on the date of publication of
the ITC’s notice of final determinationin the Federal Register, and to requirea cash deposit for each entry of subject
1 Narrow Woven Ribbons With Woven Selvedge
From the People’s Republic of China: Preliminary
Affirmative Countervailing Duty Determination andAlignment of Final Countervailing Duty
Determination With Final Antidumping Duty
Determination, 74 FR 66090 (December 14, 2009).
2 The Department instructed CBP to discontinue
the suspension of liquidation on April 13, 2010, in
accordance with section 703(d) of the Act. Section
703(d) states that the suspension of liquidation
pursuant to a preliminary determination may notremain in effect for more than four months.

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merchandise in an amount equal to the
net countervailable subsidy rates noted
below.
Exporter/manufacturer

Net subsidy
rate

Yama Ribbons and Bows Co.,Ltd .........................................
Changtai Rongshu Textile Co.,Ltd .........................................
All Others ..................................

1.56
117.95
1.56

Termination of the Suspension of
Liquidation
The Department will also instruct
CBP to terminate the suspension ofliquidation for entries of narrow woven
ribbons from the PRC entered, orwithdrawn from warehouse, forconsumption prior to the publication of
the ITC’s notice of final determination,and refund any cash deposits made andrelease any bonds posted between
December 14, 2009 (i.e., the date of
publication of the Department’s
Preliminary Determination) and the dateof publication of the ITC’s final
determination in the Federal Register.
This notice constitutes thecountervailing duty order with respect
to narrow woven ribbons from the PRC,
pursuant to section 706(a) of the Act.
Interested parties may contact the
Department’s Central Records Unit,
Room 1117 of the main Commerce
Building, for copies of an updated listof countervailing duty orders currently
in effect.
This order is issued and published inaccordance with section 706(a) of the
Act and 19 CFR 351.211(b).
Dated: August 30, 2010.
Ronald K. Lorentzen,
Deputy Assistant Secretary for Import
Administration.
[FR Doc. 2010–21978 Filed 8–31–10; 8:45 am]
BILLING CODE 3510–DS–P

DEPARTMENT OF COMMERCE
Patent and Trademark Office[Docket No.: PTO–P–2010–0055]

Examination Guidelines Update:
Developments in the Obviousness
Inquiry After KSR v.Teleflex
AGENCY: United States Patent andTrademark Office, Commerce.
ACTION: Notice.
SUMMARY: The United States Patent andTrademark Office (USPTO or Office) is
issuing an update (2010 KSR Guidelines
Update) to its obviousness guidelines
for its personnel to be used when
applying the law of obviousness under

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35 U.S.C. 103. This 2010 KSR
Guidelines Update highlights case law
developments on obviousness under 35
U.S.C. 103 since the 2007 decision by
the United States Supreme Court(Supreme Court) in KSR Int’l Co. v.
Teleflex Inc. These guidelines areintended to be used by Office personnel
in conjunction with the guidance in the
Manual of Patent Examining Procedurewhen applying the law of obviousness
under 35 U.S.C. 103. Members of the
public are invited to provide commentson the 2010 KSR Guidelines Update.
The Office is especially interested inreceiving suggestions of recent
decisional law in the field of
obviousness that would have particularvalue as teaching tools.
DATES: Effective Date: This 2010 KSR
Guidelines Update is effective
September 1, 2010.
ADDRESSES: Comments concerning this2010 KSR Guidelines Update may besent by electronic mail message over theInternet addressed to
KSR_Guidance@uspto.gov, or submitted
by mail addressed to: Mail Stop
Comments—Patents, Commissioner for
Patents, P.O. Box 1450, Alexandria, VA
22313–1450. Although comments may
be submitted by mail, the Office prefers
to receive comments via the Internet.
FOR FURTHER INFORMATION CONTACT:
Kathleen Kahler Fonda or Pinchus M.
Laufer, Legal Advisors, Office of Patent
Legal Administration, Office of the
Associate Commissioner for Patent
Examination Policy, by telephone at(571) 272–7754 or (571) 272–7726; bymail addressed to: Mail Stop Comments
Patents, Commissioner for Patents, P.O.
Box 1450, Alexandria, VA 22313–1450;
or by facsimile transmission to (571)273–7754, marked to the attention of
Kathleen Kahler Fonda.
SUPPLEMENTARY INFORMATION:
1. Introduction. The purpose of this2010 KSR Guidelines Update is toremind Office personnel of theprinciples of obviousness explained by
the Supreme Court in KSR Int’l Co. v.
Teleflex Inc., 550 U.S 398 (2007) (KSR),
and to provide additional guidance inview of decisions by the United States
Court of Appeals for the Federal Circuit(Federal Circuit) since KSR. This bodyof case law developed over the past
three years provides additional
examples that will be useful to Officepersonnel as well as practitioners
during the examination process.
Although every question of obviousness
must be decided on its own facts, thesecases begin to clarify the contours of theobviousness inquiry after KSR, and help
to show when a rejection on this basis
is proper and when it is not.

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This 2010 KSR Guidelines Update
does not constitute substantive rulemaking and hence does not have theforce and effect of law. It has beendeveloped as a matter of internal Officemanagement and is not intended tocreate any right or benefit, substantive
or procedural, enforceable by any party
against the Office. Rejections willcontinue to be based upon thesubstantive law, and it is theserejections that are appealable.
Consequently, any failure by Officepersonnel to follow this 2010 KSR
Guidelines Update is neither appealable
nor petitionable.
After a review of the principles ofobviousness and Office policy as
reflected in the Manual of Patent
Examining Procedure (MPEP), this 2010
KSR Guidelines Update addresses anumber of issues that arise when Officepersonnel consider whether or not aclaimed invention is obvious. The
concepts discussed are grounded inFederal Circuit cases, and correlatedwith existing Office policy as
appropriate. A number of cases whichhave been selected for theirinstructional value on the issue ofobviousness will be discussed in detail.
The law of obviousness will continue
to be refined, and Office personnel areencouraged to maintain an awareness ofprecedential case law from the Federal
Circuit and precedential decisions of theBoard of Patent Appeals andInterferences (Board) in this area. The
Office will train Office personnel andupdate the MPEP as necessary to reflect
the current state of the law.
2. Principles of Obviousness and the
Guidelines. In response to the Supreme
Court’s April 2007 decision in KSR, theOffice developed guidelines for patentexaminers to follow when determining
obviousness of a claimed invention andpublished these guidelines in theFederal Register and Official Gazette.
See Examination Guidelines for
Determining Obviousness Under 35
U.S.C. 103 in View of the Supreme
Court Decision in KSR International Co.
v. Teleflex Inc., 72 FR 57526 (Oct. 10,2007), 1324 Off. Gaz. Pat. Office 23(Nov. 6, 2007) (2007 KSR Guidelines).
The 2007 KSR Guidelines have been
incorporated in the MPEP. See MPEP
§ 2141 (8th ed. 2001) (Rev. 6, Sept.
2007). The purpose of the 2007 KSR
Guidelines was to give Office personnel
practical guidance on how to evaluate
obviousness issues under 35 U.S.C.
103(a) in accordance with the Supreme
Court’s instruction in KSR. The 2007
KSR Guidelines also alerted Officepersonnel to the importance ofconsidering rebuttal evidence submitted

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by patent applicants in response to
obviousness rejections.
The 2007 KSR Guidelines pointed out,
as had the Supreme Court in KSR, thatthe factual inquiries announced in
Graham v. John Deere, 383 U.S. 1, 17–
18 (1966) (scope and content of the priorart; differences between the claimed
invention and the prior art; level ofordinary skill in the art; and secondary
indicia of nonobviousness), remain thefoundation of any determination of
obviousness. It remains true that ‘‘[t]hedetermination of obviousness isdependent on the facts of each case.’’Sanofi-Synthelabo v. Apotex, Inc., 550
F.3d 1075, 1089 (Fed. Cir. 2008) (citing
Graham, 383 U.S. at 17–18 (1966)). As
for the reasoning required to support an
obviousness determination, the 2007
KSR Guidelines noted that the teachingsuggestion-motivation (TSM) test was
but one possible approach. The 2007
KSR Guidelines identified six otherrationales gleaned from the KSR
decision as examples of appropriatelines of reasoning that could also be
used. The six other rationales identified
in the 2007 KSR Guidelines are: (1)Combining prior art elements according
to known methods to yield predictable
results; (2) simple substitution of one
known element for another to obtain
predictable results; (3) use of a known
technique to improve similar devices,
methods, or products in the same way;(4) applying a known technique to a
known device, method, or productready for improvement to yieldpredictable results; (5) obvious to try—choosing from a finite number ofidentified, predictable solutions, with areasonable expectation of success; and(6) known work in one field of endeavor
may prompt variations of it for use ineither the same field or a different one
based on design incentives or othermarket forces if the variations are
predictable to one of ordinary skill in
the art. Any rationale employed must
provide a link between the factual
findings and the legal conclusion of
obviousness.
It is important for Office personnel torecognize that when they do choose toformulate an obviousness rejection
using one of the rationales suggested by
the Supreme Court in KSR anddiscussed in the 2007 KSR Guidelines,
they are to adhere to the instructions
provided in the MPEP regarding thenecessary factual findings. However, the2007 KSR Guidelines also stressed thatwhile the Graham inquiries and theassociated reasoning are crucial to aproper obviousness determination, theSupreme Court in KSR did not place any
limit on the particular approach to betaken to formulate the line of reasoning.

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In other words, the KSR decision is not
to be seen as replacing a single test for
obviousness—the TSM test—with theseven rationales listed in the 2007 KSR
Guidelines. See MPEP §§ 2141 and 2143
(8th ed. 2001) (Rev. 8, July 2010)(references to the MPEP are to Revision
8 of the 8th Edition of the MPEP unlessotherwise indicated). It remains Officepolicy that appropriate factual findings
are required in order to apply theenumerated rationales properly. If a
rejection has been made that omits oneof the required factual findings, and in
response to the rejection a practitioner
or inventor points out the omission,
Office personnel must either withdraw
the rejection, or repeat the rejection
including all required factual findings.
3. The Impact of the KSR Decision.
KSR’s renewed emphasis on thefoundational principles of Graham
coupled with its abrogation of the strict
TSM test have clearly impacted themanner in which Office personnel andpractitioners carry out the business ofprosecuting patent applications withregard to issues of obviousness.
However, Office personnel as well aspractitioners should also recognize thesignificant extent to which theobviousness inquiry has remained
constant in the aftermath of KSR.
In footnote 2 of the 2007 KSR
Guidelines, the Office acknowledgedthat ongoing developments in the law ofobviousness were to be expected in thewake of the KSR decision. That footnotealso stated that it was ‘‘not clear which
Federal Circuit decisions will retain
their viability’’ after KSR. See 2007 KSR
Guidelines, 72 FR at 57,528 n.2. The
edition of the MPEP that was current
when the KSR decision was handed
down had made the following statementin § 2144:

hsrobinson on DSK69SOYB1PROD with NOTICESThe rationale to modify or combine theprior art does not have to be expressly statedin the prior art; the rationale may be
expressly or impliedly contained in the priorart or it may be reasoned from knowledge
generally available to one of ordinary skill in
the art, established scientific principles, orlegal precedent established by prior case law.

MPEP § 2144 (8th ed. 2001) (Rev. 5,
Aug. 2006) (citing five pre-KSR Federal
Circuit opinions and two decisions of
the Board). The KSR decision has
reinforced those earlier decisions thatvalidated a more flexible approach toproviding reasons for obviousness.
However, the Supreme Court’s
pronouncement in KSR has at the sametime clearly undermined the continued
viability of cases such as In re Lee, 277
F.3d 1338 (Fed. Cir. 2002), insofar as
Lee appears to require a strict basis inrecord evidence as a reason to modify
the prior art.

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The Supreme Court’s flexible
approach to the obviousness inquiry isreflected in numerous pre-KSR
decisions, as can be seen in a review of
MPEP § 2144. This section provides
many lines of reasoning to support a
determination of obviousness based
upon earlier legal precedent that had
condoned the use of particular examplesof what may be considered common
sense or ordinary routine practice (e.g.,
making integral, changes in shape,
making adjustable). Thus, the type of
reasoning sanctioned by the opinion in
KSR has long been a part of the patentexamination process. See MPEP § 2144.
Although the KSR approach is flexible
with regard to the line of reasoning tobe applied, the 2007 KSR Guidelines
and MPEP § 2143 state: ‘‘The Supreme
Court in KSR noted that the analysis
supporting a rejection under 35 U.S.C.
103 should be made explicit.’’ MPEP
§ 2143. In Ball Aerosol v. Limited
Brands, 555 F.3d 984 (Fed. Cir. 2009),
the Federal Circuit offered additional
instruction as to the need for an explicit
analysis. The Federal Circuit explained,
as is consistent with the 2007 KSR
Guidelines, that the Supreme Court’s
requirement for an explicit analysis
does not require record evidence of an
explicit teaching of a motivation tocombine in the prior art.
[T]he analysis that ‘‘should be madeexplicit’’ refers not to the teachings in theprior art of a motivation to combine, but tothe court’s analysis * * *. Under the flexible
inquiry set forth by the Supreme Court, thedistrict court therefore erred by failing to takeaccount of ‘‘the inferences and creative
steps,’’ or even routine steps, that an inventor
would employ and by failing to find a
motivation to combine related pieces fromthe prior art.

Ball Aerosol, 555 F.3d at 993. The
Federal Circuit’s directive in Ball
Aerosol was addressed to a lower court,
but it applies to Office personnel aswell. When setting forth a rejection,
Office personnel are to continue to makeappropriate findings of fact as explainedin MPEP §§ 2141 and 2143, and must
provide a reasoned explanation as towhy the invention as claimed would
have been obvious to a person ofordinary skill in the art at the time of
the invention. This requirement for
explanation remains even in situations
in which Office personnel may properly
rely on intangible realities such ascommon sense and ordinary ingenuity.
When considering obviousness, Officepersonnel are cautioned against treating
any line of reasoning as a per se rule.
MPEP § 2144 discusses supporting arejection under 35 U.S.C. 103 byreliance on scientific theory and legal
precedent. In keeping with the flexible

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approach and the requirement for
explanation, Office personnel may
invoke legal precedent as a source of
supporting rationale when warranted
and appropriately supported. See MPEP
§ 2144.04. So, for example, automating amanual activity, making portable,
making separable, reversal or
duplication of parts, or purifying an old
product may form the basis of arejection. However, such rationales
should not be treated as per se rules, butrather must be explained and shown toapply to the facts at hand. A similar
caveat applies to any obviousness
analysis. Simply stating the principle(e.g., ‘‘art recognized equivalent,’’‘‘structural similarity’’) without
providing an explanation of its
applicability to the facts of the case athand is generally not sufficient toestablish a prima facie case ofobviousness.
Many basic approaches that apractitioner may use to demonstratenonobviousness also continue to apply
in the post-KSR era. Since it is now
clear that a strict TSM approach is not
the only way to establish a prima faciecase of obviousness, it is true thatpractitioners have been required to shift
the emphasis of their nonobviousness
arguments to a certain degree. However,familiar lines of argument still apply,
including teaching away from theclaimed invention by the prior art, lackof a reasonable expectation of success,and unexpected results. Indeed, they
may have even taken on added
importance in view of the recognition in
KSR of a variety of possible rationales.
At the time the KSR decision was
handed down, some observers
questioned whether the principles
discussed were intended by theSupreme Court to apply to all fields ofinventive endeavor. Arguments weremade that because the technology at
issue in KSR involved the relatively
well-developed and predictable field ofvehicle pedal assemblies, the decision
was relevant only to such fields. The
Federal Circuit has soundly repudiatedsuch a notion, stating that KSR applies
across technologies:
This court also declines to cabin KSR to the‘‘predictable arts’’ (as opposed to the‘‘unpredictable art’’ of biotechnology). In fact,
this record shows that one of skill in thisadvanced art would find these claimed‘‘results’’ profoundly ‘‘predictable.’’In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009). Thus, Office personnel
should not withdraw any rejection
solely on the basis that the invention
lies in a technological area ordinarily
considered to be unpredictable.
The decisions of the Federal Circuit
discussed in this 2010 KSR Guidelines

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Update provide Office personnel as wellas practitioners with additional
examples of the law of obviousness. The
purpose of the 2007 KSR Guidelines
was, as stated above, to help Officepersonnel to determine when a claimed
invention is not obvious, and to provide
an appropriate supporting rationale
when an obviousness rejection isappropriate. Now that a body of caselaw is available to guide Officepersonnel and practitioners as to theboundaries between obviousness andnonobviousness, it is possible in this2010 KSR Guidelines Update to contrast
situations in which the subject matter
was found to have been obvious withthose in which it was determined not tohave been obvious. Thus, Officepersonnel may use this 2010 KSR
Guidelines Update in conjunction withthe 2007 KSR Guidelines (incorporated
into MPEP §§ 2141 and 2143) to provide
a more complete view of the state of thelaw of obviousness.
This 2010 KSR Guidelines Update
provides a ‘‘teaching point’’ for each
discussed case. The ‘‘teaching point’’
may be used to quickly determine therelevance of the discussed case, butshould not be used as a substitute forreading the remainder of the discussionof the case in this 2010 KSR Guidelines
Update. Nor should any case in this2010 KSR Guidelines Update be appliedor cited in an Office action solely on thebasis of what is stated in the ‘‘teaching
point’’ for the case.
4. Obviousness Examples fromFederal Circuit Cases. The impact of theSupreme Court’s decision in KSR can be
more readily understood in the context
of factual scenarios. The cases in this2010 KSR Guidelines Update arebroadly grouped according toobviousness concepts in order toprovide persons involved with patent
prosecution with ready access to theexamples that are most pertinent to theissue at hand. The first three groups
correspond directly with three of therationales identified in the 2007 KSR
Guidelines. These rationales—
combining prior art elements,
substituting one known element foranother, and obvious to try—have eachbeen the subject of a significant numberof post-KSR obviousness decisions. The
fourth group focuses on issues
concerning consideration of evidence
during prosecution. Office personnel aswell as practitioners are reminded of thetechnology-specific obviousness
examples previously posted on the
Office’s Web site at http://
www.uspto.gov/web/offices/pac/dapp/
opla/ksr/ksr_training_materials.htm.
Although the other rationales
discussed in the 2007 KSR Guidelines

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are not the focus of separate discussions
in this 2010 KSR Guidelines Update, itwill be noted that obviousness concepts
such as applying known techniques,design choice, and market forces are
addressed when they arise in theselected cases. The cases included inthis 2010 KSR Guidelines Update
reinforce the idea, presented in the 2007
KSR Guidelines, that there may be morethan one line of reasoning that canproperly be applied to a particular
factual scenario. The selected decisions
also illustrate the overlapping nature of
the lines of reasoning that may be
employed to establish a prima facie caseof obviousness. Although the 2007 KSR
Guidelines presented the rationales as
discrete, self-contained lines ofreasoning, and they may indeed be
employed that way, it is useful torecognize that real-world situations may
require analyses that may not be soreadily pigeon-holed into distinct
categories.
A. Combining Prior Art Elements. In
discussing the obviousness rationale
concerning combining prior art
elements, identified as Rationale A, the2007 KSR Guidelines quoted KSR andnoted that ‘‘it can be important to
identify a reason that would haveprompted a person of ordinary skill in
the relevant field to combine theelements in the way the claimed new
invention does.’’ KSR, 550 U.S. at 401.
In view of the cases decided since KSR,
one situation when it is important to
identify a reason to combine known
elements in a known manner to obtain
predictable results is when the
combination requires a greater
expenditure of time, effort, or resources
than the prior art teachings. Even
though the components are known, thecombining step is technically feasible,
and the result is predictable, theclaimed invention may nevertheless benonobvious when the combining step
involves such additional effort that noone of ordinary skill would haveundertaken it without a recognizedreason to do so. When a combination
invention involves additional
complexity as compared with the priorart, the invention may be nonobvious
unless an examiner can articulate areason for including the added features
or steps. This is so even when theclaimed invention could have beenreadily implemented.
Example 4.1. In re Omeprazole Patent
Litigation, 536 F.3d 1361 (Fed. Cir.
2008). Teaching point: Even where ageneral method that could have been
applied to make the claimed productwas known and within the level of skillof the ordinary artisan, the claim maynevertheless be nonobvious if the

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problem which had suggested use of themethod had been previously unknown.
The case of In re Omeprazole Patent
Litigation is one in which the claims inquestion were found to be nonobvious
in the context of an argument to
combine prior art elements. The
invention involved applying entericcoatings to a drug in pill form for the
purpose of ensuring that the drug did
not disintegrate before reaching its
intended site of action. The drug at
issue was omeprazole, the generic namefor gastric acid inhibitor marketed as
Prilosec®. The claimed formulation
included two layers of coatings over theactive ingredient.
The district court found that Astra’s
patent in suit was infringed bydefendants Apotex and Impax. The
district court rejected Apotex’s defensethat the patents were invalid for
obviousness. Apotex had argued that theclaimed invention was obvious because
coated omeprazole tablets were known
from a prior art reference, and because
secondary subcoatings inpharmaceutical preparations generally
were also known. There was noevidence of unpredictability associatedwith applying two different entericcoatings to omeprazole. However,Astra’s reason for applying anintervening subcoating between theprior art coating and omeprazole had
been that the prior art coating was
actually interacting with omeprazole,
thereby contributing to undesirable
degradation of the active ingredient.
This degradation of omeprazole byinteraction with the prior art coating
had not been recognized in the prior art.
Therefore, the district court reasoned
that based on the evidence available, aperson of ordinary skill in the art would
have had no reason to include a
subcoating in an omeprazole pill
formulation.
The Federal Circuit affirmed the
district court’s decision that the claimed
invention was not obvious. Even thoughsubcoatings for enteric drug formulation
were known, and there was no evidenceof undue technical hurdles or lack of areasonable expectation of success, theformulation was nevertheless not
obvious because the flaws in the priorart formulation that had prompted themodification had not been recognized.
Thus there would have been no reason
to modify the initial formulation, eventhough the modification could havebeen done. Moreover, a person of skill
in the art likely would have chosen adifferent modification even if he or she
had recognized the problem.
Office personnel should note that inthis case the modification of the prior
art that had been presented as an

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argument for obviousness was an extra
process step that added an additional
component to a known, successfully
marketed formulation. The proposed
modification thus amounted to extra
work and greater expense for noapparent reason. This is not the same as
combining known prior art elements A
and B when each would have been
expected to contribute its own known
properties to the final product. In the
Omeprazole case, in view of the
expectations of those of ordinary skill in
the art, adding the subcoating would nothave been expected to confer any
particular desirable property on the
final product. Rather, the final productobtained according to the proposed
modifications would merely have been
expected to have the same functional
properties as the prior art product.
The Omeprazole case can also be
analyzed in view of the discovery of apreviously unknown problem by thepatentee. If the adverse interaction
between active agent and coating had
been known, it might well have been
obvious to use a subcoating. However,since the problem had not beenpreviously known, there would havebeen no reason to incur additional timeand expense to add another layer, eventhough the addition would have beentechnologically possible. This is true
because the prior art of record failed tomention any stability problem, despite
the acknowledgment during testimony
at trial that there was a known
theoretical reason that omeprazole
might be subject to degradation in thepresence of the known coating material.
Example 4.2. Crocs, Inc. v. U.S.
International Trade Commission, 598
F.3d 1294 (Fed. Cir. 2010). Teaching
point: A claimed combination of prior
art elements may be nonobvious where
the prior art teaches away from theclaimed combination and the
combination yields more than
predictable results.
The case of Crocs, Inc. v. U.S.
International Trade Commission is a
decision in which the claimed foam
footwear was held by the Federal Circuit
to be nonobvious over a combination ofprior art references.
The claims involved in theobviousness issue were from Crocs’ U.S.
Patent No. 6,993,858, and were drawn tofootwear in which a one-piece molded
foam base section formed the top of theshoe (the upper) and the sole. A strap
also made of foam was attached to thefoot opening of the upper, such that thestrap could provide support to the
Achilles portion of the wearer’s foot.
The strap was attached via connectorsthat allowed it to be in contact with thebase section, and to pivot relative to the

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base section. Because both the baseportion and the strap were made offoam, friction between the strap and thebase section allowed the strap tomaintain its position after pivoting. In
other words, the foam strap did not fallunder the force of gravity to a position
adjacent to the heel of the base section.
The International Trade Commission(ITC) determined that the claims were
obvious over the combination of twopieces of prior art. The first was the
Aqua Clog, which was a shoe that
corresponded to the base section of the
footwear of the ‘858 patent. The second
was the Aguerre patent, which taught
heel straps made of elastic or anotherflexible material. In the ITC’s view, theclaimed invention was obvious because
the prior art Aqua Clog differed from theclaimed invention only as to thepresence of the strap, and a suitablestrap was taught by Aguerre.
The Federal Circuit disagreed. The
Federal Circuit stated that the prior art
did not teach foam heel straps, or thata foam heel strap should be placed incontact with a foam base. The Federal
Circuit pointed out that the prior art
actually counseled against using foam asa material for the heel strap of a shoe.
The record shows that the prior art would
actually discourage and teach away from theuse of foam straps. An ordinary artisan inthis field would not add a foam strap to thefoam Aqua Clog because foam was likely to
stretch and deform, in addition to causing
discomfort for a wearer. The prior art depicts
foam as unsuitable for straps.

Id. at 1309.
The Federal Circuit continued, statingthat even if—contrary to fact—theclaimed invention had been a
combination of elements that were
known in the prior art, the claims still
would have been nonobvious. There
was testimony in the record that theloose fit of the heel strap made the shoe
more comfortable for the wearer thanprior art shoes in which the heel strap
was constantly in contact with thewearer’s foot. In the claimed footwear,
the foam heel strap contacted thewearer’s foot only when needed to help
reposition the foot properly in the shoe,thus reducing wearer discomfort that
could arise from constant contact. This
desirable feature was a result of thefriction between the base section andthe strap that kept the strap in placebehind the Achilles portion of thewearer’s foot. The Federal Circuit
pointed out that this combination‘‘yielded more than predictable results.’’
Id. at 1310. Aguerre had taught thatfriction between the base section andthe strap was a problem rather than anadvantage, and had suggested the use ofnylon washers to reduce friction. Thus

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the Federal Circuit stated that even if allelements of the claimed invention had
been taught by the prior art, the claims
would not have been obvious because
the combination yielded more than
predictable results.
The Federal Circuit’s discussion in
Crocs serves as a reminder to Officepersonnel that merely pointing to thepresence of all claim elements in theprior art is not a complete statement ofa rejection for obviousness. In
accordance with MPEP § 2143 A(3), a
proper rejection based on the rationalethat the claimed invention is acombination of prior art elements also
includes a finding that results flowing
from the combination would have been
predictable to a person of ordinary skill
in the art. MPEP § 2143 A(3). If results
would not have been predictable, Officepersonnel should not enter anobviousness rejection using the
combination of prior art elements
rationale, and should withdraw such arejection if it has been made.
Example 4.3. Sundance, Inc. v.
DeMonte Fabricating Ltd., 550 F.3d
1356 (Fed. Cir. 2008). Teaching point: A
claimed invention is likely to be
obvious if it is a combination of known
prior art elements that would reasonably
have been expected to maintain theirrespective properties or functions after
they have been combined.
Sundance involved a segmented andmechanized cover for trucks, swimming
pools, or other structures. The claim
was found to be obvious over the priorart applied.
A first prior art reference taught thata reason for making a segmented cover
was ease of repair, in that a single
damaged segment could be readily
removed and replaced when necessary.
A second prior art reference taught theadvantages of a mechanized cover forease of opening. The Federal Circuit
noted that the segmentation aspect of
the first reference and themechanization function of the second
perform in the same way after
combination as they had before. The
Federal Circuit further observed that aperson of ordinary skill in the art would
have expected that adding replaceable
segments as taught by the first reference
to the mechanized cover of the otherwould result in a cover that maintained
the advantageous properties of both ofthe prior art covers.
Thus, the Sundance case points outthat a hallmark of a proper obviousness
rejection based on combining known
prior art elements is that one of ordinary
skill in the art would reasonably haveexpected the elements to maintain theirrespective properties or functions after
they have been combined.

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Example 4.4. Ecolab, Inc. v. FMC
Corp., 569 F.3d 1335 (Fed Cir. 2009).
Teaching point: A combination of
known elements would have been
prima facie obvious if an ordinarily
skilled artisan would have recognized
an apparent reason to combine thoseelements and would have known how to
do so.
In the case of Ecolab, Inc. v. FMC
Corp., an ‘‘apparent reason to combine’’
in conjunction with the technical ability
to optimize led to the conclusion thatthe claimed invention would have been
obvious.
The invention in question was a
method of treating meat to reduce theincidence of pathogens, by spraying themeat with an antibacterial solution
under specified conditions. The parties
did not dispute that a single prior art
reference had taught all of the elementsof the claimed invention, except for thepressure limitation of ‘‘at least 50 psi.’’
FMC had argued at the district courtthat the claimed invention would havebeen obvious in view of the first prior
art reference mentioned above in viewof a second reference that had taught theadvantages of spray-treating at pressuresof 20 to 150 psi when treating meat witha different antibacterial agent. The
district court did not find FMC’s
argument to be convincing, and denied
the motion for judgment as a matter oflaw that the claim was obvious.
Disagreeing with the district court, theFederal Circuit stated that ‘‘there was anapparent reason to combine theseknown elements—namely to increase
contact between the [antibacterial
solution] and the bacteria on the meat
surface and to use the pressure to wash
additional bacteria off the meat surface.’’Id. at 1350. The Federal Circuit
explained that because the second
reference had taught ‘‘using highpressure to improve the effectiveness ofan antimicrobial solution when sprayedonto meat, and because an ordinarily
skilled artisan would have recognized
the reasons for applying [the claimed
antibacterial solution] using highpressure and would have known how to
do so, Ecolab’s claims combining highpressure with other limitations
disclosed in FMC’s patent are invalid asobvious.’’ Id.
When considering the question of
obviousness, Office personnel should
keep in mind the capabilities of aperson of ordinary skill. In Ecolab, theFederal Circuit stated:
Ecolab’s expert admitted that one skilled in
the art would know how to adjust application
parameters to determine the optimum
parameters for a particular solution. The
question then is whether it would have been
obvious to combine the high pressure

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parameter disclosed in the Bender patent
with the PAA methods disclosed in FMC’s‘676 patent. The answer is yes.

Id. If optimization of the application
parameters had not been within thelevel of ordinary skill in the art, theoutcome of the Ecolab case may wellhave been different.
Example 4.5. Wyers v. Master LockCo., No. 2009–1412, —F.3d—, 2010 WL
2901839 (Fed. Cir. July 22, 2010).
Teaching point: The scope of analogous
art is to be construed broadly andincludes references that are reasonably
pertinent to the problem that theinventor 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.
In the case of Wyers v. Master LockCo., the Federal Circuit held that theclaimed barbell-shaped hitch pin locks
used to secure trailers to vehicles were
obvious.
The court discussed two different setsof claims in Wyers, both drawn to
improvements over the prior art hitch
pin locks. The first improvement was aremovable sleeve that could be placed
over the shank of the hitch pin lock sothat the same lock could be used withtowing apertures of varying sizes. The
second improvement was an external
flat flange seal adapted to protect theinternal lock mechanism fromcontaminants. Wyers had admitted thateach of several prior art references
taught every element of the claimed
inventions except for the removablesleeve and the external covering. Master
Lock had argued that these references,in combination with additionalreferences teaching the missing
elements, would have rendered theclaims obvious.
The court first addressed the questionof whether the additional references
relied on by Master Lock wereanalogous prior art. As to the referenceteaching the sleeve improvement, thecourt concluded that it dealt specificallywith using a vehicle to tow a trailer, andwas therefore in the same field of
endeavor as Wyers’ sleeve
improvement. The reference teaching
the sealing improvement dealt with apadlock rather than a lock for a tow
hitch. The court noted that Wyers’
specification had characterized theclaimed invention as being in the fieldof locking devices, thus at leastsuggesting that the sealed padlock
reference was in the same field of
endeavor. However, the court also
observed that even if sealed padlocks
were not in the same field of endeavor,
they were nevertheless reasonably
pertinent to the problem of avoiding
contamination of a locking mechanism

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for tow hitches. The court explainedthat the Supreme Court’s decision in
KSR ‘‘directs [it] to construe the scope of
analogous art broadly.’’ Wyers, slip. op.
at 12. For these reasons, the court foundthat Master Lock’s asserted referenceswere analogous prior art, and therefore
relevant to the obviousness inquiry.
The court then turned to the questionof whether there would have beenadequate motivation to combine theprior art elements as had been urged by
Master Lock. The court recalled theGraham inquiries, and also emphasizedthe ‘‘expansive and flexible’’ post-KSR
approach to obviousness that must not‘‘deny factfinders recourse to common
sense.’’ Wyers, slip op. at 13 (quoting
KSR, 550 U.S. at 415 and 421). The
court stated:
KSR and our later cases establish that thelegal determination of obviousness may
include recourse to logic, judgment, andcommon sense, in lieu of expert testimony* * *.
Thus, in appropriate cases, the ultimate
inference as to the existence of a motivation
to combine references may boil down to aquestion of ‘‘common sense,’’ appropriate forresolution on summary judgment or JMOL.

Id. at 15 (citing Perfect Web Techs., Inc.
v. InfoUSA, Inc., 587 F.3d 1324, 1329
(Fed. Cir. 2009); Ball Aerosol, 555 F.3d
at 993).
After reviewing these principles, thecourt proceeded to explain why
adequate motivation to combine had
been established in this case. With
regard to the sleeve improvement, it
pointed out that the need for different
sizes of hitch pins was well known in
the art, and that this was a known
source of inconvenience and expense
for users. The court also mentioned themarketplace aspect of the issue, notingthat space on store shelves was at apremium, and that removable sleevesaddressed this economic concern. As tothe sealing improvement, the court
pointed out that both internal andexternal seals were well-known means
to protect locks from contaminants. The
court concluded that the constituent
elements were being employed inaccordance with their recognizedfunctions, and would have predictably
retained their respective functions whencombined as suggested by Master Lock.
The court cited In re O’Farrell, 853 F.2d
894, 904 (Fed. Cir. 1988) for the
proposition that a reasonable
expectation of success is a requirement
for a proper determination of
obviousness.
Office personnel should note that
although the Federal Circuit invoked theidea of common sense in support of aconclusion of obviousness, it did not
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court explained why a person ofordinary skill in the art at the time of
the invention, in view of the facts
relevant to the case, would have foundthe claimed inventions to have been
obvious. As stated in the MPEP:

hsrobinson on DSK69SOYB1PROD with NOTICESThe key to supporting any rejection under
35 U.S.C. 103 is the clear articulation of thereason(s) why the claimed invention would
have been obvious. The Supreme Court in
KSR noted that the analysis supporting arejection under 35 U.S.C. 103 should bemade explicit. The Court quoting In re Kahn,
441 F.3d 977, 988, 78 USPQ2d 1329, 1336
(Fed. Cir. 2006), stated that ‘‘[R]ejections on
obviousness cannot be sustained by mereconclusory statements; instead, there must be
some articulated reasoning with somerational underpinning to support the legal
conclusion of obviousness.’’

MPEP § 2141 III. Office personnel
should continue to provide a reasoned
explanation for every obviousness
rejection.
Example 4.6. DePuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567
F.3d 1314 (Fed. Cir. 2009). Teaching
point: Predictability as discussed in KSR
encompasses the expectation that prior
art elements are capable of beingcombined, as well as the expectationthat the combination would haveworked for its intended purpose. An
inference that a claimed combination
would not have been obvious isespecially strong where the prior art’s
teachings undermine the very reason
being proffered as to why a person ofordinary skill would have combined the
known elements.
The claim in DePuy Spine was
directed to a polyaxial pedicle screw
used in spinal surgeries that included acompression member for pressing ascrew head against a receiver member.
A prior art reference (Puno) disclosed
all of the elements of the claim except
for the compression member. Instead,the screw head in Puno was separated
from the receiver member to achieve a
shock absorber effect, allowing somemotion between receiver member andthe vertebrae. The missing compression
member was readily found in anotherprior art reference (Anderson), which
disclosed an external fracture
immobilization splint for immobilizing
long bones with a swivel clamp capableof polyaxial movement until rigidly
secured by a compression member. It
was asserted during trial that a personof ordinary skill would have recognizedthat the addition of Anderson’s
compression member to Puno’s device
would have achieved a rigidly lockedpolyaxial pedicle screw covered by theclaim.
In conducting its analysis, the Federal
Circuit noted that the ‘‘predictable

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result’’ discussed in KSR refers not only
to the expectation that prior art
elements are capable of being physicallycombined, but also that the combination
would have worked for its intended
purpose. In this case, it was successfullyargued that Puno ‘‘teaches away’’ from arigid screw because Puno warned thatrigidity increases the likelihood that thescrew will fail within the human body,rendering the device inoperative for its
intended purpose. In fact, the reference
did not merely express a generalpreference for pedicle screws having a‘‘shock absorber’’ effect, but rather
expressed concern for failure and statedthat the shock absorber feature‘‘decrease[s] the chance of failure of thescrew of the bone-screw interface’’because ‘‘it prevent[s] direct transfer ofload from the rod to the bone-screw
interface.’’ Thus, the alleged reason tocombine the prior art elements of Puno
and Anderson—increasing the rigidityof the screw—ran contrary to the prior
art that taught that increasing rigidity
would result in a greater likelihood of
failure. In view of this teaching and the
backdrop of collective teachings of theprior art, the Federal Circuit determinedthat Puno teaches away from the
proposed combination such that aperson of ordinary skill would havebeen deterred from combining thereferences as proposed. Secondary
considerations evaluated by the Federal
Circuit relating to failure by others andcopying also supported the view thatthe combination would not have been
obvious at the time of the invention.
B. Substituting One Known Element
for Another. As explained in the 2007
KSR Guidelines, the substitution
rationale applies when the claimed
invention can be viewed as resulting
from substituting a known element for
an element of a prior art invention. The
rationale applies when one of ordinary
skill in the art would have beentechnologically capable of making thesubstitution, and the result obtained
would have been predictable. See MPEP
§ 2143(B).
Example 4.7. In re ICON Health &Fitness, Inc., 496 F.3d 1374 (Fed. Cir.
2007). Teaching point: When
determining whether a reference in adifferent field of endeavor may be used
to support a case of obviousness (i.e., isanalogous), it is necessary to consider
the problem to be solved.
The claimed invention in ICON was
directed to a treadmill with a folding
tread base that swivels into an uprightstorage position, including a gas spring
connected between the tread base andthe upright structure to assist in stably
retaining the tread base in the storage
position. On reexamination, thePO 00000

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examiner rejected the claims as obvious
based on a combination of references
including an advertisement (Damark) fora folding treadmill demonstrating all of
the claim elements other than the gas
spring, and a patent (Teague) with a gas
spring. Teague was directed to a bed
that folds into a cabinet using a novel
dual-action spring that reverses force as
the mechanism passes a neutral
position, rather than a single-action
spring that would provide a force
pushing the bed closed at all times. The
dual-action spring reduced the force
required to open the bed from the closed
position, while reducing the force
required to lift the bed from the open
position.
The Federal Circuit addressed the
propriety of making the combination
since Teague comes from a different
field than the application. Teague wasfound to be reasonably pertinent to the
problem addressed in the application
because the folding mechanism did not
require any particular focus ontreadmills, but rather generally
addressed problems of supporting theweight of such a mechanism andproviding a stable resting position.
Other evidence was considered
concerning whether one skilled in theart would have been led to combine theteachings of Damark and Teague.
Appellant argued that Teague teaches
away from the invention because it
directs one skilled in the art not to use
single-action springs and does notsatisfy the claim limitations as the dualaction springs would render theinvention inoperable. The Federal
Circuit considered the arguments andfound that while Teague at most teaches
away from using single-action springs todecrease the opening force, it actually
instructed that single-action springs
provide the result desired by theinventors, which was to increase theopening force provided by gravity. As toinoperability, the claims were notlimited to single-action springs andwere so broad as to encompass anythingthat assists in stably retaining the tread
base, which is the function that Teague
accomplished. Additionally, the factthat the counterweight mechanism from
Teague used a large spring, whichappellant argued would overpower thetreadmill mechanism, ignores themodifications that one skilled in the art
would make to a device borrowed fromthe prior art. One skilled in the art
would size the components from Teague
appropriately for the application.
ICON is another useful example forunderstanding the scope of analogous
art. The art applied concerned retaining
mechanisms for folding beds, nottreadmills. When determining whether a

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reference may properly be applied to an
invention in a different field of
endeavor, it is necessary to consider the
problem to be solved. It is certainly
possible that a reference may be drawn
in such a way that its usefulness as ateaching is narrowly restricted.
However, in ICON, the ‘‘treadmill’’concept was too narrow a lens throughwhich to view the art in light of theprior art teachings concerning the
problem to be solved. The Teague
reference was analogous art because‘‘Teague and the current application
both address the need to stably retain afolding mechanism,’’ id. at 1378, andbecause ‘‘nothing about ICON’s folding
mechanism requires any particularfocus on treadmills,’’ id. at 1380.
ICON is also informative as to therelationship between the problem to besolved and existence of a reason tocombine. ‘‘Indeed, while perhaps notdispositive of the issue, the finding that
Teague, by addressing a similar
problem, provides analogous art to
ICON’s application goes a long way
towards demonstrating a reason tocombine the two references. Because
ICON’s broad claims read on
embodiments addressing that problem
as described by Teague, the prior art
here indicates a reason to incorporate its
teachings.’’ Id. at 1380–81.
The Federal Circuit’s discussion in
ICON also makes clear that if thereference does not teach that a
combination is undesirable, then it
cannot be said to teach away. An
assessment of whether a combination
would render the device inoperable
must not ‘‘ignore the modifications thatone skilled in the art would make to a
device borrowed from the prior art.’’ Id.
at 1382.
Example 4.8. Agrizap, Inc. v.
Woodstream Corp., 520 F.3d 1337 (Fed.
Cir. 2008). Teaching point: Analogous
art is not limited to references in thefield of endeavor of the invention, butalso includes references that would
have been recognized by those ofordinary skill in the art as useful for
applicant’s purpose.
Agrizap involved a stationary pest
control device for electrocution of pests
such as rats and gophers, in which thedevice is set in an area where the pest
is likely to encounter it. The only
difference between the claimed device
and the prior art stationary pest control
device was that the claimed device
employed a resistive electrical switch,while the prior art device used amechanical pressure switch. A resistive
electrical switch was taught in two priorart patents, in the contexts of a handheld pest control device and a cattle
prod.

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In determining that the claimed
invention was obvious, the Federal
Circuit noted that ‘‘[t]he asserted claims
simply substitute a resistive electricalswitch for the mechanical pressure
switch’’ employed in the prior art
device. Id. at 1344. In this case, the priorart concerning the hand-held devices
revealed that the function of thesubstituted resistive electrical switch
was well known and predictable, andthat it could be used in a pest control
device. According to the Federal Circuit,the references that taught the hand-helddevices showed that ‘‘the use of ananimal body as a resistive switch tocomplete a circuit for the generation ofan electric charge was already wellknown in the prior art.’’ Id. Finally, theFederal Circuit noted that the problem
solved by using the resistive electricalswitch in the prior art hand-helddevices—malfunction of mechanicalswitches due to dirt and dampness—
also pertained to the prior art stationary
pest control device.
The Federal Circuit recognizedAgrizap as ‘‘a textbook case of when theasserted claims involve a combinationof familiar elements according to known
methods that does no more than yieldpredictable results.’’ Id. Agrizap
exemplifies a strong case of obviousness
based on simple substitution that was
not overcome by the objective evidenceof nonobviousness offered. It also
demonstrates that analogous art is not
limited to the field of applicant’s
endeavor, in that one of the referencesthat used an animal body as a resistive
switch to complete a circuit for thegeneration of an electric charge was notin the field of pest control.
Example 4.9. Muniauction, Inc. v.
Thomson Corp., 532 F.3d 1318 (Fed.
Cir. 2008). Teaching point: Because
Internet and Web browser technologies
had become commonplace forcommunicating and displaying
information, it would have been obvious
to adapt existing processes toincorporate them for those functions.
The invention at issue in Muniauction
was a method for auctioning municipal
bonds over the Internet. A municipality
could offer a package of bond
instruments of varying principal
amounts and maturity dates, and aninterested buyer would then submit abid comprising a price and interest rate
for each maturity date. It was also
possible for the interested buyer to bid
on a portion of the offering. The claimed
invention considered all of the notedparameters to determine the best bid. It
operated on conventional Web browsers
and allowed participants to monitor thecourse of the auction.

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The only difference between the prior
art bidding system and the claimed
invention was the use of a conventional
Web browser. At trial, the district court
had determined that Muniauction’s
claims were not obvious. Thomson
argued that the claimed invention
amounted to incorporating a Web
browser into a prior art auction system,
and was therefore obvious in light ofKSR. Muniauction rebutted theargument by offering evidence ofskepticism by experts, copying, praise,and commercial success. Although the
district court found the evidence to be
persuasive of nonobviousness, theFederal Circuit disagreed. It noted thata nexus between the claimed invention
and the proffered evidence was lacking
because the evidence was notcoextensive with the claims at issue. For
this reason, the Federal Circuit
determined that Muniauction’s evidenceof secondary considerations was notentitled to substantial weight.
The Federal Circuit analogized thiscase to Leapfrog Enterprises, Inc. v.
Fisher-Price, Inc., 485 F.3d 1157 (Fed.
Cir. 2007), cited in the 2007 KSR
Guidelines. The Leapfrog case involved
a determination of obviousness based on
application of modern electronics to aprior art mechanical children’s learning
device. In Leapfrog, the court had notedthat market pressures would haveprompted a person of ordinary skill to
use modern electronics in the prior art
device. Similarly in Muniauction,market pressures would have prompteda person of ordinary skill to use aconventional Web browser in a methodof auctioning municipal bonds.
Example 4.10. Aventis Pharma
Deutschland v. Lupin Ltd., 499 F.3d
1293 (Fed. Cir. 2007). Teaching point: A
chemical compound would have been
obvious over a mixture containing thatcompound as well as other compounds
where it was known or the skilledartisan had reason to believe that somedesirable property of the mixture wasderived in whole or in part from theclaimed compound, and separating theclaimed compound from the mixture
was routine in the art.
In Aventis, the claims were drawn to
the 5(S) stereoisomer of the bloodpressure drug ramipril instereochemically pure form, and tocompositions and methods requiring
5(S) ramipril. The 5(S) stereoisomer is
one in which all five stereocenters in
the ramipril molecule are in the S rather
than the R configuration. A mixture ofvarious stereoisomers including 5(S)ramipril had been taught by the priorart. The question before the court waswhether the purified single stereoisomer

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would have been obvious over the
known mixture of stereoisomers.
The record showed that the presenceof multiple S stereocenters in drugs
similar to ramipril was known to be
associated with enhanced therapeutic
efficacy. For example, when all of thestereocenters were in the S form in therelated drug enalapril (SSS enalapril) as
compared with only two stereocentersin the S form (SSR enalapril), thetherapeutic potency was 700 times as
great. There was also evidence toindicate that conventional methods
could be used to separate the various
stereoisomers of ramipril.
The district court saw the issue as aclose case, because, in its view, there
was no clear motivation in the prior art
to isolate 5(S) ramipril. However, theFederal Circuit disagreed, and foundthat the claims would have been
obvious. The Federal Circuit cautionedthat requiring such a clearly statedmotivation in the prior art to isolate 5(S)ramipril ran counter to the Supreme
Court’s decision in KSR. The court
stated:hsrobinson on DSK69SOYB1PROD with NOTICES

Requiring an explicit teaching to purify the5(S) stereoisomer from a mixture in which itis the active ingredient is precisely the sortof rigid application of the TSM test that was
criticized in KSR.

Id. at 1301. The Aventis court alsorelied on the settled principle that inchemical cases, structural similarity canprovide the necessary reason to modify
prior art teachings. The Federal Circuitalso addressed the kind of teaching thatwould be sufficient in the absence of an
explicitly stated prior art-based
motivation, explaining that an
expectation of similar properties in lightof the prior art can be sufficient, even
without an explicit teaching that thecompound will have a particular utility.
In the chemical arts, the cases
involving so-called ‘‘lead compounds’’
form an important subgroup of theobviousness cases that are based on
substitution. The Federal Circuit has
had a number of opportunities since theKSR decision to discuss thecircumstances under which it would
have been obvious to modify a known
compound to arrive at a claimed
compound. The following cases explore
the selection of a lead compound, theneed to provide a reason for any
proposed modification, and thepredictability of the result.
Example 4.11. Eisai Co. Ltd. v. Dr.
Reddy’s Labs., Ltd., 533 F.3d 1353 (Fed.
Cir. 2008). Teaching point: A claimed
compound would not have been
obvious where there was no reason tomodify the closest prior art leadcompound to obtain the claimed

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compound and the prior art taught thatmodifying the lead compound would
destroy its advantageous property. Any
known compound may serve as a leadcompound when there is some reason
for starting with that lead compoundand modifying it to obtain the claimed
compound.
Eisai concerns the pharmaceuticalcompound rabeprazole. Rabeprazole is a
proton pump inhibitor for treating
stomach ulcers and related disorders.
The Federal Circuit affirmed the district
court’s summary judgment ofnonobviousness, stating that no reason
had been advanced to modify the priorart compound in a way that would
destroy an advantageous property.
Co-defendant Teva based its
obviousness argument on the structuralsimilarity between rabeprazole andlansoprazole. The compounds wererecognized as sharing a common core,
and the Federal Circuit characterized
lansoprazole as a ‘‘lead compound.’’ Theprior art compound lansoprazole was
useful for the same indications as
rabeprazole, and differed fromrabeprazole only in that lansoprazole
has a trifluoroethoxy substituent at the
4-position of the pyridine ring, while
rabeprazole has a methoxypropoxy
substituent. The trifluoro substituent of
lansoprazole was known to be abeneficial feature because it conferred
lipophilicity to the compound. The
ability of a person of ordinary skill tocarry out the modification to introduce
the methoxypropoxy substituent, andthe predictability of the result were notaddressed.
Despite the significant similarity
between the structures, the Federal
Circuit did not find any sufficientreason to modify the lead compound.
According to the Federal Circuit:Obviousness based on structural similarity
thus can be proved by identification of somemotivation that would have led one ofordinary skill in the art to select and thenmodify a known compound (i.e. a leadcompound) in a particular way to achieve theclaimed compound. * * * In keeping withthe flexible nature of the obviousness
inquiry, KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 127 S.Ct. 1727, 1739, 167 L.Ed.2d705 (2007), the requisite motivation can comefrom any number of sources and need notnecessarily be explicit in the art. See Aventis
Pharma Deutschland GmbH v. Lupin, Ltd.,499 F.3d 1293, 1301 (Fed. Cir. 2007). Rather‘‘it is sufficient to show that the claimed andprior art compounds possess a ‘sufficiently
close relationship * * * to create an
expectation,’ in light of the totality of theprior art, that the new compound will have‘similar properties’ to the old.’’ Id. (quoting
Dillon, 919 F.2d at 692).

Eisai, 533 F.3d at 1357. The prior art
taught that introducing a fluorinated

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substituent was known to increase
lipophilicity, so a skilled artisan would
have expected that replacing thetrifluoroethoxy substituent with amethoxypropoxy substituent would
have reduced the lipophilicity of thecompound. Thus, the prior art createdthe expectation that rabeprazole would
be less useful than lansoprazole as adrug for treating stomach ulcers andrelated disorders because the proposed
modification would have destroyed anadvantageous property of the prior art
compound. The compound was not
obvious as argued by Teva because,
upon consideration of all of the facts ofthe case, a person of ordinary skill in
the art at the time of the invention
would not have had a reason to modify
lansoprazole so as to form rabeprazole.
Office personnel are cautioned thatthe term ‘‘lead compound’’ in aparticular opinion can have a contextual
meaning that may vary from the way a
pharmaceutical chemist might use theterm. In the field of pharmaceuticalchemistry, the term ‘‘lead compound’’has been defined variously as ‘‘achemical compound that has
pharmacological or biological activity
and whose chemical structure is used asa starting point for chemical
modifications in order to improve
potency, selectivity, or pharmacokinetic
parameters;’’ ‘‘[a] compound thatexhibits pharmacological properties
which suggest its development;’’ and ‘‘apotential drug being tested for safety
and efficacy.’’ See, e.g.,http://
en.wikipedia.org/wiki/Lead_compound,accessed January 13, 2010; http://
www.combichemistry.com/
glossary_k.html, accessed January 13,
2010; and http://www.building
biotechnology.com/glossary4.php,
accessed January 13, 2010.
The Federal Circuit in Eisai makes it
clear that from the perspective of thelaw of obviousness, any known
compound might possibly serve as alead compound: ‘‘Obviousness based on
structural similarity thus can be provedby identification of some motivationthat would have led one of ordinary
skill in the art to select and then modify
a known compound (i.e. a leadcompound) in a particular way toachieve the claimed compound.’’ Eisai,
533 F.3d at 1357. Thus, Office personnel
should recognize that a proper
obviousness rejection of a claimed
compound that is useful as a drug might
be made beginning with an inactive
compound, if, for example, the reasonsfor modifying a prior art compound toarrive at the claimed compound havenothing to do with pharmaceuticalactivity. The inactive compound would
not be considered to be a lead

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compound by pharmaceutical chemists,
but could potentially be used as suchwhen considering obviousness. Officepersonnel might also base an
obviousness rejection on a known
compound that pharmaceuticalchemists would not select as a leadcompound due to expense, handlingissues, or other business considerations.
However, there must be some reason forstarting with that lead compound otherthan the mere fact that the ‘‘leadcompound’’ merely exists. See Altana
Pharma AG v. Teva Pharmaceuticals
USA, Inc., 566 F.3d 999, 1007 (Fed. Cir.
2009) (holding that there must be somereason ‘‘to select and modify a known
compound’’); Ortho-McNeil
Pharmaceutical, Inc. v. Mylan Labs,
Inc., 520 F.3d 1358, 1364 (Fed. Cir.
2008).
Example 4.12. Procter & Gamble Co.
v. Teva Pharmaceuticals USA, Inc., 566
F.3d 989 (Fed. Cir. 2009). Teaching
point: It is not necessary to select asingle compound as a ‘‘lead compound’’in order to support an obviousness
rejection. However, where there wasreason to select and modify the leadcompound to obtain the claimed
compound, but no reasonable
expectation of success, the claimed
compound would not have been
obvious.
A chemical compound was also foundto be nonobvious in Procter & Gamble.
The compound at issue was
risedronate—the active ingredient ofProcter & Gamble’s osteoporosis drugActonel®. Risedronate is an example ofa bisphosphonate, which is a class ofcompounds known to inhibit bone
resorption.
When Procter & Gamble sued Teva for
infringement, Teva defended by arguing
invalidity for obviousness over one ofProcter & Gamble’s earlier patents. The
prior art patent did not teachrisedronate, but instead taught thirty-six
other similar compounds including 2pyr EHDP that were potentially usefulwith regard to osteoporosis. Teva argued
obviousness on the basis of structuralsimilarity to 2-pyr EHDP, which is apositional isomer of risedronate.
The district court found no reason to
select 2-pyr EHDP as a lead compoundin light of the unpredictable nature of
the art, and no reason to modify it so as
to obtain risedronate. In addition, there
were unexpected results as to potency
and toxicity. Therefore the district court
found that Teva had not made a prima
facie case, and even if it had, it was
rebutted by evidence of unexpected
results.
The Federal Circuit affirmed the
district court’s decision. The Federal
Circuit did not deem it necessary in this

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case to consider the question of whether
2-pyr EHDP had been appropriately
selected as a lead compound. Rather,
the Federal Circuit stated that if 2-pyr
EHDP is presumed to be an appropriate
lead compound, there must be both areason to modify it so as to makerisedronate, and a reasonable
expectation of success. Here there was
no evidence that the necessary
modifications would have been routine,
so there would have been no reasonable
expectation of success.
Procter & Gamble is also informativein its discussion of the treatment of
secondary considerations of nonobviousness. Although the court foundthat no prima facie case of obviousness
had been presented, it proceeded toanalyze Procter & Gamble’s profferedevidence countering the alleged prima
facie case in some detail, thus shedding
light on the proper treatment of such
evidence.
The Federal Circuit noted in dicta thateven if a prima facie case of obviousness
had been established, sufficientevidence of unexpected results wasintroduced to rebut such a showing. At
trial, the witnesses consistently testified
that the properties of risedronate were
not expected, offering evidence that
researchers did not predict either the
potency or the low dose at which thecompound was effective, and that thesuperior properties were unexpected
and could not be predicted. Tests
comparing risedronate to a compoundin the prior art reference showed thatrisedronate outperformed the othercompound by a substantial margin,
could be administered in a greater
amount without an observable toxic
effect, and was not lethal at the samelevels as the other compound. The
weight of the evidence and thecredibility of the witnesses were
sufficient to show unexpected resultsthat would have rebutted an
obviousness determination. Thus,
nonobviousness can be shown when aclaimed invention is shown to have
unexpectedly superior properties whencompared to the prior art.
The court then addressed theevidence of commercial success of
risedronate and the evidence thatrisedronate met a long-felt need. The
court pointed out that little weight was
to be afforded to the commercial successbecause the competing product was also
assigned to Procter & Gamble. However,the Federal Circuit affirmed the district
court’s conclusion that risedronate met
a long-felt, unsatisfied need. The court
rejected Teva’s contention that because
the competing drug was available before
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emphasized that whether there was along-felt unsatisfied need is to beevaluated based on the circumstances asof the filing date of the challenged
invention—not as of the date that theinvention is brought to market.
It should be noted that the leadcompound cases do not stand for the
proposition that identification of asingle lead compound is necessary inevery obviousness rejection of achemical compound. For example, one
might envision a suggestion in the prior
art to formulate a compound having
certain structurally defined moieties, or
moieties with certain properties. If aperson of ordinary skill would have
known how to synthesize such acompound, and the structural and/or
functional result could reasonably havebeen predicted, then a prima facie caseof obviousness of the claimed chemicalcompound might exist even without
identification of a particular leadcompound. As a second example, it
could be possible to view a claimed
compound as consisting of two known
compounds attached via a chemical
linker. The claimed compound might
properly be found to have been obvious
if there would have been a reason tolink the two, if one of ordinary skill
would have known how to do so, andif the resulting compound would havebeen the predictable result of thelinkage procedure. Thus, Officepersonnel should recognize that incertain situations, it may be proper toreject a claimed chemical compound as
obvious even without identifying asingle lead compound.
Example 4.13. Altana Pharma AG v.
Teva Pharmaceuticals USA, Inc., 566
F.3d 999 (Fed. Cir. 2009). Teaching
point: Obviousness of a chemicalcompound in view of its structuralsimilarity to a prior art compound may
be shown by identifying some line ofreasoning that would have led one ofordinary skill in the art to select andmodify a prior art lead compound in aparticular way to produce the claimed
compound. It is not necessary for thereasoning to be explicitly found in theprior art of record, nor is it necessary forthe prior art to point to only a single
lead compound.
Although the decision reached by theFederal Circuit in Altana involved amotion for preliminary injunction anddid not include a final determination of
obviousness, the case is nevertheless
instructive as to the issue of selecting alead compound.
The technology involved in Altana
was the compound pantoprazole, whichis the active ingredient in Altana’s
antiulcer drug Protonix®. Pantoprazole
belongs to a class of compounds known

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as proton pump inhibitors that are used
to treat gastric acid disorders in thestomach.
Altana accused Teva of infringement.
The district court denied Altana’s
motion for preliminary injunction for
failure to establish a likelihood of
success on the merits, determining that
Teva had demonstrated a substantial
question of invalidity for obviousness inlight of one of Altana’s prior patents.
Altana’s patent discussed a compoundreferred to as compound 12, which was
one of eighteen compounds disclosed.
The claimed compound pantoprazole
was structurally similar to compound
12. The district court found that one ofordinary skill in the art would haveselected compound 12 as a leadcompound for modification, and theFederal Circuit affirmed.
Obviousness of a chemical compoundin view of its structural similarity to aprior art compound may be shown byidentifying some line of reasoning thatwould have led one of ordinary skill in
the art to select and modify the prior art
compound in a particular way to
produce the claimed compound. The
necessary line of reasoning can be
drawn from any number of sources andneed not necessarily be explicitly foundin the prior art of record. The Federal
Circuit determined that ample evidence
supported the district court’s findingthat compound 12 was a natural choicefor further development. For example,
Altana’s prior art patent claimed that its
compounds, including compound 12,
were improvements over the prior art;
compound 12 was disclosed as one of
the more potent of the eighteen
compounds disclosed; the patentexaminer had considered thecompounds of Altana’s prior art patent
to be relevant during the prosecution of
the patent in suit; and experts had
opined that one of ordinary skill in theart would have selected the eighteen
compounds to pursue further
investigation into their potential as
proton pump inhibitors.
In response to Altana’s argument thatthe prior art must point to only a single
lead compound for further
development, the Federal Circuit statedthat a ‘‘restrictive view of the leadcompound test would present a rigid
test similar to the teaching-suggestionmotivation test that the Supreme Court
explicitly rejected in KSR * * *. The
district court in this case employed aflexible approach—one that wasadmittedly preliminary—and found thatthe defendants had raised a substantial
question that one of skill in the art
would have used the more potent
compounds of [Altana’s prior art]
patent, including compound 12, as a

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starting point from which to pursue
further development efforts. Thatfinding was not clearly erroneous.’’ Id. at
1008.
C. The ‘‘Obvious to Try’’ Rationale.
The question of whether a claimed
invention can be shown to be obvious
based on an ‘‘obvious to try’’ line ofreasoning has been explored extensively
by the Federal Circuit in several cases
since the KSR decision. The 2007 KSR
Guidelines explain, in view of theSupreme Court’s instruction, that thisrationale is only appropriate when there
is a recognized problem or need in theart; there are a finite number ofidentified, predictable solutions to therecognized need or problem; and one ofordinary skill in the art could havepursued these known potential
solutions with a reasonable expectationof success. The case law in this area isdeveloping quickly in the chemical arts,
although the rationale has been appliedin other art areas as well.
Some commentators on the KSR
decision have expressed a concern that
because inventive activities are always
carried out in the context of what hascome before and not in a vacuum, few
inventions will survive scrutiny underan obvious to try standard. The cases
decided since KSR have proved this fear
to have been unfounded. Courts appear
to be applying the KSR requirement for‘‘a finite number of identified
predictable solutions’’ in a manner thatplaces particular emphasis on
predictability and the reasonable
expectations of those of ordinary skill in
the art.
In a recent Federal Circuit decision,
the court pointed out the challenging
nature of the task faced by the courts—
and likewise by Office personnel—when
considering the viability of an obvious
to try argument: ‘‘The evaluation of the
choices made by a skilled scientist,
when such choices lead to the desired
result, is a challenge to judicial
understanding of how technical advanceis achieved in the particular field of
science or technology.’’ Abbott Labs. v.
Sandoz, Inc., 544 F.3d 1341, 1352 (Fed.
Cir. 2008). The Federal Circuit
cautioned that an obviousness inquiry
based on an obvious to try rationale
must always be undertaken in thecontext of the subject matter inquestion, ‘‘including the characteristicsof the science or technology, its state ofadvance, the nature of the known
choices, the specificity or generality ofthe prior art, and the predictability of
results in the area of interest.’’ Id.
Example 4.14. In re Kubin, 561 F.3d
1351 (Fed. Cir. 2009). Teaching point: A
claimed polynucleotide would havebeen obvious over the known protein

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that it encodes where the skilled artisan
would have had a reasonable
expectation of success in deriving theclaimed polynucleotide using standard
biochemical techniques, and the skilledartisan would have had a reason to try
to isolate the claimed polynucleotide.
KSR applies to all technologies, rather
than just the ‘‘predictable’’ arts.
The Federal Circuit’s decision in In re
Kubin was an affirmance of the Board’s
decision in Ex parte Kubin, 83 USPQ2d
1410 (Bd. Pat. App. & Interf. 2007), andthe Board in turn had affirmed theexaminer’s determination that theclaims in question would have been
obvious over the prior art applied. A
discussion of Ex parte Kubin was
included in the 2007 KSR Guidelines.
See 2007 KSR Guidelines, 72 FR at
57532. The claimed invention in Kubin
was an isolated nucleic acid molecule.
The claim stated that the nucleic acidencoded a particular polypeptide. The
encoded polypeptide was identified in
the claim by its partially specified
sequence, and by its ability to bind toa specified protein. A prior art patent to
Valiante taught the polypeptide
encoded by the claimed nucleic acid,but did not disclose either the sequenceof the polypeptide, or the claimed
isolated nucleic acid molecule.
However, Valiante did disclose that by
employing conventional methods, suchas those disclosed by a prior art
laboratory manual by Sambrook, thesequence of the polypeptide could bedetermined, and the nucleic acidmolecule could be isolated. In view ofValiante’s disclosure of the polypeptide,and of routine prior art methods forsequencing the polypeptide andisolating the nucleic acid molecule, theBoard found that a person of ordinary
skill in the art would have had areasonable expectation that a nucleic
acid molecule within the claimed scope
could have been successfully obtained.
Relying on In re Deuel, 51 F.3d 1552
(Fed. Cir. 1995), Appellant argued that
it was improper for the Office to use thepolypeptide of the Valiante patent
together with the methods described in
Sambrook to reject a claim drawn to a
specific nucleic acid molecule without
providing a reference showing orsuggesting a structurally similar nucleic
acid molecule. Citing KSR, the Board
stated that ‘‘when there is motivation tosolve a problem and there are a finite
number of identified, predictable
solutions, a person of ordinary skill has
good reason to pursue the known
options within his or her technicalgrasp. If this leads to anticipatedsuccess, it is likely the product not of
innovation but of ordinary skill andcommon sense.’’ The Board noted that

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the problem facing those in the art was
to isolate a specific nucleic acid, andthere were a limited number of methods
available to do so. The Board concluded
that the skilled artisan would have hadreason to try these methods with thereasonable expectation that at least one
would be successful. Thus, isolating thespecific nucleic acid molecule claimed
was ‘‘the product not of innovation butof ordinary skill and common sense.’’The Board’s reasoning was substantiallyadopted by the Federal Circuit.
However, it is important to note that in
the Kubin decision, the Federal Circuit
held that ‘‘the Supreme Court in KSR
unambiguously discredited’’ the Federal
Circuit’s decision in Deuel, insofar as it‘‘implies the obviousness inquiry cannot
consider that the combination of theclaim’s constituent elements was‘obvious to try.’ ’’ Kubin, 561 F.3d at
1358. Instead, Kubin stated that KSR‘‘resurrects’’ the Federal Circuit’s own
wisdom in O’Farrell, in which ‘‘todifferentiate between proper andimproper applications of ‘obvious totry,’ ’’ the Federal Circuit ‘‘outlined twoclasses of situations where ‘obvious totry’ is erroneously equated withobviousness under § 103.’’ Kubin, 561
F.3d at 1359. These two classes ofsituations are: (1) When what would
have been ‘‘obvious to try’’ would havebeen to vary all parameters or try eachof numerous possible choices until one
possibly arrived at a successful result,where the prior art gave either no
indication of which parameters werecritical or no direction as to which ofmany possible choices is likely to be
successful; and (2) when what was‘‘obvious to try’’ was to explore a newtechnology or general approach that
seemed to be a promising field ofexperimentation, where the prior art
gave only general guidance as to theparticular form of the claimed invention
or how to achieve it. Id. (citing
O’Farrell, 853 F.2d at 903).
Example 4.15. Takeda Chemical
Industries, Ltd. v. Alphapharm Pty.,
Ltd., 492 F.3d 1350 (Fed. Cir. 2007).
Teaching point: A claimed compound
would not have been obvious where it
was not obvious to try to obtain it froma broad range of compounds, any one ofwhich could have been selected as thelead 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 theparticular modifications necessary totransform the lead compound into theclaimed compound.
Takeda is an example of a chemicalcase in which the Federal Circuit foundthat the claim was not obvious. The

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claimed compound was pioglitazone, amember of a class of drugs known as
thiazolidinediones (TZDs) marketed by
Takeda as a treatment for Type 2
diabetes. The Takeda case brings
together the concept of a ‘‘leadcompound’’ and the obvious-to-try
argument.
Alphapharm had filed an Abbreviated
New Drug Application with the Foodand Drug Administration, which was atechnical act of infringement of
Takeda’s patent. When Takeda brought
suit, Alphapharm’s defense was that
Takeda’s patent was invalid due toobviousness. Alphapharm argued that a
two-step modification—involving
homologation and ring-walking—of aknown compound identified as‘‘compound b’’ would have produced
pioglitazone, and that it was therefore
obvious.
The district court found that there
would have been no reason to selectcompound b as a lead compound. There
were a large number of similar prior art
TZD compounds; fifty-four were
specifically identified in Takeda’s priorpatent, and the district court observedthat ‘‘hundreds of millions’’ were moregenerally disclosed. Although theparties agreed that compound b
represented the closest prior art, onereference had taught certain
disadvantageous properties associatedwith compound b, which according to
the district court would have taught theskilled artisan not to select thatcompound as a lead compound. The
district court found no prima facie caseof obviousness, and stated that even if
a prima facie case had been established,
it would have been overcome in thiscase in view of the unexpected lack of
toxicity of pioglitazone.
The Federal Circuit affirmed thedecision of the district court, citing theneed for a reason to modify a prior art
compound. The Federal Circuit quoted
KSR, stating:
The KSR Court recognized that ‘‘[w]hen
there is a design need or market pressure tosolve a problem and there are a finite numberof identified, predictable solutions, a personof ordinary skill has good reason to pursue
the known options within his or her
technical grasp.’’ KSR, 127 S.Ct. at 1732. Insuch circumstances, ‘‘the fact that a
combination was obvious to try might showthat it was obvious under § 103.’’ Id. That is
not the case here. Rather than identify
predictable solutions for antidiabetic
treatment, the prior art disclosed a broad
selection of compounds any one of which
could have been selected as a lead compound
for further investigation. Significantly, theclosest prior art compound (compound b, the
6-methyl) exhibited negative properties thatwould have directed one of ordinary skill in
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case fails to present the type of situation
contemplated by the Court when it statedthat an invention may be deemed obvious if
it was ‘‘obvious to try.’’ The evidence showedthat it was not obvious to try.

Takeda, 492 F.3d at 1359.
Accordingly, Office personnel should
recognize that the obvious to try
rationale does not apply when theappropriate factual findings cannot be
made. In Takeda, there was arecognized need for treatment ofdiabetes. However, there was no finite
number of identified, predictable
solutions to the recognized need, and noreasonable expectation of success. There
were numerous known TZD
compounds, and although one clearly
represented the closest prior art, its
known disadvantages rendered it
unsuitable as a starting point for further
research, and taught the skilled artisan
away from its use. Furthermore, even if
there had been reason to selectcompound b, there had been no
predictability or reasonable expectationof success associated with the particularmodifications necessary to transformcompound b into the claimed
compound pioglitazone. Thus, anobviousness rejection based on an
obvious to try rationale was not
appropriate in this situation.
Example 4.16. Ortho-McNeil
Pharmaceutical, Inc. v. Mylan Labs,
Inc., 520 F.3d 1358 (Fed. Cir. 2008).
Teaching point: Where the claimed anticonvulsant drug had been discovered
somewhat serendipitously in the courseof research aimed at finding a new antidiabetic drug, it would not have been
obvious to try to obtain a claimed
compound where the prior art did notpresent 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.
The Ortho-McNeil case provides
another example in which a chemicalcompound was determined not to be
obvious. The claimed subject matter was
topiramate, which is used as an anticonvulsant. As in DePuy Spine, whether
the combination would predictably beeffective for its intended purpose is partof the obviousness analysis.
In the course of working toward a new
anti-diabetic drug, Ortho-McNeil’s
scientist had unexpectedly discoveredthat a reaction intermediate had anticonvulsant properties. Mylan’s defense
of invalidity due to obviousness rested
on an obvious to try argument.
However, Mylan did not explain why it
would have been obvious to begin withan anti-diabetic drug precursor,
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topiramate, if one had been seeking ananti-convulsant drug. The district court
ruled on summary judgment that OrthoMcNeil’s patent was not invalid for
obviousness.
The Federal Circuit affirmed. The
Federal Circuit pointed out that there
was no apparent reason why a person ofordinary skill would have chosen theparticular starting compound or theparticular synthetic pathway that led to
topiramate as an intermediate.
Furthermore, there would have been no
reason to test that intermediate for
anticonvulsant properties if treating
diabetes had been the goal. The Federal
Circuit recognized an element ofserendipity in this case, which runs
counter to the requirement forpredictability. Summarizing theirconclusion with regard to Mylan’s
obvious to try argument, the Federal
Circuit stated:hsrobinson on DSK69SOYB1PROD with NOTICES[T]his invention, contrary to Mylan’scharacterization, does not present a finite(and small in the context of the art) numberof options easily traversed to show
obviousness * * *. KSR posits a situation
with a finite, and in the context of the art,
small or easily traversed, number of options
that would convince an ordinarily skilledartisan of obviousness* * * . [T]his clearly is
not the easily traversed, small and finite
number of alternatives that KSR suggested
might support an inference of obviousness.

Id. at 1364. Thus, Ortho-McNeil helps
to clarify the Supreme Court’s
requirement in KSR for ‘‘a finite
number’’ of predictable solutions whenan obvious to try rationale is applied:
Under the Federal Circuit’s case law‘‘finite’’ means ‘‘small or easily
traversed’’ in the context of the art inquestion. As taught in Abbott, discussed
above, it is essential that the inquiry beplaced in the context of the subject
matter at issue, and each case must be
decided on its own facts.
Example 4.17. Bayer Schering Pharma
A.G. v. Barr Labs., Inc., 575 F.3d 1341
(Fed. Cir. 2009). Teaching point: A
claimed compound would have been
obvious where it was obvious to try toobtain 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 theoutcome of obtaining the claimed
compound was reasonably predictable.
In Bayer the claimed invention was anoral contraceptive containing
micronized drospirenone marketed asYasmin®.
The prior art compound drospirenone
was known to be a poorly water-soluble,
acid-sensitive compound with
contraceptive effects. It was also known
in the art that micronization improves

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the solubility of poorly water soluble
drugs.
Based on the known acid sensitivity,
Bayer had studied how effectively an
enteric-coated drospirenone tabletdelivered a formulation as compared to
an intravenous injection of the same
formulation to measure the ‘‘absolutebioavailability’’ of the drug. Bayer added
an unprotected (normal) drospirenone
tablet and compared its bioavailability
to that of the enteric-coated formulationand the intravenous delivery. Bayer
expected to find that the enteric-coatedtablet would produce a lower
bioavailability than an intravenous
injection, while the normal pill would
produce an even lower bioavailability
than the enteric-coated tablet. However,they found that despite observations
that drospirenone would quickly
isomerize in a highly acidic
environment (supporting the belief thatan enteric coating would be necessary topreserve bioavailability), the normal pill
and the enteric-coated pill resulted in
the same bioavailability. Following thisstudy, Bayer developed micronizeddrospirenone in a normal pill, the basis
for the disputed patent.
The district court found that a person
having ordinary skill in the art would
have considered the prior art result thata structurally related compound,spirorenone, though acid-sensitive,
would nevertheless absorb in vivo,
would have suggested the same resultfor drospirenone. It also found thatwhile another reference taught thatdrospirenone isomerizes in vitro when
exposed to acid simulating the humanstomach, a person of ordinary skill
would have been aware of the study’s
shortcomings, and would have verified
the findings as suggested by a treatise on
the science of dosage form design,
which would have then showed that noenteric coating was necessary.
The Federal Circuit held that thepatent was invalid because the claimed
formulation was obvious. The Federal
Circuit reasoned that the prior art would
have funneled the formulator toward
two options. Thus, the formulator
would not have been required to try all
possibilities in a field unreduced by theprior art. The prior art was not vague inpointing toward a general approach orarea of exploration, but rather guided
the formulator precisely to the use ofeither a normal pill or an enteric-coatedpill.
It is important for Office personnel torecognize that the mere existence of alarge number of options does not in andof itself lead to a conclusion ofnonobviousness. Where the prior art
teachings lead one of ordinary skill in
the art to a narrower set of options, then

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that reduced set is the appropriate one
to consider when determining
obviousness using an obvious to try
rationale.
Example 4.18. Sanofi-Synthelabo v.
Apotex, Inc., 550 F.3d 1075 (Fed. Cir.
2008). Teaching point: A claimed
isolated stereoisomer would not havebeen obvious where the claimed
stereoisomer exhibits unexpectedly
strong therapeutic advantages over theprior art racemic mixture without thecorrespondingly expected toxicity, andthe resulting properties of theenantiomers separated from the racemic
mixture were unpredictable.
The case of Sanofi also sheds light on
the obvious to try line of reasoning. The
claimed compound was clopidogrel,
which is the dextrorotatory isomer ofmethyl alpha-5(4,5,6,7-tetrahydro(3,2c)thienopyridyl)(2-chlorophenyl)acetate. Clopidogrel is an antithrombotic compound used to treat or
prevent heart attack or stroke. The
racemate, or mixture of dextrorotatory
and levorotatory (D- and L-) isomers of
the compound, was known in the priorart. The two forms had not previously
been separated, and although the
mixture was known to have antithrombotic properties, the extent towhich each of the individual isomers
contributed to the observed propertiesof the racemate was not known and was
not predictable.
The district court assumed that in theabsence of any additional information,
the D-isomer would have been prima
facie obvious over the known racemate.
However, in view of the evidence of
unpredicted therapeutic advantages of
the D-isomer presented in the case, thedistrict court found that any prima faciecase of obviousness had been overcome.
At trial, the experts for both parties
testified that persons of ordinary skill in
the art could not have predicted thedegree to which the isomers would haveexhibited different levels of therapeutic
activity and toxicity. Both parties’
experts also agreed that the isomer withgreater therapeutic activity would most
likely have had greater toxicity. Sanofi
witnesses testified that Sanofi’s own
researchers had believed that the
separation of the isomers was unlikely
to have been productive, and experts forboth parties agreed that it was difficult
to separate isomers at the time of theinvention. Nevertheless, when Sanofi
ultimately undertook the task ofseparating the isomers, it found thatthey had the ‘‘rare characteristic of‘absolute stereoselectivity,’ ’’ whereby
the D-isomer provided all of thefavorable therapeutic activity but nosignificant toxicity, while the L-isomer
produced no therapeutic activity but

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virtually all of the toxicity. Based on
this record, the district court concluded
that Apotex had not met its burden ofproving by clear and convincing
evidence that Sanofi’s patent wasinvalid for obviousness. The Federal
Circuit affirmed the district court’s
conclusion.
Office personnel should recognizethat even when only a small number ofpossible choices exist, the obvious to try
line of reasoning is not appropriate
when, upon consideration of all of theevidence, the outcome would not havebeen reasonably predictable and theinventor would not have had areasonable expectation of success. In
Bayer, there were art-based reasons to
expect that both the normal pill and theenteric-coated pill would betherapeutically suitable, even though
not all prior art studies were incomplete agreement. Thus, the result
obtained was not unexpected. In Sanofi,
on the other hand, there was strong
evidence that persons of ordinary skill
in the art, prior to the separation of theisomers, would have had no reason to
expect that the D-isomer would havesuch strong therapeutic advantages ascompared with the L-isomer. In otherwords, the result in Sanofi was
unexpected.
Example 4.19. Rolls-Royce, PLC v.
United Technologies Corp., 603 F.3d
1325 (Fed. Cir. 2010). Teaching point:
An obvious to try rationale may beproper when the possible options forsolving a problem were known andfinite. 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.
In Rolls-Royce the Federal Circuit
addressed the obvious to try rationale inthe context of a fan blade for jet engines.
The case had arisen out of aninterference proceeding. Finding thatthe district court had correctly
determined that there was nointerference-in-fact because RollsRoyce’s claims would not have been
obvious in light of United’s application,
the Federal Circuit affirmed.
The Federal Circuit described the fan
blade of the count as follows:
Each fan blade has three regions—an inner,an intermediate, and an outer region. The
area closest to the axis of rotation at the hub
is the inner region. The area farthest from thecenter of the engine and closest to the casing
surrounding the engine is the outer region.
The intermediate region falls in between. The
count defines a fan blade with a sweptforward inner region, a swept-rearward
intermediate region, and forward-leaningouter region.

Id. at 1328.

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United had argued that it would havebeen obvious for a person of ordinary
skill in the art to try a fan blade designin which the sweep angle in the outerregion was reversed as compared withprior art fan blades from rearward to
forward sweep, in order to reduce
endwall shock. The Federal Circuitdisagreed with United’s assessment thatthe claimed fan blade would have been
obvious based on an obvious to try
rationale. The Federal Circuit pointed
out that in a proper obvious to try
approach to obviousness, the possible
options for solving a problem must havebeen ‘‘known and finite.’’ Id. at 1339,
citing Abbott, 544 F.3d at 1351. In thiscase, there had been no suggestion in
the prior art that would have suggested
that changing the sweep angle as RollsRoyce had done would have addressed
the issue of endwall shock. Thus, theFederal Circuit concluded that changing
the sweep angle ‘‘would not havepresented itself as an option at all, letalone an option that would have been
obvious to try.’’ Rolls-Royce, 603 F.3d at
1339. The decision in Rolls-Royce is areminder to Office personnel that theobvious to try rationale can properly be
used to support a conclusion of
obviousness only when the claimed
solution would have been selected froma finite number of potential solutions
known to persons of ordinary skill in
the art.
Example 4.20. Perfect Web
Technologies, Inc. v. InfoUSA, Inc., 587
F.3d 1324, 1328–29 (Fed. Cir. 2009).
Teaching point: Where there were afinite 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.
The Perfect Web case provides anexample in which the Federal Circuit
held that a claimed method for
managing bulk e-mail distribution was
obvious on the basis of an obvious to tryargument. In Perfect Web, the method
required selecting the intended
recipients, transmitting the e-mails,
determining how many of the e-mails
had been successfully received, andrepeating the first three steps if a predetermined minimum number ofintended recipients had not received thee-mail.
The Federal Circuit affirmed the
district court’s determination onsummary judgment that the claimed
invention would have been obvious.
Failure to meet a desired quota of e-mailrecipients was a recognized problem inthe field of e-mail marketing. The prior

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art had also recognized three potential
solutions: Increasing the size of theinitial recipient list; resending e-mails
to recipients who did not receive themon the first attempt; and selecting a newrecipient list and sending e-mails tothem. The last option corresponded to
the fourth step of the invention asclaimed.
The Federal Circuit noted that basedon ‘‘simple logic,’’ selecting a new list ofrecipients was more likely to result in
the desired outcome than resending tothose who had not received the e-mailon the first attempt. There had been no
evidence of any unexpected result
associated with selecting a newrecipient list, and no evidence that themethod would not have had areasonable likelihood of success. Thus,
the Federal Circuit concluded that, as
required by KSR, there were a ‘‘finite
number of identified, predictable
solutions,’’ and that the obvious to try
inquiry properly led to the legal
conclusion of obviousness.
The Federal Circuit in Perfect Web
also discussed the role of common sensein the determination of obviousness.
The district court had cited KSR for the
proposition that ‘‘[a] person of ordinary
skill is also a person of ordinary
creativity, not an automaton,’’ and foundthat ‘‘the final step [of the claimed
invention] is merely the logical result ofcommon sense application of the maxim‘try, try again.’ ’’ In affirming the district
court, the Federal Circuit undertook an
extended discussion of common sense
as it has been applied to the
obviousness inquiry, both before andsince the KSR decision.
The Federal Circuit pointed out thatapplication of common sense is notreally an innovation in the law ofobviousness when it stated, ‘‘Common
sense has long been recognized to
inform the analysis of obviousness if
explained with sufficient reasoning.’’
Perfect Web, 587 F.3d at 1328 (emphasis
added). The Federal Circuit thenprovided a review of a number ofprecedential cases that inform theunderstanding of common sense,
including In re Bozek, 416 F.2d 1385,
1390 (CCPA 1969) (explaining that apatent examiner may rely on ‘‘common
knowledge and common sense of theperson of ordinary skill in the art
without any specific hint or suggestion
in a particular reference’’) and In re
Zurko, 258 F.3d 1379, 1383, 1385 (Fed.
Cir. 2001) (clarifying that a factual
foundation is needed in order for an
examiner to invoke ‘‘good common
sense’’ in a case in which ‘‘basic
knowledge and common sense was notbased on any evidence in the record’’).

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hsrobinson on DSK69SOYB1PROD with NOTICESThe Federal Circuit implicitly
acknowledged in Perfect Web that thekind of strict evidence-based teaching,suggestion, or motivation required in In
re Lee, 277 F.3d 1338, 1344 (Fed. Cir.
2002), is not an absolute requirement foran obviousness rejection in light of theteachings of KSR. The Federal Circuit
explained that ‘‘[a]t the time [of the Lee
decision], we required the PTO to
identify record evidence of a teaching,suggestion, or motivation to combinereferences.’’ However, Perfect Web went
on to state that even under Lee, common
sense could properly be applied whenanalyzing evidence relevant toobviousness. Citing DyStar Textilfarben
GmbH v. C.H. Patrick Co., 464 F.3d
1356 (Fed. Cir. 2006), and In re Kahn,
441 F.3d 977 (Fed. Cir. 2006), two cases
decided shortly before the Supreme
Court’s decision in KSR, the Federal
Circuit noted that although ‘‘a reasoned
explanation that avoids conclusory
generalizations’’ is required to use
common sense, identification of a‘‘specific hint or suggestion in aparticular reference’’ is not.
5. Federal Circuit Cases Discussing
Consideration of Evidence. Officepersonnel should consider all rebuttal
evidence that is timely presented by theapplicants when reevaluating any
obviousness determination. In the caseof a claim rendered obvious by a
combination of prior art references,applicants may submit evidence orargument to demonstrate that the resultsof the claimed combination were
unexpected.
Another area that has thus far
remained consistent with pre-KSR
precedent is the consideration of
rebuttal evidence and secondary
considerations in the determination of
obviousness. As reflected in the MPEP,
such evidence should not be consideredsimply for its ‘‘knockdown’’ value;rather, all evidence must be reweighed
to determine whether the claims arenonobvious.
Once the applicant has presented rebuttal
evidence, Office personnel should reconsider
any initial obviousness determination inview of the entire record. See, e.g., In re
Piasecki, 745 F.2d 1468, 1472, 223 USPQ
785, 788 (Fed. Cir. 1984); In re Eli Lilly & Co.,
90 F.2d 943, 945, 14 USPQ2d 1741, 1743
(Fed. Cir. 1990). All the rejections of recordand proposed rejections and their bases
should be reviewed to confirm theircontinued viability.

MPEP § 2141.
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, or summarily
dismiss it as not compelling or insufficient.
If the evidence is deemed insufficient to

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rebut the prima facie case of obviousness,
Office personnel should specifically set forth
the facts and reasoning that justify thisconclusion.

MPEP § 2145. The following cases
exemplify the continued application ofthese principles both at the Federal
Circuit and within the Office. Note thatthese principles were at issue in someof the cases previously discussed, andhave been addressed there in a morecursory fashion.
Example 5.1. PharmaStem
Therapeutics, Inc. v. Viacell, Inc., 491
F.3d 1342 (Fed. Cir. 2007). Teaching
point: Even though all evidence must be
considered in an obviousness analysis,
evidence of nonobviousness may beoutweighed by contradictory evidence
in the record or by what is in thespecification. Although a reasonable
expectation of success is needed tosupport a case of obviousness, absolute
predictability is not required.
The claims at issue in PharmaStem
were directed to compositions
comprising hematopoietic stem cells
from umbilical cord or placental blood,and to methods of using suchcompositions for treatment of blood andimmune system disorders. The
composition claims required that thestem cells be present in an amountsufficient to effect hematopoietic
reconstitution when administered to ahuman adult. The trial court had foundthat PharmaStem’s patents were
infringed and not invalid on
obviousness or other grounds. On
appeal, the Federal Circuit reversed the
district court, determining that theclaims were invalid for obviousness.
The Federal Circuit discussed theevidence presented at trial. It pointed
out that the patentee, PharmaStem, had
not invented an entirely new procedureor new composition. Rather,PharmaStem’s own specification
acknowledged that it was alreadyknown in the prior art that umbilicalcord and placental blood-based
compositions contained hematopoietic
stem cells, and that hematopoietic stem
cells were useful for the purpose ofhematopoietic reconstitution.
PharmaStem’s contribution was toprovide experimental proof thatumbilical cord and placental blood
could be used to effect hematopoietic
reconstitution in mice. By extrapolation,
one of ordinary skill in the art would
have expected this reconstitution
method to work in humans as well.
The court rejected PharmaStem’s
expert testimony that hematopoietic
stem cells had not been proved to exist
in cord blood prior to the experiments
described in PharmaStem’s patents. The
court explained that the expert

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testimony was contrary to the inventors’
admissions in the specification, as wellas prior art teachings that disclosed
stem cells in cord blood. In this case,PharmaStem’s evidence ofnonobviousness was outweighed bycontradictory evidence.
Despite PharmaStem’s usefulexperimental validation ofhematopoietic reconstitution using
hematopoietic stem cells from umbilicalcord and placental blood, the Federal
Circuit found that the claims at issue
would have been obvious. There had
been ample suggestion in the prior art
that the claimed method would haveworked. Absolute predictability is not anecessary prerequisite to a case ofobviousness. Rather, a degree ofpredictability that one of ordinary skill
would have found to be reasonable issufficient. The Federal Circuit
concluded that ‘‘[g]ood science anduseful contributions do not necessarily
result in patentability.’’ Id. at 1364.
Example 5.2. In re Sullivan, 498 F.3d
1345 (Fed. Cir. 2007). Teaching point:
All evidence, including evidence
rebutting a prima facie case ofobviousness, must be considered whenproperly presented.
It was found to be an error in Sullivan
for the Board to fail to consider
evidence submitted to rebut a prima
facie case of obviousness.
The claimed invention was directed
to an antivenom composition
comprising F(ab) fragments used to treat
venomous rattlesnake bites. The
composition was created from antibody
molecules that include three fragments,
F(ab)2, F(ab) and F(c), which haveseparate properties and utilities. There
have been commercially available
antivenom products that consisted ofwhole antibodies and F(ab)2 fragments,
but researchers had not experimented
with antivenoms containing only F(ab)fragments because it was believed that
their unique properties would prevent
them from decreasing the toxicity ofsnake venom. The inventor, Sullivan,
discovered that F(ab) fragments are
effective at neutralizing the lethality ofrattlesnake venom, while reducing theoccurrence of adverse immune reactions
in humans. On appeal of the examiner’s
rejection, the Board held that the claim
was obvious because all the elements ofthe claimed composition were
accounted for in the prior art, and thatthe composition taught by that prior art
would have been expected by a personof ordinary skill in the art at the timethe invention was made to neutralize
the lethality of the venom of arattlesnake.
Rebuttal evidence had not been
considered by the Board because it

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considered the evidence to relate to theintended use of the claimed
composition as an antivenom, rather
than the composition itself. Appellant
successfully argued that even if theBoard had shown a prima facie case ofobviousness, the extensive rebuttal
evidence must be considered. The
evidence included three expert
declarations submitted to show that theprior art taught away from the claimed
invention, an unexpected property or
result from the use of F(ab) fragment
antivenom, and why those having
ordinary skill in the art expected
antivenoms comprising F(ab) fragments
to fail. The declarations related to morethan the use of the claimed
composition. While a statement ofintended use may not render a known
composition patentable, the claimed
composition was not known, andwhether it would have been obvious
depends upon consideration of the
rebuttal evidence. Appellant did notconcede that the only distinguishing
factor of its composition is the statementof intended use and extensively argued
that its claimed composition exhibits
the unexpected property of neutralizing
the lethality of rattlesnake venom while
reducing the occurrence of adverse
immune reactions in humans. The
Federal Circuit found that such a use
and unexpected property cannot beignored—the unexpected property isrelevant and thus the declarations
describing it should have been
considered.
Nonobviousness can be shown whena person of ordinary skill in the art
would not have reasonably predicted
the claimed invention based on theprior art, and the resulting invention
would not have been expected. Allevidence must be considered whenproperly presented.
Example 5.3. Hearing Components,
Inc. v. Shure Inc., 600 F.3d 1357 (Fed.
Cir. 2010). Teaching point: Evidence
that has been properly presented in atimely manner must be considered on
the record. Evidence of commercial
success is pertinent where a nexus
between the success of the product andthe claimed invention has been
demonstrated.
The case of Hearing Components
involved a disposable protective
covering for the portion of a hearing aidthat is inserted into the ear canal. The
covering was such that it could bereadily replaced by a user as needed.
At the district court, Shure hadargued that Hearing Components’patents were obvious over one or moreof three different combinations of prior
art references. The jury disagreed, anddetermined that the claims were

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nonobvious. The district court upheld
the jury verdict, stating that in view of
the conflicting evidence presented by
the parties as to the teachings of thereferences, motivation to combine, andsecondary considerations, thenonobviousness verdict was sufficiently
grounded in the evidence.
Shure appealed to the Federal Circuit,but the Federal Circuit agreed with the
district court that the jury’s
nonobviousness verdict had been
supported by substantial evidence.
Although Shure had argued before thejury that the Carlisle reference taught an
ear piece positioned inside the ear
canal, Hearing Components’ credible
witness countered that only the molded
duct and not the ear piece itself wastaught by Carlisle as being inside the ear
canal. On the issue of combiningreferences, Shure’s witness had given
testimony described as ‘‘rather sparse,
and lacking in specific details.’’ Id. at1364. In contradistinction, Hearing
Components’ witness ‘‘describedparticular reasons why one skilled in
the art would not have been motivated
to combine the references.’’ Id. Finally,
as to secondary considerations, theFederal Circuit determined that Hearing
Components had shown a nexus
between the commercial success of its
product and the patent by providing
evidence that ‘‘the licensing fee for acovered product was more than cut in
half immediately upon expiration’’ ofthe patent.
Although the Hearing Components
case involves substantial evidence ofnonobviousness in a jury verdict, it isnevertheless instructive for Officepersonnel on the matter of weighing
evidence. Office personnel routinely
must consider evidence in the form ofprior art references, statements in thespecification, or declarations under 37
CFR 1.131 or 1.132. Other forms ofevidence may also be presented duringprosecution. Office personnel arereminded that evidence that has beenpresented in a timely manner should
not be ignored, but rather should beconsidered on the record. However, notall evidence need be accorded the same
weight. In determining the relative
weight to accord to rebuttal evidence,
considerations such as whether a nexus
exists between the claimed invention
and the proffered evidence, and whether
the evidence is commensurate in scopewith the claimed invention, areappropriate. The mere presence of somecredible rebuttal evidence does notdictate that an obviousness rejection
must always be withdrawn. See MPEP
§ 2145. Office personnel must consider
the appropriate weight to be accorded toeach piece of evidence. An obviousness

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rejection should be made or maintained
only if evidence of obviousness
outweighs evidence of nonobviousness.
See MPEP § 706(I) (‘‘The standard to be
applied in all cases is the‘preponderance of the evidence’ test. In
other words, an examiner should rejecta claim if, in view of the prior art andevidence of record, it is more likely than
not that the claim is unpatentable.’’).
MPEP § 716.01(d) provides further
guidance on weighing evidence inmaking a determination of patentability.
Example 5.4. Asyst Techs., Inc. v.
Emtrak, Inc., 544 F.3d 1310 (Fed. Cir.
2008). Teaching point: Evidence of
secondary considerations ofobviousness such as commercial successand long-felt need may be insufficient toovercome a prima facie case ofobviousness if the prima facie case isstrong. An argument for nonobviousness
based on commercial success or longfelt need is undermined when there isa failure to link the commercial successor long-felt need to a claimed featurethat distinguishes over the prior art.
The claims at issue in Asyst
concerned a processing system for
tracking articles such as silicon wafers
which move from one processing station
to the next in a manufacturing facility.
The claims required that eachprocessing station be in communication
with a central control unit. The Federal
Circuit agreed with the district courtthat the only difference between theclaimed invention and the prior art toHesser was that the prior art had taught
the use of a bus for this communication,
while the claims required a multiplexer.
At trial, the jury had concluded that
Hesser was not relevant prior art, but
the district court overturned that
conclusion and issued a judgment as amatter of law (JMOL) that the claims
would have been obvious in view of
Hesser. Because the evidence showedthat persons of ordinary skill in the art
would have been familiar with both thebus and the multiplexer, and that they
could have readily selected andemployed one or the other based on
known considerations, the Federal
Circuit affirmed the district court’s
conclusion that the claims were invalid
for obviousness.
The Federal Circuit also discussed
arguments that the district court had
failed to consider the objective evidenceof nonobviousness presented by Asyst.
Asyst had offered evidence ofcommercial success of its invention.
However, the Federal Circuit pointed
out that Asyst had not provided therequired nexus between the commercial
success and the claimed invention,emphasizing that ‘‘Asyst’s failure to linkthat commercial success to the features

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in Hesser undermines the probative
force of the evidence * * *.’’ Id. at 1316.
Asyst had also offered evidence fromothers in the field praising the invention
as addressing a long-felt need. Onceagain, the Federal Circuit found theargument to be unavailing in view of theprior art, stating that ‘‘[w]hile theevidence shows that the overall system
drew praise as a solution to a felt need,
there was no evidence that the success* * * was attributable to thesubstitution of a multiplexer for a bus,which was the only material difference
between Hesser and the patented
invention.’’ Id. The Federal Circuit also
reiterated, citing pre-KSR decisions, that‘‘as we have often held, evidence of
secondary considerations does notalways overcome a strong prima facie
showing of obviousness.’’ Id. (citing

Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1372 (Fed. Cir. 2007); Ryko Mfg.
Co. v. Nu-Star, Inc., 950 F.2d 714, 719–
20 (Fed. Cir. 1991); Newell Cos. v.
Kenney Mfg. Co., 864 F.2d 757, 768(Fed. Cir. 1988)).
When considering obviousness, Officepersonnel should carefully weigh any
properly presented objective evidence ofnonobviousness against the strength ofthe prima facie case. If the asserted
evidence, such as commercial success or
satisfaction of a long-felt need, isattributable to features already in theprior art, the probative value of theevidence is reduced.
6. Conclusion. This 2010 KSR
Guidelines Update is intended to be
used by Office personnel in conjunction
with the guidance provided in MPEP§§ 2141 and 2143 (which incorporates
the 2007 KSR Guidelines) to clarify thecontours of obviousness after KSR. It

Case

53659

addresses a number of issues that arise
when Office personnel consider
whether or not a claimed invention is
obvious. While Office personnel areencouraged to make use of these tools,
they are reminded that every question of
obviousness must be decided on its own
facts. The Office will continue tomonitor the developing law ofobviousness, and will provide
additional guidance and updates asnecessary.
Dated: August 20, 2010.
David J. Kappos,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.

Appendix
The following table contains the cases set
out as examples in this 2010 KSR Guidelines
Update and the teaching points of the case.

Teaching point
Combining Prior Art Elements

In re Omeprazole Patent Litigation,
536 F.3d 1361 (Fed. Cir. 2008).
Crocs, Inc. v. U.S. Int’l Trade
Comm’n., 598 F.3d 1294 (Fed.
Cir. 2010).
Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed.
Cir. 2008).
Ecolab, Inc. v. FMC Corp., 569
F.3d 1335 (Fed. Cir. 2009).
Wyers v. Master Lock Co., No.
2009–1412, —F.3d—, 2010 WL
2901839 (Fed. Cir. July 22,2010).
DePuy Spine, Inc. v. Medtronic
Sofamor Danek, Inc., 567 F.3d
1314 (Fed. Cir. 2009).

Even where a general method that could have been applied to make the claimed product was known andwithin 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.
A claimed combination of prior art elements may be nonobvious where the prior art teaches away from theclaimed combination and the combination yields more than predictable results.
A claimed invention is likely to be obvious if it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they have beencombined.
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.
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 alegal conclusion of obviousness so long as it is explained with sufficient reasoning.
Predictability as discussed in KSR encompasses the expectation that prior art elements are capable ofbeing 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.
Substituting One Known Element for AnotherIn re ICON Health & Fitness, Inc.,
496 F.3d 1374 (Fed. Cir. 2007).
Agrizap, Inc. v. Woodstream Corp.,
520 F.3d 1337 (Fed. Cir. 2008).

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Muniauction, Inc. v. Thomson
Corp., 532 F.3d 1318 (Fed. Cir.
2008).
Aventis Pharma Deutschland v.
Lupin, Ltd., 499 F.3d 1293 (Fed.
Cir. 2007).
Eisai Co. Ltd. v. Dr. Reddy’s Labs.,
Ltd., 533 F.3d 1353 (Fed. Cir.
2008).
Procter & Gamble Co. v. Teva
Pharmaceuticals USA, Inc., 566
F.3d 989 (Fed. Cir. 2009).

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When determining whether a reference in a different field of endeavor may be used to support a case ofobviousness (i.e., is analogous), it is necessary to consider the problem to be solved.
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.
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 forthose functions.
A chemical compound would have been obvious over a mixture containing that compound as well as othercompounds where it was known or the skilled artisan had reason to believe that some desirable propertyof 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.
A claimed compound would not have been obvious where there was no reason to modify the closest prior
art lead compound 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 compoundwhen there is some reason for starting with that lead compound and modifying it to obtain the claimed
compound.
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 theclaimed compound, but no reasonable expectation of success, the claimed compound would not havebeen obvious.

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53660Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Case

Teaching point

Altana Pharma AG v. Teva
Pharms. 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 beshown by identifying some line of reasoning that would have led one of ordinary skill in the art to selectand modify a prior art lead compound in a particular way to produce the claimed compound. It is notnecessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for theprior art to point to only a single lead compound.
The Obvious To Try Rationale

In re Kubin, 561 F.3d 1351 (Fed.
Cir. 2009).

TakedaChem.
Indus.
v.
Alphapharm Pty., Ltd., 492 F.3d
1350 (Fed. Cir. 2007).
Ortho-McNeil Pharmaceutical, Inc.
v. Mylan Labs, Inc., 520 F.3d
1358 (Fed. Cir. 2008).
Bayer Schering Pharma A.G. v.
Barr Labs., Inc., 575 F.3d 1341
(Fed. Cir. 2009).
Sanofi-Synthelabo v. Apotex, Inc.,
550 F.3d 1075 (Fed. Cir. 2008).
Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325
(Fed. Cir. 2010).
Perfect Web Techs., Inc. v.
InfoUSA, Inc., 587 F.3d 1324
(Fed. Cir. 2009).

A claimed polynucleotide would have been obvious over the known protein that it encodes where theskilled 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.
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 wasno predictability or reasonable expectation of success in making the particular modifications necessary
to transform the lead compound into the claimed compound.
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 aclaimed 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 fromamong a number of unpredictable alternatives.
A claimed compound would have been obvious where it was obvious to try to obtain it from a finite andeasily traversed number of options that was narrowed down from a larger set of possibilities by the priorart, and the outcome of obtaining the claimed compound was reasonably predictable.
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.
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.
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.
Consideration of Evidence

PharmaStem Therapeutics, Inc. v.
ViaCell, Inc., 491 F.3d 1342
(Fed. Cir. 2007).
In re Sullivan, 498 F.3d 1345 (Fed.
Cir. 2007).
Hearing Components, Inc. v. Shure
Inc., 600 F.3d 1357 (Fed. Cir.
2010).
Asyst Techs., Inc. v. Emtrak, Inc.,
544 F.3d 1310 (Fed. Cir. 2008).

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 areasonable expectation of success is needed to support a case of obviousness, absolute predictability is
not required.
All evidence, including evidence rebutting a prima facie case of obviousness, must be considered whenproperly presented.
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 theclaimed invention has been demonstrated.
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 theprior art.

[FR Doc. 2010–21646 Filed 8–31–10; 8:45 am]

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