Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53643 

1Narrow Woven Ribbons With Woven Selvedge 

From the People’s Republic of China: Preliminary 

Affirmative Countervailing Duty Determination and 

Alignment of Final Countervailing Duty 

Determination With Final Antidumping Duty 

Determination, 74 FR 66090 (December 14, 2009). 

2The 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 not 

remain in effect for more than four months. 

(8) Narrow woven ribbons comprised 

at least 85 percent by weight of threads 

having a denier of 225 or higher; 

(9) Narrow woven ribbons constructed 

from pile fabrics (i.e., fabrics with a 

surface effect formed by tufts or loops of 

yarn that stand up from the body of the 

fabric); 

(10) Narrow woven ribbon affixed 

(including by tying) as a decorative 

detail to non-subject merchandise, such 

as a gift bag, gift box, gift tin, greeting 

card or plush toy, or affixed (including 

by tying) as a decorative detail to 

packaging containing non-subject 

merchandise; 

(11) Narrow woven ribbon that is (a) 

affixed to non-subject merchandise as a 

working component of such non-subject 

merchandise, such as where narrow 

woven ribbon comprises an apparel 

trimming, book marker, bag cinch, or 

part of an identity card holder, or (b) 

affixed (including by tying) to nonsubject merchandise as a working 

component that holds or packages such 

non-subject merchandise or attaches 

packaging or labeling to such nonsubject merchandise, such as a ‘‘belly 

band’’ around a pair of pajamas, a pair 

of socks or a blanket; 

(12) Narrow woven ribbon(s) 

comprising a belt attached to and 

imported with an item of wearing 

apparel, whether or not such belt is 

removable 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 or 

a scrapbook kit, in which the individual 

lengths of narrow woven ribbon(s) 

included in the kit are each no greater 

than eight inches, the aggregate amount 

of 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 the 

narrow woven ribbon(s) is only one of 

multiple items included in the kit. 

The merchandise subject to this order 

is 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; and 

6307.90.9889. The HTSUS statistical 

categories and subheadings are provided 

for convenience and customs purposes; 

however, the written description of the 

merchandise under the order is 

dispositive. 

Countervailing Duty Order 

According to section 706(b)(2) of the 

Act, duties shall be assessed on subject 

merchandise entered, or withdrawn 

from warehouse, for consumption on or 

after the date of publication of the ITC’s 

notice of final determination if that 

determination is based upon the threat 

of 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 of 

material injury which, but for the 

suspension of liquidation under section 

703(d)(2), would have led to a finding 

of material injury, then entries of the 

merchandise subject to the 

countervailing duty order, the 

liquidation of which has been 

suspended under section 703(d)(2), 

shall be subject to the imposition of 

countervailing duties under section 

701(a).’’ In addition, section 706(b)(2) of 

the Act requires CBP to refund any cash 

deposits or bonds of estimated 

countervailing duties posted since the 

Department’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 not 

accompanied by a finding that injury 

would have resulted but for the 

imposition of suspension of liquidation 

of entries since the Department’s 

Preliminary Determination 1 was 

published in the Federal Register, 

section 706(b)(2) of the Act is 

applicable. 

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 the 

amount 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 to 

reinstitute suspension of liquidation 2

effective on the date of publication of 

the ITC’s notice of final determination 

in the Federal Register, and to require 

a cash deposit for each entry of subject 

merchandise in an amount equal to the 

net countervailable subsidy rates noted 

below. 

Exporter/manufacturer Net subsidy 

rate 

Yama Ribbons and Bows Co., 

Ltd ......................................... 1.56 

Changtai Rongshu Textile Co., 

Ltd ......................................... 117.95 

All Others .................................. 1.56 

Termination of the Suspension of 

Liquidation 

The Department will also instruct 

CBP to terminate the suspension of 

liquidation for entries of narrow woven 

ribbons from the PRC entered, or 

withdrawn from warehouse, for 

consumption prior to the publication of 

the ITC’s notice of final determination, 

and refund any cash deposits made and 

release any bonds posted between 

December 14, 2009 (i.e., the date of 

publication of the Department’s 

Preliminary Determination) and the date 

of publication of the ITC’s final 

determination in the Federal Register. 

This notice constitutes the 

countervailing 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 list 

of countervailing duty orders currently 

in effect. 

This order is issued and published in 

accordance 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 and 

Trademark Office, Commerce. 

ACTION: Notice. 

SUMMARY: The United States Patent and 

Trademark 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 


hsrobinson on DSK69SOYB1PROD with NOTICES
53644 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

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 are 

intended to be used by Office personnel 

in conjunction with the guidance in the 

Manual of Patent Examining Procedure 

when applying the law of obviousness 

under 35 U.S.C. 103. Members of the 

public are invited to provide comments 

on the 2010 KSR Guidelines Update. 

The Office is especially interested in 

receiving suggestions of recent 

decisional law in the field of 

obviousness that would have particular 

value as teaching tools. 

DATES: Effective Date: This 2010 KSR 

Guidelines Update is effective 

September 1, 2010. 

ADDRESSES: Comments concerning this 

2010 KSR Guidelines Update may be 

sent by electronic mail message over the 

Internet 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; by 

mail 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 this 

2010 KSR Guidelines Update is to 

remind Office personnel of the 

principles 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 in 

view of decisions by the United States 

Court of Appeals for the Federal Circuit 

(Federal Circuit) since KSR. This body 

of case law developed over the past 

three years provides additional 

examples that will be useful to Office 

personnel as well as practitioners 

during the examination process. 

Although every question of obviousness 

must be decided on its own facts, these 

cases begin to clarify the contours of the 

obviousness inquiry after KSR, and help 

to show when a rejection on this basis 

is proper and when it is not. 

This 2010 KSR Guidelines Update 

does not constitute substantive rule 

making and hence does not have the 

force and effect of law. It has been 

developed as a matter of internal Office 

management and is not intended to 

create any right or benefit, substantive 

or procedural, enforceable by any party 

against the Office. Rejections will 

continue to be based upon the 

substantive law, and it is these 

rejections that are appealable. 

Consequently, any failure by Office 

personnel to follow this 2010 KSR 

Guidelines Update is neither appealable 

nor petitionable. 

After a review of the principles of 

obviousness and Office policy as 

reflected in the Manual of Patent 

Examining Procedure (MPEP), this 2010 

KSR Guidelines Update addresses a 

number of issues that arise when Office 

personnel consider whether or not a 

claimed invention is obvious. The 

concepts discussed are grounded in 

Federal Circuit cases, and correlated 

with existing Office policy as 

appropriate. A number of cases which 

have been selected for their 

instructional value on the issue of 

obviousness will be discussed in detail. 

The law of obviousness will continue 

to be refined, and Office personnel are 

encouraged to maintain an awareness of 

precedential case law from the Federal 

Circuit and precedential decisions of the 

Board of Patent Appeals and 

Interferences (Board) in this area. The 

Office will train Office personnel and 

update 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, the 

Office developed guidelines for patent 

examiners to follow when determining 

obviousness of a claimed invention and 

published these guidelines in the 

Federal 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 Office 

personnel to the importance of 

considering rebuttal evidence submitted 

by patent applicants in response to 

obviousness rejections. 

The 2007 KSR Guidelines pointed out, 

as had the Supreme Court in KSR, that 

the factual inquiries announced in 

Graham v. John Deere, 383 U.S. 1, 17– 

18 (1966) (scope and content of the prior 

art; differences between the claimed 

invention and the prior art; level of 

ordinary skill in the art; and secondary 

indicia of nonobviousness), remain the 

foundation of any determination of 

obviousness. It remains true that ‘‘[t]he 

determination of obviousness is 

dependent 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 other 

rationales gleaned from the KSR 

decision as examples of appropriate 

lines 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 product 

ready for improvement to yield 

predictable results; (5) obvious to try— 

choosing from a finite number of 

identified, predictable solutions, with a 

reasonable expectation of success; and 

(6) known work in one field of endeavor 

may prompt variations of it for use in 

either the same field or a different one 

based on design incentives or other 

market 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 to 

recognize that when they do choose to 

formulate an obviousness rejection 

using one of the rationales suggested by 

the Supreme Court in KSR and 

discussed in the 2007 KSR Guidelines, 

they are to adhere to the instructions 

provided in the MPEP regarding the 

necessary factual findings. However, the 

2007 KSR Guidelines also stressed that 

while the Graham inquiries and the 

associated reasoning are crucial to a 

proper obviousness determination, the 

Supreme Court in KSR did not place any 

limit on the particular approach to be 

taken to formulate the line of reasoning. 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53645 

In other words, the KSR decision is not 

to be seen as replacing a single test for 

obviousness—the TSM test—with the 

seven 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 unless 

otherwise indicated). It remains Office 

policy that appropriate factual findings 

are required in order to apply the 

enumerated rationales properly. If a 

rejection has been made that omits one 

of 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 the 

foundational principles of Graham 

coupled with its abrogation of the strict 

TSM test have clearly impacted the 

manner in which Office personnel and 

practitioners carry out the business of 

prosecuting patent applications with 

regard to issues of obviousness. 

However, Office personnel as well as 

practitioners should also recognize the 

significant extent to which the 

obviousness inquiry has remained 

constant in the aftermath of KSR. 

In footnote 2 of the 2007 KSR 

Guidelines, the Office acknowledged 

that ongoing developments in the law of 

obviousness were to be expected in the 

wake of the KSR decision. That footnote 

also 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 statement 

in § 2144: 

The rationale to modify or combine the 

prior art does not have to be expressly stated 

in the prior art; the rationale may be 

expressly or impliedly contained in the prior 

art or it may be reasoned from knowledge 

generally available to one of ordinary skill in 

the art, established scientific principles, or 

legal 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 that 

validated a more flexible approach to 

providing reasons for obviousness. 

However, the Supreme Court’s 

pronouncement in KSR has at the same 

time 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 in 

record evidence as a reason to modify 

the prior art. 

The Supreme Court’s flexible 

approach to the obviousness inquiry is 

reflected 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 examples 

of 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 patent 

examination process. See MPEP § 2144. 

Although the KSR approach is flexible 

with regard to the line of reasoning to 

be 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 to 

combine in the prior art. 

[T]he analysis that ‘‘should be made 

explicit’’ refers not to the teachings in the 

prior art of a motivation to combine, but to 

the court’s analysis * * *. Under the flexible 

inquiry set forth by the Supreme Court, the 

district court therefore erred by failing to take 

account 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 from 

the 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 as 

well. When setting forth a rejection, 

Office personnel are to continue to make 

appropriate findings of fact as explained 

in MPEP §§ 2141 and 2143, and must 

provide a reasoned explanation as to 

why the invention as claimed would 

have been obvious to a person of 

ordinary 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 as 

common sense and ordinary ingenuity. 

When considering obviousness, Office 

personnel are cautioned against treating 

any line of reasoning as a per se rule. 

MPEP § 2144 discusses supporting a 

rejection under 35 U.S.C. 103 by 

reliance on scientific theory and legal 

precedent. In keeping with the flexible 

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 a 

manual activity, making portable, 

making separable, reversal or 

duplication of parts, or purifying an old 

product may form the basis of a 

rejection. However, such rationales 

should not be treated as per se rules, but 

rather must be explained and shown to 

apply 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 at 

hand is generally not sufficient to 

establish a prima facie case of 

obviousness. 

Many basic approaches that a 

practitioner may use to demonstrate 

nonobviousness 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 facie 

case of obviousness, it is true that 

practitioners 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 the 

claimed invention by the prior art, lack 

of 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 the 

Supreme Court to apply to all fields of 

inventive endeavor. Arguments were 

made that because the technology at 

issue in KSR involved the relatively 

well-developed and predictable field of 

vehicle pedal assemblies, the decision 

was relevant only to such fields. The 

Federal Circuit has soundly repudiated 

such 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 this 

advanced 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 


hsrobinson on DSK69SOYB1PROD with NOTICES
53646 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

Update provide Office personnel as well 

as practitioners with additional 

examples of the law of obviousness. The 

purpose of the 2007 KSR Guidelines 

was, as stated above, to help Office 

personnel to determine when a claimed 

invention is not obvious, and to provide 

an appropriate supporting rationale 

when an obviousness rejection is 

appropriate. Now that a body of case 

law is available to guide Office 

personnel and practitioners as to the 

boundaries between obviousness and 

nonobviousness, it is possible in this 

2010 KSR Guidelines Update to contrast 

situations in which the subject matter 

was found to have been obvious with 

those in which it was determined not to 

have been obvious. Thus, Office 

personnel may use this 2010 KSR 

Guidelines Update in conjunction with 

the 2007 KSR Guidelines (incorporated 

into MPEP §§ 2141 and 2143) to provide 

a more complete view of the state of the 

law of obviousness. 

This 2010 KSR Guidelines Update 

provides a ‘‘teaching point’’ for each 

discussed case. The ‘‘teaching point’’ 

may be used to quickly determine the 

relevance of the discussed case, but 

should not be used as a substitute for 

reading the remainder of the discussion 

of the case in this 2010 KSR Guidelines 

Update. Nor should any case in this 

2010 KSR Guidelines Update be applied 

or cited in an Office action solely on the 

basis of what is stated in the ‘‘teaching 

point’’ for the case. 

4. Obviousness Examples from 

Federal Circuit Cases. The impact of the 

Supreme Court’s decision in KSR can be 

more readily understood in the context 

of factual scenarios. The cases in this 

2010 KSR Guidelines Update are 

broadly grouped according to 

obviousness concepts in order to 

provide persons involved with patent 

prosecution with ready access to the 

examples that are most pertinent to the 

issue at hand. The first three groups 

correspond directly with three of the 

rationales identified in the 2007 KSR 

Guidelines. These rationales— 

combining prior art elements, 

substituting one known element for 

another, and obvious to try—have each 

been the subject of a significant number 

of post-KSR obviousness decisions. The 

fourth group focuses on issues 

concerning consideration of evidence 

during prosecution. Office personnel as 

well as practitioners are reminded of the 

technology-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 

are not the focus of separate discussions 

in this 2010 KSR Guidelines Update, it 

will be noted that obviousness concepts 

such as applying known techniques, 

design choice, and market forces are 

addressed when they arise in the 

selected cases. The cases included in 

this 2010 KSR Guidelines Update 

reinforce the idea, presented in the 2007 

KSR Guidelines, that there may be more 

than one line of reasoning that can 

properly 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 case 

of obviousness. Although the 2007 KSR 

Guidelines presented the rationales as 

discrete, self-contained lines of 

reasoning, and they may indeed be 

employed that way, it is useful to 

recognize that real-world situations may 

require analyses that may not be so 

readily pigeon-holed into distinct 

categories. 

A. Combining Prior Art Elements. In 

discussing the obviousness rationale 

concerning combining prior art 

elements, identified as Rationale A, the 

2007 KSR Guidelines quoted KSR and 

noted that ‘‘it can be important to 

identify a reason that would have 

prompted a person of ordinary skill in 

the relevant field to combine the 

elements 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, the 

combining step is technically feasible, 

and the result is predictable, the 

claimed invention may nevertheless be 

nonobvious when the combining step 

involves such additional effort that no 

one of ordinary skill would have 

undertaken it without a recognized 

reason to do so. When a combination 

invention involves additional 

complexity as compared with the prior 

art, the invention may be nonobvious 

unless an examiner can articulate a 

reason for including the added features 

or steps. This is so even when the 

claimed invention could have been 

readily implemented. 

Example 4.1. In re Omeprazole Patent 

Litigation, 536 F.3d 1361 (Fed. Cir. 

2008). Teaching point: Even where a 

general method that could have been 

applied to make the claimed product 

was known and within the level of skill 

of the ordinary artisan, the claim may 

nevertheless be nonobvious if the 

problem which had suggested use of the 

method had been previously unknown. 

The case of In re Omeprazole Patent 

Litigation is one in which the claims in 

question were found to be nonobvious 

in the context of an argument to 

combine prior art elements. The 

invention involved applying enteric 

coatings 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 name 

for gastric acid inhibitor marketed as 

Prilosec®. The claimed formulation 

included two layers of coatings over the 

active ingredient. 

The district court found that Astra’s 

patent in suit was infringed by 

defendants Apotex and Impax. The 

district court rejected Apotex’s defense 

that the patents were invalid for 

obviousness. Apotex had argued that the 

claimed invention was obvious because 

coated omeprazole tablets were known 

from a prior art reference, and because 

secondary subcoatings in 

pharmaceutical preparations generally 

were also known. There was no 

evidence of unpredictability associated 

with applying two different enteric 

coatings to omeprazole. However, 

Astra’s reason for applying an 

intervening subcoating between the 

prior 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 by 

interaction with the prior art coating 

had not been recognized in the prior art. 

Therefore, the district court reasoned 

that based on the evidence available, a 

person 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 though 

subcoatings for enteric drug formulation 

were known, and there was no evidence 

of undue technical hurdles or lack of a 

reasonable expectation of success, the 

formulation was nevertheless not 

obvious because the flaws in the prior 

art formulation that had prompted the 

modification had not been recognized. 

Thus there would have been no reason 

to modify the initial formulation, even 

though the modification could have 

been done. Moreover, a person of skill 

in the art likely would have chosen a 

different modification even if he or she 

had recognized the problem. 

Office personnel should note that in 

this case the modification of the prior 

art that had been presented as an 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53647 

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 no 

apparent 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 not 

have been expected to confer any 

particular desirable property on the 

final product. Rather, the final product 

obtained 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 a 

previously unknown problem by the 

patentee. 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 been 

previously known, there would have 

been no reason to incur additional time 

and expense to add another layer, even 

though the addition would have been 

technologically possible. This is true 

because the prior art of record failed to 

mention 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 the 

presence 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 the 

claimed 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 of 

prior art references. 

The claims involved in the 

obviousness issue were from Crocs’ U.S. 

Patent No. 6,993,858, and were drawn to 

footwear in which a one-piece molded 

foam base section formed the top of the 

shoe (the upper) and the sole. A strap 

also made of foam was attached to the 

foot opening of the upper, such that the 

strap could provide support to the 

Achilles portion of the wearer’s foot. 

The strap was attached via connectors 

that allowed it to be in contact with the 

base section, and to pivot relative to the 

base section. Because both the base 

portion and the strap were made of 

foam, friction between the strap and the 

base section allowed the strap to 

maintain its position after pivoting. In 

other words, the foam strap did not fall 

under 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 two 

pieces 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 another 

flexible material. In the ITC’s view, the 

claimed invention was obvious because 

the prior art Aqua Clog differed from the 

claimed invention only as to the 

presence of the strap, and a suitable 

strap was taught by Aguerre. 

The Federal Circuit disagreed. The 

Federal Circuit stated that the prior art 

did not teach foam heel straps, or that 

a foam heel strap should be placed in 

contact with a foam base. The Federal 

Circuit pointed out that the prior art 

actually counseled against using foam as 

a material for the heel strap of a shoe. 

The record shows that the prior art would 

actually discourage and teach away from the 

use of foam straps. An ordinary artisan in 

this field would not add a foam strap to the 

foam 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, stating 

that even if—contrary to fact—the 

claimed 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 the 

loose fit of the heel strap made the shoe 

more comfortable for the wearer than 

prior art shoes in which the heel strap 

was constantly in contact with the 

wearer’s foot. In the claimed footwear, 

the foam heel strap contacted the 

wearer’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 the 

friction between the base section and 

the strap that kept the strap in place 

behind the Achilles portion of the 

wearer’s foot. The Federal Circuit 

pointed out that this combination 

‘‘yielded more than predictable results.’’ 

Id. at 1310. Aguerre had taught that 

friction between the base section and 

the strap was a problem rather than an 

advantage, and had suggested the use of 

nylon washers to reduce friction. Thus 

the Federal Circuit stated that even if all 

elements 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 Office 

personnel that merely pointing to the 

presence of all claim elements in the 

prior art is not a complete statement of 

a rejection for obviousness. In 

accordance with MPEP § 2143 A(3), a 

proper rejection based on the rationale 

that the claimed invention is a 

combination 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, Office 

personnel should not enter an 

obviousness rejection using the 

combination of prior art elements 

rationale, and should withdraw such a 

rejection 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 their 

respective properties or functions after 

they have been combined. 

Sundance involved a segmented and 

mechanized cover for trucks, swimming 

pools, or other structures. The claim 

was found to be obvious over the prior 

art applied. 

A first prior art reference taught that 

a 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 the 

advantages of a mechanized cover for 

ease of opening. The Federal Circuit 

noted that the segmentation aspect of 

the first reference and the 

mechanization function of the second 

perform in the same way after 

combination as they had before. The 

Federal Circuit further observed that a 

person 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 other 

would result in a cover that maintained 

the advantageous properties of both of 

the prior art covers. 

Thus, the Sundance case points out 

that 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 have 

expected the elements to maintain their 

respective properties or functions after 

they have been combined. 


hsrobinson on DSK69SOYB1PROD with NOTICES
53648 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

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 those 

elements 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 that 

the claimed invention would have been 

obvious. 

The invention in question was a 

method of treating meat to reduce the 

incidence of pathogens, by spraying the 

meat with an antibacterial solution 

under specified conditions. The parties 

did not dispute that a single prior art 

reference had taught all of the elements 

of the claimed invention, except for the 

pressure limitation of ‘‘at least 50 psi.’’ 

FMC had argued at the district court 

that the claimed invention would have 

been obvious in view of the first prior 

art reference mentioned above in view 

of a second reference that had taught the 

advantages of spray-treating at pressures 

of 20 to 150 psi when treating meat with 

a different antibacterial agent. The 

district court did not find FMC’s 

argument to be convincing, and denied 

the motion for judgment as a matter of 

law that the claim was obvious. 

Disagreeing with the district court, the 

Federal Circuit stated that ‘‘there was an 

apparent reason to combine these 

known 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 high 

pressure to improve the effectiveness of 

an antimicrobial solution when sprayed 

onto meat, and because an ordinarily 

skilled artisan would have recognized 

the reasons for applying [the claimed 

antibacterial solution] using high 

pressure and would have known how to 

do so, Ecolab’s claims combining high 

pressure with other limitations 

disclosed in FMC’s patent are invalid as 

obvious.’’ Id. 

When considering the question of 

obviousness, Office personnel should 

keep in mind the capabilities of a 

person of ordinary skill. In Ecolab, the 

Federal 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 

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 the 

level of ordinary skill in the art, the 

outcome of the Ecolab case may well 

have been different. 

Example 4.5. Wyers v. Master Lock 

Co., 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 and 

includes references that are reasonably 

pertinent to the problem that the 

inventor was trying to solve. Common 

sense may be used to support a legal 

conclusion of obviousness so long as it 

is explained with sufficient reasoning. 

In the case of Wyers v. Master Lock 

Co., the Federal Circuit held that the 

claimed barbell-shaped hitch pin locks 

used to secure trailers to vehicles were 

obvious. 

The court discussed two different sets 

of claims in Wyers, both drawn to 

improvements over the prior art hitch 

pin locks. The first improvement was a 

removable sleeve that could be placed 

over the shank of the hitch pin lock so 

that the same lock could be used with 

towing apertures of varying sizes. The 

second improvement was an external 

flat flange seal adapted to protect the 

internal lock mechanism from 

contaminants. Wyers had admitted that 

each of several prior art references 

taught every element of the claimed 

inventions except for the removable 

sleeve and the external covering. Master 

Lock had argued that these references, 

in combination with additional 

references teaching the missing 

elements, would have rendered the 

claims obvious. 

The court first addressed the question 

of whether the additional references 

relied on by Master Lock were 

analogous prior art. As to the reference 

teaching the sleeve improvement, the 

court concluded that it dealt specifically 

with using a vehicle to tow a trailer, and 

was therefore in the same field of 

endeavor as Wyers’ sleeve 

improvement. The reference teaching 

the sealing improvement dealt with a 

padlock rather than a lock for a tow 

hitch. The court noted that Wyers’ 

specification had characterized the 

claimed invention as being in the field 

of locking devices, thus at least 

suggesting 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 

for tow hitches. The court explained 

that 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 found 

that Master Lock’s asserted references 

were analogous prior art, and therefore 

relevant to the obviousness inquiry. 

The court then turned to the question 

of whether there would have been 

adequate motivation to combine the 

prior art elements as had been urged by 

Master Lock. The court recalled the 

Graham inquiries, and also emphasized 

the ‘‘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 the 

legal determination of obviousness may 

include recourse to logic, judgment, and 

common 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 a 

question of ‘‘common sense,’’ appropriate for 

resolution 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, the 

court 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 the 

marketplace aspect of the issue, noting 

that space on store shelves was at a 

premium, and that removable sleeves 

addressed this economic concern. As to 

the sealing improvement, the court 

pointed out that both internal and 

external seals were well-known means 

to protect locks from contaminants. The 

court concluded that the constituent 

elements were being employed in 

accordance with their recognized 

functions, and would have predictably 

retained their respective functions when 

combined 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 the 

idea of common sense in support of a 

conclusion of obviousness, it did not 

end its explanation there. Rather, the 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53649 

court explained why a person of 

ordinary skill in the art at the time of 

the invention, in view of the facts 

relevant to the case, would have found 

the claimed inventions to have been 

obvious. As stated in the MPEP: 

The key to supporting any rejection under 

35 U.S.C. 103 is the clear articulation of the 

reason(s) why the claimed invention would 

have been obvious. The Supreme Court in 

KSR noted that the analysis supporting a 

rejection under 35 U.S.C. 103 should be 

made 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 mere 

conclusory statements; instead, there must be 

some articulated reasoning with some 

rational 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 being 

combined, as well as the expectation 

that the combination would have 

worked for its intended purpose. An 

inference that a claimed combination 

would not have been obvious is 

especially strong where the prior art’s 

teachings undermine the very reason 

being proffered as to why a person of 

ordinary skill would have combined the 

known elements. 

The claim in DePuy Spine was 

directed to a polyaxial pedicle screw 

used in spinal surgeries that included a 

compression member for pressing a 

screw 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 some 

motion between receiver member and 

the vertebrae. The missing compression 

member was readily found in another 

prior art reference (Anderson), which 

disclosed an external fracture 

immobilization splint for immobilizing 

long bones with a swivel clamp capable 

of polyaxial movement until rigidly 

secured by a compression member. It 

was asserted during trial that a person 

of ordinary skill would have recognized 

that the addition of Anderson’s 

compression member to Puno’s device 

would have achieved a rigidly locked 

polyaxial pedicle screw covered by the 

claim. 

In conducting its analysis, the Federal 

Circuit noted that the ‘‘predictable 

result’’ discussed in KSR refers not only 

to the expectation that prior art 

elements are capable of being physically 

combined, but also that the combination 

would have worked for its intended 

purpose. In this case, it was successfully 

argued that Puno ‘‘teaches away’’ from a 

rigid screw because Puno warned that 

rigidity increases the likelihood that the 

screw will fail within the human body, 

rendering the device inoperative for its 

intended purpose. In fact, the reference 

did not merely express a general 

preference for pedicle screws having a 

‘‘shock absorber’’ effect, but rather 

expressed concern for failure and stated 

that the shock absorber feature 

‘‘decrease[s] the chance of failure of the 

screw of the bone-screw interface’’ 

because ‘‘it prevent[s] direct transfer of 

load from the rod to the bone-screw 

interface.’’ Thus, the alleged reason to 

combine the prior art elements of Puno 

and Anderson—increasing the rigidity 

of 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 the 

prior art, the Federal Circuit determined 

that Puno teaches away from the 

proposed combination such that a 

person of ordinary skill would have 

been deterred from combining the 

references as proposed. Secondary 

considerations evaluated by the Federal 

Circuit relating to failure by others and 

copying also supported the view that 

the 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 been 

technologically capable of making the 

substitution, 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 a 

different field of endeavor may be used 

to support a case of obviousness (i.e., is 

analogous), it is necessary to consider 

the problem to be solved. 

The claimed invention in ICON was 

directed to a treadmill with a folding 

tread base that swivels into an upright 

storage position, including a gas spring 

connected between the tread base and 

the upright structure to assist in stably 

retaining the tread base in the storage 

position. On reexamination, the 

examiner rejected the claims as obvious 

based on a combination of references 

including an advertisement (Damark) for 

a 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 was 

found to be reasonably pertinent to the 

problem addressed in the application 

because the folding mechanism did not 

require any particular focus on 

treadmills, but rather generally 

addressed problems of supporting the 

weight of such a mechanism and 

providing a stable resting position. 

Other evidence was considered 

concerning whether one skilled in the 

art would have been led to combine the 

teachings 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 not 

satisfy the claim limitations as the dualaction springs would render the 

invention inoperable. The Federal 

Circuit considered the arguments and 

found that while Teague at most teaches 

away from using single-action springs to 

decrease the opening force, it actually 

instructed that single-action springs 

provide the result desired by the 

inventors, which was to increase the 

opening force provided by gravity. As to 

inoperability, the claims were not 

limited to single-action springs and 

were so broad as to encompass anything 

that assists in stably retaining the tread 

base, which is the function that Teague 

accomplished. Additionally, the fact 

that the counterweight mechanism from 

Teague used a large spring, which 

appellant argued would overpower the 

treadmill mechanism, ignores the 

modifications that one skilled in the art 

would make to a device borrowed from 

the prior art. One skilled in the art 

would size the components from Teague 

appropriately for the application. 

ICON is another useful example for 

understanding the scope of analogous 

art. The art applied concerned retaining 

mechanisms for folding beds, not 

treadmills. When determining whether a 


hsrobinson on DSK69SOYB1PROD with NOTICES
53650 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

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 a 

teaching is narrowly restricted. 

However, in ICON, the ‘‘treadmill’’ 

concept was too narrow a lens through 

which to view the art in light of the 

prior 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 a 

folding mechanism,’’ id. at 1378, and 

because ‘‘nothing about ICON’s folding 

mechanism requires any particular 

focus on treadmills,’’ id. at 1380. 

ICON is also informative as to the 

relationship between the problem to be 

solved and existence of a reason to 

combine. ‘‘Indeed, while perhaps not 

dispositive 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 to 

combine 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 the 

reference 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 that 

one 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 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. 

Agrizap involved a stationary pest 

control device for electrocution of pests 

such as rats and gophers, in which the 

device 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 a 

mechanical pressure switch. A resistive 

electrical switch was taught in two prior 

art patents, in the contexts of a handheld pest control device and a cattle 

prod. 

In determining that the claimed 

invention was obvious, the Federal 

Circuit noted that ‘‘[t]he asserted claims 

simply substitute a resistive electrical 

switch for the mechanical pressure 

switch’’ employed in the prior art 

device. Id. at 1344. In this case, the prior 

art concerning the hand-held devices 

revealed that the function of the 

substituted resistive electrical switch 

was well known and predictable, and 

that it could be used in a pest control 

device. According to the Federal Circuit, 

the references that taught the hand-held 

devices showed that ‘‘the use of an 

animal body as a resistive switch to 

complete a circuit for the generation of 

an electric charge was already well 

known in the prior art.’’ Id. Finally, the 

Federal Circuit noted that the problem 

solved by using the resistive electrical 

switch in the prior art hand-held 

devices—malfunction of mechanical 

switches due to dirt and dampness— 

also pertained to the prior art stationary 

pest control device. 

The Federal Circuit recognized 

Agrizap as ‘‘a textbook case of when the 

asserted claims involve a combination 

of familiar elements according to known 

methods that does no more than yield 

predictable results.’’ Id. Agrizap 

exemplifies a strong case of obviousness 

based on simple substitution that was 

not overcome by the objective evidence 

of nonobviousness offered. It also 

demonstrates that analogous art is not 

limited to the field of applicant’s 

endeavor, in that one of the references 

that used an animal body as a resistive 

switch to complete a circuit for the 

generation of an electric charge was not 

in 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 for 

communicating and displaying 

information, it would have been obvious 

to adapt existing processes to 

incorporate 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 an 

interested buyer would then submit a 

bid 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 noted 

parameters to determine the best bid. It 

operated on conventional Web browsers 

and allowed participants to monitor the 

course of the auction. 

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 of 

KSR. Muniauction rebutted the 

argument by offering evidence of 

skepticism by experts, copying, praise, 

and commercial success. Although the 

district court found the evidence to be 

persuasive of nonobviousness, the 

Federal Circuit disagreed. It noted that 

a nexus between the claimed invention 

and the proffered evidence was lacking 

because the evidence was not 

coextensive with the claims at issue. For 

this reason, the Federal Circuit 

determined that Muniauction’s evidence 

of secondary considerations was not 

entitled to substantial weight. 

The Federal Circuit analogized this 

case 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 a 

prior art mechanical children’s learning 

device. In Leapfrog, the court had noted 

that market pressures would have 

prompted a person of ordinary skill to 

use modern electronics in the prior art 

device. Similarly in Muniauction, 

market pressures would have prompted 

a person of ordinary skill to use a 

conventional Web browser in a method 

of 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 that 

compound as well as other compounds 

where it was known or the skilled 

artisan had reason to believe that some 

desirable property of the mixture was 

derived in whole or in part from the 

claimed compound, and separating the 

claimed compound from the mixture 

was routine in the art. 

In Aventis, the claims were drawn to 

the 5(S) stereoisomer of the blood 

pressure drug ramipril in 

stereochemically pure form, and to 

compositions 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 of 

various stereoisomers including 5(S) 

ramipril had been taught by the prior 

art. The question before the court was 

whether the purified single stereoisomer 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53651 

would have been obvious over the 

known mixture of stereoisomers. 

The record showed that the presence 

of multiple S stereocenters in drugs 

similar to ramipril was known to be 

associated with enhanced therapeutic 

efficacy. For example, when all of the 

stereocenters were in the S form in the 

related drug enalapril (SSS enalapril) as 

compared with only two stereocenters 

in the S form (SSR enalapril), the 

therapeutic potency was 700 times as 

great. There was also evidence to 

indicate that conventional methods 

could be used to separate the various 

stereoisomers of ramipril. 

The district court saw the issue as a 

close case, because, in its view, there 

was no clear motivation in the prior art 

to isolate 5(S) ramipril. However, the 

Federal Circuit disagreed, and found 

that the claims would have been 

obvious. The Federal Circuit cautioned 

that requiring such a clearly stated 

motivation in the prior art to isolate 5(S) 

ramipril ran counter to the Supreme 

Court’s decision in KSR. The court 

stated: 

Requiring an explicit teaching to purify the 

5(S) stereoisomer from a mixture in which it 

is the active ingredient is precisely the sort 

of rigid application of the TSM test that was 

criticized in KSR. 

Id. at 1301. The Aventis court also 

relied on the settled principle that in 

chemical cases, structural similarity can 

provide the necessary reason to modify 

prior art teachings. The Federal Circuit 

also addressed the kind of teaching that 

would be sufficient in the absence of an 

explicitly stated prior art-based 

motivation, explaining that an 

expectation of similar properties in light 

of the prior art can be sufficient, even 

without an explicit teaching that the 

compound will have a particular utility. 

In the chemical arts, the cases 

involving so-called ‘‘lead compounds’’ 

form an important subgroup of the 

obviousness cases that are based on 

substitution. The Federal Circuit has 

had a number of opportunities since the 

KSR decision to discuss the 

circumstances 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, the 

need to provide a reason for any 

proposed modification, and the 

predictability 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 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 

compound when there is some reason 

for starting with that lead compound 

and modifying it to obtain the claimed 

compound. 

Eisai concerns the pharmaceutical 

compound rabeprazole. Rabeprazole is a 

proton pump inhibitor for treating 

stomach ulcers and related disorders. 

The Federal Circuit affirmed the district 

court’s summary judgment of 

nonobviousness, stating that no reason 

had been advanced to modify the prior 

art compound in a way that would 

destroy an advantageous property. 

Co-defendant Teva based its 

obviousness argument on the structural 

similarity between rabeprazole and 

lansoprazole. The compounds were 

recognized as sharing a common core, 

and the Federal Circuit characterized 

lansoprazole as a ‘‘lead compound.’’ The 

prior art compound lansoprazole was 

useful for the same indications as 

rabeprazole, and differed from 

rabeprazole 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 a 

beneficial feature because it conferred 

lipophilicity to the compound. The 

ability of a person of ordinary skill to 

carry out the modification to introduce 

the methoxypropoxy substituent, and 

the predictability of the result were not 

addressed. 

Despite the significant similarity 

between the structures, the Federal 

Circuit did not find any sufficient 

reason to modify the lead compound. 

According to the Federal Circuit: 

Obviousness based on structural similarity 

thus can be proved by identification of some 

motivation that would have led one of 

ordinary skill in the art to select and then 

modify a known compound (i.e. a lead 

compound) in a particular way to achieve the 

claimed compound. * * * In keeping with 

the 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.2d 

705 (2007), the requisite motivation can come 

from any number of sources and need not 

necessarily 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 and 

prior art compounds possess a ‘sufficiently 

close relationship * * * to create an 

expectation,’ in light of the totality of the 

prior 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 

substituent was known to increase 

lipophilicity, so a skilled artisan would 

have expected that replacing the 

trifluoroethoxy substituent with a 

methoxypropoxy substituent would 

have reduced the lipophilicity of the 

compound. Thus, the prior art created 

the expectation that rabeprazole would 

be less useful than lansoprazole as a 

drug for treating stomach ulcers and 

related disorders because the proposed 

modification would have destroyed an 

advantageous property of the prior art 

compound. The compound was not 

obvious as argued by Teva because, 

upon consideration of all of the facts of 

the 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 that 

the term ‘‘lead compound’’ in a 

particular opinion can have a contextual 

meaning that may vary from the way a 

pharmaceutical chemist might use the 

term. In the field of pharmaceutical 

chemistry, the term ‘‘lead compound’’ 

has been defined variously as ‘‘a 

chemical compound that has 

pharmacological or biological activity 

and whose chemical structure is used as 

a starting point for chemical 

modifications in order to improve 

potency, selectivity, or pharmacokinetic 

parameters;’’ ‘‘[a] compound that 

exhibits pharmacological properties 

which suggest its development;’’ and ‘‘a 

potential 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 the 

law of obviousness, any known 

compound might possibly serve as a 

lead compound: ‘‘Obviousness based on 

structural similarity thus can be proved 

by identification of some motivation 

that would have led one of ordinary 

skill in the art to select and then modify 

a known compound (i.e. a lead 

compound) in a particular way to 

achieve 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 reasons 

for modifying a prior art compound to 

arrive at the claimed compound have 

nothing to do with pharmaceutical 

activity. The inactive compound would 

not be considered to be a lead 


hsrobinson on DSK69SOYB1PROD with NOTICES
53652 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

compound by pharmaceutical chemists, 

but could potentially be used as such 

when considering obviousness. Office 

personnel might also base an 

obviousness rejection on a known 

compound that pharmaceutical 

chemists would not select as a lead 

compound due to expense, handling 

issues, or other business considerations. 

However, there must be some reason for 

starting with that lead compound other 

than the mere fact that the ‘‘lead 

compound’’ merely exists. See Altana 

Pharma AG v. Teva Pharmaceuticals 

USA, Inc., 566 F.3d 999, 1007 (Fed. Cir. 

2009) (holding that there must be some 

reason ‘‘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 a 

single compound as a ‘‘lead compound’’ 

in order to support an obviousness 

rejection. However, where there was 

reason to select and modify the lead 

compound to obtain the claimed 

compound, but no reasonable 

expectation of success, the claimed 

compound would not have been 

obvious. 

A chemical compound was also found 

to be nonobvious in Procter & Gamble. 

The compound at issue was 

risedronate—the active ingredient of 

Procter & Gamble’s osteoporosis drug 

Actonel®. Risedronate is an example of 

a bisphosphonate, which is a class of 

compounds known to inhibit bone 

resorption. 

When Procter & Gamble sued Teva for 

infringement, Teva defended by arguing 

invalidity for obviousness over one of 

Procter & Gamble’s earlier patents. The 

prior art patent did not teach 

risedronate, but instead taught thirty-six 

other similar compounds including 2- 

pyr EHDP that were potentially useful 

with regard to osteoporosis. Teva argued 

obviousness on the basis of structural 

similarity to 2-pyr EHDP, which is a 

positional isomer of risedronate. 

The district court found no reason to 

select 2-pyr EHDP as a lead compound 

in 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 

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 a 

reason to modify it so as to make 

risedronate, 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 informative 

in its discussion of the treatment of 

secondary considerations of nonobviousness. Although the court found 

that no prima facie case of obviousness 

had been presented, it proceeded to 

analyze Procter & Gamble’s proffered 

evidence 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 that 

even if a prima facie case of obviousness 

had been established, sufficient 

evidence of unexpected results was 

introduced 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 the 

compound was effective, and that the 

superior properties were unexpected 

and could not be predicted. Tests 

comparing risedronate to a compound 

in the prior art reference showed that 

risedronate outperformed the other 

compound by a substantial margin, 

could be administered in a greater 

amount without an observable toxic 

effect, and was not lethal at the same 

levels as the other compound. The 

weight of the evidence and the 

credibility of the witnesses were 

sufficient to show unexpected results 

that would have rebutted an 

obviousness determination. Thus, 

nonobviousness can be shown when a 

claimed invention is shown to have 

unexpectedly superior properties when 

compared to the prior art. 

The court then addressed the 

evidence of commercial success of 

risedronate and the evidence that 

risedronate met a long-felt need. The 

court pointed out that little weight was 

to be afforded to the commercial success 

because 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 

Actonel®, there was no unmet need that 

the invention satisfied. The court 

emphasized that whether there was a 

long-felt unsatisfied need is to be 

evaluated based on the circumstances as 

of the filing date of the challenged 

invention—not as of the date that the 

invention is brought to market. 

It should be noted that the lead 

compound cases do not stand for the 

proposition that identification of a 

single lead compound is necessary in 

every obviousness rejection of a 

chemical 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 a 

person of ordinary skill would have 

known how to synthesize such a 

compound, and the structural and/or 

functional result could reasonably have 

been predicted, then a prima facie case 

of obviousness of the claimed chemical 

compound might exist even without 

identification of a particular lead 

compound. 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 to 

link the two, if one of ordinary skill 

would have known how to do so, and 

if the resulting compound would have 

been the predictable result of the 

linkage procedure. Thus, Office 

personnel should recognize that in 

certain situations, it may be proper to 

reject a claimed chemical compound as 

obvious even without identifying a 

single 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 chemical 

compound in view of its structural 

similarity to a prior art compound may 

be shown by identifying some line of 

reasoning that would have led one of 

ordinary skill in the art to select and 

modify a prior art lead compound in a 

particular way to produce the claimed 

compound. It is not necessary for the 

reasoning to be explicitly found in the 

prior art of record, nor is it necessary for 

the prior art to point to only a single 

lead compound. 

Although the decision reached by the 

Federal Circuit in Altana involved a 

motion for preliminary injunction and 

did not include a final determination of 

obviousness, the case is nevertheless 

instructive as to the issue of selecting a 

lead compound. 

The technology involved in Altana 

was the compound pantoprazole, which 

is the active ingredient in Altana’s 

antiulcer drug Protonix®. Pantoprazole 

belongs to a class of compounds known 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53653 

as proton pump inhibitors that are used 

to treat gastric acid disorders in the 

stomach. 

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 in 

light of one of Altana’s prior patents. 

Altana’s patent discussed a compound 

referred 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 of 

ordinary skill in the art would have 

selected compound 12 as a lead 

compound for modification, and the 

Federal Circuit affirmed. 

Obviousness of a chemical compound 

in view of its structural similarity to a 

prior art compound may be shown by 

identifying some line of reasoning that 

would have led one of ordinary skill in 

the art to select and modify 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 and 

need not necessarily be explicitly found 

in the prior art of record. The Federal 

Circuit determined that ample evidence 

supported the district court’s finding 

that compound 12 was a natural choice 

for 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 patent 

examiner had considered the 

compounds 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 the 

art would have selected the eighteen 

compounds to pursue further 

investigation into their potential as 

proton pump inhibitors. 

In response to Altana’s argument that 

the prior art must point to only a single 

lead compound for further 

development, the Federal Circuit stated 

that a ‘‘restrictive view of the lead 

compound 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 a 

flexible approach—one that was 

admittedly preliminary—and found that 

the 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 

starting point from which to pursue 

further development efforts. That 

finding 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 of 

reasoning has been explored extensively 

by the Federal Circuit in several cases 

since the KSR decision. The 2007 KSR 

Guidelines explain, in view of the 

Supreme Court’s instruction, that this 

rationale is only appropriate when there 

is a recognized problem or need in the 

art; there are a finite number of 

identified, predictable solutions to the 

recognized need or problem; and one of 

ordinary skill in the art could have 

pursued these known potential 

solutions with a reasonable expectation 

of success. The case law in this area is 

developing quickly in the chemical arts, 

although the rationale has been applied 

in 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 has 

come before and not in a vacuum, few 

inventions will survive scrutiny under 

an 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 that 

places 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 advance 

is 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 the 

context of the subject matter in 

question, ‘‘including the characteristics 

of the science or technology, its state of 

advance, the nature of the known 

choices, the specificity or generality of 

the 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 have 

been obvious over the known protein 

that it encodes where the skilled artisan 

would have had a reasonable 

expectation of success in deriving the 

claimed polynucleotide using standard 

biochemical techniques, and the skilled 

artisan would have had a reason to try 

to isolate the claimed polynucleotide. 

KSR applies to all technologies, rather 

than just the ‘‘predictable’’ arts. 

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), and 

the Board in turn had affirmed the 

examiner’s determination that the 

claims 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 acid 

encoded a particular polypeptide. The 

encoded polypeptide was identified in 

the claim by its partially specified 

sequence, and by its ability to bind to 

a specified protein. A prior art patent to 

Valiante taught the polypeptide 

encoded by the claimed nucleic acid, 

but did not disclose either the sequence 

of the polypeptide, or the claimed 

isolated nucleic acid molecule. 

However, Valiante did disclose that by 

employing conventional methods, such 

as those disclosed by a prior art 

laboratory manual by Sambrook, the 

sequence of the polypeptide could be 

determined, and the nucleic acid 

molecule could be isolated. In view of 

Valiante’s disclosure of the polypeptide, 

and of routine prior art methods for 

sequencing the polypeptide and 

isolating the nucleic acid molecule, the 

Board found that a person of ordinary 

skill in the art would have had a 

reasonable 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 the 

polypeptide 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 or 

suggesting a structurally similar nucleic 

acid molecule. Citing KSR, the Board 

stated that ‘‘when there is motivation to 

solve 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 technical 

grasp. If this leads to anticipated 

success, it is likely the product not of 

innovation but of ordinary skill and 

common sense.’’ The Board noted that 


hsrobinson on DSK69SOYB1PROD with NOTICES
53654 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

the problem facing those in the art was 

to isolate a specific nucleic acid, and 

there were a limited number of methods 

available to do so. The Board concluded 

that the skilled artisan would have had 

reason to try these methods with the 

reasonable expectation that at least one 

would be successful. Thus, isolating the 

specific nucleic acid molecule claimed 

was ‘‘the product not of innovation but 

of ordinary skill and common sense.’’ 

The Board’s reasoning was substantially 

adopted 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 the 

claim’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 ‘‘to 

differentiate between proper and 

improper applications of ‘obvious to 

try,’ ’’ the Federal Circuit ‘‘outlined two 

classes of situations where ‘obvious to 

try’ is erroneously equated with 

obviousness under § 103.’’ Kubin, 561 

F.3d at 1359. These two classes of 

situations are: (1) When what would 

have been ‘‘obvious to try’’ would have 

been to vary all parameters or try each 

of numerous possible choices until one 

possibly arrived at a successful result, 

where the prior art gave either no 

indication of which parameters were 

critical or no direction as to which of 

many possible choices is likely to be 

successful; and (2) when what was 

‘‘obvious to try’’ was to explore a new 

technology or general approach that 

seemed to be a promising field of 

experimentation, where the prior art 

gave only general guidance as to the 

particular 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 from 

a broad range of compounds, any one of 

which could have been selected as the 

lead compound for further investigation, 

and the prior art taught away from using 

a particular lead compound, and there 

was no predictability or reasonable 

expectation of success in making the 

particular modifications necessary to 

transform the lead compound into the 

claimed compound. 

Takeda is an example of a chemical 

case in which the Federal Circuit found 

that the claim was not obvious. The 

claimed compound was pioglitazone, a 

member 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 ‘‘lead 

compound’’ and the obvious-to-try 

argument. 

Alphapharm had filed an Abbreviated 

New Drug Application with the Food 

and Drug Administration, which was a 

technical act of infringement of 

Takeda’s patent. When Takeda brought 

suit, Alphapharm’s defense was that 

Takeda’s patent was invalid due to 

obviousness. Alphapharm argued that a 

two-step modification—involving 

homologation and ring-walking—of a 

known 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 select 

compound b as a lead compound. There 

were a large number of similar prior art 

TZD compounds; fifty-four were 

specifically identified in Takeda’s prior 

patent, and the district court observed 

that ‘‘hundreds of millions’’ were more 

generally disclosed. Although the 

parties agreed that compound b 

represented the closest prior art, one 

reference had taught certain 

disadvantageous properties associated 

with compound b, which according to 

the district court would have taught the 

skilled artisan not to select that 

compound as a lead compound. The 

district court found no prima facie case 

of obviousness, and stated that even if 

a prima facie case had been established, 

it would have been overcome in this 

case in view of the unexpected lack of 

toxicity of pioglitazone. 

The Federal Circuit affirmed the 

decision of the district court, citing the 

need 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 to 

solve 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 

technical grasp.’’ KSR, 127 S.Ct. at 1732. In 

such circumstances, ‘‘the fact that a 

combination was obvious to try might show 

that 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, the 

closest prior art compound (compound b, the 

6-methyl) exhibited negative properties that 

would have directed one of ordinary skill in 

the art away from that compound. Thus, this 

case fails to present the type of situation 

contemplated by the Court when it stated 

that an invention may be deemed obvious if 

it was ‘‘obvious to try.’’ The evidence showed 

that 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 the 

appropriate factual findings cannot be 

made. In Takeda, there was a 

recognized need for treatment of 

diabetes. However, there was no finite 

number of identified, predictable 

solutions to the recognized need, and no 

reasonable 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 select 

compound b, there had been no 

predictability or reasonable expectation 

of success associated with the particular 

modifications necessary to transform 

compound b into the claimed 

compound pioglitazone. Thus, an 

obviousness 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 course 

of 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 not 

present a finite and easily traversed 

number of potential starting 

compounds, and there was no apparent 

reason for selecting a particular starting 

compound from among a number of 

unpredictable alternatives. 

The Ortho-McNeil case provides 

another example in which a chemical 

compound 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 be 

effective for its intended purpose is part 

of the obviousness analysis. 

In the course of working toward a new 

anti-diabetic drug, Ortho-McNeil’s 

scientist had unexpectedly discovered 

that 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 with 

an anti-diabetic drug precursor, 

especially the specific one that led to 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53655 

topiramate, if one had been seeking an 

anti-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 of 

ordinary skill would have chosen the 

particular starting compound or the 

particular 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 of 

serendipity in this case, which runs 

counter to the requirement for 

predictability. Summarizing their 

conclusion with regard to Mylan’s 

obvious to try argument, the Federal 

Circuit stated: 

[T]his invention, contrary to Mylan’s 

characterization, does not present a finite 

(and small in the context of the art) number 

of 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 skilled 

artisan 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 when 

an 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 in 

question. As taught in Abbott, discussed 

above, it is essential that the inquiry be 

placed 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 to 

obtain it from a finite and easily 

traversed number of options that was 

narrowed down from a larger set of 

possibilities by the prior art, and the 

outcome of obtaining the claimed 

compound was reasonably predictable. 

In Bayer the claimed invention was an 

oral contraceptive containing 

micronized drospirenone marketed as 

Yasmin®. 

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 

the solubility of poorly water soluble 

drugs. 

Based on the known acid sensitivity, 

Bayer had studied how effectively an 

enteric-coated drospirenone tablet 

delivered a formulation as compared to 

an intravenous injection of the same 

formulation to measure the ‘‘absolute 

bioavailability’’ of the drug. Bayer added 

an unprotected (normal) drospirenone 

tablet and compared its bioavailability 

to that of the enteric-coated formulation 

and the intravenous delivery. Bayer 

expected to find that the enteric-coated 

tablet 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 that 

an enteric coating would be necessary to 

preserve bioavailability), the normal pill 

and the enteric-coated pill resulted in 

the same bioavailability. Following this 

study, Bayer developed micronized 

drospirenone 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 that 

a structurally related compound, 

spirorenone, though acid-sensitive, 

would nevertheless absorb in vivo, 

would have suggested the same result 

for drospirenone. It also found that 

while another reference taught that 

drospirenone isomerizes in vitro when 

exposed to acid simulating the human 

stomach, 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 no 

enteric coating was necessary. 

The Federal Circuit held that the 

patent 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 the 

prior art. The prior art was not vague in 

pointing toward a general approach or 

area of exploration, but rather guided 

the formulator precisely to the use of 

either a normal pill or an enteric-coated 

pill. 

It is important for Office personnel to 

recognize that the mere existence of a 

large number of options does not in and 

of itself lead to a conclusion of 

nonobviousness. Where the prior art 

teachings lead one of ordinary skill in 

the art to a narrower set of options, then 

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 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. 

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 of 

methyl alpha-5(4,5,6,7-tetrahydro(3,2- 

c)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 prior 

art. The two forms had not previously 

been separated, and although the 

mixture was known to have antithrombotic properties, the extent to 

which each of the individual isomers 

contributed to the observed properties 

of the racemate was not known and was 

not predictable. 

The district court assumed that in the 

absence 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, the 

district court found that any prima facie 

case 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 the 

degree to which the isomers would have 

exhibited different levels of therapeutic 

activity and toxicity. Both parties’ 

experts also agreed that the isomer with 

greater 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 for 

both parties agreed that it was difficult 

to separate isomers at the time of the 

invention. Nevertheless, when Sanofi 

ultimately undertook the task of 

separating the isomers, it found that 

they had the ‘‘rare characteristic of 

‘absolute stereoselectivity,’ ’’ whereby 

the D-isomer provided all of the 

favorable therapeutic activity but no 

significant toxicity, while the L-isomer 

produced no therapeutic activity but 


hsrobinson on DSK69SOYB1PROD with NOTICES
53656 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

virtually all of the toxicity. Based on 

this record, the district court concluded 

that Apotex had not met its burden of 

proving by clear and convincing 

evidence that Sanofi’s patent was 

invalid for obviousness. The Federal 

Circuit affirmed the district court’s 

conclusion. 

Office personnel should recognize 

that even when only a small number of 

possible choices exist, the obvious to try 

line of reasoning is not appropriate 

when, upon consideration of all of the 

evidence, the outcome would not have 

been reasonably predictable and the 

inventor would not have had a 

reasonable expectation of success. In 

Bayer, there were art-based reasons to 

expect that both the normal pill and the 

enteric-coated pill would be 

therapeutically suitable, even though 

not all prior art studies were in 

complete 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 the 

isomers, would have had no reason to 

expect that the D-isomer would have 

such strong therapeutic advantages as 

compared with the L-isomer. In other 

words, 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 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. 

In Rolls-Royce the Federal Circuit 

addressed the obvious to try rationale in 

the context of a fan blade for jet engines. 

The case had arisen out of an 

interference proceeding. Finding that 

the district court had correctly 

determined that there was no 

interference-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 the 

center 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-leaning 

outer region. 

Id. at 1328. 

United had argued that it would have 

been obvious for a person of ordinary 

skill in the art to try a fan blade design 

in which the sweep angle in the outer 

region was reversed as compared with 

prior art fan blades from rearward to 

forward sweep, in order to reduce 

endwall shock. The Federal Circuit 

disagreed with United’s assessment that 

the 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 have 

been ‘‘known and finite.’’ Id. at 1339, 

citing Abbott, 544 F.3d at 1351. In this 

case, 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, the 

Federal Circuit concluded that changing 

the sweep angle ‘‘would not have 

presented itself as an option at all, let 

alone an option that would have been 

obvious to try.’’ Rolls-Royce, 603 F.3d at 

1339. The decision in Rolls-Royce is a 

reminder to Office personnel that the 

obvious to try rationale can properly be 

used to support a conclusion of 

obviousness only when the claimed 

solution would have been selected from 

a 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 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. 

The Perfect Web case provides an 

example 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 try 

argument. 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, and 

repeating the first three steps if a predetermined minimum number of 

intended recipients had not received the 

e-mail. 

The Federal Circuit affirmed the 

district court’s determination on 

summary judgment that the claimed 

invention would have been obvious. 

Failure to meet a desired quota of e-mail 

recipients was a recognized problem in 

the field of e-mail marketing. The prior 

art had also recognized three potential 

solutions: Increasing the size of the 

initial recipient list; resending e-mails 

to recipients who did not receive them 

on the first attempt; and selecting a new 

recipient list and sending e-mails to 

them. The last option corresponded to 

the fourth step of the invention as 

claimed. 

The Federal Circuit noted that based 

on ‘‘simple logic,’’ selecting a new list of 

recipients was more likely to result in 

the desired outcome than resending to 

those who had not received the e-mail 

on the first attempt. There had been no 

evidence of any unexpected result 

associated with selecting a new 

recipient list, and no evidence that the 

method would not have had a 

reasonable 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 sense 

in 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 found 

that ‘‘the final step [of the claimed 

invention] is merely the logical result of 

common 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 and 

since the KSR decision. 

The Federal Circuit pointed out that 

application of common sense is not 

really an innovation in the law of 

obviousness 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 then 

provided a review of a number of 

precedential cases that inform the 

understanding of common sense, 

including In re Bozek, 416 F.2d 1385, 

1390 (CCPA 1969) (explaining that a 

patent examiner may rely on ‘‘common 

knowledge and common sense of the 

person 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 not 

based on any evidence in the record’’). 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53657 

The Federal Circuit implicitly 

acknowledged in Perfect Web that the 

kind 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 for 

an obviousness rejection in light of the 

teachings 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 combine 

references.’’ However, Perfect Web went 

on to state that even under Lee, common 

sense could properly be applied when 

analyzing evidence relevant to 

obviousness. 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 a 

particular reference’’ is not. 

5. Federal Circuit Cases Discussing 

Consideration of Evidence. Office 

personnel should consider all rebuttal 

evidence that is timely presented by the 

applicants when reevaluating any 

obviousness determination. In the case 

of a claim rendered obvious by a 

combination of prior art references, 

applicants may submit evidence or 

argument to demonstrate that the results 

of 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 considered 

simply for its ‘‘knockdown’’ value; 

rather, all evidence must be reweighed 

to determine whether the claims are 

nonobvious. 

Once the applicant has presented rebuttal 

evidence, Office personnel should reconsider 

any initial obviousness determination in 

view 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 record 

and proposed rejections and their bases 

should be reviewed to confirm their 

continued 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 

rebut the prima facie case of obviousness, 

Office personnel should specifically set forth 

the facts and reasoning that justify this 

conclusion. 

MPEP § 2145. The following cases 

exemplify the continued application of 

these principles both at the Federal 

Circuit and within the Office. Note that 

these principles were at issue in some 

of the cases previously discussed, and 

have been addressed there in a more 

cursory 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 be 

outweighed by contradictory evidence 

in the record or by what is in the 

specification. Although a reasonable 

expectation of success is needed to 

support a case of obviousness, absolute 

predictability is not required. 

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 such 

compositions for treatment of blood and 

immune system disorders. The 

composition claims required that the 

stem cells be present in an amount 

sufficient to effect hematopoietic 

reconstitution when administered to a 

human adult. The trial court had found 

that PharmaStem’s patents were 

infringed and not invalid on 

obviousness or other grounds. On 

appeal, the Federal Circuit reversed the 

district court, determining that the 

claims were invalid for obviousness. 

The Federal Circuit discussed the 

evidence presented at trial. It pointed 

out that the patentee, PharmaStem, had 

not invented an entirely new procedure 

or new composition. Rather, 

PharmaStem’s own specification 

acknowledged that it was already 

known in the prior art that umbilical 

cord and placental blood-based 

compositions contained hematopoietic 

stem cells, and that hematopoietic stem 

cells were useful for the purpose of 

hematopoietic reconstitution. 

PharmaStem’s contribution was to 

provide experimental proof that 

umbilical 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 

testimony was contrary to the inventors’ 

admissions in the specification, as well 

as prior art teachings that disclosed 

stem cells in cord blood. In this case, 

PharmaStem’s evidence of 

nonobviousness was outweighed by 

contradictory evidence. 

Despite PharmaStem’s useful 

experimental validation of 

hematopoietic reconstitution using 

hematopoietic stem cells from umbilical 

cord 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 have 

worked. Absolute predictability is not a 

necessary prerequisite to a case of 

obviousness. Rather, a degree of 

predictability that one of ordinary skill 

would have found to be reasonable is 

sufficient. The Federal Circuit 

concluded that ‘‘[g]ood science and 

useful 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 of 

obviousness, must be considered when 

properly 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 have 

separate properties and utilities. There 

have been commercially available 

antivenom products that consisted of 

whole 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 of 

snake venom. The inventor, Sullivan, 

discovered that F(ab) fragments are 

effective at neutralizing the lethality of 

rattlesnake venom, while reducing the 

occurrence 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 of 

the claimed composition were 

accounted for in the prior art, and that 

the composition taught by that prior art 

would have been expected by a person 

of ordinary skill in the art at the time 

the invention was made to neutralize 

the lethality of the venom of a 

rattlesnake. 

Rebuttal evidence had not been 

considered by the Board because it 


hsrobinson on DSK69SOYB1PROD with NOTICES
53658 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 

considered the evidence to relate to the 

intended use of the claimed 

composition as an antivenom, rather 

than the composition itself. Appellant 

successfully argued that even if the 

Board had shown a prima facie case of 

obviousness, the extensive rebuttal 

evidence must be considered. The 

evidence included three expert 

declarations submitted to show that the 

prior 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 more 

than the use of the claimed 

composition. While a statement of 

intended use may not render a known 

composition patentable, the claimed 

composition was not known, and 

whether it would have been obvious 

depends upon consideration of the 

rebuttal evidence. Appellant did not 

concede that the only distinguishing 

factor of its composition is the statement 

of 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 be 

ignored—the unexpected property is 

relevant and thus the declarations 

describing it should have been 

considered. 

Nonobviousness can be shown when 

a person of ordinary skill in the art 

would not have reasonably predicted 

the claimed invention based on the 

prior art, and the resulting invention 

would not have been expected. All 

evidence must be considered when 

properly 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 a 

timely manner must be considered on 

the record. Evidence of commercial 

success is pertinent where a nexus 

between the success of the product and 

the claimed invention has been 

demonstrated. 

The case of Hearing Components 

involved a disposable protective 

covering for the portion of a hearing aid 

that is inserted into the ear canal. The 

covering was such that it could be 

readily replaced by a user as needed. 

At the district court, Shure had 

argued that Hearing Components’ 

patents were obvious over one or more 

of three different combinations of prior 

art references. The jury disagreed, and 

determined that the claims were 

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 the 

references, motivation to combine, and 

secondary considerations, the 

nonobviousness 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 the 

jury 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 was 

taught by Carlisle as being inside the ear 

canal. On the issue of combining 

references, Shure’s witness had given 

testimony described as ‘‘rather sparse, 

and lacking in specific details.’’ Id. at 

1364. In contradistinction, Hearing 

Components’ witness ‘‘described 

particular reasons why one skilled in 

the art would not have been motivated 

to combine the references.’’ Id. Finally, 

as to secondary considerations, the 

Federal 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 a 

covered product was more than cut in 

half immediately upon expiration’’ of 

the patent. 

Although the Hearing Components 

case involves substantial evidence of 

nonobviousness in a jury verdict, it is 

nevertheless instructive for Office 

personnel on the matter of weighing 

evidence. Office personnel routinely 

must consider evidence in the form of 

prior art references, statements in the 

specification, or declarations under 37 

CFR 1.131 or 1.132. Other forms of 

evidence may also be presented during 

prosecution. Office personnel are 

reminded that evidence that has been 

presented in a timely manner should 

not be ignored, but rather should be 

considered on the record. However, not 

all 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 scope 

with the claimed invention, are 

appropriate. The mere presence of some 

credible rebuttal evidence does not 

dictate that an obviousness rejection 

must always be withdrawn. See MPEP 

§ 2145. Office personnel must consider 

the appropriate weight to be accorded to 

each piece of evidence. An obviousness 

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 reject 

a claim if, in view of the prior art and 

evidence of record, it is more likely than 

not that the claim is unpatentable.’’). 

MPEP § 716.01(d) provides further 

guidance on weighing evidence in 

making 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 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 longfelt need is undermined when there is 

a failure to link the commercial success 

or long-felt need to a claimed feature 

that distinguishes over the prior art. 

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 each 

processing station be in communication 

with a central control unit. The Federal 

Circuit agreed with the district court 

that the only difference between the 

claimed invention and the prior art to 

Hesser 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 a 

matter of law (JMOL) that the claims 

would have been obvious in view of 

Hesser. Because the evidence showed 

that persons of ordinary skill in the art 

would have been familiar with both the 

bus and the multiplexer, and that they 

could have readily selected and 

employed 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 evidence 

of nonobviousness presented by Asyst. 

Asyst had offered evidence of 

commercial success of its invention. 

However, the Federal Circuit pointed 

out that Asyst had not provided the 

required nexus between the commercial 

success and the claimed invention, 

emphasizing that ‘‘Asyst’s failure to link 

that commercial success to the features 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices 53659 

of its invention that were not disclosed 

in Hesser undermines the probative 

force of the evidence * * *.’’ Id. at 1316. 

Asyst had also offered evidence from 

others in the field praising the invention 

as addressing a long-felt need. Once 

again, the Federal Circuit found the 

argument to be unavailing in view of the 

prior art, stating that ‘‘[w]hile the 

evidence shows that the overall system 

drew praise as a solution to a felt need, 

there was no evidence that the success 

* * * was attributable to the 

substitution 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 not 

always 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, Office 

personnel should carefully weigh any 

properly presented objective evidence of 

nonobviousness against the strength of 

the prima facie case. If the asserted 

evidence, such as commercial success or 

satisfaction of a long-felt need, is 

attributable to features already in the 

prior art, the probative value of the 

evidence 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 the 

contours of obviousness after KSR. It 

addresses a number of issues that arise 

when Office personnel consider 

whether or not a claimed invention is 

obvious. While Office personnel are 

encouraged 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 to 

monitor the developing law of 

obviousness, and will provide 

additional guidance and updates as 

necessary. 

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. 

Case Teaching point 

Combining Prior Art Elements 

In re Omeprazole Patent Litigation, 

536 F.3d 1361 (Fed. Cir. 2008).

Even where a general method that could have been applied to make the claimed product was known and 

within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem 

which had suggested use of the method had been previously unknown. 

Crocs, Inc. v. U.S. Int’l Trade 

Comm’n., 598 F.3d 1294 (Fed. 

Cir. 2010).

A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the 

claimed combination and the combination yields more than predictable results. 

Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. 

Cir. 2008).

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 been 

combined. 

Ecolab, Inc. v. FMC Corp., 569 

F.3d 1335 (Fed. Cir. 2009).

A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan 

would have recognized an apparent reason to combine those elements and would have known how to 

do so. 

Wyers v. Master Lock Co., No. 

2009–1412, —F.3d—, 2010 WL 

2901839 (Fed. Cir. July 22, 

2010).

The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a 

legal conclusion of obviousness so long as it is explained with sufficient reasoning. 

DePuy Spine, Inc. v. Medtronic 

Sofamor Danek, Inc., 567 F.3d 

1314 (Fed. Cir. 2009).

Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of 

being combined, as well as the expectation that the combination would have worked for its intended purpose. An inference that a claimed combination would not have been obvious is especially strong where 

the prior art’s teachings undermine the very reason being proffered as to why a person of ordinary skill 

would have combined the known elements. 

Substituting One Known Element for Another 

In re ICON Health & Fitness, Inc., 

496 F.3d 1374 (Fed. Cir. 2007).

When determining whether a reference in a different field of endeavor may be used to support a case of 

obviousness (i.e., is analogous), it is necessary to consider the problem to be solved. 

Agrizap, Inc. v. Woodstream Corp., 

520 F.3d 1337 (Fed. Cir. 2008).

Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for applicant’s 

purpose. 

Muniauction, Inc. v. Thomson 

Corp., 532 F.3d 1318 (Fed. Cir. 

2008).

Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for 

those functions. 

Aventis Pharma Deutschland v. 

Lupin, Ltd., 499 F.3d 1293 (Fed. 

Cir. 2007).

A chemical compound would have been obvious over a mixture containing that compound as well as other 

compounds where it was known or the skilled artisan had reason to believe that some desirable property 

of the mixture was derived in whole or in part from the claimed compound, and separating the claimed 

compound from the mixture was routine in the art. 

Eisai Co. Ltd. v. Dr. Reddy’s Labs., 

Ltd., 533 F.3d 1353 (Fed. Cir. 

2008).

A claimed compound would not have been obvious where there was no reason to modify the closest prior 

art 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 compound 

when there is some reason for starting with that lead compound and modifying it to obtain the claimed 

compound. 

Procter & Gamble Co. v. Teva 

Pharmaceuticals USA, Inc., 566 

F.3d 989 (Fed. Cir. 2009).

It is not necessary to select a single compound as a ‘‘lead compound’’ in order to support an obviousness 

rejection. However, where there was reason to select and modify the lead compound to obtain the 

claimed compound, but no reasonable expectation of success, the claimed compound would not have 

been obvious. 


hsrobinson on DSK69SOYB1PROD with NOTICES
53660 Federal 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 be 

shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select 

and modify a prior art lead compound in a particular way to produce the claimed compound. It is not 

necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the 

prior art to point to only a single lead compound. 

The Obvious To Try Rationale 

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

Cir. 2009).

A claimed polynucleotide would have been obvious over the known protein that it encodes where the 

skilled artisan would have had a reasonable expectation of success in deriving the claimed 

polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason 

to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ‘‘predictable’’ arts. 

Takeda Chem. Indus. v. 

Alphapharm Pty., Ltd., 492 F.3d 

1350 (Fed. Cir. 2007).

A claimed compound would not have been obvious where it was not obvious to try to obtain it from a 

broad range of compounds, any one of which could have been selected as the lead compound for further investigation, and the prior art taught away from using a particular lead compound, and there was 

no predictability or reasonable expectation of success in making the particular modifications necessary 

to transform the lead compound into the claimed compound. 

Ortho-McNeil Pharmaceutical, Inc. 

v. Mylan Labs, Inc., 520 F.3d 

1358 (Fed. Cir. 2008).

Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of 

research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a 

claimed compound where the prior art did not present a finite and easily traversed number of potential 

starting compounds, and there was no apparent reason for selecting a particular starting compound from 

among a number of unpredictable alternatives. 

Bayer Schering Pharma A.G. v. 

Barr Labs., Inc., 575 F.3d 1341 

(Fed. Cir. 2009).

A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and 

easily traversed number of options that was narrowed down from a larger set of possibilities by the prior 

art, and the outcome of obtaining the claimed compound was reasonably predictable. 

Sanofi-Synthelabo v. Apotex, Inc., 

550 F.3d 1075 (Fed. Cir. 2008).

A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly 

expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture 

were unpredictable. 

Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 

(Fed. Cir. 2010).

An obvious to try rationale may be proper when the possible options for solving a problem were known 

and finite. However, if the possible options were not either known or finite, then an obvious to try rationale cannot be used to support a conclusion of obviousness. 

Perfect Web Techs., Inc. v. 

InfoUSA, Inc., 587 F.3d 1324 

(Fed. Cir. 2009).

Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning. 

Consideration of Evidence 

PharmaStem Therapeutics, Inc. v. 

ViaCell, Inc., 491 F.3d 1342 

(Fed. Cir. 2007).

Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness 

may be outweighed by contradictory evidence in the record or by what is in the specification. Although a 

reasonable expectation of success is needed to support a case of obviousness, absolute predictability is 

not required. 

In re Sullivan, 498 F.3d 1345 (Fed. 

Cir. 2007).

All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when 

properly presented. 

Hearing Components, Inc. v. Shure 

Inc., 600 F.3d 1357 (Fed. Cir. 

2010).

Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the 

claimed invention has been demonstrated. 

Asyst Techs., Inc. v. Emtrak, Inc., 

544 F.3d 1310 (Fed. Cir. 2008).

Evidence of secondary considerations of obviousness such as commercial success and long-felt need may 

be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined when there is a 

failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the 

prior art. 

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

BILLING CODE P 


hsrobinson on DSK69SOYB1PROD with NOTICES