The decisions of the Federal Circuit discussed in the 2010 KSR Guidelines Update provide additional examples of the law of obviousness. The purpose of the 2007 KSR Guidelines was 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.

The 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.

Examples + Teaching Points

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358 (Fed. Cir. 2008). Teaching point: 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). 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.

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.

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.

Perfect Web Technologies, Inc. v. Info USA, 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.

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.

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.

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.

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 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.

The technology-specific obviousness examples previously posted on the Office’s Web site are here.

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The United States Patent and Trademark Office (USPTO) issued an update to its obviousness guidelines to be used when applying the law of obviousness under 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.


The purpose of the 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.

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 teaching-suggestion-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.

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 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.

See all of the 2010 KSR Guidelines Update here.

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.

Comments concerning the KSR Guidelines Update may be sent by electronic mail message over the Internet addressed to, 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.

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The Federal Circuit recently affirmed that an admission that an accused infringing device practices an industry standard may, without more, be the basis for a finding of infringement.  Fujitsu, LG and Philips v. Netgear, US Court of Appeals for the Federal Circuit (10-1045).

Philips asserted claims of U.S. patent no. 4,974,952, Fujitsu asserted claims from U.S. patent no. 6,018,642, and LG asserted claims of U.S. patent no. 6,469,993 all against Netgear. Each patent describes and claims a different aspect of wireless communications technologies. They accused Netgear of infringing by implementing wireless networking protocols for sending and receiving messages between a base station, such as a wireless router, and a mobile station, such as a laptop.

The three plaintiffs, part of a licensing pool (Via Licensing) that purports to include patents that any manufacturer of 802.11 and WMM compliant products must license. The plaintiffs never identified particular claims or accused products prior to filing.  The plaintiffs argued that by simply complying with the standard, Netgear necessarily infringed the asserted claims. The court said that the plaintiffs must show evidence of infringement for each accused product. Fujitsu, LG, and Philips appealed the district court’s denial of summary judgment of infringement and grant of summary judgment of noninfringement.

Netgear argued that the court should establish a rule precluding the use of industry standards in assessing infringement. Instead, Netgear wants any plaintiff to separately accuse and prove infringement for all accused products, even if those products all comply with a standard that is relevant to the patent-in-suit. It argued that it is legally incorrect to compare claims to a standard rather than directly to accused products. Netgear also argued that a holding that practicing a standard infringes a patent would amount to an automatic conclusion of infringement against all future accused infringers. It argues that these later litigants would be deprived of a fair opportunity to prove that their products do not infringe.

An amicus brief by Association of Corporate Counsel, supporting Netgear, argued that it is dangerous to assess infringement based on a standard because the text of a standard may not be specific enough to ensure that all possible implementations infringe a patent claim. Further, it argues that many standard sections are optional and that users may never activate a potentially infringing feature. Finally, to allow this type of analysis would have a “chilling effect” on industries that rely on standards. It argues that companies would be less likely to comply with industry standards if a patent owner can argue that all compliant products infringe.

Philips argueds that it is more efficient for courts to assess infringement based on industry standards when applicable. It can alleviate the need for highly technical fact-finding such as the review of complicated source code and save judicial resources by not requiring the courts to separately consider products that all function in accordance with that standard.

The Federal Circuit affirmed that this can certainly be the case:

We hold that a district court may rely on an industry standard in analyzing infringement. If a district court construes the claims and finds that the reach of the claims includes any device that practices a standard, then this can be sufficient for a finding of infringement. We agree that claims should be compared to the accused product to determine infringement. However, if an accused product operates in accordance with a standard, then comparing the claims to that standard is the same as comparing the claims to the accused product. We accepted this approach in Dynacore where the court held a claim not infringed by comparing it to an industry standard rather than an accused product. An accused infringer is free to either prove that the claims do not cover all implementations of the standard or to prove that it does not practice the standard.

Public policy weighs in favor of this approach. If a court determines that all implementations of a standard infringe the claims of a patent, then it would be a waste of judicial resources to separately analyze every accused product that undisputedly practices the standard. This is not prejudicial to present or future litigants. If two products undisputedly operate in the same manner, a finding of infringement against one will create a persuasive case against the other. In such a case, there will be no prejudice.

We acknowledge, however, that in many instances, an industry standard does not provide the level of specificity required to establish that practicing that standard would always result in infringement. Or, as with the ’952 patent, the relevant section of the standard is optional, and standards compliance alone would not establish that the accused infringer chooses to implement the optional section. In these instances, it is not sufficient for the patent owner to establish infringement by arguing that the product admittedly practices the standard, therefore it infringes. In these cases, the patent owner must compare the claims to the accused products or, if appropriate, prove that the accused products implement any relevant optional sections of the standard. This should alleviate any concern about the use of standard compliance in assessing patent infringement. Only in the situation where a patent covers every possible implementation of a standard will it be enough to prove infringement by showing standard compliance.

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In March 2010 the United States Patent and Trademark Office (USPTO) and the United Kingdom Intellectual Property Office (IPO) announced plans to begin cooperation on increasing the efficiency and quality of the patent examination process by making greater use of each other’s work on commonly filed patent applications and eliminating duplication of work.  This initiative will yield efficiencies in patent processing and thus shorten the innovation cycle.  Work sharing is central to the efforts of both patent offices to fuel economic growth and create jobs – which are high priorities for both governments.

The offices have completed foundational work and preliminary studies and will begin work-sharing implementation in October.  The initial phase of implementation will focus on maximizing re-use during examination of commonly filed applications by providing access to work completed and currently made available by each office.  This will be combined with examiner training, data collection and analysis to gauge effectiveness and make necessary adjustments.  At the same time the offices will work on such longer-term issues as easier access to each office’s application files to create a more robust work-sharing environment.

“By enabling both offices to maximize the use of each other’s search and examination results, this work-sharing initiative should reduce patent backlogs and help us process patents more efficiently,” Under Secretary and Director of the USPTO David Kappos commented.  “I believe that it will serve as a model for our efforts at work-sharing with other countries as a means to improve the global patent system and bring innovation to market sooner.”

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Seminar – The Entire Market Value Rule and the End of Casual Empiricism

The entire market value rule (or “EMVR”) allows for the recovery of patent infringement damages based on the value of the entire product that contains an infringing component (when the patent-related feature is the basis for consumer demand). It has historically been a potent tool for patentholders claiming damages in intellectual property cases. However, increased scrutiny of the application of the EMVR suggests that more rigorous, empirical approaches are needed to provide adequately detailed evidence of consumer-driven demand. In this seminar:

David C. Giardina, Esq., Partner at Sidley Austin LLP, will address the impact recent cases such as Lucent Technologies v. Gateway Inc. may have on future damages claims and analytic requirements by the courts.

Iain M. Cockburn, Ph.D., George Schultz Professor of Economics, The University of Chicago Booth School of Business; Dean Designate, Yale School of Management, will discuss hedonic analysis, a method that uses actual product, price, and sales data, to evaluate consumer demand.

John R. Hauser, Sc.D., Professor of Marketing and Head of the Management Science Area of MIT Sloan School of Management, will focus on the use of conjoint analysis, a survey methodology that can be employed in the absence of sufficient market data, to assess consumer preferences.

Join a panel of experts, along with moderator Analysis Group Managing Principal Jeffrey A. Cohen, author of Intangible Assets: Valuation and Economic Benefit, as they address these issues and your questions at this complimentary breakfast program.

October 29, 2010

7:30 AM – 9:15 AM (CST)

Gleacher Center, Chicago


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The Program:

Kauffman FastTrac® TechVenture is a hands-on business development program specifically designed to assist scientists, inventors, engineers and IT developers in southwest Ohio to commercialize a new technology or take an existing tech business to the next level.

The Format:

Kauffman FastTrac® TechVenture will be presented over a eight-week period beginning Tuesday, October 19, 2010. Each week local subject experts will discuss business development and management topics, including:

  • Entering and Capturing the Market
  • Financial considerations
  • Entrepreneurship and Building Your Team
  • Protecting Your Intellectual Property
  • Identifying Funding and Working With Investors
  • Cash Management and Operations

In addition to the subject experts, professional business coaches and mentors will then work individually with each company to develop that topic in the company’s business plan.

The Team:

Kauffman FastTrac® TechVenture is sponsored by BIOSTART and Hamilton County Business Center, members of the Ohio Edison Incubation program. The topic presenters, coaches and mentors are high powered, local business professionals who have launched successful careers and businesses.

The Result:

Upon completion of the entire Kauffman FastTrac® TechVenture program, each participant will have the tools to create a world class enterprise or to take an existing business to the next level. All companies that complete the program are also eligible to participate in the TechVenture Cincy Business Plan Competition in January, 2011. Prizes of $5,000, $3,000 and $1,000 will be awarded to the top three business plans.

DATES: Tuesdays from 10/19 through 12/7/10

TIME: 6:00pm – 9:00pm

LOCATION: Hamilton County Business Center (HCBC)
1776 Mentor Avenue
Conference Room 160
Cincinnati, OH 45212

COST: $250 per person (an $895 value)

BUSINESS PLAN COMPETITION: January, 2011 (date TBA) Open only to program participants.

Visit BioStart to complete an application. Class size is limited to 10. For more information regarding Kauffman FastTrac® TechVentureTM contact:  Carol Frankenstein (BIOSTART) or  Mary Myers (HCBC)

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The still fresh ruling by CAFC on Goeddel v. Sugano reversed the decision by BPAI which held that Sugano is entitled to its filing date of its initial Japanese application and BPAI consequently awarded Sugano priority on counts of two interferences. The decision highlights the BPAI’s misinterpretation of PHOSITA’s function and we are encouraged to look at the non-obviousness requirement and PHOSITA once more and consequently agree with CAFC’s reversal of BPAI’s decision.

Let us acquaint ourselves with brief facts of the case before moving on to the discussion. The patents in question relate to human fibroblast interferon (“hFIF”), also called interferon beta or b-IF. This interferon is produced in the human body and is effective in combating pathogens and tumors. Scientists therefore sought to produce this interferon in large quantities for therapeutic use.

In the human body, there exists a genome that codes for hFIF. There exists a precursor form of hFIF (with 187 amino acids) and a mature form with 166 amino acids.

The subject matter for both patents is a recombinant DNA process for directly producing the mature hFIF.

Following are the details regarding date of filing for Sugano and Goeddel.


  • Japan: 19th March 1980
  • US: 5th June 1995


  • US: 25th Sept 1980

Goeddel’s claim is that Sugano’s earlier application does not comply with the written description and enablement requirement of 35 U.S.C. § 112 and would not function to produce mature hFIF. Sugano claims that a person skilled in the art (PHOSITA) could “envision” how to modify the precursor gene to obtain the mature hFIF.

Any mention of PHOSITA must start with the non-obviousness condition fulfillment for patentability.

Non-obviousness is often explained by using the reference of PHOSITA. A person having ordinary skill in the art is a legal fiction defined in the Patent Act of many jurisdictions. The PHOSITA is a test of “obviousness” which is one of the largest gray areas in patent law.

The US Patent Act defines obviousness as follows:

A patent may not be obtained though the invention … if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (35 U.S.C. § 103 (A))

KSR v. Teleflex described how obviousness should be determined:

“In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under §103. One of the ways in which a patent’s subject matter can be proved obvious is by noting that there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent’s claims.”

In the Windsurfing case, the obviousness requirement was explained as follows. The test for obviousness postulated a person who was skilled in the field but not inventive and was invested with the common general knowledge available in the field at the priority date, being presented with the prior knowledge or prior use relied upon. The test is to ask whether the alleged inventive step would have been obvious to that person.

Clear guidelines exist for determination of obviousness and can be summarized as follows:

  1. Construe prior document as at the date of its publication
  2. Compare disclosure in each prior document separately with the disclosure in the patentee’s claim
  3. To ask whether on making the comparison the prior document discloses the same invention as that disclosed in the patentee’s claim.

The non-obviousness criterion asks whether the claimed invention would have been obvious to a person of ordinary skill in the art the time the claimed invention was made. The non-obviousness inquiry allows for a combination of prior-art references while the novelty requirement is based on a single prior-art document. The test for non-obviousness is not an objective one and hence this is a much litigated field. The test for non-obviousness brings to the forefront the PHOSITA – person skilled in the art. The reason the role of the PHOSITA becomes crucial where doctrine of equivalents is concerned is because of the knowledge regarding the interchangeability of the elements that give rise to the infringement.

Under the non-obviousness requirement, the question one asks is whether a person with ordinary skill in the art would have known to make the appropriate changes in the prior art so as to arrive at the invention in question. If the answer is yes, the invention is unpatentable. The interchangeability standard asks whether a person with ordinary skill in the art would have known that the element in the claim can be replaced by its equivalent. If the answer is yes, infringement exists because the differences between the accused and original invention are insubstantial.

Thus, both the non-obviousness requirement and the doctrine of equivalents, rely on the opinion of the PHOSITA as a deciding factor. The birth of PHOSITA occurs for the first time in Hotchkiss as “skill possessed by an ordinary mechanic.” The role gets more definitive in Graham v. Deere and attains its present form in KSR v. Teleflex.

Hotchkiss v. Greenwood

Hotchkiss was the owner of a patent for door knobs made out of porcelain and of all kinds of clay used in pottery. Greenwood infringed on their patent. Upon filing a suit for infringement, Greenwood’s defense was that Hotchkiss’ patent did not fulfill the requirement of non-obviousness as the material was in common use and no other skill or ingenuity was involved in the construction of the door knob.

The court condemned the patent holding that there was an absence of skill, novelty and ingenuity and that the improvement of using clay over other previously used material was not the work of an inventor but that of an ordinary mechanic.

“[U]nless more ingenuity and skill . . . were required . . . than were possessed by an ordinary mechanic acquainted with the business, there was an absence of that degree of skill and ingenuity which constitute essential elements of every invention. In other words, the improvement is the work of the skillful mechanic, not that of the inventor.”

The Hotchkiss test laid the cornerstone of the judicial evolution suggested by Jefferson and left to the courts by Congress. The language in the case, and in those which followed, gave birth to “invention” as a word of legal art signifying patentable inventions.

Graham v. Deere

Petitioners sued for infringement of a patent, consisting of a combination of old mechanical elements, for a device designed to absorb shock from plow shanks in rocky soil to prevent damage to the plow.

Petitioners claim that the small difference in flex effectively absorbs the tremendous forces of the shock of obstructions.

Court held that “person having ordinary skill in the prior art would immediately see that the thing to do was what Graham did.”

Holding that the patent did not fulfill the non-obviousness requirement the Court laid down that obviousness should be determined by looking at:

  1. the scope and content of the prior art;
  2. the level of ordinary skill in the art;
  3. the differences between the claimed invention and the prior art; and
  4. objective evidence of non-obviousness.

KSR v. Teleflex

Teleflex sued KSR for infringement of its patent for adjustable pedal assembly with electronic throttle control.

The court sought to resolve the question of non-obviousness with more consistency and has applied the TSM test.

If the inventive step or technique used to improve one’s device is recognizable by a person skilled in the art, the non-obviousness criterion is not fulfilled.

Thus PHOSITA plays a crucial role in determining non-obviousness of an invention. Extrapolating this legal fiction’s role into doctrine of equivalents, if a person with ordinary skill in the art could have known of the interchangeability of an ingredient not contained in the patent with one that was, infringement under doctrine of equivalents can be established.

The only difference in the role of PHOSITA between the two scenarios is the timing. The non-obviousness question is raised before the issuance of a patent while the question of interchangeability arises at the time of infringement.

Reverting back to the case on hand, BPAI misinterpreted the role of PHOSITA and the written description and enablement requirement. The question is not whether PHOSITA could envision the conversion from precursor form to mature form of hFIF or not. It was whether the written description accompanying the patent application can actually convey to PHOSITA that the applicant is in possession of the method of conversion from precursor to mature hFIF. Sugano’s Japanese application fails to describe the exact method of converting from precursor form to mature form of hFIF.

BPAI must not undermine the importance of precedents in construing the function of PHOSITA. Courts at various levels have at various times highlighted the non-obviousness requirement and PHOSITA’s function and how the two are to be determined. One would do well to heed these decisions.

Today’s post is by Guest Barista Shalini Menezes of D:ic.t:um.

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Fellow bloggers J. Matt Buchanan ( and Stephen M. Nipper ( are joining forces to create a new law firm Buchanan Nipper LLC.

In 2008, Matt opened the doors to his new firm, Buchanan Intellectual Property Office LLC (BIPO). Steve has been with Dykas, Shaver & Nipper, LLP in Idaho.

The new firm is set to open October 1, 2010.

Best wishes Matt & Steve!

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