MVS Filewrapper® Blog: Supreme Court Defines Scope of Definiteness Required in Patent Claims

Today the U.S. Supreme Court issued its decision in Nautilus, Inc. v. Biosig Instruments, Inc. defining the standard for definiteness necessary to meet the requirements of 35 U.S.C. Section 112, second paragraph.  The decision unanimously rejected the "insolubly ambiguous" standard previously employed by the Federal Circuit to determine whether patent claims meet the statutory requirement to "particularly point out and distinctly claim the subject matter which the applicant regards as the invention."

The dispute between the two exercise equipment manufacturers Nautilus Inc. and Biosig Instruments Inc. related to heart rate monitors patented by Biosig in 1994. Biosig accused Nautilus of infringing its patented heart rate monitors in exercise equipment (such as treadmills). Nautilus alleged the Biosig patent was invalid due to "indefiniteness" of its claims. The U.S. Court of Appeals for the Federal Circuit ruled in favor of Biosig finding its patent to be valid, concluding the claimed term "spaced relationship" of electrodes measuring a user's heart rate was sufficiently described as to be understood by a person of ordinary skill in the art to which the invention pertains. The U.S. Supreme Court reversed this decision, finding the Federal Circuit's standard for permitting vaguely written claims—so long as they are not "insolubly ambiguous"to be insufficient for informing skilled artisans about the scope of an invention when reviewing claim language. The dispute between the companies has now been remanded back to the Federal Circuit for reconsideration; however, it is unclear whether the outcome of the infringement decision will ultimately change upon application of the definiteness standard set forth by the Court. 

The test set forth by the Court to determine whether a patent is invalid for indefiniteness is as follows: a claim is indefinite if, when read in light of the specification of the patent (and the prosecution history) "fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention." (Emphasis added). Therefore, the standard for meeting the written description requirement mandates that claims provide "reasonable certainty" to skilled artisans. This overturns the standard previously employed by the Federal Circuit which only required that a claim is "amenable to construction" and is not "insolubly ambiguous."

The decision provides clear incentive for patent drafters to eliminate 'zones of uncertainty' or ambiguity from patent claims. Such incentive is provided in the form of the Court's criticism of drafting and patent examination that results in ambiguity relating to claim terms or scope.

A complete copy of the opinion can be found here.

MVS Filewrapper® Blog: Supreme Court Issues Indefiniteness and Inducement Decisions

The Supreme Court this week issued its decisions in two much anticipated IP cases.  The Court's decision in Limelight Networks v. Akamai Tech. concludes that at least one underlying act of direct patent infringement must be present for a claim of inducement of infringement.  In Nautilus v. BioSig the Court instituted a new standard for indefiniteness, supplanting the existing "insolubly ambiguous" standard. 

 

The full opinions can be found here and here.  More thorough analyses of these cases will follow shortly.   

MVS Filewrapper® Blog: "Insolubly Ambiguous" Standard not Applicable at the USPTO

In In re Packard the Federal Circuit held that the USPTO need not follow the insolubly ambiguous standard in order to satisfy a prima facie rejection for indefiniteness.  Rather, the Federal Circuit held that

when the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claims claim as [indefinite]. 

(emphasis added).  The Federal Circuit tempered this holding by citing to Georgia-Pacific Corp. v. U.S. Plywood Corp., 258 F.2d 124, 136 (2d Cir. 1958), stating,

At the same time, this requirement is not a demand for unreasonable precision.  The requirement, applied to the real world of modern technology, does not contemplate in every case a verbal precision of the kind found in mathematics. . . .  Rather, how much clarity is required necessarily invokes some standard of reasonable precision in the use of language in the context of the circumstances.

 The patent application on appeal (Serial No. 12/004,324) was directed to a coin change holder shown in Figures 1 and 2 above.  Claims 28 through 37 were on appeal—claims 1 through 27 were cancelled during prosecution.  Claim 28 is representative of the issue on appeal:

28.       I claim a small, thin, flat plane, rectangular change holding card and wallet/billfold or purse construction with the front top side of the card comprising three raised, straight, parallel, double flanged separators and two raised, straight, parallel, double flanged side edges and a raised side edge end thereby forming four parallel, side by side, flanged coin holding channels or rows of the same length and of different widths, one for quarters, one for dimes, one for nickels, and one for pennies, that are similarly blocked at one side edge by the raised side end edge with the other side of the channel/rows open except for small, fixed, flexible, partially moveable, rubber or plastic retainers that are attached to the topside and ends of the double flanged separators such that coins can be retained on the card and yet slide freely above the surface of the card and obliquely overlap as necessary within the channel/rows between the separators while the bottom, back side of the card is constructed with a wallet, billfold or purse extending from it.

The Examiner rejected the claim as indefinite for lack of written description and as obvious.  The Examiner asserted that multiple limitations were indefinite for lacking antecedent basis or "were otherwise unclear."  Mr. Packard appealed to the Patent Trial and Appeal Board (PTAB).  The PTAB affirmed the rejection citing MPEP § 2173.05(e) which states, "[a] claim is indefinite when it contains words or phrases whose meaning is unclear."  Mr. Packard appealed the PTAB's decision to the Federal Circuit.  On appeal, Mr. Packard argued that the test applied by the PTAB, as set forth in the MPEP, fails to meet the insolubly ambiguous standard articulated by the Federal Circuit. 

The Federal Circuit noted that no case had previously addressed the question presented by this case—"what standard for indefiniteness should the U.S. Patent and Trademark Office apply to pre-issuance claims." The Federal Circuit made clear that a different standard applies to pre-issuance claims (i.e. patent applications under prosecution) that to post-issuance claims (i.e. when an issued patent is being challenged).  Further, the Federal Circuit noted a basis for its decision is that "Congress assigned to the USPTO the responsibility to examine applications to ensure compliance with the statutory criteria for issuance of a patent."  Thus, "indefiniteness rejections by the USPTO arise in a different posture from that of indefiniteness challenges to an issued patent."  

MVS Filewrapper® Blog: 2014 Supreme Court Cases Relating to Intellectual Property

On January 10, 2014 the Supreme Court agreed to review a variety of intellectual property cases in the upcoming session, including two patent cases, a copyright case, and a trademark case (including Lanham Act claim).  A brief overview of these cases is provided and more detail will be available once decisions are entered by the Court.

Limelight Networks, Inc. v. Akamai Technologies, Inc. (U.S., No. 12-786.)

Question Presented to the Supreme Court: Whether the Federal Circuit erred in holding that a defendant may be held liable for inducing patent infringement under 35 U.S.C. § 271(b) even though no one has committed direct infringement under § 271(a).

The Federal Circuit dismissed the “single-entity” rule for finding induced infringement of a method/process claim, finding that steps taken by multiple parties can result in induced infringement. The Federal Circuit stated, “To be clear, we hold that all the steps of a claimed method must be performed in order to find induced infringement, but that it is not necessary to prove that all the steps were committed by a single entity.” If the Supreme Court upholds the Federal Circuit’s ruling, a patentee has increased opportunity to assert induced infringement for method/process claims in the marketplace.

Nautilus, Inc., v. Biosig Instruments, Inc. (U.S., No. 13-369)

Question Presented to the Supreme Court: Does the Federal Circuit’s acceptance of ambiguous patent claims with multiple reasonable interpretations—so long as the ambiguity is not “insoluble” by a court—defeat the statutory requirement of particular and distinct patent claiming? Does the presumption of validity dilute the requirement of particular and distinct patent claiming?

The Federal Circuit reversed a district court decision that a patent claim to a heart rate monitor was invalid for indefiniteness as a matter of law because of its use of the claim term “spaced relationship” in describing the positioning of two electrodes with respect to each other. The Court held that this claim term was not one that is “insolubly ambiguous” when the intrinsic evidence is considered from the perspective of a person of skill in the art. It considered the functionality of the claimed monitor, as described in the specification, as did the USPTO when the claim was under reexamination. “[T]he claims provide inherent parameters sufficient for a skilled artisan to understand the bounds of ‘spaced relationship.’” Judge Schall concurred in the result but would have used a more narrow analysis, explaining that he would not have used the functional limitation to address the definiteness issue.

 

POM Wonderful LLC v. The Coca-Cola Company, U.S. (No. 12-761)

Question Presented to the Supreme Court: Whether the court of appeals erred in holding that a private party cannot bring a Lanham Act claim challenging a product label regulated under the Food, Drug, and Cosmetic Act.

The case arising out of the 9th Circuit resulted in affirming judgment in favor of Coca-Cola, finding that POM's Lanham Act challenge to Coca-Cola’s “Pomegranate Blueberry” name was barred under the Food Drug and Cosmetic Act (FDCA).  Applicability of Section 43(a) of the Lanham Act, 15 U.S.C. 1125(a) (authorizing actions of false/misleading description of goods), The FDCA and/or state law claims will be addressed.

American Broadcasting Companies, Inc. v. Aereo, Inc. (U.S., No. 13-461)

Question Presented to the Supreme Court: Does a company “publicly perform” a copyrighted television program when it retransmits a broadcast of that program to thousands of paid subscribers over the Internet?

The Second Circuit denied reviewal of a panel decision that online streaming of TV programs to individual subscribers is not an infringing public performance. The panel found that the creation of a copy of a broadcast that is transmitted to individual subscribes failed to establish infringement as streaming “to the public.”

MVS Filewrapper® Blog: Bring on the New Year—What is in Store for IP in 2014?

Happy New Year to all of our FilewrapperÒ followers! We hope 2013 was a productive year and wish you the best in 2014. As the New Year quickly approaches we would like to share with you a few predictions for 2014 for you to look forward to and for which to prepare!

·         Increased opportunities for quasi-litigation under AIA.  Various new mechanisms are available to challenge patents under the America Inventors Act (also referred to as “AIA” or “Patent Reform”) many provisions of which took effect in 2013. New strategies are available to challenge patents at the USPTO instead of challenging in court, providing distinct advantages—and some disadvantages.  Inter Partes Review, Post-Grant Review and transitional programs specific for business method patents are quasi-litigation proceedings which are heard by a panel of USTPO administrative law judges.  Ex Parte Reexamination—which has been available since 1981—also remains to allow a patent challenge to be heard by a patent examiner, requiring little from the challenger other than filing required papers with some evidence of patent invalidity.  The cost for ex-parte reexamination has significantly increased, although it remains a far less expensive option than litigation with the courts.

·         (Finally) an international design patent application is available!  Design patents protect a product’s new, original and ornamental design.  Design patents present a smart option for investment in protecting a product, since they cost significantly less than utility patents and are generally granted at a much faster rate.  In addition to these benefits of filing design patents, changes in international design registration under the Hague Agreement may facilitate more effective international protection for your design inventions.  Effective December 18, 2013 a single international application designating a variety of countries for protection can be filed through the International Bureau of WIPO.  This is beneficially a single international application to be filed at one location, which will ultimately be examined by many different Offices thereafter to provide more prompt and cost effective options for design protection.  Over 60 countries and territories—including the European Union—are members of the Hague Agreement.  However, there are various countries that are excluded from this treaty (e.g. Australia, Canada, China, Mexico, Japan, India, and Brazil), which would require a separate application as has been done in the past for foreign design patents.  Nonetheless, the Hague Agreement provides significant improvements for international design protection.

·         (Some USPTO) Fees Decrease January 1, 2014.  In addition to the new classification of “micro-entity” status for Applicants to receive 75% reduction of some USPTO fees that took effect in 2013, the New Year also brings certain fee reductions.  Notably, Issue Fee payments for granted patents are substantially reduced (from $1,780 to $960 for large entity), along with the removal of publication fees and assignment recordation fees.  Reissue patent, design patent and plant patent issue fees are also decreasing.  In addition, in 2014 certain PCT fees will be eligible for payment under small and micro entity status.

·         The search continues for a test to determine patentable subject matter under §101.  The Supreme Court will hear CLS Bank v. Alice in 2014 after the Federal Circuit’s en banc decision in 2013 found many software patents to be ineligible.  The Supreme Court will again try to define an abstract idea in considering whether claims to a computerized method (using a computer-readable medium and a computer to implement instructions) is patentable subject matter.  Both the Federal Circuit and patentees are still searching for a test under §101 that is “consistent, cohesive, and accessible [to provide] guidance and predictability for patent applicants and examiners, litigants, and the courts.”

·         We may receive further guidance on Claim Indefiniteness.  The Supreme Court is expected to grant certiorari on Nautilus v. Biosig Instruments involving indefiniteness under §112, second paragraph to determine whether claims having multiple reasonable interpretations are too ambiguous and would render a patent unenforceable for lack of written description.

·         Protecting American from “Patent Trolls.”  As previously reported on FilewrapperÒ, there is legislative movement in the House and Senate to limit lawsuits which can be filed by non-practicing entities (NPEs or Patent Trolls).  There seems to be great energy around limiting “frivolous” lawsuits in our court system.  In early 2014, the Senate will consider a companion bill to Senate 1720 ("Patent Transparency and Improvements Act of 2013"), which is said to already have support from the White House.  If legislation passes the Senate, then the House and Senate bills will need to be reconciled before being sent to the President.

·         New Patent Director.  Stay tuned for further administrative changes at the USPTO as the new Director, Michelle Lee, takes office January 13, 2014. The former Google executive has been made deputy director of the USPTO, and in that capacity will take on the duties of acting director.  Lee has issued statements planning to “attack” the backlog of unexamined patents (remains at more than 500,000) and improve patent quality with improved inter partes review.

MVS Filewrapper® Blog: Intrinsic Evidence Can Provide Adequate Support to Overcome Indefiniteness

In Biosig Instruments, Inc. v. Nautilus, Inc., the Federal Circuit reversed a decision by the U.S. District Court for the Southern District of New York finding a patent invalid for indefiniteness, relying on intrinsic evidence.  Biosig Instruments, Inc. (“Biosig”) is the assignee of U.S. Patent No. 5,337,753 (“the ’753 patent”).  The ’753 patent is directed to a heart rate monitor for use with exercise equipment and exercise procedures.  Biosig sued Nautilus, Inc. (“Nautilus”) for patent infringement alleging that claims 1 and 11 of the ’753 patent were infringed by Nautilus’s exercise equipment that has a mounted heart rate monitor. 

In the late 1990s, Biosig was in negotiations with Stairmaster Company—Nautilus’s predecessor—regarding Biosig’s patented technology, but the companies failed to reach an agreement.  Stairmaster, and eventually Nautilus, started to sell exercise equipment with mounted heart rate monitors.  Biosig sued Nautilus in August 2004, alleging that the equipment infringed its patent.  Following reexaminations and re-filed patent infringement suits, the District Court for the Southern District of New York eventually conducted a Markman hearing on the asserted claims of the ’753 patent in September 2011.  Among the terms the court construed was the term “spaced relationship.”  The district court construed the term to mean that “there is a defined relationship between the live electrode and the common electrode on one side of the cylindrical bar and the same or a different defined relationship between the live electrode and the common electrode on the other side of the cylindrical bar.”  Following the district court’s claim construction, Nautilus moved for summary judgment of non-infringement and invalidity for indefiniteness.

In February 2012, the district court ruled on the summary judgment motions, denying the motion for summary judgment of non-infringement and granting the motion for invalidity based on indefiniteness.  The district court’s holding of invalidity for indefiniteness was founded on the conclusion that the term “spaced relationship” was ambiguous, despite the fact that the court had construed the term in its Markman order.  Biosig appealed the district court’s grant of summary judgment, with the sole issue on appeal being the indefiniteness of “spaced relationship.” 

On appeal, the Federal Circuit’s analysis began with a summary of the standards of indefiniteness, stating “[a] claim is indefinite only when it is ‘not amenable to construction’ or ‘insolubly ambiguous.’”  The Court went on to discuss words of degree, for which “the court must determine whether the patent provides ‘some standard for measuring that degree.’”  In this instance, the Court concluded that the term was not indefinite, as it “was amenable to construction,” whereas “indefiniteness . . . would require a showing that a person of ordinary skill would find ‘spaced relationship’ to be insolubly ambiguous—that it fails to provide sufficient clarity delineating the bounds of the claim to one skilled in the art.”  The Federal Circuit specifically relied on the intrinsic evidence that the district court used in construing the term in its Markman order.  In doing so, the Federal Circuit noted that the specification described the “spaced relationship” of the electrodes in terms of their function, and cited the evidence submitted during the reexamination, including a declaration by the inventor, used to traverse a rejection by the USPTO.  In light of the specification and intrinsic evidence, the Federal Circuit held that the term “spaced relationship” was not indefinite; and therefore, that the grant of summary judgment was in error.  Accordingly, the Federal Circuit reversed the district court’s invalidity determination and remanded the case for further proceedings.

MVS Filewrapper® Blog: New and Useful - February 21, 2013

·         In U.S. Polo Assoc., Inc. v. PRL USA Holdings, Inc., the Second Circuit Court of Appeals found that the natural zone of expansion doctrine did not permit the United States Polo Association (“USPA”) to expand its offerings into a line of fragrances and affirmed the district court’s entry of a permanent injunction prohibiting such use.  The USPA filed a declaratory judgment to approve use of its Double Horseman mark, accompanied by the words “U.S. POLO ASSN.,” “USPA,” and/or “1890,” in the sale of men’s fragrances.  PRL counterclaimed, seeking entry of a permanent injunction precluding such use—which the district court granted.  USPA’s argument was centered on the, so called, natural zone of expansion doctrine.  USPA argued that its history of selling branded apparel provided it with the right to expand into related markets, i.e., apparel sales give rise to the right to expand into fragrances.  The district court gave little weight to USPA’s survey and found that PRL’s survey gave strong evidence of a likelihood of confusion.  The Second Circuit found that the district court’s holdings regarding the survey evidence did not abuse its discretion and that the previous litigation and USPA’s history did not support USPA’s argued natural right to expand.

·         In Function Media, L.L.C. v. Google, Inc., the Federal Circuit Court of Appeals held that the denial of a pre-trial motion for summary judgment of non-infringement is not sufficient to show that the district court delegated claim construction to the jury.  Function Media (“FM”) sued Google for infringement of three patents directed at “facilitate[ing] advertising on multiple advertising outlets such as newspapers and websites.”  Slip op. at p. 2.  The district court held that one patent was invalid for being indefinite “because the specification did not disclose sufficient structure for its sole independent claim’s means plus function term ‘means for transmitting.’”  Id. at pp. 5–6 (citations omitted).  A jury found the asserted claims in other two patents invalid and not infringed.  FM moved for judgment as a matter of law (“JMOL”) that the claims were not invalid, which the district court granted with respect to four claims.  This did not alter the jury verdict of non-infringement. 

FM appealed on a number of grounds, including an assertion that the district court gave the claim interpretation to the jury.  The argument was based on the fact that the district court denied Google’s motion for summary judgment of non-infringement. FM argued that the denial of summary judgment demonstrated that there were unresolved issues regarding claim scope, which were subsequently left to the jury rather than construed by the court.  The Federal Circuit did not agree that the district court improperly gave the claim interpretation to the jury, the Federal Circuit stated, “We hold that the denial of a pre-trial motion for summary judgment of non-infringement does not, by itself, show that the district court delegated claim construction to the jury.  This is especially true where, as here, the jury was instructed to apply the district court's claim constructions.”  Id. at pp. 21–22. 

·         In Cephalon, Inc. v. Watson Pharma., Inc. , the Federal Circuit Court of Appeals reversed a district court’s holding of invalidity for lack of enablement stating, “Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention.”  Slip op. at p. 2.  Throughout the discussion of enablement, the Federal Circuit highlighted that the burden is on Watson to show lack of enablement—undue experimentation—and to do so by clear and convincing evidence.  The district court’s analysis was that, “the disclosures lacked teachings directed to formulating and co-administering two separate dosage forms . . . to achieve an effervescent reaction.  The lack of disclosure of such methods of co-administration would, according to the court, necessitate undue experimentation to practice the invention.”  Id. at p. 11 (citations omitted).  Watson merely provided “[u] nsubstantiated statements indicating that experimentation would be ‘difficult’ and ‘complicated.’”  Id. at pp. 15–16.  The Federal Circuit found that these statements did not meet the standard of clear and convincing evidence to establish undue burden as opposed to reasonable experimentation.  As such, the Federal Circuit reversed the district court’s holding of invalidity and remanded.

·         The United States Patent and Trademark Office published the final rules and guidelines governing First-Inventor-to-File.  (http://www.uspto.gov/news/pr/2013/13-10.jsp)  There were two separate Federal Register publications and each is briefly discussed below.  A more thorough discussion of each is forthcoming.

o   Changes to Implement First Inventor to File Provisions of Leahy-Smith America Invents Act

This publication sets forth the changes that will be necessary to implement the First-Inventor-to-File standards.  It addresses changes regarding each of the following:

§  The addition of definitions in the AIA to the rules of practice;

§  The submission of affidavits or declarations regarding:  disclosures in priority disputes under the first-to-file standards and prior public disclosures;

§  Standards regarding a U.S. Patent or Published Applications having a prior art effect as of the filing date of a foreign priority application;

§  Elimination of the provisions regarding statutory invention registrations; and

§  Adoption of requirements for nonprovisional applications filed on or after March 16, 2013, that claim priority to or the benefit of the filing date of an application filed prior to March 16, 2013.

o   Examination Guidelines for Implementing First Inventor to File Provisions of Leahy-Smith America Invents Act

This publication sets forth the changes the changes to the examination guidelines under the First-Inventor-to-File standard.  The publication is also meant to clarify and respond to questions provided during the public comment period regarding whether there is a requirement that the mode of disclosure by an inventor or joint inventor be the same as the mode of disclosure of an intervening disclosure.

Federal Circuit reaffirms anticipatory reference must have all elements as arranged in the claim

In a recent decision, the Federal Circuit affirmed a district court's finding of indefiniteness but reversed the district court's holding of anticipation of other claims.  The district court held the means-plus-function limitations did not have corresponding structure disclosed in the specification, rendering them indefinite, and that the combination of two examples in a prior art publication anticipated the remaining asserted claims.

The Federal Circuit agreed the means-plus-function limitations were indefinite.  The limitations were computer-implemented, which means to be definite, the specification must disclose "more than simply a general purpose computer or microprocessor," but instead must disclose "the special purpose computer programmed to perform the disclosed algorithm."  There was no such disclosure here, so the Federal Circuit held the claims were correctly held indefinite.

Regarding anticipation, however, the court reaffirmed its previous cases holding in order to anticipate, it is not enough for all elements of the claim to be disclosed in a single reference.  All the elements must also be disclosed as arranged in the claim.  Here, the claim elements were spread across two different examples given in the allegedly anticipatory reference, so the Federal Circuit reversed the district court's summary judgment of anticipation because the reference did not disclose the elements as they were arranged in the claim.

More detail of Net MoneyIN, Inc. v. VeriSign, Inc. after the jump.

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High materiality without explanation for nondisclosure leads to inference of intent to deceive

In a recent decision, the Federal Circuit affirmed a district court's finding of inequitable conduct for one patent but reversed on a second, affirmed a finding of no invalidity of the second patent, but vacated the finding of infringement after modifying the district court's claim construction of a claim term.  The court also reversed the finding of indefiniteness of a third patent.

The court continued its recent discussions of when (if ever) an inference of intent to deceive is permissible to support an inequitable conduct finding where there is no independent evidence of such intent.  Here, the majority affirmed the district court's inference of intent based on high materiality, proof of knowledge of the withheld art, and a lack of credible explanation for the nondisclosure.  Judge Lourie dissented, arguing the majority conflated intent with materiality.  Given the apparent disagreement  on this issue, a case presenting the issue of when (or whether) such an inference is permissible seems to be a candidate for en banc review.

More detail of Praxair, Inc. v. ATMI, Inc. after the jump.

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No evidence of intent to deceive, no inequitable conduct

In a recent decision, the Federal Circuit reversed a district court's grant of summary judgment of inequitable conduct against the patentee.  At issue was whether the patentee's failure to disclose a letter describing an aspect of the prior art constituted inequitable conduct.  The court reversed finding that the alleged infringer had failed to provide sufficient facts to support an inference of intent to deceive.

The defendant's theory involved a plan by the patentee to switch law firms once it appeared the first firm intended to disclose the letter, and preventing the second firm from discovering the existence of the letter.  The opinion provided a clear look of how the Federal Circuit will analyze inequitable conduct.  The court teed up its analysis by stating:

To successfully prove inequitable conduct, the accused infringer must present "evidence that the applicant (1) made an affirmative misrepresentation of material fact, failed to disclose material information, or submitted false material information, and (2) intended to deceive the [PTO]."  Further, at least a threshold level of each element -- i.e., both materiality and intent to deceive -- must be proven by clear and convincing evidence.  And even if this elevated evidentiary burden is met as to both elements, the district court must still balance the equities to determine whether the applicant's conduct before the PTO was egregious enough to warrant holding the entire patent unenforceable.  Thus, even if a threshold level of both materiality and intent to deceive are proven by clear and convincing evidence, the court may still decline to render the patent unenforceable.

Most important to the court was that an accused infringer proves threshold levels of intent to deceive the PTO and materiality with clear and convincing evidence. The clear and convincing standard requires that the evidence be strong enough to show that an inference of intent to deceive is the "single most reasonable inference able to be drawn from the evidence."  In this case, there was simply "no evidence, direct or indirect," to support the inference the defendant sought to draw.  As a result, the finding of inequitable conduct was reversed.

More on Star Scientific, Inc. v. R.J. Reynolds Tobacco Co. after the jump.

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