Public & Experimental Use: Reduction to Practice Requires Knowledge that Invention Works for Intended Purpose

In re Omeprazole Patent Litigation (Fed. Cir. 2008)

The CAFC has affirmed a lower court trial finding that AstraZeneca’s Prilosec (omeprazole with an enteric coating and a subcoating) patents are infringed by the ANDA filings of Apotex, Torpharm, and Impax. (See U.S. Patent Nos. 4,786,505 and 4,853,230). This complex consolidated case has been handled by Judge Jones of the Southern District of New York. The case includes several important procedural issues, but here I focus on public use.

Public Use of a Pharmaceutical Formulation: Under 35 U.S.C. § 102(b), a patent will be considered invalid if the invention was “in public use” more than one year before the filing date. (i.e., before the “critical date”). The use in question was Astra’s large clinical trials used to test its omeprazole formulation. The district court ruled for Astra on two separate grounds: First that the clinical trials were an “experimental use” and therefore cannot qualify as public uses and second that the formulation was not yet ready for patenting until after the trials were completed.

Experimental Use and Reduction to Practice: In a series of cases over the past decade, the Federal Circuit has made clear that the experimental use defense “cannot negate a public use” that occurs after the invention is reduced to practice. At the same time, public use now requires proof that an invention is “ready for patenting” which generally requires reduction to practice (or at least being enabled to practice). For the most part, this rather new interpretation of public use subsumes the experimental use defense.

Here, the pills had been manufactured and were being used by clinical subjects. However, there were not “reduced to practice” because RTP requires knowledge “that the invention would work for its intended purpose.” On appeal, the Federal Circuit refused to overturn the lower court’s factual findings – instead agreeing the formulation was not reduced to practice because the company lacked experience of how it would perform clinically:

[Astra’s expert witness] testified that as of May 1983 the Astra scientists did not have enough information to satisfy themselves that the Phase III formulation would work for its intended purpose. Instead, he testified that the Astra scientists thought the Phase III formulation “had a good possibility to be used as a marketing drug” but that the team did not have long-term stability data and had “no experience of how it performed in clinical studies.”


The Astra scientists had long understood that omeprazole could provide a safe and effective treatment for certain gastrointestinal diseases. The challenge they faced was developing a formulation to deliver omeprazole to the small intestine, a challenge that was made difficult by omeprazole’s sensitivity to acidic environments, such as the stomach. Impax has not demonstrated that, without conducting the Phase III clinical tests, the inventors knew that the Phase III formulation would achieve the goals of long-term stability and in vivo stability such that it would be effective as a treatment for gastrointestinal disease.

Because the efficacy of the formulation was not reduced to practice, its use could not be a public use.


  • Of interest here is the idea that reduction to practice requires knowledge that the invention will work for its “intended purposes.” The specification of these patents detail the need for stability, so that purpose is clear. Because “purposes of the invention” have been used to limit claim scope, many modern patent applications don’t include such information. In those cases, will the purpose be found in extrinsic evidence?
  • The court here focused on reduction to practice to fulfill the “ready for patenting” prong of the public use analysis. Seemingly, the defendants may have had a better shot trying to show ready for patenting based on evidence that “prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.”

Patent Assignment Must be in Writing; But Some Transfers are not Assignments

PatentLawPic260Akira Akazawa v. Link New Tech (Fed. Cir. 2008).

Yasumasa Akazawa was the inventor and owner of a patent covering a new way to change engine coolant. When he died intestate in 2001, his wife and daughters inhereted his entire estate. The daughters then transferred their interest to the mother, and the mother assigned the patent to Akira Akazawa. Akira Akazawa then sued New Link for infringement.

The question on appeal is whether Akira Akazawa properly holds title (because of the non-written intestate transfer).

35 USC §261 has been interpreted to require that patent assignments be in writing. “Applications for patent, patents, or any interest therein, shall be assignable in law by an instrument in writing.”  Thus, New Link questions whether the intestate transfer of rights satisfies the writing requirements of Section 261.

The CAFC rejected this argument — holding that although ASSIGNMENTS must be in writing, there are other means of transfering patent ownership that need not be in writing. In particular, transfer through “operation of law” need not be in writing under the statute.

On remand, the district court must determine whether, under Japanese intestate law, the title to the patent properly transferred as an operation of law – or whether an assignment was necessary.

If the district court concludes that the ‘716 patent was transferred to [the heirs] upon Yasumasa’s death, then the subsequent transfers between [the heirs] and Akira conveyed ownership of the ‘716 patent to Akira. If, however, the district court concludes that under Japanese law the ‘716 patent was transferred to the estate of Yasumasa which then fell under the control of an administrator or executor, a written assignment in accordance with § 261 may then be necessary to convey the patent from the estate to Yasumasa’s heirs.

Vacated and remanded.


CAFC Reaffirms that Doctrine of Equivalents Applies to Ranges

US Philips v. Iwasaki (Fed. Cir. 2007)

Philips sued Iwasaki for infringement of its patents covering mercury-tungsten halogen light. The district court awarded summary judgment of non-infringement to Iwasaki.

Vitiation and the Doctrine of Equivalents: The asserted patent claims a target concentration of 1.6 ± 0.4 × 10-4 µmol/mm3. Based on that claim language, the district court ruled that the claim was “intended to establish the demarcation of boundaries [with] the type of precision that is closely analogous to the metes and bounds of a deed of real property.”  Thus, according to the court, allowing the claim to cover any concentration outside of the clearly claimed limits would vitiate the limitation.

On appeal, the CAFC rejected the notion that an expanded numerical range would vitiate the claim language.

“A reasonable juror could make a finding that a quantity of halogen outside that range is insubstantially different from a quantity within that range without “ignore[ing] a material limitation” of the patent claim.”

This decision conforms to prior decisions that allow equivalents for numerical ranges, but not for other limits (such as a claimed “majority.” Moore).

Notice of Infringement: 35 U.S.C. § 287(a) provides that damages for patent infringement only begin to accrue once the infringer was “notified of the infringement.” (Marking constitutes constructive notice). Notice requires a charge of infringement directed to a specific product, device, or action. The notice must also normally include the patentee’s identity. Here, the infringement letter (sent by “Mr. Rolfes”) did not specifically indicate that Philips was the assignee, but the court found notice sufficient because (1) Philips was correctly listed as the assignee of the patent and (2) Philips had granted the sending party the “responsibility for licensing and enforcing” the patent. Thus, Philips may collect damages from the date of receipt of the letter.


  • Rounding in Claim Construction: “‘1.0’ may be said to have more significant digits than ‘1’ with no decimal point. Because [the claimed] ‘10-6’ and ‘10-4’ are simply the numbers 0.000001 and 0.0001 expressed as powers of ten, the claim language provides no basis for inferring any level of precision beyond the single digit ‘1.’ The way that power-of-ten quantities are used in the specification, discussed supra, confirms that the quantities of halogen described by the claims are not intended to be more precise.” — Why does this matter — Less precision means that the accused product may still literally infringe due to rounding.
  • Approximately: “[T]erms like ‘approximately’ serve only to expand the scope of literal infringement, not to enable application of the doctrine of equivalents.”

Bayh-Dole Act is Not a “Patent Law” Sufficient to Create CAFC Jurisdiction

ScreenShot065WARF v. Xenon Pharmaceuticals (Fed. Cir. 2007) (nonprecedential opinion).

In 2006, WARF won a $1 million verdict in a breach of contract case against Xenon. Although contracts are normally issues of state law, WARF’s original complaint also raised technology transfer issues under the Bayh-Dole Act. (35 U.S.C. §§ 200, et seq.).

On appeal, the CAFC found that it lacked subject matter jurisdiction over the appeal because it did not arise under the patent laws. In this vein, the court first concludes that Bayh-Dole’s inclusion in Title 35 does not necessarily indicate that it is a “patent law.” Rather, the general rule is that contract or licensing disputes do not implicate patent laws unless they require some determination of patent issues such as validity or infringement.

“[M]ere inclusion in Title 35 of the United States Code does not make a statute a patent law under which a claim may arise. At its heart, the Bayh-Dole Act concerns government funding agreements – contracts in the language of 35 U.S.C. § 201 – an area that is outside our section 1295(a) jurisdiction.”

Of course, if Title 35 contains non-patent laws, it makes sense that there may also be patent laws not found in Title 35.

Even if Bayh-Dole was a “patent law,” the appellate panel found that it would still not have jurisdiction over the case because the provisions of Bayh-Dole (1) did not create WARF’s cause of action and (2) are not necessary to determine any other rights of relief.

Case transferred to the Seventh Circuit Court of Appeals.

Enablement: Claimed “surfactant” not enabled by three working examples

Par Pharmaceuticals v. Roxane Labs (Fed. Cir. 2007) (Nonprecedential)

Par’s megestrol acetate suspension is prescribed to people who lose their appetites — often during treatment for cancer or AIDS. Interestingly, the company created this popular drug while attempting to design around a megestrol patent owned by BMS.

After obtaining patent protection, Par sued Roxane for infringement. The district court, however, granted summary judgment of invalidity under 35 USC 112 ¶ 1 — finding that “Par is not entitled to the broad claims it asserts.”

Enablement analysis begins with the presumptions that an issued claim is enabled and that a challenge to enablement requires clear and convincing evidence.  Unlike its close analog written description, enablement is reviewed by the CAFC on a de novo basis.

A claim is enabled when a PHOSITA can make and use the claim without undue experimentation. Broader claims, of course, require broader disclosure to ensure that their “full scope” is enabled. The unpredictable nature of an area of technology often serves patentees well as they argue non-obviousness. (It cannot be obvious if the results could not have been predicted). However, the enablement requirement demands more disclosure for unpredictable arts.

Broad Claims: Here, Par’s claim includes the following elements: “(a) megestrol acetate; … and (c) a surfactant.”  The CAFC finds this claim very broad because it would “allow the choice of any surfactant in any concentration.” (emphasis in original). In its disclosure, Par described three working examples and only one new surfactant. As a matter of law, the CAFC found that “these three working examples do not provide an enabling disclosure commensurate with the entire scope of the claims.”


  • This opinion, drafted by Judge Moore may begin to provide some indication of her style.
  • Does this make sense: Because the applicant broadly claimed “a surfactant,” the specification must enable various types of surfactants. If, the claim had been written even more broadly — by eliminating that limitation — there would have been no need to include a description of various types of surfactants.

CAFC Continues to Support Strong State Immunity from Patent Infringement

BPMC v. California Department of Health (Fed. Cir. 2007).

There is a reason why states generally support strong patent rights: States are increasingly major patent holders – based on inventions developed through federal grants. At the same time, states are generally immune from being sued for infringement. In this case, the CAFC allows the State of California to assert immunity based essentially on a case-numbering technicality.

The facts are simple: Kaiser filed a declaratory judgment action against the patent holder BPMC back in 1997. The California DOH intervened in that case — an action generally considered a waiver of immunity. That case was dismissed for improper venue. In 2006, BPMC filed an identical (mirror image) infringement action against the DOH asserting the identical patent and issues and in the same venue as the 1997 action. The issue here is whether the waiver in the original case of California’s 11th Amendment immunity applies also to the new case. 

Here, the CAFC narrowly construed the state’s waiver of immunity to be strictly limited to the same action. The court noted precedent that the waiver would apply if BPMC had been able to file its case as a revival of the original action an “numbered as that cause of action.”

The appellate panel also rejected BPMC’s argument that the DOH should be judicially estopped from changing its position in this litigation. According to the court, the about-face was excusable because of an intervening change in the law of immunity. (Florida Prepaid). 

Expect that this case will receive a petition for certiorari.


Important Unenforceability Case – CAFC Affirms Multiple Counts of Misconduct

Nilssen v. Osram Sylvania (Fed. Cir. 2007)

In a unanimous panel opinion, the CAFC has affirmed a district court finding that Ole Nilssen’s patents are unenforceable due to inequitable conduct. Although Nilssen prosecuted his own patents pro se, the CAFC cut him no slack since he was smart enough to “cite the [MPEP], patent statutes and regulations, and case law during prosecution.”

Unenforceability of Non-Asserted Patents: In a related family of patents, misconduct during prosecution of one of the patents can lead to the whole family being found unenforceable. Reversing that theory, the CAFC agreed that the lower court properly found several of Nilssen’s non-asserted patents to be unenforceable. (Although the court did not create any strict limit on the potential bleed-through, it should be noted that Nilssen originally asserted infringement of those patents, but later dropped those claims.)

Expert Testimony: Following Ferring, the CAFC agreed that Nilssen’s failure to disclose a close relationship with his 132 declarant constituted inequitable conduct.

Small Entity Fees: Although not during prosecution, pretending to be a small entity when paying maintenance fees can also lead to unenforceability. Here, the court found that payment of the small entity fee after licensing to Philips demonstrated an “obvious intent to mislead.”

Priority Claims: Misleading priority claims can also constitute inequitable conduct.


CAFC: No Sua Sponte Summary Judgment; No Baseless Suit Without Claim Construction

ScreenShot063EON-Net v. Flagstar Bancorp (Fed. Cir. 07-1132) (non-precedential)

In 2006, the Washington State district court granted summary judgment of non-infringement in Flagstar’s favor. The court also applied sanctions against the patentee’s attorneys – a NYC class action boutique — for filing the “baseless” litigation. [link]

Sua Sponte Summary Judgment: A summary judgment motion for non-infringement must at least point to “specific ways in which the accused system [does] not meet the claim limitations.” (Exigent Technology). Without at least that threshold level of information, the court must reject such a motion. 

Here, the court issued its summary judgment decision on sua sponte grounds (i.e., using grounds that had not been particularly raised in the SJ motion). Because EON did not have an opportunity to respond, the CAFC vacated and remanded.

“The district court should have given Eon-Net an opportunity to fully present its arguments on these issues, even if the district court ultimately would have reached the same conclusion. We have previously held that where a district court construes a patent without following the necessary steps, we should remand the matter for further proceedings so that the district court can follow the appropriate steps.”

Sanctions: Normally, an attorney is required to perform a “reasonable pre-filing inquiry” that includes an infringement analysis prior to filing a patent infringement complaint. Here, the district court sanctioned Eon’s counsel for not performing such an inquiry.

In a major exception to the inquiry requirement, however, “an attorney may not be sanctioned solely for failing to conduct a reasonable inquiry as long as the complaint is well-founded.” Of course, in patent cases, a patent claim can rarely be deemed unfounded prior to claim construction.

“[W]ithout a full claim construction analysis it is impossible to assess whether Eon-Net’s claim construction was unrealistic.”

Furthermore, the “mere fact” that EON sent identical complaints to dozens of other companies is insufficient to establish that the complaint was filed for a sanctionable “improper purpose.”

Ford Design Patents Block Import of Repair Parts – Infringers Call for Patent Reform

Patent.Law031In re Certain Automotive Parts, 2007 WL 2021234 (ITC 2007)

Ford Motor Company owns dozens of design patents covering various aspects of its vehicle designs. D496,890, for example, covers a vehicle grille; D493,552 covers a vehicle head lamp; D503,135 covers a bumper lower valance; and D496,615 covers a side view mirror. In 2005, Ford initiated a Section 337 action before the International Trade Commission (ITC) asking for an exclusion order against various auto parts importers whose imports violated the Ford design patents. For the most part, the accused parts are used to repair post-crash vehicles.

An administrative law judge (ALJ) found that the majority of the asserted patents were valid and infringed, although some patents were invalid.  The ITC then issued an order to exclude importation of the unlicensed repair parts.

Repair doctrine: Over the years, courts have created a non-statutory doctrine of permissible repair. Under the doctrine, post-sale repairs made to a patented object are not considered actionable. On the other hand, reconstruction of the patented object will be actionable as an unlicensed “making” of the invention.

Although interesting, the repair doctrine does not apply here. The accused infringers are not repairing anything — rather, they are importing replacement parts that on their own are infringing.

Calls for Patent Reform: After losing on the merits, the would-be importers have jumped on the patent reform bandwagon asking for a “repair parts” exception to the design patent laws. [Quality Parts Coalition]. Car manufacturers would like to go the other way — adding vehicle hull design protection to the Copyright Act. [See Boat Hull statute]

Appeal: The case, captioned as Ford v. ITC, 07–1357, is now on appeal at the CAFC — A decision is expected summer 2008.  The critical question for Ford — will the patents pass the CAFC’s dreaded points-of-novelty test?

Threatening Letters to Infringer’s Clients Are Not Actionable Unless “Objectively Baseless” (Although They Will Create DJ Jurisdiction)

PatentLawPic039GP Industries v. Eran (Fed. Cir. 2007)

Eran makes “leakproof” rain gutter covers. Several Eran employees were fired during the summer of 2005.  Those individuals reorganized as GPI — a potential competitor to Eran. As a preemptive strike, Eran mailed letters to its distributors and contractors noting that GPI’s planned to sell a competitive product that infringed Eran’s patent.

After GPI filed for declaratory judgment, the district court (Nebraska) granted GPI’s motion for a preliminary injunction — stopping Eran from “(1) seeking to prevent GPI from making and selling its gutter products during the pendency of this litigation and (2) making vague and unspecified allegations of infringement against GPI in the marketplace.”

On appeal, the CAFC reversed — finding that the preliminary injunction had been improperly granted.

The party seeking a preliminary injunction has the burden of showing: “(1) a reasonable likelihood of success on the merits; (2) irreparable harm; (3) a balance of hardships in its favor; and (4) public interest in favor of the injunction.” Once granted, a preliminary injunction will only be vacated for clear error.

Injunction against Communications: Based on First Amendment rights and 35 U.S.C. § 287 (notice), injunctions relating to communications must pass a higher hurdle. In particular, “bad faith” is required in order to bar communications.

“One has a right to inform others of his or her patent rights. See 35 U.S.C. § 287. Thus, an injunction against communication is strong medicine that must be used with care and only in exceptional circumstances.”

In Globetrotter Software, the CAFC held that “bad faith” communications require “objectively baseless claims.”  Notably, these determinations are based on federal law that preempt any state laws that may be less strict.

Here, the CAFC found that Eran’s statements could not be “objectively baseless” since the lower court had noted the real potential that Eran would eventually succeed on the merits of the case.

Preliminary Injunction Reversed


  • Hovey Williams of Kansas City, Missouri represented the patentee, Eran.
  • Kirton & McConkie of Salt Lake City, Utah represented the accused infringer.

CAFC Denies Joint Infringement Claim and Maps Out Infringement Avoidance Schemes

BMC v. Paymentech (Fed. Cir. 2007)

BMC’s patents cover a method for processing a debit transaction without using a PIN. The payment industry is divided so that there is no single party that infringes an entire claim. However, when combined, the effort of a payee’s agent, an ATM network, and a financial institution

The usual rule is that direct infringement occurs only when a single actor performs each and every element” of an asserted claim. Likewise, inducement requires proof of underlying single-actor direct infringement.  Under a doctrine akin to agency, all actions ‘controlled’ by the single actor are considered to be performed by the single actor.  Thus, courts have long held that you cannot avoid liability by simply “having someone else carry out one or more of the steps” on your behalf. 

Here, BMC acts for an extension of the law in cases where parties are cooperating in a manner that infringes the patent – even though no single party controls the others. The CAFC, however, refused to extend the law — even while admitting that its decision paves a clear pathway for would-be infringers to avoid liability:

“This court acknowledges that the standard requiring control or direction for a finding of joint infringement may in some circumstances allow parties to enter into arms-length agreements to avoid infringement.”

The CAFC’s concern, of course is that allowing this type of joint infringement would greatly increase potential liability of many many companies. For instance, here, BMC would like to hold ATM networks liable even though their actions do not involve any novel part of BMC’s invention. Without any controlling party, BMC’s claim of infringement fails.

As part of its justification, the court cited Mark Lemley’s divided infringement article. In that article, Lemley argues that patent drafters can avoid most potential joint infringement problems by drafting claims that focus on one party at a time.


  • The doctrine of control is certainly not as strict as typical agency doctrine.  And, in this opinion the court gives some positive language to capture bad behavior. For instance, the court noted approvingly that district courts have held parties liable for who ‘mastermind’ a scheme of contracting-out steps of a patented process.  As a strict liability claim, the CAFC is correct to avoid undue expansion of the class of potential defendants. However, the hole created by the CAFC is potentially quite large — I have proposed a new cause of action for conspiratorial infringement that would not require a single controlling entity, but would require a mens rea requirement similar to that of inducement.  
  • Related Material:
  • Fromson v. Advance Offset Plate, Inc., 720 F.2d 1565, 1568 (Fed. Cir. 1985) (finding no direct infringement by manufacturer who performed the first step of a process claim even where its customer performed the other step of the claim)
  • Cross Medical Products, 424 F.3d at 1311 (rejecting patentees’ efforts to combine the acts of surgeons with those of a medical device manufacturer to find direct infringement of an apparatus claim).
  • An expanded joint infringement notion is supported by the CAFC’s recent On Demand decision where the court noted that “[i]t is not necessary for the acts that constitute infringement to be performed by one person or entity.”
  • In PharmaStem, the CAFC did not decide the issue, but noted that the “viability and scope of [the theory of joint infringement] liability is a subject of considerable debate.”
  • Applied Interact, LLC v. Vermont Teddy Bear Co., Inc.  2005 WL 2133416 (S.D.N.Y.,2005), the district court noted that infringement by separate entities requires “some connection” between the entities.
  • Free Standing Stuffer, Inc. v. Holly Dev. Co., 187 U.S.P.Q. 323 (N.D. Ill. 1974), requires a “sufficient connection to, or control over” third party entities performing some of the elements.
  • Cordis Corp. v. Medtronic AVE, Inc., 194 F. Supp. 2d 323 (D. Del. 2002) (requiring close relationship between defendant and the doctors performing part of the patented process).
  • Shields v. Halliburton Co., 493 F.Supp. 1376 (W.D. La. 1980) (finding defendants liable for infringement based on the combined actions of two entities).
  • Wegner well thought viewpoint from 2001
  • Sriranga Veeraraghavan, Joint Infringement of Patent Claims: Advice for Patentees, 23 Santa Clara Computer & High Tech L.J. 211 (2006).


Minimal Patent Infringement Complaint

McZeal v. Sprint Nextel (Fed. Cir. 2007).

McZeal’s pro se patent infringement complaint was dismissed for failure to state a claim. On appeal, the CAFC reversed – finding that the complaint was sufficient.

In particular, the court found that the complaint is not required to specifically describe where each element of the asserted claim is found in the accused device. Those specifics regarding infringement “is something to be determined through discovery.”


Design Patents: Corporate Parts Buyer as Ordinary Observer

PatentLawPic036Arminak v. Saint-Gobain Calmer (Fed. Cir. 2007).

In yet another serious blow to design patent protection the Federal Circuit has affirmed a lower court ruling that Arminak’s spray nozzle design is not infringed by Calmer.

Design patent infringement is defined both in 35 U.S.C. 271 and 289.  According to Section 289, a design patent is infringed by unauthorized commercial manufacture, use, or sale of the design or a “colorable imitation.”

Whoever during the term of a patent for a design, without license of the owner, (1) applies the patented design, or any colorable imitation thereof, to any article of manufacture for the purpose of sale, or (2) sells or exposes for sale any article of manufacture to which such design or colorable imitation has been applied shall be liable to the owner to the extent of his total profit, but not less than $250, recoverable in any United States district court having jurisdiction of the parties. 35 U.S.C. 289.

Infringement: Overshadowing the statutory guidelines is the CAFC’s judicially created infringement jurisprudence. According to the CAFC, infringement requires satisfaction of two distinct tests: First, in the eyes of an “ordinary observer,” the accused design as a whole must be deceivingly similar to the patented design. Second, the accused design must appropriate one or more points-of-novelty that distinguish the design from the prior art.

Ordinary Observer: Like the PHOSITA in utility patent cases, the ordinary observer is a mythical being. However, instead of being ‘skilled in the art,’ the ordinary observer is aware of the patented design, but is not an expert in the art.

Arminak manufactures and sells spray nozzles. However, Arminak does not sell on a retail level.  Rather, the nozzles are purchased by other manufacturers who join them with bottles full of product.

The corporate nozzle buyers can distinguish between Arminak & Calmer nozzles without much trouble. Once assembled, retail customers have difficulty in distinguishing between the nozzles once assembled.  The case then turns on whether the ordinary observer is defined as the corporate buyer of the nozzle or a retail customer of the fully assembled product.

Sitting by designation, Judge Holderman determined that the ordinary observer should be defined by the patentee’s corporate structure. Because Arminak’s products pass through a middle-man for further processing, it cannot count the downstream retail purchasers as ordinary observers who “buy and use” the sprayer. Rather, the ordinary observer is the corporate nozzle buyer.  (Thus, eventual customer confusion regarding the final product makes no difference).

It was undisputed that a corporate buyer would not be deceived by overall similarities between the accused and patented designs — thus no infringement.

Point of Novelty: The panel also found that the accused design did not appropriate any “points of novelty” of the patented invention. In doing so, the court found that a side-by-side detailed comparison between the accused product and the patent design drawings was appropriate.

To establish infringement in a design patent case, the district court is required to compare the patented design with the accused design. Without comparing the patented design with the accused design, there was no way for the district court to determine whether an ordinary observer would find the accused design deceptively similar and whether the accused design appropriated points of novelty.

For utility patent experts, this type of analysis is second nature. However, for over 100 years prior to founding the CAFC, the rule has been that design patent infringement jurisprudence does not allow for such “side by side” examination. See Gorham Manufacturing Co. v. White, 81 U.S. 511 (1871) (rejecting a side-by-side comparison as leading to an ‘expert’ result rather than that of an ‘ordinary observer’).

Inducement Requires Proof of Underlying Direct Infringement

PatentLawPic033ACCO v. ABA Locks and Belkin (Fed. Cir. 2007).

ACCO’s patent covers a method for locking a computer. Belkin’s lock can be used in an infringing manner (as well as in a non-infringing manner). At trial Belkin and ABA were found liable for willfully inducing infringement.

Inducement requires an underlying direct infringement; some action to encourage the direct infringement; and specific intent to encourage the infringement. Direct infringement requires either evidence of “specific instances of direct infringement” or proof that using accused device “necessarily infringes.”

Here, ACCO provided no evidence that any customer (apart from the expert witness) ever used the lock in an infringing manner. And, although the arguably “most natural” way of using the lock would infringe, there were other non-infringing ways of using the lock. (Belkin described a non-infringing use in its instruction manual).

  • The court suggested that a customer survey or other customer testimony would have been appropriate.

Based on ACCO’s failure to prove direct infringement, the CAFC reversed — finding no infringement.


  • This decision is a reminder to litigators, not anything new.

Invention Obvious in Part Because Inventors Were Experts

PatentLawPic032Daiichi Sankyo v. Apotex (Fed. Cir. 2007).

Apotex filed an ANDA to begin making a generic version of Daiichi’s patented ear infection medication method – FLOXIN Otic. Daiichi sued and won a bench trial. On appeal, the CAFC reversed — finding the patented invention obvious.

Level of Skill: The nonobvousness doctrine requires an examination of what would be available to a person having ordinary skill in the art (PHOSITA). That inquiry is premised on a definition of the mythical PHOSITA.  The general theory is that highly educated and trained PHOSITA know more and tend to think more inventions are obvious. On the other hand, a PHOSITA with little education or training would have more difficulty in making connections and finding obviousness.

The 1983 Orthopedic Equipment decision outlines factors for determining a PHOSITA – including education level of the inventor.

Here, the CAFC found that the lower court erred by picking a pediatrician as the PHOSITA in creation of compounds to treat ear infections without damaging a patient’s hearing. Rather, the skill level should be an otologist who is engaged in developing pharmaceutical formulations. The court primarily based its PHOSITA Skill Level on the inventors’ skill level and the skill level of their peers (which, almost by definition will be the same).

Obviousness: Based on the high level of skill in the art, the CAFC concluded that an otologist would have found the patented method obvious.

Reversed — Patented Invention is Obvious

DDC Comment: Although the education level of the inventor appears to be relevant to determining the PHOSITA skill level, there are a few reasons why that data point should be excluded from the list of factors. The common major mistake here is to search for a PHOSITA capable of making the invention rather than simply searching for the level of a skilled worker in the area. The PHOSITA skill level inquiry is not a search for what it takes to be a successful inventor. Rather, the PHOSITA is merely a skilled worker.  The inventor’s biographical information may be indicative of a skill level for invention, but that is not the PHOSITA inquiry. 

Under 35 USC 103(a), patentability of an invention “shall not be negatived by the manner in which the invention was made.” Of course, the process of inventing is intimately tied-in with the inventor’s skill and education level. In essence, use of the inventor’s biographical information in determing the PHOSITA skill level allows the court to ask whether the invention would have been obvious to someone standing in the shoes of the inventor. That methodology nothing more than a backdoor approach to asking whether any steps that the inventor took included non-obvous leaps — a legally impermissible question.


  • This case was originally decided in July 2007, but was recently republished as a precedential decision. The OrangeBookBlog covered the original release.

Examiner’s Oral Promise Does Not Bind PTO

ScreenShot051In re Milton (Patent Petition 2007, App. No. 09/938,465)

During a telephone conversation, the Patent Examiner stated that a replacement office action would be forthcoming. Relying on that statement, the applicant did not respond to the already pending office action. Unfortunately, the Examiner did not issue the new office action and the case went abandoned.

37 C.F.R. 1.2 makes clear that an applicant should not rely on any oral promise from a patent Examiner. Applying this rule, the director of petitions rejected Milton’s petition for revival.

The oral promise could have immediately been memorialized in an interview summary — something that was not done in this case until after the abandonment.

At the time of Petitioner’s reliance, the understanding was a mere oral promise. This section of the C.F.R. expressly prohibits Petitioner’s reliance on the oral understanding, and withdrawal of the holding of the abandonment based on an action which is in contravention to a regulation would be improper.

Petition denied.


  • Thanks to Hal Wegner for providing information on this case.
  • The real party here is HP.

KSR Extended to Obviate Component Purified from Known Mixture

Aventis Pharma & King Pharma v. Lupin Ltd. (Fed. Cir. 2007).

Altace is the King/Aventis brand of ramipril – a top-selling ACE inhibitor.  The patent claims ramipril formulated “substantially free of other isomers.” The district court found the patent not invalid, but only by a slim margin. On appeal the CAFC reversed – finding the patent invalid as obvious.

Prior Art: One reference (‘944 patent) was filed as a continuation-in-part of an already abandoned patent application. That application was eventually revived, but Aventis argued on appeal that the ‘944 patent should not be awarded the filing date of the parent.  The CAFC found this a potentially interesting argument, but refused to hear the argument because Aventis had failed to make the argument at the district court level.

The appellate panel also agreed that the experimental results of a Shering Doctor constituted 102(g)/103(a) prior art because the Doctor had not abandoned, suppressed, or concealed her prior invention.

Obviousness of a Purified Form: The district court, ruling pre-KSR, found the patent nonobvious. On appeal, the CAFC took a different view – finding that the purified form of a known mixture is prima facie obvious if a PHOSITA would have some reason to believe that the mixture derives properties from particular components.

However, if it is known that some desirable property of a mixture derives in whole or in part from a particular one of its components, or if the prior art would provide a person of ordinary skill in the art with reason to believe that this is so, the purified compound is prima facie obvious over the mixture even without an explicit teaching that the ingredient should be concentrated or purified.

The prima facie case of obviousness is especially difficult to rebut where, as here, the potency of the mixture varies directly with the amount of isomer in the mixture.

The court implicitly distinguished this case from Forest Labs — noting that obviousness may be rebutted by showing difficulty in purifying the mixture.

[A] purified compound is not always prima facie obvious over the mixture; for example, it may not be known that the purified compound is present in or an active ingredient of the mixture, or the state of the art may be such that discovering how to perform the purification is an invention of patentable

Reversed, Patent Invalid as Obvious

Gillespie v. DWIDAG: Prosecution Arguments Limit Claim Scope

ScreenShot050Gillespie v. DWIDAG Systems (Fed. Cir. 2007)

During prosecution, Gillespie argued around a cited prior art mine roof bolt reference — arguing that the collar of the bolt ‘appears to be cylindrical on the outside, thus impractical…’ Reviewing claim construction de novo, the appellate panel led by Judge Newman limited the claim scope to only cover non-cylindrical collars. (Following the maxim that a “patentee is held to what he declares during the prosecution of his patent.”).

Gillespie argued that the claims should not be limited by his statements because the non-cylindrical collar shape did not turn out to be material to allowance. (The Examiner provided alternative reasons for allowance). The CAFC rejected that potential loophole – finding that Gillespie’s argument was sufficient regardless of its importance in the prosecution process.

DWIDAG’s bolts were thus found to not infringe this new construction.


  • The court appears to have been careful not to use the term disclaimer


Extending Liebel-Flarsheim: “distinctly different” embodiment of claim elements must be enabled

ScreenShot049Automotive Technologies International v. BMW, et al. (Fed. Cir. 2007).

ATI’s patent claims are directed to an automotive side impact crash sensor used to trigger an airbag and include the following means-plus-function limitation:

“means responsive to the motion of said mass upon acceleration of said housing in excess of a predetermined threshold value, for initiating an occupant protection apparatus”

Following ATI’s suggestion, the district court construed the means limitation to include both mechanical and electronic sensor structures. Then, based on this interpretation, the district court ruled the patent invalid for lack of enablement. (summary judgment).  

On appeal, the CAFC affirmed the ruling — finding that the specification did not enable the full scope of the claimed invention.

The specification describes the mechanical sensor in detail with multiple figures. The electronic sensor, however, is only shown in a sparse “conceptual” Figure 11 (see image at right) and described in broad terms as potentially operating “through variety of technologies using, for example, optics, resistance change, capacitance change or magnetic reluctance change.”

Enabling One Embodiment Is Insufficient: Following on the heels of Liebel-Flarsheim v. Medrad, this case reaffirms the principle that the full scope of a claim must be enabled. Enablement of a single embodiment is not sufficient. Thus, the patent’s enablement of one mode of practicing the invention (the mechanical sensor) was not sufficient to satisfy the enablement requirement.

Looking back, Liebel-Flarsheim discussed “full scope” enablement as being “at least reasonable enablement of the scope of the [claim] range.” Here, the CAFC further defines that principle by noting that electronic sensors must be particularly enabled because they are “distinctly different” from the enabled mechanical sensor.

Novel Aspects Must Be Enabled: ATI also argued that Figure 11 and its accompanying text were enabling — especially when coupled with the knowledge of one having ordinary skill in the art. This argument was rejected based on the CAFC’s combined measure of law and fact. As a matter of law, enablement of the novel aspects of an invention must be enabled by the specification even if implementation would have been within the PHOSITA’s skill level. As a matter of fact, the CAFC concluded that sensor mechanism must be a novel aspect based on statements in the specification that side impact sensing is a “new field” and that the only available side-impact switch was a crush sensor.


  • Its unclear how the enablement doctrine will work in conjunction with the doctrine of equivalents.
  • The summary judgment was reviewed de novo for clear and convincing evidence of non-enablement sufficient to overcome the patent’s presumption of validity.
  • Disclaimer: My former firm, McDonnell Boehnen Hulbert & Berghoff LLP, handled this appeal on behalf of the plaintiff. Although I have not worked on the case, MBHB took-over the case while I was of counsel last year.

Prosecution Disclaimer Narrows SOME of the claims

ScreenShot025Ormco v. Align Technology (CAFC 2007, 06–1240)

Here, prosecution disclaimer narrowed Ormco’s patent claim scope, but only for some of the claims.

Ormco’s invention relates to computer-aided design of orthodontics.  During prosecution Ormco distinguished its invention based on its automated calculation of final tooth position even though the claims do not explicitly require fully automated calculations.  Although finding the disclaimer clear, the CAFC required some relation between the disclaimer and any affected claim before narrowing claim scope. As a consequence, the scope disclaimer only applies to claims directed at finish tooth positions and not to other claims — such as those directed to preliminary organization of tooth data.

Dissent: Dissenting from the majority opinion, Judge Kathleen O’Malley (N.D.Ohio, sitting by designation) criticized both the majority and the lower court for their procedural sloppiness.  Judge O’Malley would have remanded to wait for a more developed opinion from the district court.


  • In passing, the court reminds us that the existence of prosecution disclaimer is determined within the claim construction phase – and thus reviewed de novo.
  • The patents at issue are quite hefty for this type of technology – 97 pdf pages.