Tag Archives: Enablement

CAFC Reaffirms that Doctrine of Equivalents Applies to Ranges

Patent, Patent Cases 2007, Vitiation, ,

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.

Notes:

  • 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.”

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

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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.”

Notes:

  • 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.

Prepare for the new IDS rules.

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For the past two years, the PTO has been discussing its trio of rules — Continuation Rules; Claim Rules; and Disclosure Rules. The first two sets are in final form and are set to be implemented November 1, 2007. The third set — disclosure rules — are in “secret final form” and are waiting for White House (OMB) approval before being implemented.

Under patent office rules, everyone involved with the prosecution of a patent application has a duty to disclose any information to the PTO that may be material to patentability. This information is typically prior art known to the inventor or attorney and or evidence of prior use or sale. Failure to comply with the duty of disclosure can result in the patent being held unenforceable (after a showing of intent & materiality).

In some cases, extensive pre-filing prior art searches reveal dozens (if not hundreds) of prior art references that are all then submitted to the PTO for review. Understandably, patent examiners do not have time to review all those references in any detail — and my own empirical evidence suggests that examiners do not examine more than twenty references. [LINK]

The PTO’s disclosure proposal would set a breaking point of twenty references that may be submitted to the Office ‘without explanation.’ Applicants who submit more than twenty references (or “very long” documents) will be required to personally review the submissions and provide information regarding their materiality as well as an explanation as to why the particular application is not preempted by the prior art reference.

Although the Final Version of the rules is not yet available (it is being kept secret by the PTO), their one-paragraph statement is as follows:

The U.S. Patent and Trademark Office (Office) amends its regulations on information disclosure statement (IDS) requirements and other related matters to improve the quality and efficiency of the examination process. These changes would enable the examiner to focus in on the relevant portions of submitted prior art at the very beginning of the examination process, give higher quality first actions, and minimize wasted steps. This action would make the following changes relating to submissions of IDSs by applicants: Impose a requirement for the personal review of, and to provide information about, certain citations; eliminate the fees for, but permit only timely, IDS submissions; and only permit the filing of an IDS after the mailing of a notice of allowance if a claim is admitted to be unpatentable and a narrowing amendment is also submitted. The Office would also: permit third parties to submit prior art up until the mailing of a notice of allowance after application publication; no longer permit an IDS to meet the submission requirement for a request for continued examination (RCE); permit, after payment of the issue fee, certain amendments and petitions so applicants will not have to file a continuation application or an RCE for such items; and revise the protest rule to better set forth options that applicants have for dealing with unsolicited information received from third parties. 

These rules are likely to become effective in early 2008. In the meantime, applicants may be advised to submit their prior art ASAP.

Claimed ‘plant cell’ must enable monocots and dicots; CAFC affirms noninfringement and invalidity of Monsanto GM corn patents

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Monsanto Co. v. Syngenta Seeds, Inc. (Fed. Cir. 2007)

Monsanto and its Dekalb subsidiary hold three patents covering Roundup-Ready Corn.

  • 4,940,835 covers a GM gene that confers glyphosate resistance to plants.
  • 5,538,880 covers the process of producing herbicide and insect resistant corn.
  • 6,013,863 covers the process of producing glyphosate resistant corn having a marker gene.

Syngenta grew Dekalb GM seeds that had been produced according to the patented methods and then grew genetically identical progeny exhibiting the same GM traits. 

In the ensuing infringement litigation, the district court held that the ‘835 patent invalid for under 35 USC 112 for lack of enablement and held that Syngenta did not infringe the two process patents because the accused infringer did not perform the initial step of the claims. (That initial step of “bombarding … cells with DNA-coated microprojectiles” was performed by Bayer prior to issuance of the patents).

Enablement: The ‘835 patent is not limited to corn. Rather, it claims to be applicable to ‘plant cells.’ During claim construction, the district court found that the patent scope extended to all plant cells – including both monocots and dicots. However, the ‘835 patent was filed before genetic transformation of monocot cells was possible.

“The claim requires transformation of the plant cell. Without the ability to transform a monocot cell, one skilled in the art could not determine whether the plant gene could carry out the claimed functions and thus fall within the scope of the claim.”

Thus, the ‘835 patent is invalid for lack of enablement.

Infringement of Dependent Process Claims: Generally, a dependent claim includes all the limitations of its parent.  Here, however, Monsanto argues that its process claim structure necessitates an alternative viewpoint.  In particular, Monsanto argued in the alternative that its Claim 4 is (1) not a dependent and (2) even if a dependent does not require all the limitations of Claim 1. The process claims line-up as follows:

  • Claim 1: A process for producing a fertile transgenic Zea mays plant comprising the steps of …
  • Claim 4: A process comprising obtaining progeny from a fertile transgenic plant obtained by the process of claim 1 which comprise said DNA.

Thus, Claim 4 is directed to a process of growing seeds from a plant that was produced according to the manner of claim 1.  This could be considered a claim directed to a process of using a product of a process.

The CAFC quickly shot-down Monsanto’s argument — holding that claim 4 is a dependent and the all element rule applies.

“Although in a somewhat unusual format, claim 4 is dependent from claim 1 because it only stands if all three steps recited in claim 1 have been performed. In other words, the additional fourth step of obtaining progeny depends on the performance of the process comprising the three steps recited in claim 1 for obtaining a fertile transgenic plant. Claim 4 contains each element of a dependent claim.”

The court also repeated its rule that one “cannot infringe” a dependent claim without also infringing the parent claim.

271(g) Infringement: Under 271(g), a product made by a patented process also creates infringement liability.  Here, however, Syngenta could not be held liable because several steps of the process were performed prior to issuance of the patent.

“Infringement is not possible under § 271(g) when the three first steps of the claimed process are performed before the issuance of the patent.”

Summary judgment of noninfringement and invalidity affirmed.

 

 

Peter Detkin on the New Patent Market

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DetkinPeter Detkin is Intel’s former director of patents, licensing, and litigation who coined the term patent troll. More recently, Detkin co-founded Intellectual Ventures. IV’s product is intellectual property and IP licenses. The company buys patents from small companies and individual inventors and also files patents on its own inventions.

Detkin has an interesting new article in John Marshall’s RIPL journal titled “Leveling the Patent Playingfield.” In the article, Detkin does a great job of explaining IV’s role in the process.

Normally small players have great difficulty simply avoiding being marginalized by major players.  One part of IV’s business is to aggregate the patent rights held by small players and then use its newfound size and power to license those portfolios.

Although IV’s purpose is clearly to make money, he also sees the results as helping the little guy:

“By matching patent owners with patent users, this market may enable small inventors to have a greater stake in their technological efforts.”

The article is an interesting and quick read (especially for a law review).

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

Enablement, Patent, Patent Cases 2007, Patent Prosecution

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.

Notes:

  • 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.

Continuation Rules to Issue August 21

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After some persistence, the PTO revealed the substance of the new continuation rules to Dow Jones reporter Stuart Weinberg:

Applicants will have the right to file two so-called continuations and one request for continued examination. Applicants seeking additional continuations will need to explain why the request is necessary. Current practice allows applicants to file an unlimited number of continuations. . . . [The PTO also] plans to limit the number of claims an applicant may include in an initial application to 25. Applicants that include more than 25 claims will be required to include a prior-art search, a detailed report that explains how their invention differs from what’s already in the public domain. The new rules, which will be published on the PTO’s Web site Tuesday [August 21], are scheduled to go into effect Nov. 1.

…The number of continuation requests has been rising in recent years. In 2006, almost 30% of applications were devoted to continuation requests, up from 27% in 2005 and 25% in 2004, Peterlin said. . . . Peterlin alluded to misuse of continuations when discussing the pending rule changes. “What we have found is, sometimes, people engage in a little
post-filing research,” she said, adding that, while this may make good business sense, it doesn’t make for an effective patent system.

Although we have not seen the final rules, it appears that applicants will not be losing rights at the time the final rules are published. Rather, the new rules will become effective on November 1, 2007. Do expect the rules to be retroactive in that they will apply to pending applications.

Pre-view of rules via Venable Law Firm

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Ex Parte Kubin: Overcoming the Deuel

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Ex Parte Kubin (BPAI 2007) (Precedential)

Kubin’s patent claims are directed to a cDNA molecule (NAIL) that serves as an NK cell surface marker. During examination, the examiner found them obvious. On appeal to the Board of Patent Appeals and Interferences (BPAI or Board), the applicant constructed an argument based on In re Deuel (Fed. Cir. 1995), that its cDNA claims cannot be “made obvious by mere knowledge of a desired protein sequence and methods for generating the DNA that encodes that protein.” (Quoting Deuel). 

The Board, however, affirmed the rejection, finding the claims invalid because the cDNA structure would have been “obvious to try.”  This case likely eviscerates any strength still remaining in Deuel.

[T]he Supreme Court recently cast doubt on the viability of Deuel to the extent the Federal Circuit rejected an “obvious to try” test. Under KSR, it’s now apparent “obvious to try” may be an appropriate test in more situations than we previously contemplated. . . .

Thus, isolating NAIL cDNA was “the product not of innovation but of ordinary skill and common sense,” leading us to conclude NAIL cDNA is not patentable as it would have been obvious to isolate it.

Kubin’s claims were also challenged on enablement and written description because they claimed only 80% identity with the described DNA sequence.

On enablement, the Board noted a parallel from its obvious to try analysis. Although there are certainly caveats, the Board appears to have held that a compound that is obvious to try is necessarily enabled because it would not require undue experimentation to make and use the invention.

The amount of experimentation to practice the full scope of the claimed invention might have been extensive, but it would have been routine. The techniques necessary to do so were well known to those skilled in the art.

Written Description: On the other hand, the Board found that “appellants did not describe the invention [] sufficiently to show they had possession of the claimed genus of nucleic acids.”

Rejections affirmed on obviousness and written description.

Notes:  

  • This is one of two precedential BPAI opinions for 2007.
  • The application appears to be owned by Immunex, a company now owned by Amgen after a $17B purchase.

Broadened Continuation Receives Broad Construction; Enablement Questioned

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Saunders Group v. Comfortrac (Fed. Cir. 2007).

Typical use of continuation practice: (1) Patentee files application claiming feature B1 (as the only described embodiment of generic class B). (2) Competitor releases product that would be infringing except for its feature B2. (3) Patentee files continuation that replaces B1 with the generic element B. (4) patent issues. What happens in upcoming litigation?

This scenario, which is exemplified in Saunders Group, raises at least three particular litigation issues listed in order applicability: (1) whether the broad scope of element B has been properly enabled; (2) whether the specific element B1 is an essential element of the invention whose removal would be a violation of the written description requirement discussed in Gentry Gallery; and (3) whether the broad term B should be construed in a limited fashion to avoid problems 1 and 2 (applying the maxim that claims should be construed to preserve validity).

We know from Saunders Group, of course, that it is impermissible to import limitations into a claim even when hoping to preserve validity of the claim.  Especially where here, there was no question that “the applicant expressly and unambiguously state[ed] his intention to claim broadly.”

Here, the lower court had issued a summary judgment of non-infringement based on its narrow claim construction (construing B as B1). The CAFC reversed that holding, but suggested that invalidity under enablement is the correct avenue to pursue on remand:

[W]e hold only that the court’s validity analysis cannot be used as basis for adopting a narrow construction of the claims. Instead, any validity issues that the defendants have preserved and wish to press can be addressed on remand, as was done in the Liebel-Flarsheim case. See Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371 (Fed. Cir. 2007) (holding invalid claims that had been given a broad construction at the patentee’s behest in an earlier appeal).

Notes:

  • This type of case may soon be history if new continuation rules are truly effected.

CAFC: “Near the Edge” Not Indefinite; Curing Inequitable Conduct

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PatentLawPic001Young v. Lumenis, Inc. (Fed. Cir. 2007)

Dr. Young invented a surgical method of declawing a cat using lasers. (feline onychectomy).  Lumenis makes surgical lasers that were allegedly during unauthorized infringing surgeries.

Lumenis is a manufacturer, seller, and distributor of surgical laser instruments that were alleged to have been used to perform Young’s patented surgical procedure.

Young filed an infringement suit and Lumenis counted with an inter partes reexamination. (Patent 6,502,579). The PTO issued an office action rejecting the claims and the district court found the patent invalid and unenforceable

Indefinite: In particular, the district court found the word “near” to be indefinite as it was used in claimed step: “forming [an] incision in the epidermis near the edge of the ungual crest.”  Although the district court roughly understood its meaning, it found “near” to be indefinite because it “fails to distinguish the invention over the prior art and does not permit one of ordinary skill to know what activity constitutes infringement.”

On appeal, the CAFC reversed — noting again that claims are indefinite only when they are “not amenable to construction or are insolubly ambiguous.”  An indefiniteness ruling necessarily requires claim construction and examination of any intrinsic evidence. Here, the intrinsic evidence resolves the meaning of near — with both a drawing and reference to cat-sized measurements.  Here, the court distinguished the infamous Amgen case that found “about” to be indefinite: in Amgen, the potential error range of “about” was quite wide and the term had been added to the claims post-filing.

Inequitable conduct — better late than never: The CAFC also disagreed with the lower court’s finding of inequitable conduct — finding that Young’s late submission of contrary deposition statements cured any potential problem: “The essence of the duty of disclosure is to get relevant information before an examiner in time for him to act on it, and that did occur here.”

Reversed

BPAI May Not Substitute its Engineering Expertise for Hard Evidence (In an Interference)

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Brand v. Miller (Fed. Cir. 2007).

Both Capital Machine and Miller Veneers claim rights in a new method of cutting veneer from logs using a “tapered filch.”  Brand, the inventor on Capital’s application now works for Miller, and the two companies had a close-relationship at the time of the applications. Capital filed its patent first, but Miller argued that Capital’s invention had been entirely derived from a documents and information provided by Miller.

Derivation: In an interference, impermissible derivation requires a showing of prior conception by the junior party and communication of concepts to the senior party that would enable construction and operation of the invention.  These elements are questions of fact.

In an interference, the BPAI awarded priority to Miller, finding that Miller’s communications to Capital were sufficiently enabling. In its appeal to the CAFC, Capital argued that the BPAI had improperly relied upon its own experience instead of evidence in holding that the Miller communication was enabling.

Substantial Evidence of Factual Findings: Appeals from the BPAI interference decision are governed by Section 706 of the Administrative Procedures Act (APA). The CAFC’s interpretation of that section requires that “findings of fact by the Board must in all cases be supported by substantial evidence in the [four corners of the closed] record.” Thus, it is impermissible for the BPAI to base factual findings on its own experience as opposed to evidence on record.

 Here, the court found that the board had-indeed “substituted its own expertise for record evidence” of how the information communicated by Miller would be arranged to perform the claimed method. “Under such circumstances the Board’s decision was not supported by substantial evidence in the record.”

Microsoft v. AT&T: Extraterritorial Enforcement of US Patents

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Microsoft Corp. v. AT&T Corp., 550 U. S. ____ (2007).

In a 7-1 decision, the Supreme Court held that Section 271(f) of the Patent Act does not extend to cover foreign duplication of software.

There is no such thing as a world-wide patent. Rather, patent law is territorial. A US patent covers infringing acts that occur in the US but generally disregards extraterritorial activity. The lone statutory exception is Section 271(f) of the Patent Act, which calls for infringement liability for the unauthorized supply of "components" of a patented invention for "combination" abroad.

Todays business reality has considerably dulled the teeth of 271(f) in the area of manufacturing — few physical components are shipped abroad from the US.  Through Microsoft and others, the US continues to be a leader in software development and the export of software.  Of course, Microsoft does not export its software by loading millions of CDs on a cargo ship. Rather, it sends only a few copies to foreign OEM distributors who load copies of the software onto PCs for sale.

AT&T is the assignee of a patent covering a computer for encoding and compressing recorded speech. In the US, a computer with Microsoft WIndows installed infringes the patent. The question in this case, is whether the foreign installed software can be considered a "component" supplied from the US under 271(f). 

The question before us: Does Microsoft’s liability extend to computers made in another country when loaded with Windows software copied abroad from a master disk or electronic transmission dispatched by Microsoft from the United States? Our answer is "No."

As can be seen from the various amici briefs, reasonable minds can differ regarding two statutory elements: (1) whether software — without being tied to a physical medium — can be classified as a "component;" and (2) whether the foreign-made copy was "supplie[d]" from the US. Abiding by its principle against extraterritorial application of laws — especially patent laws — the Supreme Court answered both of these questions in a restrictive fashion:

  • Abstract Software: Until it is expressed as a computer-readable "copy," e.g., on a CD-ROM, Windows software indeed any software
    detached from an activating medium remains uncombinable. . . . Abstract software code is an idea without physical embodiment, and as such, it does not match §271(f)’s categorization: "components" amenable to "combination."     [DDC: Software is never without a physical embodiment?]
  • Supply of Copies: [T]he very components supplied from the United States, and not copies thereof, trigger §271(f) liability when combined abroad to form the patented invention at issue. Here, as we have repeatedly noted,  the copies of Windows actually
    installed on the foreign computers were not themselves supplied from the United States.     [Therefore no liability for foreign-made copies]

Dissent by Justice Stevens: In my view, Justice Stevens – in a solo dissent – has the more sensible view of component.

[I]f a disk with software inscribed on it is a "component," I find it difficult to understand why the most important ingredient of that component is not also a component.

(more…)

PTO: Second Pair of Eyes and Quality Review

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The PTO has been quietly expanding its patent quality review program using both pre and post-allowance approaches.  The general perception is that the quality review is both over-inclusive and under-inclusive.  It must certainly be true that the review is catching some patents.  However, the following quote — reportedly from a Patent Examiner — suggests that the review program — at least the top-secret post-allowance review — may be somewhat misdirected in its approach.

“[I]f your claims are long and all the t’s and i’s are crossed and dotted, those cases will get a pass.  If the claims are short and the subject matter is easily comprehensible, they will get reviewed. (A note to attorney out there — make those claims long, heh).  Short claims will get many rejections no matter how novel or unobvious they are.  They will make the applicant to put anything in for an allowance.  First action allowance will get pulled (at least in my group).” (via G. Ahronian)

Many patent attorneys draft their initial claim in short-abstract form. I have heard of the two finger approach for the first claim which requires the text of claim one to fit under your index and middle fingers. My approach has long been to provide an initial claim that is long and detailed so that the examiner can understand the invention in concrete form.  With later independent claims, I begin to draw-out the scope to cover a larger ranger of enabled scope.  I wonder how this approach fares under the new quality review process. Of course, this approach must be used within the applicable rules — notably 37 CFR 1.75(g), which requires that the “least restrictive claim should be presented as claim number 1, and all dependent claims should be grouped together with the claim or claims to which they refer to the extent practicable.” 

Notes:

  • Secrets at the PTO: The PTO has been stingy and secretive with all information regarding its Office of Patent Quality Assurance (OPQA). What we do know is that OPQA rejections (or their underlying reasoning) are not provided to patent applicants or placed into any publicly available record.  Any further information regarding operation of the OPQA would be appreciated (either via email or comment). dcrouch@gmail.com.
  • Litigation Notes: Anyone litigating a recently issued patent may want to submit a FOIA request to the PTO to obtain OPQA information regarding the patent in question. A routing sheet may be available. Examiners — Is an internal record maintained regarding OPQA rejections?

CAFC Expands Scope of Declaratory Judgment Jurisdiction

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SanDisk v. STMicroelectronics (Fed. Cir. 2007).

SanDisk and ST were undergoing explicitly “friendly discussions” regarding cross-licensing of flash-memory technology rights. At a “settlement” meeting, ST showed a powerpoint presentation that mapped its claims to SanDisk technology and openly discussed SanDisk’s [alleged] infringement.

Apprehension: To avoid a declaratory judgment suit, ST’s attorney told SanDisk that “ST has absolutely no plan whatsoever to sue SanDisk.”  SanDisk agreed that it would at least wait until the following Tuesday to sue.   License proposals were exchanged, but SanDisk eventually didn’t like the deal.  About one month after the initial meetings, SanDisk sued for declaratory judgment of noninfringement and invalidity.

Case Dismissed: The district court dismissed the case — finding no actual controversy under the Declaratory Judgment Act “because SanDisk did not have an objectively reasonable apprehension of suit.”  Under Article III of the constitution, courts only have jurisdiction over actual “cases and controversies.” In regards to patent related declaratory judgment actions, the Federal Circuit has held that such a case or controversy only exists when a party has an objectively reasonable apprehension of being sued for patent infringement.

Deleting The Reasonable Apprehension Test: In the meantime, the Supreme Court decided MedImmune v. Genentech — tearing a large hole through the CAFC’s DJ reasonable apprehension test. 

“The Supreme Court’s opinion in MedImmune represents a rejection of our reasonable apprehension of suit test.”

Under the CAFC’s new rule, a patentee can create a situation amenable to declaratory judgment jurisdiction by making statements far short of threatening legal action. In particular, DJ jurisdiction can exist when the patentee’s position vis-a-vis a DJ plaintiff either (1) indicate that the DJ plaintiff is taking illegal actions or (2) pushes the DJ plaintiff toward abandoning legitimate activities.

“Article III jurisdiction may be met where the patentee takes a position that puts the declaratory judgment plaintiff in the position of either pursuing arguably illegal behavior or abandoning that which he claims a right to do.”

In particular, the following should be closely considered when writing cease and desist letters:

“We hold only that where a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party, and where that party contends that it has the right to engage in the accused activity without license, an Article III case or controversy will arise and the party need not risk a suit for infringement by engaging in the identified activity before seeking a declaration of its legal rights.”

Here, the CAFC found that ST’s activities were sufficient to create DJ jurisdiction.  In particular, the claim charts mapping out infringement along with ST’s discussion of SanDisk’s “infringement” were sufficient to create jurisdiction. There was no need to cut-off license negotiations prior to filing suit. Furthermore, ST’s self-serving statement that it did not intend to sue did “not moot the actual controversy created by its acts.” 

Vacated and remanded.

Notes:

  • The rule still requires some activity by the patentee: “In the context of conduct prior to the existence of a license, declaratory judgment jurisdiction generally will not arise merely on the basis that a party learns of the existence of a patent owned by another or even perceives such a patent to pose a risk of infringement, without some affirmative act by the patentee.”
  • Concurrence: In a concurring opinion, Judge Bryson spells the fear of many patent holders: “it would appear that under the court’s standard virtually any invitation to take a paid license relating to the prospective licensee’s activities would give rise to an Article III case or controversy if the prospective licensee elects to assert that its conduct does not fall within the scope of the patent.”

The New Law of Enablement

Enablement, Patent,

Liebel-Flarsheim v. Medrad (Fed. Cir. 2007).

This case raises an interesting enablement issue. The issue involves how we should interpret patent claims that extend coverege over material that is not enabled.  This is an important question because most patent claims are written to literally cover embodiments that are not fully enabled. 

Facts: Liebel-Flarsheim’s patent describes a preferred embodiment of a needle holder that includes an associated pressure jacket but do not enable a jacket-free embodiment.  The patent claims did not claim (or even mention) the pressure jacket and thus, based on comprising language, were construed to cover injectors regardless of whether they have an associated pressure jacket.  Medrad’s accused products do not have the pressure jacket.

Lower Court: The lower court found the patent invalid as not enabled — holding that it would have taken undue experimentation to practice the claimed invention without the pressure jacket.

Argument on Appeal: Liebel argues that "the asserted claims do not recite or require the absence of a pressure jacket and the court improperly focused on such an embodiment."  In particular, the question of creating an embodiment without a pressure jacket is not one of "experimentation" but rather additional follow-on innovation.

Appellate Decision: On appeal, CAFC panel found the patent invalid as not enabled.

We have previously construed the claims … such that they are not limited to an injector with a pressure jacket, and therefore the full scope of the claimed inventions includes injectors with and without a pressure jacket. That full scope must be enabled, and the district court was correct that it was not enabled.

…

There must be “reasonable enablement of the scope of the range” which, in this case, includes both injector systems with and without a pressure jacket.

…

The irony of this situation is that Liebel successfully pressed to have its claims include a jacketless system, but, having won that battle, it then had to show that such a claim was fully enabled, a challenge it could not meet. The motto, “beware of what one asks for,” might be applicable here.

Invalidity affirmed.

Notes:

  • "During the prosecution of the front-loading patents, Liebel removed all references in the claims to a pressure jacket."

Zyprexa Patent Upheld on Appeal

Anticipation, CAFC, Chemical, Motivation to Combine, Obviousness, Patent, Patent Cases 2006, Pharma, Public Use, Teaching Away, ,

OlanzapineEli Lilly v. Zenith Goldline (Fed. Cir. 2006)

Lilly’s patent covers olanzapine (Zyprexa®) and its use for the treatment of schizophrenia. Three generic manufacturers (Zenith (IVAX), Dr. Reddy’s, and Teva) filed an ANDA and Lilly responded with a complaint in the Southern District of Indiana.  After a bench trial, the district court agreed with Lilly that the patent was valid, infringed, and enforceable.  The defendants appealed to the Court of Appeals of the Federal Circuit.

Anticipation: To anticipate the invention, a prior art reference “must disclose each and every feature of the claimed invention, either explicitly or inherently.”  However, in both Petering and Schaumann, prior art references that disclosed the family of the claimed compound were found to anticipate the claimed compound — even though the claimed compounds were not specifically discussed.

Here, the CAFC found that those cases were not applicable because the closest reference to olanzapine did not spell out “a definite and limited class of compounds that enabled a person of ordinary skill in the art to at once envisage each member in this limited class.”

Obviousness: The CAFC agreed that the prior art references did not suggest a the compound. In addition, Lilly provided strong evidence of secondary considerations, including: “(1) a long-felt and unmet need; (2) failure of others; (3) industry acclaim; and (4) unexpected results.”

The record shows a long-felt need for a safer, less toxic, and more effective clozapine-like drug; a decade (or more) of failure to find a replacement for clozapine; a reasonable amount of commercial success for olanzapine; and a number of awards for olanzapine as indicators of industry acclaim.

Public Use: Prior to filing the patent application, Lilly conducted Phase I clinical safety trials. The court found, however, that the trials were well within the experimental use exception:

In this case, Lilly tailored its tests to their experimental drug safety and efficacy purpose, adequately monitored for results, and maintained confidentiality throughout the duration of the study. The trial court did not err in finding no public use.

 

Filing of Sequence Listings on EFS-Web Version 1.1

Patent, Patent Prosecution

SingerBy Chris Singer, PhD

With the release of EFS-Web 1.1 on < ?xml:namespace prefix ="" st1 />October 14, 2006, the USPTO has streamlined the filing of sequence listings for practitioners and patentees. The prior version of EFS-Web was limited because it allowed submission of files in .pdf format only and was not enabled to handle sequence listings, which are typically written as text files (.txt). The latest version of EFS-Web overcomes this limitation and allows practitioners to submit electronically files such as sequence listings, computer program listings, and mega tables. This eliminates the need to submit these types of files on supplemental electronic media (e.g., CD-R, 3.5″ disk, etc.), which avoided fees relating to application size (currently $250 for large entities and $125 for small entities per 50 pages after the first 100).< ?XML:NAMESPACE PREFIX = O />

According to sources at the USPTO Electronic Business Center, the requirements of Title 37 of the Code of Federal Regulations (37 C.F.R. §§ 1.52(e), 1.821-1.825) have been relaxed for sequence listings that are filed using EFS-Web 1.1. Specifically, filers need only submit a single .txt file containing the sequence listing and an amendment that incorporates the sequence listing into the specification. Practitioners no longer need to include the compliance statement under 37 C.F.R. § 1.821(f) or the paper copy of the sequence listing (or the duplicate copies of the sequence listing on CD-R in lieu of a paper copy) when filing sequence listings using EFS-Web. However, the USPTO recommends that filers include a statement that the content of the sequence listing does not extend beyond the original disclosure (i.e., does not contain new matter), either as a separate document, or as a part of the “Applicant arguments/remarks made in an Amendment” section of a response.

For the time being, the USPTO will also accept sequence listings filed through EFS-Web 1.1 in a .pdf format; however the practice is strongly discouraged, since the USPTO must convert such .pdf files to .txt files to accommodate the sequence listing in its database. As a result, filing sequence listings in .pdf format creates the possibility that conversion could introduce errors in the sequence that could compromise its capacity to be accurately processed and searched, and could even affect sufficiency of disclosure under 35 U.S.C. § 112.

NOTE: This USPTO News Update was written by Christopher Singer.  Chris has a PhD in bio-inorganic chemistry from Northwestern University and is a patent attorney at MBHB.

Patent Reform Bills: Do Not Forget the Details

Patent, Patent Legislation, , , ,

< ?xml:namespace prefix ="" o />ED: The following note was submitted for anonymous publication by a practicing patent attorney:

For all the public debate over controversial broad objectives in the various pending patent reform bills, there has been remarkably little published academic or other attention to whether or not the extensive new specific draft language in these bills will accomplish those objectives without drafting errors creating unintended ambiguities in judicial interpretations.  This note will particularly question, an example that seems to be in common to the pending bills, the draft language for the crucial definition of the “effective date” of an application or patent. 

The seriousness of current patent reform legislative efforts has been more than adequately demonstrated over the past two years.  There have been a number of Congressional hearings, other public debates and IPL association activities over the [evolving] versions of H.R. 2795 in 2005, the Berman/Boucher H.R. 5299 in 2004, major FTC and other studies and reports on patent reform, etc.  Now, on < ?xml:namespace prefix ="" st1 />August 4, 2006 Senators Hatch and Leahy have introduced “their own” Bill, S. 3818, the “Patent Reform Act of 2006”( for which there will be a House equivalent).  Although there will be considerable further debate into the next term of Congress, passage of some form of major new patent legislation next year seems quite likely.   Many of these patent reform proposals are not that controversial.  In particular, clarifications of “willful infringement,” §103(c), inter partes reexaminations, assignee filing, restoration of the prior patent venue statute, an “opposition system” of some kind, elimination of most interferences (and other “secret prior art” business investment uncertainties) with some form of “first inventor to file” plus some form of associated changes in §102 and “prior user” defenses,  etc.  Thus, there are highly likely to be a number of major changes in the present patent statute even if the most controversial provisions end up removed or amended in the final legislation.   

This note is not about any controversial issues.  Rather, the intent here is simply to encourage better reviewing, by both the patent bar and academia, of specific drafting language issues that might present serious future ambiguities or unintended legal consequences, which seems to be getting insufficient attention.   Whatever version of any of these draft bills is enacted, it will generate a great deal of new statutory language for which there will be no legal precedents.  This new language will at best only be eventually interpreted in “cases of first impression” by individual panels of the Federal Circuit.   That should give readers pause to consider that some Federal Circuit interpretations of even relatively old patent law language have been quite controversial, and some have even been unanimously overruled by the Supreme Court.  This in turn should strongly suggest that very careful attention be paid to completely new and untested statutory language to insure that it is as completely unambiguous and as completely free of possible unintended interpretations as possible.   All members of the patent bar and their clients will be greatly affected by any of the pending “patent reform” bills. 

No doubt those authoring the specific legislative language consider that it does not have any possible ambiguities or misinterpretations, to them.  However, legal and Congressional history is full of such surprises.   The frequent necessity for subsequent “technical corrections” legislation is evidence enough.  For example, it took several years for passage of technical correction legislation to fix an unintended problem created by the 1999 AIPA legislation’s amendment of 35 USC §102(e).  Patent law is a specialized legal area of uniquely semantically clever lawyers, who unfortunately rarely apply themselves to legislation in advance.   Furthermore Congressional staff members, no matter how brilliant, are highly unlikely to have sufficient patent law practice background to be able to anticipate all of the possible interrelated consequences of major changes in patent statutory language. 

Thus, there should logically be a much broader participation by the patent bar in careful and critical reading of draft legislation and providing thoughtful comments on specific wording in time to fix it.  That is, not just depending on brief summaries of the intentions or alleged effects of this legislation by proponents or opponents.   Especially from lobbyists who have never practiced patent law, “planted” newspaper and magazine articles, and other very incomplete and unreliable sources.  More advance consideration is needed by those who can actually understand this legislation, the legal problems it is addressing, and the full ramifications of the specific legislative language.  In many cases this may be merely to suggest minor wording changes.  Even if the legislation itself is not changed, the legislative history might be improved in some cases.  This would also seem to be a far more meaningful activity for law school professors than non-pending legislative proposals which no one with any influence is supporting.  

To pick just one example in this draft legislation language, consider the critical S. 3818 definition of the term “effective filing date of a claimed invention,” which is identical or similar to that of  other patent reform Bills.   All competent patent attorneys are familiar with this date and its criticality.  It is even more crucial for the proposed “first to file” system.  Under long established current case law it means the filing date of a patent application having full 35 USC §112 support for what is being presently claimed (in its subsequent patent or in any other pending applications claiming priority date benefit therefrom).  It has not ever meant the filing date of an application containing a bare unsupported claim with no §112 enablement of any kind.  

So, let us consider the actual language of S. 3818 “SEC. 3” on p. 2.   It contains in subsections (h)(1) and (2) a new definition of the “effective filing date of a claimed invention.”  It states that the “effective filing date of a claimed invention” is:

“(1) the filing date of the patent or the application for patent containing the claim to the invention;  or 

 (2) if the patent or application for patent is entitled to a right of priority of any other application under  .. or an earlier filing date in the United States under .., the filing date of the earliest such application in which the claimed invention is disclosed in the manner provided by the first paragraph of section 112.” [Emphasis supplied]

First, note that SEC.3 (h) subsections (1) and (2) are defined in the alternative – “or”.  Note that the first alternative, (h)(1), has no §112 requirement at all.  It would literally provide an “effective filing date” for an application or patent merely “containing the claim” irrespective of whether or not it ever had any §112 enablement support as of its filing date, incongruously unlike the alternative (h)(2).  [As all patent attorneys know, a §112 enablement attempted to be added after the filing date is illegal “new matter.”]  Thus a literal reading of Sec. 3 (h)(1), especially as read in contrast to alternative (h)(2) (normal statutory interpretation) would give an “effective filing date” to a patent application filed with a bare claim to an invention even if there was no enablement example or description whatsoever for that claimed invention!   That is, granting a “first inventor to file” date for a bare concept suggestion with no teaching of any way to make or use it.   Yet, if that same application or patent had a foreign or U.S. priority claim it would not get that date benefit, because then (h)(2) would apply instead, appropriately requiring that “the claimed invention is disclosed in the manner provided by the first paragraph of section 112.”  Furthermore, would not applicants filing a continuation or divisional also lose this literally defined (h)(1) original effective filing date by thereby converting the application and its ultimate patent from (h)(1) to (h)(2)?

It someone can clearly explain why a normal judge would not read this proposed statute this way if it is enacted, this reader would gratefully appreciate the enlightenment.

Now, confusing this reader further, please note that on page 5 of this Bill you will find in a new §102(b)((3) another, different, and not cross-referenced definition [why?] of the same critical term for when a patent or application is “effectively filed,” but here only “under subsection (a)(2).” This effective filing date definition is only with respect to “subject matter described in the patent or application -”..”as of the filing date ..” [emphasis supplied]  

There is also a subparagraph Sec. 3 (h)(2)(i) on page 3 stating that:

 “(i) The term “claimed invention” means the subject matter defined by a claim in a patent or an application for a patent.”

Why is this Sec. 3 (h)(2)(i) definition presented only as a subparagraph of (h)(2), thus by normal statutory interpretation only defining the term “claimed invention” just in (h)(2)?  As noted above, the same term “claimed invention” also appears in (h) itself prior to both (h)(1) and (h)(2).  Was this deliberate for some reason?

Further as to the vital question of what would still be prior art, or not, this p. 3 et sec S. 3818 version of a whole new 35 USC §102 definition of prior art seems shorter and simpler than that of  prior bills.  That may be desirable, but it should also trigger patent attorney and client interest in what is being left out of the present statute and all its case law, and how situations will be handled if this Bill becomes law.  For example, the present and very important “on sale” bar defense would be eliminated in this and other pending legislation. However, the prior pending H.R. 2795 §102 had been revised to make it clear that software in one’s own sold products would remain prior art to later attempts of others to patent it.  That was widely considered vital to avoid judicial debates over whether or not that internal software would be considered “publicly known,” since that would be the only other §102 defense left for this now-common situation under this new §102 .   Yet S. 3818 seems to have left out that vital provision. 

Finally, just for a couple of other drafting examples, the S. 3818 amendment of §103 in (c)(1)(A) on page 6 restores an undisputed typographical error previously caught and corrected in the amended version of H.R. 2795.  Namely, “through” instead of “though” in: “A patent for the claimed invention may not be obtained through [sic] the claimed invention;..”   Also, what does the last line of S. 3818 Sec. 5 (b)(2) on p. 20 mean by “..such claim, the infringer.”?  

In conclusion, there are undoubtedly other potential unintended interpretations or drafting errors subject to unpredictable D.C. and Federal Circuit de novo interpretations in all this new language that ought to be under a lot more academic and other public discussion.   Especially those relating to 35 USC §102 and other extremely important statutory sections affecting all aspects of patent law practice.  The introductory remarks for S. 3818 by Senator Hatch have welcomed further useful input on this draft legislation.  Careful and timely review and correction of specific language ought to be provided by all those in a position to do so.

Cite as NOTE, “Patent Reform Bills: Do Not Forget the Details”, Patently-O, available at https://patentlyo.com/patent/2006/08/patent_reform_b.html.

PVPA Not Infringed When Seller Lacked Knowledge

Patent, Patent Cases 2006

Rewritten Aug 1:Softred

Syngenta Seeds v. Delta Cotton (Fed. Cir. 2006).

In a case involving a variety of soft winter wheat, the CAFC has effectively reversed a jury’s finding of infringement and damages under Section 2567 of the Plant Variety Protection Act (PVPA) because the accused seed seller did not have proven knowledge that the seeds were protected. 

Here, Delta was reselling seeds that had been provided by local farmers.  Delta’s apparent "don’t ask don’t tell" policy with regard to the variety of seed enabled it to escape liability under the PVPA. 

Lanham Act: Syngenta also accused Delta of "reverse passing off" because Delta was selling the Syngenta variety of seed under the Delta Cotton name.  Reverse passing off is generally thought of as "misrepresenting someone else’s goods or services as [your] own." Dastar.

The CAFC agreed with Syngenta that reverse passing off has no scienter requirement and thus proof of Delta’s knowledge would not be required.  However, Syngenta did not show proof that the misidentification of goods caused any harms to Syngenta’s business or mark.

Reversed

(more…)

Court Order Dismissing Patent Suit Does Not Trigger 180-Day Exclusivity Period Under Hatch-Waxman

Patent, Patent Cases 2006
GenericChallengeApotex v. FDA, No. 06-5105 (D.C. Cir. June 6, 2006)
By Aaron Barkoff of the Orange Book Blog,
The Court of Appeals for the D.C. Circuit today upheld an FDA rule stating that a district court order dismissing a patent suit for lack of subject matter jurisdiction is not a “court decision” under the Hatch-Waxman Act, and is therefore insufficient to trigger the first ANDA filer’s 180-day exclusivity period.

Apotex had challenged the FDA rule on the basis that it was inconsistent with the D.C. Circuit’s holdings in two prior cases.  In those cases, the court found that FDA’s rationale for the rule–that the FDA has insufficient resources to inquire into the legal effects of settlements, such as estoppel, that lead to dismissals–was not adequately justified.

Now, however, the D.C. Circuit has upheld FDA’s rule–largely because the FDA offered a better justification this time around.  According to the court, “FDA is indisputably correct that equitable estoppel in the patent law context rarely presents pure issues of law amenable to easy resolution.  . . .  We have little doubt that applying this standard would force FDA, an agency lacking patent law expertise, to resolve borderline questions about the estoppel effects of patent-holder declarations.”  The court continued:

As FDA sees it, the uncertainty inherent in an estoppel-based inquiry would lead to two inter-related problems, neither of which relates to the drain-on-resources rationale set forth [previously].  First, FDA believes that the uncertainty would “undermine marketplace certainty and interfere with business planning and investment.”  And second, FDA worries that forcing it to parse court decisions will invite fruitless litigation from generic drug manufacturers seeking to trigger, or to avoid triggering, exclusivity periods.

The D.C. Circuit concluded:  “In our view, these perfectly reasonable propositions adequately support FDA’s position that an estoppel-based approach to the court decision trigger is ill-advised.”

Dennis Crouch’s Comment: I asked Aaron to write this short review of the Apotex case for Patently-O.  He has the primary documents and much more detail at his site, the Orange Book Blog.