Tag Archives: Enablement

Inventor’s Post-filing Publication Disparaging Invention Leaves Patent Unenforceable

AIPLATalk217Research Corporation Technologies v. Microsoft (D. Az. 2006).

After a bench trial, Arizona District Court Judge Manual Real of found that RCT’s patents were unenforceable based on inequitable conduct that occurred during prosecution of the patents in suit. And, because it was an “exceptional case,” the judge granted Microsoft’s request for $8 million in attorney fees.

Back in 2001, RCT sued Microsoft for its patents directed to a “blue noise mask” used in halftoning digital images.  The new procedure was touted in the patent application as being “visually pleasing” and lacking “low frequency graininess at every level of gray.”  At the same time the inventors published a paper that reported resulted of “visually annoying clumps” with graininess.  In the paper, the inventors reportedly rejected the claimed algorithm in favor of another technique that was inconsistent with the patent.  That paper was never submitted to the PTO. 

The court found this seemingly contradictory information material because a “reasonable Patent Examiner clearly would have considered [the contradictory information] important to at least the written description and enablement requirement for patentability.”  For intent, the judge found that:

It is not credible that they did not know that a reasonable Examiner would consider it important to know that patent applicants’ reported efforts to practice the applications’ disclosed No K technique had led to “visually annoying clumps,” not the “visually pleasing” images promised by the patent applications and their patent claims.” 

In addition, the inventors were awful on the stand — one was “not credible” and the other “evasive.” Thus, further supporting the finding of intent to mislead the PTO.

AIPLATalk218According to a release by Microsoft’s attorney John Vandenberg*, the patents previously had been asserted against Hewlett-Packard Company, Seiko Epson Corporation, and Lexmark International, each of whom had settled out of court and taken a license. In awarding Microsoft attorney fees, the Court found it to be an “exceptional case” and that RCT knew or should have known of the inequitable conduct before the Patent Office. 

A couple of readers wrote-in to identify Judge Manny Real as a legendary old-school federal judge, and former chief judge in the central district of California. It appears that Judge Real is sitting by designation for this patent case. 

Biotech: Written Description Does Not Require Recitation Of A Known Structure

AIPLATalk216Falker-Gunter Falkner v. Inglis (Fed. Cir. 2006, 05–1324)

by Donald Zuhn, PhD

In an appeal from a decision of the PTO Board, the Federal Circuit affirmed judgment for Appellees (Inglis et al.) in an interference involving vaccines comprising modified viral vectors. In particular, the subject matter of the interference concerned vaccines comprising a poxvirus vector having a deleted or inactivated essential gene, wherein the modified poxvirus is capable of producing infectious viral particles when grown in a host cell modified to produce the absent essential viral gene product. In contrast with the vaccines of the invention, traditional vaccines had been prepared by deleting or inactivating inessential genes in the viral vector, since the deletion or inactivation of essential genes made it difficult to produce vaccines in commercial quantities.

On appeal, Appellants (Falkner et al.) reiterated several arguments made before the Board, each concerning the common issue of whether Appellees had adequately described and enabled a poxvirus-based vaccine. Specifically, Appellants argued that because Appellees did not identify any essential poxvirus genes or the inactivation of any such genes, Appellees had not sufficiently described and enabled vaccines comprising a poxvirus vector having a deleted or inactivated essential gene.

With respect to the Board’s determination that Appellees had sufficiently described vaccines comprising poxvirus vectors having modified essential genes, the Court noted that there was undisputed testimony before the Board that at the time of filing of Appellees’ earliest application, the DNA sequence of the poxvirus genome and the locations of essential poxvirus genes had been disclosed in the scientific literature. Adhering to the well-established rule that "[a] patent need not teach . . . what is well known in the art," the Court held that "there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." In affirming the Board’s determination that Appellees adequately described the invention, the Court concluded that because "accessible literature sources clearly provided, as of the relevant date, [poxvirus] genes and their nucleotide sequences (here "essential genes"), satisfaction of the written description requirement does not require either the recitation or incorporation by reference (where permitted) of such genes and sequences."

NOTE: This post was written by Donald Zuhn, PhD. Don is a true expert in cutting edge biotech patent law and practices both prosecution and litigation at MBHB LLP in Chicago. (zuhn@mbhb.com).

DJ Counterclaims Allow Adjudication of Invalidity Counterclaims Even After Noninfringement Decision

The Old Town Canoe Company: Our First Hundred YearsOld Town Canoe v. Confluence Holdings (Fed. Cir. 2006, 05–1123).

Old Town sued Confluence, asserting infringement of its patent covering layered polyethylene canoes. Confluence filed declaratory judgment counterclaims of invalidity and unenforceability.

After a few days of trial, the judge called it quits — first ruling that as a matter of law, the patents were not infringed, and the next day taking further arguments and ruling that the patents were not invalid and not unenforceable.

On appeal, the CAFC majority agreed that the claims were not infringed (based on claim construction) and then bit into the validity analysis.

Enablement: Because the time and temperature settings of the canoe manufacturing process were not disclosed, a jury could find that undue experimentation was required.

Best mode: Best mode requirement only applies to the claimed invention. However, the defendant’s evidence that a preferred mode had not been disclosed to the PTO was enough to overcome the Court’s judgment as a matter of law.

Inequitable Conduct: Without evidence of intent, the patentee’s failure to disclose the best mode is not “material” as a matter of law.

J. Mayer’s Dissent: Dissenting-in-part, Judge Mayer argued that after the district court decided that the defendant did not infringe, the declaratory judgment jurisdiction of the counterclaims vanished.  Those counterclaims became moot.  Thus, the lower court’s decision on validity and enforceability should be vacated.

Practice Strategy: This case is a prime example of why a defendant should include declaratory judgment counterclaims rather than just defenses.  With counterclaims, the plaintiff will need the defendant’s agreement to end the case.

Should the Patent Office Kill Late Claiming?: Proposed Continuation Change

In January 2006, the PTO proposed dramatic changes to patent continuation practice that would essentially allow only one continuation (or CIP or RCE) per application. [Link]. 

Although the PTO has justified these changes based on a need to reduce examiner workload, the real controversy with extended continuations is what I call “late claiming.” 

There are many different ways to “claim” an invention in a patent application.  Often, an applicant may pursue one aspect of the invention in the original application, and then file continuations to obtain coverage for other aspects.  That practice is fine and legal, but can create business problems when the applicant waits until learning of a competitor product before adding claims that cover that new product.

Late claiming occurs when the applicant adds new claims to cover what has arisen in the marketplace since filing the original patent application.

According to the law, those new claims are generally legitimate so long as they are enabled by the original written description.  However, the possibility of late claiming creates another potential down-the-road liability for product developers.

Is late claiming a problem?
Will the PTO rule change reduce late claiming?

Federal Circuit Further Limits Doctrine of Equivalents under “Specific Exclusion” Principle

AIPLATalk170Bicon, Inc. v. The Straumann < ?xml:namespace prefix ="" st1 ns ="" "urn:schemas-microsoft-com:office:smarttags" />Co., (Fed. Cir. 2006, 05–1168)

By Thomas Fairhall

The Federal Circuit’s decision in Bicon appears to mark a further narrowing in the scope and availability of the doctrine of equivalents (DOE), particularly for patents where the claim recites physical structures.  Significantly, the court’s doctrine of equivalents discussion makes no mention of the familiar tests for DOE coverage, i.e., the function/way/result test of the Graver Tank decision, or the “insubstantial differences” test of Hilton Davis Chemical Co. v. Warner-Jenkinson Co., 62 F.3d 1512 (Fed. Cir. 1995), rev’d & remanded, 520 U.S. 17 (1997).   Rather, the Court invoked a new exclusion principle essentially foreclosing coverage under the Doctrine in cases where a claim contains a detailed recitation of structure, stating that such a claim is accorded “limited recourse to the doctrine of equivalents.”   Slip op. at 17.     For support of this rule, the court cites cases purportedly standing for “an exclusion rule” that denies any coverage under the doctrine for subject matter where such subject matter is “inconsistent with the language of the claim.”  Slip op. at 17-18, citing Sci-Med Life Sys. Inc. v. Advanced Cardiovascular Sys., 242 F.3d 1337 (Fed. Cir. 2001); Ethicon Endo-Surgery Inc. v. U.S. Surgical Corp., 149 F.3d 1309 (Fed. Cir. 1998), and other cases. 

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The problem is that, by definition, a claim term that is expanded under the DOE is, in some fashion, “inconsistent” with the literal scope of the claim.   Bicon suggests that such inconsistencies are resolved by barring application of the DOE.  Bicon is difficult to reconcile with prior precedent upholding findings of infringement under the DOE, decisions which by definition accommodate inconsistency between the claims and the accused device.

 

The particular invention at issue in Bicon pertained to a dental implant.   The court was examining language in the claim preamble, which, in a separate portion of the opinion, was found to be an affirmative limitation of the claim.   The claim at issue, claim 5 of U.S. Patent 5,791,731, recited:

 

5.         An emergence cuff member for use in preserving the interdermal papilla during the procedure of placing an abutment on a root member implanted in the alveolar bone of a patient in which

            [a] the abutment has a frusto-spherical basal surface portion and

            [b] a conical surface portion having a selected height extending therefrom comprising . . . [body of claim].

 

The accused device had a trumpet-shaped, concave surface, which was argued to be equivalent to the convex frusto-spherical basal surface of part [a] of the preamble.     In rejecting the patentee’s equivalency argument, the court stated:

           

The problem that [the patentee] faces in this regard is that limitation [a] and [b] of the claim contain a detailed recitation of the shape of the abutment, including that it has a frusto-spherical basal portion.  A claim that contains a detailed recitation of structure is properly accorded limited recourse under the doctrine of equivalents. See Tanabe Seiyaku Co. v. Int’l Trade Comm’n, 109 F.3d 726 732 (Fed. Cir. 1997)(“The sharply restricted nature of the claims has much to do with the scope we accord to the doctrine of equivalents.”). That principle has special application in a case such as this one, where the claim recites a particular shape for the basal portion of the abutment that clearly excludes distinctly different and even opposite shapes.  In such cases, we have explained, “by defining the claim in a way that clearly excluded certain subject matter, the patent implicitly disclaimed the subject matter that was excluded and thereby barred the patentee from asserting infringement under the doctrine of equivalents.”   Sci-Med Life Sys. Inc. v. Advanced Cardiovascular Sys., 242 F.3d 1337, 1346 (Fed. Cir. 2001) [further citations omitted]; Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1317 (Fed. Cir. 1998)(subject matter is “specifically excluded” from coverage under the doctrine of equivalents if its inclusion is “inconsistent with the language of the claim.”)

 

Both of the structures in the Straumann system that are possible candidates for equivalence to the abutment base recited in the claim fall victim to this principle of specific exclusion.  As we have noted, the basal portion of the Straumann abutment is frusto-conical, not frusto-spherical, and the neck of the Straumann root member is concave, not convex.  These shapes are clearly contrary to, and thus excluded by, the patentee’s characterization of its abutment as having a convex, frusto-spherical shape.

 

Slip op. at 17-18. 

 

There are several things of note in this analysis.  Significantly, the Federal Circuit does not engage in any function/way/result analysis under Graver Tank, or any examination of whether the differences in geometry between the accused device and the claimed invention are insubstantial under Hilton-Davis.    Rather, the Federal Circuit seems to be excluding availability of the doctrine of equivalences completely, based solely on a textual analysis of the claim itself and noting that the accused product is not within the literal scope of the patent.

 

The decision raises the question of whether the bar on availability of the doctrine of equivalents, based on the “specific exclusion principle”, is a question of law that might be amenable to summary judgment.  If so, it would avoid the factual disputes associated with a function/way/result or insubstantial differences analysis.   It is at least arguable that this “specific exclusion principle” is one of law and amenable to summary judgment.

 

The rule of exclusion based on a textual analysis of a claim brings to the fore the tension in the doctrine between the two opposing principles of 1) allowing some additional claim scope beyond the literal bounds of the claim in an appropriate case under the Doctrine, while (2) preserving the public notice function of claims.  The decision in Bicon lands squarely on the side of the upholding the latter principle at the expense of the former.   It doing so, it is consistent the trend of the Federal Circuit cutting back on the scope of the DOE.  Creative litigants will surely apply the Bicon exclusion principle to other areas besides the mechanical arts.   Virtually any claim is amenable to a “specific exclusion principle” argument. 

 

If the Federal Circuit’s specific exclusion doctrine is interpreted as meaning that a selection of a particular claim term operates as a matter of law as a disclaimer of coverage under the doctrine for subject matter not within the literal definition of that term, then the death knell for the doctrine has basically been rung.

 

Links:

CAFC Explains Materiality Standard for Inequitable Conduct

AIPLATalk056

Digital Control (DCI) v. Charles Machine Works (aka DitchWitch) (Fed. Cir. 2006).

By Mark Chael,

DCI appealed the lower courts’ decision that its patents were unenforceable for inequitable conduct. DCI’s three asserted patents involve Horizontal Directional Drilling, which enables the creation of horizontal holes in the ground through with utility lines can be placed by allowing a worker to locate and/or orient the boring tool as it moves through the ground.

The district court previously awarded partial summary judgment to DitchWitch finding that there was no genuine issue of material fact that misstatements and omissions made by the inventor during prosecution of the patents were material. After a bench trial, the lower court held that the misstatements and omissions were made with intent to deceive and the level of materiality and inference of intent were both high. Thus, the lower court held that the patents were unenforceable.

The CAFC, however, held there were genuine issue of material fact regarding the materiality of the inventor’s failure to disclose prior art. The CAFC thus vacated the district court’s ruling that the patents were unenforceable and remanded for further proceedings regarding the materiality of the failure to disclose prior art.

Before reviewing the lower court’s determination that DitchWitch was entitled to summary judgment on the issue of materiality, the CAFC addressed the proper standard for determining whether a misstatement by omission is material. What follows in the text of the opinion is a comprehensive, yet succinct, summary of the development and current standing of the law of inequitable conduct and material misrepresentation, in view of the Patent Office’s amendment of Rule 56 (duty of candor and good faith / duty of disclosure). This panel followed the “reasonable examiner” materiality standard of old Rule 56, which “new Rule 56 was not intended to replace or supplant.”

Dr. Mark Chael’s prior research in biochemistry, molecular biology, and cellular biology make him well equipped to understand the intricacies involved in biotech and pharmaceutical patents. He is an associate at the intellectual property law firm McDonnell Boehnen Hulbert & Berghoff in Chicago.

Links:

Read the opinion.

Supreme Court: LabCorp Briefing Round I [UPDATED]

InfringingProducts008LabCorp v. Metabolite (on writ of certiorari).

This case involves a patented method of correlating a body protein level with a vitamin B deficiency.  (U.S. Patent No. 4,940658).  The claim in question (Claim 13) includes two steps: (1) assaying a body fluid for an elevated level of total homocysteine and (2) correlating an elevated level of total homocysteine with a folate deficiency. (paraphrased).

The patent holder won at trial and at the CAFC.  The defendant, Metabolite, then brought its case to the Supreme Court arguing that the patent is invalid because it “claim[s] a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.”

Interestingly, the question presented is not firmly grounded in any particular rule of patent law.  Rather, it implicitly raises issues of indefiniteness, enablement, written description, and patentable subject matter. (to name a few).  However, the Supreme Court has given some indication that it is most interested in this case because of the issue it raises regarding the patenting of natural phenomena under Diehr.

LabCorp has filed its brief on the merits as have a number of third parties:

Petitioner’s Brief  PDF (211 KB)

In Part I, Petitioner LabCorp’s stance is essentially that the law is correct, but that it has been misapplied in this case.

Claim 13 violates this Court’s longstanding rule barring patents on “laws of nature, natural phenomena, and abstract ideas.”

According to LabCorp, the claim involves “no actual invention beyond the scientific discovery it recites.”  The claimed correlation is a scientific principle or law of nature, and its discovery alone cannot be patentable.  The “trivial pre-solution” activity of assaying “cannot transform claim 13 into a patentable invention.”  Here, Petitioner never strays far from the precedential pillars of Diehr, Chakrabarty, Funk Bros., and Flook.

In Part II, LabCorp goes on to argue that the claim is neither definite, enabled, nor adequately described.  The Brief appears to ask the court to invalidate any claim that includes a “correlating” step unless the process of how to calculate a correlation is spelled out in the specification. 

The Federal Circuit relied on the accepted dictionary definition of “correlate” as meaning “to establish a mutual or reciprocal relationship between.” But nothing recited in the claim or disclosed in the specification tells a practitioner how to actively “establish” a “relationship” between a particular test result and a vitamin deficiency. At most, the Patent discloses that such a scientific relationship

exists.

More is required for a valid claim. . . .

In the remaining sections of the Brief, Petitioner argues that, on policy grounds, a very broad claim hinders scientific and technological progress and that the lower court judgment should be reversed.

Solicitor General’s Amicus Brief for the U.S. Government  PDF (165 KB)

The Solicitor General with assistance from the PTO’s counsel has filed its brief that falls closely in line with its prior unsuccessful brief in opposition to the petition for certiorari. 

In line with Petitioner, the Government agreed that the patent “appears to [impermissibly] claim all substantial practical applications of the natural relationship.” However, the Brief specifically states that this case should not be decided on an issue of whether a law of nature has been improperly claimed because the lower court record has not been developed on this issue. Directly addressing Petitioner’s part II, the Government argues that the specification does satisfy the requirements of 35 USC 112 “by describing, enabling, and claiming the method.”

Intellectual Property Owner’s Association (IPO) Brief  PDF (97 KB)

IPO realized that the question presented for review in this case does not directly challenge the current standards for patentable subject matter. However, the Supreme Court has indicated an interest in considering whether the patent-in-suit claimed patentable subject matter. 

IPO believes that the current standards for patentable subject matter, as set forth by the Court in

Diehr, correctly delineate between those innovations that should be eligible for patent protection and those that should not. Accordingly, IPO believes that this case should not serve as a vehicle for overturning or altering those standards. Rather, this case should reinforce the standards of Diehr and thus, support the expectation that innovations in yet unknown areas of technology will be eligible for patent protection.

Specifically, IPO argues that a broad scope of subject matter eligibility properly places research and development decision-making into the hands of individuals and private entities rather than in the judiciary. This “free market” approach “beset allocates research and development resources without judicial entanglement.”  The requirements of novelty, nonobviousness, and description protect against over-reaching patents and warrant against further restricting patentability based on subject matter.

* NOTE: I was a coauthor of the IPO brief along with Paul Berghoff and Joshua Rich from MBHB as counsel for IPO.  The IPO Board of Directors approved the Brief.

Affymetrix Brief PDF (104 KB)

Affymetrix is a supplier of commercial DNA microarrays and “has an interest in ensuring that patents not issue on basic laws of nature so as to impede scientific progress in analyzing DNA and gene expression.”  Affymetrix argues that the fact that “elevated levels of an amino acid in the blood correlated to a vitamin deficiency” is a natural phenomenon that leaves claim 13 unpatentable under current precedent.

Interestingly, Affymetrix argues that ambiguity of whether a claim impermissibly covers a natural phenomena should be resolved in favor of invalidity to avoid serious constitutional questions. (citing Feist).

Public Patent Foundation PDF (375 KB)

PubPat argues that the CAFC has gone astray by over-reaching the permissible bounds of patentable subject matter. (Citing Alappat and State Street). Rather, PubPat would have the Court return directly to Flook.

Reviews Coming:

Download Bear Stearns & Lehman Brothers Amicus Brief.PDF (3617 KB)

Download American Heart Association.PDF (3800 KB)

Download AARP.PDF (4033.7K)

Download AMA.pdf (2553.5K)

Download AMEX.pdf (527.0K)

Download AmerClin.pdf (3007.8K)

Download CCIA.PDF (2590.7K)

Download IBM.pdf (2283.3K)

Download NYCBLA.pdf (691.6K)

Download PatNotProf.pdf (999.6K)

Download PeoplMedSoc.pdf (3316.8K)

Under 102(g), Conception of Prior Art Requires Appreciation of Invention

Invitrogen Corp. v. Clontech Laboratories (Fed. Cir. 2005).

By Donald Zuhn, Ph.D. (Patently-O Guest Author).

In an appeal from a District Court judgment invalidating more than two hundred claims in three Invitrogen patents as being anticipated under § 102(g)(2), the Federal Circuit vacated and remanded, holding that the District Court misapplied the law of appreciation when determining the date of conception for researchers at Columbia University. The Federal Circuit, however, affirmed the District Court’s rulings on enablement, written description, and infringement.

The patents at issue relate to a genetically modified version of the enzyme reverse transcriptase, that has use in the field of molecular biology. Naturally-occurring (or unmodified) reverse transcriptase possesses both DNA polymerase and RNase H activities, the former permitting the enzyme to synthesize a DNA copy (cDNA) of a messenger RNA (mRNA) template, and the latter permitting the enzyme to degrade the mRNA template following cDNA synthesis. In contrast, the genetically modified enzyme lacks RNase H activity, and therefore, is unable to degrade the mRNA template following cDNA synthesis, allowing researchers to reuse the mRNA template to create additional cDNA copies..

While neither party disputed the District Court’s determination that Invitrogen had reduced a modified reverse transcriptase lacking RNase H activity to practice in January of 1987, Invitrogen did find fault with the lower court’s ruling that Drs. Stephen Goff and Naoko Tanese, two researchers at Columbia University, had conceived of such an enzyme before Invitrogen had reduced the enzyme to practice. Drs. Goff and Tanese had begun their work in 1984 by preparing a panel of bacterial mutants having modified reverse transcriptase genes. The panel included two mutants that the Columbia University researchers would later show possess modified reverse transcriptase lacking RNase H activity. However, due to limitations in the assays that Drs. Goff and Tanese were using to measure RNase H activity, they were unable to conclusively establish that any of the mutants possessed modified reverse transcriptase lacking RNase H activity at the time the mutant panel was prepared. In March of 1987, Drs. Goff and Tanese used a new assay that they had developed to finally establish that two of the mutants from their panel possessed the modified enzyme. They were also able to correlate the results obtained with their new assay with their late 1986 sequencing analysis of the mutants.

Following a series of pre-trial motions regarding the issues of conception, enablement, written description, and infringement, the District Court determined, inter alia, that Drs. Goff and Tanese (a) had conceived of a genetically modified reverse transcriptase lacking RNase H activity either in December of 1984 when they had isolated mutants possessing modified reverse transcriptase, or in January of 1986 when they had sequenced the reverse transcriptase genes in these mutants; (b) had actually reduced their invention to practice in March of 1987 when they established that two mutants from their panel possessed modified reverse transcriptase; and (c) were diligent in reducing their invention to practice, and did not abandon, conceal, or suppress it. However, despite these rulings, the District Court refused to find that the work of Drs. Goff and Tanese anticipated Invitrogen’s patents under § 102(g)(2), arguing that anticipation posed factual questions requiring resolution on a claim by claim basis.

Stating that conception “require[s] more than unrecognized accidental creation,” and instead “requires that the inventor appreciate that which he has invented,” the Federal Circuit found that the District Court erred by establishing Drs. Goff and Tanese’s conception before January of 1987 and granting partial summary judgment for Clontech. Relying on decisions of its predecessor Court, which “require some connection between the physical result (the invention) and the belief (by the inventor),” the Federal Circuit determined that the record was inconsistent with the District Court’s notion that Drs. Goff and Tanese set out to create a modified reverse transcriptase or appreciated in 1984 that their mutant panel contained two mutants possessing modified reverse transcriptase. Rather, the Federal Circuit believed that this case “fit[] squarely within the unrecognized, accidental duplication cases.”

However, while the Federal Circuit determined that the evidence excluded both dates of conception proposed by the District Court, the Federal Circuit also found that Dr. Goff’s deposition testimony precluded it from finding that the District Court abused its discretion in refusing to grant partial summary judgment for Invitrogen on the issue of conception. In particular, Dr. Goff had testified that he had formed a suspicion in late 1986, based on his difficulties analyzing the mutants, that two of the mutants possessed modified reverse transcriptase lacking RNase H activity. Because a reasonable fact-finder presented with Dr. Goff’s testimony could conclude that the evidence preceding the researchers’ March 1987 testing might suffice, under the applicable standard, to corroborate Dr. Goff’s suspicions about the two mutants, the Federal Circuit vacated the District Court’s invalidity judgment and remanded the case for further proceedings.

NOTE: This post was written by patent attorney Donald Zuhn, PhD. Don is a true expert in cutting edge biotech patent law and practices both litigation and prosecution at MBHB LLP in Chicago. (zuhn@mbhb.com).

CAFC reverses jury finding of invalidity and noninfringement.

InfringingProducts009Callicrate v. Wadsworth (Fed. Cir. 2005).

Callicrate sued Wadsworth for infringement of its patented bull castration tools. After a trial, a jury found all of the claims anticipated, obvious, and not infringed.  On appeal, the CAFC disregarded the jury verdict and reversed.

Infringement:  The defendant admitted that its devices include all of the claim elements. Based on that admission, the CAFC determined that the jury had “no basis” for finding no infringement and that there is “no reason for a new trial.”  (Although each element was included, the defendant argued that the components were “not connected in the particular manner recited in the claims.  The CAFC does not seem to have addressed that point specifically since the jury instructions asked simply whether “each and every element” of the claim was included).

Enabling Disclosure: Callicarate’s patent claim priority to an earlier patent, but could be invalidated if they were shown to be not fully enabled by the earlier patent.  The district court found that the earlier patent did not contain adequate disclosure to support the claimed mechanism because (1) the only disclosure of the claimed mechanism is in the background section of the earlier patent; (2) the background section contains disparaging remarks about this mechanism; and (3) the patentee distinguished his assembly mechanism from the claimed mechanism during prosecution.

However, the CAFC held that these reasons were insufficient for a finding of a lack of enablement.  First, the background section can be used to enable a claim. Second, disparaging remarks do not make it any less likely that one of ordinary skill in the art would, after reading the background, know how to make and use the invention.

Defendant Challenging Claim Construction: In a cross-appeal, the defendant challenged certain claim construction terms.  However, the CAFC refused to hear that appeal because the defendant had not objected to the district court’s construction and had conceded infringement of the newly challenged element. (note: the CAFC has finally drawn a line for when it will not review claim construction).

Conclusion: Reversed and remanded because jury verdict was against the weight of the evidence.

USPTO Releases New Business Method Guidelines: Requires “physical transformation” or “concrete and tangible result”

In the wake of the Lundgren case, the USPTO has released a set of interim examination guidelines for determining subject matter eligibility of patent applications. (Link).  The guidelines will be used by examiners “in determining, on a case-by-case basis, whether a claimed invention falls within a judicial exception to statutory subject matter (i.e., is nothing more than an abstract idea, law of nature, or natural phenomenon), or whether it is a practical application of a judicial exception to statutory subject matter.”

The crux of the new guidelines is that an invention falls within the scope of 35 U.S.C. 101 “if the claimed invention physically transforms an article or physical object to a different state or thing, or if the claimed invention otherwise produces a useful, concrete, and tangible result.”  The application itself should enable one of ordinary skill in the art to understand the utility of the invention.

(more…)

Single Embodiment Of Claim Element Fails To Describe Element Generically

Patentlyo007LizardTech v. Earth Resource Mapping (Fed. Cir. 2005).

On summary judgment, the district court deemed LizardTech’s patent invalid for failing to meet the written description requirement of 35 USC 112 para 1.  The asserted patents were related to the use of discrete wavelet transform (DWT) to compress digital images.

The specification provides an example method for creating a seamless DWT including the step of “maintain[ing] updated sums” — that procedure is the focus of claim 1.  Claim 21, however, is a broader claim that lacks the “maintains updated sums” limitation.  The specification did not explicitly describe a method that did not include that limitation. (Although claim 21 was included in the original disclosure)

On appeal, the CAFC paid lip service to the rule that a claim will not be invalidated under Section 112 for only disclosing a single embodiment.  However, the court went on to determine that claim 21 was directed at “all seamless DWT’s” — a coverage not adequately supported by the single embodiment.

After reading the patent, a person of skill in the art would not understand how to make a seamless DWT generically and would not understand LizardTech to have invented a method for making a seamless DWT, except by “maintaining updating sums of DWT coefficients.”

[A] patentee cannot always satisfy the requirements of section 112, in supporting expansive claim language, merely by clearly describing one embodiment of the thing claimed.

As noted by David Long, this case is a “must read for those addressing written description (or enablement) issues.

Comments:

  • I see this as a quite odd decision.  First, although claim 21 arguably covers either “seamless DWT” or  “non-seamless DWT,” such a result is explicitly claimed.  The CAFC did not point to any element of claim 21 that was not sufficiently described.  Rather, the court found the claim invalid because an an embodiment arguably covered by the claim (seamless DWT) was not sufficiently described. 
  • A fellow patent attorney and Patently-O reader e-mailed this morning with a different take:

Section 112 requires that the patentee have both possession of the invention and an enabling disclosure. In this case, the Court found that because the patentee had only described (and apart from claim 21) claimed the one embodiment that required “maintaining updating sums of DWT coefficients” this shows that the method including this element was really the scope of what the patentee considered their invention. That is, the patentee didn’t think they had invented a more generic way of creating a seamless DWT that did not include that element.

The Court went on to say that any such generic method is also not enabled — first because it is not described in the specification and second because it is not within the ability of one of ordinary skill to practice without undue experimentation. As the Court noted, both these requirements usually rise or fall together. The last paragraph of the opinion makes clear, however, that even assuming that patentee had possession of this invention (by virtue of claim 21 being part of the original application) the claim is still not enabled. That is, even if one of ordinary skill in the art read claim 21 and recognized that it covered a generic method of creating a seamless DWT, that person still would not have been able to come up with the generic method (i.e., one not using the updating sums element) without undue experimentation. Therefore, the claim doesn’t satisfy the requirements of 112.

Thus, after this case (and as was the case, no pun intended, before LizardTech) one is free to describe one or more embodiments in the application and draft claims that cover other broader embodiments that are not described in the application. Those broader claims will be valid provided that the patentee had possession of those broader embodiments and the broader embodiments are enabled. Presumably they would be enabled because, even though not described in the application, they would still be within the ability of one of ordinary skill in the art to practice without undue experimentation.

  • The lesson for prosecutors is that broad claims will generally require multiple embodiments of each element. Specifically, if you claim A+B+C+D, do not expect that you can claim A+B+C without adequately disclosing that D is not necessary or that D can take alternative forms.
  • Philip Mann of IP Litigation Law Blog was counsel for LizardTech.

Documents:

Including Claims in Provisional Patent Applications?

An ongoing debate amongst some patent attorneys is whether to include claims in provisional applications.  According to the rules of practice, claims are not required in the provisional application. (MPEP 601).  However, there are a few good reasons for including claims in the application.

In the wake of Phillips v. AWH, it has become even more important to ensure that a patent’s specification accurately describes the meaning of the associated claim terms.  This task is all but impossible in the absence of any claim terms to describe.   Thus, it is important to draft at least a few model claims with the provisional application.  Some practitioners, such as Russ Krajec, have advocated drafting the claims but then deleting them from the application before filing.  Russ argues that claims in the provisional can only hurt the applicant.

I disagree.  The claims can be helpful in ensuring adequate disclosure and enablement — this is especially true in cases where the provisional is rushed through on a very short deadline and/or low budget.  The claims, as part of the specification, can easily tie together loose ends that may have been created in the rush.  As Todd Mayover aptly points-out, including claims in the provisional creates a clear record associating those claims with the earliest filing date or priority date.  It is also unlikely that patent attorneys would seriously stick to the practice of initially drafting claims that will eventually be deleted — this is especially true in the fast-paced area of provisional applications.  One newfound fear is that including claims in the provisional leaves the patentee open to Festo-type prosecution history estoppel.  However, we have no evidence that presenting new claims in a subsequent nonprovisional would create any such estoppel — especially since the nonprovisional is newly-filed rather than simply an amended version. 

An astute Patently-O reader provided the following comment:

I include at least one extremely broad, never likely obtainable claim in a provisional.  First under US law, it is true that a provisional need not include one in order to be considered valid.  But foreign courts can say otherwise and render the US provisional (if serving as a priority document) invalid in a foreign court. Not including a provisional claim is only useful if you are absolutely certain that you won’t go foreign.

I hear the arguments related to the effect of narrowing by amendment as creating PHE.  In the post-Festo world, you can at least explain the amendment so as to overcome the presumption of PHE.  Let’s face it, if you are relying on the DOE to win your case anyway and the case rests on whether you started broad and narrowed by amendment, you are fighting a likely unwinnable battle.  In the last 10 years or so, how many DOE cases has the Fed. Circuit actually upheld? Not too many.

No U.S. practitioner has been able to cite a case, rule, regulation, expanded Board of Appeals decision, etc. from a foreign court that has categorically said, “A U.S. provisional application serving as a priority document [to this foreign application] that does not include at least one claim is nonetheless considered a permissible priority document.”  Why take the chance of not including a claim in a provisional if there is a likelihood that the foreign counterpart could get knocked out.

Another reason to the include at least a broad claim is that most foreign laws have strict adherence to the rule that the broadest initially presented claim will set the claim scope for the application.  So if you present a very broad claim initially, you can amend narrower.  But if you present a narrower claim first then realize that you can go broader, you cannot amend to go broader.  It is for this reason you can include a “claim” that says something like, “I claim, the product comprising any feature described, either individually or in combination with any feature, in any configuration.” or a “process to […] comprising any process described, in any order, using any modality, …”

Anonymous

Please leave your own comment below.

CAFC: Genetic Tags Unpatentable Unless Function of Underlying Gene is Described

In re Fisher (Fed. Cir. 2005).

ESTs Unpatentable for Failure to Satisfy 35 U.S.C. § 101 Where Function of Underlying Gene is Unknown

by Sherri Oslick, PhD

In an opinion of great import to biotechnology patent law, the CAFC affirmed the decision of the Board of Patent Appeals that denied a patent to five expressed sequence tags (ESTs) — holding that in the absence of an identification of the function of the underlying genes, “the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent.”  In its opinions, the CAFC endorsed the 2001 PTO Utility Examination Guidelines, holding that Brenner v. Manson applies broadly to the fields of chemistry and biology and that the PTO had not applied a heightened standard for utility of ESTs. 

Monsanto, the real party in interest, had asserted that the claimed nucleic acid sequences found their use as research tools, including use in monitoring gene expression by measuring the level of mRNA through microarray technology and in identifying the presence or absence of polymorphism.  The CAFC, however, dismissed this argument and affirmed that, without presenting a specific function for the underlying gene, the claimed invention lacked a specific and substantial utility and the application in question therefore also did not meet the enablement requirement of 35 U.S.C. § 112, as it incorporates the utility requirement of 35 U.S.C. § 101. 

Following the directive from the Supreme Court in Brenner, the CAFC noted that any invention must have a substantial and specific utility. 

Substantial Utility: “an asserted use must show that the claimed invention has a significant and presently available benefit to the public.” 

Specific Utility: “an application must disclose a use which is not so vague to be meaningless” and “an asserted use must [] show that the claimed invention can be used to provide a well-defined and particular benefit to the public.”

Applying these principles, the CAFC found that the asserted utilities met neither the substantial nor the specific test.  Rejecting Monsanto’s analogy that ESTs are like a microscope, a patentable research tool used to generate data about a sample of unknown properties, the CAFC found the ESTs to be merely a starting point for further research, providing no presently available benefit. 

[W]hile a microscope can offer an immediate, real world benefit in a variety of applications, the same cannot be said for the claimed ESTs. Fisher’s proposed analogy is thus inapt. Hence, we conclude that Fisher’s asserted uses are insufficient to meet the standard for a “substantial” utility under § 101.

The CAFC also held that the asserted uses were not specific.  Asserting that any EST from the maize genome could perform any of the recited utilities, the CAFC found that Monsanto had failed to assert any utilities setting the five claimed ESTs apart from the 32,000 plus ESTs disclosed in the application or any EST for that matter.  The disclosure of such general utilities was “nebulous” and not sufficiently specific.

In dissent, Judge Rader distinguished Brenner and argued that the majority, without supporting scientific evidence, was too quick to render a value judgment that the utility of the claimed ESTs would not provide enough valuable information, that the information gained through the ESTs was too “insubstantial” to merit patent protection.  Scientific research, noted Rader, is an incremental process, and ESTs, like a microscope, possess utility, albeit limited to the laboratory setting, as research tools useful in studying other compounds.  ESTs, therefore, provide an identifiable benefit to society. Rader argued that the majority failed to recognize the complex nature of scientific discovery, and that “only the final step of a lengthy incremental research inquiry gets protection” under the majority holding.  The decision to deny protection to inventions that contribute to the “useful arts” but not to an extent justifying the exclusive right afforded by a patent, contended Rader, is more properly founded in the nonobviousness requirement of 35 U.S.C. § 103 than in the utility requirement of 35 U.S.C. § 101.

This post was written by Sherri Oslick, PhD. Sherri studied chemistry as an undergraduate at Cornell University, bio-organic chemistry as a graduate student at MIT, and biochemistry and molecular biology as a postdoctoral associate at University of Chicago.  She practices biotech patent law as a law clerk at MBHB in Chicago.  She is an Hon. Howard T. Markey Distinguished Scholar at the John Marshall Law School and will graduate later this year. [oslick@mbhb.com]

 

Links:

RIM, with the support of Canada and Intel, Ask Court for Another Review of BlackBerry Patent Case

RIMDesignPatentNTP v. Research-in-Motion (en banc review).
(Printable Version)

A new flurry of appeal briefs further complicates this closely watched case involving the fundamental question of how the U.S. patent laws can be asserted against foreign activities.  Canada based Research-in-Motion (RIM) was at the losing-end of a 2003 patent infringement trial that resulted in a permanent injunction against its popular BlackBerry system.  That judgment is stayed pending a series of appeals that have included two appellate court opinions.  Now, RIM is asking the Court of Appeals for the Federal Circuit (CAFC) to hear the appeal as an en banc panel of all twelve judges.

Background

In August, 2005, the CAFC released a second appellate opinion in the case.  The new opinion focused on the extent that a patent must be practiced within the U.S. to fall under the guise of § 271 of the Patent Act and specifically highlighted on the difference between system claims and method claims with relation to international activities.  A system, the court held, is used “within the United States” so long as the United States “is the place at which the system as a whole is put into service, i.e., the place where control of the system is exercised and beneficial use of the system obtained.”  A method, however, is only used “within the United States” if “each of the steps is performed within this country.” 

As such, RIM (RIMM) was able to avoid infringement of NTP’s method claims but not the system claims because “RIM’s customers located within the United States controlled the transmission of information and benefited from the resulting exchange of information.”

The court also opined on the inapplicability of other portions of 271 to method claims:

  • Sale: The CAFC found it unlikely that a method claim could infringe through the sale provision of 271(a).
  • Component: Distinguishing Eolas, the CAFC implied that a method claim would rarely if ever trigger 271(f).
  • Section 271(g): The import provision only applies to physical articles — and thus cannot be used to find infringement of a method for transmitting information (as claimed by NTP).

Rehearing en Banc

In the wake of the revised appellate opinion, RIM has renewed its request for an en banc rehearing – hoping that a full panel of appellate judges will eliminate the “control and beneficial use” standard for transnational infringement.  NTP opposes the rehearing. 

RIM’s Petition for Rehearing

RIMBriefDiagramIn its brief, RIM questioned the panel decision that “use” of a “patented invention” occur can “within the United States” under 35 U.S.C. 271(a) even if significant components or acts specified by the claims are outside the United States.  RIM further argued that the panel’s distinction between method and system claims was not given any justification and is “untenable.”

The Panel erred on multiple grounds. First, the Panel fails to follow the plain statutory language extraterritorially limiting  § 271(a) liability to “uses . . . within the United States.” As a result, the Panel makes an unsupported distinction between method claims and system claims creating a generic rule for all system claims that fails to consider the nature of the actual patented invention. Second, the Panel ignores basic cannons of statutory construction that forbid extending the patent statute extraterritorially absent clear Congressional direction. Third, the Panel erroneously finds § 271(a) liability based on Decca, a case decided under 28 U.S.C. 1498, the statutory language and purpose of which are entirely different from § 271(a). Fourth, the Panel misapplied that analysis and decided fact issues that should be left for the jury.

NTP’s Opposition to the Rehearing

In its opposition brief, NTP continues its barrage on RIM for its “attempts to delay purely for delay purposes.”

The Panel properly focused on the only pertinent activities for the 271(a) question presented: the acts of millions of U.S.-located BlackBerry users that put into service their U.S.-located BlackBerry handhelds to send and receive wireless emails millions of times each day using U.S.-located transceivers and US.-located email systems equipped with thousands of U.S.-located email gateway redirectors sold by RIM. The only pertinent RIM activities are those establishing inducement and contributory liability – activities conceded by RIM on appeal. Other acts that RIM raises are irrelevant. Indeed, under RIM’S reasoning, use by BlackBerry customers in other countries negates the tort of infringement arising from use in the United States. Such analysis lacks any basis in law, precedent, or reason.

NTP argued that the longstanding principles of the Decca case clearly guide this case, and that “unless [the CAFC] sua sponte intends to overturn Decca and Decca II in a manner that the Supreme Court and Congress have refused, RIM presents no issue that warrants further review.”

Microsoft’s Amicus Brief in Support of the Petition

Microsoft took time to point-out the inconsistencies between the NTP decision and the handful of other recent cases involving extraterritorial application of U.S. patent laws, and the software giant asked the court to rehear this case in conjunction with its own pending AT&T v. Microsoft to ensure a “uniform and consistent body of case law concerning the territorial reach of 35 U.S.C. § 271.” 

  • NTP v. Research in Motion, (271(f) “component” does not apply to method claims).
  • AT&T v. Microsoft, 414 F.3d 1366 (Fed. Cir. Jul. 13,2005) (271(f) “component” applies to method claims and software being sold abroad);
  • Eolas v. Microsoft, 399 F.3d 1325 (Fed. Cir. Mar. 2,2005) (271(f) “component” applies to method claims);
  • Pellegrini v. Analog Devices, 375 F.3d 1113 (Fed. Cir. 2004) (271(f) “component” does not cover export of plans/instructions of patented item to be manufactured abroad);
  • Bayer v. Housey Pharms, 340 F.3d 1367 (Fed. Cir. 2003) (271(g) “component” does not apply to importation of ‘intangible information’).

Regarding policy, Microsoft argued that limiting 271(a) U.S. patent law to not include any foreign actions, would create “an incentive for American companies to locate certain aspects of their systems outside the United States, primarily to avoid infringement liability. Such an outcome would likely result in loss of jobs, skilled workers, capital, and information technology, abroad.” On the other hand, Microsoft argued that allowing infringement for export of components under 271(f) creates “an incentive to move their research aid development abroad.”

Canadian Government’s Amicus Brief in Support of the Petition

In a rare move, the Government of Canada filed a brief supporting the petition for rehearing en banc.  The brief notes that the panel opinion does not include any discussion of the principles of comity and international law that should be considered when determining the extent that U.S. laws should be interpreted to limit activities taken on foreign soil.

Canadian%20flag“The reissued panel opinion lacks any acknowledgment or discussion of the effect of, or the effect upon, long-established international understandings and agreements regarding national jurisdiction over intellectual property. Because the decision of the panel was neither explained nor justified in terms of contemporary, internationally-accepted principles of national jurisdiction, the opinion raises questions concerning fundamental principles upon which this international intellectual property system has harmoniously been based for well over a century.”

The brief recognized that the eventual conclusion may well be that patent laws should extend transnationally.  However, the the thrust of this brief is that an expansion of extraterritorial application of the law should include a thorough analysis of the international implications.

Canadian Chamber of Commerce in Support of the Petition

The group of Canadian businesses argue that the standards created by the RIM opinion create confusion by the artificial distinction between system and process claims. Further, the group argue that the court should respect the rule of comity when construing a statute.

As the Supreme Court recently stated, courts “ordinarily construe[] ambiguous statutes to avoid unreasonable interference with the sovereign authority of other nations.” F. Hoffman-La Roche v. Empagran, 542 U.S. 155 (1994).

Seven Networks, Inc. Brief in Support of the Petition

Seven Networks argues simply that patents are “national in scope.” And, without congressional action, patents should remain national in scope.

On its face, 35 U.S.C. §271(a) is national in scope, and the statute has no extraterritorial reach. It applies to “whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States”. When a statute is silent as to its extraterritorial application, the presumption is that the statute does not have extraterritorial effect.

With reference to “control and beneficial use” standard derived from Decca, Seven argued that Decca’s decision required ownership of the foreign-located system elements.  Because RIM customers do not own the Routers located in Canada, they cannot be said to have control or be beneficially using that element.

Information Technology Association of Canada Brief in Support of the Petition

The ITAC brief takes the stance that method and system claims should be treated consistently. ITAC correctly points out that it is often quite easy to draft a “system” claim that contains the same limitations as a parallel “method” claim.

NTP’s Consolidated Response to the Amicus Briefs

  1. No amici disputes the fact that one of the patents does not even give rise to the issue of territoriality (NTP wants to avoid this altogether and just get paid).
  2. The Canadian Gov’t Brief confirms that U.S. patent laws apply when the RIM system is used Within the U.S.
  3. Microsoft supports the decision finding infringement of the system claims.
  4. The Canadian Chamber of Commerce seeks an improper advisory opinion (on product-by-process claims).
  5. The ITAC brief, prepared by RIM’s patent firm (Kirkland & Ellis) merely rehashes RIM’s old arguments.
  6. Seven Networks hopes to avoid infringement by placing its own routers abroad.

Intel’s Amicus Brief in Support of the Petition

In a brief supporting an en banc rehearing, Intel first noted that this issue is of great importance to today’s economy where many thousands of businesses operate multinationally.  Like RIM, Intel could find no “principled or policy basis” for the outcome of a multinational infringement case to depend on the form of the preamble of the claim. 

There is no reason to hold that practicing every step is essential to infringement of a claimed process, yet hold that use of every component is not essential to infringement of a claimed system.

Regarding 271(f), Intel discussed the fact that, although the four recent Federal Circuit cases discussing 271(f) purport to distinguish one another, “the ultimate holdings are difficult to square, and they lack a common analytical approach.”(See, Eolas, AT&T, Pellegrini, & NTP). “The Court has yet to take a consistent and holistic view of infringement liability in the transnational context.” 

Finally, Intel asked the court to place the burden on patent drafters — arguing that it is possible to draft claims to virtually any invention that avoids the need to extend 271(a) to cover extraterritorial activities.

In a brief filed specifically in response to Intel’s brief, RIM argued (i) that it had been filed after the deadline and thus should be considered untimely; (ii) that Intel does have a financial interest in the case; and (iii) that Intel’s brief simply rehashes old arguments.

Documents:

Links:

  • Link: Discussion of the NTP v. RIM CAFC Replacement Opinion, August 3, 2005.
  • Link: Discussion of RIM/NTP Settlement Problems, June 26, 2005.
  • Link: Expanding reach of U.S. patent law, March 6, 2005.
  • Link: Eolas v. Microsoft, March 2, 2005.
  • Link: Canada Challenges NTP ruling, January 18, 2005
  • Link: Discussion of Original NTP v. RIM decision, December 14, 2004.

Incomplete Written Analysis Results in Reversal of Summary Judgment

AceinhibitorWarner-Lambert v. Teva Pharmaceuticals (Fed. Cir. 2005).

In a dispute over Warner-Lambert’s control over its ACE inhibitor quinapril, the district court granted summary judgment of validity in Warner-Lambert’s favor.  Teva appealed, arguing that the patent was not enabled.

On appeal, the CAFC reversed and remanded.  Specifically, the appellate panel questioned the district court’s summary judgment opinion that lacked any analysis of the enablement issue:

At the outset, we find the issue of enablement difficult to review because the district court did not address it in its decision granting Warner-Lambert’s summary judgment motion. We have no way of knowing what the district court thought of Teva’s enablement defense or why the court did not address the issue in its decision. In short, we are being asked to review an incomplete record.

Based on the evidence presented by Teva and a lack of written justification for the district court judgment, the CAFC held that Teva should be given another opportunity to present its case.

Both Parties Lose Patent in Interference Proceeding

PatentlyOImage013Gary Rasmusson v. SmithKline Beecham (Fed. Cir. 2005).

Finasteride, a 5aR inhibitor, is thought to be a useful drug in the fight against prostate cancer — as well as hair loss.  In 2001, the PTO declared an interference between an application by Rasmusson and one filed on behalf of SmithKline.  The dispute revolved around whether Rasmusson’ should be allowed to claim the beneficial filing date of its earlier applications — i.e., whether the early applications enabled the later drafted claims.

Relying on articles demonstrating that various multi-active 5aR inhibitors were effective in treating prostate cancer, Rasmusson argues that a person of ordinary skill in the art at the time of his applications would have believed that administering a therapeutically effective amount of finasteride could be used for treating human prostate cancer. For that reason, Rasmusson asserts that he did not need to provide any data to demonstrate the efficacy of finasteride.

Based on published articles and expert testimony, the CAFC agreed with the BPAI that the later drafted claims were not enabled: although it was known that 5aR inhibitors blocked DHT production, at that the time of filing, “it was not clear wither DHT or testosterone caused prostate cancer.” 

Rasmusson also argued that SmithKline’s patent claims were anticipated by a reference that disclosed the claimed method of administering finasteride. SmithKline, contended that the reference could not be anticipatory because is not enabling (since the reference purports to show data that finasteride could not be used to treat prostate cancer). Agreeing with Rasmusson, the CAFC found that “proof of efficacy is not required in order for a reference to be enabled for purposes of anticipation.”

In conclusion: Rasmusson loses interference to SmithKline, but SmithKline’s patent is anticipated.  Perhaps the parties should have settled. . . .

PTO Board: Disclosure of Sequence Enables at least 5% of Natural Variance.

Blast_equationEx parte Bandman, No. 2004-2319, (BPAI 2005)

By Donald Zuhn

In an appeal from a final rejection, the PTO Board reversed rejections based on both the written description and enablement requirements of 35 U.S.C. § 112, first paragraph, and entered a new ground of rejection under 35 U.S.C. § 112, second paragraph one of the claims. (U.S. Application No. 09/915,694). 

Pointedly, the Board found that claims directed to a naturally occurring amino acid (or polynucleotide) sequence at least 95% identical to the disclosed amino acid (or polynucleotide) sequence were enabled and met the written description requirement.

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Indecipherable Patents

PatentlyOImage002The June 2005 Corporate Legal Times includes an interesting roundtable discussion on patent reform.  The participants were all in-house patent counsel.  In the discussion, Richard Rodrick of S.C. Johnson raised an issue that has not been touched by any of the proposed patent reforms.

You can write a patent application today that is almost indecipherable, and you’ve got a good chance of getting it out of the patent office with a patent. 

Anyone who regularly reads patent documents knows that Rodrick is right on the money.  Should the Patent Office be issuing more rejections based on a lack of clarity in the specification based on the requirements of Section 112?

LINKS:

March 2005 Report on New Academic Research

PatentlyOImage004

Each month I post a note discussing new research from the academic side of patent law.  This March edition includes three great articles that relate to either legislative changes (prior use statute, post grant opposition) or upcoming court decisions (Phillips claim construction case).  Feel free to e-mail suggestions for April’s edition.

  1. Tom Fairhall and Paul Churilla, Prior Use of Trade Secrets and the Intersection with Patent Law, 14 Fed. Cir. Bar J. 455.  Fairhall and Churilla present a timely article on prior use rights that notes how the current prior use statute (35 USC 273) does not provide the scope necessary to truly protect a prior user’s expectations or investments.  The article is quite timely because FTC proposals to expand the statutory prior use rights is gaining some teeth in the patent community and on the Hill.
  2. Mark Lemley, The Changing Meaning of Patent Claim Terms, available at SSRN.  Professor Lemley’s article is also timely — he discusses at what particular point in time should the meaning of claim terms be fixed.  This is important because the ordinary meaning of terms in the English language change over time.  The major temporal candidates are (i) at the time of the invention (currently used for novelty and nonobviousness); (ii) at the time the application was filed (currently used for enablement or written description); (iii) a the time the patent issues (currently used for means-plus-function claim construction); and (iv) at the time of the infringement (at least some times used to determine infringement).  Lemley agrees that each candidate has a sound legal foundation.  However, he argues that the best approach moving forward is to fix the meaning at the time the patent application is first filed.
  3. Jay Kesan and Andres Gallo, Why ‘Bad’ Patents Survive in the Market, available at SSRN. The professors provide a game theory model to show how would-be invalid patents can survive and be valuable in the marketplace.  Essentially, the transaction costs make it difficult to mount an effective challenge to improperly granted patents.  Their work will serve as the theoretical basis any proposed post-grant opposition procedures.  Specifically, the authors “conclude that a low-cost, post-grant opposition process based primarily on written submissions within a limited estoppel effect . . . will serve as an effective instrument for improving the quality of patents that are issued and enforced.”

Eight is Enough: Eight important patent cases for Spring 2005

There are lots of great cases on the Federal Circuit’s spring calendar.  Several cases pending at either the Federal Circuit or Supreme Court that are ‘worth a special look,’ according to Hal Wegner.  Here are some highlights of Mr. Wegner’s list, with my own comments.

  • Merck v. Integra, Supreme Court decision by June 27, 2005.
  • LabCorp v. Metabolite, petition for cert submitted, Supreme Court has requested Solicitor General’s Opinion on Cert.  The case involves a patentability question — whether Metabolite’s patented method of detecting vitamin B deficiency should be invalid as "because one cannot patent laws of nature, natural phenomena, and abstract ideas." 
  • Purdue Pharma v. Endo, CAFC heard oral arguments in early November on the question of whether patentee’s conduct was ‘inequitable’ for failing to disclose that results used to establish patentability were prophetic rather than experimental. A decision is expected soon.
  • SmithKline Beecham v. Apotex, awaiting decision on petition for rehearing.  This case now revolves around the question of whether use of an invention to confirm utility for FDA approval is an ‘experimental use’ that saves a patent from anticipation under 102(b).
  • Phillips v. AWH, awaiting en banc decision on claim construction methodology.
  • Eolas Technologies v. Microsoft, Federal Circuit decision awaited, hopefully discussing the scope of 271(f). The upcoming appeal of AT&T v. Microsoft presents the same ‘golden master disk‘ scenario as Eolas, and will become important if Eolas is decided on other grounds.
  • Independent Ink v. Illinois Tool Works, In January, the CAFC determined that, in an antitrust tying case, a patent presumptively defines the relevant market as the nationwide market for the patented product itself.  There is some potential for cert in this case.
  • NTP, Inc. v. Research in Motion, Ltd., there is a good chance for a rehearing in this case involving RIM’s BlackBerry product.  This case will be important in defining extraterritorial application of U.S. patent laws in the modern era of networked computing systems.
  • In re Fisher is not yet on the CAFC calendar.  In this case, the BPAI affirmed a rejection for lack of utility and enablement (101 and 112 p1) because the specification lacked a specific teaching of a substantial utility.  According to the decision, without a specific teaching of substantial utility, then virtually all chemicals would meet the requirements of section 101 as at least "useful in research."

Although not patent litigation, Sarah Stirland (one of the few reporters focusing on intellectual property) at the National Journal has written a nice article regarding the potential for legislation in the 109th Congress.

Printable Version

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