Tag Archives: Enablement

Top-Ten Pending Patent Cases

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Foley attorney Hal Wegner regularly updates his list of the top-ten most important pending patent cases ranked according to their likely impact on the law. The list follows with my own annotations.

  1. Ariad v. Eli Lilly: This en banc case is fully briefed and pending decision on the question of whether the written description requirement of Section 112 should be considered separate and distinct from the enablement requirement. In many ways, the case is about how the law should define the inventor’s “possession” of the invention.
  2. I4i v. Microsoft: A petition for en banc rehearing has been filed on issues of damages and injunctive relief.
  3. Mayo v. Prometheus: This case is on petition for certiorari to the Supreme Court on the question of patentable subject matter for medical diagnostic methods. It has the potential to be a Bilski follow-on.
  4. Bilski v. Kappos: This patentable subject matter case is pending decision at the Supreme Court.
  5. Pequignot v. Solo Cup: Question of intent necessary for false marking charges.
  6. Microsoft v. Lucent: Microsoft is expected to file a petition for certiorari on the “clear and convincing” standard required for invalidating a patent. Microsoft argues that the standard should be lowered when the most pertinent prior art was not considered during patent prosecution.
  7. Arkansas Carpenters: [UPDATED AND CORRECTED] The Second Circuit is considering whether a “reverse payment” from a patentee to an ANDA generic challenger to settle a patent challenge should be considered an antitrust violation.
  8. Costco v. Omega: This case is pending certiorari with an outstanding request for the views of the Obama administration. The case raises an important question of copyright exhaustion in the context of authorized sales of copyrighted material on foreign soil. If decided by the Supreme Court, the case will likely impact patent doctrine.
  9. Princo v. ITC: En banc argument is scheduled for March 3, 2010 on the contours of antitrust and patent misuse in the standard-setting processes.
  10. Acushnet v. Callaway: Whether the legal determination of obviousness should be made by a judge – rendering a jury’s conclusion on that question “entirely advisory.”

Recent Jury Verdicts

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Cerner v. Visicu, 4-cv-1033 (W.D. Mo., December 8, 2009) (Visicu’s asserted claims held not infringed and invalid as obvious).

Hologic, Inc. et al v. SenoRx, Inc, 08-cv-0133 (N.D. Cal. December 17, 2009) (Hologic asserted claims held not infringed and obvious).

DNT, LLC v. Sprint Nextel Corporation, 03-cv-0021 (E.D. Va. December 14, 2009) (DNT’s claims held not infringed and lacking written description & enablement)

Retractable Technologies, Inc. v. Occupational & Medical Innovations, Ltd., 08-cv.-0120 (E.D. Tex. December 18, 2009) (patent claims held infringed and valid with damages of $1.5 m). Verdict included additional $2.2m for trade secret misappropriation.

Presidio Components Inc v. American Technical Ceramics Corp, 08-cv-0335 (S.D. Cal. December 16, 2009)(patent claims held infringed and valid with damages of $1.0 m in lost profits).

Underlying data via http://lexmachina.com.

  

Patent Law Exam: Pioneering Patents

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Here is the ‘policy question’ from my 2009 patent law exam:

Essay 3 (15 points) < ?xml:namespace prefix ="" o />

 

Congressman I. N. Venter has proposed an amendment to the Patent Act that would create a special right known as a “pioneering patent.” According to the proposal, pioneering patents would be awarded for inventions that are both the product of genius and that dramatically alter the technology landscape. Examples might include the airplane and the polymerase chain reaction (PCR).  The pioneering patent would require greater evidence of nonobviousness, but the applicant would be allowed to pursue broader claims that might not otherwise satisfy the enablement and written description requirements of Section 112.  What are the pros and cons of this proposal? Would a better approach be to extend the patent term a number of additional years for inventions determined to be pioneering? (I.e., longer patents instead of broader patents).

 

 

Cases where Written Description is Satisfied, but Enablement is Lacking

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In Ariad, an en banc Federal Circuit is set to determine whether (and how) the written description requirement is separate and distinct from enablement. The questions presented read as follows:

1. Whether 35 U.S.C. § 112, paragraph 1, contains a written-description requirement separate from the enablement requirement.

2. If a separate written-description requirement is set forth in the statute, what is the scope and purpose of that requirement?

I’m interested in finding cases where the written description requirement has been critical to the outcome. More particularly, I’m interested in seeing cases where the invention is sufficiently described but is not enabled. The recent major written description cases are seemingly only tied to written description doctrine because the panels chose to focus on that argument rather than enablement. A case-in-point is Ariad v. Eli Lilly. As in most written description cases, Ariad’s patent was also challenged on enablement grounds. However, rather than reaching the enablement question, the panel majority held that question moot in the wake of their finding that the asserted claims were invalid on written description. The same result occurred in University Of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916 (Fed. Cir. 2004) (holding that “in view of our affirmance of the district court’s decisions [invalidating the claims] on the written description ground, we consider the enablement issue to be moot and will not discuss it further.”). The LizardTech decision held the asserted claim invalid under both enablement and written description doctrines.

Using the language lf LizardTech, what are examples of cases where the specification provides enough disclosure “to convince a person of skill in the art that the inventor possessed the invention” but not enough to “enable such a person to make and use the invention without undue experimentation.”

Best Mode at the BPAI

Patent

Ex parte Lin, Appeal No. 2009-4275, Application No. 10/255,216 (BPAI October 30, 2009)

The Examiner rejected Lin’s patent application for failure to comply with the best mode requirement of 35 USC § 112p1. The Board reversed that rejection because Lin had not disclosed any embodiments. “The best mode provision of 35 U.S.C. § 112 is not directed to situations where no mode has been set forth, and therefore we cannot sustain this rejection.” (Citing Spectra-Physics and In re Glass)

Although Lin won that argument, the board affirmed parallel rejections of lacking enablement, utility, and definiteness.

Under the Federal Circuit’s 2002 precedent of Bayer v. Schein Pharma, the best mode requires “actual disclosure regardless of whether [the best mode] would be within the knowledge of one of ordinary skill in the art.”

The Requirement that the Written Description be Concise

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ProlixBy Dennis Crouch

The Patent Act requires that the written description of an invention be “concise.”  35 U.S.C. 112p1. The meaning of that requirement is unclear, but but the language of Section 112 at least suggests that a written description needs to be concise in order to satisfy the enablement requirement. Of course, there is a tension between providing a disclosure that is “concise” and at the same time “full.” In Markman v. Westview, the Supreme Court recognized this tension — noting that the description must be “complete yet concise.”

In a 1967 district court case, the court focused briefly on the requirement — noting that the “descriptions contained in the patent in suit are sufficiently concise and clear to enable one skilled in the art to construct that which is taught by the patent.” San Marino Electronic Corp. v. George J. Meyer Mfg. Co., 155 U.S.P.Q. (BNA) 617 (C.D. Cal. 1967).

In my brief search, I found no cases invalidating a patent because its description was not concise. The most on-point case appears to be a pre-1952 Eighth Circuit case where the court came close to invalidating a family of patents based on their wordiness:

We think that the patents are unnecessarily prolix in verbiage and there should have been fewer claims more simply stated. They border on failure to comply with the statutory requirements concerning succinct description and particular pointing out and claiming. But consideration of the file wrappers and the trial court record has persuaded that those skilled in the art have understood them and the courts have had them explained.

National Aluminate Corp. v. Permutit Co., 145 F.2d 175 (8th Cir. 1944). It is interesting that part of the court’s problem with the patents was that they had too many claims. The USPTO does reject individual claims that it deems overly wordy or “prolix.” The idea behind those rejections is that sometimes overly-wordy claims may have the “net result of which is to confuse rather than to clarify.” However, the USPTO prolix rejections are grounded in Paragraph 2 of Section 112 — for failing the requirement of “particularly pointing out and distinctly claiming the subject matter.”

The probably more accepted use of the “concise” requirement is explained in the decision captioned Application of Knowlton, 481 F.2d 1357 (C.C.P.A. 1973). In that case the precurser to the Federal Circuit relied on the requirement to limit the power of the enablement requirement.

[I]t must be borne in mind that the disclosure need not only be full, clear and exact to satisfy the statute, it must also be concise, and that the disclosure is directed to those skilled in the art. The amount of precision necessary in any given case is always a matter of degree. Absent special circumstances it is not required that every nut, bolt and rivet actually used in mechanical inventions be described, or, in chemical cases, that the electron orbital patterns for a claimed compound be set forth.

In the right case, a defendant may well convince a court to give the concise requirement its full weight and invalidate a patent whose specification is written in confusing and overly-wordy language.

Notes:

  • I searched the BPAI database of decisions (1997–2009) and found only one case reviewing a rejection where the Examiner found claims invalid as prolix “since they contain long recitations or unimportant details which hide or obscure the invention.” Ex parte Nagano, App. No. 1996–4094 (Bd. Pat. App. Inter. 1999). In Nagano, the Board reversed the rejection – finding no support for the Examiner’s generalized assertions that the claims were confusing because of their length or contained unimportant details.

Patently-O Bits and Bytes No. 304

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  • Next Monday (December 7, 2009) at 2:00 P.M. in Room 201, the Federal Circuit will hear en banc arguments in the case of Ariad Pharmaceutical v. Eli Lilly. The case questions whether Section 112 of the Patent Act creates a written description requirement that is separate and distinct from the enablement requirement. An audio version of the oral arguments is expected to be available that same day. [Calendar]
  • PATracer reports on the pending Federal Circuit case of Kawasaki v. Bombadier. In that case, Kawasaki had sued to enforce the terms of a settlement agreement. Rather than enforcing the agreement, Judge Folsom of the E.D. Tex. dismissed the lawsuit – holding that his court lacked subject matter jurisdiction over what had become a contract dispute. In the 1994 case of Kokkonen v. Guardian Life, the Supreme Court held that unless incorporated into a court order, disputes over a settlement agreement must stand on its own jurisdictional feet. [LINK]
  • Eriq Gardner asks Can a Science-Fiction Movie Infringe a Tech-patent? His question is prompted by a lawsuit where – you guessed it – a patentee (Carl Burnett & his company Global Findability) has sued Summit Entertainment for making/distributing the Nicholas Cage film entitled “Knowing” in which Cage is portrayed as acting like he is using an allegedly infringing geo-locator. The complaint was filed by the Cahn Samuels firm in Federal Court in Washington DC. In the movie setup, the geo-locating technology is based on information provided in 1958 (and rediscovered in 2008). If pretending to be an infringer is actionable, this reconstructed history may also render the patent obvious… The movie was critically panned, but Cage’s star power still helped bring in almost $80 million in box office revenues.
  • Global Findability’s patent is actually quite interesting. It focuses on a mechanism that converts latitude, longitude, & altitude readings into a “single discrete all-natural number.” I.e., one number to uniquely identify a position anywhere (relative to the earth). [LINK]

 

A Brief Defense of the Written Description Requirement

Patent,

by Michael Risch

The Federal Circuit’s upcoming consideration of Ariad v. Lilly has generated a fair amount of buzz among those who follow patent policy. The dispute arises from the interpretation of 35 U.S.C. 112 ¶ 1, which states in relevant part:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same….

All agree that this language includes an “enablement” rule, which requires that the specification enable a person having ordinary skill in the art (the PHOSITA) to make and use the invention. More controversial is the phrase, “written description of the invention,” and whether that phrase entails a separate requirement apart from enabling the PHOSITA to make and use the invention. It appears that academics are split on the question, and most practitioners appear to disfavor a separate requirement.

This essay briefly describes the dispute, and then raises an important but under-theorized argument in favor of a separate written description requirement. The essay accepts the persuasive grammatical reading of the statute proposed by opponents of a separate written description requirement. This reading suggests that a patent disclosure is sufficient so long as the PHOSITA can practice the invention.

However, while enablement is necessary to satisfy Section 112, it is not sufficient. The statutory language certainly requires that an applicant identify the invention sufficiently to allow a PHOSITA to make and use it. However, even if the specification enables a PHOSITA to practice the invention, the applicant is not relieved of the obligation to identify the invention. Instead, the specification must contain a “description of the invention” even if such description would only serve to reinforce other parts of the disclosure that enable one to make and use the invention.

This reading of the statute is consistent with the grammatical breakdown of Section 112. It is also the preferred interpretation, because a description of the invention fulfills an important purpose in the patent system. The requirement ensures that the applicant actually invented the claimed subject matter. Reading description out of the statute would allow patent applicants to claim subject matter they did not invent, and would effectively rewrite nearly 120 years of precedent about the conception of inventions.

This is certainly not the only argument in favor of a written description requirement; a strong written description requirement provides policy benefits in clarifying claim scope and policing patentable subject matter. This essay leaves such benefits to the side, and focuses only on the statutory basis for the rule.

Finally, the essay considers the Ariad case and concludes, perhaps surprisingly, that under the vision of written description presented in this essay the claims at issue may well be described.

The remainder of the essay is available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1504631.

Precedential BPAI Opinion Rejects Functional Claim Elements as Indefinite and Not Enabled

Indefinite, Patent,

logoEx parte Rodriguez, 08-0693 (BPAI 2009) (Precedential) fd080693.pdf 

In its first precedential decision since February 2009, an expanded BPAI panel has applied the Federal Circuit's 2008 Aristocrat decision in rejecting applicant's means-plus-function (MPF) claims as indefinite for failing to provide any corresponding structures in the specification other than a general purpose computer. From Aristocrat:

For a patentee to claim a means for performing a particular function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Because general purpose computers can be programmed to perform very different tasks in very different ways, simply disclosing a computer as the structure designated to perform a particular function does not limit the scope of the claim to "the corresponding structure, material, or acts" that perform the function, as required by section 112 paragraph 6.

In Aristocrat, the Federal Circuit made clear that reference to "appropriate programing" was not sufficient to transform a general purpose computer into a specific structure for 112p6 purposes. Rather, the court indicated that an algorithm for operating the computer should also be provided in the specification.

Here, the Rodriguez claim 10 included several MPF elements such as "means for generating a random system configuration file." However, the specification did not include an algorithm for generating the file apart from a statement that "[a]ppropriate software coding can readily be prepared by skilled programmers." Based on that failure the claim was found invalid as indefinite.

The Appellants have failed to disclose any algorithm, and thus have failed to adequately describe sufficient structure, for performing the functions recited in the means elements contained in claim 10 so as to render the claim definite. Accordingly, claim 10 is unpatentable under 35 U.S.C. 112, second paragraph, as indefinite. Aristocrat, 521 F.3d at 1333.

The remaining claims did not use standard MPF claim language. However, the Board found that the remaining claims all included elements that were properly interpreted as MPF because they claimed functional elements without any "noun denoting structure." (Citing Lighting World & Linear Tech). The claim elements in question include a "system configuration generator," "system builder," and "simulation verification environment." (et al.). These are the same functional elements found in claim 10 – and thus were found indefinite for failing to provide any corresponding structure in the specification.

In many ways, this MPF structure requirement runs parallel to the written description doctrine. It may well be that one of ordinary skill in the art could easily generate a random system configuration file without undue experimentation. That potential fact is irrelevant for MPF definiteness analysis. Rather, the question for definiteness of a MPF claim is whether a corresponding structure is described in the specification.

The Board did also rejected the claims for lack of enablement under Miyazaki because the functional claim language was not "commensurate in scope with an enabling disclosure." As the use of MPF claims has dropped, this third portion of the opinion may be the most important.

Notes:

  • The patent application is owned by LSI and entitled "Automated random verification of complex and structurally-variable systems."
  • Rejected Claim 1 is listed below. 

  1. 1. An apparatus comprising: a system configuration generator configured to generate a random system configuration file of a structurally variable and complex system; a system builder configured to build a system level netlist in response to said random system configuration file; and a simulation verification environment configured to verify said structurally variable and complex system in response to said system level netlist, wherein said simulation verification environment is configured to provide automatic random verification of said structurally variable and complex system in response to said random system configuration file.

Ariad v. Lilly Amici Briefs

Patent,

NYIPLA Amicus Brief.pdf: Supporting a strong written description requirement: "By the time of the O'Reilly v. Morse decision in 1853, 56 U.S. (15 How.) 62, it was understood that attempting to dominate an entire field by generic functional claiming was prohibited when the applicant had invented and disclosed only limited techniques or apparatus to carry out such function. Though phrased differently, this doctrine has continuing vitality and is today most closely embodied in the requirement that the specification enable the full scope of the claimed invention."

Professors Janis & Holbrook.pdf: Section 112 does not support a separate written description requirement – not even one limited to the context of new matter.

Morris.DOC: The text of Section 112 does not create a separate written description requirement. Professor Morris suggests giving teeth to Section 112p2 in requiring the applicant to "particularly point[] out and distinctly claim[] what he regarded as his invention."

Novozymes.pdf: WD should be limited to new matter issues.

Holman in Support of Neither Party.PDF: The genus and species possession requirements unjustifiably discriminate against biotech inventions by creating a technology-focused super-enablement requirement. [Read Prof. Holman's Biotech IP Blog where he is following the case.]

University of California (and other major patent-holding universities): The requirements prejudice university researchers who "often make the most important basic science discoveries. . . . As a result [of the written description requirement], university researchers are denied the recognition and reward of inventorship due solely to lack of a available resources rather than lack of inventive contribution."

Patently-O Bits and Bytes No. 132

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  • Ariad v. Eli Lilly (Written Description): Ariad has filed its opening brief in the en banc Federal Circuit challenge to the statutory basis for a written description requirement that is separate and distinct from enablement requirement. The patentee’s strongest arguments are textual and historic. Although done with tact and persuasive skill, the brief asks the court to read the statute: “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” [File Attachment: Ariad v. Lilly Plaintiffs-Appellees Principal Brief.pdf (509 KB)]
  • Forest Group v. Bon Tool False Marking Case: The question on appeal is whether mass production of a falsely marked product constitutes a single instance of false marking. If the Federal Circuit agrees, the false marking statute will continue to have no impact because damages are limited by statute to $500 or less per offense. Judges Rader, Plager, and Moore will likely issue a decision in January. In oral arguments, the court struggled with the potential problem of “marking trolls” — suggesting that an amicus in this case is “pretty close to that.”
  • USPTO Website: Out of Beta
  • Patent Reform: Senator Leahy has suggested a Senate debate on patent reform “before the end of the year.”
  • Board of Patent Appeals: Numbers are in for FY2009 (ending September 30, 2009). 15,349 appeals docketed; 6,757 appeals completed; 12,489 appeals pending at the end of the FY. The Board took heroic efforts to increase its throughput by over 35% in FY2009. However, the Board was already operating in a deficit and the number of cases received in FY2009 is more than double that of FY2008.
  • Board of Patent Appeals II: Despite the backlog, the Board reports an average pendency of only 7.7 months (calculated from assignment of appeal number to decision date).
  • Patent Law Jobs:

Patently-O Bits and Bytes No. 132

Enablement, Patent, , ,
  • Ariad v. Eli Lilly (Written Description): Ariad has filed its opening brief in the en banc Federal Circuit challenge to the statutory basis for a written description requirement that is separate and distinct from enablement requirement. The patentee’s strongest arguments are textual and historic. Although done with tact and persuasive skill, the brief asks the court to read the statute: “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” [File Attachment: Ariad v. Lilly Plaintiffs-Appellees Principal Brief.pdf (509 KB)]
  • Forest Group v. Bon Tool False Marking Case: The question on appeal is whether mass production of a falsely marked product constitutes a single instance of false marking. If the Federal Circuit agrees, the false marking statute will continue to have no impact because damages are limited by statute to $500 or less per offense. Judges Rader, Plager, and Moore will likely issue a decision in January. In oral arguments, the court struggled with the potential problem of “marking trolls” — suggesting that an amicus in this case is “pretty close to that.”
  • USPTO Website: Out of Beta
  • Patent Reform: Senator Leahy has suggested a Senate debate on patent reform “before the end of the year.”
  • Board of Patent Appeals: Numbers are in for FY2009 (ending September 30, 2009). 15,349 appeals docketed; 6,757 appeals completed; 12,489 appeals pending at the end of the FY. The Board took heroic efforts to increase its throughput by over 35% in FY2009. However, the Board was already operating in a deficit and the number of cases received in FY2009 is more than double that of FY2008.
  • Board of Patent Appeals II: Despite the backlog, the Board reports an average pendency of only 7.7 months (calculated from assignment of appeal number to decision date).
  • Patent Law Jobs:

Patently-O Bits and Bytes No. 132

Enablement, , ,
  • Ariad v. Eli Lilly (Written Description): Ariad has filed its opening brief in the en banc Federal Circuit challenge to the statutory basis for a written description requirement that is separate and distinct from enablement requirement. The patentee’s strongest arguments are textual and historic. Although done with tact and persuasive skill, the brief asks the court to read the statute: “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” [File Attachment: Ariad v. Lilly Plaintiffs-Appellees Principal Brief.pdf (509 KB)]
  • Forest Group v. Bon Tool False Marking Case: The question on appeal is whether mass production of a falsely marked product constitutes a single instance of false marking. If the Federal Circuit agrees, the false marking statute will continue to have no impact because damages are limited by statute to $500 or less per offense. Judges Rader, Plager, and Moore will likely issue a decision in January. In oral arguments, the court struggled with the potential problem of “marking trolls” — suggesting that an amicus in this case is “pretty close to that.”
  • USPTO Website: Out of Beta
  • Patent Reform: Senator Leahy has suggested a Senate debate on patent reform “before the end of the year.”
  • Board of Patent Appeals: Numbers are in for FY2009 (ending September 30, 2009). 15,349 appeals docketed; 6,757 appeals completed; 12,489 appeals pending at the end of the FY. The Board took heroic efforts to increase its throughput by over 35% in FY2009. However, the Board was already operating in a deficit and the number of cases received in FY2009 is more than double that of FY2008.
  • Board of Patent Appeals II: Despite the backlog, the Board reports an average pendency of only 7.7 months (calculated from assignment of appeal number to decision date).
  • Patent Law Jobs:

Claim Construction: A Structured Framework*

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Guest post by Professor Peter S. Menell (UC-Berkeley School of Law); Matthew D. Powers (Weil, Gotshal & Manges LLP); and Steven C. Carlson (Fish & Richardson PC) 

The construction of patent claims plays a critical role in nearly every patent case. It is central to evaluation of infringement and validity, and can affect or determine the outcome of other significant issues such as unenforceability, enablement, and remedies. Yet jurists and scholars have long lamented the challenges of construing patent claim terms. The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005), stands as the most authoritative decision on claim construction doctrine. But while putting to rest various controversies, many core tensions in claim construction persist. Moreover, the decision itself does not provide a step-by-step approach to construing claims. This commentary provides a structured road map.

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An Initial Comment on Prometheus: The Irrelevance of Intangibility

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By Kevin Emerson Collins, Associate Professor of Law, Indiana University Maurer School of Law—Bloomington [BIO][Articles][PDF Version of this Post]

Background: The Machine-or-Transformation Test of Bilski

Last fall, the Federal Circuit articulated the “machine-or-transformation” test for patent eligibility in its landmark case In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc). It held that a method is eligible for patent protection only if it is either (a) limited to a “particular machine” or (b) responsible for transforming a “particular article” into a different state or thing. Id. at 954. Additionally, in a classic example of language that adds judicial wiggle room, the machine or transformation that satisfies either of these prongs “must impose meaningful limits on the claim’s scope,” it “must be central to the purpose of the claimed process,” and it must not be part of “insignificant extra-solution activity” or a “mere data-gathering step.” Id. at 961–62 (emphases added).   

The Supreme Court has accepted certiorari in Bilski, but the impending Supreme Court opinion has not stopped the Federal Circuit from issuing what is perhaps its most important case to date applying the machine-or-transformation test: Prometheus Laboratories, Inc. v. Mayo Collaborative Services. There have been two distinct types of claims that have taken center stage in recent debates over the section 101 doctrine of patent eligibility: “business methods” and what I will call “determine-and-infer methods.” The claim at issue in Bilski describes a classic business method. In contrast, Prometheus involves a determine-and-infer method. The Federal Circuit’s opinion in Prometheus opens a new window into the import of the machine-or-transformation test. Regardless of one’s views of the soundness of Federal Circuit’s reasoning in Prometheus, herein lies one of the opinion’s greatest virtues. By issuing Prometheus before the Court’s oral arguments in Bilski, the Federal Circuit has helped to clarify the stakes of the Court’s decision to sanction, reformulate, or reject the machine-or-transformation test.   

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Federal Circuit: Is a Human An Animal? Written Description; Enablement; and Inventorship

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Martek Biosciences v. Nutrinova and Lonza (Fed. Cir. 2009)

[Read part I of the discussion of Martek]

Sitting in as an expanded five-member panel, the Court of Appeals for the Federal Circuit has largely affirmed a jury verdict finding Martek’s patents valid and infringed. The case involves issues of written description, enablement, sufficiency of infringement evidence, corroboration of prior inventorship arguments, and claim construction of the word “animal.” The five members agreed as to all issues except for claim construction. On that claim construction issue, the majority opinion of Judges Newman, Gajarsa, and Moore held that a human is an animal. Judges Lourie and Rader argued in dissent that the patentee’s use of animal suggested that it did not include humans.

Is a human an animal: The four patents in suit cover various aspects of making and using the omega-3 fatty acids. Nutrinova sells allegedly infringing products for human consumption. One of the patents claims a method for achieving high concentrations of the omega-3 acids in an “animal,” and the parties contested whether an a human is an animal. The majority based its decision on the maxim that the patentee is free to be its own lexicographer. “When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls.” In its specification, Martek appears to plainly define the term animal in the following sentence: “The term ‘animal’ means any organism belonging to the kingdom Animalia.” It is undisputed that humans are classified within the kingdom Animalia – and thus, humans fit within the claims animal limitation. Q.E.D.

According to the court, once a patentee defines a term, extrinsic evidence of that term’s meaning “is simply irrelevant.” On remand, the district court will need to consider whether the patent is infringed under the broader definition.

The dissent does not disagree with the traditional maxim, but argues that the patent is not so clear in its definition:

This case illustrates the unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent. Martek’s attempt at lexicography does not conform to the way in which it otherwise describes its invention.

In particular, the dissent points to the fact that the claim in question is “a method of raising an animal” in a way that increases the “content of omega-3 highly unsaturated fatty acids in said animal” and that the field of the invention looks toward “food products derived from such animals.” The specification and claims spell out a variety of animals that could be so-raised: poultry, swine, cattle, shrimp, shellfish, milk producers, and goats. However, the specification only refers to humans when it discusses the benefits of ingesting the milk and meat of those animals.

Written Description: The accused infringers argued that the patentee had added new matter to the claims of one of the patents during prosecution and that the claims are consequently invalid under the traditional written description requirement of 35 U.S.C. § 112. The Federal Circuit disagreed – finding that the jury had sufficient evidence to reject the written description argument. In particular, the ‘594 patent generally claims “a food product.” Although that claim term had been added during prosecution, the Federal Circuit found that it was sufficiently supported by the original disclosure – noting again that “the earlier application need not describe the claimed subject matter in precisely the same terms as found in the claim.” Tech Licensing (Fed. Cir. 2008). Rather, the test is “whether the disclosure of the application relied upon reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.”

Evidence of Infringement: The claims of the ‘281 patent recite a limitation that the claimed microorganisms designed to create the omega-3 fatty acids caused less vessel damage than another other cultural medium (which used more sodium chloride). Martek did not provide results of any physical analysis of the accused infringing product to ensure that it met this limitation. Rather, Martek’s experts discussed the “literature” on the topic and a conceptual analysis of the known effects of a high chlorine concentration. On appeal, the Federal Circuit affirmed that the expert testimony was sufficient for a jury to find infringement – holding that there is no “general rule requiring one who alleges infringement of a claim containing functional limitations to perform actual tests or experiments on the accused product or method. Rather, a “patentee may prove infringement by any method of analysis that is probative of the fact of infringement.” Forest Labs. 239 F.3d 1305 (Fed. Cir. 2001).

Evidence of Prior Inventorship: It is improper to say that ‘prior inventorship’ is a defense to patent infringement. However, an accused infringer can invalidate a patent under 35 U.S.C. § 102(g)(2) by showing clear and convincing evidence that it (1) conceived of the invention before the patentee and (2) either reduced the invention to practice or was diligent in reducing the invention to practice from a time beginning before the patentee’s conception date; and (3) did not abandon, suppress, or conceal the invention. In this case, the defendants had filed a patent application on a similar invention prior to the patentee. However, that application had gone abandoned. The application properly serves as evidence of conception, but – because it was abandoned – does not serve as constructive reduction to practice. Here, the accused infringer’s defense failed because it could not provide other corroborating evidence of reduction to practice or diligence.

Enablement: The claims of the ‘567 patent were found invalid on JMOL due to lack of enablement due to a genus-species issue. Claim 1 broadly discusses growing “euryhaline microorganisms” while the specification only discloses two examples of thraustochytrium and schizochytrium organisms. The defendants’ experts testified that there were at least 10,000 different qualifying species and the district court agreed that two species were insufficient. On appeal, it appears that the patentee gave-up on its claim 1, but the Federal Circuit agreed that the other claims had been improperly invalidated because they included limitations to the specific examples proffered in the specification. Evidence presented indicated that the species of those dependent claims together encompassed “only 22 known species.”

Federal Circuit Expanded Panel

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Martek Biosciences Corp. v. Nutrinova, Inc. (Fed. Cir. 2009) (expanded panel)

Sitting in as an expanded five-member panel, the Court of Appeals for the Federal Circuit has largely affirmed a jury verdict finding Martek’s patents valid and infringed. The case involves issues of written description, enablement, sufficiency of infringement evidence, corroboration of prior inventorship arguments, and claim construction of the word “animal.”  The five members agreed as to all issues except for claim construction. On that issue, the majority opinion of Judges Newman, Gajarsa, and Moore held that a human is an animal.  Judges Lourie and Rader argued in dissent that the patentee’s use of animal suggested that it did not include humans.

I’ll write more about the case in a separate post, but here I want to focus on the procedure of an expanded panel.

Expanded Panel: It appears that the expanded panel was prompted in-part as a show dignitaries who were visiting the court.  The court claimed authority under 28 U.S.C. 46(b) which indicates that the “Federal Circuit . . . may determine by rule the number of judges, not less than three who constitue a panel.”  There is a problem with this authority. The statute calls for the court to create a “rule” for determining the number of judges. Rather than following a rule, however, the expanded panel here appears to be an ad-hoc creation. 

Notes:

  • Parallel Reexamination: As with most litigation, the patents are also under reexamination at the PTO.  As usual – and perhaps as required by the law – the Federal Circuit entirely ignored that proceeding.

Ariad v. Lilly: Federal Circuit Grants En Banc Request to Challenge Written Description Requirement

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Ariad Pharmaceuticals, MIT, and Harvard v. Eli Lilly (Fed. Cir. 2009) (en banc)

The Federal Circuit has granted Ariad's motion for an en banc rehearing of its case. The motion boldly asks whether the written description requirement should be eliminated as a doctrine that is separate and distinct from enablement. The questions:

a. Whether 35 U.S.C. ? 112, paragraph 1, contains a written description requirement separate from an enablement requirement? and

b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

Ariad's brief is due within 45 days, and Lilly's brief is then due within thirty days of that.

Briefs of amici curiae will be entertained, and any such amicus briefs may be filed without leave of court but otherwise must comply with Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29. The United States is invited to submit an amicus brief.

Value of Amicus Briefs: In its recent Cardiac Pacemaker decision, the Federal Circuit expressly indicated that it was "appreciative of these [amicus] contributions." To make one particular point in the decision, the court emphasized that Cardiac's extreme position was "not even supported by the lone amicus brief we have received in favor of including method patents within Section 271(f)'s reach."

Although the written description requirement is primarily raised in pharmaceutical and biotechnology cases, it is an increasing aspect of software patent litigation. This decision could have a significant impact both on how patents are litigated and on how they are prosecuted. The inventors here discovered an important biochemical pathway and broadly claimed uses of that pathway.

Notes:

En Banc: Methods do not have Exportable Components and Therefore Method Claims Cannot be Infringed Under Section 271(f)

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Cardiac Pacemaker v. St. Jude __ F.3d ___ (Fed. Cir. 2009) (En Banc)

In an en banc decision, the Federal Circuit has ruled that 35 U.S.C. § 271(f) “does not cover method claims.” This decision overturns the controversial 2005 decision in Union Carbide v. Shell Oil Co., 425 F.3d 1366 (Fed. Cir. 2005). The ruling was widely expected based on the Supreme Court’s 2007 decision in Microsoft Corp. v. AT&T Corp., 550 U.S. 437 (2007) (holding that “master disks” were not a 271(f) “component” when abroad to be copied and then installed to form a would-be infringing system). In reading Microsoft v. AT&T, the Federal Circuit found “a clear message that the territorial limits of patents should not be lightly breached.”

The holding is based in the logic that a process is a series of steps and, therefore, does not have any physical components amenable to export.

[M]ethod patents do have “components,” viz., the steps that comprise the method, and thus they meet that definitional requirement of Section 271(f), but the steps are not the physical components used in performance of the method.

The result in this case is that Cardiac’s process claim (Claim 4) cannot be infringed under Section 271(f).

Claim 4 of the ‘288 patent is comprised of the steps of determining a heart condition, selecting cardioversion as the appropriate therapy, and executing a cardioverting shock. Cardiac does not allege that all of those steps are carried out in the United States with respect to certain of the ICDs. Moreover, it cannot allege that the steps of the method are supplied, a contradiction in terms. Rather, Cardiac alleges that St. Jude’s shipment of a device that is capable of performing the method is sufficient to fall within the scope of Section 271(f). Although the ICD that St. Jude produces can be used to perform the steps of the method, as we have demonstrated, Section 271(f) does not apply to method or process patents. As Section 271(f) does not encompass devices that may be used to practice a patented method, St. Jude is therefore not liable for infringement … for IDCs exported abroad.

Reversed (on this issue)

Notes

  • Judge Newman dissented from the opinion – arguing that the language of 271(f) applies to any “patented invention.”
  • This case was only partially decided en banc. Part (c)(2) is en banc while the rest of the decision is decided by the panel of Judges Newman, Mayer, and Lourie. Judge Lourie signed the entire majority opinion, and Judge Newman only dissented as to Part (c)(2).
  • Cardiac Pacemaker v. Jude: Challenging 271(f) Liability for Components of a Method (Discussing briefs)

Guest Post: The Applied/Abstract Distinction is the Key to §101 Patentability

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Guest Post by Polk Wagner (Professor at the University of Pennsylvania School of Law)

Mark Lemley, Michael Risch, Ted Sichelman, and I have authored an amicus brief in the Bilski v. Doll case currently pending before the US Supreme Court. (Get the full brief here [pdf].) In that brief, we argue that the Court's precedents establish that the key to eligible subject matter is ascertaining whether an idea is claimed as applied–in which case it is eligible for patentability (assuming it is not a natural phenomenon or law of nature)–or merely in the abstract–in which case it is not.

We start with the proposition that while the range of subject matter available for patenting is very broad, it is not unlimited. But the restrictions imposed by the Supreme Court, we think, have not focused on the technology, form, or physicality of the claimed invention–the critical mistake made by the Federal Circuit in Bilski. Rather, the Court has uniformly recognized that the key to eligible subject matter is ascertaining whether an idea is claimed as applied, or claimed in the abstract.

This applied/abstract distinction has a long history in Supreme Court caselaw. It can be most clearly seen in the O'Reilly v. Morse case from 1854, where the Court invalidated a claim to all communication by electrical signal as abstract, but allowed a claim to the application of the communications method to stand. 56 U.S. 62, 112-21 (1854). That is, where Morse claimed the idea of communication by electrical signal, the claim was disallowed. But the Court did uphold Morse's claim to a system (e.g., "Morse Code") that applied the communication-by-electricity idea in a practical, concrete way.

One can discern the applied/abstract thread throughout twentieth-century Supreme Court decisions involving §101 subject matter. In Mackay Radio, the Court upheld a claim to a mathematical principle (related to the reception of radio waves) as applied to an antenna, noting that "[w]hile a scientific truth, or the mathematical expression of it, is not patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be." 306 U.S. 86, 94 (1939). In Gottschalk v. Benson, the Court denied patentability to an "abstract and sweeping" claim: the mathematical conversion of binary coded decimals into pure binary format. 409 U.S. 63, 66-67 (1972). And finally, in Diamond v. Diehr, the applied/abstract approach drove the analysis–in upholding the claims, the Court noted that the subject matter was not "directed to a mathematical algorithm or an improved method of calculation but rather recited an improved process for molding rubber articles by solving a practical problem which had arisen in the molding of rubber products." 450 U.S. 175, 181 (1981) (emphasis added). Indeed, in Diehr, the Court makes our argument for us:

It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection. . . . Arrhenius' equation is not patentable in isolation, but when a process for curing rubber is devised which incorporates in it a more efficient solution of the equation, that process is at the least not barred at the threshold by §101.

Id. at 187-88 (emphasis in original).

We also argue that echoes of this applied/abstract distinction can be seen in the related-but-distinct caselaw considering the patentability of products of nature. Here, the Supreme Court has repeatedly emphasized in this context that the patent law is designed to protect applications of human ingenuity, not simply "natures' handiwork." Thus, while a man-made organism is eligible for patentability, see Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980), a natural bacterium is not, see Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948). The boundary here is neither the form of the invention nor its ability to transform nature; instead the analysis turns on whether the patent claims describe the application of human knowledge to a practical end. In this way, a claim to an abstract idea is like a claim to a product of nature: unmoored to real-world applications of human inventiveness, and thus ineligible for patenting.

Finally, we note that the applied/abstract analytic framework nicely harmonizes Section 101 with Section 112's enablement requirement. Much like Section 101, Section 112 safeguards the essential function of the patent system: the dissemination of real-world, practical human knowledge. Claims to abstract mathematical concepts (like claims to natural products or physical phenomena) violate this tenet, by failing to demonstrate that the inventor is adding to the storehouse of useful, practical human accomplishment. (Indeed, the subject matter and enablement requirements were formerly part of the same statutory section. Patent Act of 1836, Ch. 357, 5 Stat. 117, § 6 (July 4, 1836).)

In sum, we argue that the patent statutes were wisely drafted with an expansive vision of patentable subject matter. Efforts to graft judicially created limitations onto that expansive scope in the past have proven fruitless and indeed counterproductive. This Court should not impose a requirement that patentable inventions require a machine or the physical transformation of some material. It should instead maintain the rule that patents are available for anything under the sun made by man, including discoveries of ideas, laws of nature, or natural phenomena so long as they are implemented in a practical application. In short, the test should be as it has been: where an idea is claimed as applied, it is eligible for patentability, but if it is claimed merely in the abstract it is not.