Judge Mayer Raises 101 When Not In Issue: Other Panelists Don’t

I am sure Dennis will do his usual full and grand treatment, but this one is sort of the counter-punch to Ultramercial. In I/P Engine, Inc. v. AOL Inc. (Fed. Cir. Aug. 15, 2014) (per curiam), the court split on whether the claims were properly found by the jury to have been not obvious, with Judge Chen dissenting on that point and the per curiam opinion reversing the finding of no invalidity. (The other panel members were Judge Wallach and Judge Mayer).

Recall that in Ultramercial the court emphasized that 101 was seemingly a defense, and so evidence was needed and the usual presumption of validity applied, and so on.  Here, Judge Mayer seemed to take precisely the opposite tact, though it’s not quite clear.  In addition to writing at length about what he perceives the “technological arts” test to mean and require, he wrote:

The Supreme Court has dictated that the subject mat- ter eligibility analysis must precede the obviousness inquiry. Flook, 437 U.S. at 593 (“The obligation to determine what type of discovery is sought to be patented” so as to determine whether it falls within the ambit of sec- tion 101 “must precede the determination of whether that discovery is, in fact, new or obvious.”); Bilski, 130 S. Ct. at 3225 (explaining that the issue of whether claims are directed to statutory subject matter is “a threshold test”); see also In re Comiskey, 554 F.3d 967, 973 (Fed. Cir. 2009) (“Only if the requirements of § 101 are satisfied is the inventor allowed to pass through to the other requirements for patentability, such as novelty under § 102 and . . . non-obviousness under § 103.” (citations and internal quotation marks omitted)). To fail to address at the very outset whether claims meet the strictures of section 101 is to put the cart before the horse. Until it is determined that claimed subject matter is even eligible for patent protection, a court has no warrant to consider subordinate validity issues such as non-obviousness under 35 U.S.C. § 103 or adequate written description under 35 U.S.C. § 112.

From a practical perspective, there are clear advantages to addressing section 101’s requirements at the outset of litigation. Patent eligibility issues can often be resolved without lengthy claim construction, and an early determination that the subject matter of asserted claims is patent ineligible can spare both litigants and courts years of needless litigation. To the extent that certain classes of claims—such as claims on methods of doing business—are deemed presumptively patent ineligible, moreover, the United States Patent and Trademark Office will have more resources to devote to expeditiously processing applications which disclose truly important advances in science and technology.

Even more fundamentally, the power to issue patents is not unbounded. To the contrary, the constitutional grant of authority “[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries,” U.S. Const. art. I, § 8, cl. 8, “is both a grant of power and a limitation,” Graham v. John Deere Co., 383 U.S. 1, 5 (1966); see Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 146 (1989). Section 101’s vital role—a role that sections 103 and 112 “are not equipped” to take on, Mayo, 132 S. Ct. at 1304— is to insure that patent protection promotes, rather than impedes, scientific progress and technological innovation. A robust application of section 101 ensures that the nation’s patent laws remain tethered to their constitutional moorings.

I am guessing we’ll see another en banc case soon…

More on Claiming Clones: Products of Nature and Source Limitations

Guest post by Dr. Jeffrey A. Lefstin, Professor of Law, University of California, Hastings College of Law

Jason’s excellent post on Roslin summarized the case and raised the question of whether the Federal Circuit paid insufficient attention to the inherent differences conveyed by the ‘clone’ limitation of the claims. In this post I address two other issues in Roslin:  the Federal Circuit’s interpretation of Ckakrabarty and Funk Brothers, and Roslin’s consistency with Federal Circuit precedent holding that structural or functional differences between natural and synthetic products must be defined in the claims.

Unaltered by the hand of man: Judge Dyk’s opinion in Roslin unfortunately perpetuates the view, now found in the PTO’s Myriad guidelines, that Chakrabarty requires a claimed invention to be “markedly different” from a natural product for patent-eligibility under § 101.  Myriad itself imposed no such requirement: the Court found BRCA cDNAs patent-eligible without determining that they were “markedly different” from natural sequences. And though Myriad reiterated the “markedly different” language from Chakrabarty, Chakrabarty’s discussion of ‘products of nature’ was entirely dictum. Only the question of whether living organisms were patent-eligible was before the Court in Chakrabarty; the ‘product of nature’ rejection in the case had not been sustained by the Patent Office Board of Appeals.

The Chakrabarty Court noted the claimed bacteria differed markedly from natural bacteria by way of distinguishing the case from Funk Brothers.[1] As Paul Cole’s recent post notes, the patentee had discovered that certain strains of bacteria could be mixed together without inhibiting their nitrogen-fixing capability.  Justice Douglas regarded this compatibility as the unpatentable discovery of a natural phenomenon;  the claims were unpatentable because the patentee’s application – a mixed inoculant – was “a simple step” once the underlying discovery was assumed away.

As I discuss in a recent article, Funk  was nonetheless very much a patent eligibility case. It reflects Douglas’s view – shared by Justice Stevens in Flook, and Justice Breyer in Mayo – that obvious applications of scientific discoveries or abstract ideas are not patent-eligible “inventions” within the meaning of the statute.

Whether or not we share that view, understanding it shows us that Funk was an ‘inventive application’ case, not a ‘product of nature’ case. Douglas made no reference to the ‘product of nature’ doctrine, nor to the recent cases embodying it.[2] Instead, Douglas emphasized the lack of change in the bacteria to establish that the mixed inoculant was obvious (once the patentee’s discovery was assumed away). Under the old doctrine of ‘aggregation,’ it was not invention to combine old elements where the elements were unchanged, and no new function arose from their combination. It was therefore not inventive for the patentee in Funk to combine old bacteria without changing their structure or function.

But just as many combinations of old elements become patentable when a new function emerges, the mixed inoculants of Funk would have been patentable — even if the bacteria remained unchanged — had the mixed inoculant acquired new functions not performed by its constituent bacteria. If Funk Brothers instead stood for the proposition that a combination is unpatentable if its constituents are ‘unaltered by the hand of man,’ then a very large number of inventions become patent-ineligible.  An artificial structure like an arch, formed by piling stones atop each other, would be ineligible unless the stones themselves were altered by the hand of man.  Even as ardent a skeptic of the patent system as Justice Douglas would not have gone that far.

Source limitations and expressly claimed distinctions: The second difficulty with Roslin is its demand that the ‘marked differences’ between the natural organism and the invention must be expressly claimed. As Jason discussed, the applicant in Roslin argued that cloned animals differ from their natural counterparts at least in having mitochondrial DNA derived from the egg donor, rather than the animal which donated the somatic nucleus. The Federal Circuit rejected such arguments because neither the difference in mitochondrial DNA, nor any functional consequence of that difference, was recited in the claims.

However, the same argument, albeit in the context of § 102, was before the Federal Circuit in the extensive litigation over Amgen’s recombinant erythropoietin (EPO) patents. Much like Roslin, Amgen had claims to a ‘copy’ of natural product: in that case EPO produced by mammalian cells in culture. While Amgen’s synthetic EPO differed in glycosylation from the natural product, several of the claims in the case recited only the non-natural source of the EPO, not the structural differences. The Federal Circuit recognized that the novelty of the synthetic EPO claims depended on whether synthetic EPO differed from natural EPO.  Yet the court found novelty based on the unclaimed structural and functional differences between natural and  synthetic EPO, which were demonstrated in part by the specification and prosecution history, and in part by testimony at trial. Amgen Inc. v. F. Hoffman-LaRoche Ltd, 580 F.3d 1340, 1370 (Fed. Cir. 2009). In effect, the court held that the structural and functional differences characterizing the synthetic product were inherent in the source limitations. (The court did not inquire whether all synthetic EPO molecules falling within the scope of the claims would display similar differences in glycosylation.)

Thus under Amgen, a source limitation alone (such as ‘non-naturally occurring’ or ‘purified from mammalian cells grown in culture’) may establish novelty of a product. Assuming the ‘clone’ limitation in Roslin to require derivation from nuclear transfer, then it serves as a source limitation as well. Since Roslin cannot overrule Amgen, we seem to be in a regime where differences between natural and synthetic products may be unclaimed yet confer novelty under § 102, but must be explicitly claimed to establish ‘marked difference’ under § 101. Of course, if Roslin is correct, that doctrinal inconsistency is less significant than the consequence that Amgen-type claims – and perhaps a wider category of product-by-process claims involving natural products – are now ineligible under § 101.

[1] In Chakrabarty, the Commissioner never suggested that the claimed bacteria were unpatentable under Funk, nor even raised the case.  Rather, Chakrabarty argued that if living organisms were not patent-eligible, the Court would have said so in Funk.

[2] In particular, the General Electric and Marden cases denying patentability to purified tungsten, uranium, and vanadium. The defendant had urged General Electric upon the Funk court in its brief.

Patentable Subject Matter: Relying on Benson; Construing Claims for Eligibility

By Dennis Crouch

FuzzySharp Tech. Inc. v. 3DLabs Inc. (Fed. Cir. 2011)

In a per curiam opinion marked nonprecedential, the Federal Circuit has vacated and remanded the subject matter invalidity finding of a N.D. California District Court and instead ordered the court to rework its decision in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010) and subsequent Federal Circuit decisions on point. As discussed below, FuzzySharp’s invention relates to compression software for computer graphics. U.S. Patent Nos. 6,172,679 and 6,618,047. The main idea of the invention is to avoid calculations associated with always hidden surfaces. Although the specification explains that its implementation uses “fuzzy” math to calculate always hidden surfaces. However, “fuzzy” limitations are not found in the asserted patent claims. The application was filed in 1997, but claims priority to a 1991 Australian patent application.

FuzzySharp’s appeal was filed after the district court determined that the claimed method failed to pass the machine-or-transformation and therefore, under the prevailing law at the time, the method did not constitute patentable subject matter. In re Bilski, 545 F.3d 943 (2008). In its 2010 Bislki decision, the Supreme Court rejected the notion that the machine-or-transformation test could serve as the exclusive test of the patentable subject matter of a newly invented process. In the new rubric, the machine-or-transformation test offers only an important clue.

In its opinion, the Federal Circuit largely agreed with the lower court’s conclusion that the FuzzySharp claims fail the machine-or-transformation test, but, following the new Bilski rubric, remanded for a determination on the ultimate question of patentable subject matter.

Meaningful Limitations: FuzzySharp’s asserted claims involve two elements that are potentially linked to a machine – computation and computer storage. However, the appellate panel found those elements lacked “meaningful limits” on claim scope in the same way that the recitation of a general-purpose-computer is not a meaningful limitation of a software process that will only be performed on a computer. (Citing Gottshalk v. Benson, 409 U.S. 64 (1972)).

Claim Construction: An important and arising issue is the interplay between claim construction and patentable subject matter. Under Federal Circuit precedent, claim construction appears to be a necessary precursor. However, the Supreme Court has regularly ignored details of claim language in making its determinations – focusing instead on what it saw as the invention.

Here, the court held that some claim construction is necessary: “[W]e conclude that … the patent eligibility of at least one of the asserted claims turns on questions of claim construction that the district court did not have the opportunity to address.” It will be interesting to watch how the parties argue on remand for claim construction results that favor their hoped-for subject matter eligibility outcome.


  • The per curiam panel included Judges Bryson, O’Malley, and Reyna.
  • The U.S. application was prosecuted by Carl Oppedahl’s Colorado-based firm.
  • The patentee is represented by Matthew McAndrews from the Niro firm on appeal; Jonathan Baker from Skadden Arps is handling the appellate defense.
  • Here is Claim 12 of the ‘047 patent that the Federal Circuit analyzed:

    12. A method of reducing a step of visibility computations in 3-D computer graphics from a perspective of a viewpoint, the method comprising:

    computing, before said step and from said perspective, the visibility of at least one entity selected from 3-D surfaces and sub-elements of said 3-D surfaces, wherein said computing step comprises:

    employing at least one projection plane for generating projections with said selected set of 3-D surfaces and said sub-elements with respect to said perspective;

    identifying regions on said at least one projection plane, wherein said regions are related to the projections associated with said selected 3-D surfaces, said sub-elements, or bounding volumes of said 3-D surfaces or said sub-elements;

    updating data related to said regions in computer storage; and

    deriving the visibility of at least one of said 3-D surfaces or said sub-elements from the stored data in said computer storage; and

    skipping, at said step of visibility computations, at least an occlusion relationship calculation for at least one entity that has been determined to be invisible in said computing step.



Ongoing Battles over Patentable Subject Matter

By Dennis Crouch

In Ultramercial v. Hulu, the Federal Circuit held that Ultramercial's asserted Patent No. 7,346,545 fit within the subject matter eligibility guidelines of 35 U.S.C. § 101 and was not merely an unpatentable abstract idea. The patent claims a method of distributing copyrighted products (such as a movie) over the internet. The novel idea is that the copyrighted product be both (1) offered for sale and (2) delivered for free if the consumer agrees to view an advertisement. The district court held the patent invalid under section 101. On appeal, however, the Federal Circuit reversed – holding that the patent claims a "practical application" of the idea that "advertising can serve as a currency." An important element of the decision was the finding that "[v]iewing the subject matter as a whole, the invention involves an extensive computer interface."

Now, WildTangent (one of the accused infringers) has petitioned for a rehearing en banc. The public interest organization Electronic Frontier Foundation (EFF) has filed a brief in support of the rehearing – arguing that an en banc determination is necessary in light of (1) the court's failure to follow Bilski v. Kappos; (2) inconsistencies in application of the law apparent from the court's recent decisions in Ultramercial, Classen Immunotherapies v. Biogen IDEC, and CyberSource Corp. v. Retail Decisions, Inc.; and (3) a growing intra-circuit division regarding patentable subject matter jurisprudence. This filing ties-in closely with the pending Supreme Court case of Mayo v. Prometheus, which questions the patentability of a method of personalizing the dosage of a pharmaceutical and the pending case of AMP v. Myriad, which questions the patentability of isolated human DNA. Other pending Section 101 cases include DealerTrack, Inc. v. Huber (App. No. 2010-1544) (Claims 1, 3, and 4 of U.S. Patent No. 7,181,427); FuzzySharp Tech., Inc. v. 3DLabs Inc. (App. No. 2010-1160) (U.S. Patent Nos. 6,172,679 and 6,618,047); CLS Bank Int'l. v. Alice Corp (App. No. 2011-1301) (Patent No. 7,725,375); Cognex v. ITC (App. No. 2011-1098) (Patent Nos. 7,016,539 and 7,065,262); and Fort Properties, Inc. v. American Master Lease LLC (App. No. 2009-1242) (Patent No. 6,292,788).

Operating Efficiently Post-Bilski by Ordering Patent Doctrine Decision-Making

Last year, Professor Merges and I co-authored this short article on the administration of Bilski. In light of the pending Section 101 cases and Judge Rader's opinion in Classen Immunotherapies v. Biogen, I thought I would post it here again. Download the twenty-page essay from SSRN.

Here is the introduction:

Now that the Supreme Court has decided Bilski v. Kappos, there is an enormous amount of speculation about the case's impact on patent applicants, litigants, and other participants in the patent system. Most of the commentary is concerned with the holding in Bilski, how this holding will be applied by courts and the Patent Office, and ultimately, the effect of the holding on inventors, and those who hold and seek patents.

We take a different approach; rather than try to cut through the complexity of Bilski, or predict how it will be applied, we talk about how to avoid it. We are interested in how to minimize the cost and confusion that accompany a review of patents for § 101 subject-matter eligibility. To be specific, we propose that the § 101 issue of Bilski be considered only when doing so is absolutely necessary to determine the validity of a claim or claims in a patent. We believe any claim that can be invalidated under one of the less controversial and less complex requirements for patentability—§§ 102, 103, and 112, for instance—ought to be disposed of without considering subject matter patentability. In other words, the Bilski issue should be avoided wherever it is not strictly necessary. To support this conclusion, we present a set of empirical data that indicates that the vast majority of patent claims challenged on subject matter eligibility grounds were also challenged on other patentability issues.

We set the stage for our proposal in Part II, which briefly reviews the history behind Bilski and explains its open-ended holding and individualized approach. The difficulty of applying the Bilski ruling to different types of patent claims leads us to Part III, in which we call into question an accepted (if largely implicit) principle of patent law—that the lexical priority of statutory provisions in the 1952 Patent Act dictates a necessary logical sequence of invalidity tests. We reject this widespread assumption. There is nothing in the statute that requires this.

Indeed, in Part III we argue that in many ways the very idea of a sequence of discrete patentability requirements is conceptually misleading. Claims can be and often are rejected by the Patent Office for multiple reasons, suggesting that at least certain claims suffer from defects that transcend specific statutory validity requirements. We argue further that the policy underpinnings of various requirements overlap in complex ways, so that in reality patentability doctrine does not test for a series of discrete and independent qualities that are distinct from and mutually exclusive of each other. In the same way, transcendent qualities of an invention can influence multiple doctrines simultaneously, with pioneering inventions (due to both a liberal treatment under enablement, and a broad reach under infringement doctrines) being a prime example. This demonstrates again that there is not and should not be a strong separation between various patent law doctrines. Another argument along these lines recognizes that while patentability doctrines are not discrete entities, neither is "the invention" whose validity is being considered. Patent applicants routinely present multiple, overlapping claims, all of which cover fine-grained variations on a central inventive insight or advance. So it is inaccurate to visualize patentability as a stepwise series of tests applied to a single "invention." It is not true for example that "invention X" passes § 101 and should thus proceed in logical sequence to be tested under § 102. One claim growing out of inventive insight X might present no § 101 problems at all, yet another claim in the same patent application might raise a difficult issue under this provision. Each claim, being a unique slice of the overall inventive insight, ought to be considered on its own terms, and in whatever order makes the most sense. Put another way, the mental model of a stepwise sequence of patentability determinations overlooks the highly granular nature in which different slices of the inventive concept are presented for validity testing.

This analysis is further developed in Section III.A. When a claim fails to pass muster under any single test of validity, that claim should be invalidated. No further tests should be applied. We describe this as "chain" theory of validity: once one link in the chain is broken, the claim fails, and there is no reason to proceed further. Beyond that point, any expenditure of resources on validity questions is inefficient. Pragmatic considerations enter at this point. Issues of cost, justiciability, and spillover effects are perfectly appropriate in determining the actual sequence in which validity tests are applied with respect to any particular patent claim. The non-linearity of patent validity tests, together with the principle of efficient administration, yields a simple rule: start with chain links that are, in general, easiest and cheapest to test, and when the chain fails, stop the process. That way, the costliest and most complex doctrines—the trickiest "links in the chain"— are often avoided, and in any event are put off until later. Therefore, § 101 should often be avoided, both at the Patent Office and in the courts. We justify this not only on efficiency grounds, but also by analogy to the Supreme Court rules of avoidance.

In Part IV, we apply this simple principle. It leads to several recommendations. First, though the PTO has good reasons for its longstanding practice of rejecting claims for multiple reasons, we recommend that §101 be used only as an exception or last resort even at the PTO. Next, we contend that the courts should proceed in a stepwise fashion, beginning with §§ 102, and 103, and 112, changing the order of doctrines as dictated by pragmatic considerations, and stopping as soon as a claim is conclusively invalidated. In all cases, the complex and costly process of deciding whether a claim presents patentable subject matter under § 101 should be deferred until very late in the process. Therefore, we recommend, courts should in effect hold off on the difficult task of evaluating claims under § 101—ideally deploying the full § 101 analysis only when that is essential, i.e., when a claim passes muster under the other validity doctrines.

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1953512. Thanks!

Mayo v. Prometheus: the Patentee’s Section 101 Argument

Mayo Collaborative Services v. Prometheus Labs., Inc. (Supreme Court 2011)

The briefing continues in this patentable subject matter case pending before the US Supreme Court. (Read Professor Golden's discussion of the first round of merits briefs).  In its newly filed merits brief, Prometheus attempts to refocus attention on the "concreteness" of its patented method of personalizing the dosage of a particular drug treatment. The refocus begins with the statement of the question presented.  Download 2011-10-31_Prometheus Merits Brief

Mayo, the petitioner challenging the patent, opened briefing with a question of whether a patent that "covers observed correlations between blood test results and patient health, so that the patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry."  This language of Mayo's question is directly suggestive of the decisions of Benson and Flook — both of which held claimed methods to be unpatentable.

In its brief, Prometheus restates the question in a way that instead highlights the concrete and practical application language found in Diehr and Brenner v. Manson. Prometheus asks: "Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient's dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101."

Prometheus describes its challenged invention as follows:

First, most of the claims begin with the administration of a thiopurine compound to a patient with an autoimmune disorder. As noted, the thiopurine converts within the body into metabolites that do not otherwise exist in nature.

Second, the patient's metabolite levels are determined. Because "metabolite levels are not detectable in raw human tissue," all methods for measuring their concentration require "significant chemical and physical alteration of blood or human tissue" and sophisticated laboratory equipment and machines. Some of the dependant claims, for example, specify the use of high pressure liquid chromatography (HPLC), which entails an intricate series of operations on the blood (including heating, centrifuging, separating, and adding various reagents), running the resulting solution through a computer-controlled chromatography instrument, calculating the peak height or peak area, and feeding those figures into an equation, which finally outputs the metabolite levels.

Third, the metabolite measurements are compared to the patents' reference levels, "warning" the physician about the potential efficacy or toxicity of the patient's dosage.

Several important points are hidden by the patentee's statement of its invention: First, although most of the patented claims do require administration of thiopurine some claims do not include that particular step.  Second, although current technological methods of measuring metabolite levels apparently require the extraction of human tissue and the use of "sophisticated laboratory equipment," the broadest claims only require "determining" of the metabolite levels.  Finally, it is likely important to recognize that the claimed method is about tweaking the dosage of thiopurine and at the time of the invention most of the individual elements of the claim were already well known: It was well known that thiopurine could be used to treat IBD; it was well known that that the body converted thiopurine to the claimed metabolite; it was known that individuals had varying responses to thiopurine; and it was known that dosage should be adjusted so that it would be both effective and nontoxic.

Summary of the Prometheus argument:

First, to be patent-eligible, a process must really be a process—a series of steps that involve physical action in the real world, as opposed to merely an idea or principle stated in the abstract. Second, that process must be described at a narrow and specific enough level of generality that it does not preempt abstract ideas or basic building blocks of science that go far beyond what the patentee actually invented: A process for using a telegraph is patentable; the basic idea that information might be transmitted at a distance by exploiting laws of electromagnetism is not.

A. Prometheus's patented methods describe concrete methods for improving treatment of seriously ill patients with specific synthetic drugs. These patents do not claim the "correlations" they employ in the abstract, but as part of specific physical processes employing drugs and machines. . . . As the Federal Circuit recognized, the patents-in-suit pass [the machine-or-transformation] test with flying colors and easily satisfy the requirements of §101. Mayo attempts to avoid that conclusion in three ways, none of which has merit. First, Mayo invites this Court to discard the two initial steps (administering the thiopurines and determining the resulting metabolite levels) because they were "well known" in the art. But this Court rejected that "point-of-novelty" approach over 30 years ago in Diehr and again recently in Bilski. Second, Mayo argues that those same two initial steps should be disregarded because, according to Mayo, they are not "central" to the patents' purpose. Mayo does this only by ignoring the Federal Circuit's settled construction that the claims are limited to patient treatment (a question not presented here) and that those two steps are essential to that purpose. Third, Mayo invites this Court to invent, out of whole cloth, a categorical rule that processes ending with the provision of useful information cannot be patentable—even if preceding steps involve machines and physical transformations. That argument also is inconsistent with Bilski, and it would impose an arbitrary and (in the information age) absurd limitation on patentability.

B. The patents-in-suit do not preempt natural phenomena in any relevant sense. Their "correlations" concern certain properties attending certain uses of non-natural thiopurine compounds, which would not exist but for the handiwork of man. A patent system that recognizes thiopurine compounds themselves as potentially patentable subject matter, allowing preemption of all uses of these compounds, cannot be concerned that a process patent may preempt some of their uses. . . .

C. Prometheus agrees with the United States that the Patent Act's express statutory criteria for patentability—under 35 U.S.C. §§102, 103, and 112—make expansive judicial lawmaking under §101, of the sort invited by Mayo's arguments, unnecessary. But the application of those provisions is not before the Court in this case, and presents difficult and fact-bound questions that the lower courts should address in the first instance on remand.

II. Mayo proposes to transform §101 into an invitation for ad hoc, case-by-case evaluation of whether granting a particular patent will promote or retard the progress of the useful arts. That would create an unadministrable morass for courts and patent examiners, doom any hope for consistent administration of the patent laws, and usurp Congress's authority to determine the appropriate scope of the patent laws.

III. Any change in the Court's §101 jurisprudence that permitted a ruling in Mayo's favor, on whatever grounds, would have drastic and unfortunate consequences. It would upend settled expectations by invalidating thousands of diagnostic and personalized treatment patents. And it would stifle investment and innovation in the nascent field of personalized medicine. Contrary to Mayo's understanding, government funding does not translate pure academic research into practical products that benefit patients, and doctors themselves cannot bring to bear the resources necessary to fuel innovation and commercialize inventions on a large scale. Mayo's contention that patents like these hinder medical care is also unpersuasive. The United States is the world leader in biotechnology and personalized medicine, in part because investors have committed billions of dollars in capital in reliance on the prospect of patents like these. Thousands have been issued, including many to Mayo itself. Mayo's short-sighted view would exchange long-term innovation (including cost reductions) for ephemeral savings. In any event, Congress already considered Mayo's invitation to broadly restrict patent protection for medical diagnostic and treatment methods—and chose to adopt a limited personal immunity for doctors instead.

VS Tech v. Twitter: Patentable Subject Matter

VS Tech v. Twitter, 11–cv-0043 (E.D. Virginia 2011)

Trial is set for this week in the patent infringement lawsuit between VS Tech and Twitter.  VS’s asserted U.S. Patent No. 6,408,309 claims a “method of creating an interactive virtual community of people in a field of endeavor” and has a February 2000 filing date.  The inventor is Dinesh Agarwal who has also been a patent attorney since 1985.  VS Tech was formed to pursue the lawsuit and is headquartered in Mr. Agarwal’s law office address. The first two claims of the patent are reproduced below:

What is claimed is:

1. A method of creating an interactive virtual community of people in a field of endeavor, comprising the steps of:
a) selecting a field of endeavor;
b) compiling a list of members in the selected field;
c) selecting a member from the compiled list of members based on a preselected factor;
d) obtaining biographical information about the selected member;
e) processing the biographical information in a preselected format to create a personal profile of the selected member;
f) publishing the profile of the selected member on a machine readable media; and
g) allowing the selected member to interact with the profile.

2. The method of claim 1, wherein the step (f) comprises publishing the profile of the selected member on a network of computers.

In his most recent judgment in the case, Judge Morgan denied Twitter’s motion for summary judgment of invalidity under 35 U.S.C. 101, 102 & 103 and non-infringement.

The section 101 decision is interesting in that the judge treated the machine-or-transformation test as a question of fact to be determined by the jury.  “In light of all of the foregoing considerations, the Court finds that the evidence is sufficient for a reasonable juror to conclude that the ‘309 patent is linked to a particular machine or apparatus.”  Like claim construction and obviousness, patentable subject matter is treated by the courts as a question of law. However, unlike claim construction, the appellate courts have never held that it must be the judge who decides section 101 issues.

When the case was filed in January, Patent Law reporter Joe Mullin wrote “The central role of patent lawyers in suits like this raises questions about the health of the U.S. patent system. Patent lawyers are insiders in this system, and an increasing number of them aren’t satisfied just with being very-expensive service providers to patent owners. They’re seeing the millions made by so-called patent trolls and are eager to get into the game themselves. The patent office simply isn’t set up to say no to a persistent applicant, and the patent lawyers know that as well as anybody.  Mike Masnick filed his story under the “bang-head-slowly dept.”

The following is the text of Twitter’s proposed jury instructions on what it terms “unpatentable subject matter”:

Even if an invention is both new and not obvious, a patent claim may be invalid if its subject matter is not patentable. The law establishes three categories that are not eligible for patents: laws of nature, physical phenomena, and abstract ideas.

Twitter contends that the asserted claims of the ‘309 patent claim an unpatentable abstract idea. Methods which can be performed mentally, or which are the equivalent of human mental work, are abstract ideas which cannot be patented. An abstract idea is unpatentable even if the patent claim limits the idea’s use to a particular technological environment, or adds insignificant post-solution activity. Systems that depend for their operation on human intelligence alone cannot be patented.

A useful and important clue for determining whether a patent claims unpatentable subject matter is whether the claim is tied to a particular machine or apparatus, or transforms a particular article into a different state or thing. This is called the “machine or transformation test.” To satisfy the machine prong of this test, the use of the machine must also impose meaningful limits on the claim’s scope. If the claim does not satisfy the machine-or-transformation test, this indicates that the claim may be invalid because it claims unpatentable subject matter.



Survey on Willful Infringement

Prof. David C. Berry (Cooley) is researching how In re Seagate Technology, LLC, 497 F.3d 1360 (Fed. Cir. 2007)(en banc) has altered the practical landscape of willful patent infringement. One goal of the project is to collect data from persons with recent experience evaluating whether an organization's activities create a risk of patent infringement, and deciding how to respond to that risk. Current or recent in-house counsel interested in participating in the research project are invited to complete a confidential, on-line survey at: http://www.novisystems.com/NoviSurvey/n/risksurvey.aspx.

The survey was developed in conjunction with the ABA Section of Intellectual Property Law, Special Committee on Patent Analysis and Opinions of Counsel Post-Seagate. It has approximately 30 questions, and can be completed in less than 15 minutes. The survey link will be open for responses until February 15, 2011.

Tracing the Quote: Everything that can be Invented has been Invented

Charles H. Duell was the Commissioner of US patent office in 1899. Mr. Deull's most famous attributed utterance is that "everything that can be invented has been invented." Most patent attorneys have also heard that the quote is apocryphal.

In his 1989 article, Samuel Sass traced the quote back to 1981 book titled "The Book of Facts and Fallacies" by Chris Morgan and David Langford. Sass did his work well before Gore created the Internets, so I decided to take a fresh look at the research using Google. The following chart was created based on Google's electronic compilation of 12 million books. The chart shows the frequency that the phrase "everything that can be invented" shows up in the corpus, grouped by the year of publication of each book. The chart shows that Mr. Sass is largely correct in his assessment. Google has no reference to the quote prior to 1980 in its ngram database.

However, with a bit more searching, I came across an 1899 edition of Punch Magazine that had been donated to Harvard University by the Pulitzer family. In that edition, the comedy magazine offered a look at the "coming century." In colloquy, a genius asked "isn't there a clerk who can examine patents?" A boy replied "Quite unnecessary, Sir. Everything that can be invented has been invented."

I suspect that 1899 joke is the origin of the expression. Of course, there is still Ecclesiastes.

Prometheus Laboratories v. Mayo: The Broad Scope of Statutory Subject Matter

By Jason Rantanen

Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2010)
Panel: Rader, Lourie (author), Bryson

Last Friday, the Federal Circuit released its second noteworthy post-Bilski decision (the first being Research Corp v. Microsoft).  The opinion, Prometheus v. Mayo, issued following a grant-vacate-remand order from the Supreme Court instructing the CAFC to revisit its original decision in light of Bilski.  Despite this procedural posture, however, the new opinion is quite similar to the old, arriving at the same conclusion through essentially the same reasoning.   

Prometheus initially came to the Federal Circuit following a district court grant of summary judgment of invalidity under § 101 (lack of patentable subject matter).  After the CAFC reversed the ruling of invalidity using its "machine-or-transformation" test, Mayo sought review by the Supreme Court.  The Court granted certiorari, vacated the CAFC decision, and remanded for consideration in light of its Bilski opinion.  Earlier Patently-O commentary includes a summary of the original Federal Circuit opinion and a discussion of the remand.

The patents-in-suit claim a method for determining whether a patient has received a therapeutically efficacious amount of drugs such as 6-mercaptopurine ("6-MP") and azthiopurine ("AZA"), which are used to treat inflammatory bowel diseases but can produce toxic side effects.  In the human body, these drugs metabolize into 6-MP metabolites, including 6-methylmercaptopurine ("6-MMP") and 6-thioguanine ("6-TG").  By administering the drug, measuring the subject's levels of 6-MMP and 6-TG and comparing them to pre-determined levels, toxicity can be minimized and efficacy maximized. 

Claim 1 of Patent No. 6,355,623 is representative:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a) administering a drug providing 6-thioguanine to a subject having said im-mune-mediated gastrointestinal disorder; and
    (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
    wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Although similar in most respects, some claims of the second patent-in-suit, No. 6,680,302, dispense with the "administering" step.

The Patents Do Not Claim a Physical Phenomena
On remand, the CAFC again rejected Mayo's argument that the '623 and '302 patents claim a "natural phenomenon."  In seeking a judgment of invalidity under Section 101, Mayo contended (and the district court agreed) that the "administering" and "determining" steps are merely necessary data-gathering steps for the use of the correlations between 6-TG and 6-MMP and therapeutic efficacy or toxicity in patients.  Because these correlations are simply natural phenomena, Mayo reasoned, they were unpatentable.

As before, the Federal Circuit disagreed, noting that Bilski provides a broad – although not unlimited – scope for patent protection, and “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”  Slip. Op. at 12, quoting Bilski, 130 S.Ct. at 3230.  Furthermore, the court stated, neither the Supreme Court's order to vacate and remand the original Prometheus decision nor Bilski dictates a wholly different analysis or different result.  

The crux of the CAFC's determination that the asserted claims recite a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity as opposed to the natural correlation itself rests on the specific treatment steps recited by the claims: the "administering" step and the "determining" step.  "The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment." Slip. Op. at 15-16.

In support of its conclusion, the court reiterated its earlier determination that the treatment methods in Prometheus's patents satisfy the "machine-or-transformation test.  Although this is not the exclusive test, post-Bilski, it nevertheless provides important clues to subject matter patentabilty.  In applying the machine-or-transformation framework, the court specifically rejected Mayo's argument that the disputed claims simply claim natural correlations and the associated data-gathering steps, broadly stating that the asserted claims are "claims to methods of treatment, which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition."  Slip Op. at 17.  Even leaving out the administration step does not make the claims unpatentable, as the CAFC also found the "determining" step to be transformative because it involves "[s]ome form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or some other modification of the substances to be measured, [which] is necessary to extract the metabolites from a bodily sample and determine their concentration."  Id. at 18.

In reaching this conclusion, however, the court was forced to distinguish its earlier decision In re Grams, 888 F.2d 835 (Fed. Cir. 1989), which similarly claimed a process that involved "(1) performing a clinical test on individuals and (2) based on the data from that test, determining if an abnormality existed and determining possible causes of any abnormality by using an algorithm."  Id. at 20.   Unlike the claims in Grams – which the CAFC found unpatentable "because the tests were just to 'obtain data'" (Slip Op. at 20) – the claims of the Prometheus patents "require the performing of clinical tests on individuals that were transformative." 

Mental Steps
In addition to its overarching analysis of the subject matter issue, the opinion also includes an interesting discussion of the use of mental steps in patent claims.  Although the CAFC agreed that the final "wherein" clauses are mental steps, "A subsequent mental step does not, by itself, negate the transformative nature of prior steps. Thus, when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole." Slip Op. at 21. Because no claim in the Prometheus patents claims only mental steps, "contrary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps." Id.

Additional Commentary
In addition to an extensive discussion about the decision in response to Dennis's post on Sunday, other sites commenting on the decision include:

  • Patent Docs
  • patents4life
  • IP Watchdog
  • Chris Holman's IP Blog
  • Hal Weger of Foley has suggested that another grant of certiorari may be down the road, given the opinion's refusal to discuss a three-Justice dissent from the dismissal of certiorari in Lab. Corp., 548 U.S. 124, that was cited with approval by five Justices in two concurrences in Bilski.

Research Corp. v. Microsoft: Section 101 and Process Claims

By Jason Rantanen

There are three articulated exceptions to the scope of patentable subject matter under 35 U.S.C. § 101: laws of nature, physical phenomena, and abstract ideas.  Research Corp. v. Microsoft places a high hurdle in front of challengers who seek to invalidate process patents on the third ground. 

Research Corp. Technologies v. Microsoft Corp. (Fed. Cir. 2010)
Panel: Rader (author), Newman, and Plager

Research Corporation ("RCT") owns several patents relating to digital image halftoning, which is the process of generating electronic display and print images using only a small number of pixel colors (ex.: red, blue and green in the case of color displays) while appearing to present many more colors and shades than were actually used.  Four related patents are relevant to this summary: Nos. 5,111,310, 5,341,228, 5,477,305, and 5,726,772.  The applications for the '310 and '228 patents (a continuation-in-part of the '310 patent) were filed before December 4, 1991; the remaining patents are continuations of the '228 patent and claim priority to the earlier filing dates. 

RCT brought an infringement action against Microsoft based on these patents; in response, Microsoft asserted, and the district court initially concluded, that the patents were unenforceable due to inequitable conduct, invalid and not infringed.  The Federal Circuit reversed that determination in 2008.  Microsoft subsequently sought summary judgment against the '310 and '228 patents on Section 101 patentable subject matter grounds, and asserted that the claims of the '772 patent were not entitled to the earlier priority date, thus rendering them anticipated.  The district court granted Microsoft's motions, and subsequently held that the only remaining claim, claim 29 of the '305 patent, also lacked entitlement to the earlier priority date.  Based on these ruling, the parties stipulated to a dismissal of the suit and RCT appealed.

Section 101 and Process Claims
In reversing the district court's ruling that the '310 and '228 patents failed to satisfy Section 101, the Federal Circuit identified a set of considerations that can be applied when assessing the question of abstractness.  Drawing upon the Supreme Court's precedent in this area, including its recent decision In re Bilski, the opinion first reiterates that there are only three articulated exceptions to subject matter eligibility: "laws of nature, physical phenomena, and abstract ideas." 

Focusing on the category of abstract ideas, the court noted the Supreme Court's admonition in Bilski not to provide a rigid formula or definition for abstractness.  Rather, "the Supreme Court invited this court to develop 'other limiting criteria that further the purpose of the Patent Act and are not inconsistent with its text.'" Slip Op. at 14.  With that guidance, the panel concluded that it perceived nothing abstract in the subject matter of the processes claimed in the '310 and '228 patents.  Specifically, the court observed that:

  • "The invention presents functional and palpable applications in the field of computer technology";
  • Some claims in the patents require physical components;
  • "[I]nventions with specific applications or improvements to technologies in the marketplace are not likely to be so abstract that they override the statutory language and framework of the Patent Act"; and
  • The incorporation of algorithms and formulas does not prevent patent eligibility.

Nevertheless, while finding these factors met in the instant case, the panel further noted that its analysis was limited to the context of Section 101, which provides only a coarse filter.  Abstractness challenges can also be brought against specific claims under Section 112 even if the requirements of Section 101 are met.

Comment: The court's discussion of Section 101 suggests that the issue of patentable subject matter should be analyzed with respect to the patent as a whole; in contrast, Section 112 challenges are analyzed on a per-claim basis.

Burden of Proof for Establishing Priority
In addressing the district court's ruling that the asserted claims of the '772 and '305 patents were not entitled to claim priority to the '310 and '228 filing dates, the opinion reinforced the court's prior ruling that the patent holder bears the burden of establishing priority.  As the court held, although a patent challenger has the burden of going forward with invalidating prior art, once it has done so the burden shifts to the patent holder.  Thus, in an instance where the patent holder attempts to defeat the assertion of invalidity by claiming priority to an earlier application, the patent holder bears the burden of proving the entitlement to priority – including that the claims of the earlier patent are supported by the written description of the earlier specification.

Note: The '772 and '305 patents shared the same specification as the earlier '305 and '228 patents.  If the relevant claims had been contained in the '305 or '228 patents, Microsoft would have had the burden of proving lack of written description, as opposed to the burden resting with RCT.  Thus, the fact that the claims were part of a continuation was highly significant with respect to the allocation of the burden.

Comment: A related issue is who bears the burden of proof in the context of claims to a pre-filing conception or reduction to practice date. Although not mandated by the text of the opinion, which specifically refers to the burden to establish "an earlier filing date," the court's analysis could be read to support the conclusion that the patent holder bears the burden of proof in this situation as well.

After dispensing with RCT's challenge to the district court's allocation of burden, the panel proceeded to address the priority claims on the merits.  With respect to the '772 claims, the panel agreed with the district court, concluding that they were unsupported by the prior disclosure.  The panel did reverse on the '305 claim, however, ruling that to satisfy the written description requirement for apparatus claims, the patent need not disclose every method of making the apparatus. 

Guest Post: What Ultimately Matters In Deciding the “Gene Patenting” Issue?

By Jacqueline Wright Bonilla, PhD, JD. Ms. Bonilla is a partner at Foley & Lardner and filed an amicus brief supporting Myriad's position.

In entering the fray of this discussion, I note that I, along with two of my colleagues at Foley & Lardner LLP, submitted an amicus brief in the AMP v. PTO (a/k/a ACLU v. Myriad) "gene patenting" case on behalf of our clients Rosetta Genomics and George Mason University. In addition to our brief, other colleagues at our firm submitted a different amicus brief on behalf of a different client, Alnylam Pharmaceuticals. Both briefs, along with Myriad's brief and a number of other amicus briefs filed last week, support a reversal of the district court opinion as it pertains to "isolated DNA" composition claims. These briefs agree that such claims are patent eligible under current law, and should continue to meet the threshold of 35 U.S.C. § 101 as a matter of policy and social considerations. We are sensitive to dire consequence to biotech innovation in the face of a possible alternative outcome.

As it turns out, however, while such briefs agree on patent eligibility of "isolated DNA" claims, a number of briefs differ in viewpoints regarding applicable law, and even which cases are relevant versus not. As such, a reading of just the briefs filed with the Federal Circuit so far—even without considering the ACLU brief yet to be filed, much less amicus briefs filed in support of the ACLU's position—underscores a point worth mentioning.

The point is this: reasonable minds can differ on an interpretation of what constitutes relevant case law and how it should be interpreted in this case. This point is often missed in the hubbub we see in the press. For instance, many have commented on the amicus brief filed by the Department of Justice last week. Some have accused the DOJ of misreading the law entirely and attempting to eviscerate biotechnology innovation altogether. Such viewpoints misread the point of the DOJ brief, in my opinion.

Look what the DOJ brief actually says. It argues that the district court got it wrong in certain important respects. As stated in the DOJ brief:

… the district court erroneously cast doubt on the patent-eligibility of a broad range of manmade compositions of matter whose value derives from the information encoding capacity of DNA. Such compositions—e.g., cDNAs, vectors, recombinant plasmids, and chimeric proteins, as well as countless industrial products, such as vaccines and genetically modified crops, created with the aid of such molecules—are in every meaningful sense the fruits of human ingenuity and thus qualify as "'human-made inventions'" eligible for patent protection under section 101. [] The district court therefore erred in invalidating the challenged composition claims, such as claim 2 of the '282 patent, that are directed solely to cDNAs.

DOJ brief, pages 9-10 (citations omitted). As part of this discussion, the DOJ likewise agrees with our position that claims directed to recombinant vectors comprising any isolated DNA—even DNA having a sequence exactly as it exists in nature—constitutes patentable subject matter. See DOJ brief, page 16, discussing claim 8 of the '282 patent. Thus, unlike the district court opinion, the DOJ proposal does not throw the entire biotech baby out with the bath water.

That said, it appears that the DOJ may cut off a hand of the biotech baby. It argues that "isolated DNA" comprising a sequence from genomic DNA as it exists in a body does not constitute patentable subject matter. The DOJ brief (pages 10-11) argues that the "chemical structure of native human genes is a product of nature," even "when that structure is 'isolated' from its natural environment."

This position presents a slippery slope of considerable concern to those affiliated with biotech innovators responsible for actually getting medical products to patients. For example, the DOJ sidesteps an important scientific fact: all isolated nucleotide compositions—regardless of sequence—are, in fact, engineered DNA molecules. Such DNA molecules are necessarily, by definition of their existence in an isolated form, "human made" inventions. These products simply do not exist without human intervention. Thus, how does one successfully distinguish what is really "human made"? Moreover, human involvement is needed to identify valuable isolated nucleic acid molecules, such as DNA vaccines, PCR probes, interfering or micro RNA, etc., and then isolate them. When exactly is the human involvement sufficient to meet § 101? An additional slippery slope in the DOJ position is that many non-nucleotide compositions also exist as "products of nature" in a human body or other natural physical state. These compositions include many valuable small molecule pharmaceuticals, proteins, antibodies, just to name a few. Such compositions could likewise be subject to the same legal reasoning propagated in the DOJ brief. In other words, the fallout of the DOJ's position has wide-sweeping implications, even if not as flabbergastingly debilitating as the district court opinion.

This all said, I propose that it does no good to simply assert that the DOJ (or any party or judge for that matter) incorrectly reads relevant case law and/or misunderstands the science wholesale. As mentioned already, reasonable minds can differ on case law interpretation in this case, and how to apply scientific facts to the law. The sheer number of briefs and differences in positions—see DOJ versus USPTO as just one example—indicates this phenomenon in vivid color.

Thus, at the end of the day, the Federal Circuit and/or Supreme Court may ultimately decide the outcome of this case based on policy and social/economic considerations. The courts will consider case law, of course, but in reality may only apply it after the fact. I also believe that any precedential decision issued here, either way, will necessarily have at least some negative fallout. In fact, the patent system itself intends negative fallout to some people by virtue of granting a right to exclude others for a limited time. Thus, keeping the ideals of patent law in mind, it will be critical for courts to choose a course of action that provides the most amount of good, while causing the least amount of collateral damage. In other words, forget all the clever legal mumbo-jumbo—what do we want to happen here for the better collective good?

My understanding of the patent system is that it exists for the very purpose of stimulating innovation, as well as public disclosure of that innovation. As discussed at length in our amicus brief (and by others), abolishing patent eligibility of genetic inventions—not to mention inventions in other areas of health and medicine potentially impacted by a decision here—will have more of a dampening effect on research, development and innovation than any patent right could ever have.

My hope is that courts will remain ever conscious of slippery slopes created by any one interpretation of the law and application of science. No one wins if we inappropriately dampen incentives for innovators to discover, apply and provide innovation to the benefit of humans.


US Government Argues in Court that Isolated Genes are Unpatentable

AMP v. Myriad (Fed. Cir. 2010)

In March, 2010, District Court Judge Robert Sweet held Myriad's gene patent claims invalid for failing to satisfy the subject matter eligibility requirements of 35 U.S.C. 101.  The ruling was directed toward claims that cover particular isolated DNA molecules (genes) and processes of detecting and screening for those genes, but was written broadly enough to essentially invalidate all patents covering genes that were isolated from an organism. 

Last month, I heard a rumor that Obama administration science and legal advisors outside of the USPTO supported Judge Sweet's ruling.  At the time I disregarded that suggestion as unlikely. I was wrong. [Andy Pollack at the NYTimes has the scoop]

The US Department of Justice (DOJ) has now filed an amicus brief supporting the lower court decision — arguing that isolated genes are unpatentable because they improperly claim a product of naturer [Link to Brief]:

The district court correctly held . . . that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible. Unlike the genetically engineered microorganism in Chakrabarty, the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a “human-made invention.” Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell — that is, the relationship between genotype and phenotype — is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is “isolated” from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth.

. . . .

Thus, the patent laws embrace gene replacement therapies, engineered biologic drugs, methods of modifying the properties of plants or generating biofuels, and similar advanced applications of biotechnology. Crossing the threshold of section 101, however, requires something more than identifying and isolating what has always existed in nature, no matter how difficult or useful that discovery may be.

. . . .

A product of nature is unpatentable because it is not the inventive work of humankind. That essential rule cannot be circumvented by drafting claims for the same natural product removed from its natural environment and proclaiming the result “pure.”

Several other amici have filed briefs:

Federal Circuit: Patentability of Isolated Genes

Association for Molecular Pathology v. USPTO and Myriad Genetics (Fed. Cir. 2010)

In a landmark 2010 declaratory judgment decision, a Southern District of New York court invalidated claims from seven Myriad patents associated with the BRCA1/2 breast and ovarian cancer genes.  The patents include both composition claims covering isolated DNA molecules and method claims covering the processes of detecting and screening for BRCA mutations.  The lower court held that these claims all fail the patentable subject matter eligibility test of 35 U.S.C. §101.  A typical invalidated claim includes Claim 1 of Patent No. 5,747,282 which reads “1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.” (The amino acid sequence No. 2 was provided as a part of the patent filing).

Myriad has now filed its Federal Circuit appeal brief on the merits and argues two main points: (1) that the declaratory judgment plaintiffs had no standing to sue because there was no actual case or controversy between them and Myriad and (2) that Myriad's patents cover inventions that fit well within the broad scope of Section 101 subject matter eligibility. As I wrote earlier, I believe that the Federal Circuit will reverse.

Standing: A general rule of appellate advocacy is to lead with your best argument. One caveat involves standing — when standing is argued, it is invariably argued first. Although the weaker of its two primary arguments, Myriad led with its case for no standing.

It is important to remember how this case arose — with twenty plaintiffs joining together to sue Myriad and to ask the Federal Court to declare Myriad's patents invalid.

Declaratory Judgment Jurisdiction is governed by Article III of the US Constitution, the Declaratory Judgment Act of 1934, and most recently, the 2007 Supreme Court case of MedImmune v. Genentech which eliminated the reasonable-apprehension-of-suit test that had been previously followed by the Federal Circuit. 

The basic question for this case is whether sufficient controversy and adversity exists between the parties or, as Myriad argues, did the lower court improperly provide an advisory opinion.  The Supreme Court restated its standing test in MedImmune — asking “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” Myriad argues that there is no controversy between the parties because Myriad has not taken any (recent) action toward the plaintiffs and that any controversy between the parties lacks “sufficient immediacy.”

Here, neither plaintiffs’ complaint nor the district court’s opinion identifies any “affirmative act” by Myriad within the past ten years putting plaintiffs at risk of an infringement suit. There is no allegation, much less evidence, that Myriad ever identified the patents-in-suit (or any claim thereof) to any plaintiff, or identified any plaintiff’s product or conduct as infringing. In fact, there is no allegation that Myriad was even aware of any plaintiff’s “ability and desire” to infringe (A1034-64), let alone that Myriad evaluated any product or conduct to determine infringement. Accordingly, plaintiffs have no basis for declaratory judgment jurisdiction because “the totality of the circumstances analysis in the instant case is that which has not occurred.”

The district court disagreed with these arguments — holding that a controversy existed based on Myriad's activity against researchers along with an understanding “within the research community . . . [that] Myriad has taken the position that any BRCA1/2 related activity infringes its patents and that Myriad will assert its patent rights against parties engaged in such activity.” 

Discovering the Importance of a Mutation: The important scientific discovery in this case is the knowledge that BRCA mutations predict breast and ovarian cancer.  Of course, that informational discovery by-itself cannot be patented because it represents an abstract idea rather than a useful implementation.  The mutation itself occurs in nature and therefore is not sufficiently new to be patentable. The patents therefore were drafted to cover “isolated” forms of the mutated gene and methods of isolating the gene.  As with many software algorithm patents that are “tied” to a computer, the core of the Myriad invention rests in the unpatentable information/algorithm but the claims are drafted to include technical features that ground the invention in a specific, practical use of the information discovered.  Here, once the information regarding BRCA mutations was known, the actual isolation of the genes arguably did not take any further inventing because the generic isolation process was already well known.

With this setup, the Federal Circuit will be asked to determine whether tying the informational discovery to the isolated compound or method of isolation is sufficient to move the patent outside of the scope of abstract ideas and natural phenomena.  The question may be whether the Court should follow Diehr or instead follow Flook and Benson. The Bilski decision does not help in analyzing the claim here other than by revitalizing the precedential value of Flook and Benson.

Amicus briefs supporting Myriad will be filed shortly.

Business Method Patenting in Canada

Amazon.com v. Canada (Canada Fed. Ct. 2010).

The Canadian Commissioner of Patents rejected Amazon's one-click patent application — pejoratively calling the invention a “business method.”  The Commissioner's legal hook for rejection was that business methods do not fit within the legal definition of “invention” required by s. 2 of the Canadian Patent Act. The text that provision was derived from United States law and closely follows the language of the 35 U.S.C. 101.

“[I]nvention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter.

On appeal, the Federal Court of Canada (J. Phelan) reversed — holding that business methods “can be patented in appropriate circumstances.” Namely, the court indicated that a “mere business scheme” or “disembodied idea” are not patentable because they have no “practical embodiment.” Although the court rejected a “technology” test, it went on to hold that Amazon’s invention qualified under s. 2 because (1) the system claims require a machine as an essential element of the invention and (2) the method claims are “put the into action through the use of cookies, computers, the internet and the customer’s own action” and results in a “physical effect” on those elements.

Although the Court had the power to grant the patent, it decided instead to remand the decision for “expedited re-examination” – noting that the Patent Office’s decisions on other patentability doctrines may have been tainted by the Office’s desire for this to serve as a test case on patentable subject matter eligibility.

Comparative International Law: Canadian courts often welcome a comparative analysis of the laws of its neighbors – especially the laws of the United Kingdom and United States. In the patent realm, the European Patent Convention (EPC) is also influential.  While those laws often help the courts in making policy decisions, the Canadian decision “must correspond to Canadian law. . . . International jurisprudence, and certainly the policies advocated therein, is not determinative, but at most a potential guide when applied correctly and mindfully.”  Here, the Court appears to have closely followed the US Supreme Court’s recent decision in Bilski v. Kappos, 130 U.S. 3218 (2010).


Patentable Subject Matter at the Board of Patent Appeals

The work of the Board must go on . . . . In several recent decisions, the Board of Patent Appeals (BPAI or Board) has continued to affirm rejections of claims on patentable subject matter eligibility grounds under 35 U.S.C. § 101.

In Ex parte Kelkar, App. No. 2009–004635 (BPAI, September 24 ,2010), the applicant had claimed a method of determining the similarity between two genetic profiles and a computer program stored on a recordable medium for accomplishing the method. The method involves the broad steps of iteratively matching gene expression profile pairs in clusters until a best match is found. Because the method neither recites any particular machinery nor transforms an article into a different state or thing, the Board held that it failed the machine-or-transformation test. Citing Flook (1978), the Board then held that the claim was improperly directed to an abstract algorithm because the underlying innovation was the unpatentable mathematical algorithm. Some of the method claims included a preamble statement that the method occurred “in a computer.” The Board found that limitation at most a “a field-of-use limitation that is insufficient to render the otherwise ineligible process . . . patent eligible.”

The Board went on to affirm the rejection of the computer program claims that were “stored on a recordable medium.”  The Board agreed with the examiner that those the storage medium limitation was broad enough to encompass unpatentable “carrier wave storage.” (See Nuijten (Fed. Cir. 2007)). The Board wrote:

When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering nonstatutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter). See also, Subject Matter Eligibility of Computer Readable Media, 1351 Off. Gaz. Pat. Office 212 (Feb. 23, 2010).

In Ex parte MacKenzie, App. No. 2009–-7332 (BPAI, October 4, 2010), the Board issued a new grounds of rejection under Section 101 because the claimed method was directed to an abstract process under Bilski. MacKenzie's rejected claim 1 reads as follows:

1. A method for use in a device associated with a first party for performing a signature operation on a message substantially based on the digital signature algorithm (DSA), the method comprising the steps of:

generating in the first party device a first component associated with the signature operation based on assistance from a device associated with a second party, wherein the assistance from the second party device is received as a first message from the second party device;

transmitting the first component to the second party device;

generating in the first party device a second component associated with the signature operation based on further assistance from the second party device, wherein the further assistance from the second party device is received as a second message from the second party device, wherein the second message comprises results generated using the transmitted first component; and

outputting a form of the first component and the second component as a result of the DSA signature operation.

Although MacKenzie's claim does recite various devices, the Board saw these as “nominal” limitations to “generic devices.” The Board wrote:

As the unpatentability of abstract ideas was reaffirmed by the U.S. Supreme Court in Bilski (2010), clever claim drafting involving the nominal addition of generic structures cannot circumvent the principles articulated by the Court. That is, even when a claim appears to apply an idea or concept in combination with a nominal claim to generic structure(s), one must ensure that it does not in reality seek patent protection for that idea in the abstract.

In Ex parte Venkata, App. No. 2009–007302 (BPAI, October 5, 2010), the Board held that “the claim’s body recites nothing more than software [and therefore] lacks statutory subject matter.” Venkata's claim was directed to a “system” that included two “discovery agents” that operate either via a local network or via an Internet host.

Kelkar's patent application is owned by IBM and prosecuted by its in-house patent department. MacKenzie's patent application is owned by Lucent and prosecuted by the small firm of Ryan, Mason & Lewis. Venkata's patent application is owned by Nokia and prosecuted by the small firm of Hollingsworth & Funk.


The USPTO's January 2010 guidance on the Subject Matter Eligibility of Computer Readable Media is repeated as follows. I would argue that the Nuijten decision – if read to categorically exclude transitory embodiments, is no longer good law post-Bilski.

The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to
statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101, Aug. 24, 2009; p. 2.

The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" to the claim. Cf. Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).

Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office

Prometheus v. Mayo: Patenting Medical Methods

Prometheus Labs. v. Mayo Collaborative Services (Mayo Clinic) (Fed. Cir. 2010)

This case is one of several pending Federal Circuit appeals that are questioning whether medical diagnostic and treatment methods are the proper subject of patent protection.

The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject’s metabolite blood-level to adjust future doses of the drug.  (U.S. Patents 6,355,623 and 6,680,302). Thus, most of the claims are centered around three ordered-steps of:

  1. administering the drug to the subject;
  2. determining the amount of drug in the subject’s blood; and
  3. re-calibrating the drug dosage based on step-2.

A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101.  On appeal, the Federal Circuit reversed — holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”  That Federal Circut decision was based on the court’s machine-or-transformation test that was subsequently discredited by the Supreme Court in Bilski v. Kappos (2010).  In the wake of its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus decision and remanded for a new opinion.  Seeing this as a potential watershed case, Mayo immediately requested that the Federal Circuit hear the case en banc.

Briefing by October 1: The Federal Circuit has apparently denied the en banc request and has moved-forward with a rapid briefing schedule: By October 1, 2010, both parties are scheduled to submit 20–page briefs “addressing the effect of the Supreme Court’s Bilski decision on the disposition of this case. No additional briefing or oral argument is contemplated at this time.”  The scheduling order was signed by the court clerk Jan Horbaly.

Judges in Charge: The scheduling order suggests that the remand will be taken as a supplement to the original decision. A quirk of that original decision is that the three-member panel included two judges who are not on the Federal Circuit (Chief Judge Paul Michel (Ret.) and E.D. Texas District Court Judge Ron Clark). The third member of the panel is Judge Lourie.  Federal Circuit rules indicate that Judge Clark can retain on the panel on remand, but would not be part of any en banc hearing.

Related cases include Classen Immunotherapies Inc. v. Biogen Idec (method of determining an immunization schedule) and Association for Molecular Pathology v. Myriad Genetics (gene patents). 


Guest Post by Martin Goetz


Back on November 30, 2009, Patently-O published my article “In Defense of Software Patents” in response to the editorial “Abandoning Software Patents” by Ciaran O’Riordan, Director of End Software Patents (posted on Patently-O on November 6, 2009) which had as its premise that software companies are trying to protect “software ideas”.


In this article I comment on the Bilski Opinion as well as give some concrete examples of software-only patents as well as hardware/software patents. Also, my previous article received hundreds of comments, many being negative, and part of this new post is in response to those negative comments.


Since the June 28th Supreme Court Bilski decision there have been many articles[1] on what the Opinion stated and inferred about the patentability of software.


The Opinion restated what previous Supreme Courts concluded: that laws of nature, physical phenomena, mathematics, mathematical formulas (by themselves), algorithms (by themselves), and abstract ideas (which would include software ideas) are not eligible for patent protection.


While the Bilski Opinion never directly questioned the patentability of software, the Justices wrote extensively about the meaning of Section 101, the meaning of the term “process” and why the test for patent eligibility should not exclusively be “the machine-or –transformation test”. Justice Kennedy, with the concurrence of all other Supreme Court members, wrote that the Information Age puts innovation in the hands of more people and raises new difficulties for the patent law (and the Patent Office) to determine who should or should not receive patent protection.[2]


My November 2009 Patently-O article “In Defense of Software Patents” produced hundreds of comments. Many wrote that they were against the patenting of software because software was an “algorithm” or “mathematics”. In that article my primary argument was that a computer software invention is as patentable as a computer hardware invention and the only difference is the mode of implementation. My thesis was that Software Product companies in the Software Industry are looking to patent a machine process and not a computer program, which is protected by the copyright law. I showed why software product companies can be viewed as high technology manufacturing entities and should be just as eligible for patent protection as computer hardware companies.   


In this article I give examples of patents where the preferred implementation of an inventive machine process is in software (via a computer program[3]), hardware (via circuitry), or a combination of both software and hardware.


There is little argument that “processes” and “machine processes” are patentable subject matter[4] The question has always been about the nature of software and what one is trying to patent. For over 40 years I have been involved in that argument since I received the first software patent in 1968 for an innovative way to sort large amounts data on a computer that had tape drives that could only read and write data in a forward direction (See Patent # 3,380,029, Sorting System, Issued April 23, 1968).


The Sorting System patent was dubbed a software patent but it could also have been a computer hardware patent. It was dubbed a software patent solely because the preferred implementation (the disclosure) was a logic chart (which is recognized by the patent office as a proper disclosure). My Sorting System patent would not have been controversial if the disclosure had been hardware circuitry since there were many hardware patents for sorting data on special-purpose computers and special apparatus. In my patent application I referenced six of those patents which all had unique hardware circuitry in their patent disclosure. Three of them are available online, courtesy of Google Patent Search[5].


From 1968 through 1980 my previous company, Applied Data Research filed Amicus briefs in the Prater & Wei, Benson, Johnson, Flook, and Diehr cases in which we argued that a machine process patentable in hardware is equally patentable in software. Here is exactly how we posed a “Question of Law” “in our 1980 Diehr brief:

Whether a computerized machine or industrial process that is patentable subject matter under 35 USC 101 when constructed with a hardware program (wired circuits) would also be patentable subject matter when constructed with a stored computer program (i.e., firmware or software)?

The USPTO is currently in agreement with that “Question of Law” when in 1996 it published its Examination Guidelines for Computer-Related Inventions (Final Version).  The Guidelines stated in its Introduction the following: “The Guidelines alter the procedure office personnel will follow when examining applications drawn to computer-related inventions and are equally applicable to claimed inventions implemented in hardware or software.”


In that 1980 Diehr brief we also posed the following argument to the Supreme Court:

An inventor demonstrates his new invention to his patent attorney with great pride; he has developed a cabinet for reading books out loud to the blind. The cabinet contains both a reading and talking computer. After the demonstration, the patent attorney responds:


What's inside the cabinet? Did you build it with software or hardware (a stored program or hardware circuitry)? If built with a hardware program, your machine would be patentable. But if you built it with a stored program, the Patent Office would say it was merely mathematics and, therefore, unpatentable.”

The example above of a hypothetical “cabinet for the blind” invention was back in 1980 in our Diehr Amicus brief.


Twenty years later, in 2000, a renowned inventor, Ray Kurzweil received a patent named Reading System which Reads Aloud From An Image Representation Of A Document. The patent disclosure shows a diagram of a monitor, scanner, speakers, and a PC computer composed of a processor, storage and a keyboard. The essence of the disclosure and the invention is a logic chart describing a machine system which interacts with a speech synchronizer and the various devices.  


The first sentence of the abstract in the patent stated “a reading system includes a computer and a mass storage device including software comprising instructions for causing a computer to accept an image file generated from optically scanning an image of a document.”


At that time, Ray Kurzweil’s company, Kurzweil Educational Systems marketed a special purpose hardware/software system called the Kurzweil 3000 Reading Machine which was marketed to the blind and poor readers. Their 2000 year patent protected this product from imitators. Today the company sells a software only system called Kurzweil 3000 and continues to have the protection of the patent system thru his original 2000 patent and with additional patents e.g., Reducing processing latency in optical character recognition for portable reading machine (which is a software-only patent).


Few would argue that the Kurzweil 3000 Reading Machine was not an invention and not deserving of a patent.


While I am a strong advocate for software-related patents I have always been opposed to the patenting of Business Method Patents (BMPs). In my 2006 article Patents: Where's the Invention? I stated that the Patent Office should do what the European Patent Convention did when it  ruled that anything that consists of "schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers" is not an invention and therefore not patentable.” Justice Stevens, in his Opinion[6] also wanted to ban BMP’s from being patentable subject matter when he concluded that a method of doing business is not a “process” under 101.


Although the Bilski Opinion disallowed the Bilski application they stated that under certain conditions business methods could still be patentable subject matter. On July 27th the USPTO set up more stringent rules for the issuance of BMPs in their Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos. In many ways those guidelines are similar to the way computer software and hardware patents are currently being treated under the 1996 Guidelines for Computer-Related Inventions.    


One of the greatest challenges facing the Patent office today for BMPs, software or hardware patent applications is in discovering prior art and determining if there is an invention. The USPTO “Peer to Patent” pilot project” which  allows the public (including professionals in their respective fields) to comment on patent applications is still in its infancy, but offers the potential to assist the Patent Office in rejecting the large number of applications that are filed each year. The stated goal of the pilot project was to “connect the USPTO to an open network of experts online.”   Also, private companies e.g., the Article One Partners, a patent research firm, have the potential to significantly reduce the large number of patent litigation cases.


In conclusion, while I am a strong proponent of software patents I am very aware, and agree with, many of the arguments against patents because of patent trolls, frivolous patents, e.g. Amazon’s one-click patent, and frivolous patent litigation that can put companies out of business. And I support changes in the Patent Law to reduce those problems. But if one believes in the how the Patent System has fostered innovation and helped the US grow and prosper, then there is no rational reason to eliminate technology inventions that use software as its implementation.


In my previous article there were many comments from die-hards that continued to believe that software companies are trying to patent a computer program,  Whether those die-hards still  believe that a computer program is mathematics, or a mathematical formula, or an algorithm, or an abstract idea, so be it. Computer software programs are not what software companies are trying to patent. A software patent invention is on a unique machine process —- nothing more and nothing less. And the criteria should be 1. Innovation 2. A proper disclosure and 3. Usefulness — the same requirement that is the criteria for all patentable subject matter.

[1] Click below for a sample of many of these articles. Reading the Bilski Tea Leaves For What The Supreme Court Thinks Of Software Patents Comments on Bilski and Software Patents; Here's Bilski: It's Affirmed, But . . .No Decision on Software Patentability; Supreme Court Decision Raises Software Patent Questions; Supreme Court 'Bilski' ruling doesn't rule out software, business-method patents; Software patent debate rages on; Software, pharmaceutical, and business method patents survive; Patent Office Says No to Supreme Court and Software PatentsDeath Knell For Software PatentsSoftware Is Not Necessarily Business MethodSoftware Patents and Business Method Patents Still Possible after Bilski Supreme Court Decision.


[2](Underlining and bold added) (pages 9 & 10) “The machine-or-transformation test may well provide a sufficient basis for evaluating processes similar to those in the Industrial Age—for example, inventions grounded in a physical or other tangible form. But there are reasons to doubt whether the test should be the sole criterion for determining the patentability of inventions in the Information Age. As numerous amicus briefs argue, the machine-or-transformation test would create uncertainty as to the patentability of software, advanced diagnostic medicine techniques, and inventions based on linear programming, data compression, and the manipulation of digital signals. See, e.g., Brief for Business Software Alliance 24– 25; Brief for Biotechnology Industry Organization et al. 14–27; Brief for Boston Patent Law Association 8–15; Brief for Houston Intellectual Property Law Association 17–22; Brief for Dolby Labs., Inc., et al.”


The Opinion went on to state:

It is important to emphasize that the Court today is not commenting on the patentability of any particular invention, let alone holding that any of the above-mentioned technologies from the Information Age should or should not receive patent protection. This Age puts the possibility of innovation in the hands of more people and raises new difficulties for the patent law. With ever more people trying to innovate and thus seeking patent protections for their inventions, the patent law faces a great challenge in striking the balance between protecting inventors and not granting monopolies over procedures that others would discover by independent, creative application of general principles. Nothing in this opinion should be read to take a position on where that balance ought to be struck.

[3] While the implementation is in a computer program, the disclosure for one skilled in the art, are thru flow charts (also called logic charts) and thru block diagrams.

[4]. The Bilski Opinion closely examined the meaning and the words of 35 U.S.C 101. From 35 U.S.C. 101: Inventions patentable: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent there for, subject to the conditions and requirements of this title.

[5] The Sorting Patents below were described thru and/or gates, and as methods and apparatus for sorting data. Sorting Device, Fillebrown, 5/1961 #2,985,864; Sorting Apparatus, Guerber, 5/1960 #2,935,732; Apparatus for sorting of Recorded Digital data, Dirks 3/1966 #3,242,466.


[6] (page 15) Because the text of §101 does not on its face convey the scope of patentable processes, it is necessary, in my view, to review the history of our patent law in some detail. This approach yields a much more straightforward answer to this case than the Court’s. As I read the history, it strongly supports the conclusion that a method of doing business is not a “process” under §101.


Genus-Species; Doctrine of Equivalents; and Patentable Subject Matter

By Dennis Crouch

For many, the most interesting aspect of this case comes at the end in Judge Dyk’s dissent. Dyk makes the case that genes should not be patentable. 

* * * *

Intervet Inc. v. Merial Limited (Fed. Cir. 2010)

In 2006, Intervet filed a complaint against Merial — asking the DC District Court for a declaratory judgment that Intervet’s Porcine Circovirus vaccine (PCV-2) did not infringe Merial’s gene patent.  Merial’s patent claims both the isolated DNA molecule of PCV-2 and a vector that contains the DNA.  The application includes a listing of several different sequences that all fall within the PCV-2 category. 

Although Intervet also uses a PCV-2 vector. The DJ plaintiff argues that its DNA molecule is different from the one described and deposited by Merial. The district court agreed — holding that the Intervet product was only 99.7% homologous to the closest deposited sequence and therefore outside of the literal claim scope. The district court also applied prosecution history estoppel to rejected Merial’s claims of infringement under the doctrine of equivalents (DOE). On appeal, the Federal Circuit reversed on both claim construction and DOE.

Genus Not Limited to Examples: The asserted claim includes a limitation of a “PCV-2” DNA molecule. The District Court limited that term to cover only the DNA sequences that were deposited with the PTO. On appeal, the Federal Circuit rejected that construction as overly limiting. Rather, the appellate panel held that the deposited sequences serve as a representative sample of PCV-2 DNA sequences. “Sequences are representative of the scope of broader genus claims if they indicate that the patentee has invented species sufficient to constitute the genera. Here, the deposited strains are representative species of the larger ‘type II’ genus, where the genus is identified and claimed as the invention.” In describing its invention, the specification noted that the PCV-2 desposited sequences had a 96% homology and that the invention did not cover PCV-1 sequences that at most shared 76% homology with the deposited sequences.  Taking those quantitative limits from the specification, the Federal Circuit ruled that the claimed PCV-2 molecule should be construed as being “about 96% or more homologous with the … sequences disclosed in the present specification, and about 76% or less homologous with the [disclosed PCV-1] sequence.”

What is Equivalents are Surrendered by a Narrowing Amendment: An accused infringer may still be liable even though its product does not literally infringe every element of an asserted patent claim.  Under the doctrine of equivalents (DOE), a patentee may be able to provie infringement by showing that one or more elements of the accused product are equivalent to elements in the claim.  Under the limiting doctrine of prosecution history estoppel (PHE), a patentee will ordinarly be estopped from claiming DOE over a claim element that was narrowed during prosecution. (A narrowing amendment made for purposes related to patentability creates a rebuttable presumption that estoppel applies.)

Here, one of Merial’s original claims was directed to a markush group of open reading frames (ORFs) that had been described in the specification as “ORFs 1–13.”  In an initial rejection, the examiner suggested that the limitation could refer to ORFs of non-PCV-2 molecules. Although the patentee argued that the claim was clear, it still added the limitation that the claimed ORFs were PCV-2 ORFs.  The Federal Circuit held that this was a narrowing amendment substantially related to patentability. That narrowing amendment therefore created a presumption that the patentee had surrendered all equivalents that relate to non-PCV-2 ORFs. The district court erred, however, in holding that this narrowing amendment would estopp the the patentee from asserting that the claims cover a non-claimed PCV-2 ORF as an equivalent. “Such a draconian preclusion would be beyond a fair interpretation of what was surrendered. The rationale for the amendment was to narrow the claimed universe of ORFs down to those of PCV-2, and bore only a tangential relation to the question of which DNA sequences are and are not properly characterized as PCV-2.”

Dissenting-in-part, Judge Dyk discussed his argument that the claims directed toward the isolated form of a naturally occurring gene are likely unpatentable under 35 U.S.C. § 101.

[T]he isolated DNA claim raises “substantial issues of patentable subject matter under 35 U.S.C. § 101. . . . Neither the Supreme Court nor this court has directly decided the issue of the patentability of isolated DNA molecules. Although we have upheld the validity of several gene patents, none of our cases directly addresses the question of whether such patents encompass patentable subject matter under 35 U.S.C. § 101. . . .

I think that such patents do in fact raise serious questions of patentable subject matter. The Supreme Court’s recent decision in Bilski v. Kappos has reaffirmed that “laws of nature, physical phenomena, and abstract ideas” are not patentable. No. 08-964, slip op. at 5 (U.S. June 28, 2010) (quoting Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980)); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948). Just as the patentability of abstract ideas would preempt others from using ideas that are in the public domain, see Bilski, slip op. at 13, so too would allowing the patenting of naturally occurring substances preempt the use by others of substances that should be freely available to the public. Thus, “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity.” Chakrabarty, 447 U.S. at 309. These aspects are properly conceptualized as representing a public domain, “free toall men and reserved exclusively to none.” Id. (quoting Funk Bros., 333 U.S. at 130) (quotation mark omitted).

In Funk Brothers, the Court considered the patentability of a mixture of several naturally-occurring species of bacteria. 333 U.S. at 128-31. The patented product was a mixture of bacteria used in agricultural processes, enabling plants to draw nitrogen from the air and convert it for usage. The inventor discovered that certain strains of the bacteria were effective in combination with one another, and contrary to existing assump-tions, did not exert mutually inhibitive effects on each other. The Court held that the invention was not pat-entable subject matter. Id. at 131. The inventor “did not create a state of inhibition or of non-inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not patentable.” Id. at 130. The Court furthermore noted:

The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none. He who discovers a hitherto unknown phenomenon of na-ture has no claim to a monopoly of it which the law recognizes. If there is to be invention from such a discovery, it must come from the applica-tion of the law of nature to a new and useful end.


In Chakrabarty, the Court considered whether a human-made microorganism is patentable subject matter under section 101. 447 U.S. at 305. The microorganism in question was a bacterium that had been genetically engineered to break down crude oil. In concluding that the man-made bacteria was patentable, the Court observed that the claim “is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter.” Id. at 309. The Court went on to distinguish Funk Brothers on the ground that the Chakrabarty bacterium possessed “markedly different characteristics from any found in nature. . . . His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” Id. at 310 (em-phasis added).

Thus, it appears that in order for a product of nature to satisfy section 101, it must be qualitatively different from the product occurring in nature, with “markedly different characteristics from any found in nature.” It is far from clear that an “isolated” DNA sequence is qualita-tively different from the product occurring in nature such that it would pass the test laid out in Funk Brothers and Chakrabarty. The mere fact that such a DNA molecule does not occur in isolated form in nature does not, by itself, answer the question. It would be difficult to argue, for instance, that one could patent the leaves of a plant merely because the leaves do not occur in nature in their isolated form.