• By Michael Borella —

    Supreme Court Building #2On December 6th, the Supreme Court granted certiorari to a case that presents the question of "[w]hether claims to computer-implemented inventions — including claims to systems and machines, processes, and items of manufacture — are directed to patent-eligible subject matter within the meaning of 35 U.S.C. § 101 as interpreted by this Court?"  Thus, for the third time in five years, the highest court will once again review the patent-eligibility of so-called software and business method patents.

    This case was likely destined the Supreme Court once the Federal Circuit released its six-opinion en banc decision this May, demonstrating a severe intra-circuit split.  Judge Lourie's concurrence read Justice Breyer's 2012 Mayo v. Prometheus opinion in view of former Justice Stevens' 1978 Parker v. Flook decision, the latter a case that some thought had been in part overturned by 1980's Diamond v. Diehr and 2010's Bilski v. Kappos.  In Mayo, however, Justice Breyer resurrected the "inventive concept" analysis of Flook, and its propensity to blur the lines between the inquiries of patent-eligible subject matter, anticipation, and obviousness.

    In applying this analysis in CLS Bank, Judge Lourie set forth a procedure for analyzing claims that incorporate abstract ideas.  Since then, it has been roundly criticized for failing to produce an objective, workable standard.  Chief Judge Rader wrote separately, taking an approach that attempted to apply the inventive concept analysis while keeping § 101 separate from considerations of prior art.  Other panel opinions took different methodologies, relying on procedural issues to tip the scales, or advocating a dramatic reduction in scope of the judicial exceptions to § 101.

    Regardless, the en banc panel did little to clarify the bounds of patent-eligible subject matter, and may have muddied the waters even further.  Therefore, it is not at all surprising that the Supreme Court has taken up this case.  Hopefully, the Justices will clarify whether prior art should be considered in a 35 U.S.C. § 101 analysis, whether such an analysis should be applied to claims as a whole or to claim elements on a piecemeal basis, and whether recitation of general-purpose computer hardware (either as a claim element or as the statutory type of the claim) makes a claim any less abstract.  Or, being the Supreme Court, it is within their purview to decide the case on much narrower grounds.

    Now that the case has been fully briefed, we can look to the parties for the positions that they will likely be taking during oral argument.

    Brief Overview of the Case

    In 2007, CLS Bank filed a declaratory judgment action against Alice, contending that, among other things, Alice's U.S. Patents Nos. 5,970,479, 6,912,510, and 7,149,720 were invalid under § 101.  Alice filed counterclaims alleging infringement of these three patents.  Later, Alice's U.S. Patent No. 7,725,375 was added to the action, and the parties respectively asserted invalidity and infringement contentions for this patent as well.

    All four patents are from the same family and "share substantially the same specification."  The Federal Circuit plurality described the claimed subject matter as:

    [A] computerized trading platform used for conducting financial transactions in which a third party settles obligations between a first and a second party so as to eliminate "counterparty" or "settlement" risk . . . .   Settlement risk refers to the risk to each party in an exchange that only one of the two parties will actually pay its obligation, leaving the paying party without its principal or the benefit of the counterparty's performance.  Alice's patents address that risk by relying on a trusted third party to ensure the exchange of either both parties' obligations or neither obligation.

    Between the four patents, method, computer-readable medium (CRM), and system claims were asserted.  The parties stipulated that all claims, including the method claims, require "a computer including at least a processor and memory" and electronic implementation.

    The District Court held that all asserted claims failed to meet the requirements of § 101, and thus were invalid.  Particularly, the District Court concluded that the method claims were directed to an unpatentable abstract idea, and that the CRM and system claims would similarly preempt all practical applications of this idea, despite those claims falling under a different statutory category.

    On appeal, a Federal Circuit panel reversed the District Court on all counts, holding that all claims, including the method claims, were patent eligible under § 101.  CLS Bank petitioned the full Federal Circuit for review, which was granted.  Sitting en banc, seven of the ten judges overruled the panel and affirmed the District Court's ruling regarding the method and CRM claims.   However, this majority did not agree on the rationale for their conclusion.  Further, five of the judges found that the system claims were unpatentable, while the other five concluded that these claims passed muster under § 101.  Additionally, eight of the judges indicated that the method, CRM, and system claims must rise or fall together.

    Alice's Brief

    After the en banc Federal Circuit decision, Alice found itself in a difficult position.  To obtain a favorable Supreme Court review, it has to thread the eye of a needle by arguing that the Federal Circuit has left the law in a state of disarray, without suggesting that this disarray stems from the Supreme Court's own 2012 Mayo ruling.  Also, Alice has to distinguish its method claims over those that the Court struck down in Bilski, despite a high-level similarity thereto.

    Alice CorporationAlice began its substantive analysis by noting that while the requirements of §§ 102, 103, and 112 must be met for a patent to be valid, subject matter eligibility was the solely the province of § 101.  Alice quoted Judge Rich, "[a]chieving the ultimate goal of a patent [requires] having the separate keys to open in succession the three doors of sections 101, 102, and 103."  Thus, Alice signaled early that it was going to lean on Diehr as the controlling precedent.

    In presenting its claims, Alice wisely chose a system claim, claim 26 of the '375 patent, to discuss first.  This claim explicitly recites a computer, coupled to a communications controller and data storage, which communicates with a separate device.  Clearly, this claim recites tangible, physical hardware.  Alice also presented claim 33 of the '479 patent as a representative method claim.  However, this method claim is disembodied, and does not explicitly recite any physical hardware.  Instead, Alice contended that "a person of skill in the art would understand the methods, as claimed, to require use of a computer."  As noted above, this was also stipulated to by both parties in the district court proceedings.  Alice also briefly discussed its CRM claims, noting that the media is what allows the claimed systems to use the claimed methods.

    In its review of the case so far, Alice took the opportunity to poke at Judge Lourie's plurality opinion.  For instance, Alice, pointed out that Judge Lourie "look[ed] past the claim language" when conducting his piecemeal inventive concept analysis, and re-emphasized that "claims must be considered as a whole."  This sets the stage for Alice's later attempts to drive a wedge between Justice Breyer's Mayo analysis and the approach of the Federal Circuit's plurality.

    Alice's substantive argument consists of three main parts: (i) defining the "abstract idea" exception to § 101 and contrasting it to patent-eligible disembodied concepts, (ii) reiterating that claims must be read as a whole, and (iii) asserting that, regardless of whether Alice's claims encompass abstract ideas, they are patent-eligible.

    Alice began its discussion of abstract ideas by noting that, unlike laws of nature and physical phenomena, the Court has never clearly defined what it means by that term.  However, in Alice's view, the Court has treated abstract ideas substantively the same as it has treated laws of nature.  Both are fundamental truths that reflect "relationship[s] that [have] always existed" and therefore are "part of the storehouse of knowledge of all men . . . free to all men and reserved exclusively to none."  In other words, abstract ideas were not created or invented by humans, and are instead fundamental aspects of the universe that belong in the public domain.

    Discovery of an abstract idea, such as "mathematical formulas and the like," in and of itself does not warrant a patent for the discoverer.  Instead, "[w]hen a patent claim recites such an abstract idea, it can be patented only if the claim includes other elements or steps that go beyond the fundamental truth itself, thus limiting the claimed invention to a specific application and preserving public access to the fundamental truth."  Claiming a use of an abstract idea in a particular field does not lift the claim to the level of being patent-eligible, as no one is entitled to foreclose others' use of this public domain knowledge.

    Alice painted a picture in which Gottschalk v. Benson and Flook were decided in order to avoid the preemption of an abstract idea.  In these cases, the claimed abstract ideas were both algorithms, rather and mathematical relationships, but still were considered laws of nature.  Moving on to Bilski, Alice couched that case's claims as also being an algorithmic abstract idea.  Particularly, Alice pointed to the Court's statement that Bilski's "[c]laim 4 puts the concept articulated in claim 1 into a simple mathematical formula."

    To contrast with abstract ideas, Alice introduced the notion of "disembodied concepts."  In Alice's assessment, a disembodied concept does not fall into any of the four statutory categories of § 101, and instead is a "pure mental conception."  All claimed inventions involve, in one way or another, disembodied concepts.  The language of the claim is what makes these concepts statutory.  Further, and important to Alice's argument, a disembodied concept need not be an abstract idea or a law of nature, and therefore it is inappropriate to conduct a preemption analysis on such a claim.  Therefore, Judge Lourie's approach of asking whether such an "inventive [disembodied] concept" is wrapped up in a claim will always be answered in the affirmative, rendering his analysis to be excessively restrictive.

    Alice moved on to a related topic, that all claims, whether reciting an abstract idea or not, must be read as a whole.  Alice noted that the Court has found it "improper to look to the 'heart' or 'gist' of an invention, rather than the actual invention as described in the claim's language."  Instead, all of the claim's limitations and terms must be considered, because this language defined the boundaries that the "PTO has actually found deserving of a patent and what the public may not use."  Thus, as noted in Diehr, "[t]he 'novelty' of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within [§ 101]."

    In order to drive this point home, Alice needed to synthesize the seeming discrepancies between Diehr and Mayo.  In doing so, Alice noted that, like Flook, the claim under consideration in Mayo recited an algorithm for exploiting a law of nature, and that the claim covered all practical uses of this law of nature.  Thus, the "inventive concept" analysis of Mayo does not advocate dividing the claim into abstract and non-abstract elements, because in Mayo the claim was considered as a whole.  Thus, Alice purported that the Court in Mayo did not overrule Diehr, but instead "the 'inventive concept' inquiry asks whether additional steps in a claim that on its face recites a law of nature or fundamental truth do anything more than simply say 'apply it.'"

    From all this, Alice concluded that computer-implemented inventions are necessarily physical embodiments, and that such an invention that would "preempt use of a mathematical formula or other fundamental truth — as did the inventions in Benson and Flook — is ineligible for patenting."  However, computer-implemented inventions that do not exhibit such preemption are patent-eligible.

    Alice set forth a two-part test for determining the patent-eligibility of computer-implemented inventions:

    If the claim does not, on its face, recite a mathematical formula or other fundamental truth, it is eligible.

    [I]f the claim recites a particular application of a mathematical formula, such that others would not be foreclosed from using the formula in other practical applications, it is eligible.

    Alice reminded the Court that such a test is merely a threshold test for § 101 purposes.  Sections 102, 103, and 112 prevent patents from claiming inventions too broadly or without enough specificity.

    Finally, Alice argued that its claims were valid under § 101.  Alice noted that unlike Benson, Flook, and Bilski, Alice's claims had been allowed and issued by the U.S. Patent and Trademark Office.  Therefore, they enjoyed the presumption of validity, which saddled a high burden of proof on CLS Bank to establish otherwise.

    Alice first argued that its claims are not directed to an abstract idea because they do not recite a mathematical formula, or a fundamental truth that can be reduced to a mathematical formula.  Thus, by default, Alice's claims cannot preempt others' uses of abstract ideas.  Alice contended that Judge Lourie held otherwise because Alice's method claims were drawn to a disembodied concept, and that he failed to appreciate the difference between such a concept and an abstract idea.

    Alice also took issue with the lower court's "paraphrasing and dissecting the language of Alice's claims in its hunt for a disembodied concept, instead of reviewing the claims as a whole and as written."  Alice blamed this approach for "untethering" the claims from the recited real-world application.  Again, Alice emphasized that even their disembodied method claims were understood to require an unclaimed computer implementation, which Judge Lourie improperly ignored.

    In the alternative, Alice asserted that even if its claims encompassed an abstract idea, they are directed to the specific application of using a computer as the intermediary for third-party escrow transactions.  Alice pointed out that "a differently designed computer system could implement exchanges in other ways," and provided several examples thereof.  Thus, at worst, Alice's claims are similar to those of Diehr, where an abstract idea is invoked, but the claim as a whole does not preempt all uses of that idea in any particular field.

    Analysis

    Alice's main difficulty is that its method claims are similar in both structure and content to those of Bilski, and the Court may not believe that it is appropriate to hold that Alice's claims meet the § 101 requirements when Bilski's did not.  The Court might not defer to the stipulation that these disembodied method claims must be performed by a computer — the claims, on their face, could be performed between humans, perhaps with the assistance of pencil and paper.

    On the other hand, the Court should have a hard time concluding that Alice's system claims fail to pass muster under § 101, because doing so will put hundreds of thousands of similarly-claimed patented inventions at risk of being rendered invalid.  It is unlikely that the Court will want to stir the pot to such a degree without a clear signal from Congress that software and business methods should be frowned upon.

    Alice's abstract idea / disembodied concept dichotomy is a clever approach that could potentially be adopted by the Court in some form.  It appeals to logic, and frames the Court's previous decisions in a consistent fashion.  The wildcard is whether Alice's understanding of Mayo agrees with that of its author.  Justice Breyer might respond to Alice's interpretation by saying, "That's not what I meant."  Such a statement would throw the proverbial spanner in Alice's gears.

    Lastly, students of computer science — indeed anyone who has ever used a computer — might be entertained by Alice's seven-paragraph argument that a computer is a physical machine.  Alice has raised stating the obvious to a form of art.  Too bad that such an exercise is necessary in 2014.

  •         By Sherri Oslick —

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Allergan, Inc. v. Actavis plc et al.
    2:14-cv-00188; filed March 6, 2014 in the Eastern District of Texas

    • Plaintiff:  Allergan, Inc.
    • Defendants:  Actavis plc; Actavis, Inc.; Watson Laboratories, Inc.; Actavis Pharma, Inc.

    Infringement of U.S. Patent No. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Allergan's Retasis (cyclosporine ophthalmic emulsion, used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca).  View the complaint here.


    Novartis Pharmaceuticals Corp. v. Pharmaceutics International, Inc.
    2:14-cv-01347; filed March 4, 2014 in the District Court of New Jersey

    Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Pharmaceutics International's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.


    Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals Inc. et al.
    1:14-cv-00279; filed March 4, 2014 in the District Court of Delaware

    • Plaintiff:  Amarin Pharmaceuticals Ireland Ltd.
    • Defendants:  Omthera Pharmaceuticals Inc.; AstraZeneca Pharmaceuticals LP

    Infringement of U.S. Patent No. 8,663,662 ("Stable Pharmaceutical Compositions and Methods of Using Same" issued March 4, 2014) based on AstraZeneca's anticipated marketing and sale of their Epanova™ (mixture of polyunsaturated free fatty acids derived from fish oils for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia).  View the complaint here.

    Roxane Laboratories, Inc. v. Camber Pharmaceuticals, Inc. et al.
    2:14-cv-00232; filed March 4, 2014 in the Southern District of Ohio

    • Plaintiff:  Roxane Laboratories, Inc.
    • Defendants:  Camber Pharmaceuticals, Inc.; Invagen Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease).  View the complaint here.

    Bausch & Lomb Inc. et al. v. Sandoz Inc. et al.
    1:14-cv-01325; filed March 2, 2014 in the District Court of New Jersey

    • Plaintiffs:  Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.; Mitsubishi Tanabe Pharma Corp.; Ube Industries, Ltd.
    • Defendants:  Sandoz Inc.; Sandoz International GmbH

    Infringement of U.S. Patent No. 6,780,877 ("Acid Addition Salt of Optically Active Piperidine Compound and Process for Preparing the Same," issued August 24, 2004) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Bausch & Lomb's Bepreve® (bepotastine besilate ophthalmic solution, used for the treatment of itching associated with allergic conjunctivitis).  View the complaint here.

  • CalendarMarch 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 13, 2014 – "Patent Term Adjustments and Extensions: Leveraging Exelixis, Novartis, Other Decisions, and USPTO Rule Changes" (Strafford) – 1:00 to 2:30 pm (EST)

    March 13, 2014 – "Inter Partes Review: Nuts & Bolts" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

    March 13, 2014 – "Understanding the New USPTO Final and Proposed Rules on PLT and the Hague Agreement" (West LegalEdcenter) – 12:00 to 1:00 pm (EDT)

    March 20, 2014 – "Parallel Patent Proceedings Before the PTAB and Federal Court Post-AIA — Navigating Litigation Stays, Discovery and Settlements Concurrent with PTAB Review" (Strafford) – 1:00 to 2:30 pm (EST)

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, DC

    March 25, 2014 – "Big Data Litigation in an Era of Big Data Privacy Concerns: Recent Developments in International Data Privacy Law and Their Impact on U.S. Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    March 26, 2014 – "Trade Secret vs. Patent Protection After AIA: Making the Choice — Understanding AIA's Impact on Trade Secrets, Evaluating the Protection Options, Weighing the Benefits and Risks" (Strafford) – 1:00 to 2:30 pm (EDT)

    March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

    March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

    April 23, 2014 – European biotech patent law update (D Young & Co) – 4:00 am, 7:00 am, and 12:00 pm (ET)

    April 23-25, 2014 – 2014 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) – Palm Springs, CA

    April 28-29, 2014 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    ***Patent Docs is a media partner of this conference or CLE

  • IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Inter Partes Review: Nuts & Bolts" on March 13, 2014 beginning at 2:00 pm (ET).  A panel consisting of R. Danny Huntington of Rothwell, Figg, Ernst & Manbeck, P.C.; Lori Gordon of Sterne, Kessler, Goldstein & Fox P.L.L.C.; and Judge Michael Tierney of the U.S. Patent and Trademark Office will discuss the PTAB's published guidance and suggested practice regarding:

    • Patent owner motions to amend claims
    • Motions to exclude the other side’s evidence
    • Effective use of declarations and experts
    • Deposition etiquette
    • The one-year bar
    • Joinder practice

    The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

  • West LegalEdcenterWest LegalEdcenter will be offering a live webcast entitled "Understanding the New USPTO Final and Proposed Rules on PLT and the Hague Agreement" on March 13, 2014 from 12:00 to 1:00 pm (EDT).  Miku H. Mehta and Michael C. Jones of Procopio, Cory, Hargreaves & Savitch LLP will discuss the changes and the law and the proposed and actual rules, as well as how these rules impact prosecution generally with regard to the PLT provisions, and with respect to Hague, will consider the impact on design patent prosecution.  The panel will also take a practical view and offer strategy tips.

    The registration fee for the webcast is $195.  Those interested in registering for the webinar, can do so here.

  • D Young & CoD Young & Co will be offering its next European biotech patent law update on April 23, 2014.  The 45-minute webinar will be offered at three times: 4:00 am, 7:00 am, and 12:00 pm (ET).  D Young & Co European Patent Attorneys Robert Dempster and Simon O'Brien will provide an essential update and live Q&A on EPO biotechnology case law.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.

  • MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Big Data Litigation in an Era of Big Data Privacy Concerns: Recent Developments in International Data Privacy Law and Their Impact on U.S. Litigation" on March 25, 2014 from 10:00 am to 11:15 am (CT).  MBHB attorney S. Richard Carden will review recent developments in data privacy law worldwide (focusing primarily on the Asia-Pacific and Latin American regions), and discuss the impacts of those developments on U.S. litigation.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • By Kevin E. Noonan —

    SDIPLAThe San Diego Intellectual Property Law Association (SDIPLA) is one of two groups that have filed an amicus curiae brief urging reversal of the District Court's summary judgment decision in Ariosa Inc v. Sequenom, Inc.  (The brief from the other amicus, the Biotechnology Industry Organization, BIO, will be the subject of a future post.)  The SDIPLA's position in its brief is not surprising (particularly in view of the violence with which the District Court treated established principles of patent law); what is surprising is that only two amici have shared their views with the Federal Circuit.

    (In an unusual procedural aside, certain of the appellees refused to consent to these amicus filings, ostensibly because addressing the issues in the brief would require a 60-day extension of time for filing their responsive brief.  The tactic worked, with the Federal Circuit granting the amici's motions for leave to file their briefs and appellees' motion for extension of time.  Their responsive brief is now due May 5, 2014.)

    Turning to the substance, the SDIPLA's brief poses three questions the Federal Circuit should address in the appeal:

    1.  Does a claim to a diagnostic use of a known process or known composition of matter that is statutorily patent eligible under 35 U.S.C. §101 become nonstatutory when the use is a new use of the known process or known composition of matter for the limited purpose of detection of a product of nature or natural phenomenon?

    2.  Is it relevant to the question of statutory patent eligibility of the claim of question 1 that the claimed process satisfies the machine-or-transformation test for statutory patent eligibility of a process?

    3.  Can a claim to a new diagnostic use of a known process or known composition of matter that is statutory patent eligible under 35 U.S.C. §101 be deemed preemptive of a product of nature or natural phenomenon when the new use of the known process or known composition of matter is limited to the detection of the product of nature or natural phenomenon?

    In proposing answers to these questions, the amicus brief recites claim 1 of U.S. Patent No. 6,258,540 as being representative of the claims at issue:

    A method for detecting a paternally inherited nucleic acid of fetal origin performed on a serum of plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.

    The brief argues that 35 U.S.C. § 100(b) expressly specifies that the term "process" used in § 101 encompasses "a new use of a known process, machine, manufacture, composition of matter, or material" (emphasis in brief).  The claims at issue fall within the scope of this definition, being either a new use of a known process (amplification and detection of cffDNA) or a new use of an old composition of matter (naturally occurring cffDNA) (or both).  The brief asserts that amplification and detection of DNA is patent eligible (assuming it could satisfy the other requirements of the statute); the brief cites the numerous patents granted to various aspects of in vitro amplification including, inter alia, U.S. Patent No. 4,683,195.  The brief also argues (with less force) that plasma or serum would also be patent eligible; in a footnote the amicus notes that plasma and serum must be separated "by the intervention of man" and that plasma and serum have properties that differ from blood, thus satisfying the requirements of Diamond v. Chakrabarty not disturbed by either Mayo v. Prometheus or AMP v. Myriad.  However, the brief makes the more interesting argument that, following the District Court's reasoning, claims to amplifying and detecting DNA that are patent eligible become less patent eligible when narrowed to a specific application of the technology (here, detecting cffDNA).  Established patent law would be "eviscerated if a diagnostic process which, when broadly claimed, would be patent eligible if the requirements of novelty and unobviousness were satisfied becomes ineligible for patenting when narrowed if that narrowing involves applying the process to the new use of detecting a hitherto unknown product of nature or natural phenomenon, in this case the presence of cffDNA of paternal origin in maternal blood."

    Amicus also argues that the claims of the '540 patent satisfy the "machine or transformation" test, which the brief argues is "a useful and important clue . . . for determining whether some claimed inventions are processes under §101," citing Bilski v. Kappos.  The "substantial manipulation" required in the practice of the invention likewise provide "yet further clues to the patentability of the claims" and "justify[] recognition of the patent eligibility of the '540 patent claims."

    The tension between the Supreme Court's Mayo decision and its earlier Diamond v. Diehr precedent is recited by the brief with regard to "the rigid application of the language of [Parker v.] Flook and Mayo which'"stands in stark contrast to the observation in Diamond v. Diehr [] that '[it] is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be patentable.'"

    The brief then walks through earlier Supreme Court precedent related to the patent eligibility of process claims.  These include Cochrane v. Deener (which the brief cites as the first decision recognizing that a new process can be patent eligible even if "not limited to any special arrangement of machinery"); Funk Bros. Seed Co. v. Kalo Inoculant Co. (which the brief distinguishes from the claims at issue because the '540 patentees "did not seek to patent this phenomenon but instead patented a process which, as the record in this case clearly reflects and the District Court acknowledges, takes advantage of the knowledge of that natural phenomenon by applying it to a new and very useful end, the detection of a cffDNA of paternal origin in the maternal blood" and noted that even the Funk Bros. Court recognized that claims to applications of natural phenomena were patent eligible); and Diehr.  In particular, the brief cites the portion of the Myriad decision where Justice Thomas noted with approval the patent eligibility of applications of the patentees' knowledge of the BRCA genes and the relationship of mutations in those genes to an increase propensity for developing cancer.  And the brief distinguishes the claims at issue from the claims invalidated by the Supreme Court in Mayo, on the grounds that nothing in the claims at issue in Mayo other than the natural law was inventive and in fact was well known and extensively practiced in the prior art.

    These arguments lead this amicus to propose a rule, that "a process claim which is directed to a new diagnostic use of a known process and/or known composition of matter that are otherwise eligible for patenting under §101 be itself considered patent eligible in the circumstance where the diagnosis is specifically directed to the detection of a previously unknown natural product or natural phenomenon of diagnostic significance."  The predicted consequence is that "[a]doption of such a standard of patent eligibility will also do much to further and incentivize innovation to discover and exploit new diagnostic tools without restricting other applications of the product of nature or natural phenomenon such innovation reveals, all of which is to the substantial benefit of the public."

  • By Andrew Williams —

    \ Washington - Capitol #2Last Thursday, Sen. McCaskill, along with Sen. Rockefeller, introduced the "Transparency in Assertion of Patents Act" (S. 2049).  Of course, several other bills are currently pending in the Senate that have been introduced by such politicians as Sen. Leahy (S. 1720), Sen. Hatch (S. 1612), Sen. Cornyn (S. 1013), and Sen. Schumer (S. 866).  What sets the current bill apart is that it was referred to the Committee of Commerce, Science, and Transportation instead of the Judiciary committee.  This may be due, in part, to the fact that the McCaskill bill is directed exclusively to abusive demand letters, with enforcement provisions directed to the Federal Trade Commission ("FTC").  However, the Leahy bill also contains a demand-letter provision, and also provides the FTC with enforcement power.  It will therefore be interesting to monitor this newly introduced bill to see how it will be reconciled, if at all, with the other pending Senate bills.  The McCaskill bill was scheduled for mark-up today, March 5, 2014, but that was postponed, likely until next week.

    Of course, the difficulty with any bill aimed at the sending of demand letters is that the First Amendment rights of patent holders need to be taken into account.  Congress cannot simply make the practice of sending such letters, without more, a judicial cause of action.  More importantly, the sending of such demand letters is an essential part of our patent system, allowing patent holders to put alleged infringers on notice and, ideally, facilitating licensing activity between the parties.  Care must be taken, therefore, to ensure that legitimate, non-abusive demand letters are not negatively impacted by any legislation.

    On the other hand, curbing abusive demand letters is one of the only new legislative proposals that would impact pre-litigation activity.  Such controls are essential, the anti-troll activists advocate, because many so-called "trolls" never end up in a courtroom.  Instead, the argument goes, their main objective is to "shake-down" as many companies and individuals as possible, obtaining quick settlements because accused infringers are motivated to avoid costly litigation.  If true, then some legislation impacting demand letters should be necessary if the "patent troll" problem is truly going to be addressed.

    The Innovation Act, passed by the House last December, struck an appropriate balance.  It was first made clear that the "Sense of Congress" was that the sending of purposely evasive demand letters was an abuse of the patent system.  Importantly, the redress was narrowly tailored to the perceived problem.  If a patent holder is found to have omitted certain essential facts from a demand letter, including the asserted patent and accused instrumentality, that same party could not rely on the demand letter as evidence in a willful infringement charge.  In other words, if the letter does not put the accused infringer on notice, it cannot be relied upon to establish that they had actual knowledge of the patent or that they might be infringing the patent.

    The Patent Transparency and Improvements Act (S. 1720), introduced by Sen. Leahy et al., takes a different tack, providing that "[i]t shall be an unfair or deceptive act or practice within the meaning of section 5(a)(1) of the Federal Trade Commission Act (15 U.S.C. 45(a)(1))" to engage in the abusive dissemination of demand letters.  Specifically, it will be considered abusive if the patent holder (1) falsely threatens administrative or judicial relief, (2) the assertions lack a reasonable basis in fact or law, or (3) the content is likely to materially mislead a reasonable recipient.  However, just what constitutes a threat remains unclear.  It appears that Sen. Leahy had identified a particular "troll-like" behavior that he wanted to curb, but his proposed solution could end up impacting the legitimate assertion of patent rights.

    Sen. McCaskill's bill is very similar to the provision in S. 1720.  First, the bill would require the FTC to "promulgate rules to prohibit unfair or deceptive acts and practices" in the abusive sending of demand letters.  The actions that would constitute unfair or deceptive assertion are the same as in the Leahy bill.  However, the McCaskill bill outlines just what information a demand letter should contain: (1) each patent and asserted claim; (2) a detailed description of the accused instrumentality; (3) a detailed description of the alleged activity; (4) notice that the recipient has the right to have the manufacturer defend against the alleged infringement; (5) information about any party with a direct financial interest related to the assertion of the patent; (6) any licensing commitments; (7) any methodology used to calculate compensation; (8) any activity of the patent at the Patent Office or in court; and (9) anything else the FTC deems necessary.  McCaskill's bill, much like the Leahy bill, would provide enforcement power to the FTC.  However, her bill goes beyond the Leahy equivalent in providing for enforcement power by the states' attorneys general on behalf of their residents, should it be determined that the citizens of that state are falling victim to such abusive activity.  The bill would provide for a civil penalty not to exceed $16,000 (adjusted for inflation) per violation of this rule.  The FTC would be able to intervene, and a state could not bring such an action if the FTC has already instituted a civil action.  The acknowledgement of the state attorneys general by the McCaskill bill is interesting, especially in view of their recent activity in states such as Vermont and Nebraska.

    We will continue to monitor the situation in the Senate.  Sen. Leahy recently reported that he would like to schedule the mark-up for next month, but it will likely not occur until May.  It will be interesting to see how these two bills are rectified, or to see to what extent the two committees cooperate on passage of demand letter reform.

  • By Donald Zuhn —

    USPTO SealEarlier today, in a memorandum issued to the Patent Examining Corps by Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld, the U.S. Patent and Trademark Office implemented a new procedure for determining the subject matter eligibility of claims under 35 U.S.C. § 101 in view of the Supreme Court's decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012).  The guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products" (or "Myriad-Mayo Guidance" as the file is named), indicates that "all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined using the Guidance" (emphasis in memo), and that the Myriad-Mayo Guidance is effective as of today and supersedes the Office's preliminary guidance on the Myriad decision that was issued on June 13, 2013 (see "USPTO Issues Memo on AMP v. Myriad to Examining Corps").  The memo does not specifically indicate whether the new procedure outlined in the Myriad-Mayo Guidance also supersedes the "2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature" (see "USPTO Issues Interim Guidance Regarding Mayo v. Prometheus").  The memo does note, however, that the new procedure outlined in the Myriad-Mayo Guidance does not impact the examination of claims reciting an abstract idea, which will continue to be analyzed using the guidance set forth in MPEP § 2106(II).

    Before outlining the new procedure for assessing subject matter eligibility, the memo explains that the guidance addresses the impact of the Myriad decision on the Supreme Court's long-standing "rule against patents on naturally occurring things," as expressed in the Court's decisions in Diamond v. Chakrabarty and Mayo.  The Myriad-Mayo Guidance notes that:

    Myriad relied on Chakrabarty as "central" to the eligibility inquiry, and re-affirmed the Office's reliance on Chakrabarty's criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products).  [Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107,] 2116-17.  Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., "isolated") in the claims does not automatically confer eligibility.  Id. at 2119.  See also Mayo, 132 S. Ct. at 1294 (eligibility does not "depend simply on the draftsman's art").  Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.

    (emphasis in original).

    The new procedure described in the Myriad-Mayo Guidance involves a three-step analysis in which examiners are to ask the following questions:

    1.  Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?

    2.  Does the claim recite or involve one or more judicial exceptions?

    3.  Does the claim as a whole recite something significantly different than the judicial exception(s)?

    This analysis is depicted in the memo using the following flowchart (click on flowchart to enlarge):

    Flowchart
    With regard to whether an examiner should proceed from the second question to the third question, the Myriad-Mayo Guidance states that:

    Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. In particular, claimed subject matter that must be analyzed under Question 3 to determine whether it is a natural product includes, but is not limited to: chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.

    If there is any doubt as to whether the claim recites a judicial exception (e.g., the claim recites something similar to a natural product), the claim requires further analysis under Question 3.

    (emphasis in original).

    The second part of the memo concerns the analysis of whether the claim recites something significantly different than a judicial exception.  The Myriad-Mayo Guidance indicates that:

    A significant difference can be shown in multiple ways, such as: (1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception).

    The memo then lists a dozen factors:  six that weigh toward eligibility (i.e., the claim recites something that is significantly different from a judicial exception) and six that weigh against eligibility (i.e., the claim recites something that is not significantly different from a judicial exception).  Noting that two of the factors "concern the question of whether something that initially appears to be a natural product is in fact non-naturally occurring and markedly different from what exists in nature, i.e., from naturally occurring products," the memo explains that:

    This question can be resolved by first identifying the differences between the recited product and naturally occurring products, and then evaluating whether the identified differences together rise to the level of a marked difference in structure.  Not all differences rise to the level of marked differences, e.g., merely isolating a nucleic acid changes its structure (by breaking bonds) but that change does not create a marked difference in structure between the isolated nucleic acid and its naturally occurring counterpart.

    (emphasis in original; citation omitted).

    The Myriad-Mayo Guidance further explains that "[t]he fact that a marked difference came about as a result of routine activity or via human manipulation of natural processes does not prevent the marked difference from weighing in favor of patent eligibility," citing Myriad for the proposition that "cDNA having a nucleotide sequence that is markedly different from naturally occurring DNA is eligible subject matter, even though the process of making cDNA is routine in the biotechnology art."

    In the third part of the Myriad-Mayo Guidance, which covers almost thirteen of the memo's nineteen pages, the Office applies the memo's new analytic framework to eight examples:

    A.  Composition/Manufacture Claim Reciting A Natural Product
    B.  Composition vs. Method Claims, Each Reciting A Natural Product
    C.  Manufacture Claim Reciting Natural Products
    D.  Composition Claim Reciting Multiple Natural Products
    E.  Composition vs. Method Claims, Each Reciting Two Natural Products
    F.  Process Claim Involving A Natural Principle And Reciting Natural Products
    G.  Process Claims Involving A Natural Principle
    H.  Process Claim Reciting An Abstract Idea And A Natural Product

    While practitioners are encouraged to thoroughly review the examples, the exemplary claims, subject matter eligibility determinations, and a brief summary of the rationales provided in the memo are listed below.

    Example A:

    Claim 1:  A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

    Claim 2:  A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

    The memo finds claim 1 to be drawn to ineligible subject matter and claim 2 to be drawn to eligible subject matter, explaining that "although the plasmids themselves are natural products, in claim 2 the recited 'something that initially appears to be a natural product' . . . is the bacterium containing the plasmids, and not the bacterium alone or the plasmids alone."  The memo notes that the bacterium of claim 2 was held to be patent-eligible subject matter in Chakrabarty.

    Example B:

    Claim 1:  Purified amazonic acid.

    Claim 2:  Purified 5-methyl amazonic acid.

    Claim 3:  A method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

    The memo finds claim 1 to be drawn to ineligible subject matter and claims 2 and 3 to be drawn to eligible subject matter.  With respect to claim 2, the memo states that "[t]he 5-methyl amazonic acid is structurally different than naturally occurring amazonic acid (because of the addition of the 5-methyl group), and this structural difference has resulted in a functional difference (5-methyl amazonic acid stimulates the growth of hair in addition to treating cancer)."  More importantly, however, the memo indicates that "a functional difference is not necessary in order to find a marked difference," but suggests that "the presence of a functional difference resulting from the structural difference makes a stronger case that the structural difference is a marked difference."  As for claim 3, the memo explains that "[t]he step of administering a particular dosage of amazonic acid (0.75 to 1.25 teaspoons per day) for a particular length of time (10-20 days) to a particular patient (patient with colon cancer), meaningfully limits the scope of the claim to a particular application of amazonic acid," and therefore "others are not substantially foreclosed from using amazonic acid in other ways, e.g., to treat colon cancer at other dosages or for other lengths of time, to treat other cancers, etc."

    Example C:

    Claim 1:  A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) gunpowder, (d) a cardboard body having a first compartment containing the sparking composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a plastic ignition fuse having one end extending into the second compartment and the other end extending out of the cardboard body.

    The memo finds the claim to be drawn to eligible subject matter, explaining that "the claimed elements in addition to the calcium chloride and gunpowder narrow the scope of the claim so that others are not foreclosed from using the natural products in other ways, e.g., others can still use calcium chloride in products such as concrete, foods, fire extinguishers, etc., and can still use gunpowder in other products such as rifle cartridges."

    Example D:

    Claim 1:  An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific.

    The memo finds the claim to be drawn to ineligible subject matter, explaining that "[t]he specification describes that applicant has not changed the bacteria in any way, but instead has simply combined various strains of naturally occurring bacteria together."  The memo notes that the inoculant of this claim was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948).

    Example E:

    Claim 1:  A pair of primers, the first primer having the sequence of SEQ ID NO: 1 and the second primer having the sequence of SEQ ID NO: 2.

    Claim 2:  A method of amplifying a target DNA sequence comprising:
        providing a reaction mixture comprising a double-stranded target DNA, the pair of primers of claim 1 wherein the first primer is complementary to a sequence on the first strand of the target DNA and the second primer is complementary to a sequence on the second strand of the target DNA, Taq polymerase, and a plurality of free nucleotides comprising adenine, thymine, cytosine and guanine;
        heating the reaction mixture to a first predetermined temperature for a first predetermined time to separate the strands of the target DNA from each other;
        cooling the reaction mixture to a second predetermined temperature for a second predetermined time under conditions to allow the first and second primers to hybridize with their complementary sequences on the first and second strands of the target DNA, and to allow the Taq polymerase to extend the primers; and
        repeating steps (b) and (c) at least 20 times.

    The memo finds claim 1 to be drawn to ineligible subject matter and claim 2 to be drawn to eligible subject matter.  With regard to claim 1, the memo notes that "neither of the natural products recited in the claim is markedly different," adding that "the first and second primers have the same function as their natural counterpart DNA, i.e., to hybridize to their complementary nucleotide sequences," and that "[t]he minor structural differences taken together with the lack of any functional difference between the primers and the natural DNA fail to demonstrate that the recited products are markedly different from what exists in nature."  With respect to claim 2, the memo explains that "the heating and cooling steps contain a number of limitations that narrow the scope of the claim," and that "others can still apply and use the natural products in other methods, such as a method of treatment or even an amplification method that does not involve Taq polymerase or thermal cycling."

    Example F:

    Claim 1:  A method for determining whether a human patient has degenerative disease X, comprising: obtaining a blood sample from a human patient; determining whether misfolded protein ABC is present in the blood sample, wherein said determining is
        performed by contacting the blood sample with antibody XYZ and detecting whether binding occurs between misfolded protein ABC and antibody XYZ using flow cytometry, wherein antibody XYZ binds to an epitope that is present on misfolded protein ABC but not on normal protein ABC; and
        diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present in the blood sample.

    The memo finds claim 1 to be drawn to eligible subject matter, noting that "[a] review of the specification indicates that antibody XYZ does not exist in nature, and is not purely conventional or routine in the art (it was newly created by the inventors)," and explaining that "others can still apply and use the natural principle in other methods, such as a method of treatment or a method of assessing whether a particular treatment regimen has resulted in a decrease in the amount of misfolded protein ABC in a patient's blood."

    Example G:

    Claim 1:  A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to sunlight, wherein the exposure to sunlight alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

    Claim 2:  A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising: exposing the patient to a synthetic source of white light, wherein the exposure to white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

    Claim 3:  A method for treating a mood disorder in a human patient, the mood disorder associated with
        neuronal activity in the patient’s brain, comprising: providing a light source that emits white light; filtering the ultra-violet (UV) rays from the white light; and positioning the patient adjacent to the light source at a distance between 30-60 cm for a
        predetermined period ranging from 30-60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

    The memo finds claims 1 and 2 to be drawn to ineligible subject matter and claim 3 to be drawn to eligible subject matter.  With respect to claim 1, the memo explains that "the only step in addition to the judicial exceptions is the step of exposing a patient to sunlight, and this step is not a meaningful limit on the claim scope, in that it substantially forecloses others from using or applying sunlight (a natural phenomenon) alone or in connection with the natural principle."  According to the memo, claim 2 is directed to patent ineligible subject matter, in part because "the step of exposing a patient to synthetic white light for the purpose of affecting a mood disorder is just an attempt to limit the use of the natural principle to a particular technological environment (use of artificial light as opposed to sunlight)."  Finally, with respect to claim 3, the memo notes that "the filtering and positioning steps meaningfully limit the claim to a particular application of the natural principle," and that "[o]thers are not substantially foreclosed from using or applying the natural principle in other ways, e.g., by exposing a patient to sunlight, by positioning the patient for a different length of time or at a different distance, etc."

    Example H:

    Claim 1:  A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.

    The memo indicates that "[b]ecause the claim recites an abstract idea, Question 3 should be analyzed using only the existing guidance in MPEP § 2106(II)."  The memo also notes that claim 1 was found to be directed to ineligible subject matter in Association for Molecular Pathology v. Myriad Genetics, Inc., 689 F.3d 1303, 1333-35 (Fed. Cir. 2012), aff’d in part and rev’d in part on other grounds, 569 U.S. ­­__, 133 S. Ct. 2107, 2116 (2013).