Patent Docs

Driessen v. Sony Music Entertainment (Fed. Cir. 2016)

February 11, 2016

By Joseph Herndon —

On February 10, 2016, the Federal Circuit issued a nonprecedential opinion in a case captioned Driessen v. Sony Music Entertainment, Best Buy Stores, Fye, & Target Corp. addressing issues related to means-plus-function claims and written description. While the decision is nonprecedential, it serves as a reminder to provide detailed descriptions of claim terms and to use means-plus-function terms sparingly.

James L. Driessen is the named inventor on U.S. Patent Nos. 7,003,500 ("the '500 patent"), 7,636,695 ("the '695 patent"), and 7,742,993 ("the '993 patent"). Mr. Driessen and his wife sued Sony Music Entertainment, Best Buy Stores, FYE, and Target (collectively "Sony"), alleging infringement of these patents in the U.S. District Court for the District of Utah. The District Court granted Sony's motions for summary judgment, finding some of the asserted claims of the '500 patent invalid as indefinite, and some of the asserted claims of the '500 patent, all claims of the '695 patent, and all claims of the '993 patent invalid for lack of written description.

All three patents have virtually the same specification and relate to systems and methods of purchasing downloadable content from the Internet. Rather than purchasing the content directly through the Internet, the buyer goes to a retail store to pay for the item in person. At the retail store, the buyer obtains a ticket or other "physical medium" proof of sale containing a web address specific to the item sold and a unique password that will enable its download. The buyer can then anonymously download the media content from any computer with Internet access by going to the web address and inputting the unique password provided.

Indefinite Claims

Claim 1 of the '500 patent, which contains several means-plus-function elements, provides,

1. A payment system for itemized Internet merchandise or itemized downloadable media material objects, comprising:
    a retail point of sale establishment;
    a customer access point at said retail point of sale establishment;
    URL information that is an Internet transaction location of said itemized Internet merchandise or itemized downloadable media material objects;
    means for accepting payment through an in person transaction with a customer wherein said payment is designated for purchase of said itemized Internet merchandise or itemized downloadable media material objects;
    means for storing and retrieving a record on or in a physical medium corresponding to said URL information that is an Internet transaction location of said itemized Internet merchandise or itemized downloadable media material objects;
    means for transfer of said physical medium from said retail point of sale establishment to said customer; and
    means for Internet transaction authorization on, in, or actuated from said physical medium wherein ownership rights in said itemized Internet merchandise or itemized downloadable media material objects are preselected and transferred to said customer through said transfer of said physical medium.

Primarily at issue in the case is the "means for storing and retrieving a record on or in a physical medium" limitation. This claim element was construed pursuant to 35 U.S.C. § 112(f), in which the function is identified and then the specification is analyzed to determine what is described as performing the identified function. The District Court found that the function of this element is "storing and retrieving a record on or in a physical medium". Specific terms of this element were then construed in which "storing" was construed to mean "both putting into storage and holding in storage," "retrieving" was construed to mean "taking out of storage for the purpose of presenting authentication to prove purchase," "record" was construed to mean a "unique URL corresponding to specific web merchandise or content," and "on or in a physical medium" was construed to mean the location where "the record is stored and from where it may be retrieved."

A means-plus-function claim is indefinite unless structure to perform the function is identified in the specification. Here, the District Court rejected the Driessens' contention that Figure 5 (a portion of which is reproduced below) — which depicts an "Admit One" ticket and a floppy disk — provides the necessary structure to correspond with the above function.

The District Court explained that while Figure 5 perhaps discloses examples of "physical media," it does not disclose a structure that "stor[es] and retriev[es] a record on or in a physical medium." The disk lacks structure for retrieving any record. Thus, because the specification failed to disclose any such associated structure for "storing" and "receiving" the record in a physical medium, the claims were held invalid as indefinite.

The Federal Circuit agreed with the District Court, and noted that in the context of storing "a record on or in a physical medium," it is apparent that "store" implies not only maintaining the record in a physical medium, but also getting it there to begin with. The fact that necessary structures for performing a "means for storing and retrieving a record on or in physical medium" were known in the art does not save the claims. For means-plus-function claim terms, the inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing a structure. Accordingly, a bare statement that known techniques or methods can be used does not disclose structure.

Lack of Written Description

A portion of claim 10 of the '500 patent provides:

10. A method of merchandise transfer on a computer network comprising at least one buyer computer on a network for operation by a user desiring to buy at least one product and at least one selling computer on said network operating for a purpose to sell said product, the method comprising the steps of: . . .
    sending a payment message as a response to said in person transaction either directly or through other computers on said network to said selling computer on said network;
    causing an authorization message to be created on said selling computer in or as a result of said payment message that comprises at least said specification of said product and authentication based on cryptographic key(s), said selling computer being programmed to receive said authorization message for verification of said authentication; . . .

The three terms "selling computer," "payment message," and authorization message," which first appeared when Mr. Driessen added new claims by amendment more than four years after filing the original application that became the '500 patent, also appear in all asserted claims of the '695 and '993 patents.

The District Court found that no written description for "selling computer," "payment message," or "authorization message" is provided anywhere in the specification or original application. The Driessens argued that the terms were implicitly present in the original application, but the District Court held that the asserted description of "secure web transactions" and "public key infrastructure" in these patents did not necessarily provide for "payment messages" or "authorization messages," let alone require such messages to be sent to or from "selling computers."

The Federal Circuit agreed with the District Court and cautioned that when a patent applicant adds new claims after the original filing date, the new claims must find support in the original specification. The question becomes whether one of ordinary skill in the art would consider the added claim terms to be supported by the specification as originally filed.

Here, the terms added by amendment of "selling computer," "payment message," and "authorization message" are not present anywhere in the specification or original provisional application. The fact that the words "payment," "message," "authorization," and "computer" appear individually numerous times in the specification does not provide adequate written description for the terms "selling computer," "payment message," and "authorization message" as defined in the claims. The Federal Circuit cited LizardTech and noted that the mere presence of these words in isolation does not suffice to show that the "patentee had possession of" the "selling computer," "payment message," and "authorization message" elements of the claimed invention at the time of the application, as 35 U.S.C. § 112(a) requires.

Thus, the Federal Circuit affirmed the District Court's conclusion that such claims are invalid for lack of written description.

This case serves as a lesson for using means-plus-function terms sparingly and carefully, and for having clear support in the specification for all amendments entered during prosecution. From a point of personal experience, recently, it feels like U.S. patent examiners seemingly have been told to have a heightened scrutiny with respect to section 112 issues requiring very specific support in the specification for all claim terms. While the requirements in the U.S. Patent Office are not as strict as seen in foreign jurisdictions (e.g., the EPO requires near verbatim or one-to-one use of terminology in the claims as seen in the specification), it does appear that the standards at the U.S. Patent Office have been raised somewhat.

Driessen v. Sony Music Entertainment (Fed. Cir. 2016)
Nonprecedential disposition
Panel: Circuit Judges Dyk, Mayer, and Hughes
Opinion per curiam
Celltrion’s Proposed REMICADE® Biosimilar Recommended for Approval

February 9, 2016

By Andrew Williams —

Earlier today, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody. According to a press release from Celltrion, the committee voted 21-3 to recommend approval for all sought indications, including treatment of a variety of autoimmune diseases such as Crohn's disease, ulcerative colitis, and rheumatoid arthritis. This would be the second biosimilar ever approved in the United States (U.S.) pursuant to the Biologics Price Competition and Innovation Act (BPCIA), and the first biosimilar therapeutic monoclonal antibody. If the experience with Sandoz's Zarxio^TM biosimilar is any indication, the FDA should be expected to approve the application in the next couple of months. Marketing of the drug may be delayed, however, pending the outcome of Janssen's motion for partial summary judgment and a preliminary and permanent injunction. A key consideration of that case is the Federal Circuit's Amgen v. Sandoz decision and its interpretation, which may delay marketing for an additional six months because the Notice of Commercial Marketing cannot be effective until approval by the FDA.

Last week, in advance of today's meetings, staff at the FDA released a briefing document in which they reported that the data submitted by Celltrion showed "that CT-P13 is highly similar to US-licensed Remicade, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between CT-P13 and US-licensed Remicade in terms of the safety, purity, and potency of the product." Importantly, much like Sandoz's experience with Zarxio, Celltrion benefited from the fact that CT-P13 has already been approved outside the U.S. for similar indications. For example, in the EU, South Korea, Japan, and India, Celltrion's biosimilar has been approved for all US-approved indications under the trade names Inflectra and Remsima (although no name has yet been assigned to the U.S. version of the drug). In Canada, however, the same drug has been approved for all indications except ulcerative colitis and Crohn's Disease. Because the development of CT-P13 occurred entirely outside of the U.S., Celltrion had to provide additional comparative data — in order to "scientifically justify the relevance of that data by establishing an adequate scientific bridge between EU-approved Remicade, the US-licensed reference product and CT-P13." The FDA explained that this bridging data should always include results from analytical studies, such as structural and functional data that directly compares all products, and should also include bridging PK and/or PD clinical data.

The FDA's briefing document also said that Celltrion had "provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use and potential licensure of CT-P13 for each of the seven indications for which US-licensed Remicade is currently licensed and for which CT-P13 is eligible for licensure." Celltrion is seeking to market CT-P13 for the following indications: (1) Crohn's Disease (CD), (2) Pediatric CD, (3) Ulcerative Colitis (UC), (4) Rheumatoid Arthritis, (5) Ankylosing Spondylitis, (6) Psoriatic Arthritis, and (7) Plaque Psoriasis. In addition, Celltrion is seeking approval for Pediatric CD, but according to the briefing, this indication is protected by orphan drug exclusivity until September 23, 2018. Unlike in Canada, the committee recommended approval for all sought-after indications in the U.S.

Once the FDA accepts the committee's recommendation and approves Celltrion's application, it may still be at least six months before the biosimilar drug can be marketed. Unlike Sandoz in the case of Zarxio, Celltrion provided Janssen with its aBLA after it was accepted by the FDA. Nevertheless, according to the Complaint filed by Janssen in the U.S. District Court for the District of Massachusetts, Celltrion refused to provide the requisite "other information" required by the BPCIA, which would describe the manufacturing process. Moreover, Celltrion served a notice of commercial marketing on February 5, 2015, indicating that it would begin selling the product as early as August 4, 2015. Of course, even though this notice occurred after Celltrion's application was accepted, it was significantly before actual approved (especially considering the biosimilar is not yet approved). Celltrion has responded to Janssen's injunction motions by alleging that the Notice-of-Commercial-Marketing provision of the BPCIA is not a stand-alone provision and that because it took part in the "Patent Dance," it is not required to give such notice. While Janssen's motion is pending, the Federal Circuit will be considering the almost identical issue in the Amgen v. Apotex case, which we will preview in an upcoming post.

Nevertheless, the committee's vote today is especially significant considering the intense interest focused on biosimilar therapeutic antibodies. Going into this meeting, there was a lot of uncertainty about just how much information the FDA would require in order for a biosimilar applicant to establish "no clinically meaningful differences" between its biosimilar drug and the reference product. Of course, Celltrion benefited from extensive data that it had already generated outside of the U.S. It therefore remains to be seen just how much data the FDA will require for biosimilar therapeutic antibodies that do not have such a history.
Avid Technology, Inc. v. Harmonic, Inc. (Fed. Cir. 2016)

February 8, 2016

Lesson for Defendant-Appellee's: Provide Responsive Arguments on Appeal

By Joseph Herndon —

On January 29, 2016, the Federal Circuit issued an Opinion in Avid Technology, Inc. v. Harmonic, Inc. in which the judgment of the District Court was vacated, and the case was remanded for a new trial on infringement. Avid asserted two patents against Harmonic, U.S. Patent No. 6,760,808 and No. 7,487,309. Both patents concern data storage systems that allow users to store and retrieve large files, such as movies. The main focus of the error in the District Court's judgment, as found by the Federal Circuit, was reliance on prosecution history statements for a disclaimer of claim scope. The Federal Circuit thus remanded for a new trial based on a different claim construction. More importantly, however, due to defendant Harmonic's failure to make certain arguments on appeal, Harmonic effectively has lost the opportunity to argue for non-infringement during the new trial.

Turning to the asserted patents, in the system described by Avid's patents, when a client wishes to store ("write") a file, such as a movie, the system splits the file into "segments." The segments are distributed among various storage units and stored in duplicate at different units (one primary unit and one backup). The system creates and updates segment tables listing file segments and their storage-unit locations. The segment tables may be stored together, as a catalog, and the catalogs may be stored on a catalog manager, at individual clients, at a central database, or may be distributed among several databases or clients. When a client wishes to retrieve ("read") a file, the client determines which storage units have the needed segments, and sends a request for a given segment to a storage unit, which transmits it to the client.

Claim 1 of the '808 patent is illustrative of the claims:

1. A distributed data storage system for allowing one or more client systems to access data, comprising:
    a plurality of independent storage units for storing the data;
    wherein the data is stored on the plurality of storage units in files, wherein each file includes segments of data and redundancy information for each segment, wherein each segment has an identifier, and wherein, for each file, the segments and the redundancy information for each segment are distributed among the plurality of storage units;
    wherein each storage unit comprises: means for maintaining information associating the identifier of each segment stored on the storage unit with the location of each segment on the storage unit; means for receiving a request from one of the client systems for a segment of a file, wherein a request includes the identifier of the segment of the file; and
    means, operative in response to a request from one of the client systems for a segment of a file, for retrieving the requested segment of the file from the storage unit using the information associating the identifier of each segment stored on the storage unit with the location of each segment on the storage unit; and
    means for sending the requested segment to the client system.

The italicized phrases are the focus of this case. The District Court gave the jury a claim construction of the "independent storage unit" claim element, basing that construction on statements Avid made in the prosecution history.

The second italicized claim element at issue went to the jury without a clarifying construction, over neither party's objection. The jury rejected Harmonic's validity challenge to Avid's patents, but found that Harmonic did not infringe. Avid challenged the non-infringement judgment by post-trial motions and argued that the District Court's claim construction regarding the "independent storage unit" element was incorrect and that, under a correct claim construction, that claim element is clearly met. Avid appealed the non-infringement judgment.

Prosecution History Estoppel – Disclaimer?

The District Court ruled that, during prosecution, Avid had disclaimed a system in which the central controller tells the client which storage unit the client should deal with during read and write operations. On that basis, the District Court instructed the jury that "independent storage units" means "storage units which are not centrally controlled and whose memory addresses are not globally allocated" and that "systems with independent storage units cannot use a central controller to access data, and, in particular, cannot use a central controller that identifies the storage unit on which data is stored in response to client requests."

The Federal Circuit found that the District Court erred with this claim construction because the standard for finding a disclaimer was not met. The Federal Circuit noted that "for prosecution disclaimer to attach, our precedent requires that the alleged disavowing actions or statements made during prosecution be both clear and unmistakable." But, where the alleged disavowal is ambiguous, or even "amenable to multiple reasonable interpretations," the Federal Circuit has declined to find prosecution disclaimer.

The District Court relied on two passages from an Avid submission during the prosecution history including:

[T]he claimed system, by virtue of the independent storage units, avoids using a central controller to access data. In particular, storage units "receiv[e] . . . request[s] from one of the client systems for a segment of a file." Clients do not issue requests to a central controller that in turn identifies storage units that store the data and issues requests to storage units.

The Federal Circuit found that the District Court misread this passage. In the Federal Circuit's opinion, the first portion does not itself say what exactly "access[ing] data" entails; it is the second portion that identifies what Avid means. What that portion says, by its terms, is that a central controller is excluded if it performs both of two functions: it "identifies storage units that store the data and issues requests to storage units." The language on its face does not exclude a central controller that performs only one or the other of the two stated functions — which would have been the meaning if the phrase had used "or" rather than "and." In any event, it does not do so clearly, as would be required to find a disclaimer of a central controller that merely identifies the storage units.

In short, the Federal Circuit found no clear and unmistakable disclaimer of central controllers that provide storage-unit location information for retrieving segments. The jury instruction limiting "independent storage units" in that way was incorrect.

Vacate Judgment, New Trial, Judgment of Infringement?

Now that the Federal Circuit found such an error, what action is necessary? The error, undisputedly preserved for review, concerned the legal standard (claim construction) for evaluating a central element of the infringement dispute. The error requires at least vacatur of the verdict and a remand for a new trial unless the Federal Circuit can conclude that the error was not prejudicial, i.e., was harmless.

Because there was no separate jury determination of non-infringement on a distinct ground, the error in the instruction governing this central dispute at trial would be harmless only if a reasonable jury would have been required by the evidence to find non-infringement even without the error.

But Harmonic did not even argue for that conclusion. The Federal Circuit noted that nowhere in its brief did Harmonic argue that the jury was required to find non-infringement — on any ground — even if the "independent storage units" element permits a central component that supplies storage-unit-location information to a client wishing to retrieve data from storage units. In particular, Harmonic did not argue that the evidence required a non-infringement finding based on the other claim element in dispute; its only argument regarding the second at-issue element was that the jury could reasonably find that element not to be met by the infringing product. That is not enough, because the Federal Circuit cannot infer that the jury did so find. Similarly as to the "independent storage units" element itself: Harmonic nowhere argued that, even if the construction given to the jury was wrong, the evidence still required a finding that the infringing product lacks the required independent storage units.

In short, the Federal Circuit found that Harmonic made no argument under the proper legal standard to answer Avid's argument that the instructional error was prejudicial, requiring a new trial. Thus, the Federal Circuit was at least required to remand for a new trial.

Avid actually took its argument one step further to contend that, once the legally erroneous narrowing of the claim construction is reversed, the evidence not only permits but requires a finding that Harmonic's system meets the "independent storage units" claim element. And, Harmonic still presented no argument to the contrary!!

Given that, in response to Avid's argument, Harmonic has simply not suggested an alternative claim construction on this point, or argued that any such alternative claim construction could be found not to reach the alleged product, satisfaction of this claim requirement is now settled. The Federal Circuit thus stated that infringement as a whole is to be retried, but Harmonic's assertion of non-infringement based on this claim element is not, thus narrowing the scope of issues for the new trial on remand.

Thus, because Harmonic did not properly present arguments for non-infringement in the alternative using the suggested claim construction, or even provide responsive arguments to Avid's position of infringement in view of their proposed claim construction, Harmonic effectively waived the opportunity to do so at the new trial. Thus, the error on this central trial issue required setting aside the non-infringement verdicts, which were general verdicts as to each patent, but because Harmonic did not argue that the evidence compels a finding of non-infringement independently of the construction error, satisfaction of this particular claim element is now settled.

With respect to the second claim term at issue, the Federal Circuit rejected the contention that the evidence allows a reasonable finding of infringement. The case went to the jury without a construction of the key claim language, and Avid did not meet its burden of showing that it has the only reasonable view of the claim element as long as it is un-construed. As a result, the Federal Circuit stated that Avid has not shown entitlement to more than a new trial, and thus, no entry of a judgment of infringement was made by the Federal Circuit. But, Avid received a vacatur of the judgment and a new trial in which infringement of a central claim element is satisfied providing for a second opportunity to convince another jury that Harmonic infringes.

Avid Technology, Inc. v. Harmonic, Inc. (Fed. Cir. 2016)
Panel: Circuit Judges Reyna, Taranto, and Stoll
Opinion by Circuit Judge Taranto
Court Report

February 7, 2016

By Sherri Oslick —

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

Astellas Pharma Inc. et al. v. Apotex Inc. et al.
1:15-cv-00857; filed September 22, 2015 in the District Court of Delaware

• Plaintiffs: Astellas Pharma Inc.; Astellas US LLC; Astellas Pharma US, Inc.
• Defendants: Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 6,107,458 ("Cyclic Hexapeptides Having Antibiotic Activity," issued August 22, 2000) and 6,774,104 ("Stabilized Pharmaceutical Composition in Lyophilized Form," issued August 10, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Astellas' Mycamine® (micafungin sodium, used for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; esophageal candidiasis; and prophylaxis of Candida infections in hematopoietic stem cell transplant recipients). View the complaint here.

Taro Pharmaceuticals U.S.A., Inc. et al. v. Perrigo UK FINCO Limited Partnership
1:15-cv-00859; filed September 22, 2015 in the District Court of Delaware

• Plaintiffs: Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceuticals North America, Inc.
• Defendant: Perrigo UK FINCO Limited Partnership

Infringement of U.S. Patent Nos. 8,277,780 ("Stable Liquid Desoximetasone Compositions with Reduced Oxidized Impurity" issued October 2, 2012) and 8,715,624 (same title, issued May 6, 2014) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of Taro's Topicort® (desoximetasone topical spray, used for the treatment of plaque psoriasis). View the complaint here.

AstraZeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-07009; filed September 21, 2015 in the District Court of New Jersey

• Plaintiffs: AstraZeneca Pharmaceuticals LP; Astrazeneca UK Limited; AstraZeneca AB
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Ltd.

Infringement of U.S. Patent Nos. 6,774,122 ("Formulation," issued August 10, 2004), 7,456,160 (same title, issued November 25, 2008), 8,329,680 (same title, issued December 11, 2012), and 8,466,139 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Faslodex® (fulvestrant injection, used to treat hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy). View the complaint here.

Bayer Pharma AG et al. v. Alembic Pharmaceuticals Limited et al.
1:15-cv-00832; filed September 18, 2015 in the District Court of Delaware

• Plaintiffs: Bayer Pharma AG; Bayer Intellectual Property GMBH; Bayer HealthCare Pharmaceuticals Inc.
• Defendants: Alembic Pharmaceuticals Limited; Alembic Global Holding SA; Alembic Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,613,950 ("Pharmaceutical Forms With Improved Pharmacokinetic Properties," issued December 4, 2013) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Bayer's Staxyn® (vardenafil hydrochloride, used to treat erectile dysfunction). View the complaint here.

Amgen Inc. et al. v. Hospira, Inc.
1:15-cv-00839; filed September 18, 2015 in the District Court of Delaware

• Plaintiffs: Amgen Inc.; Amgen Manufacturing, Ltd.
• Defendant: Hospira, Inc.

Infringement of U.S. Patent Nos. 5,856,298 ("Erythropoietin Isoforms," issued January 5, 1999) and 5,756,349 ("Production of Erythropoietin," issued May 26, 1998) based on Hospira's filing of a BLA to market a biosimilar version of Amgen's Epogen® (erythropoietin, used to treat anemia). View the complaint here.

Vivus, Inc. v. Teva Pharmaceuticals USA, Inc. et al.
2:15-cv-06957; filed September 18, 2015 in the District Court of New Jersey

• Plaintiff: Vivus, Inc.
• Defendants: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 9,011,905 ("Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof," issued April 21, 2015) and 9,011,906 ("Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity" issued April 21, 2015) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Vivus' Qsymia® (phentermine and topiramate extended-release capsules, used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management). View the complaint here.
Conference & CLE Calendar

February 7, 2016

February 8-9, 2016 - Naples Patent Experts Conference (University of Akron School of Law) – Naples, FL

February 9, 2016 - Patent Quality Chat webinar series (U.S. Patent and Trademark Office) – 12:00 to 1:00 pm (ET)

February 9, 2016 – "Caught in a web — how the court in Kimble v. Marvel ruled on whether payment of royalties for an expired patent in unlawful per se" (American Intellectual Property Law Association) – 12:30 – 1:30 pm (Eastern)

February 10, 2016 – "Putting the Fun in Functional Claiming: §112(f) and Related Indefiniteness Considerations after Williamson v. Citrix and Nautilus v. BioSig" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

February 11, 2016 – "Overcoming 101 Rejections for Computer and Electronics Related Patents — Leveraging USPTO Guidance and Recent Decisions to Meet 101 Patent Eligibility Requirements" (Strafford) – 1:00 to 2:30 pm (EST)

February 17, 2016 – "Section 112(a) Enablement and Written Description: Leveraging CCPA and Early Federal Circuit Decisions — Capitalizing on Past Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability" (Strafford) – 1:00 to 2:30 pm (EST)

February 24, 2016 – "Patentable Subject Matter after Alice: Best Practices for Addressing 35 U.S.C. § 101" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

March 10-11, 2016 - Advanced Patent Law Seminar (Chisum Patent Academy) – Cincinnati, OH

***Patent Docs is a media partner of this conference or CLE
USPTO Patent Quality Chat Webinar Series

February 6, 2016

The U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series on February 9, 2016 from 12:00 to 1:00 pm (ET). The latest webinar, which will be hosted by Kathleen Fonda of the Office of Patent Legal Administration (OPLA), and Tom Hughes of the Office of Patent Quality Assurance (OPQA), will address First Inventor to File (FITF) Patent Prosecution. The presenters will share some FITF statistics about filings and prosecution since FITF went into effect nearly three years ago, and present some helpful tips concerning identifying the America Invents Act (AIA) status of your application, invoking prior art exceptions during prosecution, and getting more help with application-specific questions. The presenters look forward to hearing your ideas on ways to help applicants with the prosecution of their FITF applications.

Instructions for viewing the webinar can be found here. Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.
Webinar on Functional Claiming

February 6, 2016

The American Intellectual Property Law Association (AIPLA) will be offering a webinar entitled "Putting the Fun in Functional Claiming: §112(f) and Related Indefiniteness Considerations after Williamson v. Citrix and Nautilus v. BioSig" on February 10, 2016 from 12:30 – 2:00 pm (Eastern). Nicholas Mattingly of Mattingly & Malur, PC and Bryan Wheelock of Harness Dickey & Pierce will review functional claiming and § 112(f), and help practitioners identify when a claim will and won't be found to invoke 35 U.S.C. § 112(f) (or § 112, sixth paragraph, for pre-AIA applications). The webinar will also address the disclosure needed to support functional claiming under §112(f), with a focus on adequately disclosing the algorithms to support computer-implemented inventions.

The registration fee for the program is $95 (AIPLA member rate) or $150 (non-member rate). Those interested in registering for the program, can do so here.
Webinar on Enablement and Written Description

February 6, 2016

Strafford will be offering a webinar/teleconference entitled "Section 112(a) Enablement and Written Description: Leveraging CCPA and Early Federal Circuit Decisions — Capitalizing on Past Precedent to Withstand 112(a) Rejections and Attacks on Patent Validity and Patentability" on February 17, 2016 from 1:00 to 2:30 pm (EST). Dr. Li Feng, Thomas L. Irving, and Dr. Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner, and Donna M. Meuth, Associate General Counsel of Eisai will provide guidance to patent counsel on leveraging decisions by the Court of Customs and Patent Appeals (CCPA) and the Federal Circuit regarding application of § 112 written description, examine lessons learned through CCPA and early Federal Circuit decisions, and offer strategies to overcome the challenges of § 112.

The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.
Webinar on Overcoming 101 Rejections

February 6, 2016

Strafford will be offering a webinar/teleconference entitled "Overcoming 101 Rejections for Computer and Electronics Related Patents — Leveraging USPTO Guidance and Recent Decisions to Meet 101 Patent Eligibility Requirements" on February 11, 2016 from 1:00 to 2:30 pm (EST). Charles Bieneman of Bejin Bieneman and Richard J. Holzer, Jr. of HolzerIPLaw will provide guidance for patent counsel for overcoming § 101 rejections for computer and electronics related patents, and review recent case law and USPTO guidance on § 101 patent eligibility and offer strategies to address §101 rejections.

The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.
Illumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc. (Fed. Cir. 2016)

February 4, 2016

By Kevin E. Noonan —

The Federal Circuit affirmed a decision of obviousness, and that a patentee not be able to amend claims in an inter partes review proceeding, in an opinion handed down January 29th in Illumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc. The opinion (or rather the description of the Board's procedures and the history of how the Board arrived at its decision) once again illustrates the flaws in the IPR system established under the Leahy-Smith America Invents Act of 2012.

The case was an appeal from a decision by the Patent Trial and Appeals Board (PTAB) that invalidated all challenged claims of US Patent Nos. 7,057,026 (directed towards nucleotide compositions of matter) and 8,158,346 (directed towards methods of using these compositions). These reagents and methods were related to "sequencing by synthesis" methods that use non-natural nucleotides (exemplified by a nucleotide with a 3' hydroxyl protecting group) and labeled at the base (deazapurine) with a cleavable linker (a disulfide). In the practice of these "SBS" methods, each nucleotide is incorporated into a growing nucleic acid in a stepwise fashion, wherein at each step the label is released and the 3' hydroxyl protecting group cleaved to permit extension of the nucleotide chain.

A third party filed suit against Illumina, asserting patents owned by Intelligent Bio-Systems, who responded to Illumina's counterclaim of infringement by filing an IPR petition, the District Court staying the underlying litigation until the Office decided the IPR.

Claims 1–8 of the '026 patent and claims 1, 2, 4, 11, 12, 17, 18, and 19 of the '346 patent were challenged in the IPR. Instead of rebutting the asserted grounds of invalidity (anticipation and obviousness), Illumina filed motions to amend (substitute) the challenged claims. The Board granted Illumina's motion insofar as it requested cancellation of claims, and then refused to enter the amendments on the basis that Illumina had not established that these claims are patentable over the prior art.

Replacement Claim 9 (for Claim 1) in the '026 patent is representative:

9. A nucleotide triphosphate or nucleoside molecule, having a 7-deazapurine base that is linked to a detectable label via a cleavable linker, wherein the cleavable linker is attached to the 7-position of the 7-deazapurine base and wherein the cleavable linker contains a disulfide linkage, and wherein the nucleotide triphosphate molecule has a ribose or deoxyribose sugar moiety comprising a protecting group attached via the 2′ or 3′ oxygen atom, and the disulfide linkage of the cleavable linker and the protecting group are cleavable under identical conditions.

Despite the evidence of several changes in this claim, the Board found that the only "new" limitation was that the cleavable linker "contains a disulfide bridge." The "main issue" to be decided (according to the Board) was whether the use of a disulfide bond was obvious, because all of the other limitations "were found in the prior art" (and used as the basis for instituting the IPR). Unanswered questions raised by this synopsis of the Board's reasoning are whether these limitations were found in one or several references, and in the latter circumstance whether combination itself was disclosed or obvious. Regarding the question the Board posed for the parties, the Office found that the disclosed cleavage efficiency (>90%) for both the protecting group and the label linkage could be achieved with a reasonable expectation of success and that the proposed amended claims for the '026 patent would be obvious. The Board separately found that the proposed substitute claims in the '346 patent (reciting methods for using the compositions as claimed in the '026 patent) were also not patentable over the prior art.

The Federal Circuit affirmed, in a decision by Judge Lourie, joined by Judges Bryson and Stoll. This decision illustrated once again that the deference mandated by Dickenson v Zurko weighs heavily against the patentee wherever (as here) there is a factual determination involved in the Board's decisions. The panel followed the Court's In re Gartside precedent, which established the standard of review of the Office's factual findings to be substantial evidence, a relatively lax standard.

Illumina's argument was that the Board failed to consider the combination of limitations introduced in its proposed replacement claims, specifically the use of a disulfide bond and that the disulfide bond and the 3'-hydroxyl protecting group were capable of being cleaved under "a single set of chemical conditions." Illumina argued that while methods for these different cleavages were known in the prior art, the Board improperly disregarded evidence that the combination was not known. Intelligent Bio-Systems relied upon the Board's decision to institute that held that all the limitations in the claims were known in the prior art, and that as a result the only art the Board needed to consider was art relating to disulfide linkages. (This seems improper, under the rubric that the claims and the prior art combination must be considered for all they teach but the Board nevertheless agreed with Intelligent Bio-System's logic.)

Part of the basis for the panel's ease in affirming is that in an IPR it is the patentee that bears the burden of showing patentability, which is easily rendered into a burden to prove that the claims are not unpatentable (a different and higher burden, because of the differences in presumptions this formulation of the requirement imposes). In this case, this burden shifting is evidenced by statements in the opinion that "the original claims provided a backdrop for the Board to find that one of skill in the art would have reasonably expected to succeed in using a linker with a disulfide linkage as claimed" and "[t]he heightened standard that Illumina decries is instead properly Illumina's burden to show nonobviousness, proof that one of skill in the art would not have a reasonable expectation of success in using a disulfide linkage."

And fine distinctions of language are raised by the panel, which notes that "[t]he proposed substitute claims do not require that the linker and the protecting group be cleaved at the same efficiency rates, however, only that they are cleavable under the same conditions." Regardless of the correctness of the panel's appreciation of the scope of the asserted claim limitations, using this basis for upholding an obviousness determination illustrates the extent to which a patentee is left to hope that it can discern the semantic limitations in its claims that will satisfy the burden imposed in order to be able to amend claims in an IPR. This conclusion is only enhanced by the statement in the panel decision that "nonobviousness might have been supported by evidence that one of skill in the art would not have expected there to be any set of conditions in which a disulfide linkage has lower cleavage efficiency than a protecting group and is still suitable for SBS."

The panel also opined that Illumina had not shown that the skilled worker would not have had a reasonable expectation of success at achieving the required cleavage efficiency. In addition, the panel noted that the presence of some expert testimony to that effect provided "substantial evidence" for the Board's conclusion, disregarding the existence of contrary evidence in the record and making no mention of whether the Board properly considered the strength of this competing evidence in arriving at its conclusion.

There are many anomalies that arise from the PTO's implementation of the IPR provisions of the AIA, some arising from the language of the statute and some from how the Office has implemented those provisions. The Office's overriding concern is apparently those statutory provisions that mandate conclusion of IPR proceedings within one year of institution, which has led the Board to utilize the broadest reasonable construction of claim terms (thus expanding the scope of the relevant art) and refuse to permit patentees to amend claims (citing the lack of resources available to the Board to determine whether the amendments result in patentable claims). The Board's solution to this problem has been to shift the burden of persuasion to the patentee, which is ironic: in ex parte prosecution of claims not yet vetted by an Examiner, the burdens fall on the Office and the applicant's claims are presumed patentable unless the Examiner can make out a prima facie case. In IPRs, the burdens are reversed, and patentees having claims already determined to be patentable are required to show that their claims are not unpatentable. The Office may have arrived at procedures that maximize its efficiency in arriving at decisions within the 12-month time period, but it is an open question whether these procedures arrive at the correct decision. That of course should be the principal aim of the Office's procedures, which the public has a right to expect but that cases like this one call into serious question. While a legislative solution has been proposed, and the Supreme Court is considering the proper standard for claim construction in Cuozzo v. Lee, these must provide but cold comfort for Illumina and all the other patentees being deprived of their patent claims under the current PTO regime.

Illumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc. (Fed. Cir. 2016)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Bryson, and Stoll
Opinion by Circuit Judge Lourie

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