Patent Docs

Webinar on Freedom-to-Operate Opinions

July 8, 2017

Strafford will be offering a webinar/teleconference entitled "Structuring Freedom-to-Operate Opinions: Reducing Risk of Patent Infringement — Combating Troubling FTO Results, Overcoming Potential Roadblocks, Addressing Impact of Post-Grant Process on FTO Opinions" on July 20, 2017 from 1:00 to 2:30 pm (EDT). Doris Johnson Hines of Finnegan Henderson Farabow Garrett & Dunner and Laura A. Labeots of Husch Blackwell will provide guidance to patent counsel preparing and providing freedom to operate (FTO) opinions for companies developing new products, and outline best practices for drafting FTO opinions to reduce infringement risks. The webinar will review the following topics:

• What are best practices for patent counsel when analyzing FTO issues and structuring FTO opinions?
• What is the impact of the post-grant process on FTO opinions?
• When should counsel seek FTO opinions to protect new research and products from infringement claims?

The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.
PTAB Life Sciences Report

July 5, 2017

By John Cravero —

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition: IPR2017-01102; filed March 16, 2017.

Patent at Issue: U.S. Patent No. 6,440,706 ("Digital amplification," issued August 27, 2002) claims a method for determining the ratio of a selected genetic sequence in a population of genetic sequences.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '706 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 5, and 6). View the petition here.

Related Matters: According to the petition, the '706 patent is presently the subject of the following patent infringement lawsuits: Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC and John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.). Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 7,824,889 (IPR2017-01106; filed 03/17/2017; pending); 7,915,015 (IPR2017-01107; filed 03/17/2017; pending); and 8,859,206 (IPR2017-01105; filed 03/16/2017; pending).

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition: IPR2017-01105; filed March 16, 2017.

Patent at Issue: U.S. Patent No. 8,859,206 ("Digital amplification," issued October 14, 2014) claims a method for detecting quantity of a genetic sequence in a mixed population of human genomic nucleic acid sequences comprising at least a first and a second human genomic sequence, wherein the first sequence is a sequence of a wild-type allele of a locus and a second sequence is a sequence of a mutant allele of the locus.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '206 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2-4). View the petition here.

Related Matters: According to the petition, the '206 patent is presently the subject of the following patent infringement lawsuits: Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC and John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.). Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 7,824,889 (IPR2017-01106; filed 03/17/2017; pending); 7,915,015 (IPR2017-01107; filed 03/17/2017; pending); and 6,440,706 (IPR2017-01102; filed 03/16/2017; pending).

Hospira, Inc. v. Genentech, Inc.

PTAB Petition: IPR2016-01771; filed September 9, 2016.

PTAB Trial Instituted; entered March 16, 2017.

Patent at Issue: U.S. Patent No. 7,622,115 ("Treatment with anti-VEGF antibodies," issued November 24, 2009) claims a method for treating cancer in a patient comprising administering an effective amount of bevacizumab and assessing the patient for gastrointestinal perforation during treatment with bevacizumab.

Petitioner Hospira, Inc. is challenging the '115 patent on eleven grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1-4) or obvious under 35 U.S.C. § 103(a) (grounds 5-11). View the petition here. Administrative Patent Judges Sheridan K. Snedden (author), Zhenyu Yang, and Rober A. Pollock issued a decision instituting inter partes review of whether claims 1–5 of the '115 patent are anticipated under 35 U.S.C. § 102(b) by Kabbinavar; whether claims 1–5 of the '115 patent are obvious under 35 U.S.C. § 103(a) in view of Kabbinavar; and whether claims 1–5 of the '115 patent are obvious under 35 U.S.C. § 103(a) in view of 2000 Press Release.

Related Matters: According to the petition, the '115 patent is not involved in any judicial proceedings.

Fisher & Paykel Healthcare Ltd. v. Resmed Ltd.

PTAB Petition: IPR2017-00059; filed October 11, 2016.

PTAB Trial Instituted; entered March 16, 2017.

Patent at Issue: U.S. Patent No. 8,960,196 ("Mask system with interchangeable headgear connectors," issued February 24, 2015) claims a mask for delivering breathable gas to a patient at positive pressure to treat sleep disordered breathing, the mask comprising: a mask frame having a central bore, said mask frame having no built-in or integral headgear attachment points; a sealing cushion provided to the mask frame and adapted to form a seal with the patient's face; and a headgear connector adapted to engage the mask frame, said headgear connector including a pair of lower headgear clip anchors adapted to be engaged with respective ones of a pair of lower headgear clips, said headgear connector including a forehead support connected to the headgear connector by an upper support member, said forehead support including a pair of openings adapted to attach to respective ones of a pair of upper side straps, wherein the mask frame is adapted to removably connect to more than one headgear connector, each headgear connector being different in at least one aspect.

Petitioner Fisher & Paykel Healthcare Ltd. is challenging the '196 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Richard E. Rice, Barry L. Grossman, and James J. Mayberry (author) issued a decision instituting inter partes review of whether claims 23–78, 80–82, and 84–86 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, and Gunaratnam; and whether claims 79 and 83 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, Gunaratnam, and Geist.

Related Matters: According to the petition, the '196 patent is involved in U.S. International Trade Commission Investigation No. 337–TA–1022. The '196 patent is also the subject of the following litigation: Fisher & Paykel Healthcare Ltd. v. ResMed Corp., Case No. 3:16-cv- 02068 (S.D. Cal.). Petitioner also concurrently filed a second petition seeking inter partes review of the '196 patent (IPR2017-00057; Fisher & Paykel Healthcare Ltd.; filed 10/11/2016; Institution denied 03/16/2017).

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition: IPR2017-01106; filed March 17, 2017.

Patent at Issue: U.S. Patent No. 7,824,889 ("Digital amplification," issued November 2, 2010) claims a method for determining an allelic imbalance in a biological sample, comprising the steps of: amplifying template molecules within a set comprising a plurality of assay samples to form a population of amplified molecules in each of the assay samples of the set, wherein the template molecules are obtained from a biological sample; analyzing the amplified molecules in the assay samples of the set to determine a first number of assay samples which contain a selected genetic sequence on a first chromosome and a second number of assay samples which contain a reference genetic sequence on a second chromosome, wherein between 0.1 and 0.9 of the assay samples yield an amplification product; comparing the first number of assay samples to the second number of assay samples to ascertain an allelic imbalance in the biological sample.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '889 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (grounds 1 and 4) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 5, and 6). View the petition here.

Related Matters: According to the petition, the '889 patent is presently the subject of the following patent infringement lawsuits: Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC and John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.). Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 6,440,706 (IPR2017-01102; filed 03/16/2017; pending); 7,915,015 (IPR2017-01107; filed 03/17/2017; pending); and 8,859,206 (IPR2017-01105; filed 03/16/2017; pending).

Myriad Genetics, Inc. v. Johns Hopkins University

PTAB Petition: IPR2017-01107; filed March 17, 2017.

Patent at Issue: U.S. Patent No. 7,915,015 ("Digital amplification," issued March 29, 2011) claims a method for determining an allelic imbalance in a biological sample, comprising the steps of: amplifying template molecules within a set comprising a plurality of assay samples to form a population of amplified molecules in each of the assay samples of the set, wherein the template molecules are obtained from the biological sample; analyzing the amplified molecules in the assay samples of the set to determine a first number of assay samples which contain a first allelic form of a marker and a second number of assay samples which contain a second allelic form of the marker, wherein between 0.1 and 0.9 of the assay samples yield an amplification product; comparing the first number to the second number to ascertain an allelic imbalance in the biological sample; and identifying an allelic imbalance in the biological sample.

Petitioners Myriad Genetics, Inc.; Myriad Genetic Laboratories, Inc.; Bio-Rad Laboratories, Inc.; and RainDance Technologies, Inc. are challenging the '015 patent on four grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2-4). View the petition here.

Related Matters: According to the petition, the '015 patent is presently the subject of the following patent infringement lawsuits: Esoterix Genetic Laboratories, LLC and Johns Hopkins University v. Myriad Genetics, Inc. and Myriad Genetics Laboratories, Inc., 1:16-cv-1112 (M.D.N.C.); and Esoterix Genetic Laboratories, LLC The John Hopkins University v. Ambry Genetics Corp., 16-cv-1111-WO-JEP (M.D.N.C.). Petitioners concurrently filed petitions for inter partes review of related U.S. Patent Nos. 7,824,889 (IPR2017-01106; filed 03/17/2017; pending); 8,859,206 (IPR2017-01105; filed 03/16/2017; pending); and 6,440,706 (IPR2017-01102; filed 03/16/2017; pending).

Thermo Fisher Scientific Inc. v. Bio-Rad Laboratories, Inc.

PTAB Petition: IPR2017-00054; filed October 14, 2016.

PTAB Trial Instituted; entered March 17, 2017.

Patent at Issue: U.S. Patent No. 8,236,504 ("Systems and methods for fluorescence detection with a movable detection module," issued August 7, 2012) claims a fluorescence detection apparatus for analyzing samples located in a plurality of wells in a thermal cycler, the apparatus comprising: a support structure attachable to the thermal cycler; a shuttle movably mounted on the support structure; and a detection module attached to the shuttle, the detection module including: a housing having an opening oriented toward the plurality of wells; an excitation light generator disposed within the housing; and an emission light detector disposed within the housing, wherein, when the support structure is attached to the thermal cycler, a heating element is disposed between the detection module and the sample wells and the shuttle is movable to position the detection module in optical communication with different wells of the plurality of wells through a plurality of openings extending through the heating element.

Petitioner Thermo Fisher Scientific, Inc. is challenging the '504 patent on five grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2-5). View the petition here. Administrative Patent Judges Sheridan K. Snedden, Zhenyu Yang (author), and Christopher G. Paulraj issued a decision instituting inter partes review of whether claims 23–78, 80–82, and 84–86 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, and Gunaratnam; and whether claims 79 and 83 are obvious under 35 U.S.C. § 103(a) over Ogden, Lovell, Gunaratnam, and Geist.

Related Matters: According to the petition, the '504 patent is the subject of the following litigation: Bio-Rad Labs, Inc. v. Thermo Fisher Scientific Inc., Case No. 16-358 (D. Del.). Petitioner also concurrently filed a second petition seeking inter partes review of the '504 patent (IPR2017-00055; Thermo Fisher Scientific Inc.; filed 10/14/2016; Instituted 04/03/2017).
Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong (Fed. Cir. 2017)

July 4, 2017

By Kevin E. Noonan –

Detection of paternal cell-free fetal DNA (cffDNA) in maternal blood (the technology at issue in Ariosa v. Sequenom) was in a different incarnation the subject of an interference between professors at two universities; the decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board in favor of Dennis Lo and the Chinese University of Hong Kong was reversed last week and remanded for further proceedings, in Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong.

This embodiment of the technology was directed to detecting aneuploidies, or an abnormal number of chromosomes in a cell; noted examples include Downs Syndrome (trisomy 21) and Turner's syndrome (XO). While the opinion recognizes Dr. Lo as the discoverer of cffDNA in 1996, Stanford's professor (Dr. Stephen Quake) developed a new method for detecting small changes in the number of chromosomes characteristic of aneuploidy, employing a technology the Court terms "digital analysis," which did not distinguish between paternal and maternal sources of DNA. There were four steps to Dr. Quake's claimed method as set forth in the opinion:

(1) obtaining a maternal tissue sample, preferably blood; (2) distributing single DNA molecules from this sample to a number of discrete reaction samples; (3) "[d]etecting the presence of the target in the DNA in a large number of reaction samples"; and (4) performing "[q]uantitative analysis of the detection of the maternal and fetal target sequences."

The opinion also sets forth disclosure from Dr. Quale's specification relating to the use of "second generation massively parallel sequencing [(MPS)] methods and PCR amplification of chromosome DNA as being useful in the practice of the invention.

Dr. Lo's invention, according to the opinion, was claimed in U.S. Patent Application Nos. 12/178,181; 13/070,275; 13/070,240; 12/614,350; 13/070,251; and 13/417,119. The claims of these applications were directed to "random sequencing" of cffDNA followed by sequence alignment to a reference human genome sequence to detect DNA sequence fragments specific for each chromosome, using MPS methods as in Dr. Quake's patents and application. Aneuploidies for each chromosome where they exist are detected by finding a greater frequency of aligned fragments for particular chromosomes than others.

At issue in the interference were Stanford U.S. Patent Nos. 7,888,017 and 8,008,018 and U.S. Application No. 12/393,833. The CUHK application in interference was U.S. Application No. 13/070,275. Three interferences were declared: Quake v. Lo, No. 105,920 (P.T.A.B. Apr. 7, 2014); Lo v. Quake, No. 105,923 (P.T.A.B. Apr. 7, 2014); and Lo v. Quake, No. 105,924 (P.T.A.B. Apr. 7, 2014). In a footnote, the Federal Circuit opinion notes that the Board's opinion in all three interferences "contained largely the same findings" and to the opinion cited the '920 interference throughout as being applicant to all three interferences. Dr. Quakes was accorded the benefit of his earliest provisional filing, February 2, 2007; Dr. Lo's priority date as disclosed in the Declaration of Interference was July 3, 2007. Thus, Dr. Lo and CUHK were designated as the Junior Party and would have the burden of establishing an earlier date of invention should the interference reach the priority phase.

Both parties requested the PTO declare the interferences, which were all declared in 2013, and during each of the proceedings, CUHK filed preliminary motions that Stanford's '018 patent and '833 application were invalid for failure to satisfy the written description requirement of 35 U.S.C. § 112(a) (this posing a threshold question in the interference wherein Junior Party Lo would prevail if its motion was persuasive to the Board). At least part of the basis for this allegation was that Dr. Quake changed the claims pending in the application that matured into the '018 patent to more closely parallel Dr. Lo's claims; indeed, Junior Party Lo contended that Senior Party Quake had copied the pending claims of CUHK's '181 application. These motions were supported by expert testimony, as were Stanford's rebuttals to these motions. The Board was persuaded by CUHK's motions and granted them, thus ending the interference and invalidating Stanford's patents. In these decisions, the Board (according to the panel opinion) "repeatedly credited the testimony of [CUHK's expert] Dr. Gabriel, including in finding that (1) the specification of the '018 patent is directed to the use of 'digital analysis' of predetermined targeted sequences in a sample, and (2) the language relied upon by Quake could have related to either random or targeted sequencing but that, because 'the main focus of the Quake '018 patent [was] on diagnosing aneuploidy with digital PCR, those of skill in the art would have understood the discussion of massively parallel sequencing to refer to sequencing targeted, predetermined portions of the DNA in a sample, not sequencing of random DNA'" (and was not persuaded by Stanford's attacks on that testimony). In summary, the Board stated that:

Though the Quake inventors may have possessed parts of such a method, including massively parallel sequencing, randomly fragmenting DNA, and aligning sequences to genomic sequences, the facts do not indicate that those of ordinary skill in the art would have understood the inventors had put these pieces together into a complete method of sequencing random DNA fragments and identifying the sequenced fragments to determine aneuploidy.

Stanford appealed this decision to the District Court under 35 U.S.C. § 146 in the Northern District of California (Judge Susan Illston of Sequenom fame). However, based on its decision in Biogen MA, Inc. v. Japanese Found. for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015), that the provisions of the Leahy-Smith America Invents Act precluding appeals to the district courts should apply, the parties jointly asked the District Court to transfer the appeal to the Federal Circuit, and this opinion followed.

The Federal Circuit reversed, in an opinion by Judge O'Malley, joined by Judges Reyna and Chen. The panel rejected Stanford's invitation to "rethink" its Biogen decision regarding whether appeals from interferences could no longer be brought before the district courts under § 146. On that question the opinion states that Biogen is the law in this circuit and "we, as a panel, will not revisit it." Similarly, the panel refused to consider the evidence adduced during the brief discovery period before the California District Court and the Biogen decision, because the District Court did not have subject matter jurisdiction under the panel's appreciation of the law after Biogen ("the activities in the district court are a nullity when the district court lacks subject matter jurisdiction to consider a matter," citing Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 577 (1999)) and CUHK cannot waive lack of subject matter jurisdiction. Having made this decision, the Federal Circuit's review was limited to the "four corners" of the record before the PTAB, and the panel agreed with CUHK that it would "treat the district court proceedings as if they never occurred."

Turning to the merits (which the Court reviewed for substantial evidence as the question of written description is one of fact; In re Gartside, 203 F.3d 1305, 1314 (Fed. Cir. 2000)), the panel held that the PTAB had erred in invalidating Stanford's patents. The basis for this determination was found in CUHK's expert's testimony and some of the references upon which her conclusions had been based. The deficiency arose based on the lack of correspondence between what was expressly disclosed in Stanford's patents and applications and what the references relied upon by CUHK's expert disclosed (and upon which she based her conclusion on the adequacy of disclosure question). According to the opinion:

All of the published references on which the Board relies focus on the Roche 454 platform, not the Illumina platform actually referenced in the specification. The Board did not cite evidence to connect targeted sequencing on the Roche 454 platform to targeted sequencing on the Illumina system, nor has the Board explained what it found persuasive about the Roche 454 platform references.

The evidence put forward by Stanford was that its disclosure related to a so-called "second generation" (Illumina) sequencing apparatus and that CUHK's expert relied on references directed to a "first generation" (Roche 454) machine. In addition (and perhaps providing the panel's best support for its opinion), "Dr. Gabriel and the Board failed to cite to the Roche 454 references with specificity, leaving us with no reviewable record to conclude that the disclosed methods or platform would have been applicable to Illumina on Quake's priority date." It is one thing to give deference to the PTAB and apply the substantial evidence standard; it is apparently another thing not to provide a reviewing court (or at least the Federal Circuit) with sufficient evidence for the substantiality thereof to be assessed.

The panel was also unimpressed with the distinctions raised by CUHK's expert regarding targeted versus random MPS:

The Board's finding that the '018 specification's language does not preclude targeted MPS ignores the fact that the same description might be able to disclose both random and targeted sequencing. Put another way, even if the '018 specification could indicate targeted sequencing, it could also disclose random sequencing, or it could disclose both random and targeted sequencing. The Board frames its finding in terms of an erroneous premise: the Board's task was to determine whether the '018 patent's written description discloses random MPS sequencing, as recited by the later-added claims, not whether the description does not preclude targeted MPS sequencing.

In addition, this was another instance where the Federal Circuit believed the PTAB had not properly explained its reasoning: "The Board's error on this issue is compounded by its failure to explain the meaning of key sentences and phrases in the specification's discussion of the sequencing process, and its failure to compare these statements to the claim limitations."

On remand, the panel directed the PTAB to "examine whether a person of ordinary skill in the art would have known, as of the priority date, that the '018 specification's reference to Illumina products meant random MPS sequencing as recited in the claims," based on the understanding in the art at the priority date, and should "examine whether a person of ordinary skill would have understood that the '018 patent's specification disclosed random MPS sequencing, as opposed to whether the specification did not preclude targeted MPS sequencing." Of course, should the Board find that the evidence does not support invalidating any or all of Stanford's patents or application, the interference should proceed to address other motions and ultimately put CUHK to its priority proofs regarding who was the first inventor of the claimed technology.

Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong (Fed. Cir. 2017)
Panel: Circuit Judges O'Malley, Reyna, and Chen
Opinion by Circuit Judge O'Malley
Samsung Electronics Co. v. Straight Path IP Group, Inc. (Fed. Cir. 2017)

July 3, 2017

By Joseph Herndon —

In a nonprecedential decision, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board in inter partes review proceedings which upheld the patentability of claims due to construction of the claim term "is connected to the computer nework". Namely, Samsung Electronics as well as a number of other companies (Cisco Systems, Avaya, LG Electronics, Toshiba Corp., VIZIO, Hulu, and Verizon) appealed from final written decisions of the Patent Trial and Appeal Board in inter partes review proceedings of U.S. Patent Nos. 6,108,704 ('704 patent); 6,009,469 ('469 patent); and 6,131,121 ('121 patent). In its final written decisions, the Board upheld the validity of all instituted claims, and the Federal Circuit affirmed the Board's decision.

The '704 Patent

The '704 patent, entitled "Point-to-Point Internet Protocol," generally relates to establishing a point-to-point communication link. The '469 patent and the '121 patent are continuations-in-part of the '704 patent. The specifications for the three challenged patents are largely identical. The '469 patent, entitled "Graphic User Interface for Internet Telephony Application," and the '121 patent, entitled "Point-to-Point Computer Network Communication Utility Utilizing Dynamically Assigned Network Protocol Addresses," both relate to facilitating audio communications over computer networks. Each patent explains that a first processing unit automatically transmits its associated e-mail address and IP address to a connection server. The connection server stores the addresses in a database and, in so doing, establishes the first processing unit as an active on-line party available for communication. The first processing unit sends a query to the connection server, which searches the database to determine whether a second processing unit (e.g., callee) is active and on-line. If the callee is active and online, the connection server sends the IP address of the callee from the database to the first processing unit, i.e., performs a point-to-point Internet protocol communication. The first processing unit then directly establishes the point-to-point Internet communication with the callee using the retrieved IP address. Claim 1 of the '704 patent, which is representative of the claims at issue in this appeal, recites:

1. A computer program product for use with a computer system, the computer system executing a first process and operatively connectable to a second process and a server over a computer network, the computer program product comprising:
    a computer usable medium having program code embodied in the medium, the program code comprising:
        program code for transmitting to the server a network protocol address received by the first process following connection to the computer network;
        program code for transmitting, to the server, a query as to whether the second process is connected to the computer network;
        program code for receiving a network protocol address of the second process from the server, when the second process is connected to the computer network; and
        program code, responsive to the network protocol address of the second process, for establishing a point-to-point communication link between the first process and the second process over the computer network.

First Inter Partes Review

In an earlier-filed petition for inter partes review, another petitioner, Sipnet EU S.R.O., challenged claims of the '704 patent over the same prior art references that were at issue in this appeal. In the Sipnet IPR, the Board concluded that claim 1 of the '704 patent, among others, was unpatentable as anticipated by each of the prior art references. Straight Path appealed that decision on the grounds that the Sipnet Board misconstrued the claim term "is connected to the computer network" to mean "active and on-line at registration." Straight Path IP Grp., Inc. v. Sipnet EU S.R.O., 806 F.3d 1356, 1360 (Fed. Cir. 2015). The Federal Circuit rejected the Board's claim construction and construed "is connected to the computer network" to mean "is connected to the computer network at the time that the query is transmitted to the server."

In construing the disputed claim limitation, the Federal Circuit first looked to the plain meaning of the claim language and concluded that the present tense "is" in "is connected to the computer network" plainly says that the query transmitted to the server seeks to determine whether the second unit is connected at that time, i.e., connected at the time that the query is sent. The query does not seek to determine whether the device was connected or whether it is still registered as being connected even if that registration information is no longer accurate. Thus, the Federal Circuit concluded that the claim language is not satisfied by a query that asks only for registration information, regardless of its current accuracy.

The Federal Circuit concluded that the specification does not provide a basis for adopting a construction that contradicts the plain meaning of the claim language.

Second Inter Partes Review

Returning to the present case, Samsung et. al. requested inter partes review of claims of the '704 patent, as well as claims of the '469 patent and the '121 patent, and challenged the claims at issue under 35 U.S.C. § 103(a) over a combination of references. The two references at issue are the Microsoft Windows NT 3.5, TCP/IP User Guide (1994) ("WINS") and The Open Group, Technical Standard, Protocols For X/Open PC Interworking: SMB, Version 2.0 (1992) ("NetBIOS").

The Board found that WINS and NetBIOS both describe name server technology. In particular, NetBIOS is a software interface that allows applications on different computers to communicate within a computer network, such as a local area network or the Internet. The NetBIOS name service stores registered names in a database, and a name query transaction can be initiated by an end-node in an attempt to obtain the IP address associated with a NetBIOS name. If the NetBIOS Name Server has information regarding a queried node, the NetBIOS Name Server transmits a positive response. If the NetBIOS Name Server does not have information regarding a queried node, the NetBIOS Name Server transmits a negative response. Once the IP addresses have been found for a target name, a NetBIOS session service begins. The NetBIOS session service involves directed (point-to-point) communications.

WINS is an implementation of NetBIOS. When a computer's name is registered with the WINS server, the server accepts the entry with a timestamp, an incremental unique version number, and other information. Once a computer is registered with the WINS server as active and on-line, the WINS server maintains a database of names and addresses as active and on-line by (1) releasing names once a computer is shut down properly, and (2) requiring a renewal time period in which a computer must reregister.

In its final decision, the Board adopted the Federal Circuit's prior claim construction of the phrase "is connected to the computer network" and construed it to mean "is connected to the computer network at the time that the query is transmitted to the server." The Board determined that neither the WINS reference nor the NetBIOS reference discloses the claimed "is connected to the computer network" limitation. Accordingly, the Board concluded that Appellants failed to show by a preponderance of the evidence that any of the instituted claims reciting the limitation "connected to the network" (or the counterpart claim phrases) are unpatentable.

Samsung Appeal

On appeal, Samsung argued that the Board's application of the prior claim construction was impermissible as a matter of law because the Board added a limitation not found in the claim when it purportedly required that the prior art references demonstrate "perfect accuracy" when querying whether a process is connected to the computer network.

In particular, Samsung contended that the Board found that the prior art did not satisfy the disputed limitation only because of a possible circumstance in which the WINS database may no longer be accurate, and in which the name server may be incorrect.

But Straight Path argued that not only is the prior art not designed to keep track of current online status, it is not designed to check online status when responding to a query for a user's IP address.

The Federal Circuit agreed with Straight Path and found that the Board did not import an additional "perfect accuracy" limitation. The Federal Circuit found that neither reference tracks a user's online status. The Board determined that neither WINS nor NetBIOS will determine whether the second process is connected to the computer network at the time the query is transmitted to the server, i.e., whether a user is on-line at the relevant time.

This conclusion was considered to be supported by substantial evidence. The Board determined that the references disclose that the name servers have information that a process "was" connected to the computer network. But this does not meet the claim limitation. WINS and NetBIOS both disclose querying a name server for the registered address of the callee computer. This is not sufficient though. The Federal Circuit noted that a query that asks only for registration information, regardless of its current accuracy, will not satisfy the claim limitation.

The outcome here is somewhat surprising. The prior art appears to be very close, and one would imagine that during prosecution, such a rejection under 35 U.S.C. § 103 would most certainly be upheld by a patent examiner. Here, the subtle difference of when the status check is performed was enough to distinguish over the prior art, however.

Samsung Electronics Co. v. Straight Path IP Group, Inc. (Fed. Cir. 2017)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges O'Malley and Wallach
Opinion by Chief Judge Prost
Conference & CLE Calendar

July 3, 2017

July 6, 2017 – "Lessons from PTAB Full or Partial Denials to Obtain a Denial and Avoid an IPR" (Strafford) – 1:00 to 2:30 pm (EDT)

July 11, 2017 – "Promises, Promises" (Bereskin & Parr) – 1:00 to 2:00 pm (EDT)

July 13, 2017 – "Labeling and Induced Infringement in Pharma Patent Litigation and Protecting IP Rights" (Strafford) – 1:00 to 2:30 pm (EDT)

July 24-25, 2017 – TTS North America summit*** (TTS Ltd.) – Weill Cornell Medicine in New York, NY

July 27, 2017 – "Drafting Patent Counsel Engagement and Disengagement Letters — Structuring Scope of Engagement, Confidentiality, Conflicts of Interest and Other Key Provisions" (Strafford) – 1:00 to 2:30 pm (EDT)

August 10-11, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

August 14-15, 2017 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

***Patent Docs is a media partner of this conference or CLE
Webinar on Canadian Patent Law of Utility

July 2, 2017

Bereskin & Parr will be offering a presentation entitled "Promises, Promises" on July 11, 2017 from 1:00 to 2:00 pm (EDT). Don MacOdrum, Don Cameron, Micheline Gravelle, and Michael Fenwick will provide a point-by-point analysis of the greatly anticipated decision of the Supreme Court of Canada in AstraZeneca v. Apotex, in which the Supreme Court provided new insights and direction to the Canadian patent law of utility and "the promise of the patent". The panel will discuss the implications of the decision on patent drafting, prosecution, and litigation.

Those wishing to register for the presentation can do so here.
TTS North America

July 2, 2017

TTS Ltd. will be holding the 8th annual TTS North America summit on July 24-25, 2017 at Weill Cornell Medicine in New York, NY. TTS North America is one of four summits that make up the TTS Global Initiative. The number of attendees is deliberately limited to ensure exclusivity; the summit is strictly limited to 150 high level leaders and decision-makers from all key stakeholder groups in early stage biotech innovation. The summit takes place under the Chatham House rule to ensure a quality of discussion, interaction, networking and business opportunity unlike any other event in our sector.

A full program for TTS North America, including an agenda of each event's sessions and list of speakers can be obtained here. Details regarding registration for the event can be found here.

Patent Docs and McDonnell Boehnen Hulbert & Berghoff LLP are partners of TTS North America.
Webinar on Patent Counsel Engagement and Disengagement Letters

July 2, 2017

Strafford will be offering a webinar/teleconference entitled "Drafting Patent Counsel Engagement and Disengagement Letters — Structuring Scope of Engagement, Confidentiality, Conflicts of Interest and Other Key Provisions" on July 27, 2017 from 1:00 to 2:30 pm (EDT). Angela Foster of the Law Office of Angela Foster, Michael E. McCabe of McCabe Law, and Patent Docs author Andrew W. Williams of McDonnell Boehnen Hulbert & Berghoff will prepare patent counsel to structure engagement letters and disengagement letters, highlight the key terms of the engagement and disengagement letter, and discuss negotiation strategies. The webinar will review the following topics:

• Key provisions to be included and negotiated in an engagement letter
• Key provisions in a disengagement letter
• Drafting client agreements to proactively avoid client complaints

The registration fee for the webinar is $297. Those interested in registering for the webinar, can do so here.
FDA Report: Agency Announces Expedited Review of Certain ANDAs

June 29, 2017

By Andrew Williams —

On June 27, 2017, the U.S. Food and Drug Administration issued a press release stating how it would begin implementing its plan to increase competition for prescription drugs. This comes on the heels of FDA Commissioner Scott Gottlieb's blog post last week, in which he indicated that the FDA would begin lifting the barriers to drug competition. The first of the two new initiatives announced this week was to publish a list of branded drugs that were off patent but nevertheless had no approved generics. The second initiative was to implement a policy to expedite the review of ANDAs for any drugs until there are three approved generics. However, even though the press release indicated that these initiatives reflect the Administration's goal of improving access to prescription drugs, it did not address the potential reality that there may be little economic incentive for generic manufactures to seek marketing approval for these drugs.

The FDA press release was accompanied by two documents, each of which was directed to one of the two initiatives. The first, entitled "List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic," includes two sections: (1) a list of drug products for which the FDA could immediately accept an ANDA; and (2) a list of drug products for which there might be legal, regulatory, or scientific issues. The FDA suggested that any sponsor wishing to seek approval of a drug product on the second list should first submit an initial inquiry to the Office of Generic Drugs. Such drug products on this second list can include those that are more appropriate for the 505(b)(2) abbreviated approval pathway, those for which there are "regulatory complexities," and those that are proteins and may be transition products pursuant to the BPCIA. No NDA drug products that have been approved in the past year have been included, and the FDA suggests that it will update the list every six months.

The second document was an updated "Prioritization of the Review of Original ANDAs, Amendments, and Supplements," as found in the Manual of Policies and Procedures for the Office of Generic Drugs. The accompanying "Change Control Table" indicates that the revisions found in this version were to "include prioritization of generic products for which there are fewer than three ANDAs approved for the reference listed drug (RLD) and updated certain external references." Nevertheless, this prioritization appears to be contingent on there being no blocking patents. For submissions that contain Paragraph IV certifications, additional criteria were provided before expedited review could be received.

These documents related to the expediting of certain ANDAs were released about a week after newly appointed and confirmed Commissioner Gottlieb posted to his blog, the FDA Voice. In this blog post, Commissioner Gottlieb indicated that the FDA was working on a Drug Competition Action Plan to address "some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs." The post, however, explicitly excluded patent and statutory exclusivity periods from these obstacles. The only example of "gaming" the system provided was the alleged "increasing unavailability of certain branded products for comparative testing," either through restrictions placed on distributors, or the adoption of voluntary Risk Evaluation and Mitigation Strategies (or REMS) by the NDA holder. The Commissioner also indicated that the FDA would be looking at how best to coordinate with the FTC to identify and publicize anti-competitive practices. Finally, he announced a July 18 meeting, in which the FDA would seek input from the public about ways in which the current rules were no having their intended effects. Of course, this post reverses a long-standing principal of the FDA to not get involved in issues of drug pricing. We will continue to monitor any updates from the FDA or the current administration on any policies related to generic drugs.
Prism Technologies LLC v. T-Mobile USA, Inc. (Fed. Cir. 2017)

June 28, 2017

An Obviousness Rejection in Patent-Eligibility Clothing?

By Michael Borella —

In Mayo v. Prometheus, the Supreme Court wrote "[w]e recognize that, in evaluating the significance of additional steps, the § 101 patent-eligibility inquiry and, say, the § 102 novelty inquiry might sometimes overlap." The ongoing existence of this overlap has resulted in a catch-22 for patentees — one can use prior art (or just an unsupported allegation that a claim element is conventional) to attack the validity of a patent, but the patentee cannot use the absence of such prior art to establish eligibility under § 101. Given that the § 101 inquiry is considered (or at least it is supposed to be considered) as a matter of law, patent challengers often take the less rigorous path of attacking claims under § 101 rather than § 102 or § 103, both of which have effectively higher evidentiary standards. As a consequence, § 101 has become overworked, often performing the duties of both § 102 and § 103, as well as § 112.

Or expressed in a more cynical tone, when invalidating a patent under § 101, facts don't matter.

In Mayo, Justice Breyer contended that "to shift the patent-eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do." His rationale was that "§§ 102 and 103 say nothing about treating laws of nature as if they were part of the prior art when applying those sections" and that "studiously ignoring all laws of nature when evaluating a patent application under §§ 102 and 103 would make all inventions unpatentable."

In practice, however, §§ 102 and 103 are often better-equipped to handle invalidity contentions in a consistent and logical fashion than § 101. Laws of nature are by definition not human-made, and therefore must be part of the prior art — and they can be invoked as such by judicial notice. Reading this into §§ 102 and 103 would do far less damage than what has been done by the reading of the largely unworkable two-prong test of Mayo and Alice Corp. v. CLS Bank Int'l into § 101. And to rebut Justice Breyer's second point, § 103 is already used to evaluate claims that combine elements both in the prior art and not in the prior art (or combinations of elements all within the prior art).

In short, the Court's reasoning for stuffing analyses traditionally undertaken as part of §§ 102 and 103 into § 101 might sound reasonable in theory, but falls apart in practice.

To that point, on June 23, 2017, the Federal Circuit used conclusory reasoning to invalidate claims under § 101, even though it is likely that these claims could have been easily disposed of under § 103 in a more rationally-grounded fashion.

Prism Technologies LLC brought an infringement action against T-Mobile USA, Inc. in the District of Nebraska, asserting its U.S. Patent Nos. 8,127,345 and 8,387,155. The '155 patent is a continuation of the '345 patent, and the earliest priority date of each (by way of a continuation–in-part) is in 1997. T-Mobile moved for summary judgment on the pleadings, contending that Prism's claims were ineligible under § 101. The District Court sided with Prism, the case continued to trial, and the jury determined that T-Mobile did not infringe. Prism appealed, requesting a new trial, and T-Mobile cross-appealed, re-raising its § 101 position.

Claim 1 of the '345 patent was deemed representative, and it recites:

A method for controlling access, by at least one authentication server, to protected computer resources provided via an Internet Protocol network, the method comprising:
    receiving, at the at least one authentication server from at least one access server, identity data associated with at least one client computer device, the identity data forwarded to the at least one access server from the at least one client computer device with a request from the at least one client computer device for the protected computer resources;
    authenticating, by the at least one authentication server, the identity data received from the at least one access server, the identity data being stored in the at least one authentication server;
    authorizing, by the at least one authentication server, the at least one client computer device to receive at least a portion of the protected computer resources requested by the at least one client computer device, based on data associated with the requested protected computer resources stored in at least one database associated with the at least one authentication server; and
    permitting access, by the at least one authentication server, to the at least the portion of the protected computer resources upon successfully authenticating the identity data and upon successfully authorizing the at least one client computer device.

This claim describes a common authentication technique that has been used since the early- to mid-1990s. Remote access to a computer network by an device or user often requires that the device and/or user first be authenticated before they are permitted access to use the network or the information therein. Originally focused on dial-up modem Internet access, servers centralize the authentication, authorization, and accounting (AAA) procedures so that individual remote access gateways (e.g., modem pools) do not need to maintain separate databases of device and user profiles. Such a AAA server is often referred to as a RADIUS server, as RADIUS is the protocol with which it communicates with the remote access gateways.

In any event, the Federal Circuit applied the Mayo / Alice test to evaluate the claim under § 101. In this test, one must first determine whether the claim at hand is directed to a judicially-excluded law of nature, a natural phenomenon, or an abstract idea. If so, then one must further determine whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion. But generic computer implementation of an otherwise abstract process does not qualify as "significantly more." On the other hand, a claimed improvement to a computer or technological process is not abstract.

With respect to prong one, the Court agreed with the District Court that "the asserted claims are directed to the abstract idea of providing restricted access to resources." Apparently, the Court was swayed by T-Mobile's analogies between the claim and pre-computer access control technologies.

Turning to prong two, the Court rejected the District Court's conclusion that the claim includes an inventive concept beyond the aforementioned abstract idea, because its elements "modify the way the Internet functions to provide secure access over a protected computer resource." Instead, the Court found that the claim merely recites "a host of elements that are indisputably generic computer components." Looking to the text of the specification, the Court found enough evidence to conclude that the applicant admitted, or at least implied, that the additional elements of the claim were conventional. The Court further asserted that the combination of these elements was merely a set of "generic computer components employed in a customary manner."

As such, the Court ruled the claims invalid under § 101.

The irony here is that, as discussed above, there would be ample evidence to challenge the validity of these claims under § 103. Prior to 1997, companies such as Livingston Enterprises and Funk Software were designing, implementing, and selling RADIUS servers, and these servers were deployed within several large telecommunications networks (see the Wikipedia page on RADIUS and the citations therein for detail). The functions of these servers were largely indistinguishable from the plain language of claim 1.

In viewing the prosecution history of the '345 patent, the applicant submitted numerous non-patent literature (NPL) references disclosing the existence of such RADIUS servers. In fact, the applicant submitted so many of these references that the Examiner contended that the volume of references was excessive and that he only performed a "cursory review" thereof. None of these NPL references were cited against the claims during prosecution of the '345 patent. Therefore, it is questionable whether they were fully considered by the Examiner, and this may explain why these claims were allowed in view of well-known prior art.

Thus, even if it is proper to invalidate this patent (or at least claim 1), this case demonstrates that doing so under § 101 rather than § 103 can be fraught with peril. Here, the Federal Circuit applied conclusory reasoning under both prongs of Alice to do so, despite its recent insistence in Enfish v. Microsoft and McRO v. Bandai Namco Games America that such a practice of viewing the claims at a high level was inappropriate. On the other hand, it is likely that a reasoned analysis under § 103 could have come to the same result without all of the judicial hand waving, and without doing further violence to the patent statute.

Prism Technologies LLC v. T-Mobile USA, Inc. (Fed. Cir. 2017)
Nonprecedential disposition
Panel: Chief Judge Prost and Circuit Judges Lourie and Schall
Opinion by Chief Judge Prost

recent posts

about