Patent Docs

USPTO Seeks Comments and Will Hold Roundtables on Examination Time

November 3, 2016

By Donald Zuhn –-

In a Federal Register notice (81 Fed. Reg. 73383) published last week, the U.S. Patent and Trademark Office issued a request for public feedback regarding the Office's reevaluation of its examination time goals. The Office also announced that it would be holding five roundtables in Alexandria, VA; Detroit, MI; Denver, CO; Dallas, TX; and San Jose, CA as part of its Examination Time Analysis (ETA). According to the Office's ETA External Outreach webpage, the dates and times of the roundtables are as follows:

The Office's request for comments indicates that the solicited public feedback will be used "as an input to help ensure that the Office's examination time goals accurately reflect the amount of time needed by examiners to conduct quality examination in a manner that responds to stakeholders' interests." The notice points out that the current examination time goals were created over forty years ago and have been adjusted twice, noting that since the examination time goals were originally developed, "significant changes to the examination process have occurred, including increased use of electronic tools, changes in law due to court decisions, a growing volume of prior art, and progress in technology, which results in increasingly complex subject matter in applications."

With regard to written comments, the Office's notice provides seven categories of questions on which it is seeking feedback (although the notice indicates that the Office welcomes any other comments on examination time). The seven categories of questions are:

(1) Do you perceive a difference in the quality of examination performed in complex technologies compared to less complex technologies? If yes, which do you perceive as higher quality and why? In what aspect(s) is the quality of examination higher?

(2) What factors do you consider when estimating the amount of time needed to take various steps in prosecution, such as preparing responses to Office actions or preparing for interviews? In particular, if you prosecute applications in a variety of technology areas, how do those factors vary among the technologies?

(3) Are the applications you prosecute more or less complex than in the past, e.g., 10 years ago? What factors contribute to the increase or decrease in complexity? Do you believe the increase or decrease in complexity has affected the amount of time it takes to prosecute the applications? If so, by how much? Do you believe the increase or decrease in complexity has affected the quality of examination? If so, how?

(4) In order to increase the quality of examination, do you believe that an increase in the time allotted for examination should be designated for specific activities, such as interviews, or left to the discretion of the examiner? What activities would you prioritize and allocate more time to?

(5) Are there any portions of Office actions which you feel do not add value or quality to the examination? If yes, what are they?

(6) What other activities beyond examining, such as research or training, could examiners spend time on that would add value? Why do you believe these activities could add value?

(7) While the focus of this request for comments and the roundtables is to find the appropriate amount of time for examination, cost and pendency are also contributing factors. Do these factors raise a concern that should be considered?

Written comments, which must be submitted by December 27, 2016 to be considered, can be submitted by e-mail to ExternalExaminationTimeStudy@USPTO.gov, or by regular mail addressed to: Mail Stop Comments—Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450, marked to the attention of Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy. The Office is also seeking public feedback through the interactive collaboration tool, IdeaScale (additional information regarding IdeaScale can be found in the Office's notice or the ETA External Outreach webpage.

Those interested in attending any of the roundtables can find registration information in the Office's notice or the ETA External Outreach webpage.

The ETA External Outreach webpage also provides some background material illustrating the use of examination time goals in the context of individual examiner evaluation, and as an input for forecasting pendency and hiring needs. Slides 12 to 18 may be of particular interest to practitioners and applicants as these slides provide information on production units, examining hours, and counts, and the role that technology complexity and seniority play in setting examination time goals.
USPTO Issues Memorandum on Recent Subject Matter Eligibility Decisions

November 2, 2016

By Michael Borella —

On November 2nd, the U.S. Patent and Trademark Office published an update to its guidance regarding the examination of claims with respect to the patent-eligibility requirements of 35 U.S.C. § 101 (see Memorandum entitled "Recent Subject Matter Eligibility Decisions"). Notably, this update addresses the recent McRO v. Bandai Namco Games America and BASCOM Global Internet Services v. AT&T Mobility Federal Circuit cases, both of which found challenged claims to be eligible. The update does not, however, discuss the November 1st Amdocs (Israel) v. Openet Telecom Federal Circuit decision (another finding of eligible claims), though the USPTO indicated that a further update would tackle that case.

A claimed invention is eligible for patenting if it meets the requirements of the two-step test set forth by the Supreme Court in Alice Corp. v. CLS Bank Int'l. According to the 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." A goal of this test is to prevent one from patenting judicial exclusions, and thereby preempting others from using these basic scientific tools.

Starting with McRO, the USPTO stated that "the claims were directed to an improvement in computer-related technology (allowing computers to produce 'accurate and realistic lip synchronization and facial expressions in animated characters' that previously could only be produced by human animators), and thus did not recite a concept similar to previously identified abstract ideas." Further, the USPTO acknowledged that the Federal Circuit emphasized the patent's specification in doing so, particularly that the Court relied on "the specification's explanation of how the claimed rules enabled the automation of specific animation tasks that previously could not be automated when determining that the claims were directed to improvements in computer animation instead of an abstract idea."

Additionally, "the claims at issue described a specific way (use of particular rules to set morph weights and transitions through phonemes) to solve the problem of producing accurate and realistic lip synchronization and facial expressions in animated characters, rather than merely claiming the idea of a solution or outcome." As a consequence, the McRO invention "improved the existing technological process, unlike cases such as Alice where a computer was merely used as a tool to perform an existing process."

Turning to BASCOM, the USPTO characterized that case as standing for the principle that "an inventive concept may be found in the non-conventional and non-generic arrangement of [known] elements."

Based on McRO and BASCOM, the USPTO made the following recommendations to its examining corps:

• When applying step one of Alice, "[e]xaminers should consider the claim as a whole . . . and should not overgeneralize the claim or simplify it into its 'gist' or core principles, when identifying a concept as a judicial exception;"

• When applying step two of Alice, "examiners should consider the additional elements in combination, as well as individually, when determining whether a claim as a whole amounts to significantly more, as this may be found in the nonconventional and non-generic arrangement of known, conventional elements;"

• "An improvement in computer-related technology . . . may also be claimed as a set of 'rules' (basically mathematical relationships) that improve computer-related technology by allowing computer performance of a function not previously performable by a computer;"

• Indications that a claim is directed to such an improvement include "a teaching in the specification about how the claimed invention improves a computer or other technology," as well as claiming "a particular solution to a problem or a particular way to achieve a desired outcome defined by the claimed invention, as opposed to merely claiming the idea of a solution or outcome."

The USPTO also considered preemption. In Alice, the Supreme Court noted its concern about preemption, but did not explicitly make preemption analysis a factor in the two-part test. The Federal Circuit has not been a paragon of consistency on preemption, with the USPTO noting that "some recent [Federal Circuit] decisions discuss the absence of preemption as confirming the analysis that the claimed invention is not directed to a judicial exception . . . or includes an inventive step." But others "do not consider the absence of preemption as conferring patent eligibility." The USPTO's guidance to examiners was equally abstruse, essentially instructing the corps to reconsider each of the two steps of Alice if an applicant argues that its claim does not preempt all applications of a judicial exclusion. Nonetheless, the USPTO did promise it will address preemption further in a forthcoming update to the guidance.

Finally, the USPTO indicated that examiners should avoid relying on non-precedential Federal Circuit § 101 decisions "unless the facts of the application under examination uniquely match the facts at issue in the non-precedential decision."

Aside from its nebulous approach to preemption, the USPTO should be commended for publishing this guidance. Its reading of the case law is accurate and reasonable. But more importantly, it has clarified the burden of the examiner in providing a proper § 101 analysis — claims should not be subjected to a 10,000-foot view during step one, and innovative combinations of elements should be considered during step two. Also, the USPTO has provided a road map for applicants to (i) avoid eligibility disputes during prosecution, and (ii) if that fails, to amend or argue their claims in light of the recent case law.

In particular, the McRO case should be at the top of every software and business method practitioner's handbook. The USPTO has taken the position that using a computer to perform a task that produces an otherwise-unobtainable result can be eligible if the steps to perform that task are well-specified. Given the prevalence of machine learning and big data across wide swathes of technologies, many applicants who have struggled to protect their inventions may now be seeing the light at the end of the tunnel.
In re Efthymiopoulos (Fed. Cir. 2016)

November 1, 2016

By Donald Zuhn —

Last month, in In re Efthymiopoulos, the Federal Circuit affirmed the determination by the U.S. Patent and Trademark Office Patent Trial and Appeal Board affirming the Examiner's rejection of all pending claims of Appellant Constantin Efthymiopoulos's U.S. Patent Application No. 08/737,141 as being obvious. The '141 application relates to methods of treating or preventing influenza by administering the drug zanamivir by oral inhalation. Claim 14 is representative:

14. A method for treating a human suffering from an infection by an influenza virus, wherein the method comprises administering to the human an effective amount of 5-acetamido-2,3,4,5-tetradeoxy-4-guanidino-D-glycero-D-galacto-non-2-enopyranosonic acid, wherein the 5-acetamido-2,3,4,5-tetradeoxy-4-guanidino-D-glycero-D-galacto-non-2-enopyranosonic acid is administered by inhalation through the mouth alone.

5-acetamido-2,3,4,5-tetradeoxy-4-guanidino-D-glycero-D-galacto-non-2-enopyranosonic acid is the chemical name for zanamivir.

During prosecution of the '141 application, the Examiner rejected the pending claims as being obvious in view of Australian Patent No. AU-A1-27242/92 ("Von Itzstein II"), in view of International Publication No. WO 91/16320 ("Von Itzstein I") and several other references. Von Itzstein I discloses intranasal administration, but not oral inhalation, of zanamivir, and Von Itzstein II discloses administration of a compound similar to zanamivir by "inhalation" for the treatment and prevention of influenza. The Examiner determined that (1) zanamivir and the compound disclosed in Von Itzstein II were similar enough that it would have been obvious to use zanamivir in the method of Von Itzstein II; (2) even though Von Itzstein II did not teach oral inhalation, there are only two possible inhalation methods (i.e., oral and nasal); and (3) other prior art references taught inhalers, that oral inhalation delivers more drug to the lungs than nasal inhalation, and that influenza infects the lungs. The Examiner therefore concluded that it would have been obvious to treat influenza by oral inhalation of zanamivir. The Board affirmed the Examiner's rejections and found Appellant's evidence of secondary considerations (i.e., unexpected results) to be unpersuasive.

In an opinion authored by Chief Judge Prost and joined by Judge Bryson, with Judge Newman dissenting, the Federal Circuit concluded that the Board did not err in affirming the Examiner's rejection of Appellant's claims. In particular, the majority opinion states that:

There is also no dispute that Von Itzstein II discloses several pages of different administration methods for an adjacent homologue of zanamivir to achieve the same result—treating or preventing influenza. In particular, Von Itzstein II expressly discloses administration through "oral," "nasal," or other forms "suitable for administration by inhalation," among other methodologies.

The majority opinion also points out that the Board "agreed with the examiner's conclusion that Von Itzstein II's disclosure of administration through 'inhalation' includes oral inhalation," and that the Board had indicated that:

[I]nhalation can only be carried out via the nose or the mouth. Since Von Itzstein II does not limit its disclosure to nasal inhalation, it is reasonably understood to disclose inhalation by either the nose alone, the mouth alone, or both.

As for Appellant's evidence of unexpected results, the majority opinion states that "[t]he record shows that the Board thoroughly considered and discussed [Appellant's expert] Dr. Hayden's declaration in its decision and found that Dr. Hayden's testimony insufficient to overcome the prima facie case of obviousness." The majority opinion therefore affirmed the Board's decision affirming the Examiner's rejection of the pending claims of the '141 application.

In a dissenting opinion, Judge Newman writes that:

The PTAB and now this court rule that it was obvious to administer this drug by oral inhalation, although there is no reference, no prior art, no suggestion, proposing that this mode of application might succeed, or that it should be tried. There was evidence of skepticism even as oral inhalation was evaluated. There was no contrary evidence. The evidence on which the Board and now this court rely is the evidence in the patent application itself, describing oral inhalation, its benefits, and its effectiveness. Upon learning this information from this inventor's disclosure, the Board found that it was obvious, and my colleagues agree that it is obvious to them.

Judge Newman points out that both the Board and the Examiner recognized that Von Itzstein II does not specifically teach inhalation of zanamivir through the mouth, adding that:

Nor does any other reference teach or suggest treatment of influenza by oral inhalation of this compound or any related compound. My colleagues nonetheless deem this treatment of influenza obvious on the ground that inhalation occurs only through the nose or the mouth. Thus the court rules that the discovery of effective treatment by oral inhalation is obvious to the court, although not obvious to experts, and not suggested in the prior art.

As for the teachings of Von Itzstein II, Judge Newman notes that "there is extensive discussion in Von Itzstein II directed to all of the known forms of oral administration of this product—plus parenteral, topical, rectal, vaginal, and intranasal administration—but Von Itzstein II lacks any mention of oral inhalation," adding that "[t]he description of suitable formulations continues for almost three more pages, but does not mention or suggest oral inhalation." Judge Newman also asserts that "[t]he Board's statement that inhalation is 'reasonably understood' to include oral inhalation is without authority," explaining that "[t]here was no record showing or supporting such an understanding," and that "[t]his mode of therapy is taught only by this inventor." Judge Newman therefore concluded that "[t]here was not substantial evidence to support the Board's ruling of obviousness."

In re Efthymiopoulos (Fed. Cir. 2016)
Panel: Chief Judge Prost and Circuit Judges Newman and Bryson
Opinion by Chief Judge Prost; dissenting opinion by Circuit Judge Newman
Guest Post — The Emergent Microbiome: A Revolution for the Life Sciences — Part VIII, The Microbiome and Immunotherapy I

October 31, 2016

By David Puleo* and Anthony D. Sabatelli** —

Introduction

Cancer immunotherapy or immuno-oncology (I-O) has gone mainstream. You may have heard about these topics in the media. Along with having surgery and radiation therapy, Former President Jimmy Carter was treated with the monoclonal antibody pembrolizumab (Keytruda®) that stimulated his immune system to fend or fight off melanoma that had metastasized to his brain. His remarkable response has highlighted the power of immunotherapy. After his son Beau succumbed to brain cancer, Vice President Joe Biden helped spearhead the Cancer Moonshot, a national initiative to cure cancer, one of the main goals of which is furthering immunotherapy research. The White House has dedicated $1 Billion to this initiative. This article will introduce you to immunotherapy and how it is now beginning to intersect with the microbiome. Recent patent filings suggest that intellectual property protection will be an important part of the research efforts in this field. Bolded patent documents are further summarized in the table at the end of this installment.

What is Immunotherapy?

Put simply, immunotherapy harnesses the body's own immune system to fight cancer. Immunotherapy refers to those pharmacological agents that stimulate an immune response and, further, have been used to combat various forms of cancer. The most widely recognized immunotherapeutic class is the immune checkpoint proteins, which are a set of proteins that act as either stimulators or inhibitors of the immune system. The pharmaceutical industry has begun targeting the inhibitory immune checkpoint proteins. By dampening or attenuating the "off-switch", an immune response is enhanced. The most well-known checkpoint targets are cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), and programmed death ligand 1 (PD-L1). A number of FDA-approved biologics, termed immune checkpoint inhibitors or checkpoint blockades, are on the market targeting these receptors, including ipilimumab (Yervoy®, Bristol-Myers Squibb, anti-CTLA-4), pembrolizumab (Keytruda®, Merck, anti-PD-1), and nivolumab (Opdivo®, Bristol-Myers Squibb, anti-PD-1), and have been used to treat a number of indications, including melanoma.

One glaring problem or challenge associated with immunotherapy is that the majority (60-80%) of patients, aptly termed "non-responders", do not respond to single agent therapy. Most non-responders lack sufficient amount of those immune cells, known as tumor-infiltrating lymphocytes (TILs), that are necessary to mobilize an anti-cancer immune response. Given this poor patient response and unwanted side effects, such as immunotherapy-induced colitis, due to single agent immune checkpoint inhibitor treatment, efforts have turned toward administering these biologics and other immunotherapeutics in combination. For instance, Bristol-Meyers Squibb's (BMS) Opdivo®-Yervoy® treatment is the first combination therapy approved for metastatic melanoma. Also, Opdivo® recently fell short to make its endpoint in a clinical trial as a single agent for frontline non-small cell lung cancer (NSCLC) therapy. This clinical trial was further highlighted at the recent European Society of Medical Oncology 2016 Congress, where Merck's Keytruda® was viewed as the heavy hitter (and is a serious contender for frontline NSCLC therapy). Given the recent Opdivo® results, BMS is looking to combine the biologic with other therapies, including Nektar Therapeutics' TIL-inducing NKTR-214. In theory, this combination should decrease the percentage of Opdivo® non-responders for a number of indications.

Microbiome-based Therapeutics as Combination Therapy

Two back-to-back articles in a 2015 issue of Science (350, 1079-1089) addressed how the microbiome could be a game-changer in I-O. Both articles highlighted the importance of commensal gut microbiota in the efficacy of single agent immunotherapy. The first paper was published by Laurence Zitvogel, Director of INSERM and Group Leader of Tumor Immunology and Anti-cancer Immunotherapy at Institut Gustave Roussy in France. Her group had previously determined that the efficacy of the chemotherapeutic cyclophosphamide was dependent on the microbiome composition [Science 342, 971-976 (2013)]. They extended this work to immunotherapy and found that the bacterium Bacteroides fragilis improved the antitumor efficacy of an anti-CTLA-4 antibody. Given these intriguing results, Zitvogel filed patent application WO2016063263 for the administration of Bacteroides supplements to patients on an anti-CTLA-4 mAb, e.g. Yervoy®. Zitvogel and Institut Gustave Roussy are now partnering with the French biotech, Enterome Biosciences to further this research.

The second paper was published by Thomas Gajewski from The University of Chicago. His group found that Bifidobacterium improved the antitumor efficacy of an anti-PD-L1 antibody in a mouse model of melanoma. Although Gajewski filed patent application US20150352206 directed to specific immunotherapeutic combination therapies, this patent does not mention manipulation of the microbiome. Gajewski has licensed his work to Evelo Biosciences, known for their OncobioticTM Platform that was summarized in Part VI of the Series. Evelo recently merged with Epiva Biosciences; the new company retains the name Evelo. Both owned by Flagship Ventures, these companies were targeting the microbiome but doing so in different ways. Whereas Evelo was trying to treat cancer, Epiva was trying to treat autoimmune and inflammatory diseases (patent application US20160235792 summarizes Epiva's efforts). Evelo is using its trademarked platform to identify "cancer-associated bacteria" and further hopes to develop "onco-microbials" and "immuno-microbials", microbiome modulators for the treatment of cancer (namely lung, skin, prostate, and colon cancers) and autoimmune diseases, respectively.

The Future: Combinations of Microbiome Modulators and Checkpoint Inhibitors?

Since the previous studies by Zitvogel and Gajewski were performed in mice, scientists have yet to determine whether this translates to humans as well. It is unclear whether microbiome modulators could be used in combination with or would have any effect on other forms of immunotherapy, such as IDO inhibitors or CAR-T. However, it is evident that the interplay between the microbiome and targeted therapies is not straightforward and only adds a further layer of complexity to personalized medicine. Utilizing the microbiome-based diagnostics highlighted in Part VI of the Series, it is possible to identify and further compare the microbiomes of responder and non-responder patients being treated with similar immunotherapies. In doing so, one can further correlate a patient's microbiome composition with the clinical efficacy of immunotherapeutics. This data could be used to supplement non-responders with missing or deficient microbiome components to make their treatments more efficacious. Thus, combination therapies of immunotherapeutics with microbiome modulators are likely the way of the future. Several patent applications reflect this trend. An early patent application WO2003063593 from the defunct Vion Pharmaceuticals refers to using combinations of an immunomodulatory agent, such as anti-CD8 antibody, cyclosporine A, or methotrexate, with tumor-targeted bacteria in order to reduce solid tumor growth. US20160144014 discloses combinations of Clostridia and an immune modulator. Within the next several years, the terms "oncobiotics" and "immunobiotics" will likely become part of everyday scientific vernacular.

* David Puleo is a Ph.D. Candidate in the Pharmacology Department at Yale University. Prior to attending Yale, David graduated from Boston College with a B.S. in Biochemistry, after which he worked for two years in the Center for Proteomic Chemistry at Novartis Institutes for BioMedical Research in Cambridge, MA.
** Dr. Sabatelli is a Partner with Dilworth IP

For additional information regarding this topic, please see:

• "The Emergent Microbiome: A Revolution for the Life Sciences — Part VII, The Microbiology of the Built Environment," October 5, 2016
• "The Emergent Microbiome: A Revolution for the Life Sciences – Part V, Patents Relating to Obesity and Metabolic Disorders," February 28, 2016
• "The Emergent Microbiome: A Revolution for the Life Sciences – Part IV, Obesity and other Metabolic Disorders," February 18, 2016
• "Jackson Laboratory Hosts Microbiome Symposium Related to Cancer and Immunology," January 19, 2016
• "The Emergent Microbiome: A Revolution for the Life Sciences – Part III, Psychobiotics," October 13, 2015
• "The Emergent Microbiome: A Revolution for the Life Sciences – Part II, 2015 Patent Trends," August 11, 2015
• "The Emergent Microbiome: A Revolution for the Life Sciences – Part I, R&D Leaders," August 10, 2015
Synopsys, Inc. v. Mentor Graphics Corp. (Fed. Cir. 2016)

October 30, 2016

By Michael Borella —

Synopsys brought a patent infringement action against Mentor Graphics in the Northern District of California, alleging infringement of various claims of U.S. Patent Nos. 5,530,841, 5,680,318, 5,748,488, and 6,836,420. Claim 1 of the '841 patent recites:

A method for converting a hardware independent user description of a logic circuit, that includes flow control statements including an IF statement and a GOTO statement, and directive statements that define levels of logic signals, into logic circuit hardware components comprising:
    converting the flow control statements and directive statements in the user description for a logic signal Q into an assignment condition AL(Q) for an asynchronous load function AL( ) and an assignment condition AD(Q) for an asynchronous data function AD( ); and
    generating a level sensitive latch when both said assignment condition AL(Q) and said assignment condition AD(Q) are nonconstant;
    wherein said assignment condition AD(Q) is a signal on a data input line of said flow through latch;
    said assignment condition AL(Q) is a signal on a latch gate line of said flow through latch; and
    an output signal of said flow through latch is said logic signal Q.

In short, the invention provides for conversion of a user's functional description of a logic circuit into an arrangement of hardware components that perform the logic circuit's functions.

Traditionally, a user would specify the hardware components for fabrication. But, as circuit complexity grew, this task became complex and cumbersome. Hardware description languages (HDLs) were created that allow the user to specify the desired operation of the logic circuit, rather than its components and interconnects. Early HDLs still required that the user specify some aspects of the components and interconnects. The '841 patent, as well as the other patents-in-suit, describe a way to translate functional descriptions in an HDL to hardware component descriptions without requiring that the user specify any hardware components. Notably, the claims recite translating one type of logical description to another — no actual components are required to be arranged or built.

The District Court construed the claims as not requiring the use of a computer, or any other type of hardware. This construction was not challenged by the parties.

Mentor Graphics moved for summary judgment, contending that the claims were ineligible under 35 U.S.C. § 101. The District Court granted this motion, stating that "each of the steps in the claimed methods can be performed by a skilled designer either mentally or with pencil and paper," and that the claims were broad enough to cover an abstract mental process. Further, the District Court noted that the process had previously been performed mentally by the inventors. Finding that the claimed process therefore preempted a "building block of human ingenuity," the District Court found the asserted claims of the '841, '318, and '488 patents to be ineligible (the claims of the '420 patent had previously been ruled to be obvious in an inter partes review).

On review, the Federal Circuit applied the two-prong patent-eligibility test as set forth by the Supreme Court in Alice Corp. v. CLS Bank Int'l. According to the 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." A goal of this test is to prevent one from patenting judicial exclusions, and thereby preempting others from using these basic scientific tools.

Applying the first prong, the Court cited its CyberSource Corp. v. Retail Decisions, Inc. case for the principle that mental processes are ineligible abstract ideas, as such processes (in the Court's view) are basic scientific tools. With reference to claim 1, the Court noted that the method as claimed could be performed mentally or with pencil and paper. This conclusion was supported by admissions as much by the inventors, as well as the District Court's claim construction.

Synopsys argued that, in practice, the claimed invention would have to be performed on a computer to carry out any meaningful conversion. But the Court shut down this line of reasoning, because the claims "are so broad as to read on an individual performing the claimed steps mentally or with pencil and paper." Further, the Federal Circuit's recent reasoning in the Enfish, LLC v. Microsoft Corp. and McRO, Inc. v. Bandai Namco Games Am. Inc. cases did not apply. These cases held that an improvement to computer technology or a computer itself can be enough to lift an invention over the eligibly threshold. Since a computer need not be involved in the carrying out of the claimed invention, the claims cannot be viewed as such an improvement.

Regarding preemption, Synopsys argued that the claims did not preempt all ways of converting functional descriptions of logic circuits to hardware component descriptions thereof. However, the Court quickly (and in a circular fashion) dismissed this notion, stating that "[w]here a patent's claims are deemed only to disclose patent-ineligible subject matter under the [Alice] framework, as they are in this case, preemption concerns are fully addressed and made moot."

Applying the second prong, the Court looked for an inventive concept in the claims. Synopsys's arguments relied on a well-worn notion — that an inventive concept can be established by the absence of anticipation or obviousness. This line of reasoning, however, has been frequently and consistently rejected by the Court.

Here, the Court noted that an inventive concept can include technical solutions, such as those present in the claims of DDR Holdings v. Hotels.com and BASCOM Global Internet Servs. v. AT&T Mobility. Particularly, the Court observed that the only claim elements that went beyond the abstract idea of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" were the use of assignment conditions. But these elements served to "merely aid in mental translation as opposed to computer efficacy," and were therefore insufficient to provide a technical advance.

Consequently, the claims failed to satisfy the second prong of Alice, and were rendered ineligible as a result.

This case provides yet another illustration of how a technical tool, when not claimed properly, can be deemed non-technical by a reviewing court. Granted, the claims here were drafted well before the Alice decision and satisfied the USPTO's requirements at that time, so we should not criticize their author too harshly.

An argument that might have been more viable than those presented in this case was that the claims were not directed to a fundamental building block or scientific tool — instead they recited an arrangement of a number of such tools (e.g., HDL specifications, control flow logic, and the mapping thereof into digital logic). Still, such a point may have been dead on arrival due to the patentee's admissions that the claimed invention could be and had been performed manually.

Which brings us to that very issue. In McRO, the Federal Circuit appeared to take the position that there is a difference between merely automating a known manual process and automating a process that is not known to have been previously performed manually. Namely, the former is not patent-eligible while the opposite can be true for the latter. This case does not contradict McRO's holding, as the Court repeatedly emphasized evidence that the inventors had been performing the claimed process manually. Nonetheless, this is an area that the Federal Circuit should clarify, as a distinction between the eligibility of processes that have been performed manually and processes that theoretically could be performed manually may provide ways of protecting complex software inventions that, in practice, require computer implementation to provide results of any significance.

Synopsys, Inc. v. Mentor Graphics Corp. (Fed. Cir. 2016)
Panel: Circuit Judges Lourie, Moore, and Chen
Opinion by Circuit Judge Chen
Conference & CLE Calendar

October 30, 2016

November 1, 2016 – "Patent Prosecution and Defeating Abstractness: Minimizing the Risk of Sect. 101 Rejection — Lessons From Recent Federal Circuit Court Decisions" (Strafford) – 1:00 to 2:30 pm (EDT)

November 1, 2016 – "Drug Substance Patents: Leveraging New FDA Guidance, Protecting Composition of Matter Patents, Drafting Solid Form Claims" (Strafford) – 1:00 to 2:30 pm (EDT)

November 1-2, 2016 – "European Patent Practice" (The John Marshall Law School Center for Intellectual Property, Information & Privacy Law and Kuhnen & Wacker) – Chicago, IL

November 2, 2016 – "Obviousness After Apple v. Samsung" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)

November 3, 2016 – "How to Engineer Your Application to Avoid Alice Rejections" (LexisNexis) – 2:00 pm (EST)

November 9, 2016 – "Evolution of Patent Litigation: Interface of Judicial and Administrative Patent Proceedings" (Federal Circuit Bar Association) – Northeastern University School of Law, Boston, MA

November 15, 2016 – "Covered Business Method (CBM) Patent Review: Another Way to Kill Software Patents?" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

***Patent Docs is a media partner of this conference or CLE
IPO Webinar on Obviousness After Apple v. Samsung

October 29, 2016

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Obviousness After Apple v. Samsung" on November 2, 2016 from 2:00 to 3:00 pm (ET). Robert Asher of Sunstein Kann Murphy & Timbers, Kenneth Corsello of IBM Corp., and Justin Hasford of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will discuss the likely impact of the Apple v. Samsung case, as well as of the recent Federal Circuit opinion in Arendi v. Apple, where the court overruled the PTAB invalidation of Arendi's patents, stressing that "common sense" critiques of an invention must be supported by substantial evidence and explained with sufficient reasoning. The panel will also draw lessons from the recent PTAB decision Innopharma v. Senju Pharmceutical, where after institution the patentee was able to prove to the PTAB both unexpected technical effects and the nexus between those technical effects and commercial success.

The registration fee for the webinar is $135 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
FCBA Program Patent Litigation

October 29, 2016

The Federal Circuit Bar Association (FCBA) will be offering a program entitled "Evolution of Patent Litigation: Interface of Judicial and Administrative Patent Proceedings" on November 9, 2016 from 4:00 to 7:15 pm (EDT) at the Northeastern University School of Law in Boston, MA. Erik Belt of McCarter & English will moderate a panel consisting of the Honorable Todd M. Hughes, U.S. Court of Appeals for the Federal Circuit, the Honorable Judge F. Dennis Saylor IV, U.S. District Court for the District of Massachusetts, and the Honorable Jacqueline W. Bonilla, Patent Trial and Appeal Board.

Additional information regarding the program can be found here.
Webinar on Covered Business Method (CBM) Patent Review

October 29, 2016

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Covered Business Method (CBM) Patent Review: Another Way to Kill Software Patents?" on November 15, 2016 from 10:00 am to 11:15 am (CT). In this presentation, MBHB attorney and Patent Docs author Joseph Herndon will provide a review of CBMs and PTAB decisions focusing on both early and more recent trends by the PTAB. Topics will include:

• What are CBMs?
• Non-uniformity in PTAB rulings
• Differing Views on the Subject Matter Considered: Specification, Claims, or Both?
• How CBMs are used against Software patents

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

October 27, 2016

By John Cravero and Richard Martin —

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

Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc.

PTAB Petition: IPR2016-01317; filed June 29, 2016.

PTAB Trial Instituted September 19, 2016.

Patent at Issue: U.S. Patent No. 8,822,438 ("Methods and compositions for treating cancer," issued September 2, 2014) claims methods for treating cancer comprise administering a 17α-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3β-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid.

Petitioner Argentum Pharmaceuticals Inc. is challenging the '438 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Lora M. Green, Rama G. Elluru, and Kristina M.Kalan (author) issued a decision instituting review of claims 1-20 of the '438 patent under 35 U.S.C. § 103 as being obvious over O'Donnell and Gerber, and claims 1–4 and 6–11 under 35 U.S.C. § 103 as being obvious over Barrie and Gerber. View the decision here. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00286 (Amerigen Pharmaceuticals, Ltd. v. Janssen Oncology, Inc., Petitioner Amerigen Pharmaceuticals; filed 12/06/2015; Instituted 05/31/2016), adding Argentum as a petitioner to IPR2016-00286 and terminating IPR2016-01317 under 37 C.F.R. § 42.72.

Related Matters: According to the petition, the '438 patent is involved in several litigation proceedings: BTG International Ltd. et al. v. Glenmark Pharmaceuticals Inc., USA et al., 2-16-cv-03743 (District of New Jersey), filed June 24, 2016; BTG International Ltd. et al. v. Amerigen Pharmaceuticals, Inc. et al., 2-16-cv-02449 (District of New Jersey), filed May 2, 2016; Janssen Biotech, Inc. et al. v. Mylan Pharmaceuticals Inc. et al., 1-15-cv-00130 (Northern District of West Virginia), filed August 4, 2015; Janssen Biotech, Inc. et al. v. Amneal Pharmaceuticals LLC et al., 1-15-cv-00679 (District of Delaware), filed August 3, 2015; BTG International Ltd. et al. v. Actavis Laboratories FL, Inc. et al., 9-15-cv-81076-DMM (Southern District of Florida), filed August 3, 2015; and BTG International Ltd. et al. v. Actavis Laboratories FL, Inc., et al., 2-15-cv-05909-KM-JBC (District of New Jersey), filed July 31, 2015.

Praxair Distribution, Inc. et al. v. Mallinckrodt Hospital Products IP LTD. et al.

PTAB Petitions:

IPR2016-00777, filed March 23, 2016

IPR2016-00778, filed March 23, 2016

IPR2016-00779, filed March 23, 2016

IPR2016-00780, filed March 23, 2016

PTAB Trial Instituted September 22, 2016.

Patents at Issue:

IPR2016-00777 U.S. Patent No. 8,282,966 ("Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide," issued October 9, 2012). View the petition here.

IPR2016-00778 U.S. Patent No. 8,431,163 ("Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas," issued April 30, 2013). View the petition here.

IPR2016-00779 U.S. Patent No. 8,293,284 ("Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide, issued October 23, 2012). View the petition here.

IPR2016-00780 U.S. Patent No. 8,795,741 ("Methods for treating patients who are candidates for inhaled nitric oxide treatment," issued August 5, 2014). View the petition here.

The involved patents are all related and share substantially the same specification, which discloses methods of reducing the risk of an adverse event, such as pulmonary edema, associated with treating a patient with inhaled nitric oxide gas.

Administrative Patent Judges Lora M. Green, Tina E. Hulse (author), and Robert A. Pollock issued one decision for all four petitions stating that the decision addresses issues common to each of the cases. The decision denies institution of Inter Partes Review of (1) claims 1–29 of the '966 patent (IPR2016-00777); (2) claims 1–25 of the '163 patent (IPR2016-00778); (3) claims 1–30 of the '284 patent (IPR2016-00779); and (4) claims 1–44 of the '741 patent (IPR2016-00780). View the decision here.

Related Matters: According to the petition, the '966 patent is involved in litigation in the District of Delaware, captioned INO Therapeutics LLC v. Praxair Distribution, Inc., No. 1:15-cv-00170 (GMS). Petitioner previously filed petitions requesting inter partes review of the claims of each of the involved patents: Case IPR2015-00522, filed 01/05/2015; denied 07/29/2015 (the '966 patent); Case IPR2015-00524, filed 01/05/2015, denied 07/29/2015 (the '284 patent); Case IPR2015-00525, filed 01/05/2015, denied 07/29/2015 (the '163 patent); Case IPR2015-00526, filed 01/05/2015, denied 07/29/2015 (the '741 patent).

Mylan Laboratories Ltd. v. Aventis Pharma S.A.

PTAB Petition: IPR2016-00712; filed March 15, 2016.

PTAB Trial Instituted September 22, 2016.

Patent at Issue: U.S. Patent No. 8,927,592 ("Antitumoral use of cabazitaxel," issued January 6, 2015) claims a method for treating a patient with prostate cancer that has progressed during or after treatment with docetaxel, comprising administering to said patient a dose of 20 to 25 mg/m2 of cabazitaxel, or a hydrate or solvate thereof, in combination with a corticoid.

Petitioner Mylan Laboratories Ltd. is challenging the '592 patent on ten grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Brian P. Muryphy (author), Tina E. Hulse, and Christopher M. Kaiser issued a decision instituting review of claims 1, 2, 5, 12, 13, 17–20, 22–25, and 27–29 as being obvious over Winquist and the TROPIC Listing in view of Attard and Beardsley; and claims 3 and 4 as being obvious over Winquist, the TROPIC Listing, and Didier; claims 7–9 as being obvious over Winquist, the TROPIC Listing, and Mita; claims 10, 11, 14, and 16 as being obvious over Winquist, the TROPIC Listing, and Tannock; claims 21, 26, and 30 as being obvious over Winquist, the TROPIC Listing, and Pivot; and claim 15 as being obvious over Winquist, the TROPIC Listing, Pivot, and Tannock. The decision denies instituting a portion of Ground 1, but the claims denied under Petitioner's Ground 1 are instituted under other Grounds so that claims 1-5 and 7-30 of the '592 patent are instituted. View the decision here.

Related Matters: According to the petition, the '592 patent is involved in several litigation proceedings: Sanofi-Aventis U.S. LLC et al. v. Mylan Laboratories Ltd., C. A. No. 15-03392 (MAS)(LHG), filed in the District of New Jersey; Sanofi-Aventis U.S. LLC et al. v. Apotex Corp. et al., C. A. No. 15-01835; Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical, Inc., C. A. No. 15-01836; Sanofi-Aventis U.S. LLC et al. v. Accord Healthcare, Inc., C. A. No. 15-02520; Sanofi-Aventis U.S. LLC et al. v. BPI Labs, LLC et al., C. A. No. 15-02521; Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy Laboratories, Inc. et al., C. A. No. 15-02522; Sanofi-Aventis U.S. LLC et al. v. Glenmark Generics Inc. et al., C. A. No. 15- 02523; Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC, C. A. No. 15- 02631; and Sanofi-Aventis U.S. LLC et al. v. Actavis LLC et al., C. A. No. 15-03107.

Teva Pharmaceuticals USA, INC. v. AstraZeneca AB.

PTAB Petition: IPR2016-01122; filed June 1, 2016.

PTAB Trial Instituted September 23, 2016.

Patent at Issue: U.S. Patent No. RE44,186 ("Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method," issued April 30, 2013) claims Dipeptidyl peptidase IV (DP 4) inhibiting compounds, pharmaceutical compositions, and methods of treating diabetes, insulin resistance, hyperglycemia, hyperinsulinemia, impaired glucose homeostasis, or impaired glucose tolerance in a mammal comprising administering to the mammal a pharmaceutical composition.

Petitioner Teva Pharmaceuticals USA, Inc. is challenging the '186 patent on four grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney, Rama G. Elluru (author), and Christopher G. Paulraj issued a decision granting Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2015-01340 (Mylan Pharms., Inc. v. AstraZeneca AB, LLC , Petitioner Mylan Pharmaceuticals; filed 06/04/2015; Instituted 05/02/2016), adding Teva as a petitioner to IPR2015-01340 and terminating IPR2016-01122 under 37 C.F.R. § 42.72. View the decision here.

Related Matters: According to the petition, the '186 patent is involved in several litigation proceedings: AstraZeneca AB v. Mylan Pharmaceuticals Inc., 14- cv-00696 (D. Del. 2014); AstraZeneca AB v. Mylan Pharmaceuticals Inc., 14-cv- 00094 (D.W. Va. 2014); AstraZeneca AB v. Aurobindo Pharma Ltd. et al., 14-cv- 014696 and 14-cv-00664 (D. Del. 2014); AstraZeneca AB v. Actavis Laboratories FL, Inc., 14-cv-01356 (D. Del. 2014); AstraZeneca AB v. Sun Pharma Global FZE et al., 14-cv-00694 (D. Del. 2014); AstraZeneca AB v. Amneal Pharmaceuticals LLC., 14-cv-00697 (D. Del. 2014); and AstraZeneca AB v. Wockhardt Bio AG et al., 14-cv-00696 (D. Del. 2014).

Elekta Inc. v. Varian Medical Systems, Inc. et al.

PTAB Petition: IPR2016-00843; filed April 5, 2016.

PTAB Trial Instituted September 28, 2016.

Patent at Issue: U.S. Patent No. 8,696,538 ("Methods and apparatus for the planning and delivery of radiation treatments," issued April 15, 2014) claims a method for planning delivery of radiation dose to a target region within a subject, and a program product comprising a non-transitory computer-readable medium comprising computer readable instructions which, when executed by a processor, cause the processor to execute a method for planning delivery of radiation dose to a target region within a subject.

Petitioner Elekta Inc. is challenging the '538 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or obvious under 35 U.S.C. § 103(a) (grounds 2, 3, 4, 5, and 6). View the petition here. Administrative Patent Judges Brian J. McNamara, Patrick M Boucher, and Garth D. Baer (author) issued a decision instituting review of claims 23, 25, and 26 as being obvious under 35 U.S.C. § 103(a) over Earl '261 and Otto; claims 39–41 as being obvious under 35 U.S.C. § 103(a) over Earl '261, Otto, Yu, and Podgorsak; claims 23, 25, and 26 as being obvious under 35 U.S.C. § 103(a) over Duthoy and Otto; and claims 39–41 as being obvious under 35 U.S.C. § 103(a) over Duthoy, Otto, Yu, and Podgorsak. View the decision here.

Related Matters: According to the petition, the '538 patent is involved in litigation captioned Varian Medical Systems, Inc. et al. v. Elekta AB et al., No. 3:15-cv-04428 (N.D. Cal., Sept. 25, 2015), and proceedings pending before the International Trade Commission in Investigation No. 337-TA-968.

Merial, Inc. v. Sergeant's Pet Care Products, Inc

PTAB Petition: IPR2016-00798; filed March 25, 2016.

PTAB Trial Instituted September 29, 2016.

Patent at Issue: U.S. Patent No. 8,614,244 ("Spot-on pesticide composition," issued December 24, 2013) claims an A spot-on pesticide composition for animals, specifically mammals, including dogs and cats, which composition comprises a combination of active components, including fipronil and a pyrethroid.

Petitioner Merial Inc. challenged the '244 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Toni R. Scheiner, Sheridan K. Snedden, and Susan L. C. Mitcell (author) issued a decision denying instituting of Inter Partes review of claims 1-22 as being obvious under 35 U.S.C. § 103(a). View the decision here.

Related Matters: According to the petition, the '244 patent is not involved in any co-pending litigation or administrative matter.

Smith & Nephew, Inc. et al. v. Arthrex, Inc.

PTAB Petition: IPR2016-00817; filed March 30, 2016.

PTAB Trial Instituted September 29, 2016.

Patent at Issue: U.S. Patent No. 6,875,216 ("Tapered bioabsorbable interference screw for endosteal fixation of ligaments," issued April 5, 2005) claims a bioabsorbable interference screw having a tapered profile which extends along substantially the entire length of the screw where the tapered profile makes the screw easy to insert while providing superior fixation resulting from a progressively increasing diameter.

Petitioners Smith & Nephew, Inc. and Arthrocare Corp. are challenging the '216 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges William V. Saindon, Barry L. Grossman, and Timothy J. Goodson (author) issued a decision instituting review of claims 1–7 as being obvious in view of Endo-Fix; claims 1–7 as being obvious in view of Endo-Fix and Weiler; claims 1–7 as being obvious in view of Simon; and claims 1–7 as being obvious in view of Simon and Weiler. View the decision here.

Related Matters: According to the petition, the '216 patent is related to two other patents for which inter partes review has been requested. The '216 patent is a division of U.S. Patent No. 6,629,977, which is the subject of IPR2016-00819 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 10/04/2016). Also, U.S. Patent No. 7,322,986, which is the subject of IPR2016-00818 (Smith & Nephew, Inc. and Arthrocare Corp. v. Arthrex, Inc.; Petitioners Smith & Nephew, Inc. and Arthrocare Corp.; filed 03/30/2016; instituted 10/04/2016), is a continuation of the '216 patent. The '977, '216, and '986 patents have been asserted by Patent Owner in the U.S. District Court for the Eastern District of Texas in Arthrex, Inc. v. Smith & Nephew, Inc., Civil Action No. 2:2015-cv-01047.

Apotex Inc. et al. v. Eli Lilly & Company

PTAB Petition: IPR2016-01190; filed July 1, 2016.

PTAB Trial Instituted September 30, 2016.

Patent at Issue: U.S. Patent No. 7,772,209 ("Antifolate combination therapies," issued August 10, 2010) claims a method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent.

Petitioners Apotex Inc. and Apotex Corp. are challenging the '209 patent on one ground as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Michael P. Tierney (author), Jacqueline Wright Bonilla, and Tina E. Hulse issued a decision instituting review of claims 1-20 of the '438 patent as being obvious under 35 U.S.C. § 103(a) over Niyikiza in view of U.S. Patent No. 5,217,974 and in further view of European Patent Application No. 0,595,005 A1. The panel also granted Petitioner's Motion under 37 C.F.R. § 42.122 for Joinder to IPR2016-00237 (Neptune Generics, LLC. v. Eli Lilly & Compnay, Petitioners GKC General Partner II, LLC; GKC Partners II, LLC; Gerchen Keller Capital, LLC; and Neptune Generics, LLC; filed 11/24/2015; Instituted 06/03/2016), adding Apotex Inc. and Apotex Corp as petitioners to IPR2016-00237 and terminating IPR2016-01190 under 37 C.F.R. § 42.72. View the decision here.

Related Matters: According to the petition, the '209 patent is the subject of litigation in the Southern District of Indiana, in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Case No. 1:10-cv-1376.

The '209 patent also has been challenged in the following instituted inter partes reviews: IPR2016-00237 and IPR2016-00240 by Neptune, and in IPR2016-00318 by Sandoz Inc. Several parties, including Petitioner, seek to join the instituted reviews. Specifically, in addition to the current case, IPR2016-01335 (Wockhardt) and IPR2016-01341 (Teva and Fresenius) seek to join IPR2016-00237. Also, IPR2016-01191 (Apotex), IPR2016-01337 (Wockhardt), and IPR2016-01343 (Teva and Fresenius) seek to join IPR2016-00240. Additionally, IPR2016-01429 (Apotex et. al.), IPR2016-01393 (Wockhardt) and IPR2016-01340 (Teva and Fresenius) seek to join IPR2016-00318.

Lupin Ltd. et al. v. Horizon Therapeutics, Inc.

PTAB Petition: IPR2016-00829; filed April 1, 2016.

PTAB Trial Instituted September 30, 2016.

Patent at Issue: U.S. Patent No. 9,095,559 ("Methods of therapeutic monitoring of nitrogen scavenging drugs," issued August 4, 2015) claims methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.

Petitioners Lupin Ltd. and Lupin Pharmaceuticals Inc. are challenging the '559 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Toni R. Scheiner, Deborah Katz (author), and Grace Karaffa Obermann issued a decision instituting review of claims 1-15 of the '559 patent on the grounds that claims 1, 2, 4, 5, 7–10, 12, and 13 are obvious under 35 U.S.C. § 103 over Blau, Simell, and 2010/0008859 A1 (the '859 Publication); and claims 3, 6, 11, 14, and 15 are obvious under 35 U.S.C. § 103 over Blau, Simell, the '859 publication, and Saul W. Brusilow et al., Treatment of Episodic Hyperammonia in Children with Inborn Errors of Urea Synthesis, 310 NEW ENGLAND JOURNAL OF MEDICINE 1630–34 (1984). View the decision here.

Related Matters: According to the petition, the '559 patent is the subject of litigation in the District Court for the District of New Jersey captioned Horizon Therapeutics, Inc v. Lupin Ltd. et al, Case No. 1:15-cv-07624 as well as Horizon Therapeutics, Inc. v. Par Pharmaceutical, Inc., Case No. 1:16-cv-03910-RBK-JS, also in the District of New Jersey. The petition also states that U.S. Patent No. 8,404,215, which issued from the parent application of the '559 patent, was the subject of IPR2015-01127, filed by Par Pharmaceutical, Inc., and IPR2016-00284, which was instituted and joined with the IPR2015-01127 proceeding.

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