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  • FCBA Program Patent Litigation

    Federal Circuit Bar AssociationThe 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

    MBHB Logo 2McDonnell 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

    By John Cravero and Richard Martin —

    USPTO SealAbout 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.

  • PTAB Update — Patent Office Proposes Rule Amendment to Recognize Patent Agent-Client Privilege

    By Andrew Williams —

    USPTO SealWhen Congress created the post-issuance proceedings before the Patent Trial and Appeal Board as part of the Leahy-Smith America Invents Act ("AIA"), it did so with the recognition that they would be adjudicatory in nature.  It was with this understanding that the Patent Office promulgated rules making the Federal Rules of Evidence applicable to these proceedings.  See 37 C.F.R. § 42.62(a).  This of course meant that the attorney-client privilege could be asserted by licensed attorneys practicing before the Board.  Unfortunately, this also created a dilemma for patent agents and their clients.  On the one hand, patent agents are able to represent petitioners and patent owners before the Board, but on the other hand, there was no indication that their communications with their clients would be protected by the privilege.  In view of this background, the Patent Office published a Notice of Proposed Rule Making on October 18, 2016.  Specifically, the Office proposed to amend the rules of practice before the PTAB "to recognize that, in connection with discovery conducted in certain proceedings at the [USPTO], communications between U.S. patent agents and foreign patent practitioners and their clients are privileged to the same extent as communications between clients and U.S. attorneys."  81 Fed. Reg. 71,653 (Oct. 18, 2016).  This new rule would not only apply to IPRs, PGRs, and CBMs, but would also apply to derivation proceedings.  The comment period closes on December 19, 2016.

    The rule proposed by the Office seeks to add 37 C.F.R. § 42.57, entitled "Privilege for patent practitioners," which would read:

    (a) Privileged communications.  A communication between a client and a domestic or foreign patent practitioner that is reasonably necessary or incident to the scope of the patent practitioner's authority shall receive the same protections of privilege as if that communication were between a client and an attorney authorized to practice in the United States, including all limitations and exceptions.

    (b) Definitions.  The term ''domestic patent practitioner'' means a person who is registered by the United States Patent and Trademark Office to practice before the agency under section 11.6.  ''Foreign patent practitioner'' means a person who is authorized to provide legal advice on patent matters in a foreign jurisdiction, provided that the jurisdiction establishes professional qualifications and the practitioner satisfies them, and regardless of whether that jurisdiction provides privilege or an equivalent under its laws.

    This proposed rule ultimately emerged from a roundtable held by the Patent Office in February 2015, during which comments on attorney-client privilege issues were solicited.  The responses that the Office received unanimously supported a rule recognizing this privilege.  Subsequently, when the Patent Office published proposed rule amendments before the PTAB in August 2015 (see "PTAB Finally Proposes Rule Amendments: The More Things Change . . ."), it included a request for comments on the subject of attorney-client privilege or other limitations on discovery in PTAB proceedings.  The Office received responses that "overwhelmingly favored" such a rule, with commentators noting that the rule would lead to clarity and consistency, and could serve to reduce uncertainty and discovery costs.

    This proposed rule, of course, comes on the heels of the In re Queen's University at Kingston case, in which the Federal Circuit clarified that communications between a patent agent a client were privileged in federal court when the patent agent acts within the scope of their authorized practice.  The Office pointed out in the Notice that when privileges vary across jurisdictions, it can "lead to administrative inefficiencies and inconsistencies in outcome . . . ."  The Office believes that this rule "would improve public understanding of how privilege questions are decided before PTAB, and would help further judicial economy by providing PTAB judges with a clear, concise statement of when privilege applies."

    To be clear, this rule would only apply when the practitioner performs legal work he or she is authorized to practice.  For example, the Notice makes clear that "communications between clients and U.S. patent agents relating to patent application matters would be protected as privileged under the rule, but communications between these parties regarding litigation strategies would not be protected."  Nevertheless, the Office believes the rule can apply to communications from in-house counsel performing the functions of a patent attorney, even in jurisdictions that do not grant in-house counsel privilege-type protections.

    Comments should be sent to acprivilege@uspto.gov, but they can also be submitted via U.S. mail at: Mail Stop OPIA Director of the United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, attn: "Soma Saha, Patent Attorney, Patent Trial Proposed Rule on Privilege."  Again, the comment period closes on December 19, 2016.

  • Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc. (Fed. Cir. 2016)

    By Kevin E. Noonan —

    MIT SealThe Federal Circuit recently affirmed a district court's claim construction and determination that claim terms were not indefinite in Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc.

    The case involved U.S. Patent Nos. 5,770,193 and 5,759,830, directed to three-dimensional scaffolds for growing cells in vitro for in vivo organ culture.  In the prior art, in vitro cell growth for in vivo organ culture was performed using either permanent synthetic polymer scaffolds or biodegradable scaffolds (the latter being comprised typically of collagen).  The limitations of the prior art included the permanence of the scaffold in the former and variability in degradation of the collagen scaffold.  Prior art scaffolds were also unsuitable for solid organs (liver, pancreas) due to limited diffusion into inner organ cells and resulting cell death.

    Shire PharmaceuticalsThe scaffolds of the '193 and '830 patents promoted vascularization that overcame the diffusion problem in the art, with the specification reciting that the scaffolding "must be 'shaped to maximize surface area to allow adequate diffusion of nutrients and growth factors to the cells.'"  The scaffolds of these patents permitted "a variety of organs, including skin, liver, kidneys, blood vessels, nerves, and muscles which functionally resemble the naturally occurring organ" to be produced.

    Claim 1 is representative and illustrates (in italics) the claim terms at issue:

    1.  A cell-scaffold composition prepared in vitro for growing cells to produce functional vascularized organ tissue in vivo, comprising:
        a fibrous three-dimensional scaffold composed of fibers of a biocompatible, biodegradable, synthetic polymer; and
        cells derived from a vascularized tissue attached in vitro to the surface of the fibers of the scaffold uniformly throughout the scaffold;
        wherein the fibers of the scaffold provide sufficient surface area to permit attachment in vitro of an amount of the cells effective to produce the functional vascularized organ tissue in vivo; wherein the fibers of the scaffold are spaced apart such that the maximum distance over which diffusion of nutrients and gases must occur through a mass of cells attached to the fibers is between 100 and 300 microns; and
        wherein the diffusion provides free exchange of nutrients, gases and waste to and from the cells uniformly attached to the fibers of the scaffold and proliferating throughout the scaffold in an amount effective to maintain cell viability throughout the scaffold in the absence of vascularization.

    It was undisputed that Shire's accused infringing product, Dermagraft®, was "seeded with connective tissue cells called fibroblasts to grow the dermis (or inner) layer of skin for "the treatment of full-thickness diabetic foot ulcers."  And:

    After seeding onto the Dermagraft® scaffold, "[t]he fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells."  Id.  The fibroblasts attach to the top, bottom, and sides of the fibers of the mesh scaffolding that, after implantation, is gradually absorbed by the surrounding tissue.

    Shire argued that prosecution history disclaimer applied to the claim terms "vascularized organ tissue" and "cells derived from a vascularized tissue."  In particular, Shire pointed to changes in claim language necessitated by prior art rejections and declarations by the named inventors, including assertions regarding "the design of a polymer scaffold which provides adequate sites for attachment and growth of enough cells to survive and function in vivo yet does not limit survival and growth of cells adjacent to the matrix surface as cells increase in number in vitro."  The claims were granted after further extensive amendment and argument to recite the allowed claims.

    The District Court rejected Shire's contention that, in view of statements during prosecution distinguishing the prior art on the grounds that said art was limited to skin grafts (based on the thickness limitations in the art), MIT's claims should be limited to non-skin organs with regard to both the terms at issue ("vascularized organ tissue" and "cells derived from a vascularized tissue").  The District Court also rejected Shire's assertions that the term "three-dimensional scaffold" was indefinite.  The District Court found the asserted claims of the '193 and '830 patents were not invalid and were infringed on stipulated final judgment.

    The Federal Circuit affirmed, in an opinion by Judge Stoll, joined by Judges O'Malley and Chen; Judge O'Malley filed a concurring opinion.  Consistent with recent Federal Circuit precedent (Avid Tech., Inc. v. Harmonic, Inc., 812 F.3d 1040, 1045 (Fed. Cir. 2016), quoting Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1359 (Fed. Cir. 2003), and citing Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003)), the panel asserted that the standard for prosecution disclaimer was a stringent one, requiring such disclaimer to be "clear and unmistakable," citing Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1063–64 (Fed. Cir. 2016).  With regard to the claim term "vascularized organ tissue," the District Court construed the term to include skin on the basis that the ordinary meaning of the word "organ" would include skin and that there was no clear and unmistakable disclaimer of this scope in the prosecution history.  The District Court also found, and the Federal Circuit agreed, that this use of the term was consistent with how the term was used in the '193 and '830 patent specifications.  (More tellingly, the District Court found that this interpretation of the term was consistent with the parties' Joint Technology Tutorial, which was provided to the District Court as "background" during claim construction.)  Neither the District Court nor the Federal Circuit was convinced by Shire's arguments to the contrary, which the panel opinion characterized as relying on "a single sentence" from an interview summary of the priority patent that ultimately resulted in the '193 and '830 patents, regarding claims that did not recite the "vascularized organ tissue" language.  "Reading the selected sentence in the context of the entire summary and the claim terms then at issue reveals that MIT emphasized the structure of the invention's scaffold, not the type of organ it can be used to grow," according to the panel opinion.  Also unavailing was Shire's citation of statements in an inventor (Dr. Vacanti) declaration, which the District Court found were not made to distinguish the claimed invention from prior art skin grafts but rather to emphasize the diffusion-related advantages of the claimed invention.  "In the context of the overall prosecution history, the isolated statements plucked from Dr. Vacanti's declaration do not meet the high standard for prosecution disclaimer to attach," according to the Court.

    Both the District Court and the Federal Circuit were further convinced that the claims did not disclaim skin as an artificial organ falling within the scope of the claims because MIT attempted during prosecution to include this limitation but the Examiner rejected the amendment as being new matter (wherein thereafter MIT never reintroduced this limitation).  Relevant to this argument was also the fact that the claims at issue at that time contained an express organ thickness limitation and that the statements cited by Shire were used in relation to those limitations (which were not in the claims that issued in either the '193 or '830 patents).

    With regard to the District Court's construction that the claim term "cells derived from a vascularized tissue" comprise both parenchymal and non-parenchymal cells, the Federal Circuit first noted that "[t]he claims themselves do not distinguish between parenchymal and non-parenchymal cells."  Further, even Shire's expert admitted that bone-forming cells (which are a type of parenchymal cells) fell within the scope of the '193 and '830 patent claims.  In addition to this "plain meaning" interpretation, the Court found that the specification(s) of these patents were consistent with the District Court's construction.  As with Shire's earlier arguments (regarding the ""vascularized organ tissue" term), the Court found the arguments related to parenchymal versus non-parenchymal cells were not supported by Shire's citation to portions of the prosecution history, and that a skilled worker "would not read MIT's statement made during prosecution of [a related] patent—and directed to very different claim language—as limiting the term 'cells derived from a vascularized tissue' to parenchymal cells."

    Finally, the Federal Circuit reviewed the District Court's determination that the term "three-dimensional scaffold" was not indefinite.  Citing Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014), the opinion affirmed the District Court's construction according to the plain meaning of the words "three-dimensional" and the Court's reliance on a dictionary definition in rendering its decision.  In addition, the panel opinion stated, this "plain meaning" definition was supported by Shire's own expert.

    Judge O'Malley concurred to address the question of whether the District Court's judgment was "final" (and thus ripe for appeal) without a determination of damages and the question of willful infringement.  According to Judge O'Malley, "[i]n Robert Bosch, LLC v. Pylon Manufacturing Corp., 719 F.3d 1305 (Fed. Cir. 2013) (en banc), we created a broad jurisdictional rule that excepts this court from the rules of finality followed by every other Article III court of appeals" in its interpretation of 28 U.S.C. § 1292(c)(2).  This interpretation, in addition to being contrary to the interpretation of the statute by all other circuits (and producing another special rule for patent cases disfavored by the Supreme Court), is contrary to "a strong congressional policy against piecemeal reviews, and against obstructing or impeding an ongoing judicial proceeding by interlocutory appeals."  It also results, according to Judge O'Malley, in disruption of district court proceedings and encourages "piecemeal" litigation practices, contrary to the Supreme Court's interpretation of the statute in other contexts.  Flanagan v. United States, 465 U.S. 259, 263–64 (1984).

    Massachusetts Institute of Technology v. Shire Pharmaceuticals, Inc. (Fed. Cir. 2016)
    Panel: Circuit Judges O'Malley, Chen, and Stoll
    Opinion by Circuit Judge Stoll; concurring opinion by Circuit Judge O'Malley

  • Intellectual Ventures I LLC v. Symantec Corp. — Judge Mayer on the First Amendment

    By Michael Borella and George Lyons III —

    Decided September 30th, this Federal Circuit case is already making waves.  The majority opinion seems to be at tension with the Court's outcome in BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC, but the real attention-grabber is Judge Mayer's concurrence.  Therein, he argued that claims such as those under review were at odds with the First Amendment, and then reiterated his position that software is not patent eligible.  Here, we discuss his position on the intersection of patents and the First Amendment.

    Three patents owned by Intellectual Ventures (IV) were the subject of this dispute.  As an example, claim 1 of U.S. Patent No. 5,987,610 recites:

    1.  A virus screening method comprising the steps of:
        routing a call between a calling party and a called party of a telephone network;
        receiving, within the telephone network, computer data from a first party selected from the group consisting of the calling party and the called party;
        detecting, within the telephone network, a virus in the computer data; and
        in response to detecting the virus, inhibiting communication of at least a portion of the computer data from the telephone network to a second party selected from the group consisting of the calling party and the called party.

    In short, the claim is directed to detecting a computer virus in communications between two parties, and inhibiting the communication containing the virus.

    Putting eligibility issues aside for a moment, Judge Mayer wrote that "patents constricting the essential channels of online communication run afoul of the First Amendment."  In his view, "[p]atents, which function as government-sanctioned monopolies, invade core First Amendment rights when they are allowed to obstruct the essential channels of scientific, economic, and political discourse."

    Citing the '610 patent as particularly pernicious in this regard, Judge Mayer was concerned that its claims "could reasonably be read to cover most methods of screening for harmful content while data is being transmitted over a network."  Notably, he concluded that "[e]ssential First Amendment freedoms are abridged when the Patent and Trademark Office ("PTO") is permitted to balkanize the Internet, granting patent owners the right to exact heavy taxes on widely-used conduits for online expression."

    According to Judge Mayer, the judicial exceptions to 35 U.S.C. § 101 "create[] a 'patent-free zone' and place[] within it the indispensable instruments of social, economic, and scientific endeavor."

    Thus, the Judge advocated that "Section 101, if properly applied, can preserve the Internet's open architecture and weed out those patents that chill political expression and impermissibly obstruct the marketplace of ideas."

    Where to start?

    The First Amendment has two basic applications.  First, laws that put unreasonable limits on speech may be determined to be unconstitutional under the First Amendment.  Second, acts of government entities that similarly restrict speech can violate First Amendment rights.  But the right to free speech is not absolute.  For example, it is often acceptable to place reasonable time, place, and manner restrictions on certain types of speech (the oft-cited shouting "Fire!" in a crowded theater).

    From the outset, it is worth noting that a patent is neither a law nor an act.  Instead, it is a legal, time-limited monopoly over a specific invention.  Patents are not a right to practice such an invention — they provide the right to exclude others from practicing the invention.  Thus, a patent covering a method for restricting communication does not imply that the method has to be carried out by the patentee or any other party.  Instead, the patentee has the ability to prevent others from restricting communication in accordance with what is claimed.

    While U.S. patents are granted and enforced by the U.S. Federal government, any acts that occur in accordance with a claimed invention are those of the patent owner or its licensee.  To the extent that such an entity is a private party, any restriction to communication that might occur due to practicing claims like those of the '610 patent would not be that of the government.

    Further, the act of restricting communications by private parties is commonplace.  In most networking environments, there are firewalls that filter traffic to and from the Internet.  Similar firewalls are often deployed on computers within the network, along with spam filters on incoming emails.  The existence of patents on such technologies is unlikely to change these facts.

    Indeed, technology restricting communication has a fundamental and critical role in today's networking infrastructure — it keeps unwanted parties from improperly attaining certain types of information, and limits the amount of nuisance communications to which one is subjected.[1]  Without such technology, the ability for individuals and organizations to maintain trade secrets may be impeded.  Despite Judge Mayer's concern for preservation of the open Internet architecture, communication restriction technologies have served to make the Internet safer for speech, business, research, and e-commerce.

    Another way of looking at how communication patents intersect with the First Amendment, however, is by noticing that a patent's very existence may actually serve to discourage limiting speech.  Specifically, the issuance of a patent on a communication restriction technology may foster the marketplace of ideas for similar technologies.  Once they are revealed to the public, researchers and engineers may be influenced by the ideas set forth in a patent to improve on those ideas with ideas of their own.  Some of these improvements may be workarounds or otherwise non-infringing variations.  And, as Judge Mayer recognized in his concurrence, the correlation between these improvements and the patent's existence is no new revelation — for our courts or patent practitioners.  As just one example, Judge Mayer cited the Supreme Court's 1853 opinion in O'Reilly v. Morse for just this proposition:  "patent protection promotes, rather than impedes, 'the onward march of science,' . . . allowing technological innovation to proceed apace."

    In fact, despite the existence of patents of telecommunication technologies, telecommunications has reached a point where access to information has never been easier or more widespread.  Thus, a strong patent system is not inconsistent with the rapid dissemination of Mayer's "social, economic, and scientific endeavor[s]."  For the sake of argument however, we will turn to the merits of Judge Mayer's concerns.

    As noted above, First Amendment rights are important, yet limited.  That statement is not disputable.  Identifying and defining the boundaries of these rights, however, is another question entirely — one that is incredibly complicated.  Even though the First Amendment has been in existence for over 200 years, the Fifth Circuit recently noted that there are few areas of the law as "abstruse, complicated, [or] subject to great debate among jurists."  Thus, to ponder its restrictions in a vacuum would be to ponder an over-generalized misconception.

    Instead, determining the bounds of any restriction involves determining the distinct case law surrounding:  1) what type message is being conveyed (e.g., political speech, commercial speech, school-related speech, religious speech, obscene speech, speech that is critical of the government, speech that defames another, etc.); 2) who is conveying the message (e.g., a private individual, the press, governmental employees, anonymous figures, etc.); and 3) where/when/how the speech is being conveyed (e.g., historically public forums, limited and non-public forums, during the day, late at night, by one individual or an assembly, the scope of the speech, etc.).  Then, once these questions are properly answered, the court must also determine why the limitation is being imposed and employ the appropriate legal deference accordingly (e.g., content-based restrictions are often reviewed under strict scrutiny — they must be narrowly tailored to accomplish a compelling governmental interest, while content-neutral restrictions are often reviewed under intermediate scrutiny — they must be no greater than necessary to further a substantial government interest).

    The problem, however, is not just that Judge Mayer suggests some interaction between these two bodies of well-trodden jurisprudence (patent law and the First Amendment), but does so without providing any firm legal nexus between the two or suggesting how to navigate the morass of confusion invoked by the comparison.  For example, is Judge Mayer suggesting that the property rights afforded to individuals who own communication patents are, themselves, imposing a burden on the First Amendment rights of others?  Or, is this alleged burden attributable to the government, because it was responsible, per the PTO, for imposing such a burden on these First Amendment rights?  Moreover, are these burdens or restrictions content-neutral or conduct-neutral?  Is there a subset of First Amendment jurisprudence that can be analogized to patent monopolies on communication technologies (and the restrictions or burdens arising therefrom)?  Should courts borrow or incorporate some portion of the case law surrounding such a subset of First Amendment jurisprudence (assuming it exists), or create an entirely new standard or test to fill in this jurisprudential gap?  Should courts do any of this without any guidance or suggestion from the Federal Circuit or the Supreme Court?

    Looking to Judge Mayer's concurring opinion, there is no way of knowing because he does not provide any answers, nor does he even properly frame the question.  Instead, he asserts a robustly overgeneralized statement — "patents constricting essential channels of online communications run afoul of the First Amendment" — and moves on to other topics.

    It would be easy to attribute such statements to activism, or the byproduct of allowing concurrences in judicial opinions generally.  But this type of results-oriented judicial vagueness is a form of dangerous reasoning — especially when it implicates, but does not acknowledge, the intricacies of navigating the case law surrounding such a fundamental constitutional right.  And, to illustrate the dangers of this type of reasoning, and such cursory legal analysis generally, two points are worth considering.

    First, consider the parade of horribles that could follow from asserting this type of bald jurisprudential correlation.  For example, under Judge Mayer's view, would a patentee be implicated in cases where their protected device, system, or method surrounding an emerging technology was used to violate someone's Fourth Amendment rights?  Alternatively, would patents aimed at increasing the efficiency of firing mechanisms in a firearm (see, e.g., U.S. Pat. No. 3,250,034) implicate the Second Amendment?  Would patents aimed at allowing only one specifically-identified person to engage the trigger of a firearm (see, e.g., U.S. Pat. No. 5,953,844) implicate the same?  Looking to the specific legal analysis and guidance provided by Judge Mayer's concurrence, one can't help but surmise — as the advertisers for Tootsie Pop once quipped — "The world may never know!"

    This lack of clarity, however, leads to a second, and perhaps more concrete, danger.  Specifically, it is no secret that district courts rely on appellate courts to provide guidance for interpreting complex and unresolved legal issues; or, as Judge Mayer correctly identified in his concurrence:  "Article III courts," such as the one on which he sits, "do not render advisory opinions."  Moreover, in the wake of Alice Corp. v. CLS Bank Int'l, it is hard to imagine a more unsettled landscape for courts interpreting patent cases than the issues that arise under § 101 pertaining to software patents.  Thus, while not precedential or controlling, Judge Mayer's concurring opinion — and the conclusory First Amendment analysis contained therein — may carry weight in the district courts throughout the country.

    More problematic, however, is the realization that Judge Mayer's suggestions for interpreting issues under § 101 in his previous concurrences (see, e.g., Ultramercial v. Hulu) have gained traction nationally, and have even become the standard for many district courts.  Thus, a dangerous possibility could arise from his concurrence in the present case — when determining a patentee's rights, district courts might take it upon themselves to analogize the "restrictions" imposed by communication patents to one of the almost endless subsets of the jurisprudence surrounding the First Amendment.  Undoubtedly, the conflicts and uncertainty arising from such a result would be extensive.  But all is not lost.

    In fact, before rallying the defenders of patent or constitutional law, wailing that patent law as we know it is over, or calling for Judge Mayer's retirement (all of which may be natural reactions for one who reads the concurrence), it is worth taking a step back and seeing Judge Mayer's foray into First Amendment jurisprudence for exactly what it is: a new pitch for a well-known product — his unwavering distaste for software patents under § 101.

    Indeed, immediately after outlining the dire straits of the First Amendment in the light of such patents aimed at communication methods, Judge Mayer wrote in his concurrence:

    Most of the First Amendment concerns associated with patent protection could be avoided if this court were willing to acknowledge that Alice sounded the death knell for software patents . . . [as] all software implemented on a standard computer should be deemed categorically outside the bounds of section 101.

    Thus, while unnerving, Judge Mayer's First Amendment commentary is more of a means to an end, rather than the end itself.  Accordingly, although this commentary may well provide fodder for legal scholars, law school exam hypotheticals, and robust debate within our profession, hopefully, it will not gain traction or appreciable application within the district courts.  At least not until the Federal Circuit, the Supreme Court, or Judge Mayer himself, provides some semblance of a workable model for his proposition.

    [1] The widespread distributed denial of service (DDOS) attacks that made a significant number of Internet services unreachable on October 21, 2016 is just one example of how a lack of the proper communication restriction technologies can impact tens of millions of individuals.

  • Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc. (Fed. Cir. 2016)

    Federal Circuit Denies Petition for Rehearing in Medtronic v. Robert Bosch Healthcare Systems

    By Kevin E. Noonan —

    Federal Circuit SealOne of the aspects of inter partes review that differed from other post-grant review proceedings before the Board of Patent Appeals and Interferences (succeeded by the Patent Trial and Appeal Board) is a requirement for transparency with regard to the "real party in interest":  unlike in ex parte reexamination, for example, the inter partes review provisions of the Leahy-Smith America Invents Act require that a petition for inter partes review identify the real party in interest.  35 U.S.C. § 312(a)(2).  One basis for this requirement is that the statute also contains provisions for a time bar for filing an IPR, which without transparency regarding the RPI would permit a time-barred party to hide behind a strawman petitioner in contravention of the statute.  All of these considerations came into play in Medtronic v. Robert Bosch Healthcare Systems, in which a Federal Circuit panel denied Medtronic's Petition for Rehearing of its decision that it could not review the PTAB's discontinuance of IPR proceedings under 35 U.S.C. § 314(d).

    The basis of Medtronic's petition is the Supreme Court's decision in Cuozzo Speed Technologies, LLC v. Lee, which issued after the original panel decision.  The parties were involved in district court patent infringement litigation over U.S. Patent Nos. 7,769,605 and 7,870,249 owned by Bosch, and a Medtronic subsidiary (Cardiocom LLC) petitioned for IPR which was denied by the PTAB, for failure to show "a reasonable likelihood that any of the challenged claims was unpatentable on the grounds asserted."  Thereafter, Medtronic itself filed its own three petitions for review of the same patents and named Medtronic as the RPI.  Initially, the Board denied Bosch's motion that the petitions should be refused because Medtronic had not properly identified Cardiocom as the RPI; doing so would have implicated the time bar of § 315(b).  However, after permitting Bosch to seek additional discovery on the RPI identity, the Board granted Bosch's motions to dismiss, being "persuaded [by the collective evidence] that Medtronic [was] acting as a proxy for Cardiocom" (this evidence including that "Cardiocom's senior executives communicated with Medtronic while Medtronic's petitions were being prepared, and that Cardiocom paid a portion of the fees for preparing Medtronic's petitions).

    The initial panel decision dismissed Medtronic's appeal of the Board's decision to discontinue the IPRs, based on its opinion that the statute prohibited Federal Circuit review of institution decisions (and decisions whether to continue an IPR once instituted).  Medtronic petitioned for rehearing and the Court withdrew its mandate in order to review its decision in view of the intervening Supreme Court's Cuozzo decision.  In denying Medtronic's petition for rehearing, the Court once again finds review precluded by § 314(d) of the statute.  Citing the Cuozzo opinion's language that "§ 314(d) operates to bar review in cases where the challenge 'consist[s] of questions that are closely tied' or 'closely related' to 'the application and interpretation of statutes related to the Patent Office's decision to initiate inter partes review,'" the panel held that a decision to institute an IPR and a decision whether to continue an IPR once instituted (which the panel calls "reconsideration") are both barred by the statute.  Citing  Husky Injection Molding Sys. Ltd. v. Athena Automation Ltd., No. 15- 1726, 2016 WL 5335500, at *6 (Fed. Cir. Sept. 23, 2016), the panel held that "[i]t is difficult to conceive of a case more 'closely related' to a decision to institute proceedings than a reconsideration of that very decision and "[i]t would be strange to hold that a decision to institute review would not be reviewable but a reconsideration of that decision would be reviewable."  Moreover, considering that the PTAB's decision was predicated on failure of the petitioner to comply with § 312(a)(2), the panel determined that the Board's decision to discontinue is "fairly characterized" as a decision whether to institute proceedings in the first place, thereby falling squarely within the ambit of  § 314(d).  And the panel cited Wi-Fi One, LLC v. Broadcom Corp., No. 15-1944, 2016 WL 4933298, at *4 (Fed. Cir. Sept. 16, 2016) (decided after Cuozzo) as involving institution questions in the context of a statutory bar (albeit involving assignor estoppel), wherein the opinion states that "[w]e rejected the same argument, now advanced by Medtronic, that the 'under this section' language of § 314(d) limits the bar on reviewability only to questions arising under § 314."

    The opinion also recognized that the Supreme Court's Cuozzo opinion reserved constitutional questions (e.g., due process concerns) or that the PTO exceeded its statutory authority (e.g., deciding unpatentability for failure to satisfy § 112) from the scope of its decision regarding Federal Circuit unreviewability.  Regarding Medtronic's challenge under this latter reservation, the opinion relies on the Board's authority under § 318(a) to dismiss an IPR after it has been instituted as well as the principle that  "administrative agencies possess inherent authority to reconsider their decisions, subject to certain limitations, regardless of whether they possess explicit statutory authority to do so," citing Tokyo Kikai Seisakusho, Ltd. v. United States, 529 F.3d 1352, 1360 (Fed. Cir. 2008).  And the panel saw no "colorable constitutional issue" that would invoke this reservation of the Supreme Court's Cuozzo opinion.

    Finally, the panel found that Medtronic was not entitled to a writ of mandamus, insofar as its petition could be considered to request such a writ.

    It is clear that the Federal Circuit believes Congress ceded institution decisions and all ancillary procedural questions to be within the unreviewable purview of the PTAB under the PTO's statutory authority and that the Supreme Court's Cuozzo decision indicates that the Court concurs.  While it is possible that Medtronic could ask the entire Court to grant en banc review, a more fruitful approach might be to have Congress change the law (if they can make a convincing argument that the Office has interpreted the statute contrary to its intentions).

    Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc. (Fed. Cir. 2016)
    Panel: Circuit Judges Lourie, Dyk, and Hughes
    Opinion by Circuit Judge Dyk

  • Conference & CLE Calendar

    CalendarOctober 24, 2016 – "Decoding the Framework of Double Patenting: Legal Issues and Insights Uncovered!" (The Knowledge Group) – 3:00 to 5:00 pm (EST)

    October 27, 2016 – "Markman Hearing Strategies, Claim Construction in a Post-AIA PTAB Environment and the Impact of Recent SCOTUS Decisions" (Strafford) – 1:00 to 2:30 pm (EDT)

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

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

  • Webinar on Avoiding Alice Rejections

    LexisNexisLexisNexis will be offering a webinar/teleconference entitled "How to Engineer Your Application to Avoid Alice Rejections" on November 3, 2016 at 2:00 pm (EST).  JiNan Glasgow of NeoPatents and Gene Quinn of IPWatchdog.com will look at what top companies are doing to be successful at overcoming Alice rejections.  The webinar will review the following issues:

    • Reviewing the Big 4 Blockbuster Eligibility Cases — Enfish, TLI Communications, BASCOM, and McRO;
    • A Roadmap Emerges — What the big 4 cases teach about drafting software patents; and
    • Art Unit Assignments — How to cope with being unexpectedly assigned to an Art Unit.

    Those interested in registering for the webinar, can do so here.

  • Webinar on Patent Prosecution and Defeating Abstractness

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Prosecution and Defeating Abstractness: Minimizing the Risk of Sect. 101 Rejection — Lessons From Recent Federal Circuit Court Decisions" on November 1, 2016 from 1:00 to 2:30 pm (EDT).  Joseph M. Casino of Wiggin and Dana, Stephen A. Marshall of Fish & Richardson, and James L. Reed of Squire Patton Boggs will examine recent Federal Circuit decisions on patent eligibility for software, and discuss the Court's different approaches and offer best practices for demonstrating patent eligibility.  The webinar will review the following issues:

    • How are the courts applying the framework for patent eligibility created in Alice?
    • What guidance can be gleaned from the Federal Circuit’s decisions in Enfish, BASCOM, DDR Holdings, Rapid Litigation and McRo?

    • What are best practices for patent counsel to avoid patent-eligibility issues?

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