New Annual Update: Critical Patent Validity Developments in 2017-2018

This is a guest post from the Chisum Patent Academy.

The Academy is pleased to announce the September 2018 publication by Wolters Kluwer Law & Business of the annual Update for Volume I (Patentability and Validity) of the practitioner treatise, Mueller on Patent Law, authored by our co-founder, Janice M. Mueller. See below to review the Highlights.

First published in 2012 and updated annually, Volume I of the Mueller treatise addresses patentability (pre- and post-AIA), drafting patent claims, inventorship, and USPTO prosecution procedures; Volume II covers patent infringement, defenses, remedies, USPTO post-issuance procedures, design patents, and international patenting issues.

The full text of both volumes, including the 2018 Update for Volume I (Patentability and Validity), is available electronically on Wolters Kluwer’s CHEETAH legal research platform.

To review the detailed table of contents incorporating the 2018 Update for Volume I (Patentability and Validity), click here.

Highlights of the September 2018 Annual Update (Patentability and Validity):

  • The debate continues over what “means” means in patent claims. The Federal Circuit’s June 2018 decision in Zeroclick LLC v. Apple Inc. reached a contrary conclusion from that obtained in two other Circuit decisions, Welker Bearing (2008) and Williamson (2015). In Zeroclick, the Circuit vacated the Northern District of California’s judgment of invalidity and held challenged claims that did not use the word “means” were not 35 U.S.C. §112, sixth paragraph means-plus-function claims. The district court’s determinations were “couched in conclusory language” and it had “legally erred by not giving effect to the unrebutted presumption [under Williamson] against the application of §112, ¶ 6.” By taking its conclusory approach, the district court had effectively treated the claim terms “program” and “user interface code” as “nonce words” (i.e., coined for one particular situation or use), treating the nonce words as substitutes for “means,” thus bringing the disputed elements within the ambit of §112, sixth paragraph. In so doing the district court had erred for at least three related reasons. See §2.05[A].
  • Determining §101 patent-eligibility under the two-step Mayo/Alice framework continued to bedevil Federal Circuit jurisprudence in 2017-2018. The appellate court affirmed a number of district court dismissals on the pleadings because the patents in suit claimed abstract ideas and failed to implement an “inventive concept” sufficient to transform them to patent-eligible subject matter. See §3.02[D][4][e][ii].
  • On the pro-eligibility side of the ledger, one of the most important 2017-2018 cases was Vanda Pharms. Inc. v. West-Ward Pharms,, Int’l Ltd., an April 2018 split panel decision. In an opinion authored by Judge Lourie, the Circuit majority affirmed the District of Delaware’s holding that the claimed method of treating patients suffering from schizophrenia was patent-eligible under 35 U.S.C. §101. Unlike the claims held patent-ineligible by the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the claims in Vanda concerned a specific method of treating a specific disease, not merely a diagnostic method based on natural relationships. See §3.02[E][3].
  • A March 2018 Federal Circuit decision, Hologic, Inc. v. Smith & Nephew, Inc., provides a practical illustration of the written description of the invention requirement applied in its traditional priority-policing role. Notably, the patented invention in Hologic was a medical device (and its use), technology that the Circuit agreed was “predictable.” It affirmed the PTAB’s determination in an inter partes reexamination that the written description requirement was satisfied, allowing the patentee to claim priority to its published PCT application in order to remove it as intervening §102(b) prior art. The Hologic court applied the en banc 2010 Ariad decision’s “reasonably conveys” test to mean, at least in the case on review, that the priority disclosure need not necessarily or explicitly disclose (e.g., by depicting in drawings) every claim-recited element. See §6.06.
  • The Federal Circuit’s October 2017 decision in Amgen Inc. v. Sanofi made manifest the appellate court’s warning in its controversial 2014 AbbVie decision about the “inherent vulnerab[ility]” of certain functionally-defined genus claims. The Circuit in Amgen vacated the District of Delaware’s judgement based on a jury verdict that had sustained the validity of Amgen’s claims to a genus of monoclonal antibodies useful for treating patients with high cholesterol. The Circuit remanded the Amgen case for a new trial on written description, as well as enablement, based on its determination that the district court had erred in two different ways. See §6.07[G].
  • In February 2018, USPTO officials issued a memorandum to the agency’s Patent Examining Corps that implemented the Federal Circuit’s October 2017 Amgen decision discussed above. The memorandum instructed that in view of Amgen, the agency would no longer apply the “so-called ‘newly characterized antigen’ test” in examination for written description compliance of antibody claims. In other words, characterizing an antigen in detail does not equate to providing an adequate written description of the antibody to which it binds, even when making that antibody would be a routine matter for an art worker. See §6.07[G].
  • In its March 2017 decision, In re Chudik, the Federal Circuit reversed the PTAB’s determination that Chudik’s application claims were anticipated by two different prior art references. To find anticipation, the Board improperly distorted the teachings of each reference; in one case, “tearing the invention apart.” The Chudik decision clarifies that “[p]rior art that ‘must be distorted from its obvious design’ does not anticipate a new invention.” See §7.02[B][2][b].
  • When analyzing anticipation by inherency, the Federal Circuit holds that extrinsic evidence may be used to support what is “necessarily present” in a prior art reference’s teaching. That is, “[e]xtrinsic evidence ‘may be used to interpret the allegedly anticipating reference and [to] shed light on what it would have meant to [a PHOSITA].’” Notably, such evidence need not be prior art; that is, it need not antedate the claimed invention (or the allegedly anticipatory reference). The Circuit’s January 2018 decision in Monsanto Tech. LLC v E.I. DuPont de Nemours & Co. applies this holding. See §7.03[A][3].
  • In an important follow-on to 2004’s In re Klopfenstein, the Circuit again considered whether a limited distribution of materials at scientific conferences triggered the “printed publication” bar of 35 U.S.C. §102(b) (pre-AIA). The touchstone is “public accessibility,” as defined by the case law. The Circuit’s June 2018 decision in Medtronic v. Barry provides a thorough analysis of the case law and factors to be considered in determining whether such distributions create time-barring prior art. See §7.06[E][4][b].
  • One who contributes to the conception of an “essential element” of a claimed invention qualifies as a joint inventor. The Federal Circuit’s May 2018 decision in In re VerHoef provides a straightforward example. There the Circuit affirmed a “rare” (or at least uncommon) USPTO ex parte prosecution rejection under 35 U.S.C. §102(f) (pre-AIA) of all VerHoef’s pending application claims. Although the VerHoef’s application listed VerHoef as the sole inventor, he was indisputably a co-inventor with another (i.e., his pet’s veterinarian). Thus under §102(f), VerHoef “did not himself invent the subject matter sought to be patented” (emphasis added). Rather, the inventive entity was VerHoef plus another. Even though VerHoef was an inventor (albeit joint, not sole), the Circuit clarified that §102(f) requires USPTO examiners to reject applications when the facts show the named inventorship is improper. See §8.03[B][2][b].
  • In its May 2018 decision, In re Brandt, a Federal Circuit panel emphasized the importance of the prima facie case concept as a procedural aid to the USPTO in the initial stages of patent examination, explaining why it “makes sense” given the back-and-forth nature of the negotiation. The prima facie case provides an examiner with a procedural tool to aid her efforts to issue as patents “only those claims that meet the requirements of the Patent Act.” As in Brandt, the prima facie case is raised most frequently (though not exclusively) when nonobviousness is called into question. Importantly, the Brandt panel viewed the prima facie case as an evidentiary burden-shifting device applicable only in the initial stage of patent examination, not in later validity litigation. See §9.09[A].
  • Not all Federal Circuit judges agree with Brandt’s limitation on the scope of the prima facie case. The court’s cases are inconsistent concerning whether the prima facie obviousness burden-shifting framework, routinely used during examination in the USPTO, also applies in district court litigation challenging the validity of an issued patent. A new subsection of the treatise catalogues cases rejecting and approving burden-shifting in district court litigation. See §9.09[C].
  • A new subsection examines the nonobviousness requirement of 35 U.S.C. §103 in the context of overlapping ranges or variables. When a patent claim element under examination and a cited prior art reference contain numerical ranges or variables that are “close” but not overlapping, does this proximity create a case of prima facie obviousness? Not as a per se rule, according to the Federal Circuit. But in practical terms, a very small numerical difference may suffice as the basis for a prima facie obviousness rejection. The applicant would then be obliged to come forward with rebuttal evidence or argument. See §9.09[D].
  • “Incorporation by reference” is a drafting technique commonly used in preparing patent applications. It functions as a short-cut to incorporate into a “host” document (i.e., the patent application) material from other documents such as other applications, patents, and articles, e.g., information to satisfy the enablement and/or written description of the invention requirements of 35 U.S.C. §112, first paragraph, without actually reproducing the entire (sometimes excessively long) text of the material to be incorporated. In the Circuit’s February 2018 decision in Paice LLC v. Ford Motor Co., the court approved a disputed use of incorporation by reference to obtain an earlier priority date for challenged claims. See §11.02[C].
  • Because terminal disclaimers are usually filed to obviate obviousness-type double patenting rejections, the Federal Circuit has characterized them as a “strong clue” that the USPTO examiner, and by admission, the patent applicant, considered that the claims of the terminally disclaimed patent (e.g., issuing from a continuation application of a parent patent) lacked patentable distinction over the claims of the parent patent. Nevertheless, that “strong clue” does not create a presumption or operate as an admission that the terminally disclaimed claims are patentably indistinct or merely obvious variants of the parent patent’s claims. To determine their patentability, the claims of the terminally disclaimed patent must be analyzed substantively by comparing their scope with those of the parent patent, as well as any other relevant transactional facts. Because the Eastern District of Texas failed to carry out this analysis and improperly assumed that a terminally disclaimed patent was not patentably distinct from its parent patent, the Federal Circuit reversed it in the March 2018 decision, SimpleAir, Inc. v. Google LLC. See §12.09[C].

Upcoming 2019 Seminars

In 2019, the Chisum Patent Academy will offer two small-group seminars:

  • February 21-22, 2019 in Houston; and
  • August 8-9, 2019 in Seattle.

Our small group seminars always include topics that are timely and important to professionals engaged in patent prosecution, litigation, counseling, and licensing. We update our syllabus for each seminar to include latest developments and trends. We’ll kick off each seminar with a morning review of the latest “blockbuster” Supreme Court and en banc Federal Circuit decisions. Other topics will be determined as we draw nearer to the seminar dates, and we will keep you informed about those. Past seminar syllabi are here.

The small group format of the seminars led by treatise authors Donald Chisum and Janice Mueller allows an in-depth exploration of the implications of these decisions for patent prosecution, PTO post-issue proceedings, patent portfolio evaluation, counseling, licensing, and litigation.

For more information and registration, please visit our website or email

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