Tag Archives: Written Description

35 U.S.C. 112 SPECIFICATION. (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

Omitted Elements and Written Description: Federal Circuit’s Split Decision in Allergan v. Sun Pharma

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by Dennis Crouch

I previously wrote about Allergan USA, Inc. v. MSN Laboratories Private Ltd. (Sun Pharma), No. 24-1061 (Fed. Cir. Aug. 13, 2024), focusing on Federal Circuit's about-face on obviousness-type double patenting.  My original post skipped over an important aspect of the opinion: the court's 2-1 decision favoring the patentee on the written description requirement of 35 U.S.C. § 112(a).  This portion of the case focuses once again on when an element is "essential" to the invention and therefore required in the claims.

Four key takeaways:

  1. We presume that no element is "essential."
  2. Courts should look for indications in the patent documents that the feature is critical, essential, etc.
  3. The court here relied upon broad claims in the priority filing that were later deleted in order to show the inventor possessed embodiments that did not require the element.
  4. The key focus for written description is comparing the specification with the claims.  Although expert testimony may be relevant, it must be directly tied to the intrinsic record.

All of these elements point to the idea that it is the job of the patent drafter and prosecutor to ensure the written description is sufficient, and to avoid pitfalls that might indicate otherwise.

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USPTO ARP Panel Restores MPF Sanity, but Still Rejects Xencor’s Claims

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by Dennis Crouch

In a new Appeals Review Panel (ARP), the USPTO has clarified the Office's position on means plus function claims -- explaining that the specification need not describe statutory equivalents to satisfy the written description requirement.  The outcome here shows value for the intentional use of means-plus-function limitations as a mechanism for expanding patent scope when genus claims are otherwise unavailable.

Still the court maintained the written description rejection on other grounds -- finding that the broad preamble "method of treating a patient" to be limiting and not adequately supported by the specification.  Perhaps on remand the patentee will amend the preamble to instead claim a "means of treating a patient." 

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What is Next for Enablement and Written Description of Antibody Claims?

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by Dennis Crouch

I had been following the case of Teva v. Lilly for a few years.  Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. U.S. Patent Nos. 8,586,045, 9,884,907 and 9,884,908.  The patents cover Teva's drug Ajovy, and allegedly cover Lilly's Emgality. Both drugs were approved by the FDA in September 2018.  A Massachusetts jury sided with Teva and awarded $177 million in damages, including a controversial future-lost-profit award.

Although the jury sided with Teva, District Judge Allison Burroughs rejected the verdict and instead concluded that Teva's patent claims were invalid as a matter of law for lacking

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First Amendment Finally Reaches Patent Law

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The big news from Intellectual Ventures v. Symantec (Fed. Cir. 2016) is not that the court found IV's content identification system patents invalid as claiming ineligible subject matter.  (Although that did happen). Rather, the big event is Judge Mayer's concurring opinion that makes "make two points: (1) patents constricting the essential channels of online communication run afoul of the First Amendment; and (2) claims directed to software implemented on a generic computer are categorically not eligible for patent."

Read Judge Mayer's opinion in full:

MAYER, Circuit Judge, concurring.

I agree that all claims on appeal fall outside of 35 U.S.C. § 101. I write separately, however, to make two points: (1) patents constricting the essential channels of online communication run afoul of the First Amendment; and (2) claims directed to software implemented on a generic computer are categorically not eligible for patent.

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