Patent Prosecution & Strategic Counseling

In our first blog in this multi-part series, we explored key considerations for protecting artificial intelligence (“AI”) inventions in biotech and synthetic biology. In this part 2 of the series, we will examine some key considerations and hurdles in patenting machine learning-based biotech or synthetic biology inventions.

The U.S. Patent Trial and Appeal Board (“PTAB”) recently designated its decision in Ex Parte HANNUN (Appeal 2018-003323) (“HANNUN”) as being informative regarding the application of the latest 2019 revised guidance on patent-eligible subject matter. 

As noted in our previous post, the U.S. Patent and Trademark Office (USPTO) published a request for comments for a list of questions regarding Artificial Intelligence (AI) Patent Issues in the Federal Register on August 21, 2019. While the comment period has closed, a few developments regarding AI patent issues have occurred that are particularly relevant.

On October 30, 2019, the Federal Circuit held that evidence of copying may be used to rebut an obviousness challenge, even if that evidence does not relate to the copying of a specific product.  (Liqwd, Inc. v. L’Oreal USA, Inc.; appeal from PGR2017-00012).

Artificial Intelligence (AI) inventions have aided development in nearly every industry, but perhaps none more so than synthetic biology. For synthetic biology researchers, AI has developed into a vital tool to create cutting edge applications.

Artificial Intelligence (AI) is increasingly becoming important across a diverse spectrum of technologies and businesses. As AI grows in importance in business and technology, so too grows the number of patent applications and the potential for uncertainty. Therefore, the U.S. Patent and Trademark Office (USPTO) must continue to ensure the appropriate balance in the administration of our IP system.

The Federal Circuit in Amgen Inc. v. Coherus Biosciences Inc. affirmed a district court decision that once certain subject matter is clearly and unmistakably surrendered during prosecution, the patentee is barred from asserting an infringement claim under the doctrine of equivalents.  

On July 30, 2019, the Federal Circuit held that retroactive application of IPR (inter partes review) proceedings to pre-AIA (America Invents Act) patents is not an unconstitutional taking under the Fifth Amendment (Celgene Corp. v. Peter; appeals from IPR2015-01096, IPR2015-01102, and IPR2015-01103).

Claim construction, the process by which a court interprets the scope and meaning of a patent’s claims, is a crucial part of patent litigation. In fact, claim construction can make or break a patentee’s case for infringement and/or validity.

In July 2019 the U.S. Patent Trial and Appeal Board (PTAB) newly designated four decisions as informative to highlight the PTAB’s general consensus on issues considered in these cases.  All four cases involve the PTAB applying the U.S. Patent and Trademark Office’s January 2019 guidance for determining subject matter eligibility under 35 U.S.C. § 101.  The decisions focus on whether claims integrate a judicial exception into a practical application so as to be subject matter eligible. 

The decision whether to issue a Restriction Requirement during patent prosecution lies with the patent examiner, not the patent applicant.  A Restriction Requirement can nevertheless trigger prosecution history estoppel that limits the scope of an applicant’s issued claim.  The Federal Circuit’s recent decision in UCB, Inc. v. Watson Laboratories Inc. helps show how this situation can happen and how applicants can help prevent an examiner’s decision from adversely affecting patent scope.

The Federal Circuit recently ruled that state sovereign immunity does not apply in Inter Partes Review (IPR) proceedings, closing another America Invents Act (AIA) loophole.  The case, Regents of the University of Minnesota v. LSI Corporation and Avago Technologies U.S. Inc. (Fed. Circ., 2018-1559), included the review of six Patent Trial and Appeal Board (PTAB) IPRs where the Regents of the University of Minnesota (UMN) filed motions to dismiss based on state sovereign immunity. 

Patent practitioners, inventors, in-house counsel, and patent examiners alike have been clamoring for more guidance on computer-implemented functional claim limitations invoking § 112(f) since the Federal Circuit’s en banc Williamson v. Citrix decision in 2015. To help answer some of those pleas, the U.S. Patent and Trademark Office (USPTO) published a Federal Register notice on January 7, 2019 to address issues under 35 USC § 112.

The intersection of artificial intelligence (AI) and intellectual property invokes fascinating theoretical questions.  With these questions, however, come significant practical issues that businesses, legal practitioners, and governments need to address proactively. Israel is embracing the challenge.

Andrei Iancu, the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, believes that the U.S. needs a strong patent system in order to excel and thrive in the global economy.  He has made strengthening the U.S. patent system a core part of his mission responsibilities. Director Iancu has been travelling across the country and speaking with various patent stakeholders. As part of this effort, he met with BIOCOM’s Board of Directors and Intellectual Property Committee in San Diego on April 18, 2019. 

We previously reported here on a Patent Trial and Appeal Board (PTAB) decision involving a case in which a patent eligibility rejection was overcome by replacing a “comparing” step with a recitation that the sample is from a particular patient population.  However, because the eligibility rejection was dropped by the examiner before appeal, the PTAB did not revisit the issue. 

The Federal Circuit’s decision in ATI Technologies ULC v. Iancu (April 11, 2019) highlights the proper standard to use in evaluating whether a claimed invention was reduced to practice before the effective date of a prior art reference.

The general rule is that a patent claim’s preamble does not limit the claim unless the preamble gives life, meaning, and vitality to the claim.  The Federal Circuit’s recent decision in Arctic Cat Inc. v. GEP Power Products, Inc. (March 26, 2019) considers the situation where a patentee wants a preamble to be a required claim limitation, unlike the more typical situation where a patentee does not want a claim preamble to be limiting, such as in Pacing Technologies v. Garmin International previously discussed HERE.  The court deciding in Arctic Cat that the preambles at issue were not required claim limitations highlights important considerations for patent application drafting and for crafting post-issuance arguments.

On January 23, 2019, the Federal Circuit decided Supernus Pharmaceuticals, Inc. vs. Iancu and shed light on Patent Term Adjustment (PTA).  PTA was established by the American Inventors Protection Act of 1999 and codified at 35 U.S.C. § 154(b), which defines three kinds of United States Patent and Trademark Office (USPTO) delays, “A” delay, “B” delay, and “C” delay, and sets forth certain reductions from the summation of the Type A, B, and C delays.  One of these reductions relates to Applicant delays.  For an overview of PTA, see our prior articles here and here.

As 2019 begins and intellectual property (IP) strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2018.  According to many readers, hot topics included handling IDSs and obviousness during U.S. patent prosecution, blockchain, PTAB rules, and subject matter eligibility under Section 101.