United States: Gunfights At The Deeply Divided Federal Circuit OK Corral Over "Ready For Patenting," Useful For The Intended Purpose, And Experimental Use

Decision: Barry v. Medtronic, --F.3d__, 2019 WL 302886 (Fed. Cir. Jan. 24, 2019) (Judges TARANTO, Prost, and Moore; dissenting opinion in part filed by Judge Prost)

Background: Dr. Barry sued Medtronic on two patents, which contained method and system claims. A jury, finding Medtronic infringed, rejected both public use and on-sale bar arguments. In a divided Federal Circuit opinion, Dr. Barry prevailed (infringement, no on-sale bar, no public use bar, experimental use), but Judge Prost dissented that (1) the invention was ready for patenting more than one year before the critical date and (2) that the patentee had not established an experimental use negation of on-sale and public use.

Dr. Barry worked on his ideas for a spine correction device and related surgical methods in 2003. He performed three surgeries using his inventions on Aug. 4, Aug. 5, and Oct. 14, 2003, and charged for those surgeries without mentioning to the patients that the device and methods were experimental.

Those three patients had follow-up appointments between Aug. 2003 and Jan. 2004. After the January 2004, follow up, Dr. Barry submitted a Feb. 1, 2004, abstract describing his methods for a presentation in July 2004. He also filed a U.S. patent application on December 30, 2004, ultimately resulting in U.S. Patent 7,679,358 (the '358 patent), i.e., the principal patent litigated before the Federal Circuit. The critical date for 35 U.S.C. §102(b) therefore was deemed to be December 30, 2003.

Issue: Was Dr. Barry's invention in public use or on sale before December 30, 2003? If so, were the public use and sale bars negated by experimental use?

Outcome: Affirmed (2-1).

The Federal Circuit majority found that (1) the invention was not ready for patenting prior to the critical date, eliminating both the public use and on sale bars, and (2) that up to the critical date, there was only experimental use, not public use or sale. "[E]experimental use negates invalidity under the public use bar."

The majority, concluding that "the timing of knowledge that the invention will 'work for its intended purpose' is important to both experimental use and readiness for patenting," emphasized that the "'intended purpose' need not be stated in claim limitations that define the claim scope." The majority found that substantial evidence supported the conclusion that Dr. Barry did not know his invention would work for its intended purpose until January 2004, after completion and follow up of the August and October 2003 surgeries.

The majority also rejected Medtronic's argument that the invention was accessible to the public and commercially exploited and thus was in public use prior to the critical date. The court stated that Dr. Barry was the only one who performed the claimed method and that he never relinquished control of his method invention and whatever disclosure there was during the surgeries was protected by an implied duty of confidentiality in the operating room. Furthermore, according to the majority, the evidence supported the conclusion that the surgeries were legitimate experimental use, even if Dr. Barry was compensated for them at his normal rate.

"The experimental-use inquiry asks whether the inventor's conduct would lead the ''public' to reasonably believe the invention was in the public domain[.]'" The majority concluded that the answer in this case was "no."

The Court also rejected Medtronic's argument that experimental use did not apply because the patients were not informed that Dr. Barry was experimenting during their surgeries.

We have not applied the inform-customer principle in a context, like the present, involving a method kept within the inventor's control. The underlying logic of the principle does not justify its extension here: explaining to patients (or their parents or insurers) that the procedure was experimental was not vital to keeping it from the public domain.

at *13.

Judge Prost issued a strong dissent, spanning over twenty pages.  She concluded that Dr. Barry's successful completion of three surgeries before the critical date was prima facie "on sale" or "public use." Pfaff's commercial sale and ready for patenting prongs were both satisfied. "[R]eadiness for patenting is broader than reduction to practice and is meant to answer whether the inventor could have obtained a patent on his or her invention." She concluded that by the end of the follow up of the second surgery, more than one year before the critical date, the claimed methods were reduced to practice as a matter of law.

In emphasizing that "ready for patenting" is broader than reduction to practice, Judge Prost focused on when Dr. Barry could have obtained a patent, concluding that it was at the end of the follow up of the second surgery. She reasoned that by then, Dr. Barry possessed enough to satisfy written description, enablement, and utility, particularly in view of the broad statement of intended use in the preamble of the claims. 

The gravamen of Judge Prost's dissent is that the majority asked more of the intended purpose "than what the claims and specification define it to be." 

Finally, Judge Prost was underwhelmed by the experimental use negation, finding that most of it was based on Dr.  Barry's evidence that was "just his own after-the-fact testimony."

"Dr. Barry's evidence of experimental purpose was insufficient as a matter of law to negate a bar" because it was largely based on his own litigation testimony. There was little objective evidence to support the assertion of experimental use.

Prosecution Takeaways:

Showing experimental use to negate public use or on sale argument is a very fact-intensive inquiry.  The more inventors can do to record the development path of their invention as it is happening and articulate the "intended purpose" of the invention with specificity in the claims and/or specification, the stronger a theory of experimental use may be, as well as the stronger a theory of not ready for patenting may be.

This case also serves as a cautionary tale to patent applicants to be mindful of statutory bar dates and to try and closely coordinate commercial and patenting efforts. The patents in Barry were pre-AIA patents. This caution is even stronger for AIA first inventor-to-file patents.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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