District Court Denies Motion to Dismiss for Lack of Patent Eligible Subject Matter

By Donald Zuhn —

Earlier this year, in Viveve, Inc. v. Thermigen, LLC, District Judge Rodney Gilstrap of the U.S. District Court for the Eastern District of Texas denied the Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(6) and 35 U.S.C. § 101 filed by Defendants Thermigen, LLC; ThermiAesthetics, LLC; and Dr. Red Alinsod, M.D. ("Thermigen").  In denying Thermigen's motion, the District Court determined that the patent asserted by Plaintiff Vivive, Inc. against Thermigen is not directed to a natural law or phenomenon.

In October 2016, Vivive filed a complaint against Thermigen for infringement of U.S. Patent No. 8,961,511, which is directed to a method for remodeling female genital tissue by applying heat to certain target tissue.  According to the '511 patent, the tissue to be remodeled is tightened as "a consequence of thermal denaturation of collagen as well as a longer term healing response in the tissue that includes an increased deposition of collagen."  The '511 patent also discloses that the claimed method provides an alternative to the prior art, which indicated that such remodeling required invasive surgical procedures.

In response to Vivive's complaint, Thermigen filed its motion to dismiss, arguing that the '511 patent is directed to non-patentable subject matter.  In particular, Thermigen asserted that the '511 patent is directed to the natural phenomenon that collagen is remodeled through exposure to heat, which Thermigen contended is a phenomenon that allegedly has previous, well known applications in treating tissue generally, and that the claimed method simply applies this phenomenon to a discrete area of the human body.

In deciding whether the asserted claims of the '511 patent are directed to patent-ineligible subject matter, the District Court noted that in Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, the Supreme Court set forth a two-step test for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent eligible applications of those concepts.  In the first step, the court determines whether the claims are directed to a law of nature, natural phenomenon, or abstract idea.  If the answer to this question is "no," then the inquiry is over and the claims pass muster under § 101.  However, if the answer is "yes," then the court must determine whether the elements of the claim individually, or as an ordered combination, transform the nature of the claim into a patent-eligible application.

In denying Thermigen's motion to dismiss, the District Court determined that "the '511 patent is not invalid as claiming unpatentable subject matter," finding that Thermigen's arguments "fail at step one [because] the '511 is not directed to a natural law or phenomenon," and further, that "even if [the '511 patent] were directed to a natural law or phenomenon, . . . under step two of the Mayo framework, the '511 patent improves an existing process for bringing about the tightening of female genital tissue."  With respect to the step one inquiry, the District Court agreed with Vivive's argument that remodeling is a process comprising a doctor's application of specific concrete steps to specific tissue under particularized conditions, which is simply predicated on the ability of collagen to be physically transformed by heat, rather than being a law of nature.

The District Court also noted that the Federal Circuit recently took up the patentability of similar method claims in Rapid Litigation Management Ltd. v. Cellzdirect, Inc.  In that case, the Federal Circuit addressed whether method claims covering a process for subjecting hepatocyte liver cells to multiple freeze-thaw cycles used to preserve the cells for later use was directed to a law of nature.  In Rapid Litigation Management, the Federal Circuit observed "[t]hat one way of describing the process is to describe the natural ability of the subject matter to undergo the process [which] does not make the claim 'directed to' that natural ability" (emphasis in original), adding that "[i]f that were so, we would find patent-ineligible methods of, say, producing a new compound (as directed to the individual components' ability to combine to form the new compound), treating cancer with chemotherapy (as directed to cancer cells' inability to survive chemotherapy), or treating headaches with aspirin (as directed to the human body's natural response to aspirin)."

In the instant case, the District Court determined that "the Federal Circuit's reasoning and holding in Rapid Litigation Management [is] controlling in the present case," and that "[l]ike the court in Rapid Litigation Management, here the Court is presented with a method patent comprising concrete steps, premised upon a discovery of natural law rendering the relevant subject matter amenable to certain processes."  While the claimed method in Rapid Litigation Management was based upon the ability of hepatocytes to be frozen and thawed multiple times, the District Court found that the claimed method in the instant case is based upon the ability of collagen to be denatured by heat.  The District Court also noted that like the claimed method in Rapid Litigation Management, the claimed method in the instant case provides certain advantages over the prior art.  The Court further noted that "[t]he '511 patent stands in stark contrast to those patents which the Federal Circuit has invalidated as directed to a natural law or natural phenomenon," such as Genetic Techs., Ltd. v. Merial L.L.C. and Ariosa Diagnostics, Inc. v. Sequenom, Inc., wherein "the patents typically encompass the pure observation or identification of the natural law at issue."

With respect to step two of the Mayo/Alice inquiry, the District Court noted that even if it "was persuaded that the '511 patent was 'directed to' a natural law or natural phenomenon (which it is not), the '511 patent recites an inventive concept, rendering it subject matter patent eligible."  In particular, the Court determined that "the claims of the '511 patent recite an improved treatment technique that is inventive over known techniques in the prior art," finding that "[w]hile the denaturation of collagen through application of heat was known and used for medical and cosmetic purposes in the prior art (see '511 patent, 1:39–61), the only known methods for tightening the relevant tissue required invasive surgical procedures which carried with them the risk of scarring."  According to the Court, this constituted an improvement over the prior art.  The Court also noted that one of the Defendants, Dr. Red Alinsod, had referred to the claimed method as "a fairly new concept" that was "game changing"; the Court stated that "Defendants cannot honestly extoll the 'game changing' virtues of the process at issue in the marketplace, yet argue in the courtroom that the same procedure lacks an inventive element."

Having decided that the answer to step one of the Mayo/Alice inquiry was "no," and further, that the claims of the '511 patent also recite an inventive concept, the District Court denied Thermigen's Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(6) and 35 U.S.C. § 101.

Memorandum Opinion and Order by District Judge Gilstrap