Aesthetically Useful, and Patent Eligible

Over the past seven years, the Supreme Court decisions in Mayo¹, Myriad² and Alice³, and their impact on patent eligible subject matter, have dominated the intellectual property landscape for both patent practitioners and litigators. Former Chief Judge Michel even recently discussed the significant (and many consider, negative) impact that these decisions have had patents and innovation⁴. Technologies ranging from personalized medicine and diagnostics⁵, to DNA primers, ⁶ to programs for monitoring electric power grids⁷ have all been found ineligible for patent protection under the current laws.

One area, though, that in general has remained relatively unscathed relates to devices used in aesthetic dermatology and cosmetic surgery. As many of the technical advances in this field surround the development of devices and surgical tools that utilize various forms of energy (e.g., light, lasers, heat, cooling, etc.), patent eligibility has overall not been a primary concern. However, methods that utilize such energies or devices to modify, reconstruct, or remodel a patient’s tissues, have been more difficult to judge on the eligibility spectrum. A recent decision from the Eastern District of Texas appears to provide some guidance that many aesthetic methods are indeed, eligible for protection.

The case surrounds a method for the remodeling of a female patient’s genital tissue. ⁸ The representative claim of the patent involved, U.S. 8,961,511 (“the ‘511 patent”), held by Viveve, Inc., recites:

51. A method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue, the method comprising:
heating the target tissue, and
remodeling the therapeutic zone of target tissue, wherein the heating includes heating a mucosal surface of the labia minora. ⁹

Defendant Thermigen, LLC, argued, in response to Viveve’s allegations of infringement, that the ‘511 patent is directed to a natural phenomenon, namely “that collagen is remodeled through exposure to heat . . . and that it simply applies this phenomenon to a discrete area of the human body.” ¹⁰ Thus, under the rulings in Myriad and Prometheus, the ‘511 patent should be found invalid for being directed to non-patent eligible subject matter.

In its decision, the district court set forth the two-step test for “distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim eligible applications of those concepts,” as set forth in Alice and Mayo. ¹¹ The court then found that neither element of the test was met, and thus, Viveve’s method patent was indeed eligible for patent protection.

With regard to the first test as to whether the claims are “directed to a law of nature, natural phenomena, or abstract idea,” the court echoed recent Federal Circuit guidance that cautioned against “describing the claims at such a high level of abstraction and untethered from the language of the claims.” ¹² While the defendants argued that the claims covered a law of nature, namely “the natural phenomenon that heat denatures collagen and causes remodeling – i.e., tightening or any change in the structure – of the heated tissue,” the court disagreed. ¹³

Judge Gilstrap determined that the claims were “premised upon a discovery of natural law rendering the relevant subject matter amenable to certain processes,” rather than being directed to a law of nature. ¹⁴ In addition, the claims of the ‘511 patent specified “the particular treatment area and tissues . . . on which the steps should be performed,” ¹⁵ and dictated with specificity, “the concrete steps which a doctor should take in performing the claimed method.” ¹⁶ As a result, the court found that the claims were “more than the observation or identification of a natural law or phenomenon” and thus, eligible for patenting. ¹⁷

Even though the court determined that the claims of the ‘511 patent did not meet the requirements of the first test under Alice and Mayo, the court continued with the patent eligibility analysis, finding that the claims of the ‘511 patent also recited an “inventive concept.” Specifically, the court noted that the claims set forth an improved treatment technique that was inventive over known techniques in the prior art. ¹⁸ The court noted that “while the denaturation of collagen through application of heat was known and used for medical and cosmetic purposes in the prior art . . . the only known methods for tightening the relevant tissue required invasive surgical procedures which carried with them the risk of scarring.”¹⁹ These unique characteristics were determined to be more than “routine, conventional activity,” that demonstrated that the claims were in fact directed to an inventive concept.

While a wide array of technologies and research areas such as biotechnology, computer software and related methods are struggling with navigating the recent changes in patent eligibility, aesthetic devices and methods of treatment appear to be less impacted. Combining factors such as an aging patient population, high obesity rate, and availability of disposable income to spend on cosmetic procedures²⁰ (as compared to reliance on insurance reimbursement), with a favorable path toward patent eligibility, innovation in aesthetic dermatology and cosmetic surgery appears poised for dramatic growth.