Mehl/Biophile Intern. Corp. v. Milgraum

• Decision Date: 18 May 1998
• Docket Number: Civil Action No. 97-1174.
• Parties: MEHL/BIOPHILE INTERNATIONAL CORP., et al., Plaintiffs, v. Sandy MILGRAUM, M.D., et al., Defendants.
• Court: U.S. District Court — District of New Jersey

8 F.Supp.2d 434

MEHL/BIOPHILE INTERNATIONAL CORP., et al., Plaintiffs, v. Sandy MILGRAUM, M.D., et al., Defendants.

Civil Action No. 97-1174.

United States District Court, D. New Jersey.

May 18, 1998.

COPYRIGHT MATERIAL OMITTED

Jeffrey A. Schwab, Michael Aschen, Abelman, Frayne & Schwab, New York City, George A. Arkwright, Terrence L.B. Brown, Arlington, VI, Vincent J. Paluzzi, Sterns & Weinroth, Trenton, NJ, for Plaintiffs.

Joseph J. Fleischman, James P. Flynn, Hannoch Weisman, Roseland, NJ, William F. Lee, Wayne L. Stoner, James M. Hall, Hale & Dorr, Boston, MA, Thomas A. Reed, Palomar Medical Technologies, Inc., Lexington, MA, for Defendants.

OPINION

WOLIN, District Judge.

Much of the public discourse on hair these days involves how to generate hair. Recently, television commercials have used a professional basketball player and a professional football coach to show that a certain product grows hair on the crown of the head. Unfortunately, hair removal is not discussed as often. In fact, it is unclear whether any product or process exists to remove hair permanently. Hair removal, like hair generation, could be a lucrative industry.

In this case, the Patent and Trademark Office ("PTO") granted Dr. Nardo Zaias, plaintiff, patent 5,059,192 (" '192"), which covers a method for removing hair. Zaias along with Mehl/Biophile International Corporation ("Mehl"), plaintiff, and Selvac Acquisitions Corporation ("Selvac"), plaintiff, filed suit against Dr. Sandy Milgraum, Palomar Medical Technologies, Inc. ("Palomar"), and Spectrum Medical Technologies, Inc. ("Spectrum") ("defendants"), for infringing its patent by manufacturing and selling the Epilaser®, which is a device that removes hair.

Pursuant to Rule 56 of the Federal Rules of Civil Procedure, defendants now move for summary judgment. They argue that the '192 patent is invalid because prior art anticipated it and/or made it obvious. They also seek attorneys' fees.

For the reasons expressed infra, the Court has found that one of the pieces of prior art anticipated the '192 patent. Thus, the Court will grant defendants' motion for summary judgment. The Court has decided this motion without oral argument pursuant to Rule 78 of the Federal Rules of Civil Procedure.

BACKGROUND

I. Lasers and Hair

A. Lasers

Lasers produce light of a certain type, and are classified by the material in them that is "excited" to produce the light, e.g., argon gas and ruby. Depending on the material in the laser, the laser produces light with a given wavelength, which is measured in nanometers ("nm"). For example, a ruby laser produces light with a wavelength of 694 nm, which is in the red area of the spectrum of visible light.

Certain lasers emit light in "pulses" as opposed to a continuous wave of light. When a pulse of laser light strikes a target, it creates a spot, and the size of the spot is called the "spot size," which is measured in "millimeters" ("mm"). The energy of the pulses of light is expressed in "joules," or in terms of "fluence," the energy per unit area covered by the laser beam spot when it hits a target, which is expressed as joules per square centimeter (j/cm²). The pulses a laser produces have a duration ("width"), which is measured in fractions of a second, e.g., nanosecond ("ns" or billionths of a second), microsecond (millionths of a second), or millisecond ("ms" or thousandths of a second). The wavelength, energy, fluence, spot size, and duration of the pulses are the parameters of the laser.

The laser at issue in this case is a Q-switched ruby laser. The Q-switched ruby laser has a much shorter pulse than an ordinary ruby laser. It was invented before Zaias received the patent in this case.

Since the early 1960's, studies have been performed on how lasers can be used to treat the skin. In the early 1980's, researchers at the Massachusetts General Hospital, including Dr. R. Rox Anderson, invented selective photothermolysis, which involves using a laser wavelength that the target selectively absorbs. The wavelength must have an energy level that effects a change on the target, and a pulse duration that does not conduct thermal energy to the surrounding tissue.

B. Hair

Hair grows out of the skin. More specifically, the hair shaft grows out of a hair "follicle," which is a tubular aperture in the dermis, i.e., skin. The root of the hair at the base of the follicle is called the "papilla." In the papilla, a dark pigment called melanin exists in granules, which are called melanosomes. To prevent hair regrowth, one must destroy the papilla.

According to Zaias, prior to the '192 patent, the only commercial methods for hair depilation were plucking out hair with tweezers, waxing, shaving, depilatory creams, electrolysis, or radio frequency devices. None of those methods permanently remove hair.

II. The '192 Patent

A. Events Prior to the Application for the Patent

After their discovery of selective photothermolysis in the early 1980's, seven researchers/doctors, including Dr. Luigi Polla, Dr. R. Rox Anderson, and Dr. Jeffrey Dover, at the Massachusetts General Hospital wrote and published an article in 1987 entitled "Melanosomes Are a Primary Target of Q-Switched Ruby Laser Irradiation in Guinea Pig Skin" ("1987 Article"). (Stoner Decl.Ex. 3). The purpose of their study was to "document the tissue damage induced by Q-switched ruby laser pulses in ... guinea pigs ... in an effort to define the nature and extent of pigmented cell injury." Their study used selective photothermolysis.

The parameters of the Q-switched ruby laser were: ".08-1.2 j/cm² in single 40-ns duration full width at half maximum pulses at a wavelength of 694 nm." The laser beam hit a circular aperture, which was held to the skin of the guinea pigs, of 2.5 millimeters in diameter. The authors waxed the backs of the guinea pigs prior to using the laser. They found that (1) "melanin is the fundamental target of energy absorption," (2) the laser could injure melanosomes at the right exposure without injuring unmelanized organelles, (3) when increasing radiant exposure doses were used, melanin containing cells showed degenerative alterations, (4) "pigmented structures in the deep dermis such as hair follicles are affected," and (5) dermisepidermis separation occurred at appropriate radiant exposures. In Figure One, the authors showed the disruption of the hair follicles of one of the guinea pigs. The authors concluded that their study might provide a biological basis for using the Q-switched ruby laser for removing tattoos.

The authors of the 1987 article continued to conduct research on the Q-switched ruby laser, and published additional articles. A 1989 article also failed to discuss hair depilation.

The named inventor of the '192 patent is Zaias, who is a dermatologist in Florida and a major shareholder and director of Mehl. Zaias has spent many years of his practice dealing with hair depilation. Zaias performs hair depilations, and along with Thomas Mehl, the founder of Mehl, has developed, manufactured, and sold several devices that use radio frequency energy to remove hair. Prior to December 1989, Zaias had never used a laser to try to remove hair. (Stoner Decl.Ex. 11 (Zaias dep.)).

In December 1989, Zaias attended a convention of the American Academy of Dermatology. Spectrum had a booth at the meeting to market its Q-switched ruby laser, the Spectrume RD-1200, which uses selective photothermolysis to remove tattoos without leaving scars. "Patient treatment with the SPECTRUM RD-1200[] are accomplished by delivering laser energy of 5-10 joules/cm², at a wavelength of 694 nm, through an articulate arm in a 5 mm or 7 mm spot size. A 20-40[ns] pulse is delivered every 2 seconds. ..." (Stoner Decl.Ex. 14). The Spectrum RD-1200 uses selective photothermolysis to fracture the pigment particles in the skin. In essence, pigment chromophores, and not the surrounding tissue, selectively absorb the laser's energy so that the risk of scarring is reduced. At the time of the meeting, Spectrum had conducted encouraging tests on the RD-1200's application to benign pigmented lesions.

Zaias went to Spectrum's booth, and spoke to Spectrum representatives about the RD-1200. At that time or shortly thereafter, he obtained a brochure/instruction manual ("manual") for the RD-1200. The manual described the RD-1200 and how it was used to treat patients, contained before and after photographs of patients who had tattoos removed with the RD-1200, and discussed how the laser could perform selective photothermolysis on melanin-bearing cells in the skin. While reading the manual, Zaias observed that the before and after photographs showed that the laser had removed hair from the patients' skin. Zaias admitted at his deposition that viewing the photographs sparked the idea of using the Q-switched ruby laser to remove hair. (Stoner Decl.Ex. 13).¹ The manual, however, did not discuss hair depilation.

Following this observation, Zaias telephoned Dr. R. Rox Anderson, the physician who performed the treatments in the manual, to discuss the hair that the RD-1200 had removed. Dr. Anderson interrupted Zaias and told him not to worry about it because it would grow back. Zaias concluded that Anderson did not appreciate the potential use of the RD-1200 to achieve hair depilation. (Zaias Decl. ¶ 19). Ultimately, Zaias ordered an RD-1200.

On January 16, 1990, Zaias contacted his patent attorneys about preparing a patent application because he believed that he was the first person to develop a method for using a laser to destroy the melanin in papilla. Prior to filing his patent application, Zaias forwarded a copy of the 1987 article to his patent attorneys. On April 24, 1990, Zaias filed an application for a patent for hair depilation that would not damage the surrounding tissue. Zaias submitted the 1989 article and an article written in 1988 to the PTO. The parameters discussed in the application are similar to...