Mehl/biophile International Corp., Selvac Acquisitions Corp. And Nardo Zaias, m.d.,plaintiffs-appellants v. Sandy Milgraum, M.D., Palomar Medical Technologies, Inc., and Spectrum Medical Technologies, Inc.

Citation: 192 F.3d 1362Docket: 99-1038

Court: Court of Appeals for the Federal Circuit; October 27, 1999; Federal Appellate Court

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In the patent infringement case Mehl/Biophile International Corp. v. Milgraum, the plaintiffs, including Dr. Nardo Zaias, claimed infringement of U.S. Patent No. 5,059,192 related to a laser hair removal method. The defendants, including Dr. Sandy Milgraum and Palomar Medical Technologies, argued for summary judgment, asserting that the patent claims were anticipated by a Spectrum RD-1200 laser manual and a 1987 article by Dr. Luigi Polla. The district court ruled in favor of the defendants, granting summary judgment of invalidity based on the manual. However, the appeals court found that while the manual did not disclose all elements of the invention, the Polla article did, leading to an affirmation of the lower court's ruling.

The '192 patent details a method for hair removal by destroying the hair follicle's papilla using a Q-switched ruby laser. The mechanism relies on targeting melanin in the papilla with a specific wavelength of laser light, allowing for effective destruction of the papilla while sparing surrounding tissue. The independent claim outlines the steps for aligning the laser applicator over the hair follicle, specifying the necessary characteristics of the laser's energy and its effects on the papilla. Dependent claims further elaborate on the laser applicator's parameters and operational specifics.

MEHL/Biophile initiated a lawsuit against Milgraum in the U.S. District Court for the District of New Jersey, claiming infringement of all claims of the '192 patent. Milgraum sought summary judgment for invalidity, asserting that two prior art references anticipated the patent claims. The first reference was the RD-1200 laser manual, which describes using a Q-switched ruby laser for tattoo removal, emphasizing its selective energy absorption by pigmented chromophores to minimize scarring. The second reference was the Polla article, which investigated tissue damage from the same laser in guinea pigs, detailing the method used and findings regarding melanosome disruption.

The district court evaluated both references but based its decision primarily on the RD-1200 manual. MEHL/Biophile contested the manual's relevance, arguing it did not pertain to hair removal and lacked a disclosure of a substantially vertical alignment, a claim element. Regarding the Polla article, MEHL/Biophile claimed it focused on guinea pig skin without discussing hair depilation and argued that the epilation process negated potential papilla damage from the laser.

The court's review of the summary judgment followed the standard that it is appropriate only when no genuine issues of material fact exist, drawing all reasonable inferences in favor of the non-moving party. To establish anticipation by prior art, every limitation of the claimed invention must be disclosed, either explicitly or inherently. Inherency cannot be established by mere probabilities; the disclosure must show that the natural result of the operation taught would perform the questioned function. If the prior art necessarily includes or functions in accordance with the claimed limitations, it may be deemed anticipatory, regardless of whether such characteristics are recognized by those skilled in the art.

The RD-1200 manual does not teach the limitation of aligning a laser light applicator vertically over a hair follicle opening, as it fails to mention hair follicles or the specific alignment process. The court notes that simply aiming the laser at tattooed skin does not imply a necessary alignment with hair follicles. As such, the manual does not anticipate the claimed invention since anticipation requires a single reference to explicitly teach every limitation, which it does not. 

In contrast, the Polla article provides a valid alternative ground for affirming the judgment, as it explicitly addresses alignment over hair follicles. The article is based on studies involving guinea pigs, which have hairy backs, and it discusses the effects of laser irradiation on hair follicles in detail. Key findings include the observation of follicular damage at various depths and the disruption of melanosomes and hair papillae, indicating that a person of ordinary skill would align the laser as claimed. The presence of photographic evidence of follicular changes further supports the article's relevance to the claimed invention.

The method of using a Q-switched ruby laser on guinea pig skin inherently ensures vertical alignment over hair follicle openings due to the laser beam striking a 2.5 mm circular aperture held in contact with the skin, resulting in a perpendicular alignment to the skin surface. This alignment leads to the conclusion that the operation naturally results in laser light being directed over hair follicles, supporting the claims made in the patent. MEHL/Biophile's arguments regarding the Polla article, which discusses guinea pig skin rather than human skin, are deemed irrelevant since the patent does not limit its application to human skin. Additionally, the lack of mention of hair depilation in the Polla article does not affect the anticipation analysis, as the laser parameters align with those in the patent. The intended results of the Polla method are significant, regardless of the authors' awareness of them. MEHL/Biophile's claim that the wax epilation described in the article removed the papilla contradicts the article's statement about the disruption of melanosomes in the hair papillae, which does not create a genuine issue of fact. Therefore, the Polla article anticipates claim 1 of the '192 patent, and since MEHL/Biophile did not contest the dependent claims separately, the judgment of invalidity is upheld. Each party will bear its own costs, and the decision is affirmed.