Opinion
No. C 04-2995 CRB.
September 27, 2004
ORDER DENYING PLAINTIFF'S MOTION FOR PRELIMINARY INJUNCTION
The United States Patent office issued U.S. Patent No. 6,749,624 ("the '624 patent") to Thermage, Inc. ("Thermage" or "plaintiff") on June 15, 2004. Thermage brings this suit against Syneron Medical, Ltd. and Syneron, Inc. (collectively "Syneron" or "defendants") alleging that defendants' Polaris WR system infringes claims 1, 30 and 36 of the '624 patent.
Now before the Court is plaintiff's motion for a preliminary injunction to prohibit Syneron from using, making, selling and offering to sell its Polaris WR system. Defendants resist the injunction on several grounds, including that their Polaris WR system does not infringe the patent's claims, and that substantial questions exist as to the validity of the patent. After reviewing the record and memoranda submitted by both parties and having had the benefit of oral argument, this Court concludes that Syneron has raised a substantial challenge to the validity of the '624 patent. Accordingly, plaintiff's motion for preliminary injunction is DENIED.
BACKGROUND
Thermage is a manufacturer and seller of non-invasive technologies for dermatology and plastic surgery applications such as wrinkle reduction, skin tightening, tissue contouring, acne treatment, and skin rejuvenation. Thermage's '624 patent is entitled "Fluid Delivery Apparatus" and describes "an apparatus for modifying skin surfaces and underlying tissue via the delivery of energy and fluid." Col. 1, ll. 20-22. Thermage's patent describes using various forms of energy to heat the skin and subcutaneous tissue. The procedure results in collagen formation and a tightening of the skin, creating a more youthful appearance without surgery. The epidermis is simultaneously cooled to protect the face from burning. For purposes of the preliminary injunction, Thermage focuses on claim 1 of the '624 patent, which describes a device that utilizes both light and RF energy.Syneron claims that it was the first company to develop technology combining light and RF energy (its "ELOS"™ technology) and that this technology was widespread and well known in the industry beginning in Fall 2001. Syneron was issued U.S. Patent No. 6,702,808 ("the '808 patent") in March 2004, which describes a system for simultaneously applying RF and optical or light energy to the skin. Syneron's Polaris WR System utilizes the "ELOS"™ technology and is the subject of the current litigation.
ANALYSIS
To obtain a preliminary injunction, a party must show: 1) reasonable likelihood of success on the merits; 2) irreparable harm; 3) that the balance of hardships tips in its favor; and 4) the impact of the injunction on the public interest. Guttman v. Kopykake Enters., Inc., 302 F.3d 1352, 1356 (Fed. Cir. 2002).
1. Likelihood of Success on the Merits
In order to demonstrate a likelihood of success on the merits, Thermage must show that 1) it will likely prove that Syneron infringes the '624 patent, and 2) Thermage's infringement claim will likely withstand Syneron's challenges to the validity and enforceability of the '624 patent. See Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001). This Court should not issue a preliminary injunction if Syneron asserts an infringement or invalidity defense that the patentee cannot prove "`lacks substantial merit.'" Id. at 1350-51 (quoting Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997)).
A. Infringement
Infringement analysis involves two steps: first, the scope of the claim is determined, and second, the properly construed claim is compared with the accused device to determine whether all of the claim limitations are present either literally or by a substantial equivalent. Id. at 1351. In this case, the parties dispute whether the Polaris WR system infringes the "energy delivery surface" and "cooling member" limitations of claim 1.
1. Energy Delivery Surface
In construing patent claims, a court should give the terms their plain, ordinary, and accustomed meaning to one of ordinary skill in the relevant art. Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir. 2001). A term's ordinary meaning, however, must be considered in the context of all intrinsic evidence, namely the claims, the specification, and the prosecution history. See id. at 1342-43; Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The specification is "the single best guide to the meaning of a disputed term." Vitronics Corp., 90 F.3d at 1582.
Claim 1 recites:
1. A treatment apparatus, comprising: an energy delivery device including at least a light energy member an RF energy member, and at least one energy delivery surface, the at least one energy delivery surface configured to deliver energy from the light energy member and the RF energy member to and through a skin surface and create a tissue effect at the skin surface or at a site below the skin surface; and a cooling member coupled to the energy delivery device.
Col. 23, ll. 1-10.
The claim requires that both light and RF energy must be delivered through the same energy delivery surface. However, the patent does not define the term "energy delivery surface." At oral argument, plaintiff defined "energy delivery surface" as the outer surface of the energy delivery device through which energy is delivered toward the patient. Relying on the American Heritage definition of surface, defendants define an energy delivery surface as the "layer forming the outer boundary of an object that is designed to deliver both RF and light energy through a single surface to and through the skin." The differences between the definitions are apparent when applied to the Polaris WR system.
The Polaris WR system consists of a console, hand piece (or applicator), and software. The applicator includes a light energy source (diode laser) and an RF energy source (pair of electrodes). See Kreindel Decl. ¶ 12. The two RF electrodes are located at the distal end of the applicator and are spaced apart to deliver RF energy at a depth of 2.5 mm. See id. Between the RF electrodes is a sapphire crystal light guide which delivers laser energy. Id. The tips of the two electrodes extend slightly beyond the end of the light guide. Id., fig. 1; Grundfest Decl. ¶ 45.
Plaintiff argues that the tips of the RF electrodes and light guide jointly form one energy delivery surface. Reitman Decl. ¶¶ 23-24. In the words of plaintiff's expert, "the energy delivery surface (c) is arranged with the light energy member (a) positioned between the RF electrodes (b)." Id. The RF electrodes create an electrical current through which light energy passes.
In contrast, defendants argue that the RF electrodes and light guide each have their own energy delivery surfaces. Thus, the Polaris WR applicator is comprised of three distinct energy delivery surfaces: the end of the light guide and the tips of each of the RF electrodes. Grundfest Decl. ¶¶ 44-46. In other words, the applicator end is made up of three different objects, each with their own energy delivery surface. Under defendants' narrower construction, the Polaris WR system does not infringe plaintiff's patent because each energy delivery surface transmits only type of energy: the RF electrodes transmit RF energy and the light guide transmits light energy. See Kreindel Decl. ¶ 12.
The patent specification supports plaintiff's construction. For example, the specification directly contradicts defendants' position that the RF electrodes each form their own energy delivery surface. The specification states, "[e]nergy delivery devices suited to this purpose include one or more RF electrodes. Accordingly, energy delivery device 18 can include a plurality of electrodes with or without insulation. The non-insulated sections of the RF electrodes collectively form template energy delivery surface 20." Col. 15, ll. 14-19 (emphasis added). Further, the specification states that "[o]ne or more energy delivery devices 18 can form an energy delivery surface 20 in template 12." Col. 6, ll. 64-65.
Additionally, dependent claims support plaintiff's interpretation. For example, dependent claims 8-10 describe an apparatus in which the energy delivery surface is divided into multiple sections. Col. 23, ll. 29-36. The surface of an RF energy member (electrode) and the surface of a light energy member comprise sections 1 and 2, respectively of the energy delivery surface. Id. The dependent claims lend further support that an "energy delivery surface" can be composed of both RF electrodes and a light guide. Claim 1 must be broad enough to encompass these dependent claims.
The Court accepts plaintiff's definition of energy delivery surface as the outer surface of the energy delivery device through which energy is delivered toward the patient. Defendants' Polaris WR system literally infringes this element of claim 1 because both light energy (from the light guide) and RF energy (from the electrodes) pass through the outer surface or boundary of the energy delivery device (tip of the Polaris WR applicator).
2. Cooling Member
The parties also dispute the meaning of the term "cooling member" in claim 1. The patent does not define or otherwise refer to a "cooling member." Plaintiff argues that the "cooling member" limitation requires "active cooling." Defendants assert that the ordinary meaning of a "cooling member" is "a part that cools" regardless of whether it utilizes passive or active cooling.
Plaintiff states that "active cooling" involves some mechanism or system effort to dynamically cool a target. Reitman Supp. Decl. ¶ 38. Plaintiff does not define "dynamic." According to plaintiff, an example of active cooling from the '624 patent is the flow of coolant to dissipate heat from the skin. Id. In contrast, plaintiff states that a heat sink is an example of "passive cooling" because it cools the skin surface by removing heat through the scientific properties of conduction inherent in all materials in nature. Id.
There is no specific limitation in the claim that requires "active cooling." All that claim 1 requires is a "cooling member." Although various embodiments describe the delivery of a cooling fluid, the Federal Circuit has cautioned against reading limitations from the specification into the claim. See Burke, Inc. v. Bruno Indep. Living Aids, Inc., 183 F.3d 1334, 1340 (Fed. Cir. 1999); Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d 855, 865 (Fed. Cir. 1989) ("References in a preferred embodiment, such as those present in a specification, are not claim limitations."). Further, plaintiff has not offered a definition of "dynamic" nor is any definition apparent from reading the patent and other embodiments.
The Court has adopted a broad definition of surface and similarly adopts defendants' broad definition of "cooling member" as "a part that cools." The Polaris WR system literally infringes the cooling member limitation of claim 1 because the light guide and electrodes act as a heat sink to conduct heat away from the skin. See Grundfest Supp. Decl. ¶ 30. Therefore, plaintiff has shown that defendants' Polaris WR system likely infringes claim 1 of the '624 patent.
B. Validity of the '624 Patent
Validity challenges during preliminary injunction proceedings can raise substantial questions of invalidity on evidence that would not suffice to support a judgment of invalidity at trial.See Amazon.com, 239 F.3d at 1358. In resisting a preliminary injunction, one need not make out a case of actual invalidity.Id. at 1359. Vulnerability is the issue at the preliminary injunction stage. Id. In this case, Syneron has "cast enough doubt on the validity of the [`624] patent to avoid a preliminary injunction." See id. at 1360.
1. Written Description
A patent specification must contain an adequate written description. 35 U.S.C. § 112 (2004); Moba B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319 (Fed. Cir. 2003), cert. denied, 157 L. Ed. 2d 371 (2003). The test for compliance under Section 112 requires sufficient information in the original disclosure to show that the inventor possessed the invention at the time of the original filing. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir. 1991) ("Adequate description of the invention guards against the inventor's overreaching by insisting that he recount his invention in such detail that his future claims can be determined to be encompassed within his original creation.").
One skilled in the art, reading the original disclosure, must "`immediately discern the limitation at issue'" in the claims.Purdue Pharma, L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (quoting Waldemar Link GmbH Co. v. Osteonics Corp., 32 F.3d 556, 558 (Fed. Cir. 1994)). A broad claim is invalid when the entirety of the specification clearly indicates that the invention is of a much narrower scope. See PIN/NIP, Inc. v. Platte Chem. Co., 304 F.3d 1235, 1248 (Fed. Cir. 2002).
Defendants concede that the patent discloses the use of RF energy. Further, defendants concede that light energy is listed as an alternative energy source. However, they argue that the written description does not provide support for a treatment apparatus that utilizes both light and RF energy in a single device as stated in claim 1.
Plaintiff has highlighted various excerpts from the patent to refute defendants' argument. For example, the patent specification states:
Template 12 can be used with any modality that remodels collagen including but not limited to the applications of heat, electromagnetic energy, force and chemical treatment, singularly or in combination. In addition to RF (e.g. molecular) remodeling of collagen, cellular modalities that invoke the wound healing sequence can be combined with a conforming esthetic template.
Col. 14, ll. 20-26 (emphasis added). However, the excerpted portion only discloses that electromagnetic energy can be used in combination with "heat" or "force" or "chemical treatment." As defendants point out, it does not suggest combining different types of electromagnetic energy such as light and RF energy. The second sentence only indicates that cellular modalities can be combined with a conforming esthetic template not that different forms of electromagnetic energy can be combined or used in the same device. Even if this paragraph refers to the combination of electromagnetic energy, it does not indicate which forms of electromagnetic energy (such as light and RF) should be utilized in the same device. As defendants point out, there are multiple forms of electromagnetic energy including RF, microwave, infrared light, visible light, ultraviolet light, x-rays and gamma rays.
Plaintiff also points to the phrase that "[p]atients may be treated with one or more modalities described herein to achieve optimal esthetic result." Col. 11, ll. 66-67. However, this only indicates that patients might be treated with different modalities using different devices, not that the different modalities are combined in the same device.
Plaintiff relies on language that "lumens may be used as paths for the delivery of fluids and gases, as well as providing channels for cables, catheters, guide wires, pull wires, insulated wires, optical fibers and viewing devices/scopes." Col. 4, ll. 29-34. However, this only indicates that light energycould be transmitted through the device. This does not indicate that the optical fibers are to be used together with RF energy. Additionally, optical fibers can be used for other purposes such as viewing or illuminating.
Plaintiff also states that figure 1 in the patent explicitly illustrates a device with RF electrodes and lumen. However, the portions identified as electrodes in plaintiff's declarations (Davis Decl. ¶ 12, ll. 7-8) are identified in the description as a "soft mechanical force application surface." See col. 4, ll. 20-21. Even if section 14 were identified as the energy delivery device, the description does not require the energy delivery device in figure 1 to be an electrode. Further, the lumens identified in figure 1 are not necessarily used to deliver light waves. See col. 4, ll. 30-33. Figure 1 also only shows a single energy source.
Plaintiff correctly states that nothing in the specification requires that the "one or more energy delivery devices" deliver the same type of energy. See col. 4, ll 51-54. However, this does not indicate that the energy delivery devices will necessarily deliver different types of energy. Further, plaintiff's argument is weakened because the patent specification refers to "an energy source" in the same paragraph as describing the "one or more energy delivery devices." See col. 4, ll. 54-57. Similarly, the illustrations only show a single energy source. See fig. 1.
Defendants' written description validity challenge has substantial merit and has "cast enough doubt on the validity of the [`624] patent to avoid a preliminary injunction."Amazon.com, 239 F.3d at 1360.
2. Anticipation
A prior art reference anticipates a claim if it discloses each element either expressly or under the principle of inherency. See Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1346 (Fed. Cir. 1999). Defendants assert that two patents, U.S. Patent Nos. 6,053,909 ("Shadduck" or "the `909 patent") and 6,413,253 ("Koop" or "the '253 patent") anticipate all the elements of claim 1. The parties do not dispute that both patents qualify as prior art. The patent examiner did not consider either patent in reviewing plaintiff's '624 patent application.
a. Shadduck Patent
For purposes of the preliminary injunction, plaintiff concedes that Shadduck discloses every limitation of the claim, except the "cooling member" limitation. Plaintiff's argument is based upon its claim construction that a cooling member must be active. However, this Court adopts the definition of a cooling member as "a part that cools." The Shadduck patent which describes the use of a heat sink to cool the skin's surface meets that definition. Accordingly, defendant has raised a substantial question whether Shadduck anticipates claim 1.
b. Koop Patent
Plaintiff argues that the Koop patent fails to teach the "cooling member" and the "energy delivery surface" limitations of claim 1.
Like Shadduck, Koop describes the use of a heat sink to cool the skin. As discussed above, this meets the "cooling member" limitation of claim 1.
Plaintiff further argues that Koop does not describe an "energy delivery surface." Defendants' expert responds that Koop describes an energy delivery device and such device necessarily has a surface through which the energy is delivered, otherwise the energy could not be transmitted to the tissue to be treated. Grundfest Decl. ¶ 71. Defendant has raised a substantial question whether the '624 patent was anticipated by Koop. See Amazon.com, 239 F.3d at 1359 (holding that a preliminary injunction is improper when prior art teaches key limitations of the claims in issue and one of ordinary skill in the art could fill in the gaps in the asserted references if given the opportunity to do so at trial).
Even utilizing plaintiff's "active cooling" limitation, the Koop patent anticipates claim 1. Koop describes both "passive" and "dynamic" heat sinks. The dynamic heat sink "refer[s] to those actively cooled by flowing gas or liquid, jets or spurts of coolant such as freon . . ." Col. 5, ll. 65-6. At oral argument, plaintiff conceded that this description met its definition of "active cooling." Plaintiff then argued that this embodiment fails to meet the claim limitation that the cooling member be "coupled to" the energy delivery device. However, prior art need not necessarily teach each and every limitation of the claims at issue to defeat a motion for preliminary injunction.See Amazon.com, 239 F.3d at 1359.
Defendants also argue that the Koop patent describes "dynamic cooling" through the use of "coolant spray [that] can be provided through a hand piece . . ." Col. 5, ll. 5-9. Plaintiff argues that the "coolant spray" embodiment fails to meet the claim limitation that the cooling member be "coupled to" the energy delivery device. However, the Koop patent specifically states that the hand piece "can be utilized as a hand piece for delivery device 112 and heat sink 114." Col. 6, ll. 6-8. Delivery device 112 is an energy delivery device. The hand piece that delivers the coolant, thus, must be coupled to the energy delivery device. Accordingly, defendant has raised a substantial question whether Koop anticipates claim 1.
3. Enablement
"To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation'" Genentech, 108 F.3d at 1365 (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)).
A patent specification complies with the statute even if a "reasonable" amount of routine experimentation is required. Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999). A court may consider the following factors in deciding whether a disclosure would require undue experimentation: 1) the quantity of experimentation necessary; 2) the amount of direction or guidance present; 3) the presence or absence of working examples; 4) the nature of the invention; 5) the state of the prior art; 6) the relative skill of those in the art; 7) the predictability or unpredictability of the art; and 8) the breadth of the claims. Id.
In this case, defendants have raised a substantial question whether the '624 patent is enabled. As previously discussed, the patent does not contain any working examples of a device that utilizes both light and RF energy. Contrary to plaintiff's arguments, figure 1 does not show both electrodes and a light source in the same device.
Although the patent contains some general parameters for delivering electromagnetic energy, there is no specific guidance for applying these parameters when using both light and RF energy in the same device. See col. 7, ll. 34-39; Grundfest Supp. Decl. ¶¶ 17-20. For example, the patent does not indicate whether the power and energy densities set forth would be the maximum for both energy sources or the maximums for each source. Id. ¶ 20. Additionally, there is no guidance on the sequence and duration when applying two different energies. Id. ¶ 25. Further, the patent does not disclose whether these parameters are designed to achieve any particular tissue effect.
Defendants' expert further states that the parameters actually teach away from the use of light because light is typically applied at higher power densities than the patent's suggestion of 10 joules/sec/cm². Id. ¶ 19. For example, the Polaris WR applies light at a power density of approximately 200 joules/sec/cm². Id.
Additionally, for purposes of plaintiff's motion, the Court finds that the combination of light and RF energy to treat skin was not well known in June 1999. No commercial devices used the combination of light and RF for dermatological procedures. Grundfest Decl. ¶¶ 38-39. Plaintiff has not offered any evidence to rebut defendants' expert on this point.
Both parties' experts agree that different skin treatments might require different operating parameters and that there are different variations in skin type. Grundfest Supp. Decl. ¶ 24; Reitman Supp. Decl. ¶¶ 30, 32. For example, the parameters of energy used for wrinkle reduction differ significantly from that used for hair removal. Grundfest Decl. ¶ 35. As a result, defendants argue that one skilled in the art would need to experiment with numerous independent variables such as pulse width, pulse repetition rate, wavelength, and power density and whether to use incoherent or coherent light. Grundfest Supp. Decl. ¶ 22. This would involve combining various possible parameters with various types of skin. Id. On the record before the Court, it appears that such experimentation would be extensive.
Due to the absence of working examples, the lack of guidance concerning parameters for combining light and RF energy, the extensive experimentation required, and absence of prior art disclosing the combination of light and RF to treat skin, defendants have raised a substantial question whether claim 1 is enabled.
4. Obviousness
The Court will not consider defendants' arguments relating to obviousness because defendants raised this defense for the first time in their Surreply and plaintiff has not had an opportunity to respond.
CONCLUSION
Thermage has shown that the Polaris WR system likely infringes claim 1 of the '624 patent. However, defendants have raised substantial challenges to the patent's validity. It is not necessary for this Court to consider the remaining preliminary injunction factors because Thermage has not established a likelihood of success on the merits. See Reebok Int'l Ltd. v. J. Baker Inc., 32 F.3d 1552, 1556 (Fed. Cir. 1994) ("[A] district court may properly deny a motion for preliminary injunction simply based on the movant's failure to establish a reasonable likelihood of success on the merits."). Accordingly, plaintiff's motion for preliminary injunction is hereby DENIED.
IT IS SO ORDERED.