Viveve, Inc. v. ThermiGen LLC et al, No. 2:2016cv01189 - Document 66 (E.D. Tex. 2017)

Court Description: MEMORANDUM OPINION AND ORDER. Signed by District Judge Rodney Gilstrap on 11/13/2017. (ch, )
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Viveve, Inc. v. ThermiGen LLC et al Doc. 66 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS MARSHALL DIVISION VIVEVE, INC., Plaintiff, v. THERMIGEN, LLC, THERMIAESTHETICS, LLC, & RED ALINSOD, M.D., Defendants, § § § § § § § § § § § § § Case No. 2:16-CV-1189-JRG MEMORANDUM OPINION AND ORDER On October 18, 2017, the Court held a hearing to determine the proper construction of the disputed claim terms in United States Patent No. 8,961,511 (“the ’511 Patent”). The Court has considered the arguments made by the parties at the hearing and in their claim construction briefs. (Dkt. Nos. 53, 57, & 62.) The Court has also considered the intrinsic evidence and made subsidiary factual findings about the extrinsic evidence. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005); Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The Court issues this Claim Construction Memorandum and Order in light of these considerations. Dockets.Justia.com TABLE OF CONTENTS I. BACKGROUND ................................................................................................................ 3 II. APPLICABLE LAW .......................................................................................................... 3 III. CONSTRUCTION OF AGREED TERMS ........................................................................ 6 IV. CONSTRUCTION OF DISPUTED TERMS ..................................................................... 7 A. “heating the target tissue” .............................................................................. 7 B. “remodeling the therapeutic zone of target tissue” ...................................... 14 C. Preamble: “A method for remodeling . . .” .................................................. 21 V. CONCLUSION ................................................................................................................. 28 2 I. BACKGROUND The ’511 Patent was filed on February 7, 2007, issued on February 24, 2015, and is titled “Vaginal Remodeling Device and Methods.” The ’511 Patent is generally directed to a method “for tightening tissue of the female genitalia by heating targeted connective tissue with radiant energy, while cooling the mucosal epithelial surface over the target tissue to protect it from the heat.” ’511 Patent at Abstract. The specification further states that “[t]he effect of the applied heat is to remodel genital tissue by tightening it,” and that “[t]he tightening may be 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.” Id. The specification indicates that the method covered by the ’511 Patent provides an alternative to invasive surgical procedures, which “can bring with them a risk of scarring that is entirely counterproductive with regard to the desired result.” Id. at 2:9–21. Claim 1 of the ’511 Patent is an exemplary claim and recites the following elements (disputed term in italics): 1. 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 portion of the vagina extending from the introitus inwardly to a location from 1 cm to 3.5 cm in from the introitus. II. APPLICABLE LAW A. Claim Construction “It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to which the patentee is entitled the right to exclude.’” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys., Inc., 3 381 F.3d 1111, 1115 (Fed. Cir. 2004)). To determine the meaning of the claims, courts start by considering the intrinsic evidence. Id. at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad Commc’ns Group, Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims themselves, the specification, and the prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at 861. The general rule—subject to certain specific exceptions discussed infra—is that each claim term is construed according to its ordinary and accustomed meaning as understood by one of ordinary skill in the art at the time of the invention in the context of the patent. Phillips, 415 F.3d at 1312–13; Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1368 (Fed. Cir. 2003); Azure Networks, LLC v. CSR PLC, 771 F.3d 1336, 1347 (Fed. Cir. 2014) (“There is a heavy presumption that claim terms carry their accustomed meaning in the relevant community at the relevant time.”) (vacated on other grounds). “The claim construction inquiry . . . begins and ends in all cases with the actual words of the claim.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). “[I]n all aspects of claim construction, ‘the name of the game is the claim.’” Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1298 (Fed. Cir. 2014) (quoting In re Hiniker Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998)). First, a term’s context in the asserted claim can be instructive. Phillips, 415 F.3d at 1314. Other asserted or unasserted claims can also aid in determining the claim’s meaning, because claim terms are typically used consistently throughout the patent. Id. Differences among the claim terms can also assist in understanding a term’s meaning. Id. For example, when a dependent claim adds a limitation to an independent claim, it is presumed that the independent claim does not include the limitation. Id. at 1314–15. 4 “[C]laims ‘must be read in view of the specification, of which they are a part.’” Id. (quoting Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc)). “[T]he specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’” Id. (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)); Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). But, “‘[a]lthough the specification may aid the court in interpreting the meaning of disputed claim language, particular embodiments and examples appearing in the specification will not generally be read into the claims.’” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quoting Constant v. Advanced MicroDevices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988)); see also Phillips, 415 F.3d at 1323. “[I]t is improper to read limitations from a preferred embodiment described in the specification—even if it is the only embodiment—into the claims absent a clear indication in the intrinsic record that the patentee intended the claims to be so limited.” Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004). The prosecution history is another tool to supply the proper context for claim construction because, like the specification, the prosecution history provides evidence of how the U.S. Patent and Trademark Office (“PTO”) and the inventor understood the patent. Phillips, 415 F.3d at 1317. However, “because the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes.” Id. at 1318; see also Athletic Alternatives, Inc. v. Prince Mfg., 73 F.3d 1573, 1580 (Fed. Cir. 1996) (ambiguous prosecution history may be “unhelpful as an interpretive resource”). 5 Although extrinsic evidence can also be useful, it is “‘less significant than the intrinsic record in determining the legally operative meaning of claim language.’” Phillips, 415 F.3d at 1317 (quoting C.R. Bard, Inc., 388 F.3d at 862). Technical dictionaries and treatises may help a court understand the underlying technology and the manner in which one skilled in the art might use claim terms, but technical dictionaries and treatises may provide definitions that are too broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly, expert testimony may aid a court in understanding the underlying technology and determining the particular meaning of a term in the pertinent field, but an expert’s conclusory, unsupported assertions as to a term’s definition are entirely unhelpful to a court. Id. Generally, extrinsic evidence is “less reliable than the patent and its prosecution history in determining how to read claim terms.” Id. The Supreme Court recently explained the role of extrinsic evidence in claim construction: In some cases, however, the district court will need to look beyond the patent’s intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period. See, e.g., Seymour v. Osborne, 11 Wall. 516, 546 (1871) (a patent may be “so interspersed with technical terms and terms of art that the testimony of scientific witnesses is indispensable to a correct understanding of its meaning”). In cases where those subsidiary facts are in dispute, courts will need to make subsidiary factual findings about that extrinsic evidence. These are the “evidentiary underpinnings” of claim construction that we discussed in Markman, and this subsidiary factfinding must be reviewed for clear error on appeal. Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). III. CONSTRUCTION OF AGREED TERMS The parties agreed to the construction of the following terms/phrases: Claim Term/Phrase “epithelium” Agreed Construction “surface layer tissue” (Claims 1, 5, 17, 19, 35, 37, 40, 43, 45, 48, 51, 53, 56) 6 “mucosal epithelium” “mucous surface layer tissue” (Claims 23, 24) “energy delivery element” No construction necessary—plain and ordinary meaning (Claims 5, 17, 37, 40, 45, 48, 53, 56) (Dkt. No. 63 at 2). In view of the parties’ agreement on the proper construction of the identified terms, the Court ADOPTS the parties’ agreed constructions. IV. CONSTRUCTION OF DISPUTED TERMS The parties’ dispute focuses on the meaning and scope of three phrase in the ’511 Patent. A. “heating the target tissue” Disputed Term “heating the target tissue” Plaintiff’s Proposal Plain and ordinary meaning. Defendants’ Proposal “heating the collagen tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium” 1. The Parties’ Positions The parties dispute whether the phrase “heating the target tissue” requires heating the tissue to a “to a temperature that is higher than the temperature of the epithelium,” as Defendants contend. Plaintiff argues that Defendants’ construction seeks to add two limitations to the phrase that are not recited in the claims, and are inconsistent with the remaining intrinsic evidence. (Dkt. No. 53 at 8). According to Plaintiff, the independent claims only require the target tissue to be heated. (Id. at 9). Plaintiff further argues that the temperature of the target tissue before the physician begins treatment may be the reference point for determining whether the tissue has been heated. Id. Plaintiff also contends that the additional technique of “cooling” the epithelium may be employed to create a reverse thermal gradient in certain embodiments. Id. (citing ’511 Patent at 13:30–45). 7 Plaintiff also argues that the claims asserted against Defendants do not include an epithelium limitation, and that limitation is expressly recited in other claims. (Dkt. No. 53 at 9) (citing ’511 Patent at Claims 9 and 15). According to Plaintiff, the specification cannot overcome the claim language because it repeatedly describes cooling as “embodiments of the invention.” (Dkt. No. 53 at 10) (citing ’511 Patent at 13:27, 13:30–31, 13:37–38). Plaintiff also contends that Defendants’ construction improperly limits the “target tissue” to “collagen.” (Dkt. No. 53 at 10). According to Plaintiff, Defendants’ construction is contrary to the specification because it describes “target tissue” as including both collagen and muscularis. Id. (citing ’511 Patent at 3:4347). Defendants respond that the methods of the ’511 Patent expressly “build on those of [the] prior art such as those described by Knowlton [’316].” (Dkt. No. 57 at 14) (citing ’511 Patent at 5:65–67). According to Defendants, the Knowlton prior art describes methods for heating and cooling target tissue simultaneously, i.e., creating a reverse thermal gradient in order to protect the epithelial surface. (Dkt. No. 57 at 14). Defendants argue that the surface tissue temperature is purposefully maintained lower than that of the underlying “target tissue” so as to provoke subdermal remodeling, without effecting any thermally-induced change to the surface tissue. Id. (citing Dkt. No. 57-2 at claims 1, 20, 22-24; Dkt. No. 57-3 at claims 1, 17). Defendants contend that the principle of reverse thermal gradient is an inextricable part of the invention of Knowlton, and the same must be true of the ’511 Patent. (Dkt. No. 57 at 14). Defendants further argue that every single embodiment of the method described in the specification requires that heating be accompanied by cooling. (Id. at 15) (citing ’511 Patent at 4:40–43). Defendants contend that the overlaying mucosal epithelium does not get heated to the same temperatures as the underlying “target tissue” because the overlaying mucosal epithelium is 8 cooled. (Dkt. No. 57 at 15). Defendants also argue that the ’511 Patent is clear that its claimed methods are non-invasive and substantially non-ablative of genital tissue and its goal is to eliminate the risk of scarring. Id. Defendants contend that these advantages cannot be achieved unless the claims are construed to differentiate between the lower temperature of the epithelium from the higher temperature of tissue to be remodeled underlying the epithelium. (Id. at 16). Defendants argue that the term “heating the target tissue” should be construed so that the heat is applied to the tissue underlying the surface mucosal epithelium, without ablation or the risk of scarring of the epithelial surface. Id. (citing ’511 Patent at 11:27–29). Defendants also argue that requiring the surface tissue temperature to be lower than the underlying tissue during the application of energy (i.e., heating) is a necessary aspect of the invention. (Dkt. No. 57 at 16). Defendants contend that the heating step of the claims must differentiate between tissue temperatures. Id. Defendants argue that the cooling and creation of the reverse thermal gradient are key to the invention as a whole. Id. Regarding Plaintiff’s claim differentiation argument, Defendants argue that their construction would not render the dependent claims redundant. (Id. at 17). Plaintiff replies that the claims are silent as to the temperature of the surface tissue. (Dkt. No. 62 at 5). Plaintiff also argues that Defendants’ construction would also violate the rule that “particular embodiments will not be read into the claims where the claim language is broader than the embodiments,” as well as the doctrine of claim differentiation. Id. (citing Plano Encryption Techs., LLC v. Alkami, Inc., 2017 U.S. Dist. LEXIS 135518 at *7 (E.D. Tex. Aug. 23, 2017)). Plaintiff also contends that building on the teachings of Knowlton does not mean that all aspects of the Knowlton treatments must become part of the claimed invention. (Dkt No. 62 at 5). According to Plaintiff, the ’511 Patent is clear that the inventor built on Knowlton by disclosing 9 novel methods “configured and adapted to particulars of the female genital treatment site.” Id. (citing ’511 Patent at 5:65–6:4). Plaintiff argues that the “build on” passage does not identify either the surface cooling or reverse thermal gradient as the improved features nor as a necessary part of the invention. (Dkt. No. 62 at 5). Plaintiff further argues that there are strong indicia that the patentee did not intend to limit the claims to cooling or a reverse thermal gradient. (Id. at 6). According to Plaintiff, the specification repeatedly and consistently describes the surface tissue cooling and thermal gradient features as mere embodiments of the invention. Id. Plaintiff also contends that the ’511 Patent recites these features in dependent claims. Id. Plaintiff further argues that Defendants cite no evidence that cooling the surface tissue is actually necessary to improve the likelihood that the surface tissue is not damaged. (Id. at 7). Finally, Plaintiff contends that cooling the surface tissue does not necessarily ensure that the goals of the invention are achieved. Id. For the following reasons, the Court finds that the phrase “heating the target tissue” should be construed to mean “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” 2. Analysis The phrase “heating the target tissue” appears in claims 1, 2-4, 15, 35, 36, 43, 44, 51, and 52 of the ’511 Patent. The Court finds that the phrase is used consistently in the claims and is intended to have the same general meaning in each claim. The Court further finds that the intrinsic evidence indicates that a critical aspect of the invention is the manner in which the target tissue is heated. Specifically, the intrinsic evidence indicates that maintaining the epithelium at a temperature lower than the underlying tissue is important to ensure that the epithelium is not damaged or substantially modified by the method. In other words, “[e]mbodiments of the invention 10 provide a method and apparatus for creating a reverse thermal gradient that utilizes one or more RF electrodes 30, to convey energy that manifests as heat in the target tissue, and a mechanism to cool the epithelial surface above the targeted underlying layers.” ’511 Patent at 13:12–16, see also id. at 13:43–45 (“Thus, a reverse thermal gradient is created, with a lower temperature at the mucosal epithelium, and a higher temperature in the underlying tissue.”). The Background section states that a problem with surgical approaches is that they “can bring with them a risk of scarring that is entirely counterproductive with regard to the desired result” Id. at 2:11–12. To address this shortcoming, the specification discloses embodiments that cool the epithelial surface to protect it from the heat. For example, the Abstract states that “[t]his invention relates generally to apparatus and methods for tightening tissue of the female genitalia by heating targeted connective tissue with radiant energy, while cooling the mucosal epithelial surface over the target tissue to protect it from the heat.” Id. at Abstract (emphasis added). Similarly, the Summary of the Invention section states that “[t]he method includes contacting the mucosal epithelium with a treatment tip that has an energy delivering element and a cooling mechanism.” Id. at 4:7–9 (emphasis added). The specification further adds that “[b]y delivering energy to the tissue while cooling the epithelial surface, a reverse thermal gradient is created.” Id. at 4:9–13 (emphasis added). The specification describes the reverse thermal gradient as “a lower temperature at the mucosal epithelium, and a higher temperature in the underlying tissue.” Id. at 13:43–45 (emphasis added). The specification explains that “[i]nasmuch as the overlaying mucosal epithelium is cooled by the method, it does not get heated, and is substantially unaffected by the method.” Id. at 4:60–62 (emphasis added). In other words, “[t]he epithelial surface is thus a conduit for energy passing through to underlying layers, but the energy does not manifest in the form of increased temperature at the epithelial surface. As such, the epithelium 11 itself is not damaged or substantially modified by the method.” Id. at 13:19–23 (emphasis added). Accordingly, the intrinsic evidence indicates that “heating the target tissue” should be construed to mean “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” Defendants’ construction further qualifies the “target tissue” as “collagen tissue.” During the claim construction hearing, Defendants indicated that the “collagen tissue” limitation did not appear to be material to the parties’ dispute. Notwithstanding, the Court rejects this aspect of Defendants’ construction. The specification states that “[t]he target tissue lies immediately beneath the mucosal epithelium of genital tissues, and includes the lamina propria, a connective tissue that includes collagen in the extracellular space, and the muscularis, which includes smooth muscle.” Id. at 3:43–47. The specification further states that “[t]he target zone of embodiments of the invention does not include deeper tissue, such as endopelvic fascia.” Id. at 3:47–48. Thus, the specification indicates that the target tissue is not limited to “collagen tissue,” but may also include the lamina propria and the muscularis. Accordingly, the Court rejects this aspect of Defendants’ construction. Plaintiff argues that Defendants’ construction must be rejected because the claim language is broader than the embodiments. The Court is cognizant that to impose a limited construction, it is “not enough that the only embodiments, or all of the embodiments, contain a particular limitation.” Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012). However, as indicated above, the intrinsic evidence indicates that a critical aspect of the invention is the manner in which the target tissue is heated. In particular, “heating the target tissue” means “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed. Cir. 2005) 12 (“We cannot look at the ordinary meaning of the term . . . in a vacuum. Rather, we must look at the ordinary meaning in the context of the written description and the prosecution history.”). Plaintiff also argues that the concepts of “cooling” and “reverse thermal gradient” are expressly recited in other dependent claims. (Dkt. No. 53 at 9-10). For example, claim 9 recites “the method further comprises cooling the epithelium,” and claim 15 recites “heating the target tissue creates a reverse thermal gradient from the epithelium to the target tissue.” The disputed phrase is “heating the target tissue,” and the Court’s construction addresses the manner in which the target tissue is “heated.” The Court’s construction does not limit the phrase to the cooling discussed in the dependent claims. Moreover, the doctrine of claim differentiation “only creates a presumption that each claim in a patent has a different scope; it is not a hard and fast rule of construction.” Kraft Foods, Inc. v. International Trading Co., 203 F.3d 1362, 1368 (Fed. Cir 2000) (internal quotations omitted). Even if there is overlap, the claim differentiation argument is overcome by the intrinsic evidence, which requires that it is the target tissue below the epithelium that is heated while the epithelial surface remains cool. In other words, “the doctrine of claim differentiation does not serve to broaden claims beyond their meaning in light of the specification, and does not override clear statements of scope in the specification and the prosecution history.” Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1302 (Fed. Cir. 1999) (citation omitted); see also Howmedica Osteonics Corp. v. Zimmer, Inc., 822 F.3d 1312, 1323 (Fed. Cir. 2016) (“Although it is a useful tool, claim differentiation does not require that the ‘dependent claim tail . . . wag the independent claim dog’ in this case.”) (citing N. Am. Vaccine, Inc. v. Am. Cyanamid Co., 7 F.3d 1571, 1577 (Fed. Cir. 1993)). As discussed above, the intrinsic evidence indicates that the proper scope of the phrase “heating the target tissue” is “heating the tissue underlying the epithelium to a temperature 13 that is higher than the temperature of the epithelium.” Finally, during the claim construction hearing, and in a footnote in its reply, Plaintiff argued that the “heating without cooling is enabled because the original claims as well as the specification discusses heating without reference to cooling.” (Dkt. No. 62 at 7 n.3) (citing ’511 Patent at 14:9–15:15). The specification states that “[i]n typical embodiments of the invention, the method provides for surface cooling coincident with the time that heat is being delivered to underlying tissue.” ’511 Patent at 14:9–11 (emphasis added). The specification further states that for other embodiments the method may include cooling before, after, or both before and after the application of heat. Id. at 14:11–17. However, the specification indicates that this cooling is “in addition to cooling the surface while heating the underlying tissue.” Id. (emphasis added). For the reasons discussed above, the intrinsic evidence indicates that the proper scope of “heating the target tissue” is “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” 3. Court’s Construction The Court construes the phrase “heating the target tissue” to mean “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” B. “remodeling the therapeutic zone of target tissue” Disputed Term “remodeling the therapeutic zone of target tissue” Plaintiff’s Proposal “uniform delivery of energy to achieve a therapeutic temperature of a portion of the target tissue that causes tightening or contracting without damaging the mucosal epithelium” 14 Defendants’ Proposal “tightening or contracting the collagen tissue underlying the epithelium of female genital tissue” 1. The Parties’ Positions The parties agree that “remodeling” the target tissue includes at least “tightening or contracting” of the target tissue. (Dkt. No. 57 at 17). The parties dispute whether the phrase should be construed to include the limitations of “uniform delivery of energy” and “without damaging the mucosal epithelium,” as Plaintiff proposes. Plaintiff contends that its construction identifies the “specific concrete steps,” the “specific tissue,” and the “particularized conditions” that define remodeling in the ’511 Patent. (Dkt. No. 53 at 14). Plaintiff argues that the “specific concrete steps” of “remodeling” include the uniform delivery of energy to heat the target tissue. Id. (citing ’511 Patent at 2:60–62, 8:15–18). Plaintiff further argues that the “specific tissue” for “remodeling” is the “therapeutic zone.” (Dkt. No. 53 at 14). According to Plaintiff, the specification defines the therapeutic zone as “that portion of the target tissue which attains the therapeutic temperature, for a sufficient time.” Id. (citing ’511 Patent at 11:23–25, 4:14–16). Plaintiff also argues that the “particularized conditions” for “remodeling” include tightening or contracting the tissue without “damaging the mucosal epithelium.” (Dkt. No. 53 at 15) (citing ’511 Patent at 5:9–11, 2:11–18, 2:60–62, 12:19–21, 2:9– 16). Defendants respond that “remodeling,” “therapeutic zone,” and “target tissue” are all defined terms in the specification. (Dkt. No. 57 at 18) (citing ’511 Patent at 4:14–16, 3:43–48, 13:2–5). Defendants further argue that the “phenomenon” of remodeling is the necessarily passive effect or result caused when heated tissue reaches a sufficient temperature. (Dkt. No. 57 at 18) (citing ’511 Patent at 4:14–16, 5:2–5, 11:21–23). Defendants contend that Plaintiff now seeks to redefine and expand the scope of the term with the importation of additional language. (Dkt. No. 57 at 18). According to Defendants, the insertion of the terms “uniform delivery of energy” and “without damaging the mucosal epithelium” are not required and do not make sense as appended 15 to this claim term. (Id. at 19). Defendants further argue that if Plaintiff’s construction was adopted, the independent claims of the ’511 Patent would provide twice for the separately-recited heating step. Id. Defendants contend that it would be illogical to modify this passive step with an additional active step of “uniform delivery” that is not defined in terms of a method by the patent disclosure. Id. According to Defendants, there is no description as to how uniform delivery is accomplished other than by reference to the unclaimed apparatus. Id. Defendants argue that the term “target tissue” is central to the “remodeling” term and is defined as distinct and physically separate from the epithelium. Id. Defendants also contend that Plaintiff’s limitations would be more appropriately added to the heating step. (Id. at 19-20). According to Defendants, the specification consistently ties preventing damage to the “heating step,” not the “remodeling” step as Plaintiff proposes. (Id. at 20) (citing ’511 Patent at 2:60–62, 8:8–15, 8:18–22, 13:16–26). Defendants further argue that Plaintiff’s construction renders the scope of the claim more ambiguous and would not be helpful to a jury. (Dkt. No. 57 at 20). According to Defendants, the specification provides no guidance on what exactly constitutes “uniform delivery” or “damage” of the mucosal epithelium. Id. Plaintiff replies that if Defendants’ construction is adopted, the “remodeling” limitation would encompass the prior art techniques that the inventor was improving. (Dkt. No. 62 at 9). Plaintiff argues that the specification makes clear that “uniform delivery of energy” is integral to the specification’s definition of remodeling and damage prevention. Id. (’511 Patent at 2:60–62, 8:18–19). Finally, Plaintiff argues that its construction actually narrows the scope of “remodeling” according to the specification’s description of this technique. (Dkt. No. 62 at 10). Plaintiff contends that the specification provides guidance on the concepts of “uniform delivery of energy” 16 and “without damaging the mucosal epithelium.” Id. (citing ’511 Patent at 2:56–60, 13:22–23, 12:19–21). For the following reasons, the Court finds that the phrase “remodeling the therapeutic zone of target tissue” should be construed to mean “causing a zone of tissue within the target tissue to tighten or contract by heating the zone of tissue to a therapeutic temperature.” 2. Analysis The phrase “remodeling the therapeutic zone of target tissue” appears in claims 1, 35, 43, and 51 of the ’511 Patent. The Court finds that the phrase is used consistently in the claims and is intended to have the same general meaning in each claim. The Court agrees with the parties that “remodeling” includes at least “tightening or contracting” of the target tissue. The specification states that “[r]emodeling of genital tissue, as practiced by embodiments of this invention, may be understood variously as contracting or tightening of tissue.” ’511 Patent at 13:2–4 (emphasis added). The specification also states that “[w]hether by denaturation of existing collagen, or by later deposition of new collagen, the effect of remodeling on the tissue is generally one of tissue contraction or tightening.” Id. at 5:2–5 (emphasis added). The specification further indicates that the time the remodeling may occur can vary. Specifically, the specification states that “[r]emodeling of target tissue within the therapeutic zone may occur substantially during the time when the tissue is being heated. Remodeling may also occur substantially after the heating has occurred, for example days or weeks later.” Id. at 4:63–66. Accordingly, the Court finds that “remodeling” includes at least “tightening or contracting” of the target tissue. The Court further finds that “remodeling” includes the step of heating a zone of tissue within the target tissue to a therapeutic temperature. The specification describes the “therapeutic 17 zone” as a zone of tissue within the target tissue that is heated to a therapeutic temperature. ’511 Patent at 4:14–22 (“A zone of tissue that is heated within the target tissues to a threshold level, i.e., to a therapeutic temperature that causes remodeling is termed a therapeutic zone.”). In one embodiment, the specification states that the “[t]emperature is raised to a level that is therapeutic, i.e., to a temperature that causes remodeling, as described herein.” Id. at 11:21–23. The specification further states that “[t]he therapeutic temperature, in some cases may be only as high as 45 degrees C., or as high as 80 degrees C.” Id. at 11:25–27. The specification adds that the “portion of the target tissue which attains the therapeutic temperature, for a sufficient time, is termed the therapeutic zone within the target tissue.” Id. at 11:23–25. Accordingly, the intrinsic evidence indicates that the phrase “remodeling the therapeutic zone of target tissue” should be construed to mean “causing a zone of tissue within the target tissue to tighten or contract by heating the zone of tissue to a threshold level.” To support the additional limitations of “uniform delivery of energy” and “without damaging the mucosal epithelium,” Plaintiff argues that its construction tracks the Court’s previous findings “that remodeling includes a doctor’s application of ‘specific concrete steps to specific tissue under particularized conditions.’” (Dkt. No. 53 at 13-14, 62 at 8) (citing Dkt. No. 43 at 7). The Court first notes that Plaintiff overgeneralizes the Court’s previous findings. In responding to Defendants’ Motion to Dismiss, it was Plaintiff that argued 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.” (Dkt. No. 43 at 7). In denying the Motion, the Court agreed with Plaintiff’s argument. However, the Court further clarified that it is the claims that “provide examples of how the ’511 patent dictates, with specificity, the concrete steps which a doctor should take in 18 performing the claimed method.” (Dkt. No. 43 at 9-10). In other words, the claim language itself indicates that remodeling includes a doctor’s application of “specific concrete steps to specific tissue under particularized conditions.” (Dkt. No. 62 at 8). Furthermore, the Court rejects Plaintiff’s construction because the terms “uniform delivery of energy” and “without damaging the mucosal epithelium” are unwarranted and would confuse the claim language. First, Plaintiff’s construction would create a duplicative and redundant heating step. Claim 1 separately recites “heating the target tissue,” and Plaintiff’s “uniform delivery of energy” is “heating,” which would be redundant of the previously recited “heating” step. Moreover, the disputed phrase is directed towards causing a zone of tissue within the target tissue to tighten or contract by heating the zone of tissue to a therapeutic temperature. Indeed, the specification states that “[n]ot all tissue within the target tissue necessarily reaches this threshold level of heat. In some cases, cooling from the treatment tip may penetrate into the target tissue, and in this situation, the presence of cooled tissue may have an effect on the therapeutic zone, by moving it deeper within the target tissue, for example, or by constraining its volume.” ’511 Patent at 4:16–22. For example, Figure 8 illustrates a therapeutic zone of target tissue beneath contact site 102. ’511 Patent at 14:24–29 (“Also shown below the contact site 102 (with dotted lines) are target tissue layers, the lamina propria 104 and the muscularis 106. In typical embodiments of the invention, the method includes making contact with the epithelium, delivering energy, and then moving the treatment tip to another contact site, and delivering energy there.”) 19 ’511 Patent at Figure 8. Plaintiff’s proposed “uniform delivery of energy” does nothing to clarify causing a zone of tissue within the target tissue to tighten or contract by heating the zone of tissue to a therapeutic temperature. Similarly, the limitation of “without damaging the mucosal epithelium” is captured by the recited step of “heating the target tissue.” As discussed above, a person of ordinary skill in the art would understand that “heating the target tissue” means “heating the tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium.” In other words, “[t]he epithelial surface is thus a conduit for energy passing through to underlying layers, but the energy does not manifest in the form of increased temperature at the epithelial surface. As such, the epithelium itself is not damaged or substantially modified by the method.” ’511 Patent at 13:19–23 (emphasis added). Finally, Plaintiff’s proposed limitations would introduce unwarranted ambiguity into the claim language. A jury could be confused or mislead on what exactly constitutes “uniform delivery of energy” or “without damage” of the mucosal epithelium. Turning to Defendants’ construction, the Court rejects it because it is overly broad. 20 Defendants’ construction reads the “therapeutic zone” out of the claim, and allows the “remodeling” to apply to any collagen tissue underlying the epithelium. As recited in the claims and indicated in the specification, the “therapeutic zone” is a zone within the target tissue. For example, the specification states that “[n]ot all tissue within the target tissue necessarily reaches this threshold level of heat. In some cases, cooling from the treatment tip may penetrate into the target tissue, and in this situation, the presence of cooled tissue may have an effect on the therapeutic zone, by moving it deeper within the target tissue, for example, or by constraining its volume.” ’511 Patent at 4:16–22. Defendants’ construction incorrectly reads the “therapeutic zone” out of the claims, by equating the zone with any collagen tissue underlying the epithelium. As discussed above, the “therapeutic zone” is a zone of tissue within the target tissue that is heated to a therapeutic temperature. As with the previous term, the Court also rejects Defendants’ construction because it further qualifies the “target tissue” as “collagen tissue.” The specification states that “[t]he target tissue lies immediately beneath the mucosal epithelium of genital tissues, and includes the lamina propria, a connective tissue that includes collagen in the extracellular space, and the muscularis, which includes smooth muscle.” Id. at 3:43–47. Thus, the specification indicates that the “therapeutic zone” is not limited to “collagen tissue.” 3. Court’s Construction The Court construes the phrase “remodeling the therapeutic zone of target tissue” to mean “causing a zone of tissue within the target tissue to tighten or contract by heating the zone of tissue to a therapeutic temperature.” C. Preamble: “A method for remodeling . . .” 21 Disputed Term Preamble: “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,” Plaintiff’s Proposal Preamble is limiting, all words having plain and ordinary meaning except as construed or agreed to by the parties Defendants’ Proposal A method of tightening or contracting the collagen tissue underlying the epithelium of female genital tissue including but not limited to* at least one of vulva, introitus and vagina tissue * “Comprising” is an open ended patent claim term. 1. The Parties’ Positions The parties dispute whether the “target tissue” must include tissue of the vulva, introitus, and vagina, as Plaintiff contends, or if “comprising” means that the scope of the claims include “remodeling of any female genital tissue,” as Defendants contend. Plaintiff argues that every independent claim of the ’511 Patent includes the same preamble, and that the preamble provides the antecedent basis for claim elements recited in the body of the independent claims. (Dkt. No. 53 at 16). Plaintiff also contends that Defendants’ construction is wrong because it incorporates its incorrect proposal for the phrase “remodeling.” Id. Defendants respond that the examiner rejected the claims of the application as anticipated by and obvious over the Knowlton reference, because that reference disclosed remodeling of female genital tissue, specifically the cervix. (Dkt. No. 57 at 21). Defendants contend that the patentee amended the claims to include heating the underlying tissue of at least one of three specific locations of the female genitalia: the vulva, introitus, and vagina. Id. (citing Dkt. No. 579; Dkt. No. 57-10). According to Defendants, this amendment does not reflect a limitation to the preamble of the independent claims as issued because the term “comprising” covers the remodeling of any female genital tissue. (Id. at 22). Plaintiff replies that the language of the preamble requires no construction beyond the phrase “remodeling a therapeutic zone within a target tissue.” (Dkt. No. 62 at 10). Plaintiff 22 contends that the remaining terms of the preamble have well known definitions that would be readily apparent to a person of ordinary skill in the art. Id. According to Plaintiff, the ’511 Patent is clear that its methods apply only to certain areas of genital tissue. Id. Plaintiff contends that those areas are specifically called out respectively in the independent claims. Id. Plaintiff further contends that the target tissue must include tissue of the vulva, introitus and vagina. (Id. at 10). For the following reasons, the Court finds that the preamble limits the claims by requiring the target tissue to include tissue underlying an epithelium of female genital tissue that includes at least one of vulva, introitus and vagina tissue. 2. Analysis The disputed preamble appears in claims 1, 35, 43, and 51 of the ’511 Patent. The Court finds that the preamble is used consistently in the claims and is intended to have the same general meaning in each claim. The claim language of the preamble is not confusing or ambiguous. Instead, the dispute centers on the weight that should be given to the amendments made to the preamble during prosecution. During prosecution, the examiner rejected all claims as either anticipated by or obvious over U.S. Patent No. 6,350,276 (“Knowlton ’276”). (Dkt. No. 57-6). The examiner argues that Knowlton “discloses a method for remodeling a therapeutic zone within a target tissue, the target tissue comprising tissue underlying a mucosal epithelium of female genital tissue (as in the embodiment of figures 13-14 describing the treatment of cervix, see col. 13; 35-37) . . . .” (Dkt. No. 57-8 at 3-16). The examiner explained that Knowlton discloses treatment directed to at least the cervix, which is part of “female genital tissue,” and therefore no claim was allowable due to their scope as inclusive of all female genital tissue. Id. In response to the examiner’s rejections regarding the Knowlton ’276 disclosure, the patentee amended claim 1 as follows: 23 (Dkt. No. 57-9 at 3). The patentee argued that “Claim 1, as amended, recites a method for remodeling a therapeutic zone within a target tissue, the tissue including at least one of vulva, introitus, and vagina tissue. Knowlton does not disclose a method for remodeling a therapeutic zone including at least one of vulva, introitus or vagina.” (Dkt. No. 57-9 at 10). In the February 13, 2014 Office Action, the examiner disagreed that the amended preamble overcame the rejection.1 The examiner argued that “while the claim may recite at least one of a vagina, introitus or vulva tissue are part of the target tissue, the other tissue treated in Knowlton are also considered as part of the female genital tissue. The Examiner is also of the position that claim 1, as presently recited, fails to specifically require that those portions (vulva, vagina or introitus tissue) comprising the target tissue are actually required to be either heated or remodeled by the claim.” (February 13, 2014 Office Action at 13). The examiner further stated the following: It is the Examiner’s position that the Applicant’s amendments to each of claims 1 and 41 to which attempt further specify the type of tissue forming at least a part of the therapeutic zone fail to positively require that any of the tissue of the vulva, the introitus or the vagina is actually required to be heated and/or remodeled per claim 1. Similarly, the Examiner does not believe that the apparatus of claim 41 need to treat any of the tissue of the vulva, the introitus or the vagina. That is, the Examiner is of the position that the embodiment of figures 13-14 with the description of the treatment of cervix in col. 13; 35-37, fairly provides for the claimed method and 1 The parties did not include the February 13, 2014 Office Action in the record before the Court. The Court finds that the February 13, 2014 Office Action is an important part of the prosecution history. Indeed, it is the examiner’s direct response to the arguments made by the patentee after amending the preamble. Accordingly, as indicated during the claim construction hearing, the Court takes judicial notice of the February 13, 2014 Office Action, which can be found at https://portal.uspto.gov/pair/PublicPair, and is entered with this Order as Court Exhibit A. 24 apparatus.” (February 13, 2014 Office Action at 14). The examiner further explained that “[t]his lack of a positive requirement of the treatment of the presently-recited areas in claims 1 and 41 is due in part to each limitation’s positioning within the preamble of each [ ] claim, to the claiming that it is the female genital tissue which is comprising the tissue of the vagina, introitus or vulva, and to the lack of a close end to the tissue which can comprise the therapeutic zone.” (February 13, 2014 Office Action at 15) (emphasis added). The examiner indicated that claims 26-29 were allowable “due to the fact that each actually requires the treatment of a portion of the female genital tissue (via heating a specific portion) which is not taught by Knowlton (i.e. not the cervix). Such positive claiming can be used as a guideline when drafting subsequent language.” (February 13, 2014 Office Action at 15). In the June 9, 2014 Office Action Response, the patentee amended the claims as suggested by the examiner. For example, claim 1 was amended as follows: (Dkt. No. 57-10 at 3). The patentee argued that “[b]y this response, claim 1 has been amended to incorporate the allowable subject matter of claim 26, including all of the limitations of the base claim and any intervening claims. Further, claims 27, 28 and 29 have all been re-written as independent claims, including all of the limitations of the base claim and any intervening claims.” (Id. at 10). In the October 9, 2014 Office Action Response, the patentee further amended the 25 independent claims to remove “about” to overcome a 35 U.S.C. § 112(b) rejection. (Dkt. No. 5711 at 3, 6, 12). In the “Reasons for Allowance,” the examiner stated that “[Knowlton ’276] fails to contemplate the specific areas of treatment set forth in independent claims 2 and 27-29. No other reference has been found which discloses, fairly suggests or makes obvious this area of treatment whether taken alone or in combination with the Knowlton [’276].” (Dkt. No. 57-12 at 3). As indicated above, the examiner found that the amendment to the preamble failed “to positively require that any of the tissue of the vulva, the introitus or the vagina is actually required to be heated and/or remodeled per claim 1.” (February 13, 2014 Office Action at 14). The examiner explained that “[t]his lack of a positive requirement of the treatment of the presently-recited areas in claims 1 and 41 is due in part to each limitation's positioning within the preamble of each [ ] claim, . . . and to the lack of a close end to the tissue which can comprise the therapeutic zone.” (February 13, 2014 Office Action at 15) (emphasis added). Thus, the examiner determined that the amended preamble failed to limit the heating/remodeling of the tissue to the vulva, the introitus or the vagina. Therefore, to the extent that a party contends that the preamble limits the claims to remodeling/heating of only the vulva, the introitus or the vagina tissue, the Court rejects that argument. However, as indicated in the prosecution history, the remaining claim language does limit the claims to “specific areas of treatment set forth in [the] independent claim[s].” (Dkt. No. 57-12 at 3). In addition, the plain language of the claim indicates that “the target tissue” includes the “at least one tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue.” Accordingly, the Court finds that the preamble is limiting to the extent that it requires “the target tissue” to include “tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue.” 26 That said, the Court agrees with Defendants that the use of “comprising” in the preamble indicates that the “target tissue” includes, but is not limited to, “tissue underlying an epithelium of female genital tissue comprising at least one of vulva, introitus and vagina tissue.” Georgia-Pacific Corp. v. United States Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir. 1999) (“The transitional term ‘comprising’ . . . is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.”) (citing In re Gray, 53 F.2d 520 (CCPA 1931)). “A drafter uses the term ‘comprising’ to mean ‘I claim at least what follows and potentially more.’” Vehicular Techs. Corp. v. Titan Wheel Int’l, Inc., 212 F.3d 1377, 1383 (Fed. Cir. 2000). Indeed, the examiner stated that “while the claim may recite at least one of a vagina, introitus or vulva tissue are part of the target tissue, the other tissue treated in Knowlton are also considered as part of the female genital tissue.” (February 13, 2014 Office Action at 13). Regarding the remaining portion of Defendants’ construction, the Court rejects it because it is overly broad. As discussed above, Defendants’ construction reads the “therapeutic zone” out of the claim, and allows the “remodeling” to apply to any collagen tissue underlying the epithelium. As recited in the claim and indicated in the specification, the “therapeutic zone” is a zone within the target tissue. For example, the specification states that “[n]ot all tissue within the target tissue necessarily reaches this threshold level of heat. In some cases, cooling from the treatment tip may penetrate into the target tissue, and in this situation, the presence of cooled tissue may have an effect on the therapeutic zone, by moving it deeper within the target tissue, for example, or by constraining its volume.” ’511 Patent at 4:16–22. Defendants’ construction incorrectly reads the “therapeutic zone” out of the claims, by equating the zone with any collagen tissue underlying the epithelium. As discussed above, the “therapeutic zone” is a zone of tissue within the target tissue that is heated to a therapeutic temperature. 27 The Court also rejects Defendants’ construction because it further qualifies the “target tissue” as “collagen tissue.” The specification states that “[t]he target tissue lies immediately beneath the mucosal epithelium of genital tissues, and includes the lamina propria, a connective tissue that includes collagen in the extracellular space, and the muscularis, which includes smooth muscle.” ’511 Patent at 3:43-47. Thus, the specification indicates that the “therapeutic zone” is not limited to “collagen tissue.” 3. Court’s Construction The preamble limits the claims by requiring the target tissue to include tissue underlying an epithelium of female genital tissue that includes at least one of vulva, introitus and vagina tissue. V. CONCLUSION The Court adopts the constructions above for the disputed and agreed terms of the Asserted Patent. Furthermore, the parties should ensure that all testimony that relates to the terms addressed in this Order is constrained by the Court’s reasoning. However, in the presence of the jury the parties should not expressly or implicitly refer to each other’s claim construction positions and should not expressly refer to any portion of this Order that is not an actual construction adopted by the Court. The references to the claim construction process should be limited to informing the jury of the constructions adopted by the Court. So ORDERED and SIGNED this 13th day of November, 2017. ___________________________ _ _ _ _ ____________________________________ RODNEY GILSTRAP DNEY GILSTRAP S UNITED STATES DISTRICT JUD JUDGE ITED STATES E 28 Court Exhibit A