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Viveve, Inc. v. Thermigen LLC

United States District Court, E.D. Texas, Marshall Division

November 13, 2017

VIVEVE, INC., Plaintiff,
v.
THERMIGEN, LLC, THERMIAESTHETICS, LLC, & RED ALINSOD, M.D., Defendants,

          MEMORANDUM OPINION AND ORDER

          RODNEY GILSTRAP, UNITED STATES DISTRICT JUDGE

         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.

         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 fo r remodeling . . .” .................................................. 21

         V. CONCLUSION ................................................................................................................. 28

         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., 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.

         “[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 Micro-Devices, 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”).

         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

Agreed Construction

“epithelium”

(Claims 1, 5, 17, 19, 35, 37, 40, 43, 45, 48, 51, 53, 56)

“surface layer tissue”

“mucosal epithelium”

(Claims 23, 24)

“mucous surface layer tissue”

“energy delivery element”

(Claims 5, 17, 37, 40, 45, 48, 53, 56)

No construction necessary-plain and ordinary meaning

(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

Plaintiff's Proposal

Defendants' Proposal

“heating the target tissue”

Plain and ordinary meaning.

“heating the collagen tissue underlying the epithelium to a temperature that is higher than the temperature of the epithelium”


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