Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-934; Certain Dental Implants.

U.S. Department of Homeland Security Washington, DC 20229 U.S. Customs and Border Protection HQ H275977 July 13, 2016 OT:RR:BSTC:IPR H275977 RES CATEGORY: 19 U.S.C. §1337; Unfair Competition David A. Hickerson Partner Foley & Lardner LLP Washington Harbor 3000 K St, N.W. Suite 600 Washington, D.C. 20007-5109 RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-934; Certain Dental Implants. Dear Mr. Hickerson: This is in reply to your letter dated May 24, 2016, on behalf of Instradent USA, Inc. (“Instradent”), in which you requested a ruling, pursuant to 19 C.F.R. Part 177, as to whether certain dental implants are outside the scope of the above referenced Limited Exclusion Order (“LEO”) and not subject to exclusion from entry for consumption into the United States. In addition to the submitted ruling request, you also met with members of my staff on May 6, 2016, where you presented information on the redesigned implants and you provided us with samples of both the accused and redesigned products. FACTS: The Commission instituted Investigation No. 337-TA-934 (“the ‘934 LEO”) on October 27, 2014, based on a complaint filed by Nobel Biocare Services AG of Switzerland and Nobel Biocare USA, LLC of Yorba Linda, California (“Nobel”/”Complainant”) against Instradent USA, Inc. (formerly Neodent USA, Inc.) of Andover, Massachusetts, and JJGC Indústria e Comércio de Materiais Dentários S/A of Paraná, Brazil (collectively “Respondents”). See 79 Fed. Reg. 63940-41 (Oct. 27, 2014). Nobel alleged violations against the respondents of section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337) by reason of patent infringement of one or more claims of U.S. Patent Nos. 8,764,443 (“the ’443 patent”), and 8,714,977 (“the ’977 Patent”). Id. Specifically, Nobel asserted that Instradent’s “Drive CM” dental implants infringed on claims 15-19, 29, 30, and 32 of the ‘443 patent and infringed on claims 1-5 and 19 of the ‘977 patent. Id at 63940. During the investigation, the parties designated three of the Neodent Drive CM dental implant models as representative products for the purpose of the infringement analysis: the 5.0 mm x 13 mm implant (“5.0 mm”), the 4.3 mm x 13 mm implant (“4.3 mm”), and the 3.5 mm x 13 mm implant (“3.5 mm”) (collectively “the accused products”). See Administrative Law Judge Initial Determination (“FID”) at 4-5 (Oct. 27, 2015). Nobel accused all three representative models of infringing the ‘443 patent, but only accused the 5.0 mm and 4.3 mm implants of infringing the ‘977 patent. Id. On October 27, 2015, the Administrative Law Judge (“ALJ”) issued his Final Initial Determination, finding a violation of Section 337, based upon his determinations that the accused products infringed independent claim 15 and dependent claims 18, 19, 30, and 32 of the ‘443 patent. See FID at 97 – 101. The ALJ determined that each of the representative products practiced all the elements of claim 15 of the ‘443 patent as the accused products are (a) dental implants with (b) a thread extending above the implant body in a spiral trajectory where (c) the outer surface of the thread possesses a wave pattern with at least one trough—wherein the ALJ defined the term trough as a “long, narrow depression, as between waves or ridges” (Id. at 93)—that (d) follows the spiral trajectory of the thread and (e) the depth of the trough is in the approximate range of 25 to 200 microns. Id. With regard to the ‘977 patent, the ALJ found that the 5.0 mm and 4.3 mm Drive CM products practiced all the claim limitations of independent claim 1. See FID at 37. Specifically, these accused products were dental implants that had a coronal region and an apical region with the coronal region of the body that has a frustoconical shape. Id. at 38. The implants possessed a pair of helical threads that extended from the body of the apical region, wherein each thread has a lateral edge that varied in width that had its least width near the tapered point of the apical region and its greatest width near the coronal end of the apical region. Id. The implant threads also had a variable height with the least height where the threads were adjacent to the coronal end of the apical region and the greatest thread height at the apical end of the apical region. Id. Figure 2 below demonstrates the thread width and height claim element. Lastly, the accused products possessed a bone tap that started at the apical end of the apical region where the helical threads began wherein the helical threads had a thread step measurement of between 1.5 – 2.5 mm. Id. However, the ALJ determined that the asserted claims 1-5 and 19 of the ‘977 patent were invalid as being anticipated under 35 U.S.C. § 102 based on a dental implant that was described in a catalog found to qualify as a “printed publication” prior art reference under § 102(b), and thus there was no violation of Section 337 with regard to the ‘977 patent. See FID at 63-65. On January 14, 2016, the Commission determined to review in part the ALJ’s Final Determination infringement findings with respect to claims 1-5 of the ‘977 patent, to the claim construction of the term “the coronal region having a frustoconical shape,” and the findings regarding the validity of the ‘977 patent. See 81 Fed. Reg. 3471 (Jan 21, 2016). The Commission issued its opinion on April 26, 2016, affirming the ALJ’s construction of the term “the coronal region having a frustoconical shape” to mean “the coronal region has partly or entirely, a frustoconical shape” and affirming the ALJ’s finding that the accused products infringed claims 1-5 of the ‘977 patent. See Commission Opinion “CO” at 23 (Apr. 26, 2016). The Commission reversed the ALJ’s findings that the ‘977 patent claims were invalid. See CO at 43. The Commission determined that the catalog cited by the ALJ as a prior art reference did not qualify as a “printed publication” under 35 U.S.C. § 102(b) because the respondents failed to show by clear and convincing evidence that the catalog was publicly accessible prior to the ‘977 patent filing date. See CO at 29-43. Thus, the Commission found a violation of section 337 with respect to claims 1-5 of the ‘977 patent. See CO at 43. Accordingly, the Commission determined that the appropriate remedy was a limited exclusion order (“LEO”) prohibiting entry of dental implants imported by the respondents that infringe the above listed claims of the ‘977 and ‘443 patents. See CO at 47. On April 26, 2016, the ITC issued the LEO, directing that dental implants infringing on any of the claims 1-5 of the ‘977 patent and claims 15, 18, 19, 30, and 32 of the ‘443 patent, imported by the respondents in Investigation 337-TA-934, or any of their affiliated companies, parents, subsidiaries, licensees, contractors, or other related business entities, or their successors or assigns are excluded from entry for consumption into the United Sates, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse for consumption, except under license of the owner of the ‘977 and ‘443 patents or as provided by law. See 81 F.R. 26255-56 (April 26, 2016). The LEO also provided, at the discretion of CBP, a certification process for entities seeking to import dental implants that are potentially subject to the LEO. Id. There are multiple claims associated with the ‘977 and ‘443 patents that form the basis of the LEO. However, for purposes of this ruling request, only the independent claims are at issue here. The independent claim 1 of the ‘977 patent reads as follows: A dental implant comprising: a body; a coronal region of the body, the coronal region having a frustoconical shape wherein a diameter of an apical end of the coronal region is larger than a diameter of a coronal end of the coronal region; an apical region of the body, the apical region having a core with a tapered region wherein a diameter of an apical end of the core is smaller than a diameter of a coronal end of the core and the apical end of the core is substantially flat; and a pair of helical threads extending from the body along at least a portion of the apical region, each of the threads comprising an apical side, a coronal side, and a lateral edge connecting the apical side and the coronal side, a base connecting the threads to the core, a thread height defined between the lateral edge and the base, the lateral edge having a variable width that is expanded along a segment in the direction of the coronal end of the apical region, so that a least width of the lateral edge of the threads is adjacent the apical end of the apical region and a greatest width of the lateral edge of the threads is adjacent the coronal end of the apical region, and the threads having a variable height that is expanded substantially along the segment of the implant in the direction of the apical end of the apical region, so that a least height of the threads is adjacent the coronal end of the apical region and a greatest height at apical end of the apical region; and a bone tap, wherein the helical threads starts at a said bone tap and said substantially flat apical end of the core; wherein each of the helical threads have a thread step that is defined as a distance along a longitudinal axis of the dental implant covered by a complete rotation of the dental implant, the thread step is between 1.5-2.5 mm. The independent claim 15 of the ‘443 patent reads as follows: A dental implant comprising: An implant body defining a thread extending about the implant body in a spiral trajectory, the thread defining an outer surface, wherein when seen in side view, the outer surface of the thread comprises a wave pattern with at least one trough, the wave pattern extending generally in the direction of the longitudinal axis of the implant body, the trough extending in a course that substantially follows the spiral trajectory of the thread, the wave pattern having a respective trough depth in the range of between approximately 25 to 200 um. Figure 1 below is an example depicting the dental implant that is the subject of the ‘977 patent and figure 2 is a technical diagram depicting the features of the implant threads claimed in the ‘977 patent (both pictures were taken from the ‘977 patent). Figure 3, which was not taken from the ‘977 patent but was provided by Instradent, demonstrates the features described in claim 1 of the ‘977 patent. See Ruling Request (“RR”) at 12.


Figure 1 Figure 2 Figure 3 Figure 4, which was provided by Instradent and was excerpted from Nobel’s infringement chart filed with the ITC during the investigation, demonstrates the wave pattern limitation in claim 15 of the ‘443 patent.
Figure 4 Redesigned Dental Implants You stated that during the investigation, Instradent ceased importing the dental implants that were accused in the ‘934 Investigation and that Instradent redesigned their dental implants. See RR at 4. You also indicated that the redesigned products at issue here have the same product codes/model numbers as the accused products, which was noted in the Commission Opinion as well, and that these codes will eventually be changed for the new designs. Id. at 5; CO at 44-45. You asserted that the redesigned dental implants do not infringe claim 15 of the ‘443 patent because the implants do not possess a “trough on top of the thread[s] that is distinct and separate from the underlying thread pattern.” See RR at 6-9. Figure 5 below is a diagram you submitted depicting the lack of a trough in the threads in comparison to the accused product with troughs. Id. at 7.
Accused Dental Implant (3.5 mm)   Redesigned Dental Implant (3.5 mm)   Figure 5 With respect to the ‘977 patent, you asserted that none of the redesigned implants possess the following limitations: The least width of the lateral edge of the thread is adjacent to the apical end of the apical region; The least height of the threads is adjacent to the coronal end of the apical region; A substantially flat apical end; and A bone tap that starts at the substantially flat apical end. (See RR at 14). In contrast to the above listed claim limitations, you stated that the redesigned implants have the following new features: The least width of the lateral edge of the thread is in the middle of the apical region while the coronal and apical ends of the apical region have a wider lateral edge; The greatest height of the threads is located in the middle of the apical region, while the smaller height of the threads is located in the coronal and apical ends of the apical region which give the implants a tapered look; The apical end is rounded; and The bone tap is discontinuous and starts on the thread about a half revolution up from the tip of the apical end; (See RR at 15- 18) Figures 6 and 7 below, provided by you in the ruling request, are schematics of the new designs for the 4.3 mm and 5.0 mm implants, respectively. The tables of the thread measurements, which are part of each figure, establish that the height of the threads and lateral-edge width of the threads have their greatest height and least width in the center of the apical region. For example, lateral-edge widths of the thread at the apical end, middle, and coronal end in the apical region are .31 mm, .21 mm, .43 mm, respectively. The figures also show the rounded apical end and the noncontiguous bone tap notches.
Figure 6 (See RR at 16).
Figure 7 (See RR at 17). You also highlighted the fact that the old design of the 3.5 mm implant was not accused in the ‘934 Investigation to infringe the ‘977 patent and you noted that this implant lacked the “coronal region having a frustoconical shape” limitation in claim 1 of the ‘977 patent. See RR at 11. Figure 8, which was included in the petition, shows the lack of this claim limitation in both the old and new designs.
Old Design New Design Figure 8 (See RR at 11) As a final matter, a visual examination of the sample redesigned implant reveals that it does have a round apical end rather than a flat end and that the bone tap does not start at the apical end, but rather the first bone tap notch begins approximately a half turn of the threads up from the apical end and is not continuous as the rest of the bone tap notches are offset from each other by a slight rotation. Also, there is no trough visible on the lateral edge of the threads and the narrowest part of the lateral edge appears to be the thread in the middle of the apical region. Lastly, although the thread height cannot be precisely measured at this time without the proper equipment, a visual assessment of the redesigned implant reveals that it is tapered toward the apical end. In contrast, an accused dental implant sample does not have a taper. This indicates that the thread height of the redesigned implant is the least toward the apical end of the apical region. ISSUE: Whether Instradent’s redesigned dental implants are subject to exclusion from entry for consumption into the United States. LAW AND ANALYSIS: Patent Claims Patent infringement determinations for utility patents entail two steps. The first step is to interpret the meaning and scope of the patent claims asserted to be infringed. The second step is to compare the properly construed claims to the accused device. See Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370 (1996). The first step is a question of law; the second step is a question of fact. See Freedman Seating Co. v. American Seating Company, 420 F.3d 1350, 1357 (Fed. Cir. 2005). In patent law, there are two types of infringement: direct and indirect infringement. Direct infringement includes two varieties: literal infringement and infringement under the doctrine of equivalents. Literal infringement is when every limitation recited in a claim is found in the accused device. See Strattec Security Corp. v. General Automotive Specialty Co., 126 F.3d 1411, 1418 (Fed. Cir. 1997); see also Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1349 (Fed. Circ. 1998) (“An accused device cannot infringe, as a matter of law, if even a single limitation is not satisfied.”). Additionally, a dependent claim cannot be found to infringe if the independent claim from which it depends is not found to infringe. See Becton Dickinson & Co. v. C.R. Bard Inc., 922 F.2d 792, 798 (Fed. Cir. 1990) (“The holding of noninfringement of claim 1 applies as well to all claims dependent on claim 1.”). As for the scope of protection provided, 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.” Innova/Pure Water, Inc. v. Safari Water Filtration Systems, Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004); Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“[W]e look to the words of the claims themselves…to define the scope of the patented invention.”). Furthermore, the CAFC has made clear that claim terms are given their ordinary and customary meaning, which refers specifically to the ordinary and customary meaning that the claim term would have to a person of ordinary skill in the art at the time of the invention. See Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation. See Innova, 381 F.3d at 1116. That starting point is based on the well-settled understanding that inventors are typically persons skilled in the field of the invention and that patents are addressed to and intended to be read by others of skill in the pertinent art. See Verve, LLC v. Crane Cams, Inc., 311 F.3d 1116, 1119 (Fed. Cir. 2002). The person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification. See Phillips, 415 F.3d at 1313. Often, this requires an examination of terms that have a particular meaning in a field of art. Id. Since the meaning of a claim term, as understood by persons of skill in the art, is often not immediately apparent, and since patentees frequently act as their own lexicographers, a court or administrative body responsible for making patent infringement determinations should look to sources available to the public that show what a person of skill in the art would have understood a disputed claim term to mean. Id. These sources include, for example, the words of the claims themselves, the remainder of the specification and the prosecution history, along with certain extrinsic evidence in appropriate circumstances. Id. Importantly, as stated by the CAFC in Vitronics and reaffirmed in Phillips, claims must be read in light of the specification, of which they are a part, since the 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.” Phillips, 415 F.3d at 1315 (citing Vitronics, 90 F.3d at 1582); see also Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir. 1985) (“The specification is, thus, the primary basis for construing the claims.”). While continuing to be mindful of this fine line between interpretation and importation, Phillips explains that: [T]he line between construing terms and importing limitations can be discerned with reasonable certainty and predictability if the court’s focus remains on understanding how a person of ordinary skill in the art would understand the cl