Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-890; Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof

HQ H261481 August 25, 2015 OT:RR:BSTC:IPR H261481 WMW CATEGORY: 19 U.S.C. §1337; Unfair Competition Mr. Smith Brittingham Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-890; Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof Dear Mr. Brittingham: This is in reply to your letter dated February 3, 2015, on behalf of BMC Medical Co., Ltd. (“BMC”), in which you requested a ruling, pursuant to 19 C.F.R. Part 177, as to whether certain of BMC’s products developed after the issuance by the U.S. International Trade Commission (“ITC” or “Commission”) of the above referenced limited exclusion order (“LEO”) are subject to exclusion from entry. Samples of BMC’s Elbow in io Mini-Nasal Mask (“NM2A”) model mask were included with the ruling request. FACTS: The Commission instituted investigation 337-TA-890 on August 23, 2013, based on a complaint filed by ResMed Corporation (“ResMed”). See 78 Fed. Reg. 52564 (Aug. 23, 2013). ResMed alleged violations of section 337 of the Tariff Act of 1930 (19 U.S.C. §1337) by reason of infringement of various claims of U.S. Patent Nos. 7,997,267 (“the ‘267 patent”), 7,614,398 (“the ‘398 patent”), 7,938,116 (“the ‘116 patent”), 7,341,060 (“the ‘060 patent”), 8,312,883 (“the ‘883 patent”), 7, 178,527 (“the ‘527 patent”), 7,950,392 (“the ‘392 patent”), and 7,926,487 (“the ‘487 patent”). The Commission’s notices of investigation named BMC, 3B Medical, Inc. and 3B Products, L.L.C. 3B Medical, Inc., and 3B Products, L.L.C. who distributes products made by BMC. During the course of the investigation, U.S. Patent No RE 44,453 (“the ‘453 patent”) a reissue patent, replaced the ‘398 patent. ResMed also withdrew the ‘116 patent and withdrew claims 26-28 of the ‘487 patent. On August 21, 2014, the Administrative Law Judge (“ALJ”) issued his final initial determination (“ID”), finding a violation of section 337 with respect to certain asserted claims of the ‘392, ‘267, ‘060, ‘883, ‘527, and ‘453 patent. The ALJ found no violation of section 337 with respect to the asserted claims of the ‘487 patent. (See ID at 23, 46, 57-58, 71-78, 95, 99, and 102 (August 21, 2014)). On October 22, 2014, the Commission determined it would review portions of the final ID. See 79 Fed. Reg. 63163-65 (October 22, 2014). The Commission reviewed and modified the ALJ’s construction of the claim term “gas washout vent” in the ‘487 patent. Id at 1. As a result, the Commission said it would review the ALJ’s findings on infringement, invalidity, and the technical prong of the domestic industry requirement. Id. Additionally, the Commission reviewed and modified one of the claim construction rulings made by the ALJ with regards to the ‘453 patent, therefore it would revisit the validity, infringement and domestic industry conclusions made in the ID with respect to the ‘453 patent. Ultimately, the Commission found the ‘453 patent invalid and that the domestic industry requirements were not met with respect to the ‘487 patent. Id. The Commission issued the LEO for infringement of the ‘267, ‘060, ‘883, ‘527, and ‘392 patents. On December 23, 2014 the ITC issued the LEO, directing that “[s]leep-disordered breathing treatment systems and components thereof that infringe one or more of claims 1, 9, 32, 89, and 92 of the ‘527 patent; claims 19, 21, 29, 32, and 36 of the ‘392 patent; claims 32, 33, 34, and 53 of the ‘267 patent; claims 30, 37, and 38 of the ‘060 patent; and claims 1, 3, 5, 11, 28, 30, 31, and 56 of the ‘883 patent that are manufactured by, or on behalf of, or are imported by or on behalf of BMC Medical Co., Ltd., 3B Medical, Ind., or 3B Products L.L.C. or any of their affiliated companies, parents subsidiaries, agents or other related business entities, or their successors or assigns, are excluded from entry for consumption into the United States.” All of the patents at issue in the 337-TA-890 investigation are utility patents. Independent claims 1, 9, and 89 of the ‘527 patent read as follows: 1. A nasal mask cushion assembly to sealingly connect a nasal mask to a wearer’s face, the cushion assembly comprising: A generally triangularly shaped frame of resilient material, the frame including an outer surface, an inner surface having an inwardly oriented rim extending along at least a portion of a perimeter of the frame and a notch adapted to receive the bridge of the wearer’s nose; and A generally triangularly shaped membrane of resilient material, the membrane including an aperture adapted to receive the wearer’s nose, an outer surface including a seal forming portion of the wearer’s face when the mask is in use, an inner surface opposing the rim of the frame, an edge defining the perimeter of the aperture, and a notch in a region of the membrane adapted to receive the bridge of the wearer’s nose, wherein The membrane is more flexible than the frame; The aperture of the frame is larger than the aperture of the membrane; and The edge of the membrane, in use is spaced a distance from the rim in at least the region of the membrane adapted to receive the bridge of the wearer’s nose. 9. A nasal mask cushion assembly to sealingly connect a nasal mask to a wearer’s face, the cushion assembly comprising: a generally triangularly shaped frame of resilient material, the frame including a first side adapted to contact a mask body of the nasal mask, a second side opposite the first side, an aperture extending from the first side to the second side, an inwardly oriented rim extending along at least a portion of a perimeter of the frame and a notch in a region adapted to receive the bridge of the wearer’s nose; and a generally triangularly shaped membrane of resilient material, the membrane including an aperture adapted to receive the wearer’s nose, an edge defining the perimeter of the aperture, a notch in a region adapted to receive the bridge of the wearer’s nose, a first surface including a seal forming portion disposed around the perimeter of the aperture adapted to deform and form a seal over a portion of the wearer’s face in a region between the base of the nose and the upper lip and around the sides and over the bridge of the wearer’s nose when the mask is in use, a second surface opposite the first surface that is spaced a first distance from the rim in at least the region adapted to receive the bridge of the wearer’s nose when the mask is in use, wherein the membrane is more flexible than the frame; the aperture of the membrane is smaller than the aperture of the frame; and the edge of the membrane is spaced a second distance from the rim, the second distance being variable 89. A mask cushion for sealingly connecting a mask to a wearer’s face, comprising: A frame defining at least a portion of a breathing chamber, said frame being of resilient material and having a first membrane, at least a portion of the first membrane including a first molded inwardly curved rim disposed within the breathing chamber; and A saddle-shaped second membrane of resilient material, said second membrane having a second molded inwardly curved rim forming a boundary of said breathing chamber, said second membrane curved rim spaced a distance from said first membrane curved rim, measured when the mask is not in use, a portion of said second membrane curved rim forming a face contacting seal, said second membrane curved rim spaced a sufficient distance from said first membrane curved rim such that under a normal tightening force of the mask to the wearer’s face, the second membrane curved rim remains spaced from the first membrane curved rim around at least a portion of the first membrane curved rim, wherein; The second molded inwardly curved rim is curved in a direction towards a front portion of the frame opposite the face contacting seal, and A substantially full perimeter of the second membrane curved rim is provided in covering yet spaced relation to each portion of the first membrane curved rim. Independent claim 19 of the ‘392 patent reads as follows: 19. A mask cushion for sealingly connecting a mask to a patient’s face during the administration of positive airway pressure, the cushion including: A frame of resilient material, said frame having a rim for substantially surrounding a portion of the patient’s face; A membrane of resilient material and fixed to and extending away from the frame so as to have an outer surface spaced from the rim, in at least one region of the frame, to define a gas-filled gap between the membrane and the frame before the cushion is in use, said membrane being longer than and/or fully covering or overlying the rim as seen in cross section, A seal forming portion of said outer surface forming a face contacting seal, said seal forming portion being provided only on said membrane, said seal forming portion presenting a convex sealing surface to the patient’s face; the membrane being pre-shaped to 1) generally match the contours of the patient’s face; and 2) have the same general shape as said rim, wherein said seal forming portion is resiliently deformable into the gap towards the rim in use of the cushion, and wherein the face contacting seal portion is structured such that it is not required to turn in on itself to conform with the wearer’s face, in use. Independent claim 32 of the ‘267 patent reads as follows: 32. A respiratory mask assembly for delivering breathable gas to a patient, comprising: A frame having a front surface and a rear surface adapted in use to face the patient, the frame including a main body providing an aperture therethrough for the introduction of breathable gas into a nasal breathing cavity; and A quick-release elbow assembly swivelably coupled to the front surface of the frame, the elbow assembly including a swivel elbow, Wherein the swivel elbow includes an end portion that allows quick release attachment to and detachment from the frame while allowing the elbow to swivel. Independent claim 30 of the ‘060 patent reads as follows: 30. A nasal mask assembly for nasal CPAP therapy of a patient comprising: (i) a frame including a first alignment indicator, an aperture and a channel having an inner wall, an outer wall and a channel floor; (ii) a silicone nasal seal selectively and repeatedly attachable to and detachable from the frame, the seal having a face-contacting side and a non-face contacting side, the non-face contacting side being engagable between the inner and outer walls of the frame, the nasal seal including a second alignment indicator on an outer surface of the nasal seal adapted to align with the first alignment indicator on the frame as the seal and frame are engaged with one another; (iii) a rotatable elbow provided to the frame and including one or more vent openings open to atmosphere for gas washout of exhaled carbon dioxide, the elbow being adapted to connect to a gas delivery tube in order to supply pressurized air to the entrance of the patient’s airway; (iv) a headgear assembly including relatively flexible headstraps; and (v) a stiffening support structure extending from the frame to assist in the stabilization of the nasal seal, the stiffening support structure being formed of a relatedly more rigid material in comparison to the relatively flexible headstraps, said stiffening support structure having a degree of flexibility in one direction such that variations in patient physiology can be accommodated, said stiffening support structure being stiffer in another direction generally orthogonal to the one direction to resist vertical rotation of the frame due to the weight of the mask frame and/or components supported by the frame, said stiffening support structure arranged to be positioned adjacent the cheek regions in use, said stiffening support structure having on an inside surface thereof, a layer of relatively soft and flexible material arranged between the patient’s cheek and the stiffening support structure in use, and said layer of relatively soft and flexible material having the same general shape as the stiffening support structure. Independent claim 1 of the ‘883 patent reads as follows: 1. A nasal pillow assembly to provide a supply of air at positive pressure to the entrance of an airway of a patient for treatment of sleep disordered breathing comprising: i) a patient interface provided by a cushion assembly, the cushion assembly comprising: a base portion; a pair of nasal pillows extending from the base portion, each nasal pillow being structured to direct a sealing force to the underside of the nose of the patient and comprising a first concave portion having one end extending from the base portion and a second sealing portion extending from the other end of the first concave portion, the second sealing portion having a narrower first end configured to enter the nasal passage of the patients’ nose in use and a wider second end adjacent the first concave portion, the second sealing portion defining between the narrower first end and the wider second end a tapered surface upon at least part of which sealing is adapted to occur with a patient’s nose on the underside of the nostrils in an area about the rim of the nostril openings in use, and a contour portion structured to contact and direct a stability force to the maxilla of the patient in use; ii) a patient interface retainer assembly configured to maintain in use the patient interface provided by the cushion assembly in position with respect to an underside of a patient’s nose in a region about the nostrils and to provide in use the stability force to the maxilla of the patient, the retainer assembly comprising; a left side portion and a right side portion structured to extend in use from positions on either side of the cushion assembly along the left and right cheeks of the patient towards the left and right temples, the left and right side portions including respective left and right semi-rigid stiffeners structured to add rigidity to the nasal pillows retainer assembly in certain planes and directions, and left and right side straps joined to the respective left and right stiffeners, a coronal strap portion constructed from a soft flexible fabric material and adapted to extend in use over the crown of the patient’s head between the left and right side straps; a rear strap portion constructed from a soft flexible fabric material and adapted to extend in use over the rear of the patient’s head between the left and right side straps, and a tension adjusting arrangement for adjusting the tension in the patient interface retainer assembly, wherein the tension adjusting arrangement is operatively configured to adjust the stability force delivered by the contour position against the maxilla of the patient. On February 3, 2015, BMC submitted a ruling request to CBP regarding the “io Mini-Nasal Mask” (“io mask”) to be imported by BMC, requesting a determination that said masks do not fall under the scope of the LEO. A sample of the io mask was submitted along with the ruling request. The io mask is pictured below.

BMC had previously manufactured a line of “iVolve N2” masks using a different design, which was originally at issue in the Commission’s investigation. The construction of the new io mask design is different from that of the old design. The older design is not at issue in this ruling request. ISSUE: Whether the io masks are covered by the asserted claims of the ‘527 patent, the ‘392 patent, the ‘267 patent, the ‘060 patent, and the ‘883 patent and therefore fall within the scope of the ITC’s Limited Exclusion Order in Investigation No. 337-TA-890, such that they would be excluded from entry for consumption into the United States. LAW AND ANALYSIS: 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 claim terms. For instance, although the specification often describes very specific embodiments of the invention, we have repeatedly warned against confining the claims to those embodiments.…In particular, we have expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment….That is not just because section 112 of the Patent Act requires that the claims themselves set forth the limits of the patent grant, but also because persons of ordinary skill in the art rarely would confine their definitions of terms to the exact representations depicted in the embodiments. Phillips, 415 F.3d at 1323 (internal citations omitted). Accordingly, the CAFC has provided the framework above for interpreting patent claims and reading those claims, as properly construed in light of the relevant evidence, onto an accused device. Pursuant to the Tariff Act of 1930, the ITC has authority to conduct investigations into imported articles that allegedly infringe United States patents and impose remedies if the accused products are found to be infringing. See 19 U.S.C. §1337(a)(1)(B), (b)(1), (d), (f). Specifically, 19 U.S.C. §1337(d) provides the Commission authority to direct the exclusion from entry of articles found to be infringing. Moreover, when the Commission determines that there has been a violation of section 337, it may issue two types of exclusion orders: a limited exclusion order and/or a general exclusion order. See Fuji Photo Film Co., Ltd. v. U.S. Int’l Trade Comm’n, 474 F.3d 1281, 1286 (Fed. Cir. 2007); see also Certain Ink Cartridges and Components Thereof, Inv. No. 337-TA-565, Commission Opinion (October 19, 2007). Both types of orders direct CBP to bar the infringing products from entering the country. See Yingbin-Nature (Guangdong) Wood Indus. Co. v. U.S. Int’l Trade Comm’n, 535 F.3d 1322, 1330 (Fed Cir. 2008). A limited exclusion order is “limited in that it only applies to the specific parties before the Commission in the investigation”. Id. In contrast, a general exclusion order bars importation of the infringing products by everyone, regardless of whether they were respondents in the Commission’s investigation. Id. A general exclusion order is appropriate if two exceptional circumstances apply. See Kyocera Wireless Corp. v. U.S. Int’l Trade Comm’n, 545 F.3d 1340, 1356. A general exclusion order may only be issued if (1) “necessary to prevent circumvention of a limited exclusion order,” or (2) “there is a pattern of violation of this section and it is difficult to identify the source of infringing products.” 19 U.S.C. §1337(d)(2); see also Kyocera, 545 F.3d at 1356 (“If a complainant wishes to obtain an exclusion order operative against articles of non-respondents, it must seek a GEO by satisfying the heightened burdens of §§1337(d)(2)(A) and (B).”). Additionally, a seizure and forfeiture order issued under 19 U.S.C. §1337(i) directs CBP to seize and forfeit articles imported in violation of an exclusion order when the importer previously had articles denied entry and received notice that seizure and forfeiture would result from any future attempt to import covered articles. The issuance of a limited exclusion order by the ITC binds named parties and shifts to would-be importers, “as a condition of entry, the burden of establishing noninfringement.” Hyundai Electronics Industries Co. v. U.S. Int’l Trade Comm’n, 899 F.2d 1204, 1210 (Fed. Cir. 1990). Accordingly, the burden is on BMC to establish that the products at issue are not covered by one or more of the claims at issue in the above mentioned patents. BMC’s io Mini-Nasal Mask BMC provided CBP with one sample of the io mask. The io mask is a new design based upon the iVolve N2 mask which was at issue before the ITC. See Ruling Request p.1 (February 3, 2015). BMC stated that ResMed did not assert that the iVolve N2 masks infringed upon any of the patents at issue in the LEO except for the ‘267 patent. The only difference between the iVolve N2 mask and the new io mask is the way the elbow is attached to the mask frame. Accordingly, BMC principally addressed the ‘267 patent as it relates to the io mask, but additionally identified exemplary claim elements from the other four patents that are missing from the io mask. ‘267 Patent The ‘267 patent deals with continuous positive airway pressure therapy and the devices used to implement it. A typical system has three parts, an airflow generator, a conduit, and an interface. The conduit typically being a hose of some type and the interface being a mask. Usually an “elbow” joint is used to connect the conduit and the interface. BMC states that the ‘267 patent is directed to a quick-release elbow which connects the mask to the conduit. Independent claim 32 has the following element, “a quick-release elbow assembly swivelably coupled to the front surface of the frame…” and “the swivel elbow includes an end portion that allows quick release attachment to and detachment from the frame” See U.S. Patent No. 7,997,267 at col. 37, ll. 10-15. BMC concludes stating that the io mask does not have an elbow assembly with a quick-release mechanism and therefore cannot infringe the claims of the ‘267 patent.

Upon examination of the sample io mask provided by BMC, there is no type of release mechanism present on the elbow assembly, much less a “quick release” assembly as taught by the ‘267 patent. Id. To remove the elbow attachment from the io mask would require destruction of either the elbow joint or the mask itself. As such, the io mask does not practice all of the claims of the ‘267 patent. ‘527 Patent The ‘527 patent also deals with continuous positive airway pressure therapy and the devices used to implement it. More specifically, the ‘527 patent is directed to the nasal cushion which is attached to the mask and is in contact with the face of the patient when the mask is in use. Independent claims 1, 9, and 89 all teach a nasal cushion that is composed of two layers, a frame and a membrane. BMC states that the cushion found on the io mask does not have the taught two-layered nasal cushion. Upon examination of the nasal cushion attached to the io mask, the nasal cushion appears to be formed from a single piece of resilient material. As such the io mask cannot be found to practice all of the claims of the ‘527 patent. ‘392 Patent The ‘392 patent also deals with continuous positive airway pressure therapy and the devices used to implement it. More specifically, the ‘392 patent is directed a more comfortable nasal mask. Independent claim 19 teaches of nasal cushion that is composed of two layers, a frame and a membrane. BMC states that the cushion found on the io mask does not have the taught two-layered nasal cushion. Upon examination of the nasal cushion attached to the io mask, the nasal cushion appears to be formed from a single piece of resilient material. As such the io mask cannot be found to practice all of the claims of the ‘392 patent. ‘883 Patent The ‘883 patent teaches of a nasal assembly for delivering breathable gas to a patient. Independent claims 1, 28, 30, and 31 all teach of a patient interface that has a pair of nasal pillows which through an application of force by the mask design are held to the underside of the nose. BMC states that the io mask does not use such an interface. Upon examination, the io mask does not have such nasal pillows, instead utilizes a singular triangular shaped cushion designed to fit around the nose of the patient. As such the io mask cannot be found to practice all of the claims of the ‘883 patent.
‘060 Patent The ‘060 patent also teaches of a respiratory mask assembly for delivering breathable gas to a patient. BMC argues that independent claim 30 requires both alignment indicators and a rigid yoke structure designed to assist in the stabilization of the nasal seal. Upon examination of the io mask provided by BMC, there is a ridge which extends from the mask frame which is clearly designed to mate with a corresponding slot on the cushion. There is only one configuration of the mask frame and cushion that would allow for the operation of the breathing system. As mentioned, the ‘060 patent also teaches of a rigid yoke structure incorporated into the mask design. Claim 30 teaches of stiffening support structure located over the cheeks of the patient. Upon examination of the io mask, there is no such support structure incorporated into the mask. As such the io mask cannot be found to practice all of the claims of the ‘060 patent.

HOLDING: The io Mini-Nasal mask is not covered by the claims at issue in the ‘527 patent, the ‘392 patent, the ‘267 patent, the ‘060 patent, and the ‘883 patent. Therefore, these products are not within the scope of the ITC’s limited exclusion order in Investigation No. 337-TA-890. Accordingly, the instant products may be entered for consumption into the United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse for consumption. This decision is limited to the specific facts set forth herein. If BMC manufactures or imports sleep-disordered breathing treatment systems that differ from the embodiment described above, or if future importations vary from the facts stipulated to herein, this decision shall not be binding on CBP as provided for in 19 C.F.R. §§177.2(b)(1), (2), and (4), and §§177.9(b)(1) and (2). Sincerely, Charles R. Steuart, Chief Intellectual Property Rights Branch