OT:RR:BSTC:EOE H338253 FKM
Benjamin C. Elacqua
Fish & Richardson P.C.
909 Fannin St. Suite 2100
Houston, Texas 77010
VIA EMAIL: [email protected]; [email protected]
RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1266; Certain Wearable Devices with ECG Functionality and Components Thereof
Dear Mr. Elacqua:
Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch ("EOE Branch"), Regulations and Rulings, U.S. Customs and Border Protection ("CBP") issues this ruling letter. We find that Apple Inc. ("Apple") has met its burden to show that certain redesigned wearable devices ("articles at issue") do not infringe one or more of claims 12, 13, and 19-23 of U.S. Patent No. 10,638,941 ("the '941 Patent") and claims 1, 3, 5, 8-10, 12, 15, and 16 of U.S. Patent No. 10,595,731 ("the '731 Patent). Thus, CBP's position is that the articles at issue are not subject to the limited exclusion order that the U.S. International Trade Commission ("Commission" or "ITC") issued in Investigation No. 337-TA-1266 ("the underlying investigation" or "the 1266 investigation"), pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 ("Section 337"). Entry for consumption into the United States, entry for consumption from a foreign trade zone, or withdrawal from a warehouse for consumption of the articles at issue, however, is conditioned on the drafting and submission of a certification, as provided for in this ruling, that would take effect should the Commission lift the suspension on enforcement of the limited exclusion order. We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision regarding application of an exclusion order under Section 337.
This ruling letter is the result of a request for an administrative ruling from CBP under 19 C.F.R. Part 177, which was conducted on an inter partes basis. The process involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, Apple, the ruling requester and respondent in the 1266 investigation; and (2) AliveCor, Inc. ("AliveCor"), complainant in the 1266 investigation. See, e.g., 19 C.F.R. 177.1(c).
The parties were asked to clearly identify confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]] in all of their submissions to CBP. See 19 C.F.R. 177.2; 177.8. If there is additional information in this ruling letter not currently bracketed in red [[ ]] that either party believes constitutes confidential information, and should be redacted from the published ruling, then the parties are asked to contact CBP within ten (10) working days of the date of this ruling letter. See, e.g., 19 C.F.R. 177.8(a)(3).
Please note that disclosure of information related to administrative rulings under 19 C.F.R. Part 177 is governed by, for example, 6 C.F.R. Part 5, 31 C.F.R. Part 1, 19 C.F.R. Part 103, and 19 C.F.R. 177.8(a)(3). See, e.g., 19 C.F.R. 177.10(a). In addition, CBP is guided by the laws relating to confidentiality and disclosure, such as the Freedom of Information Act ("FOIA"), as amended (5 U.S.C. 552), the Trade Secrets Act (18 U.S.C. 1905), and the Privacy Act of 1974, as amended (5 U.S.C. 552a). A request for confidential treatment of information submitted in connection with a ruling requested under 19 C.F.R. Part 177 faces a strong presumption in favor of disclosure. See, e.g., 19 C.F.R. 177.8(a)(3). The person seeking this treatment must overcome that presumption with a request that is appropriately tailored and supported by evidence establishing that: the information in question is customarily kept private or closely-held and either that the government provided an express or implied assurance of confidentiality when the information was shared with the government or there were no express or implied indications at the time the information was submitted that the government would publicly disclose the information. See Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (concluding that "[a]t least where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is 'confidential' within the meaning of exemption 4."); see also U.S. Department of Justice, Office of Information Policy: Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA (updated 10/7/2019).
I. BACKGROUND
A. ITC Investigation No. 337-TA-1266
1. Procedural History at the ITC
The Commission instituted Investigation No. 337-TA-1266 on May 26, 2021, based on a complaint filed by AliveCor. Certain Wearable Electronic Devices with ECG Functionality and Components Thereof, Inv. No. 337-TA-1266, EDIS Doc. ID 788332, Public Commission Opinion (Dec. 22, 2022) ("Comm'n Op.") at 4 (citing 86 Fed. Reg. 28382 (May 26, 2021)). The complaint, as supplemented, alleged a violation of Section 337 by reason of infringement of certain claims of the '731 patent, the '941 patent, and U.S. Patent No. 9,572,499 ("the '499 patent"). Id. The notice of investigation named Apple as the sole respondent. Id. The Commission's Office of Unfair Import Investigations ("OUII") was named as a party in the investigation. Id.
On June 27, 2022, the Administrative Law Judge ("ALJ") issued the final initial determination ("FID") finding a violation of Section 337. Id. at 5. Specifically, the ALJ determined that a violation of Section 337 occurred in the importation into the United States, the sale for importation, or the sale within the United States after importation, of the accused products that infringed the '731 and '941 patents, but these products were found not to infringe the '499 patent. Id.
On September 22, 2022, the Commission issued a notice in which it determined to review the FID in part and requested submissions responding to the Commission's issues under review and on remedy, the public interest, and bonding. Comm'n Op. at 6 (citing 87 Fed. Reg. 58819-21 (Sept. 28, 2022)). On December 7, 2022, Apple filed an emergency motion requesting the Commission to suspend any remedial order or extend the target date and stay all proceedings prior to the issuance of a Final Determination, pending the resolution of any appeal of the decision by the Patent Trial and Appeal Board ("PTAB"), which determined that the claims of the three patents are unpatentable because they are obvious under 35 U.S.C. 103. Id. at 7 (quoting Respondent Apple Inc.'s Emergency Motion to Suspend any Remedy or Extend the Target Date and Stay Proceedings Pending Resolution of any Appeal of the Patent Office's Decision that United States Patent Nos. 10,638,941, 10,595,731, and 9,572,499 Are Unpatentable at 1; see also Apple Emergency Motion to the Commission at 2. The Commission, in its review of the FID, found a violation of Section 337 as to the '941 and '731 patents and determined that the appropriate remedy was a limited exclusion order and cease and desist order. Comm'n Op. at 88. However, the Commission "determined to suspend enforcement of the orders, including the bond provision, pending final resolution of the PTAB's Final Written Decision finding the asserted claims of the '941, '731, and '499 patents unpatentable." Id.; see Apple, Inc. v. AliveCor, Inc., IPR2021-00971, Patent 10,595,731, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6, 2022); Apple, Inc. v. AliveCor, Inc., IPR2021-00972, Patent 10,638,941, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6, 2022); and 35 U.S.C. 318(b)). As of this time, final resolution of the PTAB's decision has not been reached. See AliveCor, Inc. v. Apple Inc., No. 23-1512, -1513, -1514, Notice of Oral Argument (Fed. Cir. May 21, 2024) (scheduling the oral argument for July 12, 2024).
In the limited exclusion order, the Commission ordered that "[w]earable electronic devices with ECG functionality and components thereof that infringe one or more of claims 12, 13, and 19-23 of the '941 patent; and claims 1, 3, 5, 8-10, 12, 15, and 16 of the '731 patents that are manufactured abroad by or on behalf of, or imported by or on behalf of, Respondent or any of its affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns, are excluded from entry for consumption into the United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse for consumption, for the remaining terms of the patents, except under license of the patent owner or as provided by law, except for articles or components imported for us in servicing, repairing, or replacing covered articles that were imported prior to the effective date of this Order pursuant to existing service and warranty contracts." Certain Wearable Electronic Devices with ECG Functionality and Components Thereof, Inv. No. 337-TA-1266, EDIS Doc. ID 786802, Limited Exclusion Order (Dec. 22, 2022) at 2 ("1266 LEO"). The Commission defined the articles covered by the limited exclusion order as "Apple Watches with ECG functionality, and hardware and software components thereof." Id. Additionally, consistent with the indication above, the Commission's exclusion order provides that "[t]he enforcement of this Order, including the bond provision is suspended pending final resolution of the U.S. Patent and Trademark Office, Patent Trial and Appeal Board's Final Written Decisions finding the asserted patent claims unpatentable." Id. at 3 (citing Apple, Inc. v. AliveCor, Inc., IPR2021-00971, Patent 10,595,731, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6, 2022); Apple, Inc. v. AliveCor, Inc., IPR2021-00972, Patent 10,638,941, Final Written Decision Determining All Challenged Claims Unpatentable (Dec. 6, 2022); and 35 U.S.C. 318(b)).
2. The Articles from the Underlying Investigation
The legacy articles in the underlying investigation consisted of four generations of Apple smartwatches. Certain Wearable Electronic Devices with ECG Functionality and Components Thereof, Inv. No. 337-TA-1266, EDIS Doc. ID 776234, Public Final Initial Determination (June 27, 2022) ("FID") at 5-6. These generations of Apple smartwatches, along with their corresponding model numbers, are reproduced below:
Id. at 6.
The parties stipulated that the Apple Watch Series 6 was representative with respect to the hardware of the legacy articles and that version 7.6.2 of Apple's operating system, WatchOS, was representative of all of the software implicated by the asserted patent claims. Id. (internal citations omitted).
3. The Patent Claims in the 1266 LEO
The 1266 LEO prohibits the unlicensed entry for consumption of wearable electronic devices with ECG functionality and components thereof that infringe one or more of claims 12, 13, and 19-23 of the '941 patent; and claims 1, 3, 5, 8-10, 12, 15, and 16 of the '731 patent and that are manufactured abroad by, or on behalf of, or imported by or on behalf of, Apple, or any of its affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns. See 1266 LEO at 1. In describing the patents at issue, the FID notes that they:
. . . relate to systems, devices, and methods for monitoring cardiac health and managing cardiac disease. See 941 patent at 1:26-33; 731 patent at 1:29-33. The specific cardiac condition addressed by all the asserted claims is arrhythmia, or abnormal heart rhythm. See 941 patent at 4:9-10; []. The device[] recited in the claims, including in the method claims, [is] a smartwatch (for the 941 and 731 patents) []. The smartwatch claims require an electrocardiogram (ECG) sensor and at least one other sensor. See, e.g., 941 patent at cl. 1; 731 patent at cl. 25. For most asserted smartwatch claims one of the other sensors is a photoplethysmogram (PPG) sensor, which detects heart rate optically. See 731 patent at 8:51-55. [] Whether reciting a method or apparatus, the asserted independent claims generally involve monitoring heart rate [], detecting or determining possible arrhythmia or irregularity in heart rate variability ("HRV") (e.g., "detect, based on the PPG data, the presence of an arrythmia" (731 patent at cl. 1)), and either performing an ECG or alerting the user that an ECG is called for (e.g., "receive electric signals of the user from the ECG sensor to confirm the presence of the arrythmia" (941 patent at cl. 12)).
FID at 3-4.
a. Claim 12 of the '941 Patent
The '941 patent is titled "Discordance Monitoring." Id. at 3 (citing '941 patent). Claim 12 of the '941 patent is the only independent claim, with the remaining claims depending directly from claim 12. Id. at 30. Claim 12 of the '941 patent is reproduced below:
12. A smartwatch, comprising:
a processor;
a first sensor configured to sense an activity level value of a user, wherein the first
sensor is coupled to the processor;
a photoplethysmogram ("PPG") sensor configured to sense a heart rate parameter
of the user when the activity level value is resting, wherein the PPG sensor is coupled to the processor;
an electrocardiogram ("ECG") sensor configured to sense electrical signals of a
heart, wherein the ECG sensor comprises a first electrode and a second
electrode, and wherein the ECG sensor is coupled to the processor; and
a non-transitory computer readable storage medium encoded with a computer
program including instructions executable by the processor to cause the processor to:
determine if a discordance is present between the activity level value of the user
and the heart rate parameter of the user;
based on the presence of the discordance, indicate to the user a possibility of an
arrhythmia being present; and
receive electric signals of the user from the ECG sensor to confirm the presence of
the arrhythmia.
Id. at 30-31; '941 patent at 17:52-18:19.
b. Claim 1 of the '731 Patent
The '731 patent is titled "Methods and Systems for Arrhythmia Tracking and Scoring." FID at 3 (citing '731 patent). Claim 1 of the '731 patent is the only independent claim, with the remaining claims depending directly from claim 1. Id. at 105. Claim 1 of the '731 patent is reproduced below:
1. A smart watch to detect the presence of an arrhythmia of a user, comprising:
a processing device;
a photoplethysmography ("PPG") sensor operatively coupled to the processing
device;
an ECG sensor, comprising two or more ECG electrodes, the ECG sensor
operatively coupled to the processing device;
a display operatively coupled to the processing device; and
a memory, operatively coupled to the processing device, the memory having
instructions stored thereon that, when executed by the processing device,
cause the processing device to:
receive PPG data from the PPG sensor;
detect, based on the PPG data, the presence of an arrhythmia;
receive ECG data from the ECG sensor; and
confirm the presence of the arrhythmia based on the ECG data.
Id.; '731 patent at 26:27-46.
B. 19 C.F.R. Part 177 Ruling Request
1. Procedural History
The present inter partes proceeding is the second administered by the EOE Branch under 19 C.F.R. 177 with respect to 337-TA-1266. In the first inter partes proceeding, the EOE Branch issued CBP HQ Ruling H329187, which found that the articles at issue did not infringe the claims of the '941 or '731 patents, as they "do not have executable instructions that cause a processor to perform ECG functionality" because [[ ]] HQ H329187 (dated July 18, 2023) at 18. Specifically, "[w]ithout an instance of operation causing the processor to perform ECG functionality, the articles at issue cannot be considered reasonably capable of satisfying the ECG functionality limitations." Id. at 17 (citing INVT SPE LLC v. Int'l Trade Comm'n, 46 F.4th 1361, 1371, 1376 (Fed. Cir. 2022)). Thus, the EOE Branch found that the articles at issue were not subject to the limited exclusion order. Id. at 22.
On January 31, 2024, Apple submitted a letter to CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177, which included three sets of expert declarations and exhibits (collectively, "Ruling Request"). Apple Email to EOE Branch, dated January 31, 2024. Apple "request[ed] a ruling [] that certain wearable electronic devices and components thereof to be imported by Apple are not subject to exclusion from entry for consumption into the United States, because they have been redesigned to remove the features covered by the ITC's Limited Exclusion Order [] issued on December 22, 2022 in the 1266 Investigation. Specifically, the claims of the patents asserted in the 1266 Investigation required that a smartwatch 'confirm the presence of the arrhythmia.' The redesigned Apple Watches do not do this because [[ ]]" Ruling Request at 1. In the same email, Apple confirmed that Apple had begun the process of entering into a non-disclosure agreement with AliveCor and would provide the Ruling Request to AliveCor once the agreement had been executed. Apple Email to EOE Branch, dated January 31, 2024. On February 1, 2024, Apple sent the signed agreement and confirmed that Apple provided AliveCor with access to the Ruling Request. Apple Email to EOE Branch, dated February 1, 2024.
On February 6, 2024, the EOE Branch sent the parties a preliminary message in advance of an initial conference call on February 7, 2024, in which the EOE Branch confirmed that both parties agreed to conduct the ruling request on an inter partes basis administered by the EOE Branch. See EOE Email to Parties, dated February 6, 2024. During the initial conference call, and as described in the preliminary message, the EOE Branch and the parties discussed scheduling for the inter partes ruling, and after failing to reach agreement on a proposed procedural schedule, the parties submitted proposals to the EOE Branch. See id.; Apple Email to EOE Branch, dated February 9, 2024 (establishing the parties' competing proposals). On February 14, 2024, after considering the party submissions, the EOE Branch established the procedural schedule for this inter partes proceeding.[1] EOE Branch Email to Parties, dated February 14, 2024. After multiple correspondences related to source code production, the EOE Branch modified the procedural schedule in response to the arguments made by the parties. See EOE Branch Email to Parties, dated March 21, 2024. Specifically, AliveCor argued that Apple had not produced the entirety of the source code necessary to respond to Apple's ruling request and that the source code already produced contained discrepancies. As such, AliveCor requested an additional three weeks to inspect the relevant evidence. AliveCor Email to EOE Branch, dated March 19, 2024. Apple responded that, although much of AliveCor's request was unnecessary, it agreed to produce additional source code but countered that the procedural schedule should not be extended by more than a week. Apple Email to EOE Branch, dated March 20, 2024. The parties replied to each another, and these messages resolved the outstanding issues relating to source code production. See AliveCor Email to EOE Branch, dated March 21, 2024; Apple Email to EOE Branch, dated March 21, 2024. Based on the respective positions of the parties, the EOE Branch extended the procedural schedule by one week. EOE Branch Email to Parties, dated March 21, 2024.
On April 3, 2024, AliveCor provided its response to the Ruling Request, which included one declaration, inspection images and videos, source code prints, and Exhibits A to C (collectively, "AliveCor Response"). On April 10, 2024, Apple provided its reply to AliveCor's Response, which included two declarations, one of which contained two exhibits, and Exhibits P to W (collectively, "Apple Reply"). On April 17, 2024, AliveCor provided its sur-reply, which contained a declaration and additional source code prints (collectively, "AliveCor Sur-Reply") to Apple's Reply. On April 24, 2024, the EOE Branch conducted an oral discussion with the parties, for which both parties submitted presentations. Finally, on May 1, 2024, the parties submitted post-oral discussion submissions ("Apple Post-Oral Discussion Submission" and "AliveCor Post-Oral Discussion Submission," respectively). The target date for the EOE Branch's issuance of this ruling, as of the post-oral discussion submissions, was set for May 22, 2024.
2. The Articles at Issue
The articles at issue are described in the Ruling Request as:
. . . certain wearable electronic devices and components thereof to be imported by Apple . . . [that] have been redesigned to remove the features covered by the ITC's Limited Exclusion Order [] issued on December 22, 2022 in the 1266 Investigation. Specifically, the claims of the patents asserted in the 1266 Investigation required that a smartwatch 'confirm the presence of the arrhythmia.' The redesigned Apple Watches do not do this because [[ ]]
Ruling Request at 1.
Specifically, the products for which Apple requested a ruling are the "Apple Watch Ultra 2, the Apple Watch Series 9, and earlier Apple Watches with ECG functionality (Watch Series 4 through 8 and Watch Ultra).[2] See e.g., id. at 2 n.1. In its Ruling Request, Apple argues that:
[a]ccording to the ITC, infringement requires a smartwatch that is loaded with executable instructions to analyze ECG signals: [] a "smartwatch with a 'non-transitory computer readable storage medium' loaded with instructions 'executable by the processor to cause the processor' to receive ECG signals, analyze those signals, and conclude (i.e., confirm) that 'the arrhythmia' is present from those signals."
Id. at 3 (citing FID at 43-44; Comm'n Op. at 3 (adopting this portion of the FID)) (emphasis added by Apple).
In response to the findings by the Commission, Apple has redesigned the Apple Watch product so that "[i]n the redesign, [[ ]]" Id. at 4. Specifically:
To implement the redesign, Apple changed the hardcoded part number for each Redesigned Watch and the software [[ ]] Regarding the part number, Apple hardcoded each Redesigned Watch with [[ ]] This part number uniquely identifies each Watch as having been redesigned using [[ ]] and differentiates it from any Legacy Watches considered in the 1266 Investigation, which have a "LL/A" part number. Importantly, once each Watch's part number has been hardcoded, the part number is permanent and virtually impossible to change without destroying the device. [] With respect to the software, Apple changed the source code controlling [[ ]] For each of these, the redesigned source code [[ ]] Because the part number [[ ]] serve as absolute blockades against using ECG functionality in any way that would violate the ITC's limited exclusion order.
Id. at 30-31 (internal citations omitted) (emphasis added by Apple).
II. ISSUE
Whether Apple has met its burden to show that the articles at issue do not infringe the '731 or '931 patents, and thus are not subject to the limited exclusion order issued in the 1266 investigation. See Ruling Request at 53.
III. LEGAL FRAMEWORK
A. Section 337 Exclusion Order Administration
The Commission shall investigate any alleged violation of Section 337 to determine, with respect to each investigation conducted by it under this section, whether there is a violation of this section. See 19 U.S.C. 1337(b)(1) and (c). If the Commission determines, as a result of an investigation under this section, that there is a violation of this section, it shall direct that the articles concerned, imported by any person violating the provision of this section, be excluded from entry into the United States unless the Commission finds based on consideration of the public interest that such articles should not be excluded from entry. See 19 U.S.C. 1337(d)(1).
When the Commission determines that there is a violation of Section 337, it generally issues one of two types of exclusion orders: (1) a limited exclusion order or (2) a general exclusion order. See Fuji Photo Film Co., Ltd. v. ITC, 474 F.3d 1281, 1286 (Fed. Cir. 2007). Both types of orders direct CBP to bar infringing products from entering the country. See Yingbin-Nature (Guangdong) Wood Indus. Co. v. ITC, 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. In contrast, a general exclusion order bars the importation of infringing products by everyone, regardless of whether they were respondents in the Commission's investigation." Id. A general exclusion order is appropriate only if two exceptional circumstances apply. See Kyocera Wireless Corp. v. ITC, 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 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 [general exclusion order] by satisfying the heightened burdens of 1337(d)(2)(A) and (B).").
In addition to the action taken above, the Commission may issue an order under 19 U.S.C. 1337(i) directing CBP to seize and forfeit articles attempting entry in violation of an exclusion order if their owner, importer, or consignee previously had articles denied entry on the basis of that exclusion order and received notice that seizure and forfeiture would result from any future attempt to enter articles subject to the same. An exclusion order under 1337(d)-either limited or general-and a seizure and forfeiture order under 1337(i) apply at the border only and are operative against articles presented for customs examination or articles conditionally released from customs custody but still subject to a timely demand for redelivery. See 19 U.S.C. 1337(d)(1) ("The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry."); id., at (i)(3) ("Upon the attempted entry of articles subject to an order issued under this subsection, the Secretary of the Treasury shall immediately notify all ports of entry of the attempted importation and shall identify the persons notified under paragraph (1)(C).") (emphasis added).
Significantly, unlike district court injunctions, the Commission can issue a general exclusion order that broadly prohibits entry of articles that violate Section 337 of the Tariff Act of 1930 without regard to whether the persons importing such articles were parties to, or were related to parties to, the investigation that led to issuance of the general exclusion order. See Vastfame Camera, Ltd. v. ITC, 386 F.3d 1108, 1114 (Fed. Cir. 2004). The Commission also has recognized that even limited exclusion orders have broader applicability beyond just the parties found to infringe during an investigation. See Certain GPS Devices and Products Containing Same, Inv. No. 337-TA-602, Comm'n Op. at 17, n.6, Doc ID 317981 (Jan. 2009) ("We do not view the Court's opinion in Kyocera as affecting the issuance of LEOs [limited exclusion orders] that exclude infringing products made by respondents found to be violating Section 337, but imported by another entity. The exclusionary language in this regard that is traditionally included in LEOs is consistent with 19 U.S.C. 1337(a)(1)(B)-(D) and 19 U.S.C. 1337(d)(1).").
Moreover, "[t]he Commission has consistently issued exclusion orders coextensive with the violation of section 337 found to exist." See Certain Erasable Programmable Read Only Memories, Inv. No. 337-TA-276, Enforcement Proceeding, Comm'n Op. at 11, Doc ID 43536 (Aug. 1991) (emphasis added). "[W]hile individual models may be evaluated to determine importation and [violation], the Commission's jurisdiction extends to all models of [violative] products that are imported at the time of the Commission's determination and to all such products that will be imported during the life of the remedial orders." See Certain Optical Disk Controller Chips and Chipsets, Inv. No. 337-TA-506, Comm'n Op. at 56-57, USITC Pub. 3935, Doc ID 287263 (July 2007).
Lastly, despite the well-established principle that "the burden of proving infringement generally rests upon the patentee [or plaintiff]," Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S. 191 (2014), the Commission has held that Medtronic is not controlling precedent and does not overturn its longstanding practice of placing the burden of proof on the party who, in light of the issued exclusion order, is seeking to have an article entered for consumption. See Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof, Inv. No. 337-TA-879, Advisory Opinion at 6-11. In particular, the Commission has noted that "[t]he Federal Circuit has upheld a Commission remedy which effectively shifted the burden of proof on infringement issues to require a company seeking to import goods to prove that its product does not infringe, despite the fact that, in general, the burden of proof is on the patentee to prove, by a preponderance of the evidence, that a given article does infringe. . . ." Certain Integrated Circuit Telecommunication Chips, Inv. No. 337-TA-337, Comm'n Op. at 21, n.14, USITC Pub. 2670, Doc ID 217024 (Aug. 1993), (emphasis in original) (citing Sealed Air Corp. v. ITC, 645 F.2d 976, 988-89 (C.C.P.A. 1981)).
This approach is supported by Federal Circuit precedent. See Hyundai Elecs. Indus. Co. v. ITC, 899 F.2d 1204, 1210 (Fed. Cir. 1990) ("Indeed, we have recognized, and Hyundai does not dispute, that in an appropriate case the Commission can impose a general exclusion order that binds parties and non-parties alike and effectively shifts to would-be importers of potentially infringing articles, as a condition of entry, the burden of establishing noninfringement. The rationale underlying the issuance of general exclusion orders-placing the risk of unfairness associated with a prophylactic order upon potential importers rather than American manufacturers that, vis-a-vis at least some foreign manufacturers and importers, have demonstrated their entitlement to protection from unfair trade practices-applies here [in regard to a limited exclusion order] with increased force.") (emphasis added) (internal citation omitted).
B. Patent Infringement Generally
Determining patent infringement requires two steps. Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1316 (2015). The first is to construe the limitations of the asserted claims and the second is to compare the properly construed claims to the accused product. Id. "'To establish literal infringement, every limitation set forth in a claim must be found in an accused product, exactly,' Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995) [], whereas under the doctrine of equivalents infringement occurs when 'there is equivalence between the elements of the accused product . . . and the claimed elements of the patented invention.' Duramed Pharms., Inc. v. Paddock Labs., Inc., 644 F.3d 1376, 1380 (Fed. Cir. 2011) []." Microsoft Corp. v. GeoTag, Inc., 817 F.3d 1305, 1313 (Fed. Cir. 2016). One way to establish equivalence is by showing, on an element-by-element basis, that the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented invention, which is often referred to as the function-way-result test. See Intendis GmbH v. Glenmark Pharms., Inc., 822 F.3d 1355, 1361 (Fed. Cir. 2016).
As for the first step above, "claim construction is a matter of law." SIMO Holdings, Inc. v. H.K. uCloudlink Network Tech., Ltd., 983 F.3d 1367, 1374 (Fed. Cir. 2021). Moreover, the ultimate construction of a claim limitation is a legal conclusion, as are interpretations of the patent's intrinsic evidence (the patent claims, specifications, and prosecution history). UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816, 822 (Fed. Cir. 2016) (citing Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841, 190 L. Ed. 2d 719 (2015)).[3]
"Importantly, 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." Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges." Id. at 1314. In others, courts look to public sources such as "the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art." Id.
"To begin with, the context in which a term is used in the asserted claim can be highly instructive." Phillips, 415 F.3d at 1314 ("To take a simple example, the claim in this case refers to 'steel baffles,' which strongly implies that the term 'baffles' does not inherently mean objects made of steel."). The context in which a claim term is used also includes the full chain of dependence as well as the remaining suite of claims and the written description. See Inline Plastics Corp. v. EasyPak, LLC, 799 F.3d 1364, 1371 (Fed. Cir. 2015) ("Since the specification explicitly mentions the 'alternative' . . . there can be no debate concerning the application of the doctrine of claim differentiation.").
The second step to establish infringement involves a comparison of the claims, as properly construed, to the accused product, which is a question of fact. Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1040 (Fed. Cir. 2016) (en banc).
C. The Doctrine of Equivalents
"'To establish literal infringement, every limitation set forth in a claim must be found in an accused product, exactly,' Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995) [], whereas under the doctrine of equivalents infringement occurs when 'there is equivalence between the elements of the accused product . . . and the claimed elements of the patented invention.' Duramed Pharms., Inc. v. Paddock Labs., Inc., 644 F.3d 1376, 1380 (Fed. Cir. 2011)[.]" Microsoft Corp. v. GeoTag, Inc., 817 F.3d 1305, 1313 (Fed. Cir. 2016). As such, under the doctrine of equivalents, "a product or process that does not literally infringe upon the express terms of a patent claim may nonetheless be found to infringe if there is 'equivalence' between the elements of the accused product or process and the claimed elements of the patented invention." Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 21, (1997). "The doctrine of equivalents allows the patentee to claim those insubstantial alterations that were not captured in drafting the original patent claim but which could be created through trivial changes." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733, (2002). One way to establish equivalence is by showing, on an element-by-element basis, that the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented invention, which is often referred to as the function-way-result test. See Intendis GmbH, 822 F.3d at 1361. "However, when a patent claim is narrowed during prosecution, prosecution history estoppel may limit application of the doctrine of equivalents." O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1363 (Fed. Cir. 2008). "Infringement, whether literal or under the doctrine of equivalents, is a question of fact." Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1317 (Fed. Cir. 2015).
In H284032, CBP established the standard for applying the doctrine of equivalents when administering an exclusion order under Section 337:
CBP will not extend the doctrine of equivalents when administering an exclusion order pursuant to section 337 except in two instances. The first is where the Commission found a violation of section 337, during the underlying investigation, through infringement under the doctrine. The second is, in those cases when the Commission has found only literal infringement of the asserted patents, where a respondent identified in an exclusion order fails to show a prima facie case that the doctrine does not apply to its new or modified article under the "function-way-result" or "insubstantial differences" test based on the administrative record before CBP.
HQ H284032 (dated April 7, 2017) at 26.
For a party to establish "a prima facie case," it is not required to reach "a conclusion on the ultimate issue." Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1348 (Fed. Cir. 2012); see also HQ H326593 (dated September 30, 2022). Instead, the party with such a burden must simply "present evidence 'sufficient to establish a fact or raise a presumption [regarding the relevant issue] unless disproved or rebutted.'" Transocean at 1348. (quoting Black's Law Dictionary (9th ed 2009)).
D. Patent Infringement Based on Capability or Actual Operation
When applying the two-step inquiry for patent infringement discussed above, certain cases at the U.S. Court of Appeals for the Federal Circuit ("Federal Circuit") have held that, to find infringement, a device only needs to be capable of operating according to the relevant claim limitations, while others have found that a device does not infringe unless it actually operates as claimed. See INVT SPE LLC v. ITC, 46 F.4th 1361, 1371 (Fed. Cir. 2022) (citing Finjan, Inc. v. Secure Computing Corp., 626 F.3d 1197, 1204 (Fed. Cir. 2010) for the former and ParkerVision, Inc. v. Qualcomm Inc., 903 F.3d 1354, 1361 (Fed. Cir. 2018) for the latter). "Whether infringement requires actual performance of the recited functions by the accused device depends on the claim language." INVT, 46 F.4th at 1371. "[T]he most straightforward example of this is the common distinction between method claims and apparatus claims" where "non-method claims describe capabilities without requiring that any software components be 'active' or 'enabled'" and method claims that "require[] actual performance of each claimed step." Id. (quoting and citing Finjan, 626 F.3d at 1204-05, 1206).
Nevertheless, "differences exist between apparatus claims as well, depending on the claim language. [The Federal Circuit has] construed some apparatus claims to require an infringing device to actually perform and operate according to the functional terms recited in the claim" but "construed other apparatus claims to require only capability[.]" Id. For example, in Finjan, because the "defendants admitted [the] program code for the relevant function . . . was literally present on all accused devices, the claim was infringed 'in the same way that an automobile engine for propulsion exists in a car even when the car is turned off.'" Id. at 1373 (quoting Finjan at 1205). "The presence of that programming in the accused products was all that was necessary for establishing infringement." Id. "In other words, the claims recite[d] a device with the capability of performing the recited functions when in operation without any modification or further programming." Id. at 1374. "To determine if an accused device is a device with the 'capability' of performing the recited functions, it must be able to perform those functions when it is activated and put into operation." Id. at 1375. Accordingly, the Federal Circuit has established that for infringement of:
a claim that recites capability and not actual operation, an accused device "need only be capable of operating" in the described mode. Intel Corp. v. U.S. Int'l Trade Comm'n, 946 F.2d 821, 832 (Fed. Cir. 1991). Thus, depending on the claims, "an accused device may be found to infringe if it is reasonably capable of satisfying the claim limitations, even though it may also be capable of noninfringing modes of operation." Hilgraeve Corp. v. Symantec Corp., 265 F.3d 1336, 1343 (Fed. Cir. 2001).
Finjan, 626 F.3d at 1204 (emphasis added).
Moreover, the Federal Circuit has held that an accused device is considered "reasonably capable" of satisfying the claim limitations when one can enable the mode that would infringe "without significant alteration." See INVT, 46 F.4th at 1373-75 ("We held [in Silicon Graphics and Fantasy Sports] that the apparatus claim directed to a computer, claimed in functional terms, is nonetheless infringed so long as the product is designed in such a way as to enable a user of that [product] to utilize the function . . . without having to modify [the product]-i.e., capable of the functions.") (quoting Silicon Graphics, Inc. v. ATI Techs., Inc., 607 F.3d 784, 795 (Fed. Cir. 2010) and Fantasy Sports Props., Inc. v. Sportsline.com, Inc., 287 F.3d 1108, 1118 (Fed. Cir. 2002) (internal quotation marks omitted) (emphasis added); see also Versata Software, Inc. v. SAP Am., Inc., 717 F.3d 1255, 1262 (Fed. Cir. 2013) ("[A] device does not infringe simply because it is possible to alter it in a way that would satisfy all the limitations of a patent claim[.]") (quoting High Tech Med. Instrumentation v. New Image Indus., Inc., 49 F.3d 1551, 1555 (Fed. Cir. 1995).
In sum, when the asserted claims recite capability, our case law supports finding infringement by a "reasonably capable" accused device on a case-by-case basis particularly where . . . there is evidence that the accused device is actually used in an infringing manner and can be so used without significant alterations.
Ericsson, Inc. v. D-Link Sys., Inc., 773 F.3d 1201, 1217 (Fed. Cir. 2014).
IV. LAW AND ANALYSIS
A. Sufficiency of the Evidence
To begin, AliveCor argues that Apple has not met its burden to prove that the [[ ]]. See e.g., AliveCor Response at 8-11; AliveCor Sur-Reply at 2-10; AliveCor Post-Oral Discussion Submission at 5-8. According to AliveCor, Apple has produced relevant source code relating to [[ ]]. See e.g., AliveCor Post-Oral Discussion Submission at 8. In AliveCor's view, for it to analyze the ECG functionality, it would need to ". . . fully trace ECG from start to finish." Id. In response, Apple contends that the ". . . source code in question [[ ]]." Apple Post-Oral Discussion Submission at 5, 55 ("AliveCor concludes that the [[ ]] must be different because [[ ]] are distinct. While the operating systems are distinct, the computations required to perform [[ ]]") (internal citations omitted).
Despite AliveCor arguing that it would need additional source code to "trace" the ECG functionality, Apple provided AliveCor with source code relating to: [[ ]] Apple Post-Oral Discussion Submission at 56-58. AliveCor does not dispute at least the provision of the source code identified above.
Instead, while AliveCor acknowledges that the ECG functionality is [[ ]] on the articles at issue, it nevertheless "question[s] the veracity of this evidence." Oral Discussion Transcript at 137: 17-19. Specifically, AliveCor's primary issue with Apple's source code production revolves around the fact that Apple provided one set of ECG source code for both the [[ ]] See id. at 138:15-140:7 (". . . the blocking code . . . purports to call out the blocking of the functionality. But it's still not clear, . . . it's doing that. We still don't have evidence[,] and we can't really say for sure that, in fact, the code is not being executed on the Watch. Certainly the blocking code purports to do that . . . but we can't say for sure. [] They have the code. They say it's duplicate code. We could've given it to you, but we didn't give it to you. . . . We asked for it. And they just declined to give it to us. And we think that that speaks volumes here.").
Apple responded to AliveCor's position, stating that the provision of the [[ ]] See e.g., Apple Post-Oral Discussion Submission at 5. To rebut this assertion, AliveCor raises testimony from the underlying investigation in which one of Apple's lead engineers stated that [[ ]] See AliveCor Sur-Reply at 6-7 (quoting Waydo Corporate Dep. Tr. (11/30/21) at 71:25-72:17). According to AliveCor, this raises concern as to Apple's position regarding the identical nature of the source code for both devices, as-according to AliveCor-this testimony unequivocally suggests that the source code is not cross-compatible. Id. at 7. In response, Apple has clarified its point, stating that the testimony from the underlying investigation was "directed to the [[ ]] Apple Post-Oral Discussion Submission at 55; see also Apple Reply at 24 n.15. Thus, although the [[ ]] See e.g., id.
AliveCor had multiple opportunities to reply but did not meaningfully respond to this clarification and referred instead to its expert declaration, specifically that:
[[ ]]
Jafari Sur-Reply Declaration at 35-36; see AliveCor Post-Oral Discussion Submission at 6.
Although AliveCor questions Apple's clarification of the testimony provided during the underlying investigation, it did not provide specific arguments as to why this clarification is factually inaccurate except for its expert's opinions, and no specific reasoning for why the source code at issue cannot be [[ ]] in opposition to the evidence presented by Apple. See e.g., Thomas Reply Declaration at 15-16 ("The [[ ]] [] The EGC analysis and classification algorithms printed by AliveCor on pages APL-ALIVE-177R_ECG_2_SC-0000012-34 [[ ]]"). Thus, we will continue with our analysis of infringement by the articles at issue.
B. Literal Infringement
AliveCor has not asserted in this inter partes proceeding that the articles at issue literally infringe the '731 patent. See Oral Discussion Transcript at 106: 14-21 ("Chief Terrill: . . . AliveCor, for purposes of the '941 patent, is asserting a theory of infringement under literal and DOE, but for purposes of the '731, it's just DOE, is that correct? ... Mr. Saunders [for AliveCor]: Yes, that is correct."). Therefore, the parties' dispute regarding literal infringement concerns the '941 patent only.
To begin, Apple argues that ". . . the Redesigned Watch cannot infringe as a matter of law because any hypothetical way of causing [[ ]]-to execute on Watch would require a significant modification." Ruling Request at 50. Further, ". . . there can be no evidence of even a single instance of the Redesigned Watches operating with [[ ]]" Id. at 46. Accordingly, Apple's view is that the articles cannot literally infringe the claims at issue, citing H329187, and reasoning that, in that ruling, ". . . the Branch stated that 'evidence that the articles at issue perform the claimed function at least once is crucial to show that they are reasonably capable of satisfying the claim limitations for infringement of [the] apparatus claim at issue here that is drawn to capability.' [] HQ [] H329187 at 16 (citing INVT, [46 F.4th] at 1377). And because [[ ]] required 'further modification-in the form of a software update-' they were found non-infringing. Id. at 18." Ruling Request at 40.
AliveCor counters that the articles at issue literally infringe the '941 patent because ". . . claim 12 does not require that the processor of the smartwatch necessarily carry out the 'confirm' portion of the claim[.]" AliveCor Post-Oral Discussion Submission at 10. AliveCor argues that an external processor, such as the [[ ]], can satisfy the limitation at issue, by receiving electric signals from the ECG sensor to confirm the presence of the arrhythmia. See e.g., id. at 12-13. In response, Apple raises a determination made by the Commission during the underlying investigation, specifically that:
. . . the ITC made clear what is required to practice the '941 patent's claim 12. First, the ITC found that the preamble was limiting, meaning that each limitation of the claim must be comprised by a smartwatch. Next the ITC found what was necessary to practice claim 12's "confirm" limitation. It determined that the "confirm" limitation requires that a "a smartwatch" must ". . . cause the processor" "to receive ECG signals, analyze those [ECG] signals, and conclude (i.e., confirm) that 'the arrhythmia' is present from those [ECG] signals." [] [T]he Redesigned Watch does not analyze or conclude, (i.e., confirm) anything from the ECG signals related to a possible arrhythmia. As a result, it cannot infringe. All of that key functionality-including the key ECG analysis and classification functionality that AliveCor identifies as the "most important software functionalities" that are "alone, directly responsible for the ECG software's ability to 'confirm the presence of the arrhythmia,'"-is executed [[ ]]. Thus, the Redesigned Watch does not literally infringe.
Apple Post-Oral Discussion Submission at 39 (internal citations omitted).
As Apple notes above, the Commission specifically found the preamble to claim 12 of the '941 patent to be limiting. FID at 22. Thus, the limiting preamble of claim 12, a "smartwatch comprising," dictates that, to infringe the claim, the article must be a smartwatch that comprises the recited limitations. See '941 patent at 17:52; see also Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) ("When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.") (internal citations omitted); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1306 (Fed. Cir. 1999) ("In such a case, it is essential that the court charged with claim construction construe the preamble and the remainder of the claim, as we have done here, as one unified and internally consistent recitation of the claim invention."). Nothing that AliveCor points to in its submissions overcomes Apple's argument, that relies on the Commission's findings and that is consistent with the Federal Circuit case law cited above, such that the EOE Branch finds that the claimed ECG functionality must be found on the smartwatch itself.
Moreover, as noted above, "[t]o establish literal infringement, every limitation set forth in a claim must be found in the accused product, exactly." Southwall Techs., 54 F.3d at 1575. Along these lines, AliveCor's theory of infringement depends on its recognition that, "[a]s to the final 'receive' limitation 12(f)(iii), the redesigned Apple Watch unquestionably 'receives' ECG data from the ECG sensor of the Watch, and that ECG data is ultimately used [[ ]] to 'confirm' the presence of the arrythmia." AliveCor Post-Oral Discussion Submission at 13 (internal citation omitted). Thus, because the preamble of claim 12 of the '941 patent is limiting, see FID at 22, and the claimed "smartwatch" must comprise all of the remaining limitations, infringement cannot be found, as there is no dispute between the parties that the [[ ]] performs the ECG functionality described above.[4] See e.g., Alive-Cor Post-Oral Discussion Submission at 13. For this reason, the articles at issue do not literally infringe claim 12 of the '941 patent.[5]
C. The Doctrine of Equivalents
AliveCor additionally argues in its response to the ruling request that the articles at issue infringe both the '731 and the '941 patents under the doctrine of equivalents. See e.g., AliveCor Response at 18-21. Specifically, according to AliveCor, the articles at issue ". . . infringe under the triple identity test/'function-way-result' test because the 'Remote ECG Redesign' continues to perform substantially the same function (analyzing ECG signals) in substantially the same way (by executing ECG source code causing the signals to be measured and classified) to achieve substantially the same result (to 'confirm' the presence of the arrhythmia from those ECG signals)." AliveCor Response at 21 (citing Jafari Response Declaration at 57).
In response to AliveCor's arguments regarding infringement under the doctrine of equivalents, Apple discusses the fact that AliveCor-when defending the validity of the asserted patents at the Commission and before the U.S. Patent and Trademark Office-has represented that the patents require ECG functionality on the smartwatch itself, and therefore these positions preclude AliveCor's doctrine of equivalents arguments. Apple Reply at 17. Further, Apple argues that the articles at issue and the [[ ]] are meaningfully distinct devices, in that they have "distinct [[ ]] Id. at 18. Apple continues by asserting that the doctrine of equivalence analysis must be applied on an element-by-element basis, id. at 18-19 (quoting Warner-Jenkinson, 520 U.S. at 40), and in particular that:
[t]he relevant claim element from the '941 patent, for example, is "cause the processor to . . . receive electric signals of the user from the ECG sensor to confirm the presence of the arrhythmia." The ITC construed this as requiring a processor receive ECG signals, analyze ECG signals, and confirm an arrhythmia using those ECG signals. For the '941 patent, that processor must be on the smartwatch because the '941 patent's preamble ("smartwatch comprising") is limiting. For the '731 patent, the ITC found the relevant limitation to have the same scope and the claim to be limited to a single device. In contrast, the [[ ]] As a result, the structural limitations of the smartwatch's processor analyzing ECG signals and confirming an arrhythmia are completely missing.
Id. at 19 (internal citations omitted).
At the conclusion of the oral discussion, the Branch asked that the parties' submissions ". . . address [the] EOE Branch precedent relating to CBP's application of the doctrine of equivalents and the extent that this precedent has any significance on the arguments raised by the parties thus far" in this inter partes proceeding. EOE Branch Email to Parties, dated April 24, 2024. In response, Apple applies the standard from HQ H284032 (dated April 7, 2017) and argues that ". . . Apple has made a prima facie case that [the doctrine of equivalents] does not apply. . . . . by showing that AliveCor's allegations 'lack legal sufficiency[.]'" Apple Post-Oral Discussion Submission at 44. Specifically, Apple discusses that any infringement relies on products outside of the scope of the LEO, the limitation at issue is not satisfied by the articles at issue, and no reasonable factfinder could find equivalence due to AliveCor's unambiguous statements about the scope of the patents and its application of the function-way-result test, which Apple views as incompatible with the Commission's findings on the scope of the patents. Id. In turn, AliveCor simply notes the Branch's position on the application of the doctrine of equivalents, stating that the Branch has the authority to consider the merits of the parties' positions and that Apple has not made a prima facie showing that the doctrine does not apply. AliveCor Post-Oral Discussion Submission at 13 n.7. AliveCor did not, however, discuss the standard for making a prima facie showing or how Apple failed to specifically meet this standard, instead pointing the Branch generally to "its papers and argument provided at the oral discussion." Id.
As noted previously, in H284032, CBP established the standard for applying the doctrine of equivalents when administering an exclusion order under Section 337:
CBP will not extend the doctrine of equivalents when administering an exclusion order pursuant to section 337 except in two instances. The first is where the Commission found a violation of section 337, during the underlying investigation, through infringement under the doctrine. The second is, in those cases when the Commission has found only literal infringement of the asserted patents, where a respondent identified in an exclusion order fails to show a prima facie case that the doctrine does not apply to its new or modified article under the "function-way-result" or "insubstantial differences" test based on the administrative record before CBP.
HQ H284032 at 26 (emphasis added). Accordingly, as confirmed above, the default rule is that CBP will not extend the doctrine of equivalents except in limited circumstances and then only when a respondent fails to make a prima facie showing. This approach not only furthers the sound administration of the Customs law but is consistent with the Federal Circuit's recognition that "[t]he doctrine of equivalents provides a limited exception to the principle that claim meaning defines the scope of the exclusivity right in our patent system[.]" VLSI Tech. LLC v. Intel. Corp., 87 F.4th 1332, 1341 (Fed. Cir. 2023) (emphasis added). Moreover, the Federal Circuit has "explained that liability under the doctrine is 'exceptional' [and] 'emphasized . . . that the doctrine of equivalents is the exception, however, not the rule[.]'" Id. at 1342 (quoting Honeywell International, Inc. v. Hamilton Sundstrand Corp., 523 F.3d 1304, 1313 (Fed. Cir. 2008) for the former point and quoting Eli Lilly & Co. v. Hospira, Inc., 933 F.3d 1320, 1330 (Fed. Cir. 2019) for the latter) (emphasis added).
As such, "[t]he exceptional character of the doctrine's use is maintained by closely related demands that restrict the availability of liability under the doctrine." VLSI, 87 F.4th at 1342 (emphasis added). These demands that restrict extension of the doctrine include the following:
First, proof of equivalents must be limitation specific, not focused only on the claim as a whole, though the limitation-specific inquiry of equivalence may be informed by the "role played by each element in the context of the specific patent claim." Warner-Jenkinson, 520 U.S. at 40; see DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1017 (Fed. Cir. 2006); Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed. Cir. 1998); Dawn Equipment Co. v. Kentucky Farms Inc., 140 F.3d 1009, 1015 (Fed. Cir. 1998).
Second, for the determination of whether a substitute element is only insubstantially different from a claimed element and hence an equivalent, a traditional formulation . . . asks "whether a substitute element matches the function, way, and result of the claimed element." Warner-Jenkinson, 520 U.S. at 40. Such matching requires that each of function, way, and result be "substantially the same," see Spectrum Pharmaceuticals, Inc. v. Sandoz Inc., 802 F.3d 1326, 1337 (Fed. Cir. 2015), with the "way" requirement of particular importance, as a practical matter, in keeping the doctrine properly limited. See Warner-Jenkinson, 520 U.S. at 35, 39; Union Paper-Bag Machine Co. v. Murphy, 97 U.S. 120, 125, 24 L. Ed. 935, 1878 Dec. Comm'r Pat. 199 (1877) (stressing the crucial importance of "way"); Advanced Steel Recovery, LLC v. X-Body Equipment, Inc., 808 F.3d 1313, 1320 (Fed. Cir. 2015) (similar); Zygo Corp. v. Wyko Corp., 79 F.3d 1563, 1569 (Fed. Cir. 1996) (similar); Slimfold Manufacturing Co. v. Kinkead Industries, Inc., 932 F.2d 1453, 1457-58 (Fed. Cir. 1991) (similar).
Third, we have long demanded specificity and completeness of proof as crucial to enforcing the limits on the doctrine: The patentee must provide "particularized testimony and linking argument as to the insubstantiality of the differences between the claimed invention and the accused device." Akzo Nobel Coatings, Inc. v. Dow Chemical Co., 811 F.3d 1334, 1342 (Fed. Cir. 2016) (internal quotation marks omitted); see Gemalto S.A. v. HTC Corp., 754 F.3d 1364, 1374 (Fed. Cir. 2014); Texas Instruments Inc. v. Cypress Semiconductor Corp., 90 F.3d 1558, 1566-67 (Fed. Cir. 1996); Lear Siegler, Inc. v. Sealy Mattress Co. of Michigan, 873 F.2d 1422, 1426 (Fed. Cir. 1989).
VLSI at 1342 (emphasis added). Accordingly, the Federal Circuit has placed special emphasis on the "way" requirement in the function-way-result test.
For a respondent to make a prima facie showing in this context to defeat the "limited exception" when CBP will extend the doctrine of equivalents, as noted above, it is not required to reach "a conclusion on the ultimate issue." Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1348 (Fed. Cir. 2012); see also HQ H326593 (dated September 30, 2022). Instead, the party with such a burden must simply "present evidence 'sufficient to establish a fact or raise a presumption [regarding the relevant issue].'" Transocean at 1348. (quoting Black's Law Dictionary (9th ed 2009)). Sufficient evidence in this context includes that which the EOE Branch may rely upon to determine that no reasonable factfinder "could conclude that an element of an accused device is equivalent to an element called for in the claim, or that the theory of equivalence to support the conclusion of infringement otherwise lacks legal sufficiency." HQ H329729 (dated December 1, 2023) at 13-14 (quoting U.S. Philips Corp. v. Iwasaki Elec. Co., 505 F.3d 1371, 1378-79 (Fed. Cir. 2007)).
The parties agree that, during the underlying investigation, the Commission found only literal infringement of the '731 and '941 patents. Apple Post-Oral Discussion Submission at 44; AliveCor Post-Oral Discussion Submission at 13 n.7 ("the legacy IPR branch held CBP 'will not extend the [DOE] when administering an exclusion order pursuant to section 337 except in two instance,' namely: (1) the Commission found DOE infringement below, or (2) when the Commission found literal infringement and where the respondent fails to make a prima facie showing that DOE does not apply to the new or modified articles. Pursuant to this ruling, the Branch is well within its authority to consider the respective merits of the parties' DOE positions to determine whether Apple has met its burden and made a prima facie showing that the DOE does not apply.") (quoting HQ H284032 (dated April 7, 2017 at 26)). Thus, the EOE Branch will address the second of the limited instances in which the doctrine may be extended in CBP's administration of Section 337, namely, whether Apple has failed to make a prima facie showing that the doctrine does not apply to the articles at issue under the function-way-result or insubstantial differences test, taking into consideration the framework outlined above.
1. The Function-Way-Result Test
The function-way-result test asks "whether the substitute element matches the function, way, and result of the claimed element." Tronzo v. Biomet, Inc., 156 F.3d 1154, 1160 (Fed. Cir. 1998) (quoting Warner-Jenkinson, 520 U.S. at 40). For the function-way-result test, analysis should be provided "on an element-by-element basis," such that "the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented product." Intendis GmbH, 822 F.3d at 1360 (quoting Crown Packaging Tech., Inc. v. Rexam Beverage Can Co., 559 F.3d 1308, 1312 (Fed. Cir. 2009)). Furthermore, "[e]ach prong of the function-way-result test is a factual determination." Id.
The Federal Circuit has held that discussion of the doctrine of equivalents under either the function-way-result test or the insubstantial differences test should not be based in broad, conclusory statements. See Akzo Nobel Coatings Inc. v. Dow Chem. Co., 811 F.3d 1334 (Fed. Cir. 2016). In Akzo, for example, the Federal Circuit found the following function-way-result test argument to be "broad and scant:"
Dow's and Michelman's piping and heat exchangers perform the same function (maintain the pressure) and achieve the same result (maintaining sufficient pressure to prevent boiling of the aqueous medium) in substantially the same way (by collecting the dispersed material in a contained volume) as the vessel used by the inventors in Examples 2 and 3 of the patent.
Id. at 1343. The Federal Circuit determined that "[s]uch ambiguity and generality cannot create a genuine issue of material fact," noting the statement's "failure to articulate how Dow's accused process operates in substantially the same way" or "how the differences between the two processes are insubstantial." Id.
Apple discussed the noninfringement under the function-way-result test, arguing that:
. . . the [[ ]] and Legacy Articles do not accomplish the same function, in the same way, to achieve the same result. The way the [[ ]] accomplishes the function of interpreting ECG data to confirm an arrhythmia is by causing the [[ ]] As compared to the Legacy Watches' methodology (and what is required by the Asserted Claims), this "way" is substantially more complicated, involves multiple additional functionalities [[ ]] and involves numerous additional components [[ ]] The result achieved by the [[ ]] is also different. The user [[ ]] As described above, [[ ]] is a meaningfully different result, particularly when [[ ]]
Apple Reply at 19-20 (emphasis added).
In response, AliveCor stated that the "'Remote ECG Redesign' continues to perform substantially the same function (analyzing ECG signals) in substantially the same way (by executing ECG source code causing the signals to be measured, analyzed, and classified) to achieve substantially the same result (to 'confirm the presence of the arrhythmia' from those ECG signals)." AliveCor Sur-Reply at 16-17.
As confirmed above, Apple has the burden to "present evidence 'sufficient to establish a fact or raise a presumption [regarding the relevant issue].'" Transocean at 1348. (quoting Black's Law Dictionary (9th ed 2009)). Apple has provided a sufficient basis given that, as discussed above, the articles at issue differ from the claimed invention, most notably in their operation to interpret ECG data for confirming an arrhythmia entails with more complexity, using additional functionalities and components. Notably, the difference in operation between the articles at issue and the claimed invention addresses the "way" requirement in the function-way-result test.[6] To disprove or rebut Apple's arguments, AliveCor has provided a statement about the articles at issue achieving the same function-way-result as the claimed invention that appears relatively similar to the statement in Akzo that the Federal Circuit found to be conclusory, broad, and scant. See AliveCor Sur-Reply at 16-17; Akzo, 811 F.3d at 1343.
2. The Insubstantial Differences Test
With respect to the interplay between the function-way-result and insubstantial differences tests, the Federal Circuit has "recognized that the function, way, result test [has] often sufficed to show the substantiality of the differences." Texas Instruments, 90 F.3d at 1566 (internal citation omitted). Accordingly, the EOE Branch underscores that, for CBP's administration of Section 337 as it relates to the doctrine of equivalents, if either the function-way-result test or the insubstantial differences test is not met, it is unlikely that the articles at issue would be covered under the other.
Regarding the insubstantial differences test, the analysis asks whether "the substitution . . . is a change of such substance as to make the doctrine of equivalents inapplicable." Graver Tank v. Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 610 (1950). For this test, "an important factor is whether persons reasonably skilled in the art would have known of the interchangeability of an ingredient not contained in the patent with one that was." Id. at 609.
Under the insubstantial differences test, Apple argues that the differences between the claimed invention and the articles at issue are indeed substantial, as the articles at issue [[ ]], the two being meaningfully distinct devices, with "distinct [[ ]], and the articles at issue having structural limitations in that the smartwatch lacks processor functionality to analyze ECG signals and confirm an arrhythmia. Apple Reply at 18-19. With this discussion, Apple has established a fact regarding the functionality of the articles at issue and how this functionality does in fact differ from the claimed functionality. See Tronzo, 156 F.3d at 1160. AliveCor offers little in the form of a rebuttal, simply describing the redesigned functionality and stating that:
[[ ]]
AliveCor Response at 20 (internal citation omitted) (emphasis added by AliveCor).
Further, AliveCor argues that:
the ECG analysis and ECG confirmation are (allegedly) being executed on
[[ ]] by identical source code as the WatchOS code that was previously found to infringe the AliveCor patents. . . . this alleged identity of ECG "confirm[ation]" source code between the two devices is not only evidence of no insubstantial differences, it is evidence of no differences at all.
AliveCor Sur-Reply at 16 (internal citations omitted).
Despite AliveCor's arguments regarding insubstantial differences, we find that Apple has presented, at least, a prima facie case that the articles at issue do not satisfy this test. For example, though the smartwatch and [[ ]] may work in tandem in some regards, the functionality in the patented invention, and in the legacy articles found to infringe during the underlying investigation, was contained entirely on the smartwatch, as argued by AliveCor itself on the invalidity question noted above. See Apple Reply at 17-18 (discussing AliveCor's prior arguments that the patents require the functionality at issue to exist on a smartwatch). Apple has, at least, established the fact that the articles at issue have had ECG functionality [[ ]], and established the presumption that a person reasonably skilled in the art would not have known of the interchangeability of the devices for performing this functionality. See Graver Tank, 339 U.S. at 609; see also AliveCor Sur-Reply at 13 ("As Dr. Jafari explains in his reply declaration, there was no dispute in the underlying investigation-nor could there be-that anything other than the processor of the accused Apple Watch was responsible for performing both the PPG-based and ECG-based sending and analyses.") (citing Jafari Sur-Reply Declaration at 17). AliveCor has not disproved this presumption through its arguments relating to the identical nature of the source code on the two devices. The fact that two devices share source code does not dispute the fact that a new, additional device is involved in performing the claimed functionality or the presumption that this interchangeability would not have been known for the purposes of establishing a prima facie case in this instance. See Transocean, 699 F.3d at 1348 (discussing that, for a party to establish a prima facie case, it is not required to reach "a conclusion on the ultimate issue.").
3. Claim Vitiation
"If a theory of equivalence would vitiate a claim limitation, however, then there can be no infringement under the doctrine of equivalents as a matter of law." Tronzo, 156 F.3d at 1159. A party establishing vitiation in an inter partes proceeding under 19 C.F.R. 177 would carry its burden to show a prima facie case. The Federal Circuit has confirmed that "[v]itiation is 'not an exception to the doctrine of equivalents, but instead a legal determination that the evidence is such that no reasonable [factfinder] could determine two elements to be equivalent.'" Ring & Pinion Serv. Inc. v. ARB Corp. Ltd., 743 F.3d 831, 836 (Fed. Cir. 2014) (quoting Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1356 (Fed. Cir. 2012)).
Further, "[t]he vitiation test cannot be satisfied by simply noting that an element is missing from the claimed structure or process because the doctrine of equivalents, by definition, recognizes that an element is missing that must be supplied by the equivalent substitute." Deere, 703 F.3d at 1356. "The vitiation test cannot be satisfied merely by noting that the equivalent substitute is outside the claimed limitation's literal scope." Brilliant Instruments, Inc. v. GuidTech, LLC, 707 F.3d 1342, 1347 (Fed. Cir. 2013).
Rather, vitiation applies when one of skill in the art would understand that the literal and substitute limitations are not interchangeable, not insubstantially different, and when they do not perform substantially the same function in substantially the same way, to accomplish substantially the same result. In short, saying that a claim element would be vitiated is akin to saying that there is no equivalent to the claim element in the accused device based on the well-established "function-way-result" or "insubstantial differences" tests.
Id.
Regarding claim vitiation, Apple has argued that:
[t]he ITC found that, in order to infringe the "confirm" limitations of the '941 and '731 patents, the smartwatch must "receive ECG signals, analyze those signals, and conclude (i.e., confirm) that 'the arrhythmia' is present from those signals." Confined by that holding, AliveCor has conceded that the "[ECG analysis and ECG classification] functionalities are, alone, directly responsible for the ECG software's ability to 'confirm the presence of the arrhythmia.'" [] But "analysis" and "classification" and "confirmation" are missing from the Redesigned Watch. Each of these functionalities is performed [[ ]] and never by the Redesigned Watch. Accordingly, there can be no DOE infringement. [] AliveCor tacitly admits that the Redesigned Watch is missing all of the functionality required to satisfy DOE infringement. In advancing its DOE claim, none of the function, way, or result that AliveCor alleges is performed by the [[ ]] to equivalently satisfy the "confirm" limitations is performed by the Redesigned Watch.
[]
Because the Redesigned Watch does not include an equivalent to the "confirm" limitations, as those limitations were interpreted by the ITC, the Redesigned Watch cannot infringe under DOE as a matter of law.
Apple Post-Oral Discussion Submission at 46-48. AliveCor did not specifically respond to Apple's claim vitiation arguments in a meaningful way.
Thus, Apple's arguments regarding claim vitiation, and the function-way-result and insubstantial differences tests, present a prima facie case that the articles at issue do not satisfy the relevant claim limitations when viewed on an element-by-element basis. Consequently, we find that Apple, the party with the burden under the standard established in H284032, has presented a prima facie case that the doctrine of equivalents does not apply to the articles at issue.
In light above the above, this determination does not address the parties' other arguments, as those arguments are not separate claims, but instead represent additional grounds for determining whether the products at issue should be refused entry and therefore need not be addressed here. See Solomon Technologies, Inc. v. U.S. Int'l Trade Comm'n, 524 F.3d 1310, 1320 (Fed. Cir. 2008) (Where the court stated, "[i]f we uphold the Commission's order, as we do in this case, we are not required to address every possible ground on which the Commission's order might be sustained."); see also Beloit Corp. v. Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984) ("The Commission . . . is at perfect liberty to reach a 'no violation' determination on a single dispositive issue."); Delorme Publ. Co. v. ITC, 805 F.3d 1328, 1336, n.4 (Fed. Cir. 2015) ("We leave this issue to a future case where its resolution is briefed and necessary to the outcome.").
D. Certification
The finding with respect to the articles at issue-specifically, that they implement the redesigned functionality addressed above and are not subject to the exclusion order on that basis-applies only to future articles that do not materially differ from those at issue in this ruling. See 19 C.F.R. 177.9(b)(1) ("The application of a ruling letter by a Customs Service field office to the transaction to which it is purported to relate is subject to the verification of the facts incorporated in the ruling letter, a comparison of the transaction described therein to the actual transaction, and the satisfaction of any conditions on which the ruling was based."). Thus, to the extent that future articles seeking entry are materially different from those at issue in this ruling because they do not have the same functionality or include new functionality that is relevant to the asserted claims in the exclusion order, this ruling would not cover such articles and the burden to establish admissibility under Section 337 would apply. See HQ H324813 (dated June 3, 2022) at 37.
Though this ruling analyzes whether the articles at issue, in their present condition as described above, satisfy the relevant claim limitations, the ability for post-importation modification leads the EOE Branch to the view that a certification, pursuant to paragraph 5 of the 1266 LEO, is warranted should the Commission lift suspension on enforcement of the limited exclusion order. See HQ H329187 (dated July 18, 2023) at 20-21. Moreover, while AliveCor is on notice, as provided in this ruling, regarding the use of a certification if the Commission lifts suspension on the exclusion order's enforcement, the EOE Branch considers it appropriate for AliveCor to have an opportunity to participate in the drafting process for the proposed certification, with specific procedures established when and if the Commission lifts the suspension. See id. at 21.
V. HOLDING
We find that Apple has met its burden to establish that the articles at issue do not infringe any of claims 12, 13, and 19-23 of the '941 patent or claims 1, 3, 5, 8-10, 12, 15, and 16 the '731 patent. Accordingly, we find that the articles at issue are not subject to the LEO issued as result of Investigation No. 337-TA-1266. Entry for consumption into the United States, entry for consumption from a foreign trade zone, or withdrawal from a warehouse for consumption of the articles at issue, however, is conditioned on the drafting and submission of a certification, as provided for in this ruling, that would take effect should the Commission lift the suspension on enforcement of the limited exclusion order.
The decision is limited to the specific facts set forth herein. If articles differ in any material way from the articles at issue 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), (4), and 177.9(b)(1) and (2).
Sincerely,
Dax Terrill
Chief, Exclusion Order Enforcement Branch
CC: S. Alex Lasher
Quinn Emanuel
1300 I Street NW, Suite 900
Washington, D.C. 20005
[email protected]; [email protected]
-----------------------
[1] Apple requested immediate consideration of the ruling request under 19 C.F.R. Part 177.2(d). Ruling Request at 52. This request was taken under consideration when establishing the procedural schedule in this inter partes proceeding.
[2] The parties agree that the Apple Watch SE lacks ECG functionality, was not accused of infringement during the underlying investigation, is not within the scope of the exclusion order, and, therefore, is not at issue in this ruling. Ruling Request at 2 n.2.
[3] Although claim construction is a question of law, the consideration of extrinsic evidence may constitute a subsidiary finding of fact. Teva, 135 S. Ct. at 841, 190 L. Ed. 2d at 733.
[4] We note that, for the articles at issue to operate in a manner different from that described in this ruling-for example, to circumvent any [[ ]] of the ECG functionality-Apple would need to modify the articles in the form of a software update. See HQ H329187 (dated July 18, 2023) at 18. Further, no evidence has been presented that shows a specific instance where the articles at issue have performed the infringing functionality, such that a "reasonable capability" to satisfy the claim limitations has not been shown. See id. at 16 (citing INVT, 46 F.4th at 1377).
[5] AliveCor seems to argue that the articles at issue continue to process ECG data by providing notifications relating to issues occurring while ECG readings are taking place. However, AliveCor concedes that this "processing" does not satisfy the claim limitations at issue, and therefore the Branch will not further address this point. See e.g., AliveCor Post-Oral Discussion Submission at 4-5 ("As AliveCor argued throughout its papers [], and again at the oral discussion [], the redesigned Apple Watch indisputably continues to 'process' ECG data on the Watch itself-contrary to Apple's witness declarations-by executing WatchOS code. The redesigned Watch continues to qualitatively assess the ECG data as it is being captured and notifies the user in the event of poor capture to '[h]old your hands still,' '[t]ry not to move your arms,' and '[m]ake sure to keep your finger on the crown' to generally improve the quality of ECG. Furthermore, the redesigned Apple Watch continues to display an ECG-based heart rate, which can only be computed by converting raw ECG signals into a discernible heart parameter from which a heart rate measured in BPM can be computed and continuously updated during the ECG session. This functionality unquestionably involves continued processing of ECG data on the Watch. It is not 'blocked,' as Apple alleges.
[]
Even though this 'processing' of ECG data does not constitute or dictate the claimed 'confirm the presence of the arrhythmia' limitation, it nevertheless contradicts and undercuts the significant propositions that Apple's declarants made in their declarations about the core alleged operation of the 'Remote ECG Redesign,' and Apple cannot explain away these discrepancies.") (internal citations omitted).
[6] As discussed above, the Federal Circuit has placed special emphasis on the "way" requirement in the function-way-result test. VLSI at 1342.