Has Human Milk Expired? — Current Application of the Redesign Standard in Original 337 Investigations

I. INTRODUCTION

Upon the ITC finding a violation of the Tariff Act of 1930, 19 U.S.C. § 1337 (“Section 337”) and issuing an exclusion order, respondents often find themselves facing serious business disruptions when their infringing products are blocked from importation into the United States under the exclusion order. One strategy to mitigate disruptions involves redesigning the accused products and submitting them for adjudication of non-infringement during the ITC investigation. To ensure that a redesigned product can be adjudicated in a pending ITC investigation, respondents must produce sufficient evidence regarding the redesigned products as early as possible in the investigation.[1] Because Section 337 investigations proceed so quickly, respondents must decide early whether to attempt a redesign and seek ITC adjudication.  Conversely, the complainant must decide whether to pursue discovery of a respondent’s redesigned products or try to exclude the products from the investigation entirely.

The Commission opinion in Certain Human Milk Oligosaccharides and Methods of Producing the Same (“Human Milk”) outlines the Commission’s test for redesign adjudication during Section 337 investigations.[2] The Commission applied a four-factor test to determine whether a respondent’s redesigned product was ripe for adjudication by the Administrative Law Judge (ALJ) during the investigation.

This article provides an overview of how the ITC considers redesigns in original investigations and an analysis of recent trends in the Commission’s application of the Human Milk factors.

II. AN OVERVIEW OF REDESIGNS AT THE ITC

The scope of ITC remedial orders is broad.  A remedial order is typically not limited to the specific accused products adjudicated in the Section 337 investigation, but includes all of the respondent’s infringing products within the scope of the Notice of Investigation (which usually provides a broad categorical description of the products).[3] However, a respondent can potentially alleviate the impact of a remedial order by seeking adjudication in the ITC investigation that redesigned products do not infringe.  Where a complainant has not accused a redesigned product, the respondent bears the burden of producing the redesigned product during the discovery period and proving it is ripe for adjudication.[4] If the respondent satisfies its burden, the burden shifts to the complainant to prove that the redesigned product infringes the asserted patent.[5]

In Human Milk, the ALJ articulated a four-factor test to determine when a redesign is ripe for adjudication per Commission precedent.[6] On review, the Commission adopted this approach, stating “the test for determining … the burden for adjudication of a redesign … includes four factors: (1) whether the product is within the scope of the investigation, (2) whether it has been imported, (3) whether it has been sufficiently fixed in design, and (4) whether it has been sufficiently disclosed by respondent during discovery.” Respondents must satisfy all four factors to warrant adjudication of a proposed redesign, but Human Milk and subsequent Commission opinions demonstrate the third and fourth factors are typically the most contentious.

A. The Human Milk Investigation

1. Factual Background

In the Human Milk investigation, Glycosyn LLC (“Glycosyn”) filed a complaint against Jennewein Biotechnologie GmbH (“Jennewein”) alleging violations of Section 337 for the unlawful importation and sale of certain human milk oligosaccharides made by a process involving certain bacterial strains and infringing one or more claims of two U.S. patents.[7] Specifically, Glycosyn accused Jennewein’s 2’-fucosyllactose (2’-FL) human milk oligosaccharides production methods based on an E. coli #1540 bacterial strain with β-galactosidase activity of infringement. During the investigation, Jennewein sought adjudication of a redesigned bacterial strain, TTFL12, which the complainant had not accused of infringement.[8]

As part of its efforts to introduce its redesign and have TTFL12 adjudicated, Jennewein produced two documents on August 21, 2018, demonstrating the TTFL12 strain’s relevant features.[9]The first document was an unpublished article discussing Jennewein’s strain engineering activities, and the second document was a Jennewein European patent application “disclos[ing] bacterial strains that intentionally lack β-galactosidase activity.” However, neither document referred to the strain as TTFL12.  Jennewein identified the strain’s name on September 14, 2018, in its Ground Rule 7.2 disclosure, which required Jennewein to identify any products it understood to be within the investigation’s scope. On November 5, 2018, the deadline for the closure of fact discovery, Jennewein served Glycosyn with a supplemental discovery response identifying the TTFL12 strain by name.

The ALJ issued an initial determination (“ID”) finding a Section 337 violation for infringement under the doctrine of equivalents. [10] The ALJ declined to adjudicate the proposed redesigned bacterial strain, finding Jennewein did not meet its burden per the fourth factor. Specifically, Jennewein failed to satisfy its burden to provide “extensive or sufficient discovery on the redesigned product, from either a document production or discovery response perspective.”  The ALJ reasoned “Jennewein…effectively pointed to just one document” to give Glycosyn notice of the redesigned product because “an accused infringer’s own patents are generally not considered reliable evidence of an accused product’s features in the first place.” 

Jennewein filed a petition for review of the ID, which the Commission granted—focusing on the ALJ’s “decision not to adjudicate infringement [of the] … TTFL12 strain.”[11]

2. Commission Opinion and Dissenting Views

After review, the Commission affirmed the ALJ’s infringement finding, but disagreed with the ALJ’s decision not to adjudicate TTFL12.  The Commission reversed ALJ’s decision with respect to the redesigned TTFL12 strain and determined that the redesign did not infringe any of the asserted claims.[12] The Commission’s analysis focused on whether TTFL12 was ripe for adjudication, adopting the four-factor test outlined in the ID. The Commission reiterated its general policy “in favor of adjudicating redesigns” to prevent “subsequent and burdensome proceedings that could have been resolved in the first instances.” While the Commission evaluated each factor individually, it placed greater emphasis on the fourth—i.e., whether Jennewein satisfied its burden of providing sufficient discovery.

Regarding the first factor (scope of the investigation), the Commission determined that the 2’FL produced with TTFL12 was undisputedly included within the scope of the investigation because the notice of investigation defined the accused products as “2’-fucosyllactose oligosaccharides.” As to the second factor (importation), the Commission was satisfied that the importation prong was met where evidence of shipping invoices, material safety data sheets, and a summary of imported product using TTFL12 was introduced “prior to close of fact discovery.”  The Commission determined that the third factor (sufficiently fixed) was satisfied where Jennewein’s witness testified (after the close of fact discovery) that “[TTFL12] ha[d] been in development since 2012” and “a lot of different fermentation runs have been done since then.”

The fourth factor (sufficient disclosure during fact discovery), the primary focus of the Commission’s analysis, was also satisfied.  The Commission emphasized that, prior to the close of fact discovery, “Jennewein was required to provide sufficient fact and expert discovery to put Glycosyn on notice of [TTFL12] and its relevant features.” In a footnote, the Commission disavowed the heightened standard of “extensive discovery” applied by the ALJ.[13] Instead, the Commission concluded “Jennewein presented sufficient documentary evidence” in its “Ground Rule 7.2 disclosure and its interrogatory responses served on [the close of fact discovery,]” as well as its production of two key documents two months before the close of fact discovery. According to the Commission, these documents showed “relevant features of the TTFL12 strain and establish[ed] that the strain does not infringe the asserted patent.”  While the ALJ questioned the probative value and reliability of the two documents, the Commission concluded the documents were relevant to Jennewein’s non-infringement claims. The Commission was satisfied that Jennewein’s redesign was ripe for adjudication.

Glycosyn’s apparent refusal to take discovery on TTFL12 also impacted the Commission’s final determination. The Commission highlighted that “the parties [did] not dispute that Jennewein produced relevant discovery as to TTFL12 within the fact discovery period established by the procedural schedule.”[14] According to the Commission, “if Glycosyn and its expert deemed such evidence to be insufficient, Glycosyn could and should have taken available procedural steps, such as a motion to reopen discovery or to compel further discovery, because the burden of establishing infringement remains with Glycosyn.” Ultimately, the Commission concluded TTFL12 did not infringe as “Glycosyn presented no expert evidence to establish the presence of the lacZ gene…in the TTFL12 strain.”

Commissioner Schmidtlein issued dissenting views.  In her dissent, she criticized the Commission’s decision to adjudicate whether TTFL12 infringed. Commissioner Schmidtlein asserted that, instead of putting Glycosyn on notice of TTFL12, “Jennewein’s discovery responses show that Jennewein overwhelmingly focused on the [accused strain] and . . . repeatedly disavowed importation of 2’-FL product made by any other strain besides the [accused strain].”[15] She pointed to Jennewein’s own admissions that “the [accused] strain was ‘the only strain that Jennewein was using to create’ the product that was being imported.” Moreover, it was not until “the last day of discovery” that “Jennewein provided supplemental responses stating that Jennewein had imported 2’-FL made with the TTFL12 strain.”

Further, Commissioner Schmidtlein took issue with the majority’s reliance on witness statements and hearing testimony evidence used by Jennewein to support the documents produced during discovery—evidence which is “simply not discovery.”[16] While such evidence was not irrelevant to the investigation, she opined it was “not germane to the question before the Commission, which concern[ed] what was provided during the discovery period.” Commissioner Schmidtlein’s criticism rested in her view that the complainant “was not provided sufficient information regarding the [redesigned] strain prior to the close of discovery to allow it to decide whether to assert infringement.”[17]

III. HUMAN MILK FACTORS APPLIED IN SUBSEQUENT 337 INVESTIGATIONS

The Human Milk decision illustrates a recent Commission trend in favor of adjudicating redesigned products during the Section 337 investigation, even redesigns disclosed late in discovery. Data suggests an increase in belated identification of redesigned products by respondents far into the procedural schedule—often after the deadline for infringement contentions on the accused products. According to a quantitative IAM article, this trend is evidenced by a “significant uptick in motion practice”—namely motions by complainants against the introduction of redesigned products—following the Human Milk decision.[18] Prior to the Human Milk decision in 2020, motions in limine or motions to strike redesigned and newly identified products were far less frequent with only “about three or four per year,” totaling 22 motions since 2014. In the year following the Human Milk investigation, the average “increased by 100% to about six or seven per year” with approximately eight investigations having such disputed motions against redesign products. Since 2021, the trend has continued with approximately sixteen investigations involving disputed motions against redesigned products (as of the original publication of this article).

A. Software Related Investigations

In Certain Audio Players and Controllers, the ALJ determined redesigns introduced during discovery satisfied each of the four factors of the Human Milk test.[19] In that investigation, Sonos filed a complaint against Google and Alphabet Inc. alleging violations of Section 337 based on the importation and sale of audio products that purportedly infringed several of Sonos’s U.S. patents.[20] Ultimately, the Commission found a violation of Section 337 and issued remedial orders._ftnref1

During the investigation, Google disclosed multiple redesigned products for adjudication by the Judge.[22] Initially, “Google did not produce samples, source code, documents, … or supplement any discovery directed to the Accused Products.” Eventually, on August 6, 2020, Google identified a “hypothetical alternative and further alternative designs that could be made to the Accused products.” Then on August 7, 2020, Google produced source code for the hypothetical redesigns and “made products incorporating that code available for inspection.” These disclosures came less than a month before final infringement contentions were due on August 28, 2020.

In response, Sonos moved to strike Google’s proposed redesigns, arguing Google had not met its burden for adjudication of a redesigned product. Specifically, Sonos argued Google’s redesigns were neither “fixed or definite” nor “sufficiently disclosed.” Sonos opined it would be “unfair and prejudicial” to allow Google to introduce its late-stage redesigns for adjudication. The Judge disagreed and denied Sonos’s motion based on a finding that Google’s proposed redesigns met the Human Milk four-factor test. The ALJ determined the redesigns were “sufficiently fixed such that an infringement determination [could] be made” where Google “produced source code for the alleged redesigns” and “made physical devices incorporating the source code available for inspection.” Additionally, the Judge determined the redesigns were sufficiently disclosed because Google “supplemented its interrogatory responses” and “made source code … and … physical devices incorporating the source code for the redesigns available for inspection” before fact discovery closed.

Subsequently, the ALJ determined that one proposed redesign did not infringe the asserted patents, while other redesigns and the original accused products did infringe.[23] By deploying the non-infringing redesign through a software modification, Google was allowed to continue importing the redesigned product even while the remedial orders blocked importation of other products.

In its subsequent petition for review of the ID, Sonos raised the issue again and argued that adjudicating Google’s software redesigns would “change the nature of section 337 litigation…for software cases.”[24] Sonos opined “it is exceedingly easy—and costless—for a company with Google’s resources to crank out all the manner of software proposals.” Sonos argued it could result in a recurring pattern of respondents seeking to introduce “dozens of proposals,” thereby “distract[ing] from … adjudicating the real products … actually interfering with domestic industry.” Sonos urged, “[l]eft unchecked, Google’s approach to redesigns will lead innovators to conclude that they cannot rely on the Commission’s protection” for software products. The Commission Opinion did not address the propriety of adjudicating the redesigns, but affirmed the ALJ’s finding of a violation of Section 337.

Another recent investigation involving the adjudication of a respondent’s redesigns in the software context is the matter of Certain Video Security Equipment and Systems, Related Software, Components Thereof (“Video Security”). The Commission instituted the investigation based on the complaint filed by Motorola Solutions, Inc. (“MSI”) and others, which alleged that Verkada, Inc. (“Verkada”) violated Section 337 by importing and selling allegedly infringing video security equipment and systems.[25] In the investigation, Verkada “presented eleven separate design alternatives to be adjudicated with respect to MSI’s infringement allegations.”

In response, MSI alleged Verkada “cannot establish that the [software redesigns] were fixed in design” and did not sufficiently disclose the source code with respect to one of the software redesigns.  Specifically, MSI asserted that, for at least one of the redesigns, “the source code for [the redesign] was never produced.”[26] However, because the complainants’ expert was able to opine on the infringement of the redesign despite any alleged deficiencies in discovery and “[w]ithout any indication that Complainants were unable to prepare for the hearing due to alleged discovery deficiencies,” the ALJ concluded the Human Milk factors supported the adjudication of the redesigns in the investigation.[27] The complainants petitioned the Commission for review of the ID, asserting that the respondent’s “approach to introducing redesigns be rejected because it prejudices MSI” and “creates an unclear record for enforcement of any remedial orders that issue from this investigation.”[28] Specifically, the complainant requested that the Commission review the ID’s findings as to whether certain redesigns are ripe for adjudication. However, the Commission declined to review the issue.

B. Non-Software Related Investigations

Post-Human Milk ITC decisions in non-software related investigations have revealed a similar trend of increased flexibility toward respondents seeking adjudication of redesigned products.  Similarly, these recent cases imply that it is incumbent upon complainants to assess and bring infringement contentions against newly identified products, even if the products are introduced later in the investigation.

For example, in Certain Electrical Connectors and Cages, the Commission affirmed the ALJ’s decision to adjudicate the respondents’ redesigned products under the Human Milk standard.[29] The investigation was instituted based on a complaint filed by Amphenol Corporation alleging violations of Section 337 for the importation and sale of products that infringed multiple high speed electrical connector patents. Amphenol named Luxshare Precision Industry Co., Ltd. as a respondent among other related entities. Luxshare sought adjudication of twenty-three redesigned products, arguing the products were non-infringing per the removal of an “electrically lossy material.”[30] In response, Amphenol argued the redesigned products were not ripe for adjudication because they “were identified late during discovery”—two months before fact discovery closed—which prevented Amphenol from performing tests required to assess infringement. Further, Amphenol disputed whether the redesigns were imported and sufficiently fixed to warrant adjudication.

The ALJ examined whether Luxshare’s redesigns were ripe for adjudication under the Human Milk factors. With respect to importation, the ALJ found that although there was no documentary evidence of importation, “physical samples of certain [r]edesign [p]roducts were produced in the United States by Luxshare in discovery and at least five of these samples were analyzed by Amphenol’s expert with respect to infringement of the [asserted] patent.”

With respect to the fixation requirement, the ALJ found that the redesigns were sufficiently fixed where “sample products and documentation made it clear what the final product [would] be.”[31] Luxshare’s redesigns were “described in CAD files, assembly drawings, … and physical samples of the Redesign Products were produced in discovery.”

Regarding the fourth factor, Amphenol argued Luxshare’s redesigns did not satisfy the test because the redesigns were “identified late during discovery” and the “magnitude of the case and the procedural schedule did not permit Amphenol to undertake the testing required to assess the [redesigns].” The ALJ rejected this argument, concluding that the redesigned products were “timely produced” in Luxshare’s interrogatory response nearly two months before fact discovery closed. The ALJ noted that previously the Commission found the fourth factor to be satisfied “where respondents identified redesigns at a similar stage of discovery.” Further, the ALJ cited Amphenol’s failure to provide an explanation of “why its experts performed electrical testing on the [accused products] but did not perform similar testing on the [redesign products],” and he found it weighed against Amphenol’s argument because Luxshare’s disclosure “should have been sufficient to facilitate an infringement analysis.” Because the Human Milk factors weighed in favor of adjudication and Amphenol did not address the redesigns in its infringement contentions, it could not prove infringement with respect to the redesigned products.

Amphenol petitioned the Commission for review of the ID, asserting that because Luxshare’s redesigned products were not imported and not sufficiently fixed, the ALJ erred in deciding to adjudicate the redesigned products.[32] The Commission determined to review the decision, but ultimately affirmed the ALJ’s findings on the redesigned products.

In another non-software case, Certain Polycrystalline Diamond Compacts and Articles Containing Same (“Polycrystalline Diamond”), the ALJ determined that redesigns introduced during discovery were ripe for adjudication under the Human Milk test.[33] In November 2020, U.S. Synthetic Corporation (“USS”) filed a complaint alleging violations of Section 337 based upon the importation of various articles allegedly infringing certain claims of five of its polycrystalline diamond compact patents.  USS named various respondents in the complaint, including SF Diamond Co., Ltd and SF Diamond USA, Inc. In June 2021, “one week before the close of fact discovery” and “three weeks before expert reports were due[,]” SF Diamond disclosed seven redesigned products and provided USS with “samples for each product…for inspection and testing.”[34] Additionally, SF Diamond provided USS with “updated interrogatory responses and produced documents describing the manufacturing process and various test results.”[35] SF Diamond sought adjudication of its redesigned articles.  As articulated by the ALJ, the only disputed Human Milk factor was whether the discovery on the redesigns was sufficient.  USS argued that because the samples were produced only one week before the close of fact discovery, USS was not allowed sufficient time to properly test the samples.[36] The ALJ was unpersuaded by this argument, finding that discovery was sufficient and instead “USS failed to avail itself of the opportunity to develop its infringement case” because “USS did not respond to SF Diamond’s offers to inspect, did not request additional time for testing, did not move to supplement its contentions, and otherwise did essentially nothing to make its case that the [redesigned products] infringe the claims.” Ultimately, the ALJ found no violation of Section 337 by SF Diamond. Even though the ALJ determined at least one accused product infringed all asserted claims of the asserted patents, those claims were found to be patent ineligible under 35 U.S.C. §§ 101 and 102.[37] The Commission did not review the redesign issue.

In contrast to the cases discussed above, Certain Unmanned Aerial Vehicles provides an example of a respondent’s redesigned product that failed to meet the Human Milk standard. In the original investigation, Autel Robotics USA, Inc. accused SZ DJI Technology Co. Ltd. and others (collectively “DJI”) of violating Section 337 for importing and selling infringing unmanned aerial vehicles (“UAV”).[38] The ALJ granted in part Autel’s motion to strike certain evidence that DJI produced after the close of discovery relating to its proposed redesigns for UAV rotor and battery locking mechanisms. Subsequently, the ALJ determined that the respondents had not produced sufficient evidence to prove that the redesigns were ripe for adjudication based on the third Human Milk factor (sufficiently fixed). In reviewing the ALJ’s decision to decline the adjudication of the respondent’s proposed redesigns, the Commission similarly concluded that the redesigns were not sufficiently fixed. The Commission found that while the respondents provided evidence of new rotor designs, the respondents failed to show how the redesigned rotors were used with a UAV. Because the investigation was directed to “unmanned aerial vehicles and components thereof,” the respondents had the burden of proving that the rotors were “components thereof”— constituting a part for a completed UAV. Instead, the respondents merely disclosed a redesigned rotor “without a clear connection to a complete or accused UAV product.” It was not until after the close of fact discovery and shortly before the deadline for serving rebuttal expert reports that DJI produced a UAV incorporating the redesigned rotor. Thus, DJI’s redesigns did not satisfy the Human Milk standard, and the Commission affirmed the ALJ’s decision.

IV. CONCLUSION

As demonstrated by recent ITC decisions, the Commission has adopted a fairly lenient standard when it comes to allowing the introduction of redesigned products. Based on precedent from Human Milk and other investigations, a respondent might be able to satisfy its burden by producing as little as two documents, supplemented by interrogatories and witness testimony, on the last day of fact discovery to introduce the redesigns into the investigation and have them adjudicated.[39] Even more, this flexibility towards respondents is joined by a burden on complainants to react quickly to newly identified redesigns—even redesigns substantively introduced near or on the last day of fact discovery. As previously discussed, the Commission does not look favorably on arguments suggesting that a complainant required more time or information to provide its infringement contentions without “tak[ing] available procedural steps, such as a motion to reopen discovery or to compel further discovery.”

The Commission’s flexibility toward adjudicating redesigns incentivizes respondents who are facing infringement accusations to devote the time and resources to develop non-infringing alternatives to the accused products during the original investigation. This incentive derives from the likelihood that the Commission will determine to adjudicate the redesigns if the products are complete before the end of fact discovery. Because ITC investigations typically conclude within sixteen to eighteen months and fact discovery will close within roughly five to six months of the institution of the investigation, the introduction of any redesigns to the investigation requires that respondents design, develop, implement, and import redesigns very quickly in order to be adjudicated. In some cases, developing and implementing a sufficiently-fixed redesign will not be feasible. Additionally, even if a respondent can develop and disclose a redesign before the close of fact discovery, there is no guarantee that the redesigns will necessarily avoid the scope of a remedial order from the ITC.

In the software context, small modifications to the source code can be all that is required for a redesign to be deemed non-infringing, allowing a respondent to avoid the consequences of exclusion orders by deploying a software update. In such circumstances, the low-threshold standard for adjudicating redesigns might disincentivize complainants from bringing infringement claims at the ITC in the first instance. 

While the Commission’s policy favoring the adjudication of redesigns, even when disclosed late in discovery, may incentivize respondents to develop redesigned products, it does not necessarily encourage respondents to disclose them in a timely manner. For instance, in Certain Audio Players, while respondent Google had suggested early in discovery that it might attempt to design around the asserted patents, Google did not disclose its completed redesigns until just over a month before the close of fact discovery.[40] Nonetheless, the ALJ still determined that the redesigns were ripe for adjudication.

Complainants are not necessarily left hopeless when litigating against respondents seeking to adjudicate late-disclosed redesigns. When respondents seek to introduce redesigned products into an investigation, it is incumbent upon complainants to quickly have their experts examine and analyze the redesigned products and to determine if the disclosure is adequate or if further discovery is necessary. Complainants should also advocate for the establishment of express deadlines in procedural schedules for disclosure of products, including redesigns, within the scope of the investigation and substantial completion of technical discovery prior to any deadlines for infringement contentions.[41] For example, in Certain Video Processing Devices, Components Thereof, and Digital Smart Televisions Containing the Same (“Video Processing Devices”), complainants requested additional discovery following the introduction of redesigns to the investigation. The ALJ agreed to extend fact discovery by three weeks, stating that “if Respondents would like their modifications/updated products adjudicated, they must provide Complainant with all evidence that they have with respect to the modifications/updates.”[42] Moreover, the ALJ ruled that “any evidence upon which complainant has not had an opportunity for discovery or has been withheld may not be considered.” Ultimately, for the benefit of both complainants and respondents, and to balance the interests of both parties in Section 337 investigations, the Commission should encourage the ALJs to formally adopt ground rules and procedural schedules mandating disclosures of all products within the scope of the investigation, including redesigns, sufficiently in advance of contention deadlines and the completion of discovery.

Edited for length and content from Maggie Dowlings’s original publication in ITCTLA’s 337 Reporter: The Paul J. Luckern Summer Associate Edition, 2023

[1] This article does not address the different standards for adjudication of redesigns by the International Trade Commission or U.S. Customs and Border Protection after remedy orders are issued. See, e.g., Certain Electronic Digital Media Devices and Components Thereof, Inv. No. 337-TA-796, Comm’n Op. at 129-130 (Sept. 6, 2013) (“The Commission notes that any new allegations of infringement concerning new Samsung products or redesigns can be expeditiously adjudicated through the Commission’s established post order inter partes procedures”); see also Certain Gas Spring Nailer Products and Components Thereof, Inv. No. 337-TA-1082 (Modification Proceeding), Recommended Determination at 1-3 (July 2, 2021).

[2] Certain Human Milk Oligosaccharides and Methods of Producing the Same (“Human Milk”), Inv. No. 337-TA-1120, Comm'n Op. at 18 (June 8, 2020).

[3] See id. at 19; see also Certain Road Construction Machines & Components Thereof, Inv. No. 337-TA-1088 (Modification Proceeding), Comm’n Op. at 22-34 (Sept. 14, 2020).

[4] See Human Milk, Comm’n Op. at 18-19.

[5] See Certain Two-Way Radio Equipment and Systems, Related Software and Components Thereof, Inv. No. 337- TA-1053, Comm’n Op. at 27 (Dec. 18, 2018) (noting that because patent owner “failed to put forward evidence on infringement it did not carry its burden to prove infringement by a preponderance of the evidence,” and as such, the “redesigned products are not covered by our remedial orders”).

[6] Human Milk, Comm’n Op. at 18-19; see also Certain Two-Way Radio Equipment, Inv. No. 337-TA-1053, Comm’n Op. at 8 (Dec. 18, 2018).

[7] Human Milk, Comm’n Op. at 18-19.

[8] Human Milk, Initial Determination at 30, 31 (Sept. 9, 2019).

[9] Id. at 30-31; Human Milk, Comm’n Op. at 14.

[10] Human Milk, Comm’n Op. at 2 (“The Commission [previously] terminated the investigation as to all asserted claims of the ’230 patent and certain asserted claims of the ’018 patent based on the withdrawal of the allegations pertaining to those claims”).

[11] Id. at 3–4.

[12] Id. at 18.

[13] Id. at 20, 22.

[14] Id. at 23.

[15] Human Milk, Dissenting Op. at 3.

[16] Id. at 4 (Commissioner Schmidtlein highlighted that Jennewein presented no expert report in relation to the TTFL12 strain).

[17]Id. at 5-6, 15.

[18] MICHAEL RENAUD, Levelling the Playing Field in ITC Patent Cases by Identifying Redesigns to a Set Deadline, IAM (Sept. 20, 2021), https://www.iam-media.com/article/itc-late-redesign-response-strategies-mintz-commission.

[19] Certain Audio Players and Controllers, Components Thereof, and Products Containing the Same, Inv. No. 337- TA-1191, Order No. 19 (Denying Complainant Sonos, Inc.’s Motion to Strike Hypothetical Redesigns) at 1 (Sept. 4, 2020).

[20] Audio Players and Controllers, Initial Determination at 1, 2 (Aug. 13, 2021).

[21] Audio Players and Controllers, Comm’n Op. (Feb. 1, 2022).

[22] Audio Players and Controllers, Order No. 19 (Denying Complainant Sonos, Inc.’s Motion to Strike Hypothetical Redesigns) at 1-2 (Sept. 4, 2020).

[23] Audio Players and Controllers, Initial Determination at 180-182.

[24] Audio Players and Controllers, Complainant Petition for Review at 22, 28 (August 27, 2021).

[25] Certain Video Security Equipment and Systems, Related Software, Components Thereof, and Products Containing Same, Inv. No. 337-TA-1281, Initial Determination at 1, 20 (Oct. 24, 2022).

[26] Video Security Equipment and Systems, Complainant Petition for Review at 94 (Nov. 7, 2022).

[27] Video Security Equipment and Systems, Initial Determination at 20.

[28]Video Security Equipment and Systems, Complainant Petition for Review at 93-100.

[29] Certain Electrical Connectors and Cages, Components Thereof, and Products Containing the Same, Inv. No. 337- TA-1241, Comm’n Op. at 3, 13 (Sept. 30, 2022).

[30] Electrical Connectors and Cages, Initial Determination at 31, 33-34, 38 (March 11, 2022).

[31] Id. at 31, 36-38 (quotations omitted) (relying on Certain Electronic Devices, Including Streaming Players, Televisions, Set Top Boxes, Remote Controllers, and Components Thereof, Inv. No. 337-TA-1200, Initial Determination at 90-91 (July 9, 2021)).

[32] Electrical Connectors and Cages, Comm’n Op. at 12-13.

[33] Certain Polycrystalline Diamond Compacts and Articles Containing Same, Inv. No. 337-TA-1236, Initial Determination at 1, 43 (March 3, 2022).

[34] Polycrystalline Diamond Compacts, Order No. 37 (Granting-in-Part Complainant’s Motion to Strike Portions of Respondents’ Expert Reports and Untimely Materials) at 10 (Sept. 7, 2021).

[35] Polycrystalline Diamond Compacts, Initial Determination at 41.

[36] Id. at 42-43 (“[A]ccording to Respondents it took [the expert] one week to test five samples. At that rate, it would have taken Dr. German seven weeks to test the 35 […] samples, which is unreasonable in view of the discovery schedule, particularly the fact that initial expert reports were due about four weeks after SF Diamond produced the […] samples.”).

[37] Polycrystalline Diamond Compacts, Comm’n Op. at 3 (Oct. 26, 2022).

[38] Certain Unmanned Aerial Vehicles and Components Thereof, Inv. No. 337-TA-1133, Comm’n Op. at 2, 21, 23-25 (Sept. 8, 2020).

[39] Human Milk Oligosaccharides, Comm’n Op. at 19, 23.

[40] Audio Players and Controllers, Order No. 19 (Denying Complainant Sonos, Inc.’s Motion to Strike Hypothetical Redesigns) at 1-3.

[41] See e.g., Certain Playards and Strollers, Inv. No. 337-TA-1288, Initial Determination at 9-10 (March 31, 2023) (holding that the respondents sufficiently disclosed its redesigned product despite complainants’ argument that the timing of discovery was in violation of Ground Rule 6.4.6. Ground Rule 6.4.6 provided that a respondent was required to produce all relevant discovery 30 days prior to the close of fact discovery. However, Ground Rule 6.4.6 was not in the original Ground Rules issued by the Judge and was issued within the 30-day window to the close of fact discovery, so the respondents were not required to produce all discovery relevant to redesigns by the deadline.).

[42] Certain Video Processing Devices, Components Thereof, and Digital Smart Televisions Containing the Same, Inv. No. 337-TA-1222, Order No. 39 (Revised Procedural Schedule with Certain Open Dates for the Parties to Propose) at 2 (March 8, 2021).