Case: 21-2311 Document: 41 Page: 1 Filed: 11/09/2022
`United States Court of Appeals
`for the Federal Circuit
`Appeal from the United States District Court for the
`District of Massachusetts in No. 1:20-cv-10351-IT, Judge
`Indira Talwani.
`Decided: November 9, 2022
`BRENDAN COX, Laredo & Smith, LLP, Boston, MA, ar-
`gued for plaintiff-appellee. Also represented by PAYAL
` JOHN LABBE, Marshall, Gerstein & Borun LLP, Chi-
`cago, IL, argued for defendant-appellant. Also represented
` ______________________
`Before NEWMAN, LOURIE, and PROST, Circuit Judges.


`Case: 21-2311 Document: 41 Page: 2 Filed: 11/09/2022
`PROST, Circuit Judge.
`Sunset Healthcare Solutions, Inc. (“Sunset”) appeals
`the U.S. District Court for the District of Massachusetts’s
`order granting preliminary injunctive relief to SoClean,
`Inc. (“SoClean”) requiring “Sunset to clearly associate its
`online marketing and sales . . . with the Sunset brand.” So-
`Clean, Inc. v. Sunset Healthcare Sols., Inc., 554 F. Supp. 3d
`284, 308 (D. Mass. 2021). We affirm.
`This appeal is a small part of a larger intellectual-prop-
`erty dispute between SoClean, a medical-device company
`that produces sanitizing devices for Continuous Positive
`Airway Pressure (“CPAP”) machines, and Sunset, one of its
`former distributors. As relevant here, SoClean owns
`U.S. Trademark Registration No. 6,080,195 (“the ’195 reg-
`istration”) for the configuration of replacement filters for
`its sanitizing devices:


`Case: 21-2311 Document: 41 Page: 3 Filed: 11/09/2022
`SoClean sued Sunset for patent infringement on Feb-
`ruary 20, 2020; it filed a second patent-infringement law-
`suit about a year later; and, shortly thereafter, it amended
`the complaint in the second lawsuit to assert trademark-
`infringement claims based on, among others, the ’195 reg-
`istration. The district court consolidated the two cases at
`the parties’ request.
`On April 23, 2021, SoClean asked the district court to
`preliminarily enjoin Sunset from using, selling, offering for
`sale, or making in the United States filters that SoClean
`alleged infringed the ’195 registration. The district court
`granted the motion in part, concluding that SoClean was
`likely to succeed on the merits and, accordingly, was enti-
`tled to a presumption of irreparable harm. SoClean, 554 F.
`Supp. 3d at 306–07. Balancing the equities and weighing
`the public interest, the district court concluded that So-
`Clean’s request to enjoin all sales of Sunset’s filters would
`“go[] much further than necessary” to “end any possible
`statutory violation.” Id. at 308. The district court instead
`crafted a narrow “injunction that prohibits Sunset from en-
`gaging in those practices that result in consumer confu-
`sion” and enjoined Sunset from marketing its filters “using
`images of the filter cartridge alone”; “[a]ny image, draw-
`ings, or other depictions of Sunset’s filter cartridge used for
`the purposes of promotion, marketing and/or sales shall
`prominently display the Sunset brand name in a manner
`that leaves no reasonable confusion that what is being sold
`is a Sunset brand filter.” Id.
`Sunset appeals. We have jurisdiction under 28 U.S.C.
`§§ 1292(c)(1) and 1295(a)(1).
`We review a preliminary-injunction order under the
`law of the regional circuit. Koninklijke Philips N.V. v. Tha-
`les DIS AIS USA LLC, 39 F.4th 1377, 1379 (Fed. Cir. 2022).
`The First Circuit reviews preliminary-injunction decisions
`for abuse of discretion; it reviews underlying questions of


`Case: 21-2311 Document: 41 Page: 4 Filed: 11/09/2022
`law de novo and questions of fact for clear error. Am. Inst.
`for Foreign Study, Inc. v. Fernandez-Jimenez, 6 F.4th 120,
`122 (1st Cir. 2021).
`A party seeking a preliminary injunction must estab-
`lish (1) a likelihood of success on the merits of its claim;
`(2) a likelihood of irreparable harm in the absence of pre-
`liminary relief; (3) that the balance of equities tips in its
`favor; and (4) that the injunction is in the public interest.
`Together Emps. v. Mass Gen. Brigham Inc., 32 F.4th 82, 85
`(1st Cir. 2022) (citing Winter v. Nat. Res. Def. Council, Inc.,
`555 U.S. 7, 20 (2008)). “The first two factors are the most
`important.” Id.
`Sunset raises two challenges on appeal, both relating
`to the likelihood-of-success factor. First, it argues that the
`district court abused its discretion when it concluded that
`SoClean was likely to defeat Sunset’s defense that the
`’195 registration lacks secondary meaning. Second, it con-
`tends that the district court erred in finding that the avail-
`ability of alternative designs for the filter’s head meant
`that SoClean was likely to defeat Sunset’s functionality de-
`fense. We address each in turn.
`We begin with Sunset’s secondary-meaning argu-
`ments. Sunset contends that the district court (1) afforded
`too much weight to the presumption of validity and (2) held
`Sunset to a higher standard of proof than the applicable
`preponderance-of-the-evidence standard. Neither conten-
`tion has merit.
`There is no dispute that SoClean’s trade dress is a
`product-configuration trade dress, so it is only protectable
`“upon a showing of secondary meaning.” See Wal-Mart
`Stores, Inc. v. Samara Bros., 529 U.S. 205, 216 (2000). But
`where, as here, the trade dress is federally registered, that
`registration “shall be prima facie evidence of the validity of
`the registered mark and of the registration of the mark.”


`Case: 21-2311 Document: 41 Page: 5 Filed: 11/09/2022
`15 U.S.C. § 1057(b); see also id. § 1115(a) (“Any registration
`. . . of a mark registered on the principal register provided
`by this chapter and owned by a party to an action . . . shall
`be prima facie evidence of the validity of the registered
`mark and of the registration of the mark.”). When the
`mark has been registered for fewer than five years and re-
`mains contestable, as is the case for the ’195 registration,
`“the effect of registration . . . is to shift the burden of proof
`from the plaintiff to the defendant, who must introduce suf-
`ficient evidence to rebut the presumption of the plaintiff’s
`right to exclusive use.” Borinquen Biscuit Corp. v. M.V.
`Trading Corp., 443 F.3d 112, 117 (1st Cir. 2006) (cleaned
`Though Sunset acknowledges that it bears the burden
`of showing that SoClean’s registration lacks secondary
`meaning, it nonetheless argues that the district court
`should have “decide[d] whether the evidence that was be-
`fore the [trademark] examiner, in view of Sunset’s argu-
`ments and additional evidence, is sufficient to support
`SoClean’s Section 2(f) registration.” Appellant’s Br. 23–24.
`The district court agreed that Sunset had “raise[d] ques-
`tions as to whether the [e]xaminer followed PTO proce-
`dures in approving” the ’195 registration.1 SoClean, 554 F.
`Supp. 3d at 296. It nevertheless presumed that the regis-
`tration was valid because “Sunset ha[d] pointed to no
`1 Namely, while evidence of five years’ continuous
`use is prima facie evidence that a mark has acquired dis-
`tinctiveness, 15 U.S.C. § 1052(f), the Trademark Manual of
`Examining Procedure (“TMEP”) requires additional evi-
`dence for “nondistinctive product design” like SoClean’s fil-
`ter, see TMEP § 1212.05(a). As the district court noted, the
`trademark examiner “granted SoClean the benefit of th[e]
`statutory presumption and approved the [m]ark” without
`requiring additional evidence of secondary meaning. So-
`Clean, 554 F. Supp. 3d at 296.


`Case: 21-2311 Document: 41 Page: 6 Filed: 11/09/2022
`authority for the proposition that this court may simply ig-
`nore the statutory mandate.” Id. Sunset contends that this
`was error because Congress vested courts with authority to
`review trademark registrations. Specifically, Sunset
`points to 15 U.S.C. § 1119, which states that “the court may
`determine the right to registration, order the cancelation
`of registrations, in whole or in part, restore canceled regis-
`trations, and otherwise rectify the register with respect to
`the registrations of any party to the action.”
`Sunset’s argument fails. The presumption of validity
`is not conditional; the statute provides that a certificate of
`registration “shall” result in the presumption, without
`specifying any exceptions. See 15 U.S.C. § 1057(b). Sunset
`fails to identify any statutory or legal basis to withhold the
`presumption from a registration. And “withholding the
`presumption” is the basic import of Sunset’s position, no
`matter what it acknowledges about who bears the burden;
`scrutinizing the application process and deciding whether
`the trademark examiner was correct to issue the registra-
`tion in the first place is the opposite of presuming that the
`registration as issued is valid. Sunset may still invoke
`§ 1119 and ask the district court to rectify the register if
`SoClean’s trade dress is deficient; Sunset simply bears the
`burden of proof in doing so, and SoClean is entitled to rely
`only on the presumption and need not present any evidence
`of its own. The district court did not, therefore, abuse its
`discretion when it declined to revisit the examiner’s actions
`and alter the statutory presumption of validity.
`Sunset’s second argument—that the district court held
`it to a higher burden—fares no better. To be sure, the dis-
`trict court’s opinion contains a misstatement: in discussing
`the consequence of the ’195 registration’s presumption of
`validity, it said that “the burden is on Sunset, not SoClean,
`to satisfy the ‘vigorous evidentiary requirements,’ either by
`direct or circumstantial evidence, to prove that the [m]ark
`has not obtained secondary meaning.” SoClean, 554 F.
`Supp. 3d at 298 (emphasis removed). But there are no


`Case: 21-2311 Document: 41 Page: 7 Filed: 11/09/2022
`“vigorous evidentiary requirements” on the challenger for
`proving lack of secondary meaning; a trademark challenger
`need simply show invalidity of the mark—here, that the
`’195 registration is merely descriptive—by a preponder-
`ance of the evidence. See Borinquen, 443 F.3d at 117–18.
`The “vigorous evidentiary requirements,” as the district
`court noted, apply to “the question of whether a mark has
`obtained secondary meaning.” SoClean, 554 F. Supp. 3d at
`297 (emphasis added) (citing Yankee Candle Co. v. Bridge-
`water Candle Co., 259 F.3d 25, 43 (1st Cir. 2001)). That
`burden is on the owner of a non-registered trade dress and
`so is inapplicable here. See Yankee Candle Co., 259 F.3d at
`43, 45. So, by implying that Sunset was required to meet
`“vigorous evidentiary requirements” to prove lack of sec-
`ondary meaning, it appears that the district court may
`have applied an incorrect standard.
`But the oft-repeated adage that “we review judgments,
`not opinions,” applies here. See, e.g., Omega Pats., LLC v.
`CalAmp Corp., 13 F.4th 1361, 1369 (Fed. Cir. 2021). The
`district court went on to examine Sunset’s evidence of no
`secondary meaning and found it “equivocal, at best.” So-
`Clean, 554 F. Supp. 3d at 298. Equivocal evidence plainly
`fails to satisfy a preponderance-of-the-evidence standard,
`so Sunset is wrong to suggest that the district court would
`have reached a different result had it applied the correct
`standard. The district court’s misstatement of the applica-
`ble standard of proof is harmless error. See Vanderbilt
`Univ. v. ICOS Corp., 601 F.3d 1297, 1308 (Fed. Cir. 2010)
`(finding harmless error where “[t]he district court’s find-
`ings demonstrate that under the correct legal test, [appel-
`lant] did not carry its burden”); Environ Prods. v. Furon
`Co., 215 F.3d 1261, 1266 (Fed. Cir. 2000) (“When the error
`as to the weight of proof could not have changed the result,
`the erroneous instruction is harmless.”).
`Accordingly, we affirm the district court’s finding that
`SoClean is likely to defeat Sunset’s secondary meaning de-


`Case: 21-2311 Document: 41 Page: 8 Filed: 11/09/2022
`We turn next to Sunset’s assertion that the district
`court misapplied the law by considering the availability of
`alternative designs after finding that SoClean’s trade dress
`is functional. Sunset contends that SoClean’s trade dress
`design “is entirely utilitarian” and that the district court
`erred by giving weight to the fact that alternative ways of
`designing the filter head existed. Appellant’s Br. 32, 37.
`“[A] product feature is functional, and cannot serve as
`a trademark, if it is essential to the use or purpose of the
`article or if it affects the cost or quality of the article.”
`Traffix Devices, Inc. v. Mktg. Displays, Inc., 532 U.S. 23, 32
`(2001) (cleaned up). This “doctrine prevents trademark
`law, which seeks to promote competition by protecting a
`firm’s reputation, from instead inhibiting legitimate com-
`petition by allowing a producer to control a useful product
`feature.” Qualitex Co. v. Jacobson Prods. Co, 514 U.S. 159,
`164 (1995). “The fact that a product contains some func-
`tional elements does not, however, preclude Lanham Act
`protection.” I.P. Lund Trading ApS v. Kohler Co., 163 F.3d
`27, 37 (1st Cir. 1998). A combination of functional features,
`where the combination itself is not functional, is protecta-
`ble; “[t]he crucial inquiry is into the effect that granting
`protection will have on the opportunity of others to com-
`pete.” Id.
`Sunset argues that the district court, after concluding
`that SoClean’s filter design is functional, erred in giving
`weight to the possibility that the filter’s head could have
`different shapes. Appellant’s Br. 37. That premise, how-
`ever, is incorrect: the district court never concluded that
`the filter’s design is functional. Rather, the district court
`said (1) that “direct evidence strongly suggests that the fea-
`tures of the body of” the mark are functional; (2) that “di-
`rect evidence suggests that many”—not all—“features of
`the head of the [m]ark are functional”; and (3), after a
`thoughtful discussion regarding a circuit split on the


`Case: 21-2311 Document: 41 Page: 9 Filed: 11/09/2022
`question of whether the availability of alternative designs
`is relevant indirect evidence of nonfunctionality, that alter-
`native designs SoClean had identified for the filter head
`“constitute evidence that there are some arbitrary ele-
`ments to SoClean’s filter that Sunset decided to copy where
`functionality has not otherwise been established.” So-
`Clean, 554 F. Supp. 3d at 299–302 (emphasis added). The
`takeaway for the district court was that the ’195 registra-
`tion “comprises both functional and non-functional fea-
`tures.” Id. at 302. That, combined with the statutory
`presumption of validity, was enough for the district court
`to conclude that SoClean was likely to defeat Sunset’s func-
`tionality challenge. Id.
`Sunset is also wrong in its argument that the district
`court never should have considered alternative designs.
`Most circuits, including this court, have held that alterna-
`tive designs are a relevant consideration in the functional-
`ity analysis. See Valu Eng’g Inc. v. Rexnord Corp., 278 F.3d
`1268, 1276 (Fed. Cir. 2002). The leading treatise on trade-
`mark law considers that the correct approach as well. See
`J. Thomas McCarthy, 1 McCarthy on Trademarks and Un-
`fair Competition § 7.75 (5th ed. 2021). Indeed, Sunset does
`not appear to argue that this approach is incorrect, nor do
`we believe that the First Circuit would follow a different
`path because the majority view is consistent with that
`court’s exhortation to focus the inquiry on “the effect that
`granting protection will have on the opportunity of others
`to compete.” I.P. Lund, 163 F.3d at 37. Sunset argues only
`that the availability of alternative designs should not de-
`feat a preexisting functionality finding, but as explained
`above, that is not what the district court concluded. The
`district court, therefore, did not incorrectly apply the law.
`Further, while Sunset does not overtly try to relitigate
`the functionality question, it does briefly argue about the
`functionality of the filter’s head. See Appellant’s Br. 40–42.
`In doing so, however, it relies on the same evidence that
`the district court weighed and found insufficient, and


`Case: 21-2311 Document: 41 Page: 10 Filed: 11/09/2022
`Sunset does not identify any clearly erroneous findings or
`other abuse of discretion. Accordingly, we affirm the dis-
`trict court on the functionality issue as well.
`Finally, the district court noted that, under the Trade-
`mark Modernization Act of 2020, SoClean is entitled to a
`rebuttable presumption of irreparable harm once the court
`has found that SoClean is entitled to a likelihood of success
`on the merits. Sunset did not attempt to rebut that pre-
`sumption. As for factors three and four, the district court
`concluded that the balance of the equities and considera-
`tions of public interest weigh in SoClean’s favor, and Sun-
`set has likewise not challenged those findings on appeal.
`We also note the narrowness of the preliminary injunction.
`For all of these reasons, we affirm the district court’s grant
`of the preliminary injunction.
`We have considered Sunset’s remaining arguments
`and find them unpersuasive. We affirm the district court’s
`preliminary-injunction order.

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