Bardy Diagnostics v. iRhythm Technologies - Patent Infringement Lawsuit

IN THE UNITED STAT ES D ISTRIC T COUR T FOR THE DISTRI CT OF DELAWARE Case No. 1:2 4-cv-0 1355 - JDW MEMORAN DUM Bardy Diagnostics, Inc. alleges that iRhythm T echnologie s, Inc., infring es four Bardy patents. iRhythm, in turn, claim s that Bardy infringe s five iRhythm patents. The P arties dispute the meaning of eleven cl aim terms across eight asserted patents: (1) U.S. Patent No. 12,161,473 (the ’473 Patent); (2) U.S. Patent No. 12,171,5 62 (the ’562 Patent); (3) U.S. Patent No. 12,285,261 (the ’261 Patent); and (4) U.S. Patent No. 12,310,735 (the ’735 Patent). iRhythm’s asserted patents are: (5) U.S. Patent No. 12,133,734 (the ’73 4 Patent); (6) U.S. Patent No. 12,274,554 (the ’554 Patent); (7) U.S. Pate nt No. 12,303,277 (the ’277 Patent); and (8) U.S. Patent No. 12,245,859 (the ’859 Patent). I held a Markman hearing on January 15, 2026, and now resolve the dis puted constructions. BARDY DIA GNOSTIC S, INC., Plaintiff and Coun ter - Defendant, v. IRHYTHM TEC HNOLOGIES, INC., Defendan t and Counter - Plaintiff.

2 I. LEGAL STAND ARD A. Claim Con stru ction “It is a ‘bedrock principle’ of pate nt law that ‘the claims of a patent define the invention to which the pate ntee is entitl ed the right to exclude.’” Phillips v. AW H Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (quotation omitted). Claim construction is a matter of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 837 (2015). “[T]here is no ‘magic formula or catechism’” for construing a patent claim, nor is a court “barred from consid ering a ny parti cular source s or re quired to ana lyze s ources in any specific sequence[. ]” Phillips, 415 F.3d at 1324. Instead, a court is free to attach the appro priate weight to appropriate sources “in light of the s tatutes and polici es that inform patent law. ” Id. (citation o mitted). A court generally gives the words of a claim “their ordinary and customary meani ng, ” which i s the “meaning t hat the te rm would ha ve to a person of ordi nary skil l in the art at the time of the invention, i.e., as of the effective filing date of the patent applicatio n.” Id. at 1312 - 13 (quotations omitt ed). Usually, a court first considers the claim langua ge; then t he rema ining int rinsic evid ence; a nd fin ally, th e extrin sic evidence in limited circumsta nces. See Interactive Gif t Exp., Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 - 32 (Fed. Cir. 2001). While “the claims themselves provide substantial guidance as to the me aning of p articular clai m terms [,]” a court als o must c onsider the conte xt of the surrou nding wor ds. Phillips, 415 F.3d at 1314. In addition, the pate nt specification “‘is

3 always highly relevant to the claim construction analysis ’ and indeed is often ‘the s ingle best guide to the meaning of a disputed term.’” AstraZeneca AB v. My lan Pharms. Inc., 19 F.4th 1325, 1330 (Fed. Cir. 2021) (quotation omitted). But, whi le a c ourt mus t cons true c laim s to be consi stent with the spe cif icati on, the court must “avoid the danger of reading lim itations from the speci fication into the claim ….” Phillips, 415 F.3d at 1323. This is a “ fine” distinction. Comark Co mmuni cati ons, Inc. v. Harris Corp., 156 F.3d 1182, 1186 – 87 (Fed.Cir.1998). In ad dition, “[e]ven w hen the specificatio n describe s only a sin gle embo diment, the claims of the p atent will n ot be read restrictively unles s the patentee has demonstrated a clear intention to limit the claim scope using ‘ words or ex press ions of mani fest e xclus ion or res tric tion.’ ” Hill - Rom Svcs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (quotation omitted) (alte rations in origin al). “The co urt ’ s task is not to limit claim language to exclude particular devices because th ey do not serve a perceiv ed ‘ purpose ’ of the inve ntion. Rather, t he court ’ s function is to interpret claims according to their plai n language unless the patentee has chose n to be his ow n lexicographe r in the specificatio n or h as clearly disclaim ed coverag e during pros ecut ion.” E- Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1370 (Fed. Cir. 2003) (citing Invernes s Med. Swi tzerl and GmbH v. Princ eton Bi omedi tec h Corp., 309 F.3d 1365, 1371 - 77 (Fed. Cir. 2002)). An invention may possess several advantages or purposes, and there is no requirement that every claim directed to that invention be limi ted to encompa ss a ll of them.

4 A court may refer to extri nsic evidence only if the disputed term’s ordinary and accus tomed m eaning cannot be di sce rned fr om the i ntrinsi c ev idence. See Vitro nics Corp. v. Conce ptroni c, Inc., 90 F.3d 1576, 1584 (Fed. Cir. 1996). Althou gh a court may not use extrinsic evi dence to vary or contradict the claim language, extrinsic materials “may be helpful to explain sci entific p rinciples, th e mea ning of t echnical terms, and terms o f art that app ear in the pate nt and prosecuti on his tory.” Markman v. Westvi ew In struments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995). Extrinsi c evidence is use d “to ensure that the court’s understanding of the technical aspects of the patent is consistent w ith that of a person of skill in the ar t[.]” Phillips, 415 F.3d at 1318. The Fe deral Circuit has cautioned against relying upon expert reports and testimony that is generated for the pur pose of litigation because of the lik eliho od of bias. Id.; see also Daubert v. Merre ll Dow Pharms., Inc., 509 U.S. 579, 595 (1993) (“Expe rt evidence can be both powe rful and quite mi sleading because of the difficulty in evaluating it.”) (quotation omitted). Ultimately, “[t]he construction that stays true to the claim l anguage and most naturally aligns with the patent’s description of the inventio n will be . . . the correct construc tion.” Renis haw PLC v. Marpos s Societa’ pe r Anzioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that “a claim inte rpretation that would exclude the i nventor’s device is rarely th e correct in terpretat ion[.]” Modifine Mf g. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1550 (Fed. Circ. 1996, abr ogated on other grounds by, Festo Co rp. v. S hokets u Kinzoku K ogyo Kab ushi ki Co., 234 F.3d 558 (Fed. Circ. 2000), vacated, 535 U.S. 722 (2002).

5 B. Indefiniteness “Indefiniteness is a matter of claim construction, and the same principles that generally govern claim construction are applic able to determining whether allege dly indefinite claim lan guage i s subject to co nstructio n.” Kyowa Hakka Bio, Co., Ltd. v. Ajinomot o Co., No. CV 17 - 313, 2020 WL 3403207, at *5 (D. Del. June 19, 2020) (i nternal quotations omitted). “The inte rnal coherence and context assessment of the patent, and whether it conveys claim meaning with reasonable ce rtainty, are questions of law.” Teva P harm. USA, Inc. v. San doz, Inc., 789 F.3d 1335, 1342 (Fed. Cir. 2015). A party seeking to prove indefiniteness must do so by cle ar and convincing evidence. See BASF C orp. v. Johnson M atthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017). “A pat ent's specificati on must ‘ conclud e with one o r more claims pa rticularly pointing out and distinctl y claiming the s ubject matter which the applicant regards as [the] inventi on.’” Teva, 789 F.3d at 1340 (quoting 35 U.S.C. § 112, ¶ 2). A patent claim is indefinite i f, “view ed in ligh t of the specificat ion and pro secution h istory, [it fa ils] to inform those s kill ed in t he art ab out the scope of the inventi on with r ea sonable cert ainty.” Nautil us, Inc. v. Bios ig Inst ruments, Inc., 572 U.S. 898, 901 (2014).

7 as iRhythm suggests, transmissi on of electrocardiographic signals was inhere nt in the term “wir eless tra nsceiv er” itself. Co urts avoid constructions that render s ome porti on of the claim language superfluous. Simpl eAir Inc. v. Sony Ericss on Mobile Commc’ns AB, 820 F.3d 419, 429 (Fed. Cir. 2016). The absence of an express definition of “wireless transceiver” in the ’473 Patent does not alter my construction, as nothing in the specificati on suggests that the term is limited bey ond its ordinary meaning. 2 To t he contra ry, t he sp ecif ication contempl ate s that the wireless transceiver m ay, but need no t, provide certain fun ctions, co nfirming that it can perform other func tions a s well. For exa mple, the sp ecifi cation describes the wireless transc eiver as an optional and interc hangeable component that e nables communi cation of “data or ot her informati on” with a r ange of e xternal de vice s, inc luding weara ble s ensors, mo bile communi cations devices, servers, and personal com puters. (’473 Patent at 4:28 - 29.) It also disclo se s embodiment s in which wireless co mmunicat ion is unnecessary, including hardwire d data transfer to a download station. (See ’562 Patent at 15:52 - 61.) A ltho ugh the specification descri bes some embod iment s that w ill include a wireless transc eiver that communicates e lectrocardiographic signals, a patent “ need not includ e a worki ng examp le of ev ery pos sible embod iment to enable t he full scope o f the claims. ” Bayer HealthCare LLC v. Baxalta Inc., 989 F.3d 964, 982 (Fed. Cir. 2021). Courts 2 The Parties agree that the specification do es not descri be a wirele ss tra nsceiver as a well - known or well - unde rst ood compo nent.

9 time, neither side argues that the term is indefinite (and with good reason). In that posture, I must “strive to capture the scope of the actual invention, rather than strictly limit the scope o f clai ms to disc losed emb odiments o r allo w the claim la nguage t o become divorced from w hat the speci fic ation convey s is the invention.” Retractable Tec hs., Inc. v. Bec ton, Dic kinson & Co., 653 F.3d 1296, 1305 (Fed. Cir. 2011). As a starting point, a POSA would understand “vertically” to have its plain E nglish meani ng of top - to - bot tom. T he specification informs a P OSA that, f or thes e purpos es, the top is t he face of t he devi ce, wh ich fac es a way from t he u ser when in use. Figur e 4 illustrates the dev ice, i ncludin g the mon itor reco rder, which is it em 14. The monitor recorder in cludes a sealed ho sing. (‘437 Patent at 9:42 - 43.) Th en, Figure 5 is a view of th e monitor recorder with a button that has a “ top ou ter surfa ce.” (Id. at 9:56 - 58 (emphasis added).) Figure 6, in tu rn, illustrates the extended wear electrode patch that attaches to the ski n and into w hich the monitor gets i nsert ed. The specificati on explains that there is a batter y compartme nt on the “ bottom surface of the non - conductive rec eptacle. ” (Id. at 10:37 - 40 (emphasis added).) Thes e and other, similar r eferences in th e specificatio n demonstrate to a POSA that the top of th e device, for these p urpo ses, is th e face o f the device, and the bottom is the part that attaches to the extended wear electrode patch. A POSA would therefore know to assess vertical alignment on that axis. This construc tion f ocuse s on the orie ntation of the components of the de vice, regard less of h ow the d evice is used (or whet her it is in use). I t st ands in contrast to

11 downloads of data, reprogramming, and “ transfer to succe ssive electrode patches to ensure continui ty of monitori ng. ” (‘473 Patent at 9:65 - 67.) Construing “removably secured” as “ sec ured in a m anner that contemplates or intends for r emova l and potential reuse” captures all aspec ts of t he ter m an d is in line with the in trinsic r ecord. The hous ing mus t be secu red, that is, intentionally retained within th e receptacle, and it must be removable by d esign, which allows for its reus e. This const ruction aligns with the Federal Circ uit’s holding in Dorel Ju v. Grp., I nc. v. Graco Childr en's P rods., Inc., which exp lained th at “‘removably secured’ mean [s] only that the seat and base ‘are designed at some time or anoth er to come apart’” and that the term carries “an implication that the detachment or unsec uring proc ess not do viole nce to the [inventio n].” 429 F.3d 1043 (Fed. Cir. 2005). iRhythm’s propose d limi tation t hat rem oval must oc cur “wi thout d estr uction” finds no footing in t he c laims nor t he s pecificatio n. The p atent never uses the word “destruction,” nor does i t draw a distinction between destructive and non - destructive removal. Intr oducing t hat qualifi er woul d rais e ques tions the pate nt does not pose, such as what qualifies as “destruction,” whether d amage to o ne com ponent is suff icient, and how much damage or change is too much. Th e patent do es not speak in those terms, and I wil l not s u pply them. Bardy’s construction, by contrast, does too little. Saying onl y that the hous ing is “secured such that it may be removed” risks draining the term of meaning. While th e

14 A POSA, a jury, and I can understand that the term electrical conn ection means “a connectio n that per mits the transmission of electricity.” See Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1291 (Fed. Cir. 2015). The e lectrical co nnectio n ext ends fro m the physiolo gic data co llection circu it to th e electrode an d is positio ned between a polymer upper l ayer and a polymer lower layer. (‘73 4 Patent, 15:34 - 16:4.) While the claims define t he elect rical conn ection b y what it does an d where it is located, n othing in the claim langu age demonstrates a “clear intention” to limit the electrical conn ection to a wire or to any particular conductive structure. See Liebel - Flarsh eim Co. v. Medrad, Inc., 358 F.3d 898, 906 (Fed. Cir. 2004). And a lthoug h many e mbodiment s desc ribe wi ring, the patent states that “ wiring or othe r suit able ” electrical c onnecti ons can c onnect t he electrod es with t he el ectrica l compo nents. (‘7 34 Patent at 8:49 - 51.) That language is deliberate. It makes clear that wiring is an example of an electrical connection, not its exclusive d efinition. Bardy’s pro posed con struct ion limitin g “electr ical connect ion” to a wire has no basis in th e claim lang uage, and the specific atio n’s expr ess referen ce to ot her sui table electrical co nnectio ns rules out that cons truct ion. Adopting it would improperly i mport a preferred embodiment into the claims and would exclude alt ernatives the patent contemplates. Eko Brands, LLC v. Adrian River a Maynez Enters., Inc., 946 F.3d 1367, 137 3 (Fed. Cir. 2020); Apple Inc. v. Wi - Lan Inc., 25 F. 4 th 960, 967 (Fed. Cir. 2022). Bardy’s reli ance on pros ecution arg uments fares n o better. Where, a s here, the m eaning of a

16 address them together. The te rms “[e lectrica l connec tion] e xtend ing from the physiolog ic data coll ection cir cuit to th e electro de” and “ [electrical co nnectio n] extending linearly from t he physiolo gic data collect ion circu it” describe the spatial and function al relatio nship among the electrical con nection, th e circuit, a nd the ele ctrode. They req uire electrical con tinuity b etween the circuit an d the e lectrode, but they do not require th at the elect rical con nection o riginat e at a particu lar poin t on th e circuit, proceed d irect ly, or e xclude i nterve ning com ponents. The claim language supports this construction. Claim 1 of the ’554 patent separately adds a “linearly” limitation, confirming that “extending from” alone does not impos e a require ment of directness. Readi ng such a limita tion into “e xtend ing from ” would r en der the “l inearly ” requir ement superfl uous. SimpleAir I nc., 820 F.3d at 429. The specificatio n likewise does not limit th e electr ical conn ection to a direct, unin terrupted path or one wi th inter vening c omponent s. Al though s ome fi gures and embodim ents depict relativ ely stra ight wiring, th e specificat ion disclo ses alt ernative ro uting, including curved paths, conduits, slack, coils, and undulati ons, to accommodate flexion and movemen t of th e device. (See ‘734 Patent at 8:66 -9:1, Figs. 1, 2 B, 2C.) These embodi ments confi rm that t he inve ntion p ermi ts vari ation i n routing s o long as it maintains electrical co ntinu ity. Bardy’s proposal improperly rewri tes “extending from” as “originating at” and imposes additi onal limitations that appear nowhere in the claim language. Withou t clear

19 Claim 1 requires c onfigur ation of the h ousing so that it tilts at an a ngle rel ative to the lower adhesive lay er in respo nse to the use r’s movement. Read in context, the claim describes what o ccurs at the in terfac e bet ween the d evice and t he wearer dur ing ordinary movement. When the use r moves, the adhesive layer remains attached to the skin w hile t he housi ng can co me into a non - parallel orienta tion. I do not adopt iRhyt hm’s formulation to the extent it sugge sts that the housing is the active source of the movemen t. Th at articulation risks implyin g that the hou sing itsel f actively tilts, pivots, or rotates, an interpretati o n th at the int rinsic record does not s upport. The housing doe s not actively tilt, pivot, or rotate under its own force. The user moves. The adhesive layer remains adhered. Other portio ns of the patch flex. As a res ult, the housing may ass ume an angled orientation relative to the skin. The claim is directed to that resulting relative positi on. A construction that treats the housing as the thing that “moves into” an angle risks obscur ing what t he claim r equires. Bardy’s alternative construction rewrites the c laim. Replacing “config u red to” with “specifically de signed t o” impo rts a n intent requirement that the claim language does not support. “Configured to” des cribes capability and arrangement, not subjecti ve purpose. Bardy’s addi tional “sloping relatio nship” language fares no better as i t unnecessarily complica tes the jury’s t ask whe re “ at an angle” already conveys a non - parallel or ientation.

22 understanding the term’s meaning and limits. Bardy’s alternative construction does not add anythi ng of value. It rec asts “electrical contact” as “physical contact or capaci tive connect ion,” b ut that ref ormulation does not narr ow t he term, clar ify its scope, or res olve any ambiguity. Bardy concedes that “el ectrical contact” cannot mean mere physical contact, making i ts propose d cons tructi on interna lly i nconsi ste nt. The adde d refe rence to “capac itiv e con necti on” app ears now here in the intri nsic record and would only inje ct uncertainty, not resolve it. R ewritin g the clai m to enu merate ever y possib le fo rm of electrical interacti on does not make the term more clear to a POSA or to me, s o I will not adopt it. III. CONCLUSI ON I will construe the disputed claims as described above, and I will ado pt the Parties’ agreed - upon construct ion. An approp riate Orde r foll ows. BY THE COUR T: /s/ Jos hua D. Wolson JOSHU A D. WOLS ON, J. February 19, 202 6

IN THE UNITED STATES DIS TRICT C OURT FOR THE DISTRI CT OF DELAWARE Case No. 1:2 4-cv-0 1355 - JDW ORDER AND NOW, th is 19th day of February, 202 6, for the reasons set forth in t he accompanying Memorandum, it is ORDERED that the Court construes the foll owing claims terms of U.S. Pa tent No. 12,161,473 (the ’473 Patent); U.S. Patent No. 12,171,562 (the ’562 Patent); U.S. Patent No. 12,285,261 (the ’261 Patent); U.S. Patent No. 12,310,735 (the ’735 Patent); U.S. Patent No. 12,133,734 (the ’734 Patent); U.S. Patent No. 12,274,554 (the ’554 Patent); U.S. Patent No. 12,303,27 7 (the ’277 Patent); and U.S. Patent No. 1 2,245,859 (the ’859 Patent) as follows: Claim T erm Court’s Construction “ the proce ssor is configure d to proce ss the electrocard iograph ic signals sensed ” 1 “t he proce ssor is conf igured to rece ive the electrocard iograph ic signa ls sensed and changes their form ” 1 The Parti es pr oposed t his te rm for construct ion d uring clai m const ruct ion brie fing, b ut during the Markman hearing, th ey Parties agre ed on the construction that I have adopted. BARDY DIA GNOSTIC S, INC., Plaintiff and Coun ter - Defendant, v. IRHYTHM TEC HNOLOGIES, INC., Defendan t and Counter - Plaintiff.

2 “wireles s transceiv er” “a component that can transmit wirele ssly” “vertically alig ned” “ aligned on an axis that connects the monit or reco rder with the extend ed wear electrode patch ” “remov ably secur ed” “ secure d in a manner that contemplates or intends for removal and potential reuse ” “distal/proximal” “distal” means “ positioned farther relative to the mo nitor re cor der ”; “proxim al” means “ positioned nearer relative to the monitor re corde r ” “electrical con nection ” “a connec tion tha t permits the transmission of electric ity” “[electrical connectio n] extend ing fr om the physiolog ical data coll ection cir cuit to t he electrod e ” “[electrical con nection ] extending linearly from the p hysiolo gic data collection circuit” “[first substrate layer] extends horizontally away from the housing” “[electrical connectio n] extending in the direction away from the phys iologic data collection cir cuit to t he electro de” “[electrical connectio n] extend ing lin early in the di rect ion away from the physiol ogic data collectio n circuit ” “[first substrate layer] extends in the direction horizonta lly away from the housing” “ extending at least partially below the housing ” Plain and ordinary meani ng “config ured to tilt at an angle relative to the low er adhe sive l ayer in res ponse to movemen t of th e user” “designed to move at angles relative to the ski n” “the second substrate lay er is positioned over the first substrate layer and extends horizon tall y bey ond a boun dary of the fi rst substrate laye r” “the second substrate lay er is above the first substrate l ayer, and extends beyond the boundary of the first substrate layer” “electrical con tact with ” “conta ct that cond ucts electricit y” BY THE COUR T: /s/ Joshua D. Wol son JOSHU A D. WOLS ON, J.