UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`
`
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
`
`
`
`
`ORDER NO. 12:
`
`
`
`Inv. No. 337-TA-1266
`
`
`CONSTRUING THE TERMS OF THE ASSERTED CLAIMS OF
`THE PATENTS AT ISSUE
`
`(November 4, 2021)
`
`
`
`
`AliveCor Ex. 2010 - Page 1
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`TABLE OF CONTENTS
`
`INTRODUCTION ................................................................................................................. 1
`
`IN GENERAL ........................................................................................................................ 1
`
`RELEVANT LAW ................................................................................................................ 2
`
`OVERVIEW OF THE ART AND THE LEVEL OF ORDINARY SKILL .......................... 6
`
`THE ASSERTED PATENTS ................................................................................................ 8
`
`I.
`
`II.
`
`III.
`
`IV.
`
`V.
`
`
`
`
`
`
`
`The 499 Patent ........................................................................................................... 8
`
`The 731 Patent ......................................................................................................... 10
`
`The 941 Patent ......................................................................................................... 11
`
`VI.
`
`CLAIM CONSTRUCTION ................................................................................................. 12
`
`
`
`B.
`
`Construction of the Agreed-Upon Claim Term ....................................................... 12
`
`Construction of the Disputed Claim Terms ............................................................. 13
`
`
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
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`499 Patent – Preambles ................................................................................ 13
`
`499 Patent – “alerting said first user to sense an electrocardiogram”/ “alert”
`...................................................................................................................... 15
`
`499 Patent – “heart rate sensor” ................................................................... 17
`
`499 Patent – Order of Method Steps ............................................................ 19
`
`731 Patent – “confirm the presence of the arrhythmia based on the ECG
`data” / “confirming the presence of the arrhythmia based on the ECG data”
`...................................................................................................................... 20
`
`731 Patent – Order of Method Steps ............................................................ 22
`
`941 Patent – “to confirm a presence of the arrhythmia” / “to confirm the
`presence of the arrhythmia” ......................................................................... 24
`
`941 Patent – “when the activity level is resting” / “when the activity level
`value is resting”............................................................................................ 27
`
`941 Patent – “discordance” .......................................................................... 30
`
`
`
`941 Patent – Order of Method Steps ............................................................ 30
`
`
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`I.
`
`INTRODUCTION
`
`This investigation was instituted by the Commission on May 20, 2021 to determine whether
`
`there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States,
`
`the sale for importation, or the sale within the United States after importation of certain wearable
`
`electronic devices with ECG functionality and components thereof by reason of infringement of one
`
`or more of claims 1-23 of U.S. Patent No. 10,638,941 (“the 941 patent”), claims 1-30 of U.S. Patent
`
`No. 10,595,731 (“the 731 patent”), and claims 1-4, 6-14, and 16-20 of U.S. Patent No. 9,572,499
`
`(“the 499 patent”). See 86 Fed. Reg. 28382 (May 26, 2021). The Complainant is AliveCor, Inc.
`
`(“AliveCor”), the Respondent is Apple Inc. (“Apple”), and the Office of Unfair Import
`
`Investigations (“Staff”) is a party. See id.
`
`No Markman hearing was held. However, the parties filed joint proposed claim construction
`
`charts setting forth a limited set of terms to be construed, and also filed claim construction briefs.1
`
`II.
`
`IN GENERAL
`
`The claim terms addressed below are construed for the purposes of this investigation, and
`
`those terms not in dispute need not be construed. See Vanderlande Indus. Nederland BV v. Int’l
`
`Trade Comm’n, 366 F.3d 1311, 1323 (Fed. Cir. 2004) (noting that the administrative law judge need
`
`only construe disputed claim terms). The meaning of any claim terms not presently disputed will
`
`be addressed in connection with the evidentiary hearing.
`
`1 For convenience, the briefs and chart submitted by the parties are referred to as:
`CIMB
`Complainant’s Initial Markman Brief
`CRMB
`Complainant’s Reply Markman Brief
`RIMB
`Respondent’s Initial Markman Brief
`RRMB
`Respondent’s Reply Markman Brief
`SIMB
`Staff’s Initial Markman Brief
`JC
`Joint Disclosure of Proposed Claim Constructions
`
`
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`III. RELEVANT LAW
`
`“An infringement analysis entails two steps. The first step is determining the meaning and
`
`scope of the patent claims asserted to be infringed. The second step is comparing the properly
`
`construed claims to the device accused of infringing.” Markman v. Westview Instruments, Inc., 52
`
`F.3d 967, 976 (Fed. Cir. 1995) (en banc) (internal citations omitted), aff'd, 517 U.S. 370 (1996).
`
`Claim construction is a “matter of law exclusively for the court.” Id. at 970-71. “The construction
`
`of claims is simply a way of elaborating the normally terse claim language in order to understand
`
`and explain, but not to change, the scope of the claims.” Embrex, Inc. v. Serv. Eng'g Corp., 216
`
`F.3d 1343, 1347 (Fed. Cir. 2000).
`
`Claim construction focuses on the intrinsic evidence, which consists of the claims
`
`themselves, the specification, and the prosecution history. See Phillips v. AWH Corp., 415 F.3d
`
`1303, 1314 (Fed. Cir. 2005) (en banc); see also Markman, 52 F.3d at 979. As the Federal Circuit
`
`in Phillips explained, courts must analyze each of these components to determine the “ordinary and
`
`customary meaning of a claim term” as understood by a person of ordinary skill in art at the time of
`
`the invention. 415 F.3d at 1313. “Such intrinsic evidence is the most significant source of the
`
`legally operative meaning of disputed claim language.” Bell Atl. Network Servs., Inc. v. Covad
`
`Commc'ns Grp., Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001).
`
`“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to
`
`which the patentee is entitled the right to exclude.”’ Phillips, 415 F.3d at 1312 (quoting Innova/Pure
`
`Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)); see
`
`Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“In
`
`construing claims, the analytical focus must begin and remain centered on the language of the claims
`
`themselves, for it is that language that the patentee chose to use to ‘particularly point [ ] out and
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`distinctly claim [ ] the subject matter which the patentee regards as his invention.”). The context in
`
`which a term is used in an asserted claim can be “highly instructive.” Phillips, 415 F.3d at 1314.
`
`Additionally, other claims in the same patent, asserted or unasserted, may also provide guidance as
`
`to the meaning of a claim term. Id. “Courts do not rewrite claims; instead, we give effect to the
`
`terms chosen by the patentee.” K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1364 (Fed. Cir. 1999).
`
`The specification “is always highly relevant to the claim construction analysis. Usually it is
`
`dispositive; it is the single best guide to the meaning of a disputed term.” K-2 Corp., 191 F.3d at
`
`1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “[T]he
`
`specification may reveal a special definition given to a claim term by the patentee that differs from
`
`the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” 191
`
`F.3d at 1316. “In other cases, the specification may reveal an intentional disclaimer, or disavowal,
`
`of claim scope by the inventor.” Id. As a general rule, however, the particular examples or
`
`embodiments discussed in the specification are not to be read into the claims as limitations. Id. at
`
`1323. In the end, “[t]he construction that stays true to the claim language and most naturally aligns
`
`with the patent’s description of the invention will be . . . the correct construction.” Id. at 1316
`
`(quoting Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998)).
`
`In addition to the claims and the specification, the prosecution history should be examined,
`
`if in evidence. Id. at 1317; see Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir.
`
`2004). The prosecution history can “often inform the meaning of the claim language by
`
`demonstrating how the inventor understood the invention and whether the inventor limited the
`
`invention in the course of prosecution, making the claim scope narrower than it would otherwise
`
`be.” Phillips, 415 F.3d at 1317; see Chimie v. PPG Indus. Inc., 402 F.3d 1371, 1384 (Fed. Cir.
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`2005) (“The purpose of consulting the prosecution history in construing a claim is to exclude any
`
`interpretation that was disclaimed during prosecution.”).
`
`When the intrinsic evidence does not establish the meaning of a claim, then extrinsic
`
`evidence (i.e., all evidence external to the patent and the prosecution history, including dictionaries,
`
`inventor testimony, expert testimony, and learned treatises) may be considered. Phillips, 415 F.3d
`
`at 1317. Extrinsic evidence is generally viewed as less reliable than the patent itself and its
`
`prosecution history in determining how to define claim terms. Id. “The court may receive extrinsic
`
`evidence to educate itself about the invention and the relevant technology, but the court may not use
`
`extrinsic evidence to arrive at a claim construction that is clearly at odds with the construction
`
`mandated by the intrinsic evidence.” Elkay Mfg. Co. v. Ebco Mfg. Co., 192 F.3d 973, 977 (Fed. Cir.
`
`1999).
`
`The construction of a claim term is generally guided by its ordinary meaning. However,
`
`courts may deviate from the ordinary meaning when: (1) “the intrinsic evidence shows that the
`
`patentee distinguished that term from prior art on the basis of a particular embodiment, expressly
`
`disclaimed subject matter, or described a particular embodiment as important to the invention;” or
`
`(2) “the patentee acted as his own lexicographer and clearly set forth a definition of the disputed
`
`claim term in either the specification or prosecution history.” Edwards Lifesciences LLC v. Cook
`
`Inc., 582 F.3d 1322, 1329 (Fed. Cir. 2009); see also GE Lighting Sols., LLC v. AgiLight, Inc., 750
`
`F.3d 1304, 1309 (Fed. Cir. 2014) (“the specification and prosecution history only compel departure
`
`from the plain meaning in two instances: lexicography and disavowal.”); Omega Eng’g, Inc, v.
`
`Raytek Corp., 334 F.3d 1314, 1324 (Fed. Cir. 2003) (“[W]here the patentee has unequivocally
`
`disavowed a certain meaning to obtain his patent, the doctrine of prosecution disclaimer attaches
`
`and narrows the ordinary meaning of the claim congruent with the scope of the surrender.”); Rheox,
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`Inc. v. Entact, Inc., 276 F.3d 1319, 1325 (Fed. Cir. 2002) (“The prosecution history limits the
`
`interpretation of claim terms so as to exclude any interpretation that was disclaimed during
`
`prosecution.”). Nevertheless, there is a “heavy presumption that a claim term carries its ordinary
`
`and customary meaning.” CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir.
`
`2002) (citations omitted). The standard for deviating from the plain and ordinary meaning is
`
`“exacting” and requires “a clear and unmistakable disclaimer.” Thorner v. Sony Computer Entm’t
`
`Am. LLC, 669 F.3d 1362, 1366-67 (Fed. Cir. 2012); see Epistar Corp. v. Int’l Trade Comm’n, 566
`
`F.3d 1321, 1334 (Fed. Cir. 2009) (requiring “expressions of manifest exclusion or restriction,
`
`representing a clear disavowal of claim scope” to deviate from the ordinary meaning) (citation
`
`omitted). As the Federal Circuit has explained, “[w]e do not read limitations from the specification
`
`into claims; we do not redefine words. Only the patentee can do that.” Thorner, 669 F.3d at 1366.
`
`Courts are not required to construe every claim limitation of an asserted patent. See O2
`
`Micro Intern. Ltd. v. Beyond Innovation Technology Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008)
`
`(citations omitted). Rather, “claim construction is a matter of resolution of disputed meanings and
`
`technical scope, to clarify and when necessary to explain what the patentee covered by the claims,
`
`for use in the determination of infringement.” Id. at 1362 (quoting U.S. Surgical Corp. v. Ethicon,
`
`Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997)); see also Embrex, 216 F.3d at 1347 (“The construction
`
`of claims is simply a way of elaborating the normally terse claim language in order to understand
`
`and explain, but not to change, the scope of the claims.”) (citation omitted). In addition, “[a]
`
`determination that a claim term ‘needs no construction’ or has the ‘plain and ordinary meaning’ may
`
`be inadequate when a term has more than one ‘ordinary’ meaning or when reliance on a term's
`
`‘ordinary’ meaning does not resolve the parties’ dispute.” O2 Micro, 521 F.3d at 1361. Claim
`
`construction, however, is not an “obligatory exercise in redundancy.” U.S. Surgical Corp., 103 F.3d
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`at 1568. “[M]erely rephrasing or paraphrasing the plain language of a claim by substituting
`
`synonyms does not represent genuine claim construction.” C.R. Bard, Inc. v. U.S. Surgical Corp.,
`
`388 F.3d 858, 863 (Fed. Cir. 2004).
`
`A claim must also be definite. Pursuant to pre-AIA 35 U.S.C. § 112, second paragraph:
`
`“The specification shall conclude with one or more claims particularly pointing out and distinctly
`
`claiming the subject matter which the applicant regards as his invention.” 35 U.S.C. § 112, ¶ 2. In
`
`Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court held that §
`
`112, ¶ 2 requires “that a patent’s claims, viewed in light of the specification and prosecution history,
`
`inform those skilled in the art about the scope of the invention with reasonable certainty.” Id. at
`
`2129. A claim is required to “provide objective boundaries for those of skill in the art,” and a claim
`
`term is indefinite if it “might mean several different things and no informed and confident choice is
`
`among the contending definitions.” Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1371 (Fed.
`
`Cir. 2014). A patent claim that is indefinite is invalid. 35 U.S.C. § 282(b)(3)(A).
`
`If, after a review of the intrinsic and extrinsic evidence, a claim term remains ambiguous,
`
`the claim should be construed so as to maintain its validity. Phillips, 415 F.3d at 1327. Claims,
`
`however, cannot be judicially rewritten in order to fulfill the axiom of preserving their validity. See
`
`Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed. Cir. 1999). Thus, “if the only claim construction
`
`that is consistent with the claim’s language and the written description renders the claim invalid,
`
`then the axiom does not apply and the claim is simply invalid.” Id.
`
`IV. OVERVIEW OF THE ART AND THE LEVEL OF ORDINARY SKILL
`
`The three patents in suit 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
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`941 patent at 4:9-10; 499 patent at cl. 1 (preamble). The devices recited in the claims, including in
`
`the method claims, are either a smartwatch (for the 941 and 731 patents) or a mobile computing
`
`device (for the 499 patent). The smartwatch claims require an electrocardiogram (ECG) sensor and
`
`at least one other sensor. 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. The mobile computing device claims require an ECG sensor,
`
`a heart rate sensor, and a motion sensor. E.g., 499 patent at cls. 1, 11. Whether reciting a method
`
`or apparatus, the asserted independent claims generally involve monitoring heart rate (e.g., “sensing
`
`a heart rate” (499 patent at cl. 1)), detecting or determining possible arrhythmia or irregularity in
`
`heart rate variability (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)).
`
`A person of ordinary skill in such art would likely have an engineering education and
`
`experience with cardiac-related equipment, diagnostics, and signal processing. And the parties
`
`agree that a skilled artisan at the time of the invention would have had a “bachelor of science degree
`
`in electrical engineering, mechanical engineering, biomedical engineering, computer science, or a
`
`related discipline, with at least two years of relevant work experience designing wearable devices
`
`and/or sensors for measuring physiological signals or parameters of mammals.” SIMB at 6; see
`
`CIMB at 5; RIMB at 3. This is reasonable and is adopted.
`
`Respondent additionally proposes that a skilled artisan at the time of the invention could
`
`have had a medical degree (M.D. or D.O.) and at least two years of work experience using
`
`biomedical sensors and/or analyzing their data, including in clinical practice treating patients. See
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`RIMB at 3. But it is not enough for a skilled artisan to be able to use the claimed invention; the
`
`skilled artisan must also be able to make it. See Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d
`
`1080, 1084 (Fed. Cir. 2021). A physician might know how to use the claimed inventions, but there
`
`is no reason to expect that a physician in clinical practice would be able to make them without
`
`substantially more experience and training than two years using biomedical sensors or analyzing
`
`their data.
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`Therefore, a person of ordinary skill in the art at the time of the invention would have had
`
`either (1) a bachelor of science degree in electrical engineering, mechanical engineering, biomedical
`
`engineering, computer science, or a related discipline, with at least two years of relevant work
`
`experience designing wearable devices and/or sensors for measuring physiological signals or
`
`parameters of mammals, or (2) a medical degree and at least five years of relevant work experience
`
`designing wearable devices and/or sensors for measuring physiological signals or parameters of
`
`mammals. Also, relevant experience could substitute for education and vice versa for both
`
`categories of skilled artisan.
`
`V.
`
`THE ASSERTED PATENTS
`
`Although various dependent claims have been asserted, the parties’ claim construction
`
`disputes all pertain to terms found in the independent claims, as well as to some preambles and the
`
`order of method steps. See JC at 2-4. Therefore, only the independent claims are reproduced below.
`
`
`
`The 499 Patent
`
`The 499 patent, entitled “Methods and Systems for Arrhythmia Tracking and Scoring,”
`
`issued February 21, 2017, to Gopalakrishnan, et al., and is assigned on its face to Complainant. It
`
`claims priority to provisional application No. 61/915,113, filed on December 12, 2013. See
`
`generally 499 patent.
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`The 499 patent has 20 claims, of which claims 1-4, 6-14, and 16-20 are asserted. Claims 1
`
`and 11 are independent, and the disputed terms are highlighted in bold.
`
`1.
`
`A method of determining a presence of an arrhythmia of a first user, said
`method comprising
`
`
`sensing a heart rate of said first user with a heart rate sensor coupled to said first
`user;
`
`transmitting said heart rate of said first user to a mobile computing device, wherein
`said mobile computing device is configured to sense an electrocardiogram;
`
`determining, using said mobile computing device, a heart rate variability of said first
`user based on said heart rate of said first user;
`
`sensing an activity level of said first user with a motion sensor;
`
`comparing, using said mobile computing device, said heart rate variability of said
`first user to said activity level of said first user; and
`
`alerting said first user to sense an electrocardiogram of said first user, using said
`mobile computing device, in response to an irregularity in said heart rate variability
`of said first user.
`
`11. A system for determining the presence of an arrhythmia of a first user,
`comprising
`
` a
`
` heart rate sensor coupled to said first user;
`
` a
`
` mobile computing device comprising a processor, wherein said mobile computing
`device is coupled to said heart rate sensor, and wherein said mobile computing
`device is configured to sense an electrocardiogram of said first user; and
`
` a
`
` motion sensor
`
` a
`
` non-transitory computer readable medium encoded with a computer program
`including instructions executable by said processor to cause said processor to receive
`a heart rate of said first user from said heart rate sensor, sense an activity level of
`said first user from said motion sensor, determine a heart rate variability of said first
`user based on said heart rate of said first user, compare and activity level of said first
`user to said heart rate variability of said first user, and alert said first user to record
`an electrocardiogram using said mobile computing device.
`
`
`
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`
`
`The 731 Patent
`
`The 731 patent, entitled “Methods and Systems for Arrhythmia Tracking and Scoring,”
`
`issued March 24, 2020, to Gopalakrishnan, et al., and is assigned on its face to Complainant. It
`
`derives from a series of continuation applications, one of which issued as the 499 patent, and claims
`
`priority to the same provisional application as the 499 patent. As a result, it appears to have
`
`substantially the same specification as the 499 patent. See generally 731 patent.
`
`The 731 patent has 30 claims, all of which are asserted. Claims 1, 17 and 25 are independent,
`
`and the disputed term are highlighted in bold:
`
`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.
`
`17. A method to detect the presence of an arrhythmia of a user on a smart watch,
`comprising:
`
`
`receiving PPG data from a PPG sensor of the smartwatch;
`
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`detecting by a processing device, based on the PPG data, the presence of an
`arrhythmia;
`
`receiving ECG data from an ECG sensor of the smartwatch; and
`
`confirming the presence of the arrhythmia based on the ECG data.
`
`25. A non-transitory computer-readable storage medium including instructions
`that, when executed by a processing device, cause the processing device to:
`
`
`receive PPG data from a PPG sensor of the smartwatch;
`
`detect by the processing device, based on the PPG data, the presence of an
`arrhythmia;
`
`receive ECG data from an ECG sensor of the smartwatch; and
`
`confirm the presence of the arrhythmia based on the ECG data.
`
`
`
`
`The 941 Patent
`
`The 941 patent, entitled “Discordance Monitoring,” issued May 5, 2020, to Albert, et al.,
`
`and is assigned on its face to Complainant. It claims priority to provisional application No.
`
`62/161,092, filed on May 13, 2015. See generally 941 patent.
`
`The 941 patent has 23 claims, all of which are asserted. Claims 1 and 12 are independent,
`
`and the disputed terms are highlighted in bold.
`
`A method of cardiac monitoring, comprising:
`
`1.
`
`sensing an activity level of a user with a first sensor on a smartwatch worn by the
`user;
`
`when the activity level is resting, sensing a heart rate parameter of the user with a
`second sensor on the smartwatch;
`
`determining, by a processing device, that a discordance is present between the
`activity level value and the heart rate parameter;
`
`based on the presence of the discordance, indicating to the user, using the
`smartwatch, a possibility of an arrhythmia being present; and
`
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`receiving electric signals of the user from an electrocardiogram sensor (“ECG”) on
`the smartwatch to confirm a presence of the arrhythmia, wherein the ECG sensor
`comprises a first electrode and a second electrode.
`
`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.
`
`
`VI. CLAIM CONSTRUCTION
`
`
`
`Construction of the Agreed-Upon Claim Term
`
`The parties agree that the term “arrhythmia,” which appears in all independent claims, means
`
`“a cardiac condition in which the electrical activity of the heart is irregular or is faster or slower than
`
`normal.” JC at 4. This construction is consistent with the plain and ordinary meaning of the term
`
`and with the intrinsic evidence. See 731 patent at 1:40-42 (“Arrhythmia is a cardiac condition in
`
`which the electrical activity of the heart is irregular or is faster (tachycardia) or slower (bradycardia)
`
`AliveCor Ex. 2010 - Page 14
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`

`

`than normal.”); 941 patent at 4:9-10 (arrhythmia is “an abnormality of rhythm”). It is therefore
`
`adopted.
`
`B.
`
`Construction of the Disputed Claim Terms
`
`The disputed claim terms are summarized in the parties’ Joint Disclosure of Proposed Claim
`
`Constructions. See generally JC.
`
`
`
`499 Patent – Preambles
`
`Claims
`
`499 patent:
`preambles
`
`AliveCor’s Proposed
`Construction
`The preambles are not
`limiting.
`
`JC at 2.
`
`Staff’s Proposed
`Construction
`The preambles of the
`asserted claims are
`limiting.
`
`Apple’s Proposed
`Construction
`The preambles of claims
`1 and 11 are limiting.
`
`
`
`The only place in the independent claims of the 499 patent that the term “arrhythmia”
`
`appears is in the preambles. See 499 patent at cls. 1 (“an arrhythmia of a first user”), 11 (same).
`
`Claim 7, which depends from claim 1, and claim 17, which depends from claim 11, further recites
`
`the step of “determining a presence of said arrhythmia” and the operation of “determine a presence
`
`of said arrhythmia,” respectively. See id. at cls. 7, 17. Respondent argues, among other points, that
`
`the preambles are limiting because they provide an antecedent basis for “said arrhythmia.” RIMB
`
`at 10-13. Staff agrees. See SIMB at 8. Complainant, relying principally on examples from District
`
`Court cases, argues that “the fact that the antecedent basis for a term in the body of some dependent
`
`claims is found in the preamble of the independent claims does not require a preamble to be
`
`limiting.” CIMB at 7.
`
`
`
`In one respect, at least, the preambles are undoubtedly limiting. The body of claim 1 does
`
`not describe a structurally complete method for “alerting said first user to sense an
`
`electrocardiogram . . . in response to an irregularity of said heart rate variability of said first user.”
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`AliveCor Ex. 2010 - Page 15
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`See 499 patent at 26:36-39. This is because the antecedent basis for “said first user” appears in the
`
`preamble. See id. at 26:27-28. Claim 11 similarly fails to describe a structurally complete
`
`invention, albeit a system rather than a method. See id. at 27:19-24 (“determine a heart rate
`
`variability of said first user . . . and alert said first user to record an electrocardiogram”). So the
`
`preambles are limiting to the extent they provide antecedent bases for “said first user.”
`
`Whether they are limiting with respect to “arrhythmia,” however, is a different question. See
`
`TomTom, Inc. v. Adolph, 790 F.3d 1315, 1323 (Fed. Cir. 2015) (finding one part of a preamble
`
`limiting but not another part). Nothing in the body of claims 1 or 11 requires “determining [a/the]
`
`presence of an arrhythmia,” because the recited methods stop at alerting the user to “sense” or
`
`“record” an ECG. 499 patent at cls. 1, 11. So on the surface, determining the presence of arrhythmia
`
`is just the “purpose or intended use for the invention.” Catalina Marketing Int’l, Inc. v.
`
`Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
`
`Claims 7 and 17, however, use the term “said arrhythmia,” which would be expected to
`
`require an antecedent basis. See Catalina Marketing, 289 F.3d at 808. Moreover, claims 7 and 17
`
`reiterate an entire clause of the relevant preamble, almost verbatim, before adding one limitation.
`
`Specifically, claim 1 recites “using a machine learning algorithm” for “determining a presence of
`
`an arrhythmia,” while claim 7 recites the same for “determining a presence of said arrhythmia,” and
`
`claim 11 recites “using a machine learning algorithm” for “determining the presence of an
`
`arrhythmia,” while claim 17 recites the same to “determine a presence of said arrhythmia.” 499
`
`patent at cls. 1, 7, 11, 17.
`
`Such repetition of the preamble, combined with the use of the term “said,” indicates that the
`
`“arrhythmia” portion of each preamble is limiting, and is not just the purpose or intended use of
`
`each claimed invention. Admittedly, there are instances in the case law where a preamble has been
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`AliveCor Ex. 2010 - Page 16
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`

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`found limiting for a dependent claim and not limiting for the associated independent claim. See
`
`CIMB at 7-9 (collecting cases); CRMB at 1-2 (same); see also Energizer Holdings, Inc. v. ITC, 435
`
`F.3d 1366, 1370 (Fed. Cir. 2006) (an antecedent basis need be express if it is “present by
`
`implication”). But the weight of authority is that if a preamble is limiting for a dependent claim, it
`
`is also limiting for the associated independent claim, because a dependent claim possesses all the
`
`elements of the claim from which it depends. See Catalina Marketing, 289 F.3d at 808; Monsanto
`
`Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1359 (Fed. Cir. 2007) (“claims in dependent form
`
`include all the limitations of the claim” from which they depend). And it may be true that if claims
`
`7 and 17 had been drafted without using “said” and without repeating the language of the preambles
`
`of claims 1 and 11 (and the bodies of claims 1 and