Petitioner’s Demonstratives
`
`ResMed, Inc. v. New York University
`October 2, 2023
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 1 of 87
`
`
`
`ResMed, Inc. v. New York University
`October 2, 2023
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 1 of 87
`
`
`
`Agenda
`
`• Overview
`• Claim Construction
` “analyzing the breathing patterns”
`• Disputed Limitations
` Under Petitioner’s Construction
` Under PO’s Construction
`• Motivation to Combine and Reasonable Expectation of
`Success
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 2 of 87
`
`
`
`Overview
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 3 of 87
`
`
`
`The Purported Invention (Asleep/Awake)
`
`988 Pet. at 7; 989 Cor. Pet. at 11; 990 Cor. Pet. at 12; 991 Cor. Pet. at 9; 992
`Cor. Pet. at 10.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 4 of 87
`
`
`
`The Purported Invention (Troubled Wakefulness)
`
`the
`the monitoring procedure,
`During
`processing arrangement 24 makes a
`determination as to a current state of the
`patient (e.g., whether the patient is asleep,
`awake and breathing regularly or awake
`and breathing irregularly due to distress or
`anxiousness).
`
`993 EX1001 (’994 Patent) at 3:59-63
`
`993 EX1001 (’994 Patent) at FIG. 2
`
`993 Cor. Pet. at 9; 994 Cor. Pet. at 12.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 5 of 87
`
`
`
`State of the Art
`
`This paper presents the results of a preliminary study testing a self-setting
`continuous positive airway pressure (CPAP) machine. The device adjusts
`CPAP pressure on a minute-by-minute basis according to the degree of
`upper airway obstruction. This has several advantages. First, it would aid
`compliance by allowing a minimal awake pressure, and reduce pressure-
`related side effects by presenting a lower mean pressure. Second, by
`sensing the degree of partial obstruction, it would adjust to changing upper
`airway resistance produced by changing sleep state, posture, degree of
`nasal congestion, blood alcohol
`level, hormone status and sleep
`deprivation. This would improve on, and possibly do away with, the one-
`size-fits-all pressure determination night. Finally, by constantly recording
`respiratory parameters
`to memory,
`it would document
`long-term
`compliance and efficacy, aiding long-term management.
`
`EX1012 at 1
`
`989 Cor. Pet. at 6; 990 Cor. Pet. at 7; 991 Cor. Pet. at 5; 992 Cor.
`Pet. at 5; 993 Cor. Pet. at 5; 994 Cor. Pet. at 7.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 6 of 87
`
`
`
`State of the Art
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`EX1025 at 1, 10
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 7 of 87
`
`
`
`Sullivan460 Discloses Determining Wake or Sleep States
`
`In a further embodiment, the treatment means may operate with two
`modes of delivery, a first mode for use when the patient is awake, and a
`second mode for use when the patient is asleep. In the first mode of air
`delivery, the treatment means provides a minimally intrusive air and
`pressure delivery to the patient, and hence is more comfortable. In the
`
`EX1006 (Sullivan460) at 7:30-34
`
`In another embodiment. the treatment means may additionally include
`a sleep sensor which senses whether or not the patient is asleep, and may
`also include a switching means which responds to the sleep sensor and
`automatically switches the treatment means between the two modes of air
`delivery. This embodiment addresses one of the key issues in treating blood
`
`EX1006 (Sullivan460) at 8:3-8
`
`988 Pet. at 12; 989 Cor. Pet. at 17; 990 Cor. Pet. at 18; 991 Cor. Pet. at 15; 992
`Cor. Pet. at 15; 993 Cor. Pet. at 11-12; 994 Cor. Pet. at 21-22.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 8 of 87
`
`
`
`Matthews Teaches Further Determining Troubled Wakefulness
`
`When
`a patient is awake, in REM sleep, or in distress, breathing
`tends to be more erratic and the Auto-CPAP trending
`becomes unstable. It is, therefore, important to interrupt the
`auto-CPAP controller if the patient's breathing pattern
`becomes too variable.
`
`EX1007 (Matthews) at 21:37-42
`
`988 Pet. at 12; 990 Cor. Pet. at 19; 991 Cor. Pet. at 16; 992 Cor. Pet. at 15; 993
`Cor. Pet. at 12; 994 Cor. Pet. at 22.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 9 of 87
`
`
`
`Prosecution History
`
`988 Pet. at 8
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 10 of 87
`
`
`
`Prosecution History
`
`Burton merely refers to
`
`
`
`detection of wakefulness and makes no disclosure of a
`troubled wakefulness state, as recited by Applicant's
`claim 1. Burton does not make a distinction between
`regular wakefulness and troubled wakefulness at all.
`
`988 Pet. at 8; 994 Cor. Pet. at 14-15.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 11 of 87
`
`
`
`Prosecution History
`
`993 EX1002 (’994 Prosecution History) at 119
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 12 of 87
`
`
`
`Claim Construction:
`“analyzing breathing patterns” terms
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 13 of 87
`
`
`
`Primary Dispute
`
`In a further embodiment, the sleep sensor is adapted to register that
`the patient is asleep when there is a reduced average airflow in the patient's
`upper airway. Another embodiment is adapted to register that the patient is
`20 asleep when a movement sensor detects a reduced respiration effort by the
`patient. In another embodiment. known ECG techniques are used for
`establishing whether the patient is awake or asleep.
`
`EX1006 (Sullivan460) at 8:17-22
`
`8. The system according to claim 7, wherein the breathing patterns that are
`indicative of state (i) comprise one or more patterns selected from the group
`consisting of (a) an absence of large breaths, (b) a high respiratory rate, (c) a
`low flow rate, and (d) a cluster of small breaths.
`
`994 EX1001 (’344 Patent) at Claim 8
`
`988 Reply at 4; 989 Reply at 4-6; 990 Reply at 4-6; 991 Reply at 3-5; 992 Reply
`at 3-6; 993 Reply at 4-6; 994 Reply at 3-5.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 14 of 87
`
`
`
`Primary Dispute
`
`In a further embodiment, the sleep sensor is adapted to register that
`the patient is asleep when there is a reduced average airflow in the patient's
`upper airway. Another embodiment is adapted to register that the patient is
`20 asleep when a movement sensor detects a reduced respiration effort by the
`patient. In another embodiment. known ECG techniques are used for
`establishing whether the patient is awake or asleep.
`
`3. The system according to claim 2, wherein the hardware processor
`determines the breathing patterns using the measured airflow rate or pressure.
`
`EX1006 (Sullivan460) at 8:17-22
`
`4. The System according to claim 1, wherein the processing arrangement
`determines the breathing patterns as a function at least one of the airflow rate
`and the currently applied pressure.
`
`993 EX1001 (’994 Patent) at Claim 4
`
`988 Reply at 4; 989 Reply at 4-6; 990 Reply at 4-6; 991 Reply at 3-5; 992 Reply
`at 3-6; 993 Reply at 4-6; 994 Reply at 3-5.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 15 of 87
`
`
`
`No Express Construction Necessary
`
`As these terms remain disputed, the Board
`must construe them. This sentiment is echoed in Vivid
`Techs., Inc. v. Am. Sci. & Eng’g, Inc., where it is held
`that “only those terms need to be construed that are in
`controversy… 200 F3d. 795, 803 (Fed. Cir. 1999).”
`
`988 Sur-Reply at 3
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 16 of 87
`
`
`
`No Express Construction Necessary
`
`[A]lthough the claims are construed objectively
`and without reference to the accused device, only
`those terms need be construed that are in
`controversy, and only to the extent necessary to
`resolve the controversy.
`
`988 Sur-Reply at 7; 989 Sur-Reply at 3; 990 Sur-Reply at 4; 991 Sur-Reply at 3;
`992 Sur-Reply at 3; 993 Sur-Reply at 3; 994 Sur-Reply at 3.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 17 of 87
`
`
`
`Distinguishing Between REM and Troubled Wakefulness
`
`8. The system according to claim 7, wherein the breathing patterns that are
`indicative of state (i) [REM sleep] comprise one or more patterns selected
`from the group consisting of (a) an absence of large breaths, (b) a high
`respiratory rate, (c) a low flow rate, and (d) a cluster of small breaths.
`
`994 EX1001 (’344 Patent) at Claim 8
`
`15. The system according to claim 7, wherein the breathing patterns that
`are indicative of state (iv) [troubled wakefulness] comprise one or more
`patterns selected from the group consisting of (a) pure mouth breathing, (b)
`erratic large breaths with varying inspiratory times, and (c) irregularity of
`intervals between breaths.
`
`994 EX1001 (’344 Patent) at Claim 15
`
`988 Reply at 9; 989 Reply at 3; 990 Reply at 4; 991 Reply at 3; 992 Reply at 3;
`993 Reply at 3; 994 Reply at 7
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 18 of 87
`
`
`
`Parties’ Proposed Constructions
`
`“analyzing breathing patterns” terms
`
`Petitioner’s Construction
`plain and ordinary meaning
`
`Patent Owner’s Construction
`“determining a sequence of
`parameters each of which
`characterizes a single breath in a
`series of breaths from a flow
`waveform and examining the values
`of the parameters and the order in
`which they appear in time”
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 19 of 87
`
`
`
`No Lexicography
`
`988 Sur-Reply at 3; 989 Sur-Reply at 2; 990 Sur-Reply at 3; 991 Sur-Reply at 3;
`992 Sur-Reply at 3; 993 Sur-Reply at 2; 994 Sur-Reply at 2.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 20 of 87
`
`
`
`No Lexicography
`
`Bradium Techs LLC v. Iancu, 923 F.3d 1032, 1044 (Fed. Cir. 2019) (quoting Thorner v. Sony
`Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)).
`
`988 Reply at 7; 989 Reply at 7; 990 Reply at 6; 991 Reply at 6; 992 Reply at 8; 993
`Reply at 7; 994 Reply at 6.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 21 of 87
`
`
`
`Construction Cannot Redraft Claim To Make Operable
`
`AIA Eng’g, Ltd. v. Magotteaux Int’l S/A, 657 F.3d 1264, 1276 (Fed. Cir. 2011) (internal quotations omitted)
`
`988 Sur-Reply at 7; 989 Sur-Reply at 6-7; 990 Sur-Reply at 8; 991 Sur-Reply at 7;
`992 Sur-Reply at 7; 993 Sur-Reply at 6-7; 994 Sur-Reply at 6.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 22 of 87
`
`
`
`Intrinsic Evidence - Claims
`
`• Determine REM sleep breathing pattern using “low flow rate”
` “the breathing patterns that are indicative of state (i) [REM sleep] comprise one
`or more patterns selected from the group consisting of (a) an absence of large
`breaths, (b) a high respiratory rate, (c) a low flow rate, and (d) a cluster of
`small breaths.”
`
`993 EX1001 (’344 Patent) at Claim 8
`
`988 Reply at 4; 989 Reply at 4; 990 Reply at 4; 991 Reply at 4; 992 Reply
`at 4; 993 Reply at 4; 994 Reply at 4.
`EX1051 (Kirkness Reply Decl.): ¶14 (988); ¶ 13 (989); ¶13 (990); ¶ 13
`(991); ¶ 13 (992); ¶13 (993); ¶ 13 (994)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 23 of 87
`
`
`
`Intrinsic Evidence - Claims
`
`Dependent claims do not require analysis of temporal structures
`• Determine breathing patterns using “airflow rate”
` “the hardware processor determines the breathing patterns using the measured
`airflow rate or pressure.”
` “the processing arrangement determines the breathing patterns as a function at least
`one of the airflow rate and the currently applied pressure.”
` “the data corresponding to the breathing patterns includes one of the airflow rate
`and the applied pressure.”
`
`989 EX1001 (’539 Patent) at Claim 3; 993 EX1001 (’994 Patent) at Claims 4,16
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 24 of 87
`
`
`
`Intrinsic Evidence - Claims
`
`• Determine troubled wakefulness breathing pattern using “pure mouth
`breathing”
` “the breathing patterns that are indicative of the troubled wakeful state comprise one
`or more patterns selected from the group consisting of (a) pure mouth breathing, (b)
`erratic large breaths with varying inspiratory times, and (c) irregularity of intervals
`between breaths.”
` “the breathing patterns that are indicative of state (iv) [troubled wakefulness]
`comprise one or more patterns selected from the group consisting of (a) pure mouth
`breathing, (b) erratic large breaths with varying inspiratory times, and (c) irregularity
`of intervals between breaths.”
`
`994 EX1001 (’344 Patent) at Claims 5, 15
`
`988 Reply at 4; 989 Reply at 4; 990 Reply at 4; 991 Reply 4; 992 Reply at
`4; 993 Reply at 4; 994 Reply at 4.
`EX1051 (Kirkness Reply Decl.): ¶¶ 24-33 (988); ¶¶ 24-33 (989); ¶¶ 25-33
`(990); ¶¶ 25-33 (991); ¶¶ 25-33 (992); ¶ 14 (993); ¶ 14 (994)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 25 of 87
`
`
`
`Intrinsic Evidence - Claims
`
`• Determine asleep state breathing pattern using “at least three
`obstructions”
` “the processing arrangement determines that the patient transitions from the
`awake state to the asleep state based on the indication of the patient’s
`breathing patterns, wherein the indication of the patient’s breathing patterns is
`a pattern of at least three obstructions.”
`
`988 EX1001 (’009 Patent) at Claim 24
`
`988 Reply at 4; 989 Reply at 4; 990 Reply at 4; 991 Reply at 4; 992 Reply
`at 4; 993 Reply at 4; 994 Reply at 4.
`EX1051 (Kirkness Reply Decl.): ¶14 (988); ¶ 15 (989); ¶ 15 (990); ¶ 15
`(991); ¶ 15 (992); ¶15 (993); ¶15 (994)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 26 of 87
`
`
`
`Intrinsic Evidence
`
`We note that when a construction such as this is
`inconsistent with the plain language of the claims
`and the written description, it is incorrect.
`
`Baxalta Inc. v. Genentech, Inc., 972 F.3d 1341, 1346, n.4 (Fed. Cir. 2020)
`(rejecting construction that excluded “explicitly claimed embodiments” in dependent claims)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 27 of 87
`
`
`
`Intrinsic Evidence - Specification
`Dependent claims do not require analysis of temporal structures
`The mask 20 covers the patient’s nose and/or mouth. Conventional flow
`sensors 23 are coupled to the tube 21. The sensors 23 detect the rate of
`airflow to/from patent and/or a pressure supplied to the patent by the
`generator 22. The sensors 23 may be internal or external to the generator
`22. Signals corresponding to the airflow and/or the pressure are provided to
`a processing arrangement 24 for processing.
`
`During the monitoring procedure, the processing arrangement 24 makes
`a determination as to a current state of the patient (e.g., whether the patient
`is asleep, awake and breathing regularly or awake and breathing irregularly
`due to distress or anxiousness). Such determination can be made based on a
`number of different measurements. For example, the processing
`arrangement 24 may analyze the patient's heart rate, blood pressure EEG
`data, breathing patterns, etc. in the determining the patient’s state.
`There are a number of characteristics of the patient's breathing patterns
`that may be taken into account in making such a determination. FIGS. 3
`and 4 show breathing patterns indicative of quiet, regular and relaxed
`breathing in a patient during the PAP therapy.
`993 EX1001 (’994 Patent) at 3:27-33; 3:64-4:3
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`988 Reply at 6; 989 Reply at 5; 990 Reply at 5-6; 991 Reply at 5; 992 Reply
`at 6; 993 Reply at 6; 994 Reply at 5.
`EX1051 (Kirkness Reply Decl.): ¶¶ 9-10, 14-15 (988); ¶¶ 9, 16-17 (989);
`¶¶ 9-10, 14-15 (990); ¶¶ 9-10, 14-15 (991); ¶¶ 9-10, 14-15 (992); ¶¶ 9-
`10, 14-15 (993); ¶¶ 9-10, 14-15 (994)
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 28 of 87
`
`
`
`Intrinsic Evidence - Specification
`Specification identifies patterns of troubled wakefulness and REM sleep
`Troubled Wakefulness:
`In contrast, the following exemplary characteristics may suggest that the
`patient is awake and anxious or distressed: pure mouth breathing (e.g., no
`signal from the sensors 23 which is configured to detect the patient's
`airflow from the nose); erratic large breaths with varying inspiratory times;
`irregularity of intervals between breaths (but not cyclic apneas which
`indicate Sleep and the need for higher pressure, etc).
`
`993 EX1001 (’994 Patent) at 4:20-27
`
`REM Sleep:
`This REM associated pattern of breathing may include, e.g., the absence of
`larger breaths, especially after pauses, generally high respiratory rates and
`low flow rates, and a tendency for clustering of small breaths. These
`differences in the pattern of the respiratory airflow signal from those seen
`during troubled wakefulness allow the separation of these states and can be
`used to make a change in the applied pressure.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`993 EX1001 (’994 Patent) at 4:67-5:7
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 29 of 87
`
`
`
`Intrinsic Evidence – Prosecution History
`Prosecution history does not require analysis of temporal structures
`
`Claim 9, as amended, recites "[a] system, comprising: a flow sensor provided in an
`airflow path and measuring data corresponding to a patient's breathing patterns; and a
`processing arrangement configured to analyze the breathing patterns to determine to which of
`the .following states the detected breathing pattern is indicative: (i) a REM sleep state, (ii) a
`non-troubled wake state, (iii) a non-REM sleep state and (iv) a troubled wakefulness state,
`and to adjust a pressure of an airflow supplied to an airway of the patient as a function of a
`state determined by the processing arrangement."
` As discussed above, Applicants respectfully submit that Burton does not teach or suggest
`a processing arrangement that distinguishes between regular wakefulness and troubled
`wakefulness. Rather, the "micro-arousals" cited by the Examiner refers to a light stage of
`sleep that is different from an awake or arousal state, and does not further identify whether
`the patient is anxious or uncomfortable. Therefore, Applicants respectfully submit that
`Burton does not does not teach or suggest a processing arrangement configured to determine
`"to which of the following states the detected breathing pattern is indicative: (i) a REM sleep
`state, (ii) a nontroubled wake state, (iii) a non-REM sleep state and (iv) a troubled
`wakefulness state." Therefore, Applicant respectfully submits that claim 9 is allowable over
`Burton. Because claims 8-14, 22 and 25-28 depend from and includes all of the elements of
`claim 9, it is respectfully submitted that the §103(a) rejection of these claims should also be
`withdrawn for at least the foregoing reasons.
`
`988 Reply at 5-6; 989 Reply at 5-6; 990 Reply at 5; 991 Reply at 5; 992
`Reply at 5; 993 Reply at 5-6; 994 Reply at 5.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`994 EX1002 (’344 Prosecution History) at 404
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 30 of 87
`
`
`
`Intrinsic Evidence – Prosecution History
`Patentee did not disclaim or disavow claim scope
`
`988 EX1002 (’009 Prosecution History) at 129
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 31 of 87
`
`
`
`Intrinsic Evidence - Specification
`
`Dr. Bates’ analysis of patent figures was “crude”
`
`Q. So based off your estimation, breaths 1, 3,
`7, 9, 16 have approximately the same
`amplitude?
`A. Yes, with the emphasis on the word
`approximately because the vertical
`resolution of my plotting of the X’s is pretty
`crude. Again, I’m using it for illustrative
`purposes to illustrate the theory behind my
`thinking.
`
`EX1052 (Bates Tr.) at 76:8-14
`
`989 EX2005 (Bates Decl.) ¶ 70
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 32 of 87
`
`
`
`PO’s Construction Contradicts the Intrinsic Evidence
`
`Dr. Bates’ inferences from exemplary figures do not limit the claim terms
`
`[M]ere inferences drawn from the description of an
`embodiment of the invention cannot serve to limit
`claim terms, as they are insufficient to require a
`narrower definition of a disputed term.
`
`Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 992 (Fed. Cir. 1999)
`(internal citation omitted)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 33 of 87
`
`
`
`PO’s Construction Contradicts the Intrinsic Evidence
`PO’s construction excludes breathing patterns in dependent claims
`’344 Patent, cls. 5, 15: “the breathing patterns that
`’009 Patent, cl. 24: “the processing arrangement
`are indicative of
`the troubled wakeful
`state
`determines that the patient transitions from the
`comprise one or more patterns selected from the
`awake state to the asleep state based on the indi-
`group consisting of (a) pure mouth breathing, (b)
`cation of the patient’s breathing patterns, wherein
`the indication of the patient’s breathing patterns is a
`erratic large breaths with varying inspiratory times,
`pattern of at least three obstructions.”
`and (c) irregularity of intervals between breaths.”
`
`Q. So if I have a system that detects pure
`mouth breathing, would that system be
`able to detect troubled wakefulness?
`A. Not necessarily. Pure mouth breathing is
`not a definition of troubled wakefulness. It
`may be associated with it. It may happen
`when the patient – what it says here is it
`may happen when the patient is awake,
`anxious or distressed.
`
`A.
`
`Q. So would three obstructive apnea events be
`a breathing pattern?
`It would not be a breathing pattern on its
`own because apnea events do not describe
`the way that air moves in and out of the
`lungs in any global sense. They simply say
`that air is not moving. An apnea is when air
`is not moving.
`
`993 EX1001 (’344 Patent) at Claims 5, 15
`EX1053 (Bates Tr.) at 247:5-11
`
`988 EX1001 (’009 Patent) at Claim 24
`EX1053 (Bates Tr.) at 288:14-289:3
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 34 of 87
`
`
`
`PO’s Expert’s Concurrent Patent Confirms Plain Meaning
`
`Such a method currently does not exist, despite the widespread use
`of surrogates based purely on the measurement of the pattern of
`breathing (i.e., volume inspired per breath and rate of breathing).
`
`EX1049 (Bates Patent) at 1:65-2:2
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 35 of 87
`
`
`
`PO’s Sur-Reply Confirms that Temporal Analysis Unnecessary
`
`For instance, in differentiating between REM and wakefulness, two
`parameters include temporal structures (absence of larger breaths, especially
`after pauses; a tendency for clustering of small breaths) and two include
`amplitude structures (high respiratory rates and low flow rates).
`
`988 Sur-Reply at 14
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 36 of 87
`
`
`
`Dr. Kirkness Did Not Agree With PO’s Construction
`
`Kirkness agrees with this when he says:
`“troubled wakefulness as a state in which
`breathing pattern is characterized by
`irregularity variations in the size [an
`aspect of the amplitude structure of the
`time series] and/or frequency of breaths
`[an aspect of the temporal structure of
`the time series” [Kirkness deposition
`transcript, Vol. II, p. 147, lines 5-8].”
`988 EX2005 (Bates Decl.) at 38
`
`A.
`
`988 POR at 13, 38; 989 POR at 38, 40, 47; 990 POR at 35, 45, 51; 991 POR at
`24, 35, 42; 992 POR at 13, 37; 993 POR at 13, 37, 51; 994 POR at 25, 38.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`Q.
`
`A.
`
` Would you agree that the last sentence on page 38
`is your characterization of Dr. Kirkness' testimony?
`I believe it is, yes, the parts in square brackets, yeah.
`It's a characterization of that part of his testimony.
`* * *
`Q. Did Dr. Kirkness ever expressly agree that identifying
`troubled wakefulness requires examining the
`amplitude and temporal structures of the breathing
`pattern over a sequence of breaths?
`A. What Dr. Kirkness said is said in the previous parts of
`that paragraph, the relevant parts of what he said.
`Q. You don't recall whether or not Dr. Kirkness ever
`used the words "amplitude" or "temporal," correct?
`I don't recall, no. I'm really sorry.
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 37 of 87
`
`
`
`Disputed Limitations
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 38 of 87
`
`
`
`’539 and ’344 Patents
`
`989 EX1001 (’539 Patent)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 39 of 87
`
`
`
`Overview of Instituted Grounds for Representative Patents
`
`’539 Patent (IPR2022-00989)
`Claims 1-2, 5-11, 13, 15-30:
`Ground 1: Obvious over the teachings of Sullivan995 in view of Sullivan460
`Ground 2: Obvious over the teachings of Rapoport502 in view of Sullivan460
`
`’344 Patent (IPR2022-00994)
`Claims 1, 3, 7, 9, 11, 13:
`Ground 1: Obvious over the teachings of Rapoport502 in view of Sullivan460 and Matthews
`Ground 2: Obvious over the teachings of Sullivan995 in view of Sullivan460 and Matthews
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 40 of 87
`
`
`
`Representative Claims
`
`’539 Patent
`
`’344 Patent
`
`24. A positive airway pressure system for treatment of a
`sleeping disorder in a patient, comprising:
`a generator supplying airflow and applying a pressure to
`an airway of a patient;
`a sensor measuring data corresponding to patient's
`breathing patterns from data indicate of the airflow
`supplied to the patient using at least one of a flow
`sensor or pressure sensor; and
`a hardware processor analyzing the breathing patterns to
`determine whether breathing patterns indicate an
`asleep state or an awake state have occurred.
`
`7. A system, comprising:
`a flow sensor provided in an airflow path and measuring
`data corresponding to a patient’s breathing patterns; and
`a processing arrangement configured to analyze the breath-
`ing patterns to determine to which of the following states
`the detected breathing pattern is indicative: (i) a REM
`sleep state, (ii) a non-troubled wake state, (iii) a non
`REM sleep state and (iv) a troubled wakefulness state;
`and
`a generator configured to supply an airflow to an airway of
`the patient and to adjust a pressure of the airflow sup-
`plied to an airway of the patient as a function of a state
`determined by the processing arrangement.
`
`989 EX1001 (’539 Patent) at Claim 24
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 41 of 87
`
`
`
`Prior Art Need Not Be Enabled
`
`Under § 103 [ ], a reference need not be enabled; it
`qualifies as a prior art, regardless, for whatever is
`disclosed therein.
`
`988 Reply at 15-16; 989 Reply at 16; 990 Reply at 15, 22; 991 Reply at 15, 22; 992
`Reply at 15, 22; 993 Reply at 14, 21; 994 Reply at 16, 23.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 42 of 87
`
`
`
`The ’539 Patent Family Teaches a Conventional CPAP System
`
`EX1001 (’539 Patent) at Fig. 1
`
`EX1001 (’539 Patent) at Fig. 2
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 43 of 87
`
`
`
`Rapoport502 (U.S. Patent No. 5,490,502)
`
`Undisputed: Rapoport502 teaches the same components as the claimed CPAP system
`
`EX1008 (Rapoport502) at 7
`
`989 EX1001 (’539 Patent) at 3
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 44 of 87
`
`
`
`Sullivan995 (U.S. Patent No. 5,245,995)
`Undisputed: Sullivan995 teaches the same components as the claimed CPAP system
`
`EX1005 (Sullivan995) at 2
`
`EX1005 (Sullivan995) at 10
`
`EX1005 (Sullivan995) at 2
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 45 of 87
`
`
`
`Obstructions Are A Breathing Pattern
`The ’539 Patent Family Teaches Using
`Obstructions to Determine a Breathing Pattern
`
`7. The system according to claim 5, wherein
`the hardware processor determines the patient
`breathing pattern indicative of a change from the
`awake state to the asleep state has occurred
`when the patient breathing pattern indicates a
`regular period of obstructions.
`
`989 EX1001 (’539 Patent) at 10:21-25
`
`24. A method for treatment of a sleeping disorder
`in a patient using a positive airway pressure delivery
`system that delivers a flow of breathable gases at a
`positive treatment pressure with respect to ambient
`air pressure, the flow of breathable gases being
`delivered to an airway of a patient, the method
`comprising:
`
`* * *
`increasing an applied pressure to an elevated pressure
`when the processing arrangement determines that
`the patient transitions from the awake state to the
`asleep state based on the indication of
`the
`patient’s
`breathing
`patterns, wherein
`the
`indication of the patient's breathing patterns is a
`pattern of at least three obstructions.
`
`988 Pet. 3-4; 989 Cor. Pet. 44, 38-39; 990 Cor. Pet. 4-5; 991 Cor. Pet. 3-4; 992 Cor.
`Pet. 3-4; 993 Cor. Pet. 3-4; 994 Cor. Pet. 5.
`EX1051 (Kirkness Decl.): ¶¶ 9, 15 (988); ¶¶ 9, 15 (989); ¶¶ 9, 15 (990); ¶¶ 9, 15
`(991); ¶¶ 9, 15 (992); ¶¶ 9, 15 (993); ¶¶ 9, 15 (994)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 46 of 87
`
`
`
`Obstructions Are a Breathing Pattern
`Rapoport502 and Sullivan995 Also Teach That Obstructions Are a Breathing Pattern
`
`EX1005 (Sullivan995) at 13:55-59
`
`EX1008 (Rapoport502) at 1:29-36
`
`EX1008 (Rapoport502) at Abstract
`988 Pet. at 13, 33-34, 40, 55-56, ; 989 Cor. Pet. at 19, 47, 51-52; 990 Cor. Pet. at 20,
`40, 35-36, 52-53, ; 991 Cor. Pet. at 10-11, 17, 46, 60-61 ; 992 Cor. Pet. at 16, 40, 47-
`48, 56; 993 Cor. Pet. at 11, 13-14; 994 Cor. Pet. at 16, 17
`EX1003 (Behbehani Decl.): ¶¶ 80, 162, 208 (988); ¶¶ 76, 180 (989); ¶¶ 85, 172, 224
`(990); ¶¶ 83, 166, 228 (991); ¶¶ 86, 160, 196, 220 (992); ¶¶ 70, 84, 158 (993); ¶¶ 70,
`83, (994)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 47 of 87
`
`
`
`Disputed: “analyzing the breathing patterns” to
`determine an asleep state or an awake state
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed Inc. Exhibit 1060
`ResMed Inc. v. New York University
`IPR2022-00994, Page 48 of 87
`
`
`
`Disputed Limitation: ’539 Patent
`
`24. A positive airway pressure system for treatment of a
`sleeping disorder in a patient, comprising:
`a generator Supplying airflow and applying a pressure to
`an airway of a patient;
`a sensor measuring data corresponding to patient's breath-
`ing patterns from data indicate of the airflow Supplied
`to the patient using at least one of a flow sensor or
`pressure sensor; and
`a hardware processor analyzing the breathing patterns to
`determine whether breathing patterns indicate an asleep
`state or an awake state have occurred.
`
`989 EX1001 (’539 Patent) at Claim 24
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`ResMed I
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