skin to electric current, said data indicative of heat flow, said data indicative of heart beats or
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`muscle or brain activity and said data indicative of a temperature of said individual's skin.
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`159.
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`(New) A method according to claim 157, said at least two sensors being said
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`body motion sensor and said heat flux sensor, wherein said one or more measured parameters
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`comprises data relating to calories burned and is generated using at least said data indicative of
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`motion and said data indicative of heat flow.
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`160.
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`(New) A method according to claim 159, said at least two sensors further including
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`said skin conductance sensor, wherein said data relating to calories burned is generated using at
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`least said data indicative of motion, said data indicative of heat flow, and said data indicative of
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`161.
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`(New) A method according to claim 113, said at least two sensors being said
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`body motion sensor and said body potential sensor, wherein said derived data comprises data
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`relating to calories burned and is generated using at least said data indicative of motion and
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`said data indicative of heart beats.
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`162.
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`(New) A method according to claim 118, said at least two sensors being said
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`body motion sensor and said body potential sensor, wherein said derived data comprises data
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`relating to calories burned and is generated using at least said data indicative of motion and
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`said data indicative of heart beats.
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`401 of 1701
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`163.
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`(New) A method according to claim 138, said at least two sensors being said
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`body motion sensor and said body potential sensor, wherein said derived data comprises data
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`relating to calories burned and is generated using at least said data indicative of motion and
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`said data indicative of heart beats.
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`164.
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`(New) A method according to claim 143, said at least two sensors being said
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`body motion sensor and said body potential sensor, wherein said derived data comprises data
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`relating to calories burned and is generated using at least said data indicative of motion and
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`said data indicative of heart beats.
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`165.
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`(New) A method according to claim 153, said at least two sensors being said
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`body motion sensor and said body potential sensor, wherein said one or more measured
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`parameters comprises data relating to calories burned and is generated using at least said data
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`indicative of motion and said data indicative of heart beats.
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`166.
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`(New) A method according to claim 157, said at least two sensors being said
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`body motion sensor and said body potential sensor, wherein said one or more measured
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`parameters comprises data relating to calories burned and is generated using at least said data
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`indicative of motion and said data indicative of heart beats.
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`167.
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`(New) A method according to claim 104, further comprising receiving sensor
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`data from one or more sensor devices, said one or more sensor devices measuring said sensor
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`402 of 1701
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`data from the individual, and using said sensor data in addition to said data indicative of one or
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`more measured parameters to determine said status information.
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`168.
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`(New) A method according to claim 124, further comprising receiving sensor
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`data from one or more sensor devices, said one or more sensor devices measuring said sensor
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`data from the individual, and using said sensor data in addition to said data indicative of one or
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`more measured parameters to determine said relative degree of achievement.
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`169.
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`(New) A method according to claim 153, further comprising receiving sensor
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`data from one or more sensor devices, said one or more sensor devices measuring said sensor
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`data from the individual, and using said sensor data in addition to said data indicative of one or
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`more measured parameters to determine said status information.
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`170.
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`(New) A method according to claim 157, further comprising receiving sensor
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`data from one or more sensor devices, said one or more sensor devices measuring said sensor
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`data from the individual, and using said sensor data in addition to said data indicative of one or
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`more measured parameters to determine said relative degree of achievement.
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`403 of 1701
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`REMARKS
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`Reconsideration of the present application in view of the above amendments and the
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`following remarks is respectfully requested.
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`I.
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`Status of the Claims
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`Claims 104-146 are pending in this application. In the Office Action mailed on
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`February 26, 2004, claims 104-146 were rejected. Claims 128-136 have been canceled, claims
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`104, 110,111,113,115,l16,118,120,l21, 123,124, l26,127,138,140,141, 143,145, and
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`146 have been amended, and new claims 147-170 have been added.
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`II.
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`Objection Under 35 U.S.C. §132 and Rejection Under 35 U.S.C. §112
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`The Examiner objected to the Amendment filed on November 28, 2003 under 35 U.S.C.
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`§132, stating that it added new matter into the disclosure. Specifically, the Examiner stated that
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`claims 109, 110, 122, 123, 125, 126, 128-132 contain information which is neither included nor
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`implied in the original specification. Similarly, the Examiner rejected claims 109-123, and 125-
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`146 under 35 U.S.C. §112 as containing subject matter not described in the specification.
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`With respect to claims 109 and 125, the Examiner objected to the language “wherein at
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`least two sensors” and “physiological sensors and contextual sensors.” Support for this language
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`can be found in the specification at page 5, lines 3-5 (“Sensor device 10, includes one or more
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`sensors, which are adapted to generate signals in response to physiological characteristics of an
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`individual”), page 1 1, lines 1-6 (“Sensor device 10 may include one or more sensors for
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`generating signals in response to contextual characteristics relating to the environment
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`surrounding the individual, the signals ultimately being used to generate the type of data
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`404 of 1701
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`described above. Such sensors are well known, as are methods for generating contextual
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`parametric data such as air quality, sound level/quality, ambient temperature and global
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`positioning.), and page 11, lines 17-19 (“A digital signal or signals representing certain
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`physiological and/or contextual characteristics of the individual user may be used by
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`microprocessor 20 to calculate or generate data indicative of physiological and/or contextual
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`parameters of the individual user”). Accordingly, Applicants requests that the objection and
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`rejection of the subject claims be withdrawn.
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`With respect to claims 110 and 126 (and 111 and 127, although not specifically identified
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`by the Examiner), the objected to language has been deleted from the claims. Applicants have
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`done so to expedite the prosecution of the present application, and are not admitting that the
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`objected to language lacked support. Accordingly, Applicants request that the objection and
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`rejection of the subject claims be withdrawn.
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`With respect to claim 122, the Examiner objected to the language “aggregating said data
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`indicative of one or more measured parameters with data collected from a plurality of individuals
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`to create aggregate data.” Support for this language can be found in the specification at page 21,
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`lines 13-18 (“Third parties such as insurance companies or research institutions may be given
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`access, possibly for a fee, to certain of the information stored in mirror network storage device
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`120. Preferably, in order to maintain the confidentiality of the individual users who supply data
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`to central monitoring unit 30, these third parties are not given access to such user’s individual
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`database records, but rather are only given access to the data stored in mirror network storage
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`device 120 in aggregate form”). Accordingly, Applicants request that the objection and
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`rejection of the subject claim be withdrawn.
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`405 of 1701
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`With respect to claim 123, the Examiner objected to the language “the step of creating
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`aggregate data reports based on said aggregate data.” Claim 123 has been amended to read “the
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`step of creating reports based on said aggregate data.” Support for this language can be found in
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`the specification at page 21, line 13 to page 22, line 6 (“Third parties such as insurance
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`companies or research institutions may be given access, possibly for a fee, to certain of the
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`information stored in mirror network storage device 120. Preferably, in order to maintain the
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`confidentiality of the individual users who supply data to central monitoring unit 30, these third
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`parties are not given access to such user’s individual database records, but rather are only given
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`access to the data stored in mirror network storage device 120 in aggregate form. Such third
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`parties may be able to access the information stored in mirror network storage device 120
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`through the Internet using a conventional browser program.... In addition, the third parties can
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`choose from a series of prepared reports that have information packaged along subject matter
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`lines, such as various demographic categories”). Accordingly, Applicants request that the
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`objection and rejection of the subject claim be withdrawn.
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`Applicants have canceled claims 128-136, which contained language objected to by the
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`Examiner. Applicants have done so to expedite the prosecution of the present application, and
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`are not admitting that the objected to language lacked support.
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`III.
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`Rejection Under 35 U.S.C. § 103
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`The Examiner rejected claims 104-112, 114, 117, 119, 124-127, 137, 139, 142 and 144
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`under 35 U.S.C. § l03(a) as being unpatentable over Brown, United States Patent No. 5,951,300,
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`(“Brown300”) in view of Alyfuku et al., United States Patent No. 5,410,471. The Examiner
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`rejected claims 113, 118, 138 and 143 under 35 U.S.C. § l03(a) as being unpatentable over
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`406 of 1701
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`Brown300, in view of Alyfuku et al. and further in view of Korenman et a1., United States Patent
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`No. 6,067,568. The Examiner rejected claims 115-116, 120-121, 140-141, and 145-146 under 35
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`U.S.C. § 103(a) as being unpatentable over Brown300, in view of Alyfuku et al. and Korenman
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`et al., and further in view of Pottgen et al., United States Patent No. 5,813,994 and Nasiff, United
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`States Patent No. 4,757,453. The Examiner rejected claim 122 under 35 U.S.C. § l03(a) as
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`being unpatentable over Brown30O and Alyfuku et al. and further in view of et al., United States
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`Patent No. 6,032,119 (“Brownl 19”). The Examiner rejected claim 123 under 35 U.S.C. § l03(a)
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`as being unpatentable over Brown300, Alyfuku et al. and Brown1l9, and further in view of
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`Brown et al., United States Patent No. 5,913,310 (“Brown310”). The Examiner rejected claims
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`128-136 under 35 U.S.C. § 103(3) as being unpatentable over Brown30O and Alyfuku et al., and
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`further in view of Mcllroy et al., United States Patent No. 5,583,758.
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`With respect to claims 104 and 124, the Examiner stated that Brown30O teaches a method
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`for assisting an individual to monitor, control and modify certain aspects of the individual’s
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`physiological status according to a preset physiological status goal, the method comprising
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`establishing the physiological status goal according to certain preselected physiological
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`parameters of the individual, using data indicative of one or more measured parameters to
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`compare target parameters to actual parameters, and, in the case of claim 104, providing the
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`status information to the individual, and, in the case of claim 124, providing to the individual a
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`treatment plan. The Examiner stated that Brown30O does not explicitly disclose affixing a
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`physiological monitoring device in proximity to the body of the individual and generating data
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`indicative of one or more measured parameters of the individual using the device. The Examiner
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`stated, however, that Alyfuku et al. teaches affixing a physiological monitoring device in
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`proximity to the body of the individual and generating data indicative of one or more measured
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`407 of 1701
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`parameters of the individual using the device. The Examiner thus concluded that it would have
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`been obvious to one of ordinary skill in the art at the time the invention was made to modify the
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`method disclosed in Brown300 to include affixing a physiological monitoring device in
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`proximity to the body of the individual and generating data indicative of one or more measured
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`parameters of the individual using the device as taught by Alyfuku et al.
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`Claims 104 and 124 have been amended to recite “wearing a wearable physiological
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`monitoring device on the body of the individual” and “generating data indicative of one or more
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`measured parameters of an individual using said wearable physiological monitoring device.” In
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`contrast, Alyfuku et al. describes a number of household appliances, such as a toilet, a bed, a
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`bathtub, an exercise bike, and an easy chair, having sensors incorporated therein for measuring
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`individual physiological parameters when an individual comes into proximity and/or physical
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`contact with the fixed appliance, and thus the sensor or sensors. Alyfuku et al. does not describe
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`a wearable physiological monitoring device as described in the present application and claimed
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`in amended claims 104 and 124. Furthermore, neither Alyfuku et al. nor any of the other
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`references cited by the Examiner teaches or suggests the use of a wearable physiological
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`monitoring device in a method for assisting an individual to monitor, control and modify certain
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`aspects of the individual’s physiological status according to a preset physiological status goal as
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`recited in claims 104 and 124. Instead, Alyfuku et al. and each of the other references cited by
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`the Examiner that includes a monitoring device merely describe measuring and collecting certain
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`physiological parameters using such devices.
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`On this subject, the Federal Circuit has long held that “[w]hen a rejection depends on a
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`combination of prior references, there must be some teaching, suggestion, or motivation to
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`408 of 1701
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`combine the references.” In re Rouffet, 149 F.3d 1350, 1355. The Federal Circuit has further
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`stated:
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`‘[V]irtually all inventions are combinations of old elements.’
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`Therefore an Examiner may often find every element of a claimed
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`invention in the prior art. If identification of each claimed element
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`in the prior art were sufficient to negate patentability, very few
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`patents would ever issue. Furthermore, rejecting patents by solely
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`finding prior art corrollaries for the claimed elements would
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`permit an Examiner to use the claimed invention itself as a
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`blueprint for piecing together elements in the prior art to defeat the
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`patentability of the claimed invention. Such an approach would be
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`‘an illogical and inappropriate process by which to determine
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`In re Rouffet, 149 F.3d at 1357 (citations omitted). In accord with these principles, Applicants
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`respectfully submit that if the Examiner were to reject claims 104 and 124 under 35 U.S.C.
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`§ 103(a) by combining Brown3 00 with a reference that merely teaches a wearable monitoring
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`device (of which there are many) and that does not also teach or suggest using the wearable
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`monitoring device to monitor, control and modify physiological status according to a preset
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`physiological status goal as claimed, the Examiner would be using the claimed invention as a
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`blueprint to piece together prior art elements to defeat the patentability of the invention claimed
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`in claims 104 and 124. As stated in In re Rouffet, this would be improper.
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`Accordingly, because the cited references do not teach or suggest the method as recited in
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`amended claims 104 and 124 which include the limitation a wearable physiological monitoring
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`device, Applicants submit that such claims are allowable. Furthermore, because claims 105-123
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`and 147-149 depend from claim 104, and claims 125-127, 137-146, and 150-152 depend from
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`claim 124, they are likewise believed to be allowable for the same reasons.
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`In addition, the Examiner rejected claims 105-108 by stating that Alyfuku et al., in
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`Figure 3A, provides a list of categories. Claim 105 recites “wherein said physiological status
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`409 of 1701
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`goal comprises a plurality of categories,” claim 106 recites “wherein said status information is
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`determined and provided with respect to each of said categories,” and claim 107 recites “wherein
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`said categories relate to two or more of nutrition, activity level, mind centering, sleep, and daily
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`activities.” In other words, as claimed, the categories relate to the specific physiological status
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`goal and the status information that is provided relating to that goal. In contrast, the categories
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`listed in Figure 3A of Alyfuku et al. are categories of things that may be measured by the various
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`appliances described in Alyfuku et al., and not categories of the physiological status goal or any
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`status information relating thereto. Thus, Applicants respectfully submit that these claims are
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`allowable over the cited references for this additional reason.
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`Applicants have not at the present time addressed the Examiner’s other specific rejections
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`relating to the claims depending from independent claims 104 and 124 because, as set forth
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`above, Applicants believe that those claims are allowable by virtue of their dependence on
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`claims 104 and 124. Applicants, however, reserve the right to address these specific rejections in
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`the future should it become necessary.
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`IV. New Claims
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`New claims 153 and 157 each recite a method for assisting an individual to monitor,
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`control and modify certain aspects of the individual’s physiological status according to a preset
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`physiological status goal including steps of “wearing a wearable physiological monitoring device
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`on the body of the individual, said wearable physiological monitoring device having at least two
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`sensors, said at least two sensors being two of a body motion sensor adapted to generate data
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`indicative of motion, a skin conductance sensor adapted to generate data indicative of the
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`resistance of said individual’s skin to electric current, a heat flux sensor adapted to generate data
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`410 of 1701
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`indicative of heat flow, a body potential sensor adapted to generate data indicative of heart beats
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`or muscle or brain activity of said individual, and a temperature sensor adapted to generate data
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`indicative of a temperature of said individual’s skin, said wearable physiological monitoring
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`device generating at least two of said data indicative of motion, said data indicative of resistance
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`of said individual skin to electric current, said data indicative of heat flow, said data indicative of
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`heart beats or muscle or brain activity and said data indicative of a temperature of said individual
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`skin when worn by said individual” and “generating data indicative of one or more measured
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`parameters of said individual using at least two of said data indicative of motion, said data
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`indicative of resistance of said individual’s skin to electric current, said data indicative of heat
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`flow, said data indicative of heart beats or muscle or brain activity and said data indicative of a
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`temperature of said individua1’s skin.” New claim 153 further includes the step of “using said
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`data indicative of one or more measured parameters to determine status information indicative of
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`the relative degree of achievement of said individual’s performance with relation to said
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`physiological status goal,” and new claim 157 further includes the step of “using said data
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`indicative of one or more measured parameters to determine the relative degree of achievement
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`references cited by the Examiner include a wearable physiological monitoring device including
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`the at least two specified sensors recited in new claims 153 and 157 or a method utilizing such a
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`physiological monitoring device to monitor, control and modify physiological status as recited in
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`new claims 153 and 157. Korenman (cited by the Examiner) describes a device that includes
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`only a galvanic skin response sensor, Nasiff (cited by the Examiner) describes a device that
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`includes only piezoelectric transducers for measuring body motion and activity, and Pottgen et
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`al. (cited by the Examiner) describes a device that includes only a heat flow sensor. As a result,
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`411 of 1701
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`in accordance with the Remarks herein, Applicants submit that new claims 153 and 157, and the
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`claims depending therefrom, are allowable over the cited references (Applicants note that claims
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`113, 118, 138, 143, 149 and 152 contain limitations similar to those in claims 153 and 157 and
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`therefore are likewise allowable). No new matter has been added in claims 153 and 157.
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`In addition, new dependant claims 154 and 158 each recite that the wearable
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`physiological monitoring device includes five specific sensors, namely a body motion sensor
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`adapted to generate data indicative of motion, a skin conductance sensor adapted to generate data
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`indicative of the resistance of the individual skin to electric current, a heat flux sensor adapted to
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`generate data indicative of heat flow, a body potential sensor adapted to generate data indicative
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`of heart beats or muscle or brain activity of the individual, and a temperature sensor adapted to
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`generate data indicative of a temperature of the individual’s skin. New dependent claims 154
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`and 158 further recite that the data indicative of each of the one or more measured parameters is
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`generated using at least two of the data indicative of motion, the data indicative of resistance of
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`the individual’s skin to electric current, the data indicative of heat flow, the data indicative of
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`heart beats and the data indicative of a temperature of the individual’s skin as measured by the
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`recited sensors. As was the case with new claims 153 and 157, none of the references cited by
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`the Examiner describes a wearable physiological monitoring device including the sensors
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`specified in new claims 154 and 158 or a method wherein one or more measured parameters are
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`generated using the sensor data as recited in new claims 154 and 158. Accordingly, Applicants
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`respectfully submit that new claims 154 and 158 are allowable over the cited references for this
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`additional reason. No new matter has been added in claims 154 and 158.
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`Claims 155 and 159 depend from new claims 153 and 157, respectively, and each recite
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`“said at least two sensors being said body motion sensor and said heat flux sensor, wherein said
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`412 of 1701
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`one or more measured parameters comprises data relating to calories burned and is generated
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`using at least said data indicative of motion and said data indicative of heat flow.” In the Office
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`Action mailed on February 26, 2004, the Examiner cited Pottgen et al. and Nasiff as references
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`that describe devices that measure calories burned, also known as energy expenditure. Nasiff
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`describes a device that utilizes four piezoelectric transducers, one for each arm and one for each
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`leg, to measure body motion and activity and uses that information to calculate energy
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`expenditure. Pottgen et al. describes a device that includes a heat flow sensor for measuring heat
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`flow and uses the heat flow information to calculate energy expenditure. None of the references
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`describes a wearable physiological monitoring device that includes both a body motion sensor
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`and a heat flux sensor wherein data relating to calories burned or energy expenditure is generated
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`using both data indicative of motion as measured by the body motion sensor and data indicative
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`of heat flow as measured by the heat flux sensor as recited in new claims 155 and 159.
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`Accordingly, Applicants respectfully submit that new claims 155 and 159 are allowable over the
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`cited references for this additional reason (Applicants note that claims 115, 120, 140, and 145
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`contain limitations similar to those in claims 155 and 159 and therefore are likewise allowable).
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`No new matter has been added in claims 155 and 159.
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`413 of 1701
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`CONCLUSION
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`Based on the foregoing remarks, Applicants respectfully submit that claims 104-127 and
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`137-170 are in condition for allowance.
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`If a telephone conference would facilitate prosecution of this application in any way, the
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`Examiner is invited to contact the undersigned at the number provided.
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`Respectfully submitted,
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`METZ LEWIS LLC
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`Phi p E. Levy, 40,700
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`11 Stanwix Street, 18"‘ Floor
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`Pittsburgh, Pennsylvania 15222
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`Attorneys for Applicant
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`(412) 918-1110
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`414 of 1701
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`rifle
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`PTOISBISO (osoa)
`Approved for use through 07/31/2006. OMB/0651-0031
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`us. Patent and Trademark Office: u.s. DEPARTMENT OF COMMERCE
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`Application Number
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`36242
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`Filing Date
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`First