P ‘$3.392/10587
`
`us. l'ATE;‘~JT APPLICATION’
`
`07/810.50|
`
`
`
`ROBERT K. SCHULTE. SHOREVIEW. MN.
`
`mkcom | uumc DATAkk!¢**~k**1i**shH\~k:!1Hn\*1’¢
`
`I
`
`
`
`**FOREIGN/PCT APPLICAT|0NS************
`
`FOREIGN FILING LICENSE GRANTED O3/I2/92
`
`A
`COUNTRY
`
`DRAHIIW
`
`,
`,
`CLAIMS
`
`CLAIM
`
`I
`
`
`
`
`RECEIVED
`
`
`DOUGLAS E. REEDICH
`
`
`3H OFFICE OF
`INTELLECTUAL
`PROPERTY COUNSEL
`
` P.O. BOX 33h27
`ST. PAUL, HN SBI33-3B27
`
`
`.._'\
`APPLICANT
`VERIFIED
`
`VERIFIED
`
`
`MN
`
`0
`
`lb
`
`5
`
`820.00
`
`h7983usA7A
`
`
`
`
`the Unvtad states
`This is to cartTfy that znnnxed hereto is a true copy frou the records of
`
`Patunt and Trademark Dfficn of tho applicatvon as fulud unvch vs vdcntufueu above.
`By authority of
`the
`
`
`COMMISSIONER or PATENTS AND TRADEMARKS
`
`
`
`/,'
`
`v
`
`4/ca
`
`9150291992
`
`,
`
` REPLACEMENT MYLAN EX. 1003, Page 1
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`0 ‘
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`9 '
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`REPLACEMENT MYLAN Ex. 1003, Page 1
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`

`
`p,;goT«%<,
`
`DOCKET NUMBER:
`
`m7810d01
`47983USA7A
`
`OSO
`
`O
`
`ONS
`
`§ACKGROUNQ OF THE LNVENTION
`
`FIELD O
`
`“H INVEN ON
`
`This invention relates to suspension aerosol
`formulations suitable for the administration of
`
`medicaments.
`
`In another aspect, it relates to
`
`pharmaceutical suspension aerosol formulations containing
`
`pirbuterol and in yet another aspect to aerosol
`
`formulations using 1,1,l,2,3,3,3—heptafluoropropane as the
`
`propellant.
`
`C
`
`O
`
`T
`
`AR
`
`Pirbuterol acetate is a relatively selective
`
`beta—2 adrenergic bronchodilator. MAXAIR“‘Inhaler
`
`(commercially available from 3M Pharmaceuticals, St. Paul,
`
`20
`
`MN)
`
`is a metered dose aerosol unit containing a fine-
`
`particle suspension of pirbuterol acetate in the propellant
`mixture of trichloromonofluoromethane and
`
`dichlorodifluoromethane, with sorbitan trioleate.
`
`25
`
`Chlorofluorocarbons,
`including trichloromon—
`fluoromethane and dichlorodifluoromethane, have been
`implicated in the destruction of the ozone layer and their
`
`production is being phased out. Hydrofluorocarbon 227
`
`(1,1,1,2,3,3,3-heptafluoropropane)
`
`is viewed as being less
`
`*
`
`-s
`36
`
`destructive to ozone than many chlorofluorocarbon
`propellants; furthermore, it has a low toxicity and a vapor
`
`‘ pressure suitable for use in aerosols.
`
`Patent Applications wo 91/11495 and wo 91/11496
`
`_.
`
`.,;r~
`' ,
`
`(both by weil) describe pharmaceutical suspension aerosol
`
`formulations comprising a medicinal agent, optionally a
`surfactant, and a propellant mixture containing
`
`35
`
`1,1,1,2,3,3,3—heptafluoropropane and one or more additional
`
`components, o.g., pentane, but-na, piopellant 134a,
`
`propellant 11, propellant 125, or propellant 152a.
`
`Pirhutorol is listed as a suitable medicinal agent. These
`
`.
`
`
`
`REPLACEMENT MYLAN EX. 1003, Page 2
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`REPLACEMENT MYLAN Ex. 1003, Page 2
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`

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`ELL!
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`,-.’..............‘,.......~..... a.
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`
`
`
`
`:3
`
`I
`
`-2-
`
`patent applications do not disclose
`
`the use of ethanol as
`
`a component
`
`in combination with 1,1,1,2,3,3,3—
`
`heptafluoropropane.
`
`European Patent Office Publication 0 384 371
`
`(Heiskel) describes solution aerosols in which
`
`1,l,1,2,3,3,3-heptafluoropropane or its mixture with
`
`propane, butane,
`
`isobutane, dimethyl ether, or 1,1-
`
`difluoroethane serves as the propellant. The application
`
`does not, however, disclose suspension aerosols or
`
`pharmaceutical aerosol formulations.
`
`Patent Application W0 91/02056 (Schultz et al.y
`
`describes a suspension aerosol formulation containing 0.5
`
`percent by weight of micronized pirbuterol acetate, 0.05
`
`percent by weight of either perfluorooctanoic acid or
`
`perfluorofz-butoxypropionic acid, and 1,1,1,2,3,3,3—
`heptafluoropropane. The patent application does not,
`
`however, disclose the use of ethanol as a component
`
`in
`
`combination with 1,1,l,2,3,3,3-heptafluoropropane.
`
`10
`
`15
`
`20
`
`R
`
`NV
`
`N
`
`25
`
`30
`
`35
`
`This invention provides suspension aerosol
`
`formulations comprising a therapeutically effective amount
`
`of micronized pirbuterol acetate and a propellant
`
`comprising 1,1,1,2,3,3,3-heptafluoropropane,
`
`the
`
`formulation being further characterized in that it is
`
`substantially free of perfluorinated surfactant. This
`
`invention also provides suspension aerosol formulations
`
`comprising a therapeutically effective amount of micronized
`
`pirbuterol acetate, about 0.1 to about 12 percent by weight
`of ethanol, and a propellant comprising 1,1,l,2,3,3,3—
`‘heptafluoropropane.
`This invention also provides
`suspension aerosol formulations comprising a
`
`therapeutically effective amount of micronized pirbuterol
`
`acetate, about 5 to about 12 percent by weight of ethanol,
`
`about 0.05 to about 0.5 percent by weight of oleic acid,
`
`and a propellant comprising 1,1,1,2,3,3,3-
`
`heptafluoropropanc.
`
`This invention also provides a method
`
`for inducing bronchodilation in I mammal, comprising
`
`REPLACEMENT MYLAN EX. 1003, Page 3
`
`'9.
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`. .-
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`1/“
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`3
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`1
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`7-‘
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`‘o
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`o
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`REPLACEMENT MYLAN Ex. 1003, Page 3
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`

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`
`
`administering to the mammal a formulation as described
`
`above by inhalation.
`
`D
`
`S
`
`NI
`
`The term "suspension aerosol" means that the
`
`pirbuterol acetate present in the formulation is in
`
`particulate form and the formulation is substantially free
`
`of dissolved pirbuterol acetate.
`
`10
`
`acetate is in the form of a fine powder, that is, over 90
`
`The term "micronized" means that the pirbuterol
`
`percent of the particles will have a diameter of less than
`about 10 microns.
`
`All weight percentages recited herein are based
`
`15
`
`on the total weight of the formulation unless otherwise
`indicated.
`
`The formulations of the invention contain a
`
`20
`
`25
`
`therapeutically effective amount of micronized pirbuterol
`
`acetate. Preferably, micronized pirbuterol acetate
`
`constitutes about 0.4 to about 1.0 percent by weight, more
`
`preferably about 0.45 to about 0.9 percent by weight, of
`the aerosol formulation.
`
`Ethanol can optionally be included in an aerosol
`
`formulation of the invention. when ethanol is present it
`
`constitutes from about 0.1 to about 12 percent by weight,
`
`preferably frcm about 5 to about 12 percent by weight of
`the aerosol formulation.
`
`oleic acid can optionally be
`included in an aerosol formulation of the invention that
`
`includes ethanol. when oleic acid is present it constitutes
`
`about 0.01 to about 0.5 percent by weight of the
`
`30
`
`formulation.
`
`The propellant used in the formulations of the
`
`invention is present in an amount effective to propel the
`
`formulation from a metered-dose inhaler. Typically the
`
`propellant constitutes the remainder of the weight of the
`
`35
`
`formulation once the drug and the optional ethanol and
`
`oleic acid are accounted for. Accordingly the propellant
`
`is generally present in an amount of at least about 85
`
`percent by weight based on the total weight of the
`
`formulation.
`
`The propellant comprises 1,1,1,2,3.3.3-
`
`
`
`REPLACEMENT MYLAN EX. 1003, Page 4
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`REPLACEMENT MYLAN Ex. 1003, Page 4
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`

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`
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`-4-
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`heptafluoropropane, preferably as substantially the only
`
`propellant.
`
`However, one or more other propellants such as
`
`propellant 142b (1-chloro-1,1-difluoroathone), HFC—134a,
`
`and the like can be used, preferably in formulations of the
`
`invention containing ethanol.
`Preferred formulations of the invention exhibit
`
`substantially no growth in particle size or change in
`
`crystal morphology of the pirbuterol acetate over a
`
`prolonged period, are substantially and readily
`
`redispersible, and upon redispersion do not flocculate so
`
`quickly as to prevent reproducible dosing of pirbuterol
`acetate.
`
`The suspension aerosol formulations of this
`
`invention can be prepared by combining the drug and the
`
`propellant and then dispersing the drug in the propellant
`
`using a conventional mixer or homogenizer. Pirbuterol
`
`acetate is somewhat soluble in ethanol alone. Accordingly,
`
`when oleic acid and/or ethanol are included in the
`
`formulation, it is preferred that the drug be first placed
`
`in an aerosol vial.
`
`A mixture of the propellant, oleic
`
`acid and/or ethanol can then be added, and the drug
`
`dispersed in the mixture.
`
`If desired, bulk formulation may
`
`be transferred to smaller individual aerosol vials by using
`
`10
`
`15
`
`20
`
`valve to valve transfer methods or by using conventional
`cold—£il1 methods.
`
`25
`
`In order to effect bronchodilation the
`
`formulations of the invention can be delivered to the lung
`
`by inhalation (e.g., oral or nasal) using conventional
`
`30
`
`inhalers (a.q., metered-dosed inhalers comprising an
`aerosol vial equipped with a metered—dose valve).
`
`The following examples are provided to illustrate
`
`I
`
`I
`
`the invention but should not be construed as limiting the
`
`1% 1/?‘
`
`35
`
`invention. The respirable fraction is determined using the
`test method described below.
`
`b t
`
`‘\
`
`|“'1
`
`I
`
`O
`
`Respirable Fraction
`
`In this assay the respirable fraction (the
`
`percent of particles having an aerodynamic particle size of
`
`less than 4.7 microns) at the aerosol suspension is
`
`REPLACEMENT MYLAN EX. 1003, Page 5
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`REPLACEMENT MYLAN Ex. 1003, Page 5
`
`

`
`
`
`determined using an Anderson Cascade Impactor (available
`
`from Anderson Sampler Inc,; Atlanta, GA).
`
`The aerosol vial to be tested is primed five
`A
`times. The valve and valve stem are then cleaned with
`
`methanol and dried with compressed air. The aerosol vial
`
`and a clean, dry actuator are coupled to the glass throat
`
`attached to the top of the impactor using an appropriate
`
`firing adaptor. The calibrated vacuum pump (28.3 L/min)
`
`attached to the cascade impactor is turned on. A total of
`
`20 sprays is delivered into the cascade impactor by
`
`repeatedly shaking the vial, seating it in the actuator and
`
`immediately delivering a single spray. The time between
`
`sprays is approximately 30 seconds. The cascade impactor is
`
`disassembled and each component is rinsed separately with
`
`diluent
`
`(55 parts methanol mixed with 45 parts 0.1%
`
`phosphoric acid, v/v). Each solution is analyzed for
`
`pirbuterol acetate content using high performance liquid
`
`chromatography. The respirable fraction is calculated as
`follows:
`
`% respirable = gggg recovered from plates 3-7
`
`‘
`
`X
`
`100
`
`total drug
`
`-
`
`drug recovered from
`recovered actuator and valve
`
`Example 1
`
`A 1.35 g portion of micronized pirbuterol
`
`acetate, 15.0 q of ethanol and 30 mL of glass beads were
`
`placed in a 4 ounce glass aerosol vial. The vial was sealed
`
`with a continuous valve, pressure filled with approximately
`
`133 g of 1,1,1,2,3,3,3-heptafluoropropane and then shaken
`
`.on a paint shaker for 10 minutes. The resulting formulation
`
`contained 0.9 percent by weight of pirbuterol acetate and
`
`10.0 percent by weight of ethanol. The dispersion was
`transferred into 10 mL aerosol vials which were sealed with
`
`25 pL Spraymiser““ Aerosol Valves (available from Neotechnic
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`Engineering Ltd.).
`
`This formulation was tested for its ability to
`
`deliver a consistent dose throughout the "life" of the
`
`aerosol by determining the amount of pirbuterol acetate
`
`delivered per shot for shots 1, 2, 101, 102, 201, 202, 301
`
`REPLACEMENT MYLAN EX. 1003, Page 6
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`REPLACEMENT MYLAN Ex. 1003, Page 6
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`

`
`
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`-5-
`
`and 302. The amount delivered per shot was determined using
`
`the assay described below. The results are shown in Table
`1.
`
`A firing disk was placed in a 100 mL beaker and
`
`submerged in about 30 mL of diluent
`
`(55 parts methanol] 45
`
`parts 0.1% phosphoric acid, v/v). The vial was shaken,
`
`inserted into the firing disk, and actuated. The valve and
`valve stem were rinsed into the beaker with additional
`
`10
`
`diluent. The solution in the beaker was quantitatively
`transferred to a 100 mL volumetric flask which was then
`
`brought to volume with additional diluent. The amount of
`
`pirbuterol acetate in the solution was determined using
`
`high performance liquid chromatography.
`
`Ia2ls_;
`
`yg Pirbuterol Acetate
`
`1 A
`
`2'
`
` ;'3o2
`
`371.5
`
`357.8
`
`IE
`
`193.4
`
`A 11.7 9 portion of pirbuterol acetate was placed
`
`ggample 2
`
`in a beaker then chilled in a dry
`
`ice/trichlorofluoromethane bath. A portion of prechilled
`
`1,1,1,2,3,3,3-heptafluoropropane was added to the beaker
`
`and the resulting slurry was mixed at high speed with a
`
`Virtix 45 mixer for at least 3 minutes. The dispersed
`
`concentrate was then transferred to a glass bottle and
`
`REPLACEMENT MYLAN EX. 1003, Page 7
`
`15
`
`20
`
`25
`
`30
`
`I
`
`0 2.
`
`-
`
`’.‘s
`
`\
`
`0
`
`I
`
`v
`
`‘i
`
`i
`
`REPLACEMENT MYLAN Ex. 1003, Page 7
`
`

`
`I
`."' h
`'
`
`-
`
`enough prechilled 1,1,1,2,3,3,3-heptafluropropane was added
`
`to bring the total net content weight to 1300 g. The
`
`resulting formulation contained 0.9 percent by weight of
`
`pirbuterol acetate. The formulation was transferred to a
`
`cold filling system and filled into 10 mL aluminum aerosol
`
`vials which were then sealed with 25 pL valves.
`
`Ezsmnlslz
`A 11.7 g portion of micronized pirbuterol
`acetate, 3.0 g of oleic acid and 60 g of ethanol were
`placed in a beaker and homogenized for at least 3 minutes."
`
`10
`
`The resulting slurry was transferred to a tared glass
`bottle and enough ethanol was added to bring the total
`weight of the concentrate to 144.7 g. The concentrate was
`
`15
`
`chilled then placed along with 1155 g of prechilled
`
`1,1,1,2,3,3,3-heptafluoropropane into a prechilled cold
`
`filling system. The formulation was filled into 10 mL
`
`aluminum aerosol vials which were then sealed with 25 pL
`
`Spraymiser”“ valves. The resulting formulation contained
`
`20
`
`0.90 percent by weight of pirbuterol acetate, 0.23 percent
`
`'
`
`by weight of oleic acid and 10.0 percent by weight of
`ethanol.
`
`. ‘
`
`‘
`
`25
`
`Example 4
`A 1.35 g portion of micronized pirbuterol acetate
`
`and 25 mL of glass beads were placed in a 4 ounce glass
`
`aerosol vial. The vial was sealed with a continuous valve,
`
`“ ‘
`
`pressure filled with approximately 150 g of 1,1,1,2,3,3,3-
`‘W heptafluoropropane and then shaken for at least 10 minutes
`
`.
`
`30
`
`on an automatic shaker. The resulting formulation contained
`
`_ .--
`
`.
`
`0.9 percent by weight of pirbuterol acetate. The vial was
`
`then charged with 150 psi nitrogen to aid in product
`transfer to smaller vials. The formulation was transferred
`
`to 10 mL aluminum aerosol vials sealed with continuous
`
`"
`
`35
`
`1.}:
`a;;
`
`valves by using a valve to valve transfer button. The vials
`were then chilled in dry ice then the continuous valves
`
`were removed and the vials sealed with 25 uL metering
`
`valves. Using the method described above,
`
`the respirable
`
`fraction was determined in duplicate for two separate
`
`’
`
`REPLACEMENT MYLAN EX. 1003, Page 8
`
` ‘ -
`
`-
`
`-
`
`a
`
`Q
`
`Q
`
`Q"
`
`Q
`
`Q
`
`Q
`
`Q
`
`Q
`
`Q
`
`Q
`
`q
`
`REPLACEMENT MYLAN Ex. 1003, Page 8
`
`

`
`
`
`-3-
`
`vials. Values of 59.1% and 54.8% were obtained for vial 1.
`
`Values of 53.9% and 49.3% were obtained for vial 2.
`
`Example;
`
`A 1.35 g portion of micronized pirbuterol
`
`acetate, 15.0 g of ethanol and 25 mL of glass beads were
`
`placed in a 4 ounce glass aerosol vial.
`
`The vial was
`
`sealed with a continuous valve, pressure filled with
`
`10
`
`approximately 134 g of 1,1,1,2,3,3,3-heptafluoropropane and
`then shaken on an automatic shaker for at least 10 minutes.
`
`The resulting formulation contained 0.9 percent by weight
`
`of pirbuterol acetate and 10 percent by weight of ethanol.
`Individual 10 mL aerosol vials were filled and sealed with
`
`25 uL metering valves using the method described in Example
`
`15
`
`4. Using the test method described above,
`
`the respirable
`
`fraction was determined in duplicate for two separate
`vials. Values of 34.9% and 32.5% were obtained for vial 1.
`
`values of 31.7% and 31.3% were obtained for vial 2.
`
`‘-F‘
`
`'....I._4
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`REPLACEMENT MYLAN EX. 1003, Page 9
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`REPLACEMENT MYLAN Ex. 1003, Page 9
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`

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` .___.__..._.._*._..._._ ._...-._........j_..___.__-._._...
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`.I;| l
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`._. -‘-.'|
`‘J
`
`I
`
`
`
`
`.
`
`WHAT IS CLAIMED IS:
`
`DOCKET NUMBER:
`
`47983USA7A
`
`
`
`1.
`
`A suspension aerosol formulation comprising
`
`
`
`
`
`
`
`
`"
`
`‘
`
`5
`
`a therapeutically effective amount of micronized pirbuterol
`
`acetate and a propellant comprising 1,l,1,2,3,3,3-
`
`heptafluoropropane,
`
`the formulation being further
`
`I.
`
`characterized in that it is substantially free of
`perfluorinated surfactant.
`
`
`
`
`
`
`
`
`
`I
`
`A formulation according to Claim 1,
`2.
`containing about 0.4 to about 1.0 percent by weight of
`pirbuterol acetate .
`
`15
`
`3.
`
`A formulation according to Claim 1,
`
`
`
`
`
`
`
`
`
`-
`
`containing about 0.45 to about 0.9 percent by weight
`
`pirbuterol acetate.
`
`20
`
`1,1,1,2,3,3,3-heptafluoropropane is substantially the only
`
`‘
`
`propellant.
`
`‘
`
`4.
`
`A formulation according to Claim 1, wherein
`
`. .
`
`5.
`A formulation according to Claim 4,
`substantially free of ethanol.
`
`6.
`
`A formulation according to claim 1, further
`
`comprising about 0.1 to about 12 percent by weight ethanol.
`
`30
`
`comprising about 5 to about 12 percent by weight ethanol.
`
`7.
`
`A formulation according to Claim 1 further
`
`5 "
`
`“ E
`
`L.
`‘
`
`35
`
`8.
`
`A formulation according to Claim 6, further
`
`comprising about 0.01 to about 0.5 percent by weight oleic
`acid.
`
`A formulation according to Claim 1,
`9.
`consisting essentially of 1,1,1,2,3,3,3-heptafluoropropane
`
`.
`
`and a therapeutically effective amount of pirbuterol
`acetate.
`
`REPLACEMENT MYLAN EX. 1003, Page 10
`
`
`
`REPLACEMENT MYLAN Ex. 1003, Page 1
`
`0
`
`

`
`
`
`-10-
`
`*”‘
`
`*
`
`‘
`
`
`
`A formulation according to Claim 3, wherein
`10.
`the pirbuterol acetate is present
`in an amount of about 0.4
`
`'
`
`5
`
`11.
`
`A formulation according to Claim—4,
`
`consisting essentially of a therapeutically effective
`
`
`
`
`
`
`
`
`
`
`to about 1.0 percent by weight.
`
`
`
`
`
`
`
`
`amount of pirbuterol acetate, about 5 to about 12 percent
`
`by weight ethanol, and 1,1,1,2,3,3,3—heptaf1uoropropane.
`
`
`
`.""
`
`10
`
`
`
`
`
`
`according to Claim 1 effective to induce bronchodilation.
`
`A method for inducing bronchodilation in a
`12.
`mammal, comprising the step of administering by inhalation’
`to the lung of the mammal an amount of a formulation
`
`Ill
`
`‘
`
`15
`
`13.
`
`A method of preparing a formulation
`/
`according to Claim 1" comprising the steps of:
`(i)
`combining the micronized pirbuterol acetate
`with the propellant; and
`
`
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`20 propellant.. .. '
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`A formulation according to claim 1 in an
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`(ii) dispersing the pirbuterol acetate in the
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`47983USA7A
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`DOCKET NUMBER:
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`Prarmaceutical suspension aerosol formulations
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`comprising a therapeutically effective amount of pirbuterol
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`acetate and a propellant comprising 1,1,1,2,3,3,3-
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` ff" Afl§_T_BAQI
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`heptafluoropropane.
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`The formulations optionally contain
`Also disclosed is a method of
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`oleic acid and/or ethanol.
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`10
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`preparing said formulations and a method of inducing
`bronchodilation in a mammal.
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` Docket No. 47983U$/\7A
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`OATH. POWER OF ATTORNEY, AND . ETITION
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`respective residences. citizerishipe, and mailing addresses are indicated below; (2) we have reviewed and
`understand the contents of our patent application, ..icluding the claims. as amended by any amendment
`specifically referred to herein. which is identified as US. Patent Application Serial No. 07/810.-40!. filed
`December 18. 1991; (3) we verily believe that we are the original, first. and joint inventors or discoverers
`of the invention or discovery in
`PIRBUTEROL SUSPENSION AEROSOL FORMULATIONS
`described and claimed therein and for which it patent is sought; and (4) we hereby ackntmlcdge our duty
`to disclose to the Patent and Traderriarlt Office information we are aware of which is iriaicnal
`to the
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`C4"\
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`mination of this application in accordance with Title 37, Code of Federal Regulations. §l.56(a)'.
`We hereby appoint Gary L. Griswold (Reg. No. _2_5.396), Walter N. Kirn (Reg. No._2_lJ_9_6;.
`Roger R. Tanite (Reg. No._2l.O93), Warren R. Bovee (Reg. No. 16,434), Gerald F. Chemivec (Reg. No.
`262531). Carolyn A. Bates (Reg. No. 27,853), John C. Barnes (Reg. No. 20,278). and Douglas E. Reedicli
`(Reg. No. 13.299) our attorney! with full power: (including the powers of appointment. substitution. and
`revocation) to prosecute this application and any division, continuation. continuation-in-part. reexamination.
`or reissue thereof. and to transact all business in the Patent and Trademark Office connected therewith; the
`mailing address and the telephone number of the above-mentioned attorneys are
`Attention: Douglas E. Reedich
`3M Office of Intellectual Property Counsel
`iz.o. Box my
`5! _l';=_\»_|L_l*:f_i.r1.n;s-;.t.a_55t_33.:.3;t2.7
`Telephone No. (612) 733-1500
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`Wherefore. we pray that Letters Patent be granted to its for the invention or discovery described
`and claimed in the aforementioned specification and we hereby subscribe our names tpfltihe foregoing
`ification and claims
`oath. power of attorney, and this petition,
`this 25
`day of
`@ . 19
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`/ '61
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`;«
`.1 ///2.x /
`/
`l1ol3e_rt l(_. S_§hultz
`City of Shoreview, County of Ramsey,
`State of Minnesota
`N ’V
`Citizenship: United States of America
`Post Office
`P.O. Box 33427
`Address:
`St. Paul. Minnesota 55133-3427
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`STATE OF MINNESOTA
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`COUNTY OF RAMSEY
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`Before me personally appeared Robert K. Schultz. to me known to be the person described in the
`above application for patent. who signed the foregoing instrument in my presence, and made oath before
`me to the allegations set forth therein as being under oath, on the day and year aforesaid.
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`‘
`£—|£NNE$O
`{gs gmnPhiSC1-lNElDE;lA
`WASHINGTUG COUNTY
`J?
`W comm trout In II. it
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` I
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`(54381)
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`Z’
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`"Title 37. Code of Federal Regulations. §l.56(a) ia reproduced on the hi page of this form
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`Notary Puhiic
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`O-PF-SN.lnt-$0191
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`1..., 1
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`Wherefore. we pray that Letters Patent be granted to us for the invention or dist-nv-.-ry described
`and claimed in the aforementioned specification and we hereby subscribe our names to the foregoing
`specification and claims. oath, power of attorney, and this petition.
`this
`~' n
`day of
`5.»,
`.i9'/.-'
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`Docket No. 47983 L'SA7A
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`Robert A. Moria
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`Residence:
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`City of Lino Lakes. County of Anoka.
`State of Minnesota
`Citizenship: United States of America
`Post Office PO. Box 33427
`Address:
`St. Paul. Minnesota S5133-3427
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`STATE OF MINNESOTA
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`COUNTY OF RAMSEY
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`Before me personally appeared Robert A. Moris. to me known to be the person described in the
`above application for patent. who signed the foregoing instrument in my presence. and made oath before
`me to the allegations set forth therein as being under oath, on the day and year aforesaid.
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`DMNN L. SC}-lNElDER
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`mm rwuc-unutsou
`wwuucrou CIIJNTY
`Iycau Lu: May is 19!?
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`%
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`6Ll/Z/
`Notary Public
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`‘$1.56 Duty of diaeloum fraud; striking or rejection of application.
`(a) A duty of candor and good faith toward the Patett and Tr-adenurk Office run on the inventor. on each attorney or agent who
`pnwons or proaaeutea the application and on every other individual who ia nthatantively involved in the preparation or pros::u'.ion
`of Ike application and who in aaaocialed with me invctlor. with the aaaignee or with anyone to whom there in an obligation to Iiilgfi
`the application. All auch
`have a duty to diaclonue to the Office information they are aware of which is material ta the
`examination of the application. Such information it material when then in aubnantial likelihood that a reasonable examiner would
`eouidet it irwodaal in deciding wtaechu to allow the application to ianaa aa a patent. ‘me duty is commensurate \IIi|.h the aggm or
`involveauaatiabepmparatéoaorproaaczatinaofitiis
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`In
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`a
`NF 3
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