SIN 13/509,873
`
`PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`First Inventor:
`
`Bathe
`
`Serial No.:
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`Filed:
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`13/509,873
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`Jan 6, 2011
`
`Examiner
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`Tsai, Michael Jasper
`
`Group Art Unit
`
`3771
`
`Docket No.:
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`3000-US-0026
`
`Confirmation No.:
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`8620
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`Title:
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`Gas Delivery Device And System
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`AMENDMENTIRESPONSE UNDER 37 C.F.R. § 1.111
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`This paper is being submitted in response to the Office Action dated March 15, 2013, in
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`the above-identified patent application. The USPTO was closed on Saturday, June 15,2013 and
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`Sunday, June 16, 2013. Accordingly, the three month period for reply to the Office Action
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`expires on Monday, June 17,2013 and this paper is being timely filed.
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`Amendments to the specification begin on page 2.
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`Amendments to the drawings begin on page 3.
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`Amendments to the claims begin on page 4.
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`Remarks begin on page 8.
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`Page 1 of 12
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`INO THERAPEUTICS EXHIBIT 2005
`Praxair Distribution v. INO Therapeutics
`IPR2015-00891
`
`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`IN THE SPECIFICATION
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`Please replace paragraph [0005] on pages 1-2 with the following paragraph:
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`[0005]
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`Aspects of the present invention pertain to a gas delivery device that may be
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`utilized with a gas delivery system and methods for administering therapy gas to a patient. One
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`or more embodiments of the gas delivery devices described herein may include a valve and a
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`circuit with a valve memory in communication with a valve processor and a valve transceiver.
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`One or more embodiments of the gas delivery systems described herein incorporate the gas
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`delivery devices described herein with a control module including a control central processing
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`unit (CPU) in communication with a CPU memory and CPU transceiver. As will be described
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`herein, the valve transceiver and the CPU transceiver may be in communication such that
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`information or data from the valve memory and the CPU memory may be communicated to one
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`another. The information communicated between the valve memory and the CPU memory may
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`be utilized for selecting a therapy for delivery to a patient and controlling delivery of the selected
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`therapy to the patient. The gas delivery devices and systems described herein may be utilized
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`with medical devices such as ventilators and the like to delivery gas to a patient.
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`Page 2 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`Please replace sheets I of the drawings with the Replacement Sheet filed herewith.
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`IN THE DRAWINGS
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`Page 3 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`IN THE CLAIMS
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`(Canceled)
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`(Currently Amended) A gas delivery device to administer therapy gas from a gas source,
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`1.
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`2.
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`the gas delivery device comprising:
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`a valve attachable to the gas source, the valve including an inlet and an outlet in fluid
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`communication and a valve actuator to open or close the valve to allow the gas through the valve
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`to a control module; and
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`a circuit including:
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`memory to store gas data compnsmg one or more of gas identification, gas
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`expiration date and gas concentration and
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`a processor and a transceiver in communication with the memory to send and
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`receive wireless optical line-of-sight signals to communicate the gas data to the control
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`module that controls gas delivery to a subject and to verify one or more of the correct gas,
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`the correct gas concentration and that the gas is not expired,
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`wherein the valve further comprises a data input in communication with said memory, to
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`permit a user to enter the gas data into the memory.
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`3.
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`(Original) The device of claim 2, wherein the gas data is provided in a bar code disposed
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`on the gas source and is entered into the data input by a user-operated scanning device in
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`communication with the data input.
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`4.
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`(Currently Amended) A gas delivery device to administer therapy gas from a gas source,
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`the gas delivery device comprising:
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`a valve attachable to the gas source, the valve including an inlet and an outlet in fluid
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`communication and a valve actuator to open or close the valve to allow the gas through the valve
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`to a control module; and
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`a circuit including:
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`memory to store gas data compnsmg one or more of gas identification, gas
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`expiration date and gas concentration and
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`Page 4 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`a processor and a transceiver in communication with the memory to send and
`
`receive wireless optical line-of-sight signals to communicate the gas data to the control
`
`module that controls gas delivery to a subject and to verify one or more of the correct gas,
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`the correct gas concentration and that the gas is not expired,
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`wherein the valve comprises a power source; and the transceiver periodically sends the
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`wireless opticalline-of-sight signals to the control module, wherein the signals are interrupted by
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`a duration of time at which no signal is sent.
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`5.
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`(Original) The device of claim 4, wherein the duration of time at which no signal is sent
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`comprises about 10 seconds.
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`6.
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`7.
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`(Canceled)
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`(Currently Amended) A gas delivery system comprising:
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`a gas delivery device to administer therapy gas from a gas source, the gas delivery device
`
`compnsmg:
`
`a valve attachable to the gas source, the valve including an inlet and an outlet in
`
`fluid communication and a valve actuator to open or close the valve to allow the gas
`
`through the valve to a control module that controls gas delivery to a subject; and
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`a circuit including:
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`memory to store gas data comprising one or more of gas identification, gas
`
`expiration date and gas concentration and
`
`a processor and a transceiver in communication with the memory to send
`
`and receive wireless optical line-of-sight signals to communicate the gas data to
`
`the control module that controls gas deliyery to a subject and to verify one or
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`more of the correct gas, the correct gas concentration and that the gas is not
`
`expired; and
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`a the control module, wherein the control module is in fluid communication with the
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`outlet of the valve and a ventilator, 'vvherein and the control module comprises:
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`a CPU transceiver to receive line-of-sight signals from the transceiver; and
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`Page 5 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`a central processing unit (CPU} in communication with the CPU transceiver and
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`including a CPU memory,
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`wherein the transceiver communicates the gas data to the CPU transceiver for storage in
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`the CPU memory, and
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`wherein the valve compnses a timer including a calendar timer and an event timer,
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`wherein the memory stores the date and time of opening and closing of the valve and the
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`duration of time that the valve is open and the transceiver communicates the date and time of
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`opening and closing of the valve to the CPU transceiver for storage in the CPU memory.
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`8.
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`9.
`
`(Canceled)
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`(Currently Amended) A gas delivery system comprising:
`
`a gas delivery device to administer therapy gas from a gas source, the gas delivery device
`
`compnsmg:
`
`a valve attachable to the gas source, the valve including an inlet and an outlet in
`
`fluid communication and a valve actuator to open or close the valve to allow the gas
`
`through the valve to a control module that control gas delivery to a subject; and
`
`a circuit including:
`
`memory to store gas data comprising one or more of gas identification, gas
`
`expiration date and gas concentration and
`
`a processor and a transceiver in communication with the memory to send
`
`and receive wireless optical line-of-sight signals to communicate the gas data to
`
`the control module that controls gas delivery to a subject and to verify one or
`
`more of the correct gas, the correct gas concentration and that the gas is not
`
`expired; and
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`ft the control module, wherein the control module is in fluid communication with the
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`outlet of the valve and a ventilator, wherein and the control module comprises:
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`a CPU transceiver to receive line-of-sight signals from the transceiver; and
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`a central processing unit (CPU} in communication with the CPU transceiver and
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`including a CPU memory,
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`Page 6 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`wherein the transceiver communicates the gas data to the CPU transceiver for storage in
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`the CPU memory,
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`wherein the control module further comprises an input means to enter patient information
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`into the CPU memory; and a display, and
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`wherein the CPU compares the patient information entered into the CPU memory via the
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`input means and the gas data from the transceiver.
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`10.
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`(Original) The system of claim 9, wherein the CPU comprises an alarm that is triggered
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`when the patient information entered into the CPU memory and the gas data from the transceiver
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`do not match.
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`11. - 18.
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`(Canceled)
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`Page 7 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`REMARKS
`
`Telephone Interview Summary
`
`As a preliminary matter, Applicants would like to thank Examiner Michael Tsai and SPE
`
`Justine Yu for the courtesy of their time on May 14,2013 to discuss the Non-Final Office Action
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`with Applicants' representatives Rory Alegria, the undersigned, and Erika Senska, in-house
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`counsel for the assignee. The §§ 102, 103 and 112 and double patenting rejections were
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`discussed. It was agreed that amending the second instance of "a control module" to "the control
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`module" in claims 7 and 9 would overcome the § 112 rejection.
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`It was also agreed that an
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`amendment to claims 2, 4, 7 and 9 that specified that the processor and transceiver III
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`communication with the memory send and receive wireless optical line-of-sight signals to
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`communicate the gas data to the control module that controls gas delivery to a subject and to
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`verify one or more of the correct gas, the correct gas concentration and that the gas is not
`
`expired, would overcome the present §§ 102 and 103 rejections based on U.S. 7,114,510
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`(Peters). Applicants also agreed to file a terminal disclaimer to overcome the double patenting
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`rejection based on U.S. 8,291,904.
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`The objection to the drawings was also discussed, and Applicants provided a proposed
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`Replacement Sheet. The Examiner requested that in addition to the labeling of boxes 210, 212
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`and 260 as shown in the original proposed Replacement Sheet, the unlabeled rectangular box in
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`FIG. 1 should be removed. The Replacement Sheet filed herewith reflects the requested labeling
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`and removal of the unlabeled box above the CPU 210.
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`Applicants respectfully assert that, in view of the following, this case is in condition for
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`allowance. If the Examiner wishes to further discuss this application, he is invited to contact the
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`undersigned.
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`Status of Claims
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`Claims 2-5, 7, 9 and 10 are pending in the application. Claims 2-5, 7, 9 and 10 are
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`rejected. No claims are allowed.
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`Claims 2, 4, 7 and 9 have been amended to more clearly describe and distinctly claim the
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`subject matter the Applicants consider their invention. Specifically, claims 2, 4 7 and 9 have
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`been amended to recite that the processor and transceiver send and receive wireless signals to
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`communicate gas data the control module and to verify one or more of the correct gas, the
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`Page 8 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`correct gas concentration and that the gas is not expired. Claims 7 and 9 have also been
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`amended to specify that the CPU acronym represents a central processing unit and have clarified
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`the language regarding the control module. Support for the amendments can be found at least in
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`paragraphs [0005] and [0056] of the as-filed specification. No new matter has been added by
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`this amendment.
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`Amendments to the Specification
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`Applicants request entry of the amendments to the specification to correct a typographical
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`error in paragraph [0005]. Applicants submit that one of ordinary skill in the art would readily
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`understand that the acronym CPU stands for "central processing unit" and not "control
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`processing unit."
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`Objections to the Drawings
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`The drawings have been amended to include legends and remove the unlabeled box as
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`requested by the Examiner and Applicants respectfully request withdrawal of this objection.
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`Claim Rejections - 35 U.S.C. § 112
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`Claims 7, 9, and 10 are rejected under 35 U.S.c. 112, second paragraph, as being
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`indefinite for failing to particularly point out and distinctly claim the subject matter which
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`applicant regards as the invention. Applicants submit that the amendments to claims 7 and 9
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`correct any alleged deficiencies and request that the rejection be withdrawn.
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`Double Patenting
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`Claims 2-5, 7, 9 and 10 are rejected as allegedly unpatentable over claims 1-7 of U.S.
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`Patent No. 8,291,904 (the '904 patent) for obviousness-type double patenting. While Applicants
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`do not necessarily agree with this conclusion, in the interest of furthering prosecution, Applicants
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`submit a terminal disclaimer herewith and request that the rejection be withdrawn.
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`Claim Rejections - 35 U.S.C. § 102
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`Claims 2 and 4 are rejected under 35 U.S.c. 102(b) as being anticipated by Peters et al.
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`Page 9 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`(7,114,510). Applicants respectfully traverse this basis for rejection.
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`Peters is directed to a valve with a smart handle including a memory module to log data
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`relevant to gas usage. See Peters at abstract. Essentially, the device of Peters measures how
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`long the valve is open to determine the treatment time and records other information relevant to
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`gas usage, which hospitals and clinics can use to bill individual patients according to their
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`specific usage. See Peters at col. 1, lines 34-42. Notably, the valve does not comprise a
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`processor and transceiver that communicate gas data to the control module that controls gas
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`delivery to a subject. Instead, the valve memory of Peters only stores information that is relevant
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`to billing, tracking inventory or other record-keeping functions. The Peters device stores the
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`information in the memory device until the information is transferred through the use of a PIR-2
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`reader, a wand reader 44, or through directly from a port 22' on the handle 16 to a printer. See
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`Peters at col. 6, lines 37-57. Alternatively, a transmitter may be used to transmit the information
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`to a "main computer." See Peters at col. 7, lines 1-15. However, the "main computer" is not the
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`delivery device to which the outlet port 20 connects. See Peters at col. 6, lines 18-21. The main
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`computer "uses the data that has been collected to generate reports, to track treatments, do
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`billings, and to control inventory," (see col. 7, 9-12), whereas the delivery device "is used to
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`adjust the concentration and flow rate or to mix gases administered to the patient" (see col. 6,
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`lines 18-21). Accordingly, Peters does not disclose a gas delivery device in which a valve
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`transceiver sends wireless optical line-of-sight signals to communicate the gas data to the
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`control module that actually delivers the gas to the patient.
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`There is also no indication that the "transmitter" of Peters can receive wireless signals
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`from a control module. The Peters device also does not verify one or more of the correct gas, the
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`correct gas concentrations and that the gas is not expired.
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`Accordingly, as Peters does not disclose all of the limitations of claims 2 and 4,
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`Applicants submit that these claims are novel over Peters.
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`Claim Rejections - 35 U.S.C. § 103
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`Claim 5
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`Claim 5 is rejected under 35 U.S.c. 103(a) as being unpatentable over Peters et al.
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`(7,114,510). Applicants respectfully traverse this basis for rejection.
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`Page 10 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Docket:3000-US-0026
`
`As described above, Peters does not disclose a gas delivery device comprising a valve
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`with a processor and a transceiver in communication with the memory to send and receive
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`wireless optical line-of-sight signals to communicate the gas data to the control module that
`
`controls gas delivery to a subject and to verify one or more of the correct gas, the correct gas
`
`concentration and that the gas is not expired. Indeed, these safety features are not relevant to the
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`billing, inventory tracking or other record-keeping functions of the Peters device. Furthermore,
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`as Peters relates to sending information regarding inventory and billing, there is no need to send
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`a signal as frequently as the device claimed in claim 5.
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`Instead, billing information can be
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`updated on a periodic basis (such as every day, week, or month), but there is simply no reason to
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`update billing information more frequently than one would actually send out bills. In contrast,
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`the claimed frequency of communication helps continue communication between the valve and
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`the gas delivery device without continuously sending out signals and draining the valve power
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`source. See specification at <JI [0041].
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`Accordingly, Applicants submit that Peters does not teach or suggest all of the claimed
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`features and that claim 5 is patentable as nonobvious over Peters.
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`Claims 3 and 7
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`Claims 3 and 7 are rejected under 35 U.S.c. 103(a) as being unpatentable over Peters et
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`al. (7,114,510) as applied to claim 2 above, and in further view of Zaitsu et al. (2002/0013551 ).
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`Applicants respectfully traverse this basis for rejection.
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`Zaitsu is directed to a medical pump monitor system for administering medical fluids
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`usmg a plurality of medical pumps and managing information of these medical pumps. See
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`Zaitsu abstract and <JI 1. Zaitsu is not directed to delivery of a medical gas. Accordingly, Zaitsu
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`does not disclose a control module as claimed because the controller of Zaitsu does not deliver a
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`gas to a patient. Zaitsu also fails to disclose sending and receiving wireless signals to
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`communicate gas data comprising one or more of gas identification, gas expiration date and gas
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`concentration to a control module and to verify one or more of the correct gas, the correct gas
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`concentration and that the gas is not expired. As such, Zaitsu does not remedy the deficiencies
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`of Peters described above and claims 3 and 7 are not obvious the combination of Peters and
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`Zaitsu.
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`Page 11 of 12
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`

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`AMENDMENT / RESPONSE UNDER 37 CFR § 1.111
`Serial Number: 13/509,873
`Filing Date: Jan 6, 2011
`Title: Gas Delivery Device And System
`
`Claims 9 and 10
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`Docket:3000-US-0026
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`Claims 9 and 10 are rejected under 35 U.S.c. 103(a) as being unpatentable over Peters et
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`al. (7,114,510) in view of Zaitsu et al. (2002/00l3551) as applied to claim 7 above, and in further
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`view of Rice et al. (7,980,245). Applicants respectfully traverse this basis for rejection.
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`Rice relates to an optimized system for providing medical support to a patient. See Rice
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`at abstract. Rice does not cure any of the deficiencies of Peters and Zaitsu noted above.
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`Specifically, Rice does not disclose a gas delivery device comprising a valve with a processor
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`and a transceiver in communication with the memory to send and receive wireless optical line(cid:173)
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`of-sight signals to communicate the gas data to the control module that controls gas delivery to a
`
`subject and to verify one or more of the correct gas, the correct gas concentration and that the gas
`
`is not expired. Rice also fails to disclose comparing the patient data to the gas data from the
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`transceiver. Accordingly, the combination of Peters, Zaitsu and Rice does not disclose, teach or
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`suggest all of limitations of claims 9 and 10, and these claims are not obvious over the cited
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`references.
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`CONCLUSION
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`It is believed that claims 2-5, 7, 9 and 10 are now in condition for allowance, early notice
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`of which would be appreciated. No fees are believed due with this submission.
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`If any fees are
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`due at this time, the Commissioner is authorized to charge Deposit Account No. 50-3329. Please
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`contact the undersigned if any further issues remain to be addressed in connection with this
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`submission.
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`Dated: June 17, 2013
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`Telephone: (732) 815-0404
`Attorney for Applicant
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`Respectfully submitted,
`
`By: IRory P. Alegria, Reg. #66,9471
`Rory P. Alegria
`Reg. No. 66,947
`Servilla Whitney LLC
`33 Wood Ave S
`Second Floor, Suite 210
`Iselin, NJ 08830
`
`Page 12 of 12