DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed on July 23, 2025 has been received and considered. By this amendment, claims 4-7 are amended, claims 19-25 are added, and claims 1-25 now pending in the application, with claims 8-18 withdrawn from further consideration as being drawn to a non-elected invention.
Note: The claim set submitted on November 25, 2024 included the units “pA” in claims 3 and 7, however the claim sets submitted previously on December 12, 2023 and January 8, 2024, and the current claim set of July 23, 2025 all include the units “µA” for claims 3 and 7. It is believed that the previous units of “pA” were in error.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Libbus (U.S. 2016/0045741, previously cited). Regarding claim 1, Libbus discloses a system 900f for stimulating neural activity in vagal nerves of a patient to treat bronchoconstriction in the patient, the system comprising: at least two transducers 950f-1/950f-2/940f-1/940f-2, one of the at least two transducers configured to be in signaling contact with a nerve on a right side of the patient and the other one of the at least two transducers is configured to be in signaling contact with a nerve on a left side of the patient to provide bilateral stimulation, the at least two transducers configured to be at least partially implanted in the patient (see Figure 9F and paragraph [0088]); and a voltage or current source 920a/f configured to generate electrical signals to be selectively applied to the nerve on the right side of the patient and the nerve on the left side of the patient, via the at least two transducers (see Figure 9F and paragraphs [0075] and [0088]), wherein the signal has a frequency of 50-150 Hz (“For example, the CBS subsystem 1010 may deliver a rectangular pulse stimulation signal at a fixed intensity, e.g., with…a stimulation frequency between approximately 20 Hz and approximately 100 Hz”, paragraph [0078]), and wherein the signal has a pulse duration of between 100 to 250 μsec (“In one embodiment, a pulse width in the range of 100 to 250 μSec”, paragraph [0053]), 250 μsec (“pulse width set at 250 μsec”, paragraph [0065]), or approximately 500 μsec (“For example, the CBS subsystem 1010 may deliver a rectangular pulse stimulation signal at a fixed intensity, e.g., with … a pulse width of approximately 500 μsec.”, paragraph [0078]), such that the electrical signals produce an improvement in a physiological parameter indicative of treating bronchoconstriction in the patient, wherein the system further comprises a detector for detecting the physiological parameter, and wherein the improvement in the physiological parameter is a decrease in airway smooth muscle tone, an increase in blood oxygen saturation, a decrease in blood carbon dioxide concentration, an increase in tidal mid-expiratory flow, a decrease in respiratory rate (“In other embodiments, different patient parameters may be monitored in conjunction with stimulation, including, for example, … non-cardiac parameters such as respiratory rate…Increases and decreases in these patient parameters in response to changes in stimulation intensity may be used to identify the desired physiological response.”, paragraph [0095]), an increase in total lung capacity, or an increase in forced expiration volume, from an initial measurement. Furthermore, Libbus discloses that stimulation parameters may be tailored to the patient’s response to maintain stimulation in the “neural fulcrum zone” (see paragraph [0066]), which is a combination of stimulation parameters at which autonomic engagement is achieved but for which a functional response determined by heart rate change is nullified due to the competing effects of afferently and efferently-transmitted action potentials (see paragraph [0059]). However, Libbus fails to disclose that the signal has a pulse duration of between 0.005 and 0.1 ms, rather only providing this upper limit as the lower limit given in paragraph 53. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Libbus such that the signal has a pulse duration of between 0.005 and 0.1 ms, as it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, the tailoring of the stimulation parameters to optimize stimulation in the neural fulcrum zone would be routine and conventional activity for one of ordinary skill in the art, as set out by Libbus.
Regarding claim 2, Libbus discloses the invention substantially as claimed, including a pulse duration of between 100 to 250 μsec (“In one embodiment, a pulse width in the range of 100 to 250 μSec”, paragraph [0053]), 250 μsec (“pulse width set at 250 μsec”, paragraph [0065]), or approximately 500 μsec (“For example, the CBS subsystem 1010 may deliver a rectangular pulse stimulation signal at a fixed intensity, e.g., with … a pulse width of approximately 500 μsec.”, paragraph [0078]). However, Libbus fails to expressly disclose that the electrical signals have a pulse duration of 0.01- 0.06 ms. Libbus discloses that stimulation parameters may be tailored to the patient’s response to maintain stimulation in the “neural fulcrum zone” (see paragraph [0066]), which is a combination of stimulation parameters at which autonomic engagement is achieved but for which a functional response determined by heart rate change is nullified due to the competing effects of afferently and efferently-transmitted action potentials (see paragraph [0059]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the electrical signals of Libbus to have a pulse duration of 0.01-0.06 ms, as it involves only adjusting the value of a stimulation parameter disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Libbus by making the electrical signals have a pulse duration of 0.01-0.06 ms as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, Libbus that the electrical signals have a current of 0.02 mA to 50 mA (20-50,000 µA) (“delivers between 0.02 mA and 50 mA of output current”, paragraph [0053]) or approximately 0.5 mA to approximately 7.0 mA (500-7000 µA) (“For example, the CBS subsystem 1010 may deliver a rectangular pulse stimulation signal at a fixed intensity, e.g., with … a stimulation amplitude ranging from approximately 0.5 mA to approximately 7.0 mA”, paragraph [0078]). As such, Libbus discloses that the electrical signals have a current of 1-8000 µA.
Regarding claim 4, it is respectfully submitted that the voltage or current source of Libbus is “configured to generate the electrical signals such that the electrical signals are applied only when the physiological parameter meets or exceeds a predefined threshold value” because the voltage or current source of any device is configured to generate signals as defined by the processor or controller of that device. In the same way that Applicant’s controller “causes the transducer or transducers to apply the signal when the physiological parameter is detected to be meeting or exceeding a predefined threshold value” (see Applicant’s disclosure at paragraph [90]), the voltage or current source of Libbus is configured to generate signals based on determinations made by the controller thereof. As such, it is respectfully submitted that Libbus satisfies the broadest reasonable interpretation for claim 4.
Regarding claim 5, it is respectfully submitted that it is inherent that the voltage or current source of Libbus is “configured to generate the electrical signals such that the electrical signals are applied for one or more time periods”, as any electrical signals that are applied will be applied for “one or more” time periods.
Regarding claim 6, it is respectfully submitted that the voltage or current source of Libbus is “configured to generate the electrical signals intermittently, such that the electrical signals are applied for a first time period, stopped for a second time period, reapplied for a third time period, and stopped for a fourth time period” because the voltage or current source of any device is configured to generate signals as defined by the processor or controller of that device. In the same way that Applicant’s controller “causes the signal to be applied intermittently” (see Applicant’s disclosure at paragraph [102]), the voltage or current source of Libbus is configured to generate signals based on determinations made by the controller thereof. As such, it is respectfully submitted that Libbus satisfies the broadest reasonable interpretation for claim 6.
Regarding claim 7, Libbus that the electrical signals have a current of 0.02 mA to 50 mA (20-50,000 µA) (“delivers between 0.02 mA and 50 mA of output current”, paragraph [0053]) or approximately 0.5 mA to approximately 7.0 mA (500-7000 µA) (“For example, the CBS subsystem 1010 may deliver a rectangular pulse stimulation signal at a fixed intensity, e.g., with … a stimulation amplitude ranging from approximately 0.5 mA to approximately 7.0 mA”, paragraph [0078]). As such, Libbus discloses that the electrical signals have a current of 20-1000 µA.
Regarding claim 19, Libbus that the electrical signals have a current of 0.02 mA to 50 mA (20-50,000 µA) (“delivers between 0.02 mA and 50 mA of output current”, paragraph [0053]) or approximately 0.5 mA to approximately 7.0 mA (500-7000 µA) (“For example, the CBS subsystem 1010 may deliver a rectangular pulse stimulation signal at a fixed intensity, e.g., with … a stimulation amplitude ranging from approximately 0.5 mA to approximately 7.0 mA”, paragraph [0078]). As such, Libbus discloses that the electrical signals have a current of 50-250 µA.
Regarding claim 20, it is respectfully submitted that the at least two transducers of Libbus are “configured to selectively apply the electrical signals to the nerve on the right side of the patient and the nerve on the left side of the patient only when the physiological parameter meets or exceeds a predefined threshold value” because the transducers of any device are configured to apply signals as defined by the processor or controller of that device. In the same way that Applicant’s controller “causes the transducer or transducers to apply the signal when the physiological parameter is detected to be meeting or exceeding a predefined threshold value” (see Applicant’s disclosure at paragraph [90]), the transducers of Libbus are configured to generate signals based on determinations made by the controller thereof. As such, it is respectfully submitted that Libbus satisfies the broadest reasonable interpretation for claim 20. Furthermore, Libbus discloses that “the implanted device may be configured to adjust stimulation parameters to maintain stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation” (see paragraph [0066]), where maintaining stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation is considered the selective application of electrical signals when the physiological parameter meets or exceeds a predefined threshold value.
Regarding claim 21, it is respectfully submitted that it is inherent that the at least two transducers of Libbus are “configured to selectively apply the electrical signals to the nerve on the right side of the patient and the nerve on the left side of the patient for one or more time periods”, as any electrical signals that are applied will be applied for “one or more” time periods.
Regarding claim 22, it is respectfully submitted that the at least two transducers of Libbus are “configured to selectively apply the electrical signals to the nerve on the right side of the patient and the nerve on the left side of the patient intermittently, such that the electrical signals are applied for a first time period, stopped for a second time period, reapplied for a third time period, and stopped for a fourth time period” because the transducers of any device are configured to apply signals as defined by the processor or controller of that device. In the same way that Applicant’s controller “causes the signal to be applied intermittently” (see Applicant’s disclosure at paragraph [102]), the at least two transducers of Libbus are configured to generate signals based on determinations made by the controller thereof. As such, it is respectfully submitted that Libbus satisfies the broadest reasonable interpretation for claim 22.
Regarding claim 23, Libbus discloses a controller 1030 coupled to the detector and the at least two transducers (see Figure 10), wherein the controller is configured to generate one or more control signals when the physiological parameter meets or exceeds a predefined threshold value such that the at least two transducers selectively apply the electrical signals to the nerve on the right side of the patient and the nerve on the left side of the patient in response to the one or more control signals (“the implanted device may be configured to adjust stimulation parameters to maintain stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation”, paragraph [0066]), where maintaining stimulation in the neural fulcrum zone based on detected changes in the physiological response to stimulation is considered the selective application of electrical signals when the physiological parameter meets or exceeds a predefined threshold value.
Regarding claim 24, Libbus discloses that the at least two transducers are further configured to selectively apply the electrical signals to the nerve on the right side of the patient and the nerve on the left side of the patient in response to one or more control signals (“the control system is configured to modify a stimulation parameter of the CBS subsystem in response to detected state changes”, paragraph [0009], “logic and control circuitry, including a recordable memory 29 within which the stimulation parameters are stored, that controls overall pulse generator function”, paragraph [0032], and “the control system may configured to activate the VNS subsystem to deliver electrical stimulation with a first stimulation parameter and to activate the CBS subsystem to deliver electrical stimulation with a second stimulation parameter different than the first stimulation parameter”, paragraph [0083]).
Regarding claim 25, Libbus discloses a controller wherein the controller is configured to generate one or more control signals when the physiological parameter meets or exceeds a predefined threshold value such that, in response to the one or more control signals, the at least two transducers selectively apply the electrical signals to the nerve on the right side of the patient and the nerve on the left side of the patient (“the control system may configured to activate the VNS subsystem to deliver electrical stimulation with a first stimulation parameter and to activate the CBS subsystem to deliver electrical stimulation with a second stimulation parameter different than the first stimulation parameter”, paragraph [0083]). Furthermore, Libbus discloses that the stimulation may be delivered intermittently (“Stimulation may be through multimodal application of continuously-cycling, intermittent and periodic electrical stimuli”, paragraph [0029], “The therapeutic doses include a maintenance dose that includes continuously-cycling, intermittent and periodic cycles of electrical stimulation during periods in which the pulse amplitude is greater than 0 mA (“therapy ON”) and during periods in which the pulse amplitude is 0 mA (“therapy OFF”).”, paragraph [0047], and “the output signal for CBS stimulation may have a fixed waveform and intensity delivered intermittently at a high duty cycle 24 hours a day”, paragraph [0079]).
Response to Arguments
Applicant’s arguments, filed July 23, 2025, with respect to the rejection(s) of claim(s) 1 and 4-6 under 35 USC 102(a)(2) as being anticipated by Libbus have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103 as being unpatentable over Libbus.
Conclusion
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796