DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-5, 8-15, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (Pub. No.: US 2016/0310315 A1) in view of Cook et al. (Pub. No.: US 2014/0142669 A1); hereinafter referred to as “Cook”.
Regarding claim 2, Smith discloses a method for treating or preventing bleeding in a subject (e.g. see [0009], [0011], and [0036]), the method comprising: positioning a first electrical neuromodulation stimulator (e.g. see [0031]-[0032]) in non-piercing contact with a facial region of skin of the subject in a first location targeting a trigeminal nerve (e.g. see [0010], [0031]), wherein the first electrical neuromodulation stimulator is operably connected to a trigeminal stimulation drive of a controller (e.g. see [0031]-[0032]); and activating the controller to deliver a neurostimulation treatment (e.g. see [0031]-[0032]) configured for treating and/or preventing bleeding (e.g. see [0009], [0011], and [0036]), wherein delivering the neurostimulation treatment comprises applying via the trigeminal stimulation drive, wherein the neurostimulation activations are configured to modulate activities of a sympathetic nervous system (SNS) and a parasympathetic nervous system (PNS) of the subject, thereby shortening a reaction time to form a clot (e.g. see [0036], “The triggering of the dive reflex affords a mechanism whereby the entire autonomic nervous system works together to create an increase in SVR (on the order of 25%) with a secondary drop in cardiac work and a surprising increase in cerebral blood flow. The present invention provides a device capable of triggering the dive reflex on demand, which can get an injured or bleeding soldier through the so-called “Golden Hour” where he/she needs to be transferred to acute care before death or irreversible injury occurs” Note: The “entire autonomic nervous system” will read on SNS and PNS).
Smith discloses the importance of the vagus nerve in autonomic control and the dive reflex (e.g. see [0022]-[0023]) but is silent as to positioning a second electrical or mechanical neuromodulation stimulator in piercing or non-piercing contact with an auricular region and/or head region of skin of the subject in a second location targeting a vagus nerve, wherein the second electrical or mechanical neuromodulation stimulator is operably connected to a vagal stimulation drive of the controller. Cook teaches it is known to use such a modification as set forth in figure 7, [0137] (for the vagus nerve stimulator) to provide an effect on hemostasis (blood clotting) by modulating vagus nerve activity (e.g. see [0104]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the vagus nerve stimulator in the auricular region as taught by Cook in the system/method of Smith, since said modification would provide the predictable results of an effect on hemostasis (blood clotting) by modulating vagus nerve activity.
Smith discloses the use of electrical stimulation (e.g. see [0031]-[0032]) but is silent as to via the vagal stimulation drive, and the first neurostimulation activations at a first frequency or range of frequencies and the second neurostimulation activations at a second frequency or range of frequencies. Cook teaches it is known to use such a modification as set forth in [0151], [0049] to provide selective activation or inhibition of brain structures involved in the control of the medical disorders (e.g. see [0049]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the frequency ranges taught by Cook in the system/method of Smith, since said modification would provide the predictable results of selective activation or inhibition of brain structures involved in the control of the medical disorders.
Regarding claim 3, Smith discloses targeting the trigeminal nerve comprises targeting at least one of an ophthalmic nerve branch (e.g. see [0021], [0023], [0024])
Regarding claims 4 and 5, Smith discloses the invention but is silent as to the first neurostimulation activations are delivered via the first electrical neuromodulation stimulator; and the first frequency or range of frequencies is within a range from 31 Hz to 150 Hz and the second neurostimulation activations are delivered via the second electrical neuromodulation stimulator; and the second frequency or range of frequencies is within a range from 1 Hz to 30 Hz. Cook teaches it is known to use such a modification as set forth in [0151], [0049] to provide selective activation or inhibition of brain structures involved in the control of the medical disorders (e.g. see [0049]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the vagus nerve stimulator in the auricular region as taught by Cook in the system/method of Smith, since said modification would provide the predictable results of selective activation or inhibition of brain structures involved in the control of the medical disorders.
Regarding claim 8, Smith discloses the neurostimulation treatment is a prophylactic treatment (e.g. see [0009], [0038]. Note: [0009] states “This mechanism may prevent, or at least improve tolerance and prognosis of, non-hemorrhagic brain attacks, such as strokes and TIA's and [0038] states “In a similar manner the devices disclosed herein can be used to trigger the dive reflex in a person with the intent to mitigate or prevent migraine headaches”).
Regarding claim 9, Smith discloses the first neurostimulation activations and the second neurostimulation activations are configured to increase thrombin generation at an injury site while maintaining a systemic thrombin level in the subject (e.g. see [0009], [0011], and [0036]).
Regarding claim 10, Smith discloses the injury site is an internal injury site (e.g. see [0009], [0011], and [0036]. Note: [0036] states “Even the setting where a bullet may have impaled a major internal structure such as the liver or even the spleen, would be benefited by triggering the dive reflex where the spleen is known to contract by as much as 20% upon activating the dive reflex and the hematocrit or blood volume may go up as much as 10% upon contracture of the spleen”).
Regarding claim 11, Smith discloses the first neurostimulation activations and the second neurostimulation activations are configured to reduce bleed time by at least 10% (e.g. see [0009], [0011], and [0036]. Smith does not explicitly disclose reduction of bleed time in percentage terms, however, the reduction of bleeding by “at least 10%” is an intended/inherent result of the treatment claimed and therefore considered to be met by the structural elements of the treatment parameters disclosed by Smith).
Regarding claim 12, Smith discloses the controller is activated to deliver the neurostimulation treatment via a user interface of the controller (e.g. see [0027]. Note: [0027] discloses “the controller 30 can require manual external activation and de-activation”. The manual external activation is necessarily done via some type of interface).
Regarding claim 13, Smith discloses adjusting a dose of the neurostimulation treatment responsive to receiving input via a user interface of the controller (e.g. see [0027]. Note: [0027] discloses “the controller 30 can require manual external activation and de-activation”. Repeated activation and de-activation will adjust a “dose”).
Regarding claim 14, Smith discloses the method (see rejection for claim 2 above) and further discloses the structural elements of a controller (e.g. see [0032], “controller”), a trigeminal stimulation drive (e.g. see [0032], “A controller, such as the controller 30, is operable to activate the battery cell which then generates an electrical signal applied to the skin through the conductive patch to thereby activate the trigeminal nerve”).
Smith discloses the importance of the vagus nerve in autonomic control and the dive reflex (e.g. see [0022]-[0023]) but is silent as to the vagal stimulation drive. Cook teaches it is known to use such a modification as set forth in figure 7, [0137] (for the vagus nerve stimulator) to provide an effect on hemostasis (blood clotting) by modulating vagus nerve activity (e.g. see [0104]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the vagus nerve stimulator in the auricular region as taught by Cook in the system/method of Smith, since said modification would provide the predictable results of an effect on hemostasis (blood clotting) by modulating vagus nerve activity.
Regarding claim 15, Smith discloses the use of electrical stimulation (e.g. see [0031]-[0032]) with a controller (e.g. see [0032], “controller”) but is silent as to the controller further comprises a waveform generator. Cook teaches it is known to use such a modification as set forth in [0022]-[0023] (“pulse generator”) to provide the capability to administer a variety of stimulation waveforms as disclosed in [0148]-[0152] of Cook. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a waveform generator as taught by Cook in the system/method of Smith, since said modification would provide the predictable results of providing the capability to administer a variety of stimulation waveforms as disclosed in [0148]-[0152] of Cook.
Regarding claim 19, Smith discloses the first electrical or mechanical neuromodulation stimulator and the second electrical or mechanical neuromodulation stimulator are wirelessly connected to the controller (e.g. see [0029]).
Regarding claim 21, Smith discloses neurostimulation treatment is configured to treat menstruation (e.g. see [0038]-[0041], Note: Headaches are a symptom of menstruation).
Claim(s) 6, 7,16-18, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith and Cook as applied to claim 2 above, and further in view of Hyde et al. (Pub. No.: US 2016/0279435 A1); hereinafter referred to as “Hyde”.
Regarding claims 6, 7, and 22 Smith and Cook discloses the claimed invention except for the first neurostimulation activations are delivered via the first mechanical neuromodulation stimulator; and the first frequency or range of frequencies is within a range from 75 Hz to 500 Hz and the second neurostimulation activations are delivered via the second mechanical neuromodulation stimulator; and the second frequency or range of frequencies is within a range from 20 Hz to 500 Hz. Hyde teaches it is known to use such a modification as set forth in [0060] and [0100] (for trigeminal and vagus nerve stimulation), [0061] (for stimulation range), [0066] and [0103] (for vibration/mechanical stimulation) to provide stimulus that has a waveform sufficient to modulate the activity of the at least one mechanoreceptor with a receptive field on the at least a portion of the pinna (e.g. see [0106]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the mechanical stimulation frequency ranges as taught by Hyde in the system/method of Smith and Cook, since said modification would provide the predictable results of a stimulus that has a waveform sufficient to modulate the activity of the at least one mechanoreceptor with a receptive field on the at least a portion of the pinna.
Regarding claims 16-18, Smith and Cook disclose the invention but are silent as to the first electrical or mechanical neuromodulation stimulator and the second electrical or mechanical neuromodulation stimulator are arranged on an exterior of the housing; and the trigeminal stimulation drive and the vagal stimulation drive are enclosed within the housing, the housing is configured to be positioned on facial skin of the subject, and the housing is configured to be positioned on and/or proximate to an ear of the subject. Hyde teaches it is known to use such a modification as set forth in [0069], [0078] to provide a variety of possible device configurations (e.g. see [0069], [0078]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a customizable device configuration as taught by Hyde in the system/method of Smith and Cook, since said modification would provide the predictable results of a variety of possible device configurations.
Regarding claims 20, Smith and Cook disclose the invention but is silent as to delivering the neurostimulation treatment comprises alternating applying the first neurostimulation activations with applying the second neurostimulation activations. Hyde teaches it is known to use such a modification as set forth in figure 2B, elements 212, 222 [0065] (Note: This is a functional use recitation of a system claim that the prior art is capable of and/or configured to perform) to provide multiple (two or more) neural stimulators that may all be of the same type, or may be of several different types (e.g. see [0065]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use multiple stimulators that can operate independently and alternatively as taught by Hyde in the system/method of Smith and Cook, since said modification would provide the predictable results of multiple (two or more) neural stimulators that may all be of the same type, or may be of several different types.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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