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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 9, 15, 17, 19, 23-24, 44, and 48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shantha (US 2012/0323214 A1), hereinafter Shantha.
Regarding claim 1, Shantha discloses A non-invasive neuromodulation device that is configured to stimulate the sphenopalatine ganglion for increasing collateral blood flow to the brain to preserve neural tissue following an acute ischemic stroke (Abstract: “the specially designed Iontophoresis incorporated olfactory mucosal delivery (ORE) catheter device located at the olfactory nerves, sphenoid sinus, and adjacent structures described here”, [0176] “FIG. 8 is the diagrammatic presentation 800 of the therapeutic agents and electrical impulses and therapeutic agent's delivery inventive device 220 to create Iontophoresis and electroporation”, [0079] treating stroke, [0121] ORE includes sphenopalatine ganglion, [0178]), the device comprising:
a catheter (device 220) having a proximal end and an opposing distal end (view Examiner modified Figure 9), the catheter having an inner lumen formed therein ([0177]-[0178] inflation tube);
a first balloon (balloon 527) coupled to and surrounding the catheter (view Figure 9), the first balloon including at least one electrode ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”); and
a second balloon (balloon 519) coupled to and surrounding the catheter (view Figure 9);
wherein the first balloon and the second balloon are configured and are spaced apart from one another such that in inflated states of the first balloon and the second balloon (view Figure 9), the first balloon is configured to contact or be proximate to the sphenopalatine ganglion to permit stimulation thereof by actuation of the at least one electrode ([0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope….The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon. These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields”), while the second balloon is configured to hold the non-invasive neuromodulation device in place within the nasopharynx ([0176] “FIG. 7 is the view of diagram 700 of the present invention device 220 showing two balloons holding the therapeutic agents and electrical impulses delivering part of the device 520 in position between the sphenoid sinus with a balloon 525 and nasal balloon 519 without movement at the olfactory region for the treatment of Alzheimer's. The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522. The catheter and the balloon in the sphenoid sinus can incorporate with Iontophoresis electrical embodiment to create Iontophoresis in the wall of the sphenoid sinus. These inflated balloons hold the electrical impulses and therapeutic agent's delivery system on the olfactory mucosa (ORE) to the CNS in position, especially in patients who are difficult to control their movement.”, emphasis added).
Regarding claim 2, Shantha discloses the device of claim 1 (as shown above), further including a first conduit disposed within the inner lumen and being in fluid communication with the first balloon for inflation thereof and a second conduit disposed within the inner lumen and being in fluid communication with the second balloon for inflation thereof ([0176] “The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522”, [0177] “The balloons 519 and 527 expanded by using the air or liquid by a tube in the interior connected through inflation stopcocks 522 and 526 connected by a tube to the inflation syringe located outside the nose.”).
Regarding claim 3, Shantha discloses the device of claim 2 (as shown above), wherein the first conduit and the second conduit are separate and independent from one another to permit independent inflation of the first balloon and the second balloon ([0176] “The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522”, [0177] “The balloons 519 and 527 expanded by using the air or liquid by a tube in the interior connected through inflation stopcocks 522 and 526 connected by a tube to the inflation syringe located outside the nose.”, [0178] “The interior of this balloon 527 connected to an inflation tube, which in turn connected through an inflation stopcock and a tube to the inflation syringe 526. The inflation syringe 526 used to pump air or fluid through the inflation tube to the interior of the balloon 527 so it inflates filling the sphenoid sinus cavity during the operation of the apparatus. An infusion tube is also connected to the interior of the balloon 527 and is used to pump fluid at ambient, elevated, or low temperatures through the infusion tube and to the interior of the balloon during the operation of the apparatus.”).
Regarding claim 4, Shantha discloses the device of claim 2 (as shown above), wherein the first conduit comprises a first tube that extends longitudinally within the inner lumen and the second conduit comprises a second tube that extends longitudinally within the inner lumen ([0176] “The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522”, [0177] “The balloons 519 and 527 expanded by using the air or liquid by a tube in the interior connected through inflation stopcocks 522 and 526 connected by a tube to the inflation syringe located outside the nose.”, [0178] “The interior of this balloon 527 connected to an inflation tube, which in turn connected through an inflation stopcock and a tube to the inflation syringe 526. The inflation syringe 526 used to pump air or fluid through the inflation tube to the interior of the balloon 527 so it inflates filling the sphenoid sinus cavity during the operation of the apparatus. An infusion tube is also connected to the interior of the balloon 527 and is used to pump fluid at ambient, elevated, or low temperatures through the infusion tube and to the interior of the balloon during the operation of the apparatus.”, view Figure 9: each tube extends longitudinally through the catheter for inflating the respective balloons, Figure 5 shows distinction more clearly).
Regarding claim 9, Shantha discloses the device of claim 1 (as shown above), wherein the at least one electrode comprises a plurality of electrodes ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”, view Figure 9).
Regarding claim 15, Shantha discloses the device of claim 1 (as shown above), wherein the catheter comprises a flexible tube ([0180] “All of the tubes and connectors to the balloon 527 are assembled in a connector assembly of the device 220. The inner portion of this connector assembly constitutes part of the insertion body. This assembly needs to be small in diameter and flexible for easy insertion through the nose and into the sphenoid sinus cavity ostium.”).
Regarding claim 17, Shantha discloses the device of claim 1 (as shown above), further including an external actuator (electrical output manipulator 517) that is operatively coupled to the at least one electrode for controlling operation thereof (view Figure 9, [0177] “The electrical impulses to create Iontophoresis field deliverer terminals activated through the electrical output manipulator 517.”, [0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields”) .
Regarding claim 19, Shantha discloses the device of claim 17 (as shown above), wherein the external actuator comprises an electrical stimulator ([0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields to deliver large MW therapeutic agents to the CNS bypassing blood-brain barrier.”).
Regarding claim 23, Shantha discloses the device of claim 1 (as shown above), wherein the at least one electrode is operatively connected to a conductive trace that is routed either through the inner lumen of the catheter or along an exterior of the catheter ([0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517.”, view Figure 9).
Regarding claim 24, Shantha discloses the device of claim 23 (as shown above), wherein the at least one electrode comprises a plurality of electrodes disclosed and spaced apart along an exterior of the first balloon ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”, view Figure 9), each electrode having one conductive trace operatively connected thereto, the conductive traces being routed either through a sleeve that extends along an exterior of the catheter or through the inner lumen of the catheter ([0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517.”, view Figure 9).
Regarding claim 44, Shantha discloses a method of stimulating the sphenopalatine ganglion for increasing collateral blood flow to the brain to preserve neural tissue following an acute ischemic stroke (Abstract: “the specially designed Iontophoresis incorporated olfactory mucosal delivery (ORE) catheter device located at the olfactory nerves, sphenoid sinus, and adjacent structures described here”, [0176] “FIG. 8 is the diagrammatic presentation 800 of the therapeutic agents and electrical impulses and therapeutic agent's delivery inventive device 220 to create Iontophoresis and electroporation”, [0079] treating stroke, [0121] ORE includes sphenopalatine ganglion, [0178]), the method comprising the steps of:
Deploying a non-invasive neuromodulation device intranasally ([0073] “It is a purpose of the present invention to provide a special catheter equipped with an Iontophoresis producing embodiment method to deliver large therapeutic agents molecules across the olfactory mucosa and olfactory nerve to the Alzheimer's disease afflicted central nervous system.”, [0177] “This device incorporates olfactory nerve stimulator 520 and sphenoid sinus stimulator 527, which stimulates the five cranial nerves on the lateral wall of the sinus embedded in the cavernous sinus, the internal carotid artery (Circle of Willis) in each wall of the cavernous sinus located on the lateral walls of the sphenoid sinus to create Iontophoresis”); and
Electrically stimulating the sphenopalatine ganglion with at least one electrode ([0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope….The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon. These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields”, [0292] “d) Electrical impulses act as iontophoresis, of the olfactory mucosa, sphenopalatine ganglion and sphenoid sinus lining (FIG. 17), thus augmenting the uptake of therapeutic agents from these regions to be delivered to the CNS by passing the BBB in the treatment of Alzheimer's and other neurological diseases.)”).
Regarding claim 48, Shantha discloses the method of claim 44 (as shown above), wherein the step of electrically stimulating the sphenopalatine ganglion with the at least one electrode comprises using an external actuator to control delivery of the electrical stimulation further including an external actuator (electrical output manipulator 517, view Figure 9, [0177] “The electrical impulses to create Iontophoresis field deliverer terminals activated through the electrical output manipulator 517.”, [0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields”, [0175] “The electrical impulses delivered to create Iontophoresis also pass (spillover effect) from this device to the sphenopalatine ganglion 110 and to the anterior ethmoidal nerve 107 and sphenoid sinus neural components.”) .
Claim Rejections - 35 USC § 103
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) 7, 16, 32, 38, 45, and 53-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha.
Regarding claim 7, Shantha discloses the device of claim 1 (as shown above), wherein each of the first balloon and the second balloon has a spherical shape (view Figure 8-9: balloon 519 and 527 are in spherical shape, [0178] “One part is an inflatable outer membrane or balloon 527, which is adapted in size and flexibility to fit inside the sphenoid sinus cavity.”).
Shantha fails to explicitly disclose the second balloon having dimensions that are greater than dimensions of the first balloon.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shantha to have the second balloon have dimension that are greater than dimensions of the first balloon, recognizing that the dimensions will allow for stable positioning and attachment to the cavity, which are desirable characteristics, since it has been held that changing the shape was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally the present disclosure has no criticality for having the second balloon having dimensions that are greater than dimensions of the first balloon.
Regarding claim 16, Shantha discloses the device of claim 1 (as shown above). Shantha fails to explicitly disclose wherein the second balloon (balloon 519) is located distal to the first balloon (balloon 527, view Examiner modified Figure 9)
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shantha to have the second balloon be located distal to the first balloon, recognizing that this position of the first and second balloon would be an obvious matter of design choice and would not have modified the operation of the device as the functions disclose in the instant application and the prior art reference are the same for each balloon. See MPEP 2144 VI.C. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Additionally the present disclosure has no criticality for having the second balloon be located distal to the first balloon.
Regarding claim 32, Shantha in view of Haroon teaches the device of claim 1 (as shown above). Shantha further discloses wherein each of the first balloon and the second balloon has a spherical shape (view Figure 8-9: balloon 519 and 527 are in spherical shape, [0178] “One part is an inflatable outer membrane or balloon 527, which is adapted in size and flexibility to fit inside the sphenoid sinus cavity.”).
Shantha fails to explicitly disclose the second balloon having dimensions that are greater than dimensions of the first balloon.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shantha to have the second balloon have dimension that are greater than dimensions of the first balloon, recognizing that the dimensions will allow for stable positioning and attachment to the cavity, which are desirable characteristics, since it has been held that changing the shape was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally the present disclosure has no criticality for having the second balloon having dimensions that are greater than dimensions of the first balloon.
Regarding claim 38, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha fails to explicitly disclose wherein the second balloon (balloon 519) is located distal to the first balloon (balloon 527, view Examiner modified Figure 9)
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shantha to have the second balloon be located distal to the first balloon, recognizing that this position of the first and second balloon would be an obvious matter of design choice and would not have modified the operation of the device as the functions disclose in the instant application and the prior art reference are the same for each balloon. See MPEP 2144 VI.C. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Additionally the present disclosure has no criticality for having the second balloon be located distal to the first balloon.
Regarding claim 45, Shantha discloses the method of claim 44 (as shown above), wherein the non-invasive neuromodulation device comprises a balloon catheter (device 220) including a first balloon (balloon 527) and a second balloon (balloon 519), the first balloon including at least one electrode ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”).
Shantha fails to explicitly disclose wherein the second balloon (balloon 519) is located distal to the first balloon (balloon 527, view Examiner modified Figure 9)
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Shantha to have the second balloon be located distal to the first balloon, recognizing that this position of the first and second balloon would be an obvious matter of design choice and would not have modified the operation of the device as the functions disclose in the instant application and the prior art reference are the same for each balloon. See MPEP 2144 VI.C. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975). Additionally the present disclosure has no criticality for having the second balloon be located distal to the first balloon.
Regarding claim 53, Shantha discloses the method of claim 45 (as shown above), wherein the at least one electrode is operatively connected to a conductive trace that is routed either through the inner lumen of the catheter or along an exterior of the catheter ([0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517.”, view Figure 9).
Regarding claim 54, Shantha discloses the method of claim 53 (as shown above), wherein the at least one electrode comprises a plurality of electrodes disclosed and spaced apart along an exterior of the first balloon ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”, view Figure 9), each electrode having one conductive trace operatively connected thereto ([0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517.”, view Figure 9).
Claim(s) 5-6, 10-11, 25-26, and 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claims 1 and 54 above, and further in view of Townley et al (US 2020/0100838 A1), hereinafter Townley.
Regarding claim 5, Shantha discloses the device of claim 1 (as shown above), the first inflation fluid port being in fluid communication with an inside of the first balloon via a first conduit and the second inflation fluid port being in fluid communicated with an inside of the second balloon via a second conduit ([0176] “The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522”, [0177] “The balloons 519 and 527 expanded by using the air or liquid by a tube in the interior connected through inflation stopcocks 522 and 526 connected by a tube to the inflation syringe located outside the nose.”, [0178] “The interior of this balloon 527 connected to an inflation tube, which in turn connected through an inflation stopcock and a tube to the inflation syringe 526. The inflation syringe 526 used to pump air or fluid through the inflation tube to the interior of the balloon 527 so it inflates filling the sphenoid sinus cavity during the operation of the apparatus. An infusion tube is also connected to the interior of the balloon 527 and is used to pump fluid at ambient, elevated, or low temperatures through the infusion tube and to the interior of the balloon during the operation of the apparatus.”, view Figure 9: each tube extends longitudinally through the catheter for inflating the respective balloons, Figure 5 shows distinction more clearly), the guide wire port configured to receive a semi-flexible guide wire ([0177] “The catheter provided with a guide wire 523 port to facilitate the positioning of the catheter on the ORE and inside the sphenoid sinus.”) .
Shantha fails to explicitly disclose the device further including a handle at a proximal end of the catheter, the handle including first and second inflation fluid ports and a guide wire port.
However, Townley teaches the device further including a handle (handle 210) at a proximal end of the catheter ([0042] “a handle 210 at a proximal portion 208a of the shaft 208”), the handle including first and second inflation fluid ports and a guide wire port (view Figure 16: shaft 1608, supply lumens 1684, support member 1690, guidewire GW).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Townley to have the device further include a handle at a proximal end of the catheter, the handle including first and second inflation fluid ports and a guide wire port, as these prior art references are directed to nasal neuromodulation devices. One would be motivated to do this to allow the user/clinician to easily position the device in the nasal cavity, as recognized by Townley ([0051]).
Regarding claim 6, Shantha in view of Townley discloses the device of claim 5 (as shown above), wherein the distal end of the catheter is open to permit passage of the semi-flexible guide wire (view figures 8 and 9).
Regarding claim 10, Shantha discloses the device of claim 9 (as shown above), and further discloses the balloon having “multiple electrical leads on the exterior of the balloon as shown on the balloon” ([0178], Figure 9), but fails to explicitly disclose wherein the plurality of electrodes are disposed circumferentially around the first balloon.
However, Townley teaches a device for therapeutic nasal neuromodulation wherein the plurality of electrodes are dispose circumferentially around the first balloon ([0100] “As shown in FIGS. 8 and 9, the electrodes 858 can be positioned on the expandable member 856 in a substantially symmetrical manner and a uniform distribution”, view Figures 5 and 8-9).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Townley to have the wherein the plurality of electrodes are disposed circumferentially around the first balloon, as these prior art references are directed to providing neuromodulation through the nasal pathway. One would be motivated to do this to allow for better contact with the target region.
Regarding claim 11, Shantha discloses the device of claim 9 (as shown above), and further discloses the balloon having “multiple electrical leads on the exterior of the balloon as shown on the balloon” ([0178], Figure 9), but fails to explicitly disclose wherein the plurality of electrodes are uniformly distributed across the first balloon.
However, Townley teaches a device for therapeutic nasal neuromodulation wherein the plurality of electrodes are uniformly distributed across the first balloon ([0100] “As shown in FIGS. 8 and 9, the electrodes 858 can be positioned on the expandable member 856 in a substantially symmetrical manner and a uniform distribution”, view Figures 5 and 8-9).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Townley to have the plurality of electrodes are uniformly distributed across the first balloon, as these prior art references are directed to providing neuromodulation through the nasal pathway. One would be motivated to do this to allow for better contact with the target region.
Regarding claim 25, Shantha discloses the device of claim 23 (as shown above). Shantha discloses a first negative electrode and a second positive electrode ([0226]), Shantha fails to disclose wherein each electrode can be stimulated in monopolar, bipolar, or multipolar modes.
However, Townley teaches a device for therapeutic nasal neuromodulation wherein each electrode can be stimulated in monopolar, bipolar, or multipolar modes ([0045] “For example, when therapeutic neuromodulation device 202 is configured for electrode-based, heat-element-based, and/or transducer-based treatment, the console 204 can include an energy generator 216 configured to generate RF energy (e.g., monopolar, bipolar, or multi-polar RF energy)…”, [0066] “The electrodes 444 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site.”, [0072] “For example, each electrode can be individually activated and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm (e.g., executed by the controller 218 of FIG. 2).”, [0109] “The electrodes 1144 may be configured to deliver energy in a mono-polar, bipolar, or multipolar manner.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Townley to have the electrode be stimulated in monopolar, bipolar, or multipolar modes, as these prior art references and the instant application are directed to nasal neuromodulation. One would be motivated to do this to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate the target site, as recognized by Townley ([0066]).
Regarding claim 26, Shantha in view of Townley teaches the system of claim 25 (as shown above). Shantha further discloses wherein stimulation of the electrodes by a stimulation generator is coordinated to steer current to the sphenopalatine ganglion for optimal therapeutic effect ([0175] “various structures that are going to be stimulated by the nasal stimulator of by this invention device 220 to transmit the electrical pulses to the CNS and create electroporation and Iontophoresis. Note the tip of the therapeutic agents and electrical impulses delivery device positioned in the sphenoid sinus through the ostium of the sphenoid sinus 524… The electrical impulses delivered to create Iontophoresis also pass (spillover effect) from this device to the sphenopalatine ganglion 110”).
Regarding claim 55, Shantha discloses the method of claim 54 (as shown above). Shantha discloses a first negative electrode and a second positive electrode ([0226]), Shantha fails to disclose wherein each electrode can be stimulated in monopolar, bipolar, or multipolar modes.
However, Townley teaches a device for therapeutic nasal neuromodulation wherein each electrode can be stimulated in monopolar, bipolar, or multipolar modes ([0045] “For example, when therapeutic neuromodulation device 202 is configured for electrode-based, heat-element-based, and/or transducer-based treatment, the console 204 can include an energy generator 216 configured to generate RF energy (e.g., monopolar, bipolar, or multi-polar RF energy)…”, [0066] “The electrodes 444 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site.”, [0072] “For example, each electrode can be individually activated and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm (e.g., executed by the controller 218 of FIG. 2).”, [0109] “The electrodes 1144 may be configured to deliver energy in a mono-polar, bipolar, or multipolar manner.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Townley to have the electrode be stimulated in monopolar, bipolar, or multipolar modes, as these prior art references and the instant application are directed to nasal neuromodulation. One would be motivated to do this to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate the target site, as recognized by Townley ([0066]).
Regarding claim 56, Shantha in view of Townley teaches the method of claim 55 (as shown above). Shantha further discloses wherein stimulation of the electrodes by a stimulation generator is coordinated to steer current to the sphenopalatine ganglion for optimal therapeutic effect ([0175] “various structures that are going to be stimulated by the nasal stimulator of by this invention device 220 to transmit the electrical pulses to the CNS and create electroporation and Iontophoresis. Note the tip of the therapeutic agents and electrical impulses delivery device positioned in the sphenoid sinus through the ostium of the sphenoid sinus 524… The electrical impulses delivered to create Iontophoresis also pass (spillover effect) from this device to the sphenopalatine ganglion 110”).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 1 above, and further in view of Patel (US 2024/0024664 A1), hereinafter Patel.
Regarding claim 12, Shantha discloses the device of claim 1 (as shown above). Shantha further discloses that the size of the balloon is adjusted according to the size of the patient’s nose ([0174], [0178]), but fails to explicitly disclose wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis.
However, Patel teaches methods and devices for treatment or assessment of structures or nerves accessible via the nasal cavity utilizing electrical stimulation (Abstract) wherein “In various embodiments, a dilated balloon has diameter between 5 and 40 mm, and a length between 10 and 50 mm. The size of the balloon utilized can vary and can be selected depending on the location of electrical stimulation and/or signal recording. For instance, the maxillary, the ethmoid, the frontal, and the sphenoid sinus cavities each have a unique volume and surface area distribution.” ([0043], Examiner interprets the major axis as the length and the minor axis as the diameter.).
Although, Patel does not explicitly teach these values, it would be obvious to one of ordinary skill in the art to use values within these ranges because Patel’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, Examiner would like to note that Shantha discloses adjusting the balloon size according to the nasal cavity and Patel teaches ranges given for balloons that are placed in the nasal cavity.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Patel to have wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis, as these prior art references are directed to treatment using balloon catheters in the nasal cavity. One would be motivated to do this to have the balloon sized perfectly for the nasal cavity.
Claim(s) 21-22 and 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claims 1 and 45 above, and further in view of Tal (US 2020/0171283 A1), hereinafter Tal.
Regarding claim 21, Shantha discloses the device of claim 1 (as shown above), wherein each of the first and second balloons is filled with inflation media ([0177] “The balloons 519 and 527 expanded by using the air or liquid by a tube in the interior”). Shantha fails to explicitly teach wherein each of the first and second balloons is filled with inflation media that causes the first and second balloons to be visible during fluoroscopy.
However, Tal teaches a dilatation balloon catheter for dilating and/or recanalizing occluded or narrowed vein portions and/or vascular accesses wherein “the balloon is inflated using saline, optionally with contrast enhancing material” ([0063],[0007], [0070]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Tal to have the first and second balloons is filled with inflation media that causes the first and second balloons to be visible during fluoroscopy, as these prior art references are directed to catheters with balloons placed in body lumens. One would be motivated to do this to facilitate visualization and positioning of the catheter.
Regarding claim 22, Shantha in view of Tal discloses the device of claim 21 (as shown above). Shantha fails to disclose wherein the inflation media comprises one of saline and a contrast agent that is visible under fluoroscopy.
However, Tal teaches wherein the inflation media comprises one of saline and a contrast agent that is visible under fluoroscopy ([0070] “Balloon 120 may be inflatable by pressurizing inflation medium to its interior through inflation exit port 124. Inflation medium may include saline or oil, with or without contrast enhancing materials.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Tal to have the inflation media comprises one of saline and a contrast agent that is visible under fluoroscopy, as these prior art references are directed to catheters with balloons placed in body lumens. One would be motivated to do this to facilitate visualization and positioning of the catheter.
Regarding claim 51, Shantha discloses the method of claim 45 (as shown above), further including the step of: inflating the first and second balloons using an inflation media ([0177] “The balloons 519 and 527 expanded by using the air or liquid by a tube in the interior”). Shantha fails to explicitly teach inflating the first and second ballons using an inflation media that causes the first and second ballons to be visible during fluoroscopy.
However, Tal teaches a dilatation balloon catheter for dilating and/or recanalizing occluded or narrowed vein portions and/or vascular accesses wherein “the balloon is inflated using saline, optionally with contrast enhancing material” ([0063],[0007], [0070]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Tal for inflating the first and second ballons using an inflation media that causes the first and second ballons to be visible during fluoroscopy, as these prior art references are directed to catheters with balloons placed in body lumens. One would be motivated to do this to facilitate visualization and positioning of the catheter.
Regarding claim 52, Shantha in view of Tal discloses the method of claim 51 (as shown above). Shantha fails to disclose wherein the inflation media comprises one of saline and a contrast agent that is visible under fluoroscopy.
However, Tal teaches wherein the inflation media comprises one of saline and a contrast agent that is visible under fluoroscopy ([0070] “Balloon 120 may be inflatable by pressurizing inflation medium to its interior through inflation exit port 124. Inflation medium may include saline or oil, with or without contrast enhancing materials.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Tal to have the inflation media comprises one of saline and a contrast agent that is visible under fluoroscopy, as these prior art references are directed to catheters with balloons placed in body lumens. One would be motivated to do this to facilitate visualization and positioning of the catheter.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 17 above, and further in view of Lamensdorf (US Patent 9,233,245 B2), hereinafter Lamensdorf.
Regarding claim 20, Shantha discloses the device of claim 17 (as shown above) and further discloses where the current applied has different waveforms ([0226]) and that an operator/patient may select a current from the electrical output manipulator ([0232]), but fails to explicitly disclose wherein the external actuator includes at least two different operating modes in which intensity of the electrical stimulation differs between the modes.
However, Lamensdorf teaches a method for treating a subject including applying electrical stimulation to a sphenopalatine ganglion (SPG) wherein the external actuator includes at least two different operating modes in which intensity of the electrical stimulation differs between the modes (Column 27, lines 20-26: “the control unit is configured to drive the one or more electrodes to apply the stimulation during the first period at a first stimulation strength and during the last period at a second stimulation strength, and to set the second stimulation strength to be different from the first stimulation strength, such as less than or greater than the first stimulation strength.”, Column 12, lines 15-52: acute stage and rehabilitative stage).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Lamensdorf to have the external actuator includes at least two different operating modes in which intensity of the electrical stimulation differs between the modes, as these prior art references are directed to stimulating the SPG. One would be motivated to do this as these different stages can apply different therapeutic effects (Column 64, line 28-Column 65, line 25).
Claim(s) 49-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 48 above, and further in view of Tsui (US 2020/0297238 A1), hereinafter Tsui.
Regarding claim 49, Shantha discloses the method of claim 48 (as shown above) and further discloses where “The tip of the inventive device provided with radio opaque marker 540 to identify the position of the catheter tip in the sphenoid sinus after insertion and during use with radiographic examination.”, but fails to explicitly disclose wherein the at least one electrode is radiopaque and the method further includes the step of using an image system for determining a location of the non-invasive neuromodulation device relative to anatomic landmarks as a result of the at least one radiopaque electrode.
However, Tsui teaches a method for monitoring catheters, and more specifically to medical devices and associated methods for assisting, confirming, and monitoring placement of catheters in patients wherein the at least one electrode is radiopaque ([0045] “the electrodes are radiopaque”, [0082]) and the method further includes the step of using an image system for determining a location of the non-invasive neuromodulation device relative to anatomic landmarks as a result of the at least one radiopaque electrode ([0079] “after the electrode device 200 with the electrodes 250 have been attached to the patient, an imaging (e.g., x-ray imaging) may be performed for the patient to obtain an image. The image may indicate anatomical structure(s) in the patient as well as markers 210 associated with the electrodes 250. In the illustrated example, because the electrodes 250 are aligned next to the markers 210, as shown in FIG. 2C, the positions of the markers 210 may be utilized to indicate, and/or may associate with corresponding electrodes 250. Accordingly, the markers 210 may allow a user to determine an optimal placement position of the catheter 132 to be placed inside the patient.”, [0081] “The radio-opaque markers 210 and the electrodes 250 are visible in the image.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Tsui to have the at least one electrode is radiopaque and the method further includes the step of using an image system for determining a location of the non-invasive neuromodulation device relative to anatomic landmarks as a result of the at least one radiopaque electrode, as these prior art references are directed to catheter devices placed in a body cavity. One would be motivated to do this to visualize catheter placement in regard to anatomical landmarks to confirm that the catheter has been desirably placed at the target position, as recognized by Tsui ([0079],[0094]).
Regarding claim 50, Shantha in view of Tsui teaches the method of claim 49 (as shown above). Shantha fails to explicitly disclose wherein the image system comprises one of an x-ray device, a fluoroscopy, and a CT device.
However, Tsui discloses wherein the image system comprises one of an x-ray device ([0079] “an imaging (e.g., x-ray imaging) may be performed”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Tsui to have the image system comprise one of an x-ray, a fluoroscopy, and a CT scan, as these prior art references are directed to catheter devices placed in a body cavity. One would be motivated to do this to visualize catheter placement in regard to anatomical landmarks to confirm that the catheter has been desirably placed at the target position, as recognized by Tsui ([0079],[0094]).
Claim(s) 27-31, 34, 39, 41, 43, and 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha in view of Haroon, Yasser, et al. "Embolization for control of refractory posterior epistaxis." The Egyptian Journal of Radiology and Nuclear Medicine 43.3 (2012): 407-411., hereinafter Haroon.
Regarding claim 27, Shantha disclose a method of stimulating the sphenopalatine ganglion for increasing collateral blood flow to the brain to preserve neural tissue following an acute ischemic stroke (Abstract: “the specially designed Iontophoresis incorporated olfactory mucosal delivery (ORE) catheter device located at the olfactory nerves, sphenoid sinus, and adjacent structures described here”, [0176] “FIG. 8 is the diagrammatic presentation 800 of the therapeutic agents and electrical impulses and therapeutic agent's delivery inventive device 220 to create Iontophoresis and electroporation”, [0079] treating stroke, [0121] ORE includes sphenopalatine ganglion, [0178]), the method comprising the steps of: deploying a non-invasive neuromodulation device intranasally ([0073] “It is a purpose of the present invention to provide a special catheter equipped with an Iontophoresis producing embodiment method to deliver large therapeutic agents molecules across the olfactory mucosa and olfactory nerve to the Alzheimer's disease afflicted central nervous system.”, [0177] “This device incorporates olfactory nerve stimulator 520 and sphenoid sinus stimulator 527, which stimulates the five cranial nerves on the lateral wall of the sinus embedded in the cavernous sinus, the internal carotid artery (Circle of Willis) in each wall of the cavernous sinus located on the lateral walls of the sphenoid sinus to create Iontophoresis”), the non-invasive neuromodulation device including a catheter (device 220), a first balloon (balloon 527) and a second balloon (balloon 519), the first balloon being coupled to and surrounding the catheter (view Figure 9), the first balloon including at least one electrode ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”), the second balloon coupled to and surrounding the catheter (view Figure 9); positioning the non-invasive neuromodulation device such that the first balloon is located proximate the sphenopalatine ganglion ([0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope. The insertion body consists of two parts. One part is an inflatable outer membrane or balloon 527, which is adapted in size and flexibility to fit inside the sphenoid sinus cavity.”); inflating the second balloon to retain the non-invasive neuromodulation device ([0176] “FIG. 7 is the view of diagram 700 of the present invention device 220 showing two balloons holding the therapeutic agents and electrical impulses delivering part of the device 520 in position between the sphenoid sinus with a balloon 525 and nasal balloon 519 without movement at the olfactory region for the treatment of Alzheimer's. The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522. The catheter and the balloon in the sphenoid sinus can incorporate with Iontophoresis electrical embodiment to create Iontophoresis in the wall of the sphenoid sinus. These inflated balloons hold the electrical impulses and therapeutic agent's delivery system on the olfactory mucosa (ORE) to the CNS in position, especially in patients who are difficult to control their movement.”, emphasis added); inflating the first balloon resulting in at least the at least one electrode of the first balloon contacting the sphenopalatine ganglion ([0177] “sphenoid sinus stimulator 527”, [0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope.”, view Figure 10, ); and electrically stimulating the sphenopalatine ganglion using the at least one electrode that is disposed along the first balloon ([0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope….The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon. These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields”).
Shantha fails to explicitly teach the second balloon located within the nasopharynx and retaining the device within the nasopharynx.
However, Haroon teaches double-balloon devices placed in the nasal cavity wherein “The double-balloon device was advanced into the affected nostril until reaches the nasopharynx (Fig. 1). The posterior balloon was inflated with 7–10 ml saline and the catheter extending out of the nostril is withdrawn carefully so that the balloon seats in the posterior nasal cavity” (pg. 408, 2. Patients and Methods and Figure 1(B)).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha’s device to have the second balloon located within the nasopharynx and retaining the device within the nasopharynx, as these prior art references are directed to double balloon catheters placed in the nasal cavity for treatment. One would be motivated to do this to anchor the balloon in the proper position.
Regarding claim 28, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses the method further including the step of inserting a guide wire through the catheter to guide the non-invasive neuromodulation device to a target location ([0175] “Injection port 521 utilized to pass the guide wire 523 to facilitate placement of this device with ease. The device insertion facilitated by the using flexible fiber optic nasal scope and guide wire 523.”, [0203] “a guide wire used through 350 canula to negotiate, and for the proper placement of the delivery catheter”).
Regarding claim 29, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses wherein the step of deploying the non-invasive neuromodulation device intranasally comprises inserting the non-invasive neuromodulation through the nose into the nasal cavity ([0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope.”).
Regarding claim 30, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses wherein the step of inflating the first balloon comprising inflating the first balloon until the at least one electrode is in contact with the sphenopalatine ganglion ([0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope… One part is an inflatable outer membrane or balloon 527, which is adapted in size and flexibility to fit inside the sphenoid sinus cavity…The inflation syringe 526 used to pump air or fluid through the inflation tube to the interior of the balloon 527 so it inflates filling the sphenoid sinus cavity during the operation of the apparatus…The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon.”, [0283] “a) Due to the close proximity of the olfactory nerves, sphenopalatine ganglion and its branches, and trigeminal nerves, pituitary gland, hypothalamus, it is easy to stimulate the central nervous system by transmitting Iontophoresis electrical impulses (FIGS. 1-5, 10,11) and deliver therapeutic agents through these neural pathway”)
Regarding claim 31, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses wherein the first balloon is inflated independent of inflation of the second balloon ([0178] “The inflation syringe 526 used to pump air or fluid through the inflation tube to the interior of the balloon 527 so it inflates filling the sphenoid sinus cavity during the operation of the apparatus. An infusion tube is also connected to the interior of the balloon 527 and is used to pump fluid at ambient, elevated, or low temperatures through the infusion tube and to the interior of the balloon during the operation of the apparatus”, [0176] “The syringe 526 inflates the balloon in the sphenoid sinus 525 and the balloon in the nose 519 is inflated 522”).
Regarding claim 34, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses wherein the at least one electrode comprises a plurality of electrodes ([0178] “The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon. These electrical leads are connected by electrical connectors to an electrical output manipulator 517.”)
Regarding claim 39, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses the method further including the step of using an external actuator (electrical output manipulator 517) that is operatively coupled to the at least one electrode for controlling operation thereof to provide stimulation (view Figure 9, [0177] “The electrical impulses to create Iontophoresis field deliverer terminals activated through the electrical output manipulator 517.”, [0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields”) .
Regarding claim 41, Shantha in view of Haroon teaches the method of claim 39 (as shown above), wherein the external actuator comprises an electrical stimulator ([0178] “These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate and create Iontophoresis fields to deliver large MW therapeutic agents to the CNS bypassing blood-brain barrier.”, ).
Regarding claim 43, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses the step of deploying the non-invasive neuromodulation device intranasally comprises bending the catheter to position the first balloon proximate the sphenopalatine ganglion ([0389] “During the insertion, hold the device directed towards the external canthus of the eye abutting against the outer edge of the nose, directing it upwards and backwards…Then pass further the device about another 5 centimeters as to place it on the ORE, and the tip close to or into the ostium of sphenoid sinus”, [0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope.”, [0292] “d) Electrical impulses act as iontophoresis, of the olfactory mucosa, sphenopalatine ganglion and sphenoid sinus lining (FIG. 17)”, [0180] “The inner portion of this connector assembly constitutes part of the insertion body. This assembly needs to be small in diameter and flexible for easy insertion through the nose and into the sphenoid sinus cavity ostium.”, view Figure 7).
Shantha fails to explicitly disclose the second balloon within the nasopharynx.
However, Haroon, Yasser, et al. "Embolization for control of refractory posterior epistaxis." The Egyptian Journal of Radiology and Nuclear Medicine 43.3 (2012): 407-411. Teaches double-balloon devices placed in the nasal cavity wherein “The double-balloon device was advanced into the affected nostril until reaches the nasopharynx (Fig. 1). The posterior balloon was inflated with 7–10 ml saline and the catheter extending out of the nostril is withdrawn carefully so that the balloon seats in the posterior nasal cavity” (pg. 408, 2. Patients and Methods and Figure 1(B)).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha’s device to incorporate the teachings of Haroon to have the second balloon within the nasopharynx, as these prior art references are directed to double balloon catheters placed in the nasal cavity for treatment. One would be motivated to do this to anchor the balloon in the proper position.
Regarding claim 46, Shantha discloses the method of claim 45(as shown above). Shantha further discloses wherein the non-invasive neuromodulation device is positioned such that the first balloon is located adjacent the sphenopalatine ganglion ([0389] “During the insertion, hold the device directed towards the external canthus of the eye abutting against the outer edge of the nose, directing it upwards and backwards…Then pass further the device about another 5 centimeters as to place it on the ORE, and the tip close to or into the ostium of sphenoid sinus”, [0178] “The balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope.”, [0292] “d) Electrical impulses act as iontophoresis, of the olfactory mucosa, sphenopalatine ganglion and sphenoid sinus lining (FIG. 17)”, [0180] “The inner portion of this connector assembly constitutes part of the insertion body. This assembly needs to be small in diameter and flexible for easy insertion through the nose and into the sphenoid sinus cavity ostium.”, view Figure 7).
Shantha fails to explicitly disclose the second balloon is located within the nasopharynx.
However, Haroon teaches double-balloon devices placed in the nasal cavity wherein “The double-balloon device was advanced into the affected nostril until reaches the nasopharynx (Fig. 1). The posterior balloon was inflated with 7–10 ml saline and the catheter extending out of the nostril is withdrawn carefully so that the balloon seats in the posterior nasal cavity” (pg. 408, 2. Patients and Methods and Figure 1(B)).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha’s device to incorporate the teachings of Haroon and have the second balloon is located within the nasopharynx, as these prior art references are directed to double balloon catheters placed in the nasal cavity for treatment. One would be motivated to do this to anchor the balloon in the proper position.
Regarding claim 47, Shantha in view of Haroon teaches the method of claim 46 (as shown above). Shantha fails to explicitly disclose wherein the second balloon is inflated prior to inflation of the first balloon to securely hold the non-invasive neuromodulation device within the nasopharynx prior to inflating the first balloon to contact the at least one electrode with the sphenopalatine ganglion.
However, Haroon teaches wherein “The double-balloon device was advanced into the affected nostril until reaches the nasopharynx (Fig. 1). The posterior balloon was inflated with 7–10 ml saline and the catheter extending out of the nostril is withdrawn carefully so that the balloon seats in the posterior nasal cavity… The anterior balloon is then inflated with roughly 15–30 ml saline in the anterior nasal cavity to prevent retrograde travel of the posterior balloon” (pg. 408, 2. Patients and methods)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha’s device to incorporate the teachings of Haroon to have the second balloon is inflated prior to inflation of the first balloon to securely hold the non-invasive neuromodulation device within the nasopharynx prior to inflating the first balloon to contact the at least one electrode with the sphenopalatine ganglion, as these prior art references are directed to double balloon catheters placed in the nasal cavity. One would be motivated to do this to ensure that the balloon is secure before applying the stimulation.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha in view of Haroon as applied to claim 34 above, and further in view of Townley.
Regarding claim 35, Shantha in view of Haroon teaches the method of claim 34 (as shown above), and further discloses the balloon having “multiple electrical leads on the exterior of the balloon as shown on the balloon” ([0178], Figure 9), but fails to explicitly disclose wherein the plurality of electrodes are disposed circumferentially around the first balloon.
However, Townley teaches a device for therapeutic nasal neuromodulation wherein the plurality of electrodes are dispose circumferentially around the first balloon ([0100] “As shown in FIGS. 8 and 9, the electrodes 858 can be positioned on the expandable member 856 in a substantially symmetrical manner and a uniform distribution”, view Figures 5 and 8-9).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha and Haroon to incorporate the teachings of Townley to have the wherein the plurality of electrodes are disposed circumferentially around the first balloon, as these prior art references are directed to providing neuromodulation through the nasal pathway. One would be motivated to do this to allow for better contact with the target region.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha in view of Haroon as applied to claim 39 above, and further in view of Lamensdorf.
Regarding claim 42, Shantha in view of Haroon teaches the method of claim 39 (as shown above). Shantha further discloses where the current applied has different waveforms ([0226]) and that an operator/patient may select a current from the electrical output manipulator ([0232]), but Shantha and Haroon, alone or in combination, fail to explicitly teach wherein the external actuator includes at least two different operating modes in which intensity of the electrical stimulation differs between the modes.
However, Lamensdorf teaches a method for treating a subject including applying electrical stimulation to a sphenopalatine ganglion (SPG) wherein the external actuator includes at least two different operating modes in which intensity of the electrical stimulation differs between the modes (Column 27, lines 20-26: “the control unit is configured to drive the one or more electrodes to apply the stimulation during the first period at a first stimulation strength and during the last period at a second stimulation strength, and to set the second stimulation strength to be different from the first stimulation strength, such as less than or greater than the first stimulation strength.”, Column 12, lines 15-52: acute stage and rehabilitative stage).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha and Haroon to incorporate the teachings of Lamensdorf to have the external actuator includes at least two different operating modes in which intensity of the electrical stimulation differs between the modes, as these prior art references are directed to stimulating the SPG. One would be motivated to do this as these different stages can apply different therapeutic effects (Column 64, line 28-Column 65, line 25).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha in view of Haroon as applied to claim 27 above, and further in view of Patel (US 2024/0024664 A1), hereinafter Patel.
Regarding claim 36, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha further discloses that the size of the balloon is adjusted according to the size of the patient’s nose ([0174], [0178]), but fails to explicitly disclose wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis.
However, Patel teaches methods and devices for treatment or assessment of structures or nerves accessible via the nasal cavity utilizing electrical stimulation (Abstract) wherein “In various embodiments, a dilated balloon has diameter between 5 and 40 mm, and a length between 10 and 50 mm. The size of the balloon utilized can vary and can be selected depending on the location of electrical stimulation and/or signal recording. For instance, the maxillary, the ethmoid, the frontal, and the sphenoid sinus cavities each have a unique volume and surface area distribution.” ([0043], Examiner interprets the major axis as the length and the minor axis as the diameter.).
Although, Patel does not explicitly teach these values, it would be obvious to one of ordinary skill in the art to use values within these ranges because Patel’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233. Additionally, Examiner would like to note that Shantha discloses adjusting the balloon size according to the nasal cavity and Patel teaches ranges given for balloons that are placed in the nasal cavity.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha and Haroon to incorporate the teachings of Patel to have wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis, as these prior art references are directed to treatment using balloon catheters in the nasal cavity. One would be motivated to do this to have the balloon sized perfectly for the nasal cavity
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 17 above, and further in view of Noda (US Patent 6,669,711 B1), hereinafter Noda.
Regarding claim 18, Shantha discloses the device of claim 17 (as shown above). Shantha fails to explicitly disclose wherein the external actuator is configured to be temporarily attached to a cheek of a patient.
However, Noda teaches a surgical balloon with a plurality of ballons placed in a nasal cavity wherein “a fixing device main body 26 is maintained stable by covering an area of the face including the cheek portions, nose side portions and philtrum” (Column 8, lines 51-53).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Noda to have the external actuator configured to be temporarily attached to a cheek of a patient, as these prior art references are directed to balloon catheters placed in the nasal cavity. One would be motivated to do this for stable position of the device and to allow for better visibility.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 39 above, and further in view of Noda (US Patent 6,669,711 B1), hereinafter Noda.
Regarding claim 40, Shantha in view of Haroon teaches the method of claim 39 (as shown above). Shantha and Haroon fails to explicitly disclose wherein the external actuator is configured to be temporarily attached to a cheek of a patient.
However, Noda teaches a surgical balloon with a plurality of ballons placed in a nasal cavity wherein “a fixing device main body 26 is maintained stable by covering an area of the face including the cheek portions, nose side portions and philtrum” (Column 8, lines 51-53).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha and Haroon to incorporate the teachings of Noda to have the external actuator configured to be temporarily attached to a cheek of a patient, as these prior art references are directed to balloon catheters placed in the nasal cavity. One would be motivated to do this for stable position of the device and to allow for better visibility.
Claim(s) 8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 1 above, and further in view of Subramanian (US 2017/0035997 A1), hereinafter Subramanian.
Regarding claim 8, Shantha discloses the device of claim 1 (as shown above). Shantha fails to explicitly disclose wherein a distance between the first balloon and the second ballon is between 2 cm and 20 cm.
However, Subramanian (US 2017/0035997 A1) teaches a dual double balloon catheter for delivering a radiation dose to a patient wherein a distance between the first balloon and the second ballon is between 2 cm and 20 cm ([0027] “The balloons, such as the balloons 307b and 315b, can be positioned to be spaced apart from each other as indicated at 382 by a desired amount of by about 2.5 cm from each other.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Subramanian to have the distance between the first balloon and the second balloon be between 2 cm and 20 cm, as these prior art references are directed to dual balloon catheter placed in dual catheters. One would be motivated to do this to properly position the balloons.
Additionally, Examiner would like to note that Shantha discloses wherein positioning between the sphenoid sinus and the nasal balloon will keep the stimulating part of the device located firmly in the desired location ([0175]), it would have been obvious to one skilled in the art to have modified Shantha to have the distance between the balloons be between 2 cm and 20 cm, for advantage of maintain the ballons at the target region. Additionally, it should be noted that the applicant has provided no criticality for this range.
Regarding claim 14, Shantha discloses the device of claim 4 (as shown above). Shantha fails to explicitly disclose wherein the catheter has an outer diameter of 5.8 mm and an inner diameter of 4 mm; the first tube has an outer diameter of 1.9 mm and an inner diameter of 1.7 mm; and the second tube has an outer diameter of 1.9 mm and an inner diameter of 1.7 mm.
However, Subramanian (US 2017/0035997 A1) teaches a dual double balloon catheter for delivering a radiation dose to a patient wherein the catheter has an outer diameter of 5.8 mm and an inner diameter of 4 mm; the first tube has an outer diameter of 1.9 mm and an inner diameter of 1.7 mm; and the second tube has an outer diameter of 1.9 mm and an inner diameter of 1.7 mm ([0026]-[0027] “diameter 321 of the dual double balloon catheter 100 of FIG. 1A is typically about 0.45 cm. However, the diameter 321 can be of any suitable value depending on the use of the dual double balloon catheter 100 and is not to be construed in a limiting sense…The typical diameter of the lumens 101a, 102a, 105a and 108a for inflating the balloons 307a, 307b, 315a, and 315b, are in the range of 0.8 mm to 1.5 mm, for example.”, ).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of Subramanian to have the catheter has an outer diameter of 5.8 mm and an inner diameter of 4 mm; the first tube has an outer diameter of 1.9 mm and an inner diameter of 1.7 mm; and the second tube has an outer diameter of 1.9 mm and an inner diameter of 1.7 mm, as these prior art references are directed to dual balloon catheters. One would be motivated to do this to have a suitable size to be placed in the body cavity.
Although Subramanian does not explicitly teach these values, it would be obvious to one of ordinary skill in the art to use values within these ranges because Subramanian’s ranges are shown to be effective and they overlap heavily with the claimed ranges, therefore discovering the optimum or workable ranges of a result effective variable involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 27 above, and further in view of Subramanian (US 2017/0035997 A1), hereinafter Subramanian.
Regarding claim 33, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha and Haroon, alone or in combination, fails to explicitly teach wherein a distance between the first balloon and the second ballon is between 2 cm and 20 cm.
However, Subramanian teaches a dual double balloon catheter for delivering a radiation dose to a patient wherein a distance between the first balloon and the second ballon is between 2 cm and 20 cm ([0027] “The balloons, such as the balloons 307b and 315b, can be positioned to be spaced apart from each other as indicated at 382 by a desired amount of by about 2.5 cm from each other.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha and Haroon to incorporate the teachings of Subramanian to have the distance between the first balloon and the second balloon be between 2 cm and 20 cm, as these prior art references are directed to dual balloon catheter placed in dual catheters. One would be motivated to do this to properly position the balloons.
Additionally, Examiner would like to note that Shantha discloses wherein positioning between the sphenoid sinus and the nasal balloon will keep the stimulating part of the device located firmly in the desired location ([0175]), it would have been obvious to one skilled in the art to have modified Shantha to have the distance between the balloons be between 2 cm and 20 cm, for advantage of maintain the ballons at the target region. Additionally, it should be noted that the applicant has provided no criticality for this range.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha as applied to claim 1 above, and further in view of DuBois (US 2019/0029880 A1), hereinafter DuBois.
Regarding claim 12, Shantha discloses the device of claim 1 (as shown above). Shantha fails to explicitly disclose wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis.
However, DuBois teaches an inflatable nasal balloon catheter ([0003]) wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis ([0056] “a diameter of between 10 mm and 75 mm, a length of between 5 mm and 100 mm”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of DuBois to have the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis, as these prior art references are directed to balloon catheters placed in the nasal cavity. One would be motivated do this so that the balloon has an adequate size for the body cavity.
Regarding claim 13, Shantha in view of DuBois teaches the device of claim 12 (as shown above). Shantha fails to disclose wherein the first balloon has a volume of 2.35 ml and the second balloon has a volume of 3.1 ml.
However, Dubois discloses wherein the first balloon has a volume of 2.35 ml and the second balloon has a volume of 3.1 ml ([0056] “a volume of between 0.5 ml and 450 ml for plugging a bleeding nose”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of DuBois to have the first balloon has a volume of 2.35 ml and the second balloon has a volume of 3.1 ml, as these prior art references are directed to balloon catheters placed in the nasal cavity. One would be motivated do this so that the balloon has an adequate size for the body cavity.
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shantha in view of Haroon as applied to claim 27 above, and further in view of DuBois (US 2019/0029880 A1), hereinafter DuBois.
Regarding claim 36, Shantha in view of Haroon teaches the method of claim 27 (as shown above). Shantha and Haroon, alone or in combination, fail to explicitly teach wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis.
However, DuBois (US 2019/0029880 A1) teaches an inflatable nasal balloon catheter ([0003]) wherein the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis ([0056] “a diameter of between 10 mm and 75 mm, a length of between 5 mm and 100 mm”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha to incorporate the teachings of DuBois to have the first balloon has dimensions of 10 mm/7.5 mm, as measured along a major axis/minor axis, and the second balloon has dimensions of 12.5 mm/8 mm, as measured along a major axis/minor axis, as these prior art references are directed to balloon catheters placed in the nasal cavity. One would be motivated do this so that the balloon has an adequate size for the body cavity.
Regarding claim 37, Shantha in view of Haroon in view of DuBois teaches the method of claim 36 (as shown above). Shantha and Haroon, alone or in combination, fails to teach wherein the first balloon has a volume of 2.35 ml and the second balloon has a volume of 3.1 ml.
However, Dubois discloses wherein the first balloon has a volume of 2.35 ml and the second balloon has a volume of 3.1 ml ([0056] “a volume of between 0.5 ml and 450 ml for plugging a bleeding nose”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shantha and Haroon to incorporate the teachings of DuBois to have the first balloon has a volume of 2.35 ml and the second balloon has a volume of 3.1 ml, as these prior art references are directed to balloon catheters placed in the nasal cavity. One would be motivated do this so that the balloon has an adequate size for the body cavity.
Conclusion
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/ATTIYA SAYYADA HUSSAINI/ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
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