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 Objections
Claim 11 is objected to because of the following informalities:
Claim 10 reads “a push node”. It is believed that this is a typo and should be corrected to a “push force”.
Claim 11 reads “location is based the alignment” and should be corrected to “location is based on alignment”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 9-10, 12-14 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2, recites the limitations “a first target locations”, “a second target locations”, “a third target locations”, and “a fourth target locations”. It is unclear if each of these are singular or plural locations. It is suggested the claim be amended to “a first/second/third/fourth target location” (singular) to provide proper antecedent basis for “the first/second/third/fourth target location” in the respective following lines.
Claims 9-10 recites the limitation "of the ear canal in the first and third target location" and “of the ear canal in the second and fourth target location”. There is insufficient antecedent basis for this limitation in the claim. It is unclear of which administration position and which ear canal each location is associated with during the treatment method. Additionally, it is unclear how a singular magnetic assembly as disclosed in applicant specification can simultaneously create both a pushing force in one ear and pulling force in another ear of the patient. Fig. 3 in particular appears to show the magnetic field 348 only creating a pulling force.
Claims 12 recites the limitations “the first target location and the second target location is in the middle ear of the first ear” and “the third target location and the fourth target location is the middle ear of the second ear”. There is insufficient antecedent basis for the limitations in this claim. This claim does not match the limitations cited in claim 2. It is suggested this be corrected to “first target location and fourth target location is in the middle ear of the first ear” and “the second target location and the third target location is the middle ear of the second ear”.
Claim 13 recites the limitations “the first target location is the middle ear of the first ear and the third target location is the middle ear of the first ear”. There is insufficient antecedent basis for the limitations in this claim. It is suggested this claim be amended to be dependent on claim 2. This claim also does not match the limitations cited in claim 2. It is suggested this be corrected to “first target location is the middle ear of the first ear and fourth target location is in the middle ear of the first ear”.
Claim 14 recites the limitations “the second target location is the outer ear of the first ear and the fourth target location is the outer ear of the second ear”. There is insufficient antecedent basis for the limitations in this claim. It is suggested this claim be amended to be dependent on claim 2. This claim also does not match the limitations cited in claim 2. It is suggested this be corrected “the second target location is the outer ear of the second ear and the third target location is the outer ear of the second ear”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Claims 1-17 do not include additional elements that integrate the exception into a practical application of the exception or are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a method, which is a statutory category.
Step 2A - Prong 1: Claim 1 is drawn to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers limitations capable of being performed mentally and/or by hand.
In particular, claim 1 recites the following limitations:
[A1]: selecting a location of a headrest on the medical cart that is configured to support a patient in a fist administration position and a second administration position
[B1]: determining the location and position of a simulated patient, wherein the stimulated patient is positioned in the first administration position and the second administration position
[C1]: determining a plurality of target locations based on anatomy of the simulated patient, determining (X,Y,Z) coordinates of the plurality of target locations relative to an origin location at (0,0,0)
[D1]: selecting a position of a magnetic assembly, wherein the position is relative to the origin location
[E1]: determining relative distance in space between the magnetic assembly and plurality of target locations
[F1]: selecting magnetic force directions relative to each of the plurality of target locations
[G1]: configuring the magnetic assembly where the plurality of magnetic elements are spatially located and directionally positioned such that the magnetic assembly produces magnetic force directions relative to each of the plurality of target locations.
These elements [A1]-[G1] of claim 1 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is capable of adjusting a head rest to an optimum position for treatment, determine where the patient should be positioned and where the treatment should be applied based on the anatomy of the patient, selecting where to position the magnet, selecting where the force should be applied, determine the magnetic field generated (for example is it a low, medium, or high magnetic field depending on what is need for treatment), determine the direction of the magnetic force applied by the magnet by seeing where the poles are facing, and adjusting the position of the magnet to ensure the target locations are being stimulated.
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites configuring the magnetic assembly:
[A2]: a medical cart
[B2]: a magnetic assembly comprises a plurality of magnetic elements, wherein each of the plurality of magnetic elements generates a magnetization that combines to produce a resulting magnetic field of the magnetic assembly
The elements [A2] – [B2] do not integrate the judicial exception into a practical application.
The elements [A2] – [B2] do not integrate the exception into a practical application of the exception because the elements generally link the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.04(d) and MPEP 2106.05(h). The elements do not integrate the exception to an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the configuration of the medical cart, nor does the method use a particular machine to perform the abstract idea. The examiner notes there’s no recitation of any particular machine used to perform the steps of claim 1.
Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional steps:
[A3]: determining a resulting magnetic field generated by the magnetic assembly such that the magnetic assembly generates the magnetic force directions relative to each of the plurality of target locations;
[B3]: determining a magnetization and direction for each of the plurality of magnetic elements;
The elements [A3]-[B3] do not amount to significantly more than the judicial exception itself.
Simply reciting the elements [A3]-[B3] do not qualify as significantly more because the element amounts to adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP 2106.05(g). It is noted that the claim fails to recite a structural element configured to determine a magnetic field and magnetization. Further, the determining steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Additionally, the element is well-understood, routine, and conventional as evidenced by Cameron (US 2005/0148808), Creighton (WO 2013/173235), and Pillutla (US 2009/0227830).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a medical cart or magnetic assembly, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a problem or a particular way to achieve a desired outcome.
Claims 2-17 depend from claim 1 and they recite the same abstract idea as claim 1. Furthermore, these claims are drawn to abstract ideas (that is, the claims only recite limitations that can be performed mentally or by hand or steps that amount to insignificant pre-solution data activity). Regarding claims 6-10, the claims recite expected end results of configuring the magnetic assembly towards the simulated patient.
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of medical carts and/or magnetic assemblies, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a medical cart-based problem or a particular way to achieve a desired magnetotherapy-based outcome.
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.
Claims 1, 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nishijima (US 2007/0299550) in view of Creighton (WO 2013/173235) (as cited in the applicant’s IDS). Further in view of Cameron (US 2005/0148808) (as cited in the applicant’s IDS).
Regarding claim 1, Nishijima teaches a method (a 3-D guidance and drug delivery system for magnetic nanoparticles) comprising:
determining the location and position of a simulated patient (paragraph [0064] “The inventors made an experimental system simulating the blood vessel”), wherein the simulated patient is positioned in the first administration position and the second administration position (paragraph [0070] “the drug delivery system of the present invention allows drug particles, injected into a vein, for example, by an injector or the like, to selectively pass through one of the branches of a vascular system including veins and arteries, and to be delivered along a predetermined vascular route to or close to an affected part“ and paragraph [0045] “As the bed 1 moves, the attractive forces f1, f2, f3 vary in direction to generate a Z-axis force on the magnetic particle carrier 8.” The examiner notes that the patient is in a initial administration position, the first administration position, and when the bed moves to move the magnetic force, the patient is in a second administration position. );
determining a plurality of target locations based on anatomy of the simulated patient (paragraph [0055] “The three-dimensional guidance system of the present invention can guide the magnetic particle carrier 8 through the blood vessel 9 to a target organ or cell part without using a conventional tool such as a catheter, and can administer the drugs 82 included in the magnetic particle carrier 8 to the target organ or cell part with a high local concentration.” The examiner notes that this device determines position based on a particle in a patient’s blood vessel, therefore would determine a location based on the anatomy of a patient.);
determining (X, Y, Z) coordinates of the plurality of target locations relative to an origin location at (0, 0, 0) (paragraph [0050] “The memory device 70 stores a previously measured vascular route and target position of a patient as three-dimensional route data. s” and paragraph [0026] “system controls the magnetic field intensity and gradient of the magnetic field formed by the magnetic field forming device, and thereby guides the drug particles along a predetermined vascular route close to the affected part, where the particles accumulate and aggregate.” The examiner notes that the route is stored as three-dimensional route data indicating X, Y, and Z coordinates which is relative to an origin. This is depicted in figure 3. );
selecting a position of a magnetic assembly, wherein the position is relative to the origin location (paragraph [0023] “Specifically, the driver is for moving a bed one-dimensionally by driving a bed drive motor, and the plurality of electromagnets are arranged to surround the bed, in a plane perpendicular to the bed moving direction. In this specific configuration, the magnetic particle carrier is position-controlled in one dimension by control of the bed drive motor, and position-controlled in two dimensions perpendicular to the one dimension by control of the magnetic force of the plurality of electromagnets.”) wherein the magnetic assembly comprises a plurality of magnetic elements (paragraph [0023] “the plurality of electromagnets”), wherein each of the plurality of magnetic elements generates a magnetization that combines to produce a resulting magnetic field of the magnetic assembly (paragraph [0045] “The internal magnetic particle carrier B experiences attractive forces f1, f2, f3 depending on the magnetic field intensity and gradient. As the bed 1 moves, the attractive forces f1, f2, f3 vary in direction to generate a Z-axis force on the magnetic particle carrier 8. The examiner notes that electromagnets (elements 3, 4, and 5) exhibit a magnetic force (f1, f2, and f3) that generates a resulting magnetic field (Z-axis force) to move that magnetic particle.();
determining relative distance in space between the magnetic assembly and the plurality of target locations (paragraph [0069] “the magnetic particles accumulate at a certain position, or selectively flow into one of the branch vessels, depending on the magnetic field position. This result indicates that adjusting the magnetic field forming device position relative to the blood vessel allows the magnetic particles to accumulate at a certain position, or to selectively flow into an intended branch vessel. The adjustment of the magnetic field forming device position relative to the blood vessel can be realized,” The examiner notes that to adjust the position of the magnetic field forming device the distance between the magnetic assembly and the target locations must be known.)
selecting magnetic force directions relative to each of the plurality of target locations (paragraph [0007] “In the above three-dimensional guidance system of the present invention, the magnetic particle carrier in the channel will experience a magnetic force (driving force), and move in the direction of that force”
determining a resulting magnetic field generated by the magnetic assembly such that the magnetic assembly generates the magnetic force directions relative to each of the plurality of target locations (paragraph [0007] “the magnetic particle carrier in the channel will experience a magnetic force (driving force), and move in the direction of that force, depending on the intensity and gradient of the magnetic field formed by the magnetic field forming means.”)
determining a magnetization and direction for each of the plurality of magnetic elements (paragraph [0016] “the magnetic particle carrier in the blood vessel will experience a magnetic force (driving force), and move in the direction of that force, depending on the intensity and gradient of the magnetic field formed by the magnetic field forming means.”);
Nishijima fails to teach a method for configuring a medical cart, the method comprising: selecting a location of a headrest on the medical cart that is configured to support a patient in a first administration position and a second administration position; and configuring the magnetic assembly where the plurality of magnetic elements are spatially located and directionally positioned such that the magnetic assembly produces magnetic force directions relative to each of the plurality of target locations.
Creighton teaches a device to with a magnetic assembly where the plurality of magnetic elements are spatially located and directionally positioned such that the magnetic assembly produces magnetic force directions relative to each of the plurality of target locations. (paragraph [0145] “The field and gradient are manipulated in the physical space 610. The rotation plane's normal vector 614 can be specified by the user in the global coordinate system 612 at the point in space 610, using the control button 608 or a handheld controller 622. Within the magnetic rotation plane 616 is the initial orientation of the magnetic field 618, which may be set automatically by the computer or manually by a user or operator. The user can specify the direction of the magnetic field rotation 620 in the magnetic rotation plane 616.”)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the system taught in Nishijima to move the magnet in various positions to manipulate the nanoparticle location as taught in Creighton. One of ordinary skill would have been able to recognize that the by moving both the base and the magnet in the treatment system would allow the operator to have more precise control over the navigation of the magnetic nanoparticles in the patient’s body.
Cameron teaches a method for positioning a TMS coil configuring a medical cart with a headrest (as shown in figure 1).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Nishijima and Creighton to be on a medical cart with a headrest. One of ordinary skill would have been able to recognize that the headrest would ensure proper positioning of the patient for treatment during the therapy and that the medical cart configuration would allow for easy set up for treatment of patients in multiple locations.
Regarding claim 5, Nishijima, Cameron, and Creighton teaches the method of claim 1, and Nishijima further teaches wherein each magnetic elements of the plurality of magnetic elements are selectively positioned and placed at (X, Y, Z) coordinate locations relative to the origin location, within the magnetic assembly. (paragraph [0055] “The three-dimensional guidance system of the present invention can guide the magnetic particle carrier 8 through the blood vessel 9 to a target organ or cell part without using a conventional tool such as a catheter, and can administer the drugs 82 included in the magnetic particle carrier 8 to the target organ or cell part with a high local concentration.” paragraph [0050] “The memory device 70 stores a previously measured vascular route and target position of a patient as three-dimensional route data.” and paragraph [0026] “system controls the magnetic field intensity and gradient of the magnetic field formed by the magnetic field forming device, and thereby guides the drug particles along a predetermined vascular route close to the affected part, where the particles accumulate and aggregate.” The examiner notes that the route is stored as three-dimensional route data indicating X, Y, and Z coordinates which would be relative to an origin location. This is depicted in figure 3.)
Regarding claim 17, Nishijima, Cameron, and Creighton teaches the method of claim 1, but fails to teach wherein the magnetization and direction of each of the plurality of magnetic elements is determined according mj= (mix, mjy,mjz), where m is the magnetization and j is the jth magnetic element in the magnetic assembly.
Creighton further teaches the magnetization and direction of each of the plurality of magnetic elements is determined according mj= (mix, mjy,mjz), where m is the magnetization and j is the jth magnetic element in the magnetic assembly. (paragraph [0145] “The field and gradient are manipulated in the physical space 610. The rotation plane's normal vector 614 can be specified by the user in the global coordinate system 612 at the point in space 610, using the control button 608 or a handheld controller 622. Within the magnetic rotation plane 616 is the initial orientation of the magnetic field 618, which may be set automatically by the computer or manually by a user or operator. The user can specify the direction of the magnetic field rotation 620 in the magnetic rotation plane 616.” And paragraph [011] “The remote control device can be used to manipulate the position and rotation plane in one, two, or three dimensions.”) The examiner notes that that the magnetization and direction are dependent on the global coordinate system consisting of an X, Y, and Z direction thus making the magnetization and direction of each of the plurality of magnetic elements is determined according mj= (mix, mjy,mjz), where m is the magnetization and j is the jth magnetic element in the magnetic assembly. Both Nishijima and Creighton use magnets to manipulate magnetic nanoparticles in the vasculature so it would be obvious to use the method of magnetization and direction calculation of Creighton in Nishijima as a matter of simple substitution of ways to calculate the magnetization and direction of magnets.
Claims 2, 3-4, 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Nishijima in view of Creighton in view of Cameron further in view of Shapiro (US 2014/0073835], as cited in the applicant’s IDS.
Regarding claim 2, Nishijima, Cameron and Creighton teaches the method of claim 1, and Nishijima further teaches moving a magnetic particle through a channel (paragraph [0005] “guiding an object such as a therapeutic drug to a target position along a channel”) but fails to teach that this channel is part of the ear anatomy.
Shapiro teaches moving a magnetic particle into a channel of the ear (paragraph [0002] “This disclosure relates generally to the delivery of agents to the ear of a mammal”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to use magnetic nanoparticles to treat sites that are in the inner or middle ear. One of ordinary skill in the art would have been able to recognize that infections that occur deeper into the ear tissue are difficult to reach with a therapeutic dose see paragraph [0014] of Shapiro.
Cameron further teaches a positioning system for a magnetotherapy device that repeatably identifies first through fourth target locations in a patient based on an anatomical location of ear canal anatomy. (paragraphs [0015] – [0019] “The invention also includes numerous methods of using the elements of the invention to repeatably position a transcranial magnetic stimulation (TMS) coil with respect to a patient to receive treatment. For example, a first method in accordance with the invention comprises the steps of: fixing the patient's head at a fixed position; defining a coordinate system about the fixed position; finding a treatment position on the patient for the TMS coil; recording the coordinates of the treatment position in the coordinate system.” Paragraph [0044] “The next step is to locate the patient’s MTP [motor threshold position] using established search techniques…start at 25 degrees and a point selected that is approximately 1/2 to 2/3 of the distance from the left auditory meatus (i.e. ear canal) to the vertex of the head” paragraph [0045] “In addition, as noted above, the positioner assembly 10 of the invention could be set up to target any other anatomical landmark of the patient that also produces a repeatable position relative to internal anatomy.” Paragraph [0043] “if other TMS treatments for other central nervous system diseases are being implemented, different treatment positions and planes would be identified and offset with respect to the pivot axis.” The examiner notes that the target is determined based off of the ear canal or alternatively this positioning system is dependent on an anatomical location so it would be an obvious matter of simple substitution to use the ear canal anatomy as the anatomical location. Further, since both the patient’s ears needs to be treated that would require a mapping of a position per ear and per administration position (active and passive) thus creating a first and third target location for active administration and a second and fourth target location for passive administration.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system in Nishijima to repeatedly measure a first through fourth target location over two administration positions as taught in Cameron. One of ordinary skill would have been able to recognize commercially available systems are complex and designed primarily for research purposes. Those systems use diagnostic images from MRI or PET systems to determine the spatial relationship between internal anatomy and external landmarks and then aligns to the external landmark for therapy or other studies requiring accurate localization. While this approach is useful for research purposes, it is highly impractical and complex and is thus not usable in general clinical practice. Moreover, such techniques have generally been used to overlay coordinate systems onto images and not for identifying particular treatment positions for specific therapies. See paragraph [0009] of Cameron.
Regarding claim 3, Nishijima, Cameron, and Creighton teach the method of claim 2, but fail to teach wherein the magnetization of each of the plurality of magnetic elements is the maximum magnetic saturation based on the composition material of the plurality of magnetic elements.
Shapiro teaches a method for directing agents on nanoparticles within the ear where each magnetic forces applied on the nanoparticle are dependent on the composition of the nanoparticles. (paragraph [0041] “The sizes, shapes, and coatings of agents can be varied and selected based on application parameters. The magnetic force on an agent typically varies with the volume of magnetic or magnetizable materials in that agent. Thus, to increase magnetic forces, it is desirable to choose larger agents. However, larger agents may experience larger barrier resistance to motion--for the same magnetic force, it may be more difficult to move a larger agent through a biological barrier such as a tissue membrane like the ear drum or window membranes. Larger agents may also create more damage to tissue as they move through it. For this reason, there can be a tradeoff: it may be suitable to pick agents that are big enough to experience sufficient magnetic forces but small enough to move through tissue barriers easily and without causing undesirable damage. Agents may be selected to have coatings or surfaces that allow easier passage through tissue barriers.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to have the magnetization of the magnetic elements (nano particles) be dependent on the composition material of the magnetic elements as taught in Shapiro. One of ordinary skill in the art would have been able to recognize that the magnetic forces created on agents by applied magnetic fields are known to a degree. For example, it is known that the magnetic force typically scales with the volume of magnetic or magnetizable material in the agent. Forces on agents can also be measured. Thus, agents can be selected to provide a desired degree of magnetic forces. See paragraph [0042] of Shapiro.
Regarding claim 4, Nishijima, Cameron, Creighton and Shapiro teach the method of claim 3, and Shapiro further teaches wherein the material composition of the plurality of magnets is same material composition for all of the plurality of magnets. (paragraph [0037] “In some exemplary embodiments, the magnetic fields may be provided in the form of one or more materials that are magnetic, i.e., that either exhibit a permanent magnetic field or that are capable of exhibiting a temporary magnetic field. The entire device, or selected portions thereof, may be manufactured from the one or more magnetic materials to provide a magnetic field generator.”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the magnets taught in Nishijima, Cameron, and Creighton be made of the same material as taught in Shapiro. One of ordinary skill in the art would have been able to recognize that having the same material in the magnetic elements would create a uniform magnetic field.
Regarding claim 6, Nishijima, Cameron, and Creighton teach the method of claim 2, but fail to teach explicitly wherein the resulting magnetic field creates directional forces at a desired angle or angles based on the plurality of target locations. However, the examiner notes that to move the magnetic particle to a target location, directional forces at a desired angle or angles would inherently occur.
In the alternative, Shapiro teaches that to direct magnetic elements magnets can create a magnetic field that create directional forces at a desired angle. (Figure 1 shows two magnets (element 10) placed at desired angles and create a force (F) in a specific direction to reach the target (T). Paragraph [0013] “In one embodiment, agents or active agents, e.g. particles associated with a therapeutic agent, can be applied away from a target site (e.g. ear canal or skin) and the device 10 can "push" or apply a force (F) on the particles to the target site (T).”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Nishijima, Cameron, and Creighton to have the magnets create fields that direct forces on the particles as taught in Shapiro. One of ordinary skill would have been able to recognize that typically, a single magnet can have field lines around it. The magnet can be set at an angle that creates a magnetic field along the horizontal x-axis at a desired location. A second magnet, with an opposite polarity, can be placed and angled in a configuration with respect to the first magnet so that the magnetic field is equal and opposite (along the minus x-axis) at the same desired location. The cancellation of the two fields can then create a node--a magnetic field zero or minimum. In one example, these two magnets are arranged such that the two magnetic fields overlap and can cancel at the location of the desired node point without canceling around that point. In one embodiment, a local magnetic field minimum can be created with a higher magnetic field surrounding the node. This creates magnetic forces. See paragraph [0020] of Shapiro.
Regarding claim 7, Nishijima, Cameron, Creighton and Shapiro teach the method of claim 6, and Shapiro further teaches wherein the desired angle or angles comprise orientation angles through ear drums of the patient. (paragraph [0048] “Shown in FIGS. 1 and 2A is a magnetic injection device and a method to apply it to direct magnetic or magnetizable agents through the ear drum into the middle ear.” The examiner notes that since the magnets are placed at an angle the magnetic forces would be generated in the angle the magnets face into the ear drum as noted in figure 2B.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Nishijima, Cameron, Creighton and Shapiro to be oriented through the ear drums as taught in Shapiro. One of ordinary skill would have been able to recognize that to have the therapeutic agents reach the inner ear without first puncturing the ear drum, the agents could be placed in the outer ear and the magnetic device or injector could be used to direct the agents first from the outer ear into the middle ear, and then from the middle ear into the inner ear. See paragraph [0015] of Shapiro.
Regarding claim 8, Nishijima, Cameron, Creighton and Shapiro teach the method of claim 2, Shapiro further teaches that the resulting magnetic field creates a pushing force in the direction of the middle ear at the plurality of target locations. (paragraph [0013] “In one embodiment, agents or active agents, e.g. particles associated with a therapeutic agent, can be applied away from a target site (e.g. ear canal or skin) and the device 10 can "push" or apply a force (F) on the particles to the target site (T).”)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Creighton and Cameron to have the magnets create fields that direct forces on the particles as taught in Shapiro. One of ordinary skill would have been able to recognize that typically, a single magnet can have field lines around it. The magnet can be set at an angle that creates a magnetic field along the horizontal x-axis at a desired location. A second magnet, with an opposite polarity, can be placed and angled in a configuration with respect to the first magnet so that the magnetic field is equal and opposite (along the minus x-axis) at the same desired location. The cancellation of the two fields can then create a node--a magnetic field zero or minimum. In one example, these two magnets are arranged such that the two magnetic fields overlap and can cancel at the location of the desired node point without canceling around that point. In one embodiment, a local magnetic field minimum can be created with a higher magnetic field surrounding the node. This creates magnetic forces. See paragraph [0020] of Shapiro.
Regarding claim 9, Nishijima, Cameron, Creighton, and Shapiro teach the method of claim 2, but fail to teach wherein the resulting magnetic field creates a pushing force in the direction of the ear canal at the first and the third target location, and a pulling force in the direction of the ear canal at the second and the fourth target location, wherein the direction of the pushing force and pulling force is from the outside inward along the ear canal.
Shapiro further teaches the resulting magnetic field creates a pulling force in the direction of the ear canal at the first and the third target location (paragraph [0038] “if after the magnetically injected therapy has acted in the middle or inner ear (for example, after drugs have been released from the agents into the middle or inner ear”), if it is desirable to remove the agents from the middle or inner ear, a magnet could be held near that ear. In reverse to the magnetic injection device, which applied injection forces, this magnet would pull the agents back out.” The examiner notes that this structure when applied to the method steps taught by Nishijima, Cameron, and Creighton would create a pulling force at the first and third target location.), and a pushing force of the ear canal at the second and the fourth target location (paragraph [0013] “In one embodiment, agents or active agents, e.g. particles associated with a therapeutic agent, can be applied away from a target site (e.g. ear canal or skin) and the device 10 can "push" or apply a force (F) on the particles to the target site (T). One embodiment includes a method for directing agents from the middle ear to the inner ear. Another embodiment includes a method for directing agents from the ear canal to the middle ear. Another embodiment includes a method for directing agents from the ear canal to the middle ear, and further directing agents to the inner ear.” The examiner notes that this structure when applied to the method steps taught by Nishijima, Cameron, and Creighton would create a pushing force at the second and fourth target location.), wherein the direction of the pushing force and pulling force is from the outside inward along the ear canal (paragraph [0047] “The magnetic device can be used to deliver therapeutic magnetic or magnetizable agents to the inner ears of animals and humans. The magnetic or magnetizable agents were placed in the middle ear by a syringe through the ear drum. The magnetic device can then held so that magnetic forces on the agents act to transport them from the middle ear into the inner ear.”).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Nishijima, Cameron and Creighton to have the magnets create fields that direct forces on the particles as taught in Shapiro. One of ordinary skill would have been able to recognize that typically, a single magnet can have field lines around it. The magnet can be set at an angle that creates a magnetic field along the horizontal x-axis at a desired location. A second magnet, with an opposite polarity, can be placed and angled in a configuration with respect to the first magnet so that the magnetic field is equal and opposite (along the minus x-axis) at the same desired location. The cancellation of the two fields can then create a node--a magnetic field zero or minimum. In one example, these two magnets are arranged such that the two magnetic fields overlap and can cancel at the location of the desired node point without canceling around that point. In one embodiment, a local magnetic field minimum can be created with a higher magnetic field surrounding the node. This creates magnetic forces. See paragraph [0020] of Shapiro.
Regarding claim 10, Nishijima, Cameron, Creighton and Shapiro teach the method of claim 2, Shapiro further teaches wherein the resulting magnetic field creates a pulling force in the direction of the ear canal at the first and the third target location, and a push node direction of the ear canal at the second and the fourth target location, wherein the direction of the pushing force and pulling force is from the outside inward along the ear canal (paragraph [0038] “if after the magnetically injected therapy has acted in the middle or inner ear (for example, after drugs have been released from the agents into the middle or inner ear), if it is desirable to remove the agents from the middle or inner ear, a magnet could be held near that ear. In reverse to the magnetic injection device, which applied injection forces, this magnet would pull the agents back out.” The examiner is modifying the system taught by Nishijima, Cameron, and Creighton to be able to create either a push or pull force at the first through fourth target locations in the first or second ear.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Nishijima, Cameron, Creighton and Shapiro to have the pushing and pulling force as taught by Shapiro. One of ordinary skill in the art would have been able to recognize that the treatment agents may need to be removed from the ear after being applied if they cannot be naturally cleared by the ear therefore the pulling force is necessary to allow this. See paragraph [0038] of Shapiro.
Regarding claim 12, Nishijima, Cameron, Creighton and Shapiro teach the method of claim 2, but fail to teach wherein the first target location and the fourth target location is the middle ear of the first ear, and the second target location and the third target location is the middle ear of the second ear. The examiner notes this claim has been corrected as suggested in section 112b to match the target location claim limitations in claim 2.
Shapiro further teaches targeting the middle ear with the magnetic device. (paragraph [0016] “As can be seen, the magnetic device may then be held near or proximal the ear to apply magnetic forces on the agents. The magnetic forces F then "pushes" or directs the agents 20 through the ear drum (tympanic membrane) and into the middle ear. In some examples, it is possible to deliver agents to the middle ear without puncturing the ear drum.” The examiner notes that the system taught by Nishijima, Cameron, and Creighton teach that multiple locations can have multiple targets based on the stimulation required to treat the ailment. Therefore, by modifying that system with the steps and methods taught by Shapiro the examiner notes that the first and fourth target location can be the middle ear of the first ear and the second and third target location can be the middle ear of the second ear.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to target the middle ear of both ears to ensure that treatment stays in the ear as taught by Shapiro. One of ordinary skill in the art would have been able to recognize the method can effectively treat middle and inner ear diseases such as middle ear infections (also known as otitis media or glue ear), tinnitus, sudden hearing loss, and Meniere's disease by local/topical treatment. See paragraph [0014] of Shapiro.
Regarding claim 13, Nishijima, Cameron, and Creighton teach the method of claim 1 but fail to teach wherein the first target location is the middle ear of the first ear and the fourth target location is the middle ear of the first ear. The examiner notes this claim has been corrected as suggested in section 112b to match the target location claim limitations in claim 2.
Shapiro further teaches targeting the middle ear with the magnetic device. (paragraph [0016] “As can be seen, the magnetic device may then be held near or proximal the ear to apply magnetic forces on the agents. The magnetic forces F then "pushes" or directs the agents 20 through the ear drum (tympanic membrane) and into the middle ear. In some examples, it is possible to deliver agents to the middle ear without puncturing the ear drum.” The examiner notes that the system taught by Nishijima, Cameron, and Creighton teach that multiple locations can have multiple targets based on the stimulation required to treat the ailment. Therefore, by modifying that system with the steps and methods taught by Shapiro the examiner notes that the first and fourth target location can be the middle ear of the first ear.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to target the middle ear of both ears to ensure that treatment stays in the ear as taught by Shapiro. One of ordinary skill in the art would have been able to recognize the method can effectively treat middle and inner ear diseases such as middle ear infections (also known as otitis media or glue ear), tinnitus, sudden hearing loss, and Meniere's disease by local/topical treatment. See paragraph [0014] of Shapiro.
Regarding claim 14, Nishijima, Cameron, Creighton and Shapiro teach the method of claim 2, but fail to teach wherein the second target location is the outer ear of the first ear and the third target location is the outer ear of the second ear. The examiner notes this claim has been corrected as suggested in section 112b to match the target location claim limitations in claim 2.
Shapiro further teaches targeting the middle ear with the magnetic device. (paragraph [0016] “As can be seen, the magnetic device may then be held near or proximal the ear to apply magnetic forces on the agents. The magnetic forces F then "pushes" or directs the agents 20 through the ear drum (tympanic membrane) and into the middle ear. In some examples, it is possible to deliver agents to the middle ear without puncturing the ear drum.” The examiner notes that the system taught by Nishijima, Cameron, and Creighton teach that multiple locations can have multiple targets based on the stimulation required to treat the ailment. Therefore, by modifying that system with the steps and methods taught by Shapiro the examiner notes that the second and third target location can be the middle ear of the second ear.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to target the middle ear of both ears to ensure that treatment stays in the ear as taught by Shapiro. One of ordinary skill in the art would have been able to recognize the method can effectively treat middle and inner ear diseases such as middle ear infections (also known as otitis media or glue ear), tinnitus, sudden hearing loss, and Meniere's disease by local/topical treatment. See paragraph [0014] of Shapiro.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nishijima, Cameron, Creighton further in view of Lan (CN 110269626).
Regarding claim 15, Nishijima, Cameron, and Creighton teach the method of claim 1 but fail to teach wherein the ear canal anatomy of the simulated patient is modeled on a predetermined age range and development of the patient.
Lan teaches a method for simulating an ear canal model based on patient age (page 3, paragraph 9 “making a patient model: according to the sex of the patient, the age selected height of the outer ear canal bracket is suitable” The examiner notes that if the model is based on the patient’s age then it will be changed as the patient develops.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to simulate the patient’s ear canal based on age and anatomy as taught by Lan. One of ordinary skill would have been able to recognize that ear canals are individual to the patient and treatment methods would need to vary based on the ear anatomy size of the patient to be effective.
Regarding claim 16, Nishijima, Cameron, Creighton, and Lan teach the method of claim 15 and Lan further teaches a method for simulating an ear canal model based on age range and development is a median head size and median ear canal of a child between the ages of 3-7 years old. (page 3, paragraph 9 “making a patient model: according to the sex of the patient, the age selected height of the outer ear canal bracket is suitable” The examiner notes that if the model is based on the patient’s age then it will be changed as the patient develops.)
It would be prima facie obvious to one of ordinary skill before the effective filing date to simulate the patient’s ear canal based on age and anatomy as taught by Lan. One of ordinary skill would have been able to recognize that it is not inventive to discover the optimum or workable ranges of a method by routine experimentation. The simulation of the patient’s ear canal would be dependent on the patient’s characteristics therefore any simulation would vary patient to patient. Please see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989), In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990), and MPEP 2144.05, II, A.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Nishijima, Cameron, Creighton further in view of Chen (US 2020/0000544).
Regarding claim 11, Creighton teaches the method of claim 1, but fails to teach wherein determining each of the plurality of target locations is based the alignment of simulated patient with a vertical position indicator and a horizontal position indicator on an alignment grid of the headrest.
Chen teaches a positioning system for radiation treatment of a patient (paragraph [0020] “The indexing of the shoulder pads 208 can be done, for example, using ruler grids printed on the base plate 202 that indicate the exact position on the surface of the base plate 202 onto which the shoulder pads 208 are placed, such that the exact position of the shoulder pads 208 can easily be reproduced.“; paragraph [0021] “the other head pad 216 can be moved to align with the top of the patient's head and locked in position. Similar to the shoulder pads 208, the position of the head pad 216 can be indexed, for example, using the ruler grids printed on the base plate 202. In one example, the base plate 202 has a set of grooves which the head pad 216 can be slid across to align with the top of the patient's head, and then locked to prevent movement of the head in the vertical direction”. The examiner notes that a ruler grid would have a vertical and horizontal position indicator.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method taught by Creighton determine target locations of a patient based on the alignment grid on a headrest. One of ordinary skill in the art would have been able to recognize that the treatment therapy process must be repeated over a period of a time and it is crucial to the efficacy of the treatment to make sure the target locations are accurately hit by the treatment, therefore having a marker or indicator that can show a user where to place the patient would help ensure that accuracy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li teaches a method for using magnetic nanoparticles to treat a targeted area in the body (WO 20091084078).
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/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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