DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0239476 A1 to Lee et al. (hereinafter “Lee”) in view of US 2019/0046797 A1 to Calixto et al. (hereinafter “Calixto”) and US 2009/0287278 A1 to Charvin.
Regarding claim 1, Lee teaches:
A cochlear implant (see abstract, line 1), comprising:
a cochlear lead including a plurality of electrodes (see annotated fig. 30 below and para 0069);
a housing (see fig. 30 below, 202 and para 0069: “The cochlear implant 200 includes a flexible housing 202 formed from a silicone elastomer or other suitable material, a processor assembly 204, a cochlear lead 206, and an antenna 208 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit. ”) including a magnet pocket defining a magnet pocket diameter (see para 0006: “The implant magnet may, for example, be located within a pocket in the cochlear implant housing”, and para 0069: “The magnet apparatus 100 is located within a region encircled by the antenna 208 (e.g., within an internal pocket 202a defined by the housing 202) and insures that an external antenna (discussed below) will be properly positioned relative to the antenna 208”)—the pocket diameter is inherent, due to the pocket being circular (as shown in fig. 30, 202a);
an antenna within the housing and adjacent to the magnet pocket (see fig. 30, 202, 202a, and 208 and para 0069: “The cochlear implant 200 includes a flexible housing 202 formed from a silicone elastomer or other suitable material, a processor assembly 204, a cochlear lead 206, and an antenna 208 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit.”);
a stimulation processor within the housing operably connected to the antenna and to the cochlear lead (see fig. 30, 204 and 214a below, and para 0069: “The exemplary processor assembly 204, which is connected to the electrode array 212 and antenna 208, includes a printed circuit board 214 with a stimulation processor 214a that is located within a hermetically sealed case 216”);
and
a magnet system/magnet apparatus (see fig. 3, 100 and para 0069, first sentence) located within the magnet pocket (see fig. 30, 100 and 202a and para 0069),
including a non-magnetic spacer/lubricious ring (see fig. 18, 124 and para 0063, first three sentences) including a receptacle (see annotated fig. 18 below and para 0063: “Here, however, a pair of lubricious disks 122 and a lubricious ring 124 formed from PTFE, a hard material (e.g. titanium) with a lubricious coating, or other suitable materials are positioned between the case 102 and the magnet frame 108.”)—the inside of the ring 124 forms the receptacle, and at least one magnet located within the hermetically sealed case (See fig. 30 – 100 & 216, and para 0069, last two sentences), but does not disclose wherein the housing includes a top wall above the magnet pocket, a bottom wall that does not include an opening below the magnet pocket, and a magnet aperture that extends through the top wall to the magnet pocket, wherein the receptacle defines an outer diameter that is substantially equal to the magnet pocket diameter, and wherein a hermetically sealed case located within the receptacle.
However, Calixto teaches a method and apparatus for installing an apparatus into a cochlear implant (see abstract). The system (fig. 4) contains a top wall above the magnet pocket (see fig. 4, 44), a bottom wall that does not include an opening below the magnet pocket (see fig. 4, 48), and a magnet aperture that extends through the top wall to the magnet pocket (see fig. 4, 42 and para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Calixto to arrive at the claimed invention. Such modification would improve the system by allowing for easy access and removal of the magnet system when necessary.
However, Calixto does not explicitly disclose wherein the receptacle defines an outer diameter that is substantially equal to the magnet pocket diameter, and wherein a hermetically sealed case located within the receptacle.
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Yet, Charvin teaches an implantable cochlear device (see abstract, lines 1-3 and para 0003). The device (figs. 1, 3, and 4C) contains a magnet located in a central housing/magnet pocket, a case, and a receptacle (see abstract, fig. 4A- 13 & 22, fig. 4C – 13, 131, and 23, para 0031, para 0038, para 0041, and para 0044, first sentence), wherein the receptacle (See fig. 4C, 131) defines an outer diameter that is substantially equal to the magnet pocket diameter/central housing (see annotated figs. 4A and 4C below), and wherein the case is located within the receptacle (See fig. 4C -- 131 and 23, and para 0044, first sentence.).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Calixto and Charvin to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system is securely position in the cochlear implant, ensuring the device is operating effectively while preserving the safety of the patient.
Regarding claims 2 and 8, Lee as modified teaches:
A cochlear implant as claimed in claims 1 and 7, wherein the non-magnetic spacer/lubrication ring includes a base (see fig. 18, 122) and an annular/ring-shaped side wall (see fig. 18, 124) that together define the receptacle (see fig. 18, 122 and 124, and para 0063: “To facilitate rotation of the magnet frame 108 and/or the magnets 110, lubricious friction reducing material may be provided between the case 102 and the magnet frame 108 and/or between the magnets 110 and the case 102 and magnet frame 108. For example, the magnet apparatus 100a illustrated in FIGS. 16-18 is substantially similar to the magnet apparatus 100 and similar elements are represented by similar reference numerals. Here, however, a pair of lubricious disks 122 and a lubricious ring 124 formed from PTFE, a hard material (e.g. titanium) with a lubricious coating, or other suitable materials are positioned between the case 102 and the magnet frame 108. ”).
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Regarding claim 3, Lee teaches:
A cochlear implant as claimed in claim 1, wherein the non-magnetic spacer includes a top portion and bottom portion that together define the receptacle (see annotated fig. 18 below and para 0063).
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Regarding claim 5, Lee as modified teaches:
A cochlear implant as claimed in claim 1, further comprising:
a frame within the hermetically sealed case (see fig. 16 - 102 and 104, fig. 18 – 104, 106, and 108, para 0057 – emphasis on the following sentence: “The exemplary case 102 is not limited to any particular configuration, size or shape. In the illustrated implementation, the case 102 is a two-part structure that includes the base 104 and the cover 106 which are secured to one another in such a manner that a hermetic seal is formed between the cover and the base.”, and para 0063);
wherein the hermetically sealed case defines a central axis (see fig. 16, A1 and para 0054);
the frame is rotatable relative to the hermetically sealed case about the central axis of the hermetically sealed case (see fig. 16 - A1 and para 0054);
and
the at least one magnet comprises a plurality of elongate diametrically magnetized magnets that are located in the frame and are rotatable relative to the frame (see fig. 18, 108 and 110 and para 0054).
Regarding claim 7, Lee teaches:
A cochlear implant (see abstract, line 1), comprising:
a cochlear lead including a plurality of electrodes (see annotated fig. 30 below and para 0069);
a housing (see fig. 30 below, 202 and para 0069: “The cochlear implant 200 includes a flexible housing 202 formed from a silicone elastomer or other suitable material, a processor assembly 204, a cochlear lead 206, and an antenna 208 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit. ”) including a magnet pocket defining a magnet pocket diameter (see para 0006: “The implant magnet may, for example, be located within a pocket in the cochlear implant housing”, and para 0069: “The magnet apparatus 100 is located within a region encircled by the antenna 208 (e.g., within an internal pocket 202a defined by the housing 202) and insures that an external antenna (discussed below) will be properly positioned relative to the antenna 208”)—the pocket diameter is inherent, due to the pocket being circular (as shown in fig. 30, 202a);
an antenna within the housing and adjacent to the magnet pocket (see fig. 30, 202, 202a, and 208 and para 0069: “The cochlear implant 200 includes a flexible housing 202 formed from a silicone elastomer or other suitable material, a processor assembly 204, a cochlear lead 206, and an antenna 208 that may be used to receive data and power by way of an external antenna that is associated with, for example, a sound processor unit.”);
a stimulation processor within the housing operably connected to the antenna and to the cochlear lead (see fig. 30, 204 and 214a below, and para 0069: “The exemplary processor assembly 204, which is connected to the electrode array 212 and antenna 208, includes a printed circuit board 214 with a stimulation processor 214a that is located within a hermetically sealed case 216”);
and
a magnet system/magnet apparatus (see fig. 3, 100 and para 0069, first sentence) located within the magnet pocket (see fig. 30, 100 and 202a and para 0069),
a hermetically sealed case (see para 0057, first two sentences), a non-magnetic spacer/lubrication ring (see fig. 18, 124 and para 0063, first three sentences) located within the hermetically sealed case and including a receptacle (see fig. 16 - 102, annotated fig. 18 below, para 0057 - first sentence, and para 0063),
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and at least one magnet that is located within the receptacle (which is first located in the frame, and therefore is ultimately located in the receptacle) (see abstract, para 0012, fig. 18 above, 108, 110, and the receptacle displayed above),
but does not explicitly disclose the following:
wherein the hermetically sealed case defines an outer diameter that is substantially equal to the magnet pocket diameter, a top wall above the magnet pocket, a bottom wall that does not include an opening below the magnet pocket, and a magnet aperture that extends through the top wall to the magnet pocket, and wherein the magnet system is removable from the pocket by way of the magnet aperture.
However, Charvin teaches an implantable cochlear device (see abstract, lines 1-3 and para 0003). The device (figs. 1, 3, and 4C) contains a magnet located in a central housing/magnet pocket, a case, and a receptacle (see abstract, fig. 4A- 13 & 22, fig. 4C – 13, 131, and 23, para 0031, para 0038, para 0041, and para 0044, first sentence), wherein the case (see fig. 4C below) defines an outer diameter that is substantially equal to the magnet pocket diameter/central housing (see annotated figs. 4A and 4C below), and wherein the case is located within the receptacle (See fig. 4C -- 131 and 23, and para 0044, first sentence).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Charvin to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system is securely position in the cochlear implant, ensuring the device is operating effectively while preserving the safety of the patient.
Although Charvin discloses the similarities in the diameter of the casing and magnet pocket/central housing, Charvin does not explicitly disclose wherein the casing has a top wall above the magnet pocket, a bottom wall that does not include an opening below the magnet pocket, and a magnet aperture that extends through the top wall to the magnet pocket, and wherein the magnet system is removable from the pocket by way of the magnet aperture.
However, Calixto teaches a method and apparatus for installing an apparatus into a cochlear implant (see abstract). The system (fig. 4) contains a top wall above the magnet pocket (see fig. 4, 44), a bottom wall that does not include an opening below the magnet pocket (see fig. 4, 48), and a magnet aperture that extends through the top wall to the magnet pocket (see fig. 4, 42 and para 0006), and wherein the magnet system is removable from the pocket by way of the magnet aperture (see para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Calixto and Charvin to arrive at the claimed invention. Such modification would improve the system by allowing for easy access and removal of the magnet system when necessary.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Calixto and Charvin, and further in view of US 2018/0133486 A1 to Smith et al. (hereinafter “Smith”).
Regarding claims 4 and 9, Lee teaches:
A cochlear implant as claimed in claims 1 and 7, but does not explicitly disclose wherein the at least one magnet comprises an axially magnetized magnetic disk.
However, Smith teaches a cochlear implant system and magnet for use with the system (see title and abstract). The system (fig. 5) contains at least one magnet comprises an axially magnetized magnetic disk (see fig. 5 - 124, fig. 8, and para 0041).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Lee with the teachings of Smith to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system presents less pain on the dermis when a strong magnetic field is applied, therefore making it more comfortable for the patient.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Calixto and Charvin, and further in view of US 2014/0343626 A1 to Thenuwara et al. (hereinafter “Thenuwara”).
Regarding claim 6, Lee as modified teaches:
A cochlear implant as claimed in claim 1, but does not explicitly disclose wherein the non-magnetic spacer is permanently secured to the hermetically sealed case.
However, Thenuwara teaches a system for retaining a magnet in a cochlear implant (see abstract, lines 1-4). The system (figs. 1 and 4-6) teach wherein the spacer/embedded nest (see fig. 4, 405) is permanently secured to the hermetically sealed case/magnet case (see abstract, para 0062 and 0064, and figures discussed above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Lee with the teachings of Thenuwara to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system is securely position in the cochlear implant, ensuring the device is operating effectively while preserving the safety of the patient.
Claims 26-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Charvin and Thenuwara.
Regarding claim 26, Lee teaches:
A magnet system/magnet apparatus (see fig. 3, 100 and para 0069, first sentence), comprising:
non-magnetic spacer/lubricious ring (see fig. 18, 124 and para 0063, first three sentences) including a receptacle (see annotated fig. 18 below and para 0063: “Here, however, a pair of lubricious disks 122 and a lubricious ring 124 formed from PTFE, a hard material (e.g. titanium) with a lubricious coating, or other suitable materials are positioned between the case 102 and the magnet frame 108.”)—the inside of the ring 124 forms the receptacle, and a hermetically sealed case (see para 0057, first two sentences),
but does not disclose a hermetically sealed case is located within the receptacle, and
wherein the non-magnetic spacer is permanently secured to the hermetically sealed case.
However, Charvin teaches wherein a case is located within the receptacle (See fig. 4C -- 131 and 23, and para 0044, first sentence).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Charvin to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system is securely position in the cochlear implant, ensuring the device is operating effectively while preserving the safety of the patient.
Although Charvin teaches the case is located in the receptacle, they do not explicitly disclose wherein the non-magnetic spacer is permanently secured to the hermetically sealed case.
However, Thenuwara teaches a system for retaining a magnet in a cochlear implant (see abstract, lines 1-4). The system (figs. 1 and 4-6) teach wherein the spacer/embedded nest (see fig. 4, 405) is permanently secured to the hermetically sealed case/magnet case (see abstract, para 0062 and 0064, and figures discussed above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Charvin and Thenuwara to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system is securely position in the cochlear implant, ensuring the device is operating effectively while preserving the safety of the patient.
Regarding claim 27, Lee as modified teaches:
A magnet system as claimed in claim 26, wherein the non-magnetic spacer/lubrication ring includes a base (see fig. 18, 122) and an annular/ring-shaped side wall (see fig. 18, 124) that together define the receptacle (see fig. 18, 122 and 124, and para 0063: “To facilitate rotation of the magnet frame 108 and/or the magnets 110, lubricious friction reducing material may be provided between the case 102 and the magnet frame 108 and/or between the magnets 110 and the case 102 and magnet frame 108. For example, the magnet apparatus 100a illustrated in FIGS. 16-18 is substantially similar to the magnet apparatus 100 and similar elements are represented by similar reference numerals. Here, however, a pair of lubricious disks 122 and a lubricious ring 124 formed from PTFE, a hard material (e.g. titanium) with a lubricious coating, or other suitable materials are positioned between the case 102 and the magnet frame 108. ”).
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Regarding claim 28, Lee as modified teaches:
A magnet system as claimed in claim 26, wherein the non-magnetic spacer includes a top portion and bottom portion that together define the receptacle (see annotated fig. 18 below and para 0063).
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Regarding claim 30, Lee as modified teaches:
A magnet system as claimed in claim 26, further comprising:
a frame within the hermetically sealed case (see fig. 16 - 102 and 104, fig. 18 – 104, 106, and 108, para 0057 – emphasis on the following sentence: “The exemplary case 102 is not limited to any particular configuration, size or shape. In the illustrated implementation, the case 102 is a two-part structure that includes the base 104 and the cover 106 which are secured to one another in such a manner that a hermetic seal is formed between the cover and the base.”, and para 0063);
wherein the hermetically sealed case defines a central axis (see fig. 16, A1 and para 0054);
the frame is rotatable relative to the hermetically sealed case about the central axis of the hermetically sealed case (see fig. 16 - A1 and para 0054);
and,
the at least one magnet comprises a plurality of elongate diametrically magnetized magnets that are located in the frame and are rotatable relative to the frame (see fig. 18, 108 and 110 and para 0054).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Charvin and Thenuwara, and further in view of Smith.
Regarding claim 29, Lee as modified teaches:
A magnet system as claimed in claim 26, but does not explicitly disclose wherein the at least one magnet comprises an axially magnetized magnetic disk.
However, Smith teaches a cochlear implant system and magnet for use with the system (see title and abstract). The system (fig. 5) contains at least one magnet comprises an axially magnetized magnetic disk (see fig. 5 - 124, fig. 8, and para 0041).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Lee with the teachings of Smith to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system presents less pain on the dermis when a strong magnetic field is applied, therefore making it more comfortable for the patient.
Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Smith.
Regarding claim 32, Lee teaches:
A magnet system/magnet apparatus (see fig. 3, 100 and para 0069, first sentence), comprising:
a hermetically sealed case (see para 0057, first two sentences);
a non-magnetic spacer/lubrication ring (see fig. 18, 124 and para 0063, first three sentences) located within the hermetically sealed case (case shown in fig. 16, 102 and annotated fig. 18 below) and including a receptacle (see annotated fig. 18 below and para 0063: “Here, however, a pair of lubricious disks 122 and a lubricious ring 124 formed from PTFE, a hard material (e.g. titanium) with a lubricious coating, or other suitable materials are positioned between the case 102 and the magnet frame 108.”)—the inside of the ring 124 forms the receptacle, and at least one magnet located within the receptacle (which is first located in the frame, and therefore is ultimately located in the receptacle) (see abstract, para 0012, fig. 18 above, 108, 110, and the receptacle displayed above),
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but does not explicitly disclose at least one magnet an axially magnetized magnetic disk that is located within the receptacle.
However, Smith teaches a cochlear implant system and magnet for use with the system (see title and abstract). The system (fig. 5) contains at least one magnet comprises an axially magnetized magnetic disk (see fig. 5 - 124, fig. 8, and para 0041) located in a pocket of the device (see fig. 4, para 0006).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Lee with the teachings of Smith to arrive at the claimed invention. Such modification would improve the system by ensuring the magnet system presents less pain on the dermis when a strong magnetic field is applied, therefore making it more comfortable for the patient.
Regarding claim 33, Lee as modified teaches:
A magnet system as claimed in claim 32, wherein the non-magnetic spacer/lubrication ring includes a base (see fig. 18, 122) and an annular/ring-shaped side wall (see fig. 18, 124) that together define the receptacle (see fig. 18, 122 and 124, and para 0063: “To facilitate rotation of the magnet frame 108 and/or the magnets 110, lubricious friction reducing material may be provided between the case 102 and the magnet frame 108 and/or between the magnets 110 and the case 102 and magnet frame 108. For example, the magnet apparatus 100a illustrated in FIGS. 16-18 is substantially similar to the magnet apparatus 100 and similar elements are represented by similar reference numerals. Here, however, a pair of lubricious disks 122 and a lubricious ring 124 formed from PTFE, a hard material (e.g. titanium) with a lubricious coating, or other suitable materials are positioned between the case 102 and the magnet frame 108. ”).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zimmerling (US 2017/0173334 A1) teaches a magnet arrangement for an implantable medical device, such as a cochlear implant (see abstract and para 0003).
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792