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 .
Information Disclosure Statement
The information disclosure statement filed 5 January 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. For non-patent literature document citation 1 there is no corresponding non-patent literature filed.
Specification
The use of the term VelcroTM ([0044]-[0045]), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 2-3, 5-6 are objected to because of the following informalities: ensure clarity of the claim limitations. The claims should be amended to “[…] base [[portion]] […].” Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: pressure applicator portion and support portion in Claim 1 and first portion and second portion in Claim 14.
The disclosure cites:
The pressure applicator portion and first portion can inhibit movement of a magnetic device implanted in a recipient in a cochlear implant system or in a recipient during exposure of the magnetic device to an externally generated magnetic field ([0025] and [0034]), applies pressure at the location over the magnetic device ([0034]), is mounted on the base portion ([0035]), may be rotatable relative to the base portion ([0035]), is configured to apply a targeted pressure over the location of a magnetic device implanted in a recipient to inhibit movement of the magnetic device during exposure of the magnetic device to an externally generated magnetic field ([0036]), ensures pressure is localized over the magnetic device ([0036]), provides torque mitigation during exposure to an externally generated magnetic field ([0036]);
The support portion and second portion include stabilizing bumpers mounted on the base portion ([0038] and [0047]) and can be coated in a soft material, such as a food-grade (or medical grade) self-adhesive silicone-rubber sheet or lined with a thin foam lining ([0040]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1, the claim recites the limitation “pressure applicator portion” which is interpreted under 35 U.S.C. 112(f) according to analysis made of record. The “pressure applicator portion” is described exclusively in terms of the functions they perform, without naming a structure intended to be used, and therefore applicant has not demonstrated possession of that structure.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
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 4-5, 7, and 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
The term “substantially” in Claims 4 and 5 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of applying prior art, the limitation “substantially” is interpreted as at least half or more.
Regarding Claim 7, the limitation “magnetic implant locator” renders the claim indefinite. It is unclear if the “magnetic implant locator” is intended to be claimed as part of the apparatus. For purposes of applying prior art, the “magnetic implant locator” is interpreted as part of the apparatus, as in Figs. 8A and 8B.
Regarding Claim 18, the limitation “strap” renders the claim indefinite. It is unclear if the “strap” is intended to be claimed as part of the apparatus. For purposes of applying prior art, the “strap” is interpreted as part of the apparatus, as in Figs. 6A and 6B.
Claims not explicitly addressed above are rejected as depending from a rejected claim and failing to cure deficiencies of the parent claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-11, 14-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al. (US 20210330975).
Regarding Claim 1, Davis teaches an apparatus for inhibiting movement of a magnetic device relative to a recipient that is caused by exposing the magnetic device to a magnetic field generated externally to the recipient, ([0008] “magnet rotation may be avoided by surgically removing the positioning magnet prior to the MRI procedure and then reinserting the magnet after the procedure.”), wherein the magnetic device is implanted in the recipient, ([0034] (“One example of an apparatus for opposing torque imparted onto a cochlear implant magnet (or “apparatus”) in accordance with the present inventions is generally represented by reference numeral 100”), the apparatus comprising:
a) a pressure applicator portion, ([0034] “first and second splints 102”), configured to apply pressure against the recipient at a location over the magnetic device when the apparatus is pressed against the recipient ([0044] “splints may include an inflatable structure to provide localized pressure on the area over the implanted magnet and to improve patient comfort. By way of example, but not limitation, the exemplary splint 302 illustrated in FIG. 17 is substantially similar to splint 102”); and
b) a support portion, ([0034] “strap system 104”), configured to support the apparatus against the recipient at a different location than the location over the magnetic device when the pressure applicator portion applies pressure at the location over the magnetic device, wherein the location and the different location are spaced apart from each other (Figs. 7-10 and [0034] “the strap system 104 allows the straps that pull the splints 102 against the head (i.e., against the hair, and against skull albeit with a thin layer of skin in between) to be tightened to an extent sufficient to hold the magnet in place without sliding upwardly toward the crown of the head, and maintains the splints in the desired position.”).
Regarding Claim 2, Davis teaches all limitations of Claim 1, as discussed above. Furthermore, Davis teaches a base portion from which both the pressure applicator portion and the support portion extend ([0035] “The splint body 106, which is kidney shaped in the illustrated implementation, includes strap apertures 108 and may be a multi-layer structure with an inner layer 110”).
Regarding Claim 3, Davis teaches all limitations of Claim 2, as discussed above. Furthermore, Davis teaches wherein the base portion includes a surface that extends between, and that is recessed relative to, the pressure applicator portion and the support portion ([0035] “the splints 102 may be rigid (i.e., will not flex during normal use), with a curvature that conforms to the user's head”).
Regarding Claim 4, Davis teaches all limitations of Claim 1, as discussed above. Furthermore, Davis teaches wherein the support portion substantially surrounds the pressure applicator portion (Figs. 4 and 7-10).
Regarding Claim 5, Davis teaches all limitations of Claim 2, as discussed above. Furthermore, Davis teaches wherein the support portion extends substantially around a perimeter of the base portion (Figs. 4 and 7-10).
Regarding Claim 6, Davis teaches all limitations of Claim 2, as discussed above. Furthermore, Davis teaches wherein one or more of the pressure applicator portion, ([0035] “the splints 102 may be rigid (i.e., will not flex during normal use), with a curvature that conforms to the user's head”), the support portion, (Figs. 4 and 7-10, the straps are curved in use around the user’s head), and the base portion is/are curved ([0035] “the splints 102 may be rigid (i.e., will not flex during normal use), with a curvature that conforms to the user's head” Because the base portion is interpreted as a layer of the splints 102, the base portion of Davis is interpreted as curved.).
Regarding Claim 7, Davis teaches all limitations of Claim 1, as discussed above. Furthermore, Davis teaches wherein the apparatus further comprises a cavity adapted to removably receive a magnetic implant locator ([0043] the aperture 210 is located, sized and shaped such that it is positioned over the portion of the cochlear implant housing 12 in which the relatively rigid processor assembly 14 is located,” where the rigid processor assembly 14 denotes where the magnetic implant is on the user to the operator by way of placement.).
Regarding Claim 8, Davis teaches all limitations of Claim 1, as discussed above. Furthermore, Davis teaches wherein the pressure applicator portion comprises a mound ([0046] “The splint body 406 may be shaped in, for example, a manner similar to the splints 102 […] and includes the appropriate number and arrangement of strap apertures 408 to accommodate a strap system such as the strap systems 104 […]. […] the splint body 406 includes […] an inflatable bladder 411”).
Regarding Claim 9, Davis teaches all limitations of Claim 1, as discussed above. Furthermore, Davis teaches wherein the support portion comprises a flexible material ([0035] “the splints 102 may be […] flexible enough to conform to the user's head yet stiff enough to prevent magnet rotation”).
Regarding Claim 10, Davis teaches a method for inhibiting motion of an implanted magnetic device in a recipient in response to a magnetic field that is generated externally to the recipient, ([0008] “magnet rotation may be avoided by surgically removing the positioning magnet prior to the MRI procedure and then reinserting the magnet after the procedure,” [0010] “A method of preventing rotation of a first cochlear implant magnet implanted within the head of a patient having first and second ears” and [0034] (“One example of an apparatus for opposing torque imparted onto a cochlear implant magnet (or “apparatus”) in accordance with the present inventions is generally represented by reference numeral 100”), wherein the method comprises:
a) placing an apparatus on the recipient such that a first portion of the apparatus contacts the recipient at a location that is over the implanted magnetic device, and such that a second portion of the apparatus contacts the recipient at a location adjacent to the implanted magnetic device (Figs. 7-10 and [0044] “splints may include an inflatable structure to provide localized pressure on the area over the implanted magnet and to improve patient comfort. By way of example, but not limitation, the exemplary splint 302 illustrated in FIG. 17 is substantially similar to splint 102”); and
b) securing the placed apparatus to the recipient such that the first portion and the second portion are pressed against the recipient so as to inhibit movement of the implanted magnetic device while the implanted magnetic device is exposed to the magnetic field (Figs. 7-10 and [0034] “the strap system 104 allows the straps that pull the splints 102 against the head (i.e., against the hair, and against skull albeit with a thin layer of skin in between) to be tightened to an extent sufficient to hold the magnet in place without sliding upwardly toward the crown of the head, and maintains the splints in the desired position.”).
Regarding Claim 11, Davis teaches all limitations of Claim 10, as discussed above. Furthermore, Davis teaches wherein securing the placed apparatus to the recipient further comprises strapping the apparatus to the recipient (Figs. 7-10).
Regarding Claim 14, Davis teaches a device for limiting motion of a magnetic implant in a recipient caused by an externally generated magnetic field, ([0008] “magnet rotation may be avoided by surgically removing the positioning magnet prior to the MRI procedure and then reinserting the magnet after the procedure.”), wherein the magnetic device is implanted in the recipient, ([0034] (“One example of an apparatus for opposing torque imparted onto a cochlear implant magnet (or “apparatus”) in accordance with the present inventions is generally represented by reference numeral 100”), the device comprising:
a) a first portion that is able to apply pressure on the magnetic implant when the device is secured to the recipient ([0034] “first and second splints 102” and [0044] “splints may include an inflatable structure to provide localized pressure on the area over the implanted magnet and to improve patient comfort. By way of example, but not limitation, the exemplary splint 302 illustrated in FIG. 17 is substantially similar to splint 102”); and
b) a second portion that is able to limit movement of the secured device relative to the recipient during exposure of the magnetic implant to the externally generated magnetic field ([0034] “strap system 104,” Figs. 7-10, and [0034] “the strap system 104 allows the straps that pull the splints 102 against the head (i.e., against the hair, and against skull albeit with a thin layer of skin in between) to be tightened to an extent sufficient to hold the magnet in place without sliding upwardly toward the crown of the head, and maintains the splints in the desired position.”).
Regarding Claim 15, Davis teaches all limitations of Claim 14, as discussed above. Furthermore, Davis teaches a third portion from which both the first portion and the second portion extend ([0035] “The splint body 106, which is kidney shaped in the illustrated implementation, includes strap apertures 108 and may be a multi-layer structure with an inner layer 110”).
Regarding Claim 16, Davis teaches all limitations of Claim 15, as discussed above. Furthermore, Davis teaches wherein the third portion comprises a curved surface ([0035] “the splints 102 may be rigid (i.e., will not flex during normal use), with a curvature that conforms to the user's head” Because the base portion is interpreted as a layer of the splints 102, the base portion of Davis is interpreted as curved.).
Regarding Claim 17, Davis teaches all limitations of Claim 15, as discussed above. Furthermore, Davis teaches wherein at least one of the first portion, ([0035] “the splints 102 may be […] flexible enough to conform to the user's head yet stiff enough to prevent magnet rotation”), the second portion, (Figs. 4 and 7-10, the straps are flexible in use around the user’s head), and the third portion comprises a flexible material ([0035] “the splints 102 may be […] flexible enough to conform to the user's head yet stiff enough to prevent magnet rotation”).
Regarding Claim 18, Davis teaches all limitations of Claim 14, as discussed above. Furthermore, Davis teaches wherein the device further comprises a textured surface adapted to inhibit relative movement between the device and a strap that is used to secure the device to the recipient ([0035] “The outer layers 112 have roughened surfaces 114 that reduce the likelihood that the splints 102 will slide relative to the patient's head.”).
Regarding Claim 20, Davis teaches all limitations of Claim 14, as discussed above. Furthermore, Davis teaches wherein the second portion comprises one or more bumpers ([0046] “The splint body 406 may be shaped in, for example, a manner similar to the splints 102 […] and includes the appropriate number and arrangement of strap apertures 408 to accommodate a strap system such as the strap systems 104 […]. […] the splint body 406 includes […] an inflatable bladder 411”).
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 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 20210330975) in view of Smith et al. (US 20210156934).
Regarding Claim 12, Davis teaches all limitations of Claim 10, as discussed above. However, Davis does not explicitly teach placing a magnetic implant locator in a cavity of the apparatus to assist in aligning the first portion of the apparatus over the implanted magnetic device when placing the apparatus on the recipient.
In an analogous magnetic material particle alignment field of endeavor, Smith teaches a method for inhibiting motion of an implanted magnetic device in a recipient in response to a magnetic field that is generated externally to the recipient, (Abstract “ A particle alignment method in accordance with at least one of the present inventions includes the step of positioning a cochlear implant, […] within the MRI magnetic field in such a manner that the central axis of the magnet apparatus is at least substantially parallel to the MRI magnetic field” and [0006] “The dominant MRI magnetic field B (typically 1.5 Tesla or more) may generate a significant amount of torque T on the implant magnet 26. The torque T may be sufficient to deform the housing 12 and cause reorientation of the implant magnet.”), comprising placing a magnetic implant locator in a cavity of the apparatus, (as taught by Davis, discussed above), to assist in aligning the first portion of the apparatus over the implanted magnetic device when placing the apparatus on the recipient ([0062] “the location identification template 100 may be used to identify the center of an implanted magnet apparatus (e.g., magnet apparatus 30). The location identification template 100 may be placed on the patient's head over the cochlear implant 10 and, in particular, over the particle-based magnet apparatus 30”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to combine the teachings of Davis with the location identification template of Smith because the modification allows for a clinician to denote the location of the magnetic implant, which is crucial prior to magnetic resonance imaging to ensure that the placement of the implant does not change or causes harm to the patient, as taught by Smith in [0006].
Regarding Claim 13, the modified method of Davis teaches all limitations of Claim 12, as discussed above. Furthermore, Smith teaches removing the magnetic implant locator from the cavity after securing the placed apparatus to the recipient ([0077] “After the location identification template 100 (or 100a) has been removed from the patient's head, the MRI procedure may be performed without removing the magnet apparatus 30 from the patient's head (Step S02).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to combine the teachings of Davis with the location identification template of Smith for the same reasons as Claim 12. Additionally, having the apparatus taught by Davis on to secure the magnet apparatus 30 (a cochlear implanted magnet) on minimizes potential movement of the implanted magnet.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 20210330975) in view of Westerkull (US 20160192092).
Regarding Claim 19, Davis teaches all limitations of Claim 18, as discussed above. However, Davis does not explicitly teach wherein the textured surface includes a plurality of spikes.
In an analogous implantable hearing aid field of endeavor, Westerkull teaches wherein the textured surface includes a plurality of spikes ([0047] “When attached to the skin interface 104, the inner skin adhesive surface 106 of the skin adhesive 109 facing the skin 113 may have an uneven surface texture as shown in FIG. 6 in the scale of 0.1 mm to 1 mm between peaks and valleys.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to combine the teachings of Davis with the spiked textured surface of Westerkull because the combination has the advantage of only engaging the protruding portions (spikes) onto the user’s skin and therefore there is a reduced initial adhesive force which allows the device to be relatively easily removed and relocated, if needed, as taught by Westerkull in [0047].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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