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 .
Election/Restrictions
Applicant's election with traverse of claims 5, 19,20, 28 in the reply filed on 05/13/2026 is acknowledged. The traversal is on the ground(s) that the claims identified in the restriction do not recite limitations that are mutually exclusive. This is not found persuasive because there is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species have acquired a separate status in the art in view of their divergent subject matter;
(b) the species require different field of search (for example, searching different classes/ subclasses or electronic resources, or employing different search queries);
(c) the prior art applicable to one species would not likely be applicable to the other species;
The requirement is still deemed proper and is therefore made FINAL.
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, 5, 7 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.
In claim 2, it set forth to generate a recommendation, “based on the measurement”, but in claim 1 there was no processor performing a measurement; but rather just an ultrasound device “for use” in generating data indicating a measurement; which is just the intended use of the ultrasound device; the claim need to set forth such a measurement step performed by the processor.
Furthermore, is the external device different from the ultrasound device? If so, what is meant by “measurement of the thickness of the skin flap regarding an external device; the claim is indefinite.
In claim 5, which element of the system performs the step of determines changes in the measurements over time?
In claim 7 it is unclear what is meant by “normal” use of the implant system.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rees et al. (“A comparison of imaging techniques to measure skin flap thickness in cochlear implant patients to enable pre-perative device selection. Cochlear Implants International March 22, 2002. Vol. 23, No. 4, pp.179,188).
With respect to claim 1 Rees discloses a system comprising: an ultrasound device configured to generate sound waves for use in generating data indicating a measurement of a thickness of a skin flap of a recipient (see pg. 179, methods).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-3, 5, 7, 12, 16, 18-20, 24, 26-27 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Rees et al. (“A comparison of imaging techniques to measure skin flap thickness in cochlear implant patients to enable pre-perative device selection. Cochlear Implants International March 22, 2002. Vol. 23, No. 4, pp.179,188) hereinafter Rees in view of Ibrahim (US 2007/0100395).
With respect to claim 2, Rees discloses the invention as set forth above but fails to teach further comprising: one or more processor circuits configured to generate a recommendation based on the measurement of the thickness of the skin flap regarding an external device to be placed on the recipient for coupling to an implantable device under the skin flap (see Ibrahim, invention para. 0001, “The present invention relates to a method and apparatus for determining the position of an external transceiver relative to an implanted transceiver. The invention also relates to a method and apparatus for determining a skin flap thickness of a recipient of a prosthesis comprising a transcutaneous link provided by an external transceiver and an implanted transceiver, and to a skin-flap thickness meter.”.
It would have been obvious to one skilled in the art to have a device to provide skin flap thickness as set forth by Ibrahim because doing so will allow to asses the viability of the thickness and avoid complications such as necrosis.
With respect to claim 3, Rees in view of Ibrahim disclose wherein the one or more processor circuits are further configured to generate the recommendation based on the external device having a sufficient magnetic field strength to be retained on the recipient by the implantable device (see Ibrahim para. 0021, 0022)..
With respect to claim 5, Rees in view of Ibrahim disclose wherein the ultrasound device is further configured to generate the sound waves for use in generating the data indicating multiple measurements of the thickness of the skin flap, and wherein the system determines changes in the measurements over time (see para. 0006).
With respect to claim 7, Rees in view of Ibrahim disclose further comprising:a tool that determines a location on the recipient to locate the ultrasound device during the measurement of the thickness of the skin flap, wherein the tool is configured to align the ultrasound device with an implantable device implanted under the skin flap, and wherein the tool is configured to determine the location on the recipient to locate the ultrasound device based on an expected location of an external device of an implant system during normal use of the implant system (see para. 0008).
With respect to claim 12, Rees in view of Ibrahim disclose further comprising: a sensor configured to determine an orientation of the ultrasound device or a pressure with which the ultrasound device applies to the recipient (see para. 0015).
With respect to claim 16, Rees in view of Ibrahim disclose further comprising: one or more magnets configured to be aligned with an implantable device underneath the skin flap, wherein the one or more magnets are incorporated into at least one of the ultrasound device, an external device of an implant system that comprises the implantable device, or a tool separate from the ultrasound device (see para. 0021).
With respect to claim 18, Rees in view of Ibrahim disclose a method comprising: determining a location of a measurement of a thickness of a skin flap of a recipient based on a current or expected location of an implantable device underneath the skin flap; and generating the measurement of the thickness of the skin flap (see Ibrahim para. 0001, The present invention relates to a method and apparatus for determining the position of an external transceiver relative to an implanted transceiver. The invention also relates to a method and apparatus for determining a skin flap thickness of a recipient of a prosthesis comprising a transcutaneous link provided by an external transceiver and an implanted transceiver, and to a skin-flap thickness meter.”.
using an ultrasound device (see Rees, abstract)..
It would have been obvious to one skilled in the art to have a device to provide skin flap thickness as set forth by Ibrahim because doing so will allow to asses the viability of the thickness and avoid complications such as necrosis.
With respect to claim 19, Rees in view of Ibrahim disclose further comprising: determining suitability of one or more configurations of an external component of an implant system for the recipient at the current or expected location of the implantable device using the measurement of the thickness of the skin flap, wherein the implant system further comprises the implantable device (see para. 0008, “A particular problem that the present invention seeks to address is determining a distance of separation between an external transceiver and an implanted transceiver by determining the relative position of the external transceiver to the implanted transceiver. Aother problem is when an external transmitter or transceiver has been displace,. for example when the external transceiver has fallen away from an optimum position upon the recipient. It is particularly relevant when the recipient, such as an infant, is unable to or unlikely to indicate such an occurrence and therefore cannot derive maximum hearing benefit from the implant system. Embodiments of the present invention may be particularly advantageous, as the distance between the transceivers impacts upon the amount of power that can be delivered to the implanted transceiver, and hence impacts upon a power source current and usefull life, for instance where the power source is a battery. As such embodiments of the present invention enable a determination of the distance to be made, transmission and stimulation parameters of transmissions between the transceivers may be optimised to allow for the actual distance of separation. Optimising such parameters for the actual distance of separation leads to improved performance of the implant system, and also improves battery lifetime..
With respect to claim 20, Rees in view of Ibrahim disclose for the recipient at the current or expected location of the implantable device comprises: determining suitability of one or more combinations of the external component and the implantable device for the recipient at the current or expected location of the implantable device based on pre-determined criteria that comprise a defined skin flap thickness range for which the one or more combinations are suitable “A particular problem that the present invention seeks to address is determining a distance of separation between an external transceiver and an implanted transceiver by determining the relative position of the external transceiver to the implanted transceiver. Aother problem is when an external transmitter or transceiver has been displace,. for example when the external transceiver has fallen away from an optimum position upon the recipient. It is particularly relevant when the recipient, such as an infant, is unable to or unlikely to indicate such an occurrence and therefore cannot derive maximum hearing benefit from the implant system. Embodiments of the present invention may be particularly advantageous, as the distance between the transceivers impacts upon the amount of power that can be delivered to the implanted transceiver, and hence impacts upon a power source current and usefull life, for instance where the power source is a battery. As such embodiments of the present invention enable a determination of the distance to be made, transmission and stimulation parameters of transmissions between the transceivers may be optimised to allow for the actual distance of separation. Optimising such parameters for the actual distance of separation leads to improved performance of the implant system, and also improves battery lifetime..
.
With respect to claim 18, Rees in view of Ibrahim disclose wherein determining the location of the measurement of the thickness of the skin flap comprises: detecting presence of a radio-frequency coil or an antenna in the implantable device underneath the skin flap; receiving a signal from the radio-frequency coil or the antenna; and using properties of the signal to determine alignment with the implantable device (see para. 0034).
With respect to claim 26, Rees in view of Ibrahim disclose A non-transitory computer-readable storage medium comprising instructions stored thereon that, when executed by one or more processors, cause the one or more processors to: generate a measurement of a thickness of a skin flap of a recipient based on sonic waves (see Reeese abstract) applied to the skin flap (see para. 0001, Ibrahim); and generate an indication of whether one or more configurations of an external device are able to be retained on the skin flap based on the measurement of the thickness of the skin flap (see para. 0008, Ibrahim).
It would have been obvious to one skilled in the art to have a device to provide skin flap thickness as set forth by Ibrahim because doing so will allow to asses the viability of the thickness and avoid complications such as necrosis.
With respect to claim 27, Rees in view of Ibrahim disclose wherein the instructions further cause the one or more processors to: determine if the one or more configurations of the external device have a sufficient magnetic field to be retained on the skin flap by a magnet implanted under the skin flap based on the measurement of the thickness of the skin flap (see Ibrahim, para.0008).
Allowable Subject Matter
Claims 28, 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record fails to teach the non-transitory computer-readable storage medium of claim 26, wherein the instructions further cause the one or more processors to: analyze an ultrasound image to determine a location of one or more landmarks on an implantable device under the skin flap relative to an ultrasound device; and generate the measurement of the thickness of the skin flap over the implantable device using the ultrasound device.
Further, the non-transitory computer-readable storage medium of claim 26, wherein the instructions further cause the one or more processors to: generate feedback to a user that indicates a direction or an angle to move an ultrasound device that generates the sonic waves for placement of the ultrasound device during the measurement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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