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 .
Specification
The disclosure is objected to because of the following informalities: In the first paragraph, the priority information should be listed.
Appropriate correction is required.
Claim Objections
Claims 5, 7, 8, 12, and 13 are objected to because of the following informalities:
In claims 5, 7, and 8, instances of “the least” should be “the at least”.
In claim 12, lines 6 and 7, “of” after “capture” should be deleted.
In claim 13, line 5, ‘the’ should be added before ‘recipient’.
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 38 and 39 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.
In claims 38 and 39, “the at least one candidate implanted location” lacks antecedence.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 13-17, and 38-44 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Noble et al (US Pub 2020/0138520 -cited by applicant as WO 2018/200450).
Re claims 1, 38, 41-43: Noble discloses a pre-operative surgical planning method, comprising:
obtaining anatomical data associated with a head of a recipient of an implantable auditory prosthesis, wherein the implantable auditory prosthesis includes at least one transducer (fig 16; see step 100 of the acquiring of pre-operative CT image of the cochlea, wherein the implant is an electrode which is a type of transducer);
determining, based on the anatomical data, one or more suggested implantable placements for the at least one transducer (fig 16; see step 160 of determining a patient-customized plane for electrode placement);
displaying, at a display screen, one or more visible indications of the one or more suggested implantable placements (fig 20; see E1-En as displayed indicators of electrode placements); and
predict and display on a display, at least based on the anatomical data, visible indications of an estimated outcome for the recipient with the at least one implantable component implanted at the at least one candidate implanted location (0101; see the virtual model showing the suggested placements, wherein the modeling predicts outcomes thereby allowing the trajectory model to be adjusted if necessary).
The above steps are executed via non-transitory computer readable storage media with instructions executed by a processor (0164).
Re claims 2, 3, 40: The obtaining anatomical data comprises: obtaining medical imaging of the head of the recipient which includes determining the suggested placements includes determining a bone density map of the head from the anatomical data. (fig 14; see the CT scanner to obtain medical images of bone structures as a bone density map).
Re claim 13: The method comprises determining, for at least one of the one or more suggested implantable placements, an estimated outcome for the recipient associated with the at least one of the one or more suggested implantable placements; and providing an indication of the estimated outcome for recipient associated with the at least one of the one or more suggested implantable placements (fig 20, 0101; see the virtual model showing the suggested placements, wherein the modeling predicts outcomes thereby allowing the trajectory model to be adjusted if necessary).
Re claims 14, 44: Determining the suggested candidate implantable placements for the at least one transducer includes: generating a virtual model of the head of the recipient based on the anatomical data with candidate placements in the reconstruction (fig 20; see the virtual model reconstruction of a portion of the head).
Re claim 15: Providing the one or more visible indications comprises: displaying the one or more suggested implantable placements within the virtual model of the head of the recipient (fig 20; see the suggested placements E1-En displayed on the virtual model of a portion of the head).
Re claim 16: The method includes receiving one or more user inputs setting an adjusted implantable placement of the at least one transducer; and displaying the adjusted implantable placement of the at least one transducer within the virtual model of the head of the recipient (0206, 0210; see the hardware which includes input for a user to manually edit the implant placements by adjusting the placements).
Re claim 17: Providing an indication of an estimated outcome for recipient associated with the adjusted implantable placement (fig 20; 0210; see the editing of the placements which are displayed as visual indications).
Re claim 39: The estimated outcome is predicted based on the anatomical data and based on normative data (0092; see the electrode placements based on averaged/normative data).
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 4-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Noble et al, in view of claim 1, in view of Van den Heuvel (US Pub 2013/0165737 -cited by applicant).
Re claims 4-8, 10-12: Noble discloses all features except that the transducer comprises an implantable actuator configured to deliver vibration to the head of the recipient along with which structure the actuator is to be coupled to and the suggested locations and orientations are determined to optimize, for the recipient, sound transmission from the least one implantable actuator to a cochlea of the recipient, while accounting for a bone density of the recipient as a function of voxel; or an implantable sound sensor that optimizes capture of external acoustic sound signals; or an implantable vibration sensor that optimizes an expected sensitivity of the sensor to body noises, wherein the sound sensor and vibration sensor are collocated in a sound input unit that balances an ability of the sensors to capture signals. However, Van den Heuvel implantable actuator configured to deliver vibration to the head of the recipient along with which structure the actuator is to be coupled to and the suggested locations and orientations are determined to optimize, for the recipient, sound transmission from the least one implantable actuator to a cochlea of the recipient, while accounting for a bone density of the recipient as a function of voxel; an implantable sound sensor that optimizes capture of external acoustic sound signals; and an implantable vibration sensor that optimizes an expected sensitivity of the sensor to body noises, wherein the sound sensor and vibration sensor are collocated in a sound input unit that balances an ability of the sensors to capture signals (0026, 0030; see the implantable actuator and the microphones for detecting sound deliver vibrations to the head and optimize sound transmission along with the capture of external acoustic sound signals; both components together form a sound input unit). It would have been obvious to the skilled artisan to modify Noble, to incorporate the actuator and sound sensor as taught by Van de Heuvel, in order to improve surgical planning for middle ear implants.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797