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 .
Response to Arguments
Applicant's arguments below filed 6/12/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on pages 10-11 of the Remarks:
“Applicant greatly appreciates indication the indication in the Office Action that claims 34 and 35 would be allowable if rewritten to overcome the rejections(s) under 35 U.S.C. § 112(b) and to include all of the limitations of the base claim and any intervening claims. Office Action at 18. Specifically, the Office Action indicated that claim 34 would be allowable at least because the "prior art does not teach when the tool reaches the first predetermined target adjustment in the first dimension or reaches the second predetermined target adjustment in the second dimension the first acoustic property varies within a third predetermined range different from the first predetermined range when the tool is being adjusted in the third dimension towards a third predetermined target adjustment." Id. at 18-19 (emphasis added).
Independent claim 20 has been amended to recite a first acoustic property of a plurality of acoustic properties varies within a first predetermined range when a tool is being adjusted in a first dimension and, when the tool reaches a first predetermined target adjustment in the first dimension, the first acoustic property varies within a second predetermined range that is different from the first predetermined range when the tool is being adjusted in the second dimension.
Independent claim 36 has been amended to recite adjusting a tool in a first dimension of a plurality of dimensions based on a generated acoustic calibration signal and adjusting the tool in a second dimension of the plurality of dimensions based on the generated acoustic calibration signal. A first acoustic property of the generated acoustic calibration signal varies within a first predetermined range and an acoustic marker is generated when the tool reaches a first predetermined target adjustment in the first dimension within a predefined tolerance. Generating the acoustic marker includes replacing the first predetermined range by a second corresponding predetermined range that is different from the first predetermined range. The first acoustic property of the generated acoustic calibration signal varies within the second predetermined range towards a second predetermined value until the first acoustic property reaches the second predetermined value.
Independent claim 37 has been amended to recite a first acoustic property of a plurality of acoustic properties varies within a first predetermined range when the tool is being adjusted in a first dimension towards a first predetermined target adjustment and, when the tool reaches the first predetermined target adjustment in the first dimension, the first acoustic property varies within a second predetermined range different from the first predetermined range when the tool is being adjusted in a second dimension.
In other words, Applicant believes independent claims 20, 36, and 37 have been amended herein to incorporate subject matter that was indicated to be allowable in the Office Action. Accordingly, Applicant submits that the Application, as amended herein, is in condition for allowance.”
In response the examiner respectfully asserts the art has been interpreted differently and the independent claims have been rejected under 35 USC § 112(b). In light of the examiners interpretation under the 112(b) rejections independent claim 20 is unpatentable over Wegner and independent claim is unpatentable over Wegner in view of Wapler under 35 USC § 103. However, in view of the examiners interpretation under the 35 USC § 112(b) rejection independent claim 36 no art was found to teach replacing the first predetermined range of the first acoustic property by a second predetermined range of a second acoustic property.
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 20-39 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.
Regarding claims 20, 36, and 37, lines 23-25 of claim 20 and lines 35-37 of claim 37 recite “the first acoustic property varies within a second predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension”, and lines 25-30 of claim 36 recite “wherein generating the acoustic marker comprises replacing the first predetermined range by a second corresponding predetermined range different from said first predetermined range; and adjusting the tool in a second dimension of the plurality of dimensions based on the generated acoustic calibration signal, wherein the first acoustic property of the generated acoustic calibration signal varies within the second predetermined range”. However, each of the independent claims recite “generating an acoustic calibration signal with a plurality of simultaneously perceivable acoustic properties comprising an acoustic property for each dimension of the plurality of dimensions”. Therefore, each dimension of the plurality of dimensions has its own acoustic property and it is unclear how the acoustic signal of the second dimension would have the acoustic property of the first dimension if each dimension has its own acoustic property. For examination purposes lines 23-25 of claim 20 and lines 35-37 of claim 37 will be interpreted as “a second acoustic property varies within a second predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension” and lines 25-30 of claim 36 recite “wherein generating the acoustic marker comprises replacing the first predetermined range of the first acoustic property by a second predetermined range of a second acoustic property; and adjusting the tool in a second dimension of the plurality of dimensions based on the generated acoustic calibration signal, wherein the second acoustic property of the generated acoustic calibration signal varies within the second predetermined range”. Dependent claims are also rejected due to their dependency.
Regarding claim 30, claim 30 recites “the second acoustic property varies within a third predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension towards a third predetermined target adjustment.” However, claim 20 recites that the acoustic signal is varying within a second predetermined range of the first acoustic property when the tool is being adjusted in the second dimension. Therefore, it is unclear how an acoustic signal for the second dimension would produce an acoustic signal within a second and third predetermined range without causing confusion. Additionally, it is unclear how the acoustic signal is being adjusted towards one end value of the second predetermined range if the acoustic signal varies within a third predetermined range. For examination purposes and in light of the interpretation above the limitation will be read as “the second acoustic property varies within the second predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension towards the second predetermined target adjustment.” Claim 31 is also rejected due to its dependency.
Regarding claim 34, lines 15-19 claim 34 recite “when the tool reaches the third predetermined target adjustment in the third dimension: the third acoustic property varies within a fourth predetermined range different from the third predetermined range towards one end value of the fourth predetermined range when the tool is being adjusted in the fourth dimension”. However independent claim 20 recites “generating an acoustic calibration signal with a plurality of simultaneously perceivable acoustic properties comprising an acoustic property for each dimension of the plurality of dimensions”. Therefore, each dimension of the plurality of dimensions has its own acoustic property and it is unclear how the acoustic signal of the fourth dimension would have the acoustic property of the third dimension if each dimension has its own acoustic property. For examination purposes the limitation will be read as “when the tool reaches the third predetermined target adjustment in the third dimension: a fourth acoustic property varies within a fourth predetermined range different from the third predetermined range towards one end value of the fourth predetermined range when the tool is being adjusted in the fourth dimension”.
Regarding claim 35, claim 35 recites “when the tool deviates from the first predetermined target adjustment in the first dimension beyond a predefined tolerance, the first acoustic property stops varying within the second predetermined range”. However as recited above independent claim 20 recites “generating an acoustic calibration signal with a plurality of simultaneously perceivable acoustic properties comprising an acoustic property for each dimension of the plurality of dimensions”. Additionally, as recited above it is unclear how the acoustic signal of the second dimension would have the acoustic property of the first dimension if each dimension has its own acoustic property. Therefore, it is unclear how the first acoustic property stops varying within the second predetermined range of the first acoustic property for the second dimension. For examination purposes the claim will be read as “in response to the tool reaching the first predetermined target adjustment in the first dimension, replacing the first predetermined range of the first acoustic property by the second predetermined range of the second acoustic property, when the tool deviates from the first predetermined target adjustment in the first dimension beyond a predefined tolerance, the second acoustic property stops varying within the second predetermined range and retakes the first acoustic property varying within the first predetermined range”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20-24, 28, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Wegner (US 6083163).
Regarding claim 20, Wegner discloses a method for generating an acoustic calibration signal for adjusting a tool in a plurality of dimensions, each dimension of the plurality of dimensions corresponding to a respective degree of freedom of the tool (Figs. 1 and 7, Abstract – “Error signals which correspond to deviations of the actual instrument trajectory from an optimal trajectory stored in a computer memory are translated into a set of audio signals that indicate to the user whether correction is required”, Fig. 7 shows deviation signals in three degrees of freedom), wherein the method comprises:
generating an acoustic calibration signal with a plurality of simultaneously perceivable acoustic properties comprising an acoustic property for each dimension of the plurality of dimensions (Fig. 7, Col. 3 lines 46-50 – “each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the surgeon. Thus, for example, this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate”), wherein at least one acoustic property of the plurality of acoustic properties corresponds to one of pitch, pulsing frequency, duty cycle, loudness, and tone colour of the acoustic calibration signal, wherein at least another acoustic property of the plurality of acoustic properties corresponds to another one of pitch, pulsing frequency, duty cycle, loudness and tone colour of the acoustic calibration signal (Fig. 7 shows the audio for each of the x, y, and z coordinates having a different frequency and therefore having a different pitch, Col. 3 lines 46-50 – “each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the surgeon. Thus, for example, this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate”),
wherein each acoustic property of the plurality of acoustic properties varies towards a corresponding predetermined value when the tool is being adjusted in the corresponding dimension towards a corresponding predetermined target adjustment (Fig. 7, Col. 9 lines 44-54 – “A GUI allowed the user to specify the radii of the MIDI error envelopes, sound programs, pitch, and amplitude. A number of AIFF Samples of recorded speech and sound effects were provided. The user could set the Sample Volume, playback triggering radius from the target path center in the y, Z plane, and the point along the target path in the X axis where playback would occur. AS the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic Stability is attained”);
wherein the plurality of dimensions comprises a first dimension corresponding to a first degree of freedom of the tool and a second dimension corresponding to a second degree of freedom of the tool(Col. 3 lines 45-53 – “in the system of the present invention each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the Surgeon. Thus, for example, this can be a consonant harmonic structure, Such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others”),
wherein a first acoustic property of the plurality of acoustic properties varies within a first predetermined range towards one end value of the first predetermined range when the tool is being adjusted in the first dimension towards a first predetermined target adjustment and towards another end value of the first predetermined range when the tool is being adjusted in the first dimension away from the first predetermined target adjustment (Col. 3 lines 48-53 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others.”, although the predetermined range is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency ax for the first dimension and the frequency diverges to frequency +bx or -bx depending on the direction of deviation. Therefore, it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position and frequency b when the tool moves away from the target), and
wherein, when the tool reaches the first predetermined target adjustment in the first dimension, the first acoustic property varies within a second predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension towards a second predetermined target adjustment and towards another end value of the second predetermined range when the tool is being adjusted in the second dimension away from the second predetermined target adjustment (Col. 3 lines 48-53 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others.”, although the predetermined range is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency ay for the second dimension and the frequency diverges to frequency +by or -by depending on the direction of deviation. Therefore, it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position and frequency b when the tool moves away from the target).
Regarding claim 21, Wegner further discloses wherein each acoustic property of the plurality of acoustic properties varies away from the corresponding predetermined value when the tool is being adjusted in the corresponding dimension away from the corresponding predetermined target adjustment (Fig. 7 shows the audio for each of the x, y, and z coordinates having a different frequency and varying as the error increases or decreases, Col. 9 lines 44-54 – “A GUI allowed the user to specify the radii of the MIDI error envelopes, sound programs, pitch, and amplitude. A number of AIFF Samples of recorded speech and sound effects were provided. The user could set the Sample Volume, playback triggering radius from the target path center in the y, Z plane, and the point along the target path in the X axis where playback would occur. AS the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic Stability is attained”).
Regarding claim 22, Wegner further discloses wherein at least one dimension of the plurality of dimensions corresponds to a translational degree of freedom, a rotational degree of freedom or an orientational degree of freedom of the tool, and wherein at least another dimension of the plurality of dimensions corresponds to another translational degree of freedom, rotational degree of freedom or orientational degree of freedom of the tool (Col. 3 lines 48-53 – “this can be a consonant harmonic Structure, Such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-y-Z) or angular coordinate, acceleration or others”).
Regarding claim 23, Wegner further discloses wherein at least one acoustic property of the plurality of acoustic properties is kept constant while the tool remains adjusted in the corresponding dimension at the corresponding predetermined target adjustment (Col. 9 lines 51-54 – “As the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic stability is attained”).
Regarding claim 24, Wegner further discloses wherein the method further comprises, for at least one dimension of the plurality of dimensions, generating an acoustic marker when the tool reaches the corresponding predetermined target adjustment in said at least one dimension, in particular within a predefined tolerance (Col. 3 lines 48-50 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate”, Col. 9 lines 51-54 – “As the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic stability is attained”).
Regarding claim 28, Wegner discloses wherein at least one acoustic property of the plurality of acoustic properties varies within a corresponding predetermined range towards one end value of said corresponding predetermined range when the tool is being adjusted in the respective dimension towards the corresponding predetermined target adjustment (although it is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency a and the frequency diverges to frequency +b or -b depending on the direction of deviation. Therefore, it would be obvious for one with ordinary skill in the art to vary the acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position).
Regarding claim 30, Wegner discloses wherein at least the first acoustic property and a second acoustic property of the plurality of acoustic properties correspond to pitch, wherein the first acoustic property varies within the first predetermined range towards an end value of the first predetermined range when the tool is being adjusted in the first dimension towards the first predetermined target adjustment, and wherein the second acoustic property varies within a third predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension towards a third predetermined target adjustment (Col. 3 lines 48-53 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others.”, although the predetermined range is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency a and the frequency diverges to frequency +b or -b depending on the direction of deviation. Therefore, it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position).
Regarding claim 31, Wegner discloses wherein said end value of the second predetermined range is an octave, a perfect fifth or a perfect fourth of said end value of the first predetermined range (Col. 9 lines 51-54 – “As the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic stability is attained”, a consonant triad contains a perfect fifth).
Regarding claim 32, Wegner further discloses wherein the plurality of acoustic properties comprises a first acoustic property and a second acoustic property different from the first acoustic property, wherein the first and second acoustic properties are simultaneously perceivable acoustic properties (Col. 3 lines 45-53 – “in the system of the present invention each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the Surgeon. Thus, for example, this can be a consonant harmonic structure, Such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others”).
Regarding claim 33, Wegner further discloses wherein the plurality of dimensions further comprises a third dimension corresponding to a third degree of freedom of the tool, wherein the plurality of acoustic properties further comprises a third acoustic property different from the first and second acoustic properties, wherein the first, second and third acoustic properties are simultaneously perceivable acoustic properties (Col. 3 lines 45-53 – “in the system of the present invention each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the Surgeon. Thus, for example, this can be a consonant harmonic structure, Such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others”).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Wegner (US 6083163) as applied to claim 24 above, and further in view of Rodrigues (US 20210007774).
Regarding claim 25, Wegner discloses all the elements of the claimed invention as cited in claims 20 and 24.
Conversely Wegner does not teach wherein the at least one generated acoustic marker corresponds to a discontinuous variation of the corresponding acoustic property by 5% or more.
However Rodrigues discloses wherein the at least one generated acoustic marker corresponds to a discontinuous variation of the corresponding acoustic property by 5% or more ([0164] – “generate warning tones when an optical tracked drill is closer to the target (tones of 300 Hz) or reaching the target (tones of 900 Hz)”).
The disclosure of Rodrigues is an analogous art considering it is in the field of surgical guidance.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wegner to incorporate the generated acoustic marker corresponding to a discontinuous variation of Rodrigues to achieve the same results. One would have motivation to combine because it would provide a clear indication of when the target position has been reached.
Regarding claim 26, Wegner discloses all the elements of the claimed invention as cited in claims 20 and 24.
Conversely Wegner does not teach wherein the at least one generated acoustic marker corresponds to a discontinuous variation of the corresponding acoustic property by 20% or more.
However Rodrigues discloses wherein the at least one generated acoustic marker corresponds to a discontinuous variation of the corresponding acoustic property by 20% or more ([0164] – “generate warning tones when an optical tracked drill is closer to the target (tones of 300 Hz) or reaching the target (tones of 900 Hz)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wegner to incorporate the generated acoustic marker corresponding to a discontinuous variation of Rodrigues to achieve the same results. One would have motivation to combine because it would provide a clear indication of when the target position has been reached.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Wegner (US 6083163) as applied to claim 24 above, and further in view of Abhari (US 20210228283).
Regarding claim 27, Wegner discloses all the elements of the claimed invention as cited in claims 20 and 24.
Conversely Wegner does not teach wherein generating the at least one acoustic marker comprises generating a corresponding additional acoustic signal different from the acoustic calibration signal.
However Abhari discloses wherein generating the at least one acoustic marker comprises generating a corresponding additional acoustic signal different from the acoustic calibration signal ([0092] – “the audio output may include a first pitch representing the desired position and orientation and a second pitch that changes based on the tracked position and orientation of the medical instrument”).
The disclosure of Abhari is an analogous art considering it is in the field of providing audio feedback for positioning a surgical instrument.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wegner to incorporate the different acoustic signal for the marker of Abhari to achieve the same results. One would have motivation to combine because the difference in acoustic signal would provide a more obvious indication that the instrument is in the target position.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wegner (US 6083163) as applied to claim 24 above, and further in view of Otto (US 20220022994).
Regarding claim 29, Wegner discloses all the elements of the claimed invention as cited in claims 20 and 24.
As cited above Wegner uses frequency ranges as feedback when there is a deviation in the position of the instrument conversely Wegner does not teach wherein generating the at least one acoustic marker comprises replacing the corresponding predetermined range by a new corresponding predetermined range different from said corresponding predetermined range.
However Wegner and Otto can be combined to teach wherein generating the at least one acoustic marker comprises replacing the corresponding predetermined range by a new corresponding predetermined range different from said corresponding predetermined range (Otto discloses in [0090] – “the GUI 44 may produce a first feedback type 228 in response to the controller 18 determining that the position 22 of the first object or tracker 12 is not within or outside of the first zone 32”, and in [0095] – “the GUI 44 may produce the second feedback type 218 in response to the controller 18 determining that the position 22 of the first object or tracker 12 is within the first zone 32”, therefore if the frequency ranges of Wegner are used as feedback signals it would be obvious to use a first predetermined range [marker] when the instrument is within the target region and a second predetermined range when the instrument is outside of the target region).
The disclosure of Otto is an analogous art considering it is in the field of surgical guidance.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wegner to incorporate a different acoustic signal range for the marker of Otto to achieve the same results. One would have motivation to combine because it would allow one to determine when they are within a threshold distance to the target.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Wegner (US 6083163) and further in view of Gorek (US 20180055571).
Regarding claim 34, Wegner discloses all the elements of the claimed invention as cited in claims 20, 32, and 33.
Wegner further discloses wherein the plurality of dimensions further comprises a third dimension corresponding to a third degree of freedom of the tool and a fourth dimension corresponding to a fourth degree of freedom of the tool (Col. 3 lines 50-53 – “In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others"),
wherein the third acoustic property varies within a third predetermined range towards one end value of the third predetermined range when the tool is being adjusted in the third dimension towards the third predetermined target adjustment and towards another end value of the third predetermined range when the tool is being adjusted in the second dimension away from the third predetermined target adjustment (Col. 3 lines 48-53 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others.”, although the predetermined range is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency az for the third dimension and the frequency diverges to frequency +bz or -bz depending on the direction of deviation. Therefore it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position and frequency b when the tool moves away from the target);
Conversely Wegner does not explicitly teach when the tool reaches the third predetermined target adjustment in the third dimension: the third acoustic property varies within fourth predetermined range different from the third predetermined range towards one end value of the fourth predetermined range when the tool is being adjusted in the fourth dimension towards a fourth predetermined target adjustment and towards another end value of the third predetermined range when the tool is being adjusted in the fourth dimension away from the fourth predetermined target adjustment.
However Gorek discloses when the tool reaches the third predetermined target adjustment in the third dimension: the third acoustic property varies within fourth predetermined range different from the third predetermined range towards one end value of the fourth predetermined range when the tool is being adjusted in the fourth dimension towards a fourth predetermined target adjustment and towards another end value of the third predetermined range when the tool is being adjusted in the fourth dimension away from the fourth predetermined target adjustment ([0057] – “One method for implementing an audio code involves varying one or more of the volume, pitch, frequency, pulse rate, and length of the audio tone based on the determined orientation of the sensor 12 relative to the predetermined orientation ranges… a first audible signal may be indicative of an optimal variance between the trajectory of the instrument and at least one of the first and second determined angular relationships between the sensor 12 and the reference direction”, [0052] – “audible alert tones (e.g. low frequency and/or volume tones for non-alignment and high frequency and/or volume tones for proper alignment or visa versa or any combination thereof)”, Wegner teaches acoustic signals for deviations in the x, y, and z coordinates therefore an angular deviation would be a fourth acoustic property).
The disclosure of Gorek is an analogous art considering it is in the field of providing audio feedback for surgical tool displacement.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wegner to incorporate a fourth acoustic signal for the fourth dimension of Gorek to achieve the same results. One would have motivation to combine because it would allow one to be aware of the correct or incorrect orientation of the instrument and therefore provide a safer procedure.
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Wegner (US 6083163) and further in view of Wapler (US 20210212767).
Regarding claim 37, Wegner discloses an alignment system for adjusting a tool in a plurality of dimensions, each dimension corresponding to a degree of freedom of the tool (Figs. 3 and 7, Abstract – “A computer based system and method is disclosed for positional guidance in real-time surgical applications using audio feedback…Error signals which correspond to deviations of the actual instrument trajectory from an optimal trajectory stored in a computer memory are translated into a set of audio signals that indicate to the user whether correction is required”, Fig. 7 shows deviation signals in three degrees of freedom), wherein the system comprises:
an adjustment unit (Fig. 3 groups B, C, and D) configured for:
generating an acoustic calibration signal with a plurality of simultaneously perceivable acoustic properties comprising an acoustic property for each dimension of the plurality of dimensions (Fig. 7, Col. 3 lines 46-50 – “each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the surgeon. Thus, for example, this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate”), wherein at least one acoustic property of the plurality of acoustic properties corresponds to one of pitch, pulsing frequency, duty cycle, loudness, and tone colour of the acoustic calibration signal, wherein at least another acoustic property of the plurality of acoustic properties corresponds to another one of pitch, pulsing frequency, duty cycle, loudness and tone colour of the acoustic calibration signal (Fig. 7 shows the audio for each of the x, y, and z coordinates having a different frequency and therefore having a different pitch, Col. 3 lines 46-50 – “each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the surgeon. Thus, for example, this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate”), wherein each acoustic property of the plurality of acoustic properties varies towards a corresponding predetermined value when the tool is being adjusted in the corresponding dimension towards a corresponding predetermined target adjustment (Fig. 7, Col. 9 lines 44-54 – “A GUI allowed the user to specify the radii of the MIDI error envelopes, sound programs, pitch, and amplitude. A number of AIFF Samples of recorded speech and sound effects were provided. The user could set the Sample Volume, playback triggering radius from the target path center in the y, Z plane, and the point along the target path in the X axis where playback would occur. AS the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic Stability is attained”),
wherein the target state […] corresponds to a state in which the tool is adjusted in each dimension of the plurality of dimensions to the corresponding predetermined target adjustment (Col. 3 lines 25-26 – “assisting a surgeon in positioning an article relative to a surgical target path in a patient”, the abstract discloses a surgical instrument or device being adjusted, Figs. 6-8 shows that the instrument is guided in three dimensions);
wherein the plurality of dimensions comprises a first dimension corresponding to a first degree of freedom of the tool and a second dimension corresponding to a second degree of freedom of the tool(Col. 3 lines 45-53 – “in the system of the present invention each of the two or more coordinates of the audio space may correspond to an audio theme recognizable by the Surgeon. Thus, for example, this can be a consonant harmonic structure, Such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others”),
wherein the adjustment unit is configured for generating the calibration signal such that:
a first acoustic property of the plurality of acoustic properties varies within a first predetermined range towards one end value of the first predetermined range when the tool is being adjusted in the first dimension towards a first predetermined target adjustment and towards another end value of the first predetermined range when the tool is being adjusted in the first dimension away from the first predetermined target adjustment (Col. 3 lines 48-53 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others.”, although the predetermined range is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency ax for the first dimension and the frequency diverges to frequency +bx or -bx depending on the direction of deviation. Therefore it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position and frequency b when the tool moves away from the target), and
when the tool reaches the first predetermined target adjustment in the first dimension, the first acoustic property varies within a second predetermined range different from the first predetermined range towards one end value of the second predetermined range when the tool is being adjusted in the second dimension towards a second predetermined target adjustment and towards another end value of the second predetermined range when the tool is being adjusted in the second dimension away from the second predetermined target adjustment (Col. 3 lines 48-53 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate. In the present invention spatial coordinates are broadly considered as positional (X-Y-Z) or angular coordinate, acceleration or others.”, although the predetermined range is not explicitly disclosed in the specification of Wegner Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency ay for the second dimension and the frequency diverges to frequency +by or -by depending on the direction of deviation. Therefore it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range toward an end value of frequency a when the tool is being adjusted towards the target position and frequency b when the tool moves away from the target).
Conversely Wegner does not teach a plurality of spatial markers arrangeable on the tool for marking a state of the tool in each dimension of the plurality of dimensions;
a detection system configured for registering the state of the tool in each dimension of the plurality of dimensions marked by the spatial markers;
a mapping unit for determining a target state of the tool in each dimension of the plurality of dimensions with respect to a target reference frame; and
the target state determined by the mapping unit.
However Wapler discloses a plurality of spatial markers arrangeable on the tool for marking a state of the tool in each dimension of the plurality of dimensions ([0056] – “optical tracker 16 attached to a surgical instrument 18”, Fig. 1 shows multiple markers on the optical tracker 16 that is attached to the instrument, [0065] – “determines the pose of the surgical instrument 18 by tracking the optical tracker 16 in the first tracking coordinate system 10”, [0064] – “The current orientation describes an alignment of the surgical instrument 18 in the coordinate system, for example three dimensional coordinates of the axis 24”);
a detection system configured for registering the state of the tool in each dimension of the plurality of dimensions marked by the spatial markers ([0056] – “The optical tracking system 6 is configured to track optical trackers such as an optical tracker 12 attached to a patient 14 and an optical tracker 16 attached to a surgical instrument 18”, para. [0065] discloses that the “the optical tracking system 6 determines the pose of the surgical instrument 18 by tracking the optical tracker 16 in the first tracking coordinate system 10” and that a transformation between coordinate systems is used to determine the pose of the instrument by performing a registration);
a mapping unit for determining a target state of the tool in each dimension of the plurality of dimensions with respect to a target reference frame ([0072] – “A planned trajectory 54 extending between the planned entry point 48 and the planned target 50, in the shown example between the planned entry point 48 and the planned target point 52, can also be determined based on the planning data”); and
the target state determined by the mapping unit ([0072] – “A planned trajectory 54 extending between the planned entry point 48 and the planned target 50, in the shown example between the planned entry point 48 and the planned target point 52, can also be determined based on the planning data”).
The disclosure of Wapler is an analogous art considering it is in the field of providing audio feedback for positioning a surgical instrument.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wegner to incorporate the spatial markers and detection system of Wapler to achieve the same results. One would have motivation to combine because “positions and orientations of surgical objects, such as the surgical instrument and the patient, can be determined as a basis for providing navigation instructions to the surgeon” (Wapler [0003]).
Regarding claim 38, Wegner and Wapler disclose all the elements of the claimed invention as cited in claim 37.
Wegner further discloses wherein the adjustment unit is further configured for generating the acoustic calibration signal such that each acoustic property varies away from said corresponding predetermined value when the tool is being adjusted in said corresponding dimension away from said predetermined target adjustment (although Fig. 7 of Wegner is not explained in detail in the specification Fig. 7 appears to show ranges of frequency for the error from a to b. Based on the bottom right hand corner of Fig. 7 it can be interpreted that the target frequency is frequency a and the frequency diverges to frequency +b or -b depending on the direction of deviation. Therefore it would be obvious for one with ordinary skill in the art to vary each acoustic signal within a predetermined range away from a target frequency a when the tool is being adjusted away from the target position).
Regarding claim 39, Wegner and Wapler disclose all the elements of the claimed invention as cited in claim 37.
Wegner further discloses wherein the adjustment unit is further configured for generating, for at least one dimension of the plurality of dimensions, an acoustic marker when the tool reaches the corresponding predetermined target adjustment in said at least one dimension (Col. 3 lines 48-50 – “this can be a consonant harmonic structure, such as a major triad, each tone of which corresponds to values along a specific spatial coordinate”, Col. 9 lines 51-54 – “As the instrument nears its target path, the targeting feedback pitch for X approaches the lowest pitch of the consonant triad, thus, when the target is reached, harmonic stability is attained”).
Allowable Subject Matter
Claims 35 and 36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Claims 35 and 36 are found to distinguish from the prior art in light of the examiners interpretation in the 35 U.S.C. 112(b) rejection collectively, however, allowability is not determined at this time due to pending 112 issues.
Regarding claim 35, in light of the examiners interpretation in the 35 U.S.C. 112(b) rejection it would not have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the acoustic properties of Wegner. Wegner discloses “as the instrument nears its target path, the targeting feedback pitch for x approaches the lowest pitch of the consonant triad”. The harmonic triad is used to inform the user that the target has been reached. Therefore Wegner does not teach stopping and retaking acoustic properties and it would not be obvious for one with ordinary skill in the art to stop varying the second acoustic property within the second predetermined range and retake varying first acoustic property within the first predetermined range when the tool deviates from the first predetermined target adjustment in the first dimension beyond a predefined tolerance. Thus the combination of elements is found to distinguish over the prior art collectively.
Regarding claim 36, in light of the examiners interpretation in the 35 U.S.C. 112(b) rejection it would not have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the acoustic properties of Wegner to teach claim 36. Wegner discloses “as the instrument nears its target path, the targeting feedback pitch for x approaches the lowest pitch of the consonant triad”. The harmonic triad is used to inform the user that the target has been reached. Therefore Wegner does not teach stopping and retaking acoustic properties and it would not be obvious for one with ordinary skill in the art to generate an acoustic marker when the tool reaches a first predetermined target adjustment in the first dimension and replacing the first predetermined range by a second acoustic property when the tool is adjusted in a second dimension.
Conclusion
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/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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