DETAILED ACTION
Summary
Claims 1-3, 6-11, and 19-20 are pending in the application. Claims 1-3, 6-11, and 19-20 are rejected under 35 USC 103.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/31/2026 has been entered.
Claim Objections
Claims 1, 8, 10, and 19-20 objected to because of the following informalities:
Claim 1 recites “plurality of augmentations” in line 4. It should recite “a plurality of augmentations”.
Claim 1 recites “each augmentation” in line 7. It should recite “each of the plurality of augmentations”.
Claim 8 recites “the plurality of augmentations augmentation” in lines 1-2. It should recite “the plurality of augmentations”.
Claim 8 recites “the plurality of augmentations augmentation” in lines 2-3. It should recite “the plurality of augmentations”.
Claim 10 recites “each augmentation” in line 18. It should recite “each of the augmentations”.
Claim 19 recites “each groove” in line 1. It should recite “each of the grooves”.
Claim 20 recites “each bridge” in line 1. It should recite “each of the respective bridges”.
Appropriate correction is required.
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.
Claims 1, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Shalgi et al. (U.S PGPub 2007/0255132 A1) in view of Jackson et al. (U.S PGPub 2008/0154123 A1) and Gerhart et al. (U.S PGPub 2009/0171187 A1).
Regarding Claim 1, Shalgi teaches an instrument system (Abstract), comprising:
a structure formed of a conductive material (Fig. 1, 28) [0081]-[0082], wherein the structure includes a first portion and a second portion separated by plurality of augmentations to at least produce a selected resistance between the first portion and the second portion [0103] (Fig. 6, 74), (the grooves create an air gap, and change the resistance across the groove) to at least minimize an induction of a current across the plurality of augmentations [00105] (the slots minimize an induced current across the slots),
wherein each augmentation is a groove formed in the structure [0103]+[0108]-[0109];
an electromagnetic (EM) tracking device configured to sense an emitted EM field [0017]+[0019]+[0075]+[0078].
Shalgi is silent regarding the EM tracking device is disposed between the plurality of augmentations. However, moving the position of the transducer from one portion of the instrument to between the grooves on the instrument is a mere rearrangement of parts (MPEP 2144.04(VI)(C)). The magnetic transducer would still function as an electromagnetic tracking device in the new position, and the overall operation of the instrument would remain unchanged if the location of the tracking device was moved. Therefore, rearranging the position of the tracking device on the instrument to be between the augmentations is an obvious matter of design choice.
While Shalgi teaches the tool can include any medical or surgical tool [0081]-[0082], Shalgi fails to explicitly teach an ultrasound probe comprising an ultrasound transducer configured to generate an imaging plane for imaging a subject and a navigation processor configured to execute instructions to determine a pose of the imaging plane based at least on the sensed generated one or more EM field or fields, or the EM tracking device coupled to the ultrasound probe.
Jackson teaches a system for tracking the position of an ultrasound transducer for image interpretation (Abstract). This system uses magnetic position sensor to track the position of the ultrasound transducer [0017]+[0020]. The ultrasound probe is in a housing [0018]. The system operates the ultrasound transducer to generate an imaging plane to image a subject [0044]+[0046] (the image obtain is a “scan” (imaging) plane). This system has an electromagnetic tracking device couple to the ultrasound probe (Fig. 1, 14) [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to include an ultrasound transducer imaging an imaging plane, as taught by Jackson, because accurately knowing the position of the ultrasound transducer better determine the contents of an image, thereby simplifying annotation, as recognized by Jackson [0002]+[0015]. Furthermore, one of ordinary skill would recognize that, as the tool of Shalgi can be any tool [0081]-[0082], it would have been obvious to substitute the tool of Shalgi with an ultrasound transducer, as taught by Jackson, as the substitution for one known medical or surgical tool with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the structure containing an ultrasound transducer are reasonably predictable.
The combination of references is silent that the augmentation reduces of eliminates a current flow between the first portion and the second portion.
Gerhart teaches a surgical navigation system in a magnetic field (Abstract). This system uses grooves in the instrument to reduce or eliminate a current flow between the first and second portions (Fig. 7, 50 are grooves which separate the instrument into portions) [0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to eliminate current flow between portions, as taught by Gerhart, because this reduces eddy current formations, thereby reducing distortions in the tracking, as recognized by Gerhart [0050].
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Shalgi further teaches wherein the groove is filled with a non-conductive material [0090]+[0103]+[0108]-[0109] (Shalgi recognizes that the insulating material causes the electrical discontinuity. Shalgi also recognized that the methods for creating the electrical discontinuities can be combined ([0108]-[0109]). Therefore, Shalgi suggest filing the groove of [0103] with insulating material [0090] to create the discontinuity [0108]-[0109]).
Regarding Claim 8, Shalgi teaches the invention substantially as claimed. Shalgi further teaches wherein the selected resistance across the plurality of augmentations is greater than along the a the plurality of augmentations [0089] (air is non-conductive and therefore has a higher resistance than the conductive material of the tool).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Shalgi in view of Jackson and Gerhart as applied to claim 1 above, and further in view of Jacobsen et al. (U.S PGPub 2018/0306602 A1).
Regarding Claim 2, Shalgi teaches the invention substantially as claimed. Shalgi further teaches an EM localizer [0018] configured to emit the emitted EM fields [0018]+[0075].
The Shalgi is silent regarding the EM localizer which generates the magnetic field has one or more conductive coils.
Jacobsen teaches a magnetic localization system (Abstract). This system generates magnetic fields using coils [0005]. The coils can be made of conductive material [0079].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the magnetic field generators of the combination with conductive coils, as taught by Jacobsen, as the substitution for one known magnetic field generator with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of generating the field with conductive coils are reasonably predictable.
Claims 3, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shalgi in view of Jackson, Gerhart, and Jacobsen as applied to claim 2 above, and further in view of Polz (U.S Patent 5,924,989).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. While Shalgi teaches the tool can include any medical or surgical tool [0081]-[0082], Shalgi fails to explicitly teach a navigation processor configured to execute instructions to determine a pose of the imaging plane based the EM field sensed by the tracking device.
Jackson teaches a system for tracking the position of an ultrasound transducer for image interpretation (Abstract). The system contains a navigation processor (Fig. 1, 20) [0017] to execute instructions to determine a position based at least on the sensed generated one or more EM field or fields [0022]+[0046].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to include an ultrasound transducer imaging an imaging plane, as taught by Jackson, because accurately knowing the position of the ultrasound transducer better determine the contents of an image, thereby simplifying annotation, as recognized by Jackson [0002]+[0015].
While it is implied the system determines the pose of the imaging plane [0046], Jackson is silent regarding determining a pose of the imaging plane.
Polz teaches a system for determining an ultrasonic image data set (Abstract). This system uses the position of the ultrasound to determine the position and orientation (i.e. pose) of the imaging plane (Col 1, lines 15-33) (Col 3, lines 17-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine the pose of the imaging plane, as taught by Polz, because this allows the system to more effectively obtain three-dimensional recordings of the entire volume, as recognized by Pol (Col 1, lines 46-50).
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Shalgi fails to explicitly teach a display device configured to display an image based at least in part on image data acquired in the imaging plane.
Jackson further teach a display device configured to display an image based at least in part on image data acquired in the imaging plane [0017]+[0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to include an display showing an imaging plane, as taught by Jackson, because accurately knowing the position of the ultrasound transducer better determine the contents of an image, thereby simplifying annotation, as recognized by Jackson [0002]+[0015].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shalgi view of Jackson and Gerhart, as applied to claim 1 above, and further in view of Ishibashi (Ishibashi, Kazuhisa. "Eddy current analysis of a conductor with a groove by surface integral equation with one unknown." IEEE transactions on magnetics 41.5 (2005): 1400-1403.).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Shalgi fails to explicitly teach wherein the selected resistance is defined by at least one of a depth or a width the groove.
Ishibashi teaches a method for analyzing eddy currents in a conductor with grooves (Abstract). This paper recognizes that the depth of the groove defines the resistance caused by the groove (Pg. 1403, Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of selecting the resistance of Shalgi with changing the depth of the groove, as taught by Ishibashi, as the substitution for one known method of selecting a resistance caused by a groove with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of selecting the resistance based on the depth of the groove are reasonably predictable.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shalgi in view of Jackson, Polz, Jacobsen, and Gerhart et al.
Regarding Claim 10, Shalgi teaches a system, comprising:
an electromagnetic (EM) localizer [0018], wherein the EM localizer generates one or more EM fields [0018];
a structure formed of a conductive material (Fig. 1, 28) [0081]-[0082], wherein a current is induced in the structure due to the generated one or more EM fields [0083]+[0089];
an EM tracking device configured to sense the generated one or more EM fields (Fig. 1, 34) [0017]+[0019];
wherein the structure includes a first portion and a second portion separated by plurality of augmentations to at least produce a selected resistance between the first portion and the second portion [0103] (Fig. 6, 74), (the grooves create an air gap, and change the resistance across the groove) to at least minimize an induction of a current in the structure [00105], wherein each augmentation is a groove formed in the structure [0103]+[0108]-[0109].
Shalgi is silent regarding the EM tracking device is disposed between the plurality of augmentations. However, moving the position of the transducer from one portion of the instrument to between the grooves is a mere rearrangement of parts (MPEP 2144.04(VI)(C)). The magnetic transducer would still function as an electromagnetic tracking device in the new position, and the overall operation of the instrument would remain unchanged if the location of the tracking device was moved. Therefore, rearranging the position of the tracking device on the instrument to be between the augmentations is an obvious matter of design choice.
While Shalgi teaches the tool can include any medical or surgical tool [0081]-[0082], Shalgi fails to explicitly teach an ultrasound probe and an ultrasound transducer positioned with the structure and configured to generate an imaging plane for imaging a subject, or a navigation processor configured to execute instructions to determine a pose of the imaging plane based at least on the sensed generated one or more EM fields or to track an imaging system and display an image based on acquired image data.
Jackson teaches a system for tracing the position of an ultrasound transducer for image interpretation (Abstract). This system uses magnetic position sensor to track the position of the ultrasound transducer [0017]+[0020]. The ultrasound transducer to generates an imaging plane to image a subject [0044]+[0046] (the image obtain is a “scan” (imaging) plane). This system contains a navigation processor (Fig. 1, 20) [0017] to execute instructions to determine a position based at least on a sensing of the generated one or more EM field or fields by the EM tracking device [0022]+[0046]. This system tracks an imaging device [0010] and displays the image on a display [0027]. This system has an electromagnetic tracking device couple to the ultrasound probe (Fig. 1, 14) [0021].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to include an ultrasound transducer, as taught by Jackson, because accurately knowing the position of the ultrasound transducer better determine the contents of an image, thereby simplifying annotation, as recognized by Jackson [0002]+[0015]. Furthermore, one of ordinary skill would recognize that, as the tool of Shalgi can be any tool [0081]-[0082], it would have been obvious to substitute the tool of Shalgi with an ultrasound transducer, and thus the structure being the housing of the ultrasound probe, as taught by Jackson, as the substitution for one known medical or surgical tool with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the structure containing an ultrasound transducer are reasonably predictable.
While it is implied the system determines the pose of the imaging plane [0046], Jackson is silent regarding determining a pose of the imaging plane.
Polz teaches a system for determining an ultrasonic image data set (Abstract). This system uses the position of the ultrasound to determine the position and orientation (i.e. pose) of the imaging plane (Col 1, lines 15-33) (Col 3, lines 17-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine the pose of the imaging plane, as taught by Polz, because this allows the system to more effectively obtain three-dimensional recordings of the entire volume, as recognized by Pol (Col 1, lines 46-50).
The combination is silent regarding the EM localizer which generates the magnetic field has one or more coils of conductive material.
Jacobsen teaches a magnetic localization system (Abstract). This system generates magnetic fields using coils [0005]. The coils can be made of conductive material [0079].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the magnetic field generators of the combination with conductive coils, as taught by Jacobsen, as the substitution for one known magnetic field generator with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of generating the field with conductive coils are reasonably predictable.
The combination of references is silent that the augmentation reduces of eliminates a current flow between the first portion and the second portion.
Gerhart teaches a surgical navigation system in a magnetic field (Abstract). This system uses grooves in the instrument to reduce or eliminate a current flow between the first and second portions (Fig. 7, 50 are grooves which separate the instrument into portions) [0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to eliminate current flow between portions, as taught by Gerhart, because this reduces eddy current formations, thereby reducing distortions in the tracking, as recognized by Gerhart [0050].
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Shalgi fails to explicitly teach wherein the EM tracking device is at least one of fixed to or within the structure.
Jackson further teaches wherein the EM tracking device is at least one of fixed to or within the structure [0017]+[0020].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to include an ultrasound transducer with an fixed EM tracking device, as taught by Jackson, because accurately knowing the position of the ultrasound transducer better determine the contents of an image, thereby simplifying annotation, as recognized by Jackson [0002]+[0015]. Furthermore, one of ordinary skill would recognize that, as the tool of Shalgi can be any tool [0081]-[0082], it would have been obvious to substitute the tool of Shalgi with an ultrasound transducer with the fixed EM tracking device, as taught by Jackson, as the substitution for one known medical or surgical tool with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the structure containing an ultrasound transducer are reasonably predictable.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shalgi in view Jackson and Gerhart as applied to claim 1 above, and further in view of Ota (JPH05-335137).
Regarding Claim 19, Shalgi teaches the invention substantially as claimed. Shalgi fails to explicitly teach wherein each groove defines a respective bridge between the first portion of the structure and the second portion of the structure.
Ota teaches a system with a conductor within a magnetic field [0003]-[0004]. This system has a conductor with grooves that are bridged [0007].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have bridged grooves, as taught by Ota, because this suppresses eddy currents while also reducing vibrations, as recognized by Ota [0007].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shalgi in view of Jackson, Gerhart, and Ota as applied to claim 19 above, and further in view of Bayes et al. (Bayes, Martin, and Al Horn. "Effects of Conductor Surface Condition on High Frequency Loss." (2004).).
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. Shalgi fails to explicitly teach wherein a thickness of the bridge is defined to cause a first resistance when a frequency of the EM field is between 0 Hz and 30 kHz and a second resistance when the frequency of the EM field is between is greater than 30kHz.
Bayes teaches the relationship between conductors and frequency (Abstract). This system shows the surfaces resistivity, and thus the resistance of the bridge, depends on the applied frequency, and thus would have a first resistance between 0 and 30 kHz, and a second resistance greater when the frequency is greater than 30 kHz (Table 2, Pg. S18-3-3). Furthermore, as groove (i.e. that defines a bridge) would further increase the resistance as the frequency increase (¶10, Pg. S18-3-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the groove configuration to have a groove configuration at which has different resistances at different frequencies, as taught by Bayes, as the substitution for one known bridge thickness with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the bridge thickness causing different resistances between 0-30kHz and greater than 30 kHz are reasonably predictable. While Bayes does not explicitly state 30 kHz, one of ordinary skill would recognize that is the resistance is frequency dependent, being greater than 30 kHz would necessarily have a different resistance than if the frequency was less than 30 kHz.
Response to Arguments
Applicant's arguments filed 3/31/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Gerhart was brought in to teach the conductive portions separated by slits.
Applicant argues that Jackson does not teach the augmentations on the ultrasound probe. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The augmentations are taught by Shalgi. When view with Jackson, one of ordinary skill would have been motivated to place the augmentations on the probe for at least the reasons discussed above.
Applicant argues the combined system does not teach the EM tracking device between the augmentations. The Examiner disagrees. As discussed above, placing the EM tracking device between the augmentations, rather than anywhere else on the instrument, is a routine design choice of a rearrangement of parts (MPEP 2144.04(VI)(C)). Claim 1 therefore remains rejection under 35 USC 103. For similar reasons, the other claims also remain rejected.
Conclusion
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798