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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/22/25 has been entered.
Claim Objections
Claims 10, 11, 12, and 18 are objected to because of the following informalities:
In claim 10, line 2, it appears the primary coil is the same coil now introduced in claim 1.
In claim 11, line 16, it appears ‘receive’ should be placed before ‘radio’ as the reconstruction is from the received radio signals.
In claim 12, it appears the limitation is now introduced in claim 11, unless another image is being reconstructed.
In claim 18, line 15, Examiner suggests using ‘region of interest’ instead of ‘patient’s head’ as is done in the other independent claims.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hoshino et al (US Pub 2002/0058868 -cited by applicant) in view of Green et al (US Pub 2013/0197357 -previously cited).
Re claims 1, 3: Hoshino discloses a surgical system, comprising:
a surgical tool comprising a distal end portion and a radio frequency reception coil attached to the distal end portion [0070-0073; see catheter 17 and detection coil 18]; and
a magnetic resonance imaging system configured to project a magnetic field within a field of view, wherein the magnetic resonance imaging system is configured to intraoperatively image the radio frequency reception coil in the field of view with the distal end portion of the tool and the radio frequency reception coil both positioned proximate a region of interest in the field of view, and wherein the magnetic resonance imaging system is configured to fuse the intraoperative image of the radio frequency reception coil in the field of view with imaging data from a primary radio frequency reception coil not proximate to the region of interest [0070-0073, 0082, 0101, 0102; see the magnetic resonance imaging system to image the catheter with coil 18 and the and see the primary reception RF coil 7R that obtains a reference image; the image of the catheter tip position is performed in real time as the tool is navigated relative a target region of interest such as cancer within the patient; the catheter image is proximate the ROI within the body and the reference image obtained from coil 7R is external to the patient which is not proximate the ROI].
Hoshino discloses all features except that the tool is robotically controlled and attached to a robotic system. However, Green teaches of magnetic tracking of surgical instruments, such as a scalpel [0035, 0037; see the coils and scalpel], wherein the tool can be used with a robot controller [0027]. It would have been obvious to the skilled artisan to modify Hoshino, to track a scalpel under robot control as taught by Green, as such would improve results for a procedure when a scalpel is required and make manipulation more accurate.
Re claim 2: Hoshino discloses the tool comprises a biopsy needle [0073; see the needle].
Re claim 4: Hoshino discloses the reception coil defines a loop of coil [0071; see coil 18 which is a loop].
Re claims 5-7: Hoshino (and Green) disclose all features except that the reception coil comprises an outer diameter of less than 2 mm and more than 1 mm, or 1.2 mm. However, it would have been obvious to the skilled artisan to configure the diameter to be less than 2 mm and more than 1 mm, or 1.2 mm, as such would result in predictable outcomes and would improve performance due to the size of the surgical tool.
Re claim 8: Hoshino discloses the imaging system is configured to track the radio frequency reception coil in real time [0101; see the tracking in real time].
Re claims 9, 10: Hoshino discloses the imaging system further comprises a primary radio frequency transmission coil configured to transmit radio frequency signals configured to excite magnetization in the field of view and a primary radio frequency reception coil configured to receive radio frequency signals corresponding to the excited magnetization in the field of view [0065; see the transmission coil 7T and reception coil 7R to transmit and receive the excited magnetization].
Claims 11-13, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nacev et al (US Pub 2022/0354378 -cited by applicant) in view of Hoshino et al (US Pub 2002/0058868 -cited by applicant).
Re claims 11, 13, 16, 18, 20: Nacev discloses a low-field magnetic resonance imaging system, comprising:
a dome-shaped housing defining a region of interest to project a static magnetic field between 0.03 T and 1.0 T to a patient head (Figs 5, 8; see the Halbach dome 400, 500; 0068 see the 75 mT (or 0.075 T) field), wherein the dome-shaped housing comprises:
an array of permanent magnets configured to project a magnetic field into the region of interest [0033, 0037; see the magnet assembly 308 and the “magnets”];
a gradient coil assembly [0037; see the gradient coil]; and
a radio frequency transmission coil configured to transmit radio frequency signals to excite magnetization in the region of interest [0037; see the RF transmission coils 310];
a surgical tool [0031; see the surgical tools];
a control unit comprising a processor and a memory communicatively coupled to said processor [0114, 0115; see the processor and memory], wherein said memory stores instructions executable by said processor to: transmit radio frequency pulses to the radio frequency transmission coil [0037; see the control of the transmission coils 310].
Nacev further discloses method steps of positioning the dome around a patient’s head, inserting the tool through an aperture in the dome, and transmitting/receiving for image reconstruction (see the above citations).
Nacev discloses all features except for the surgical tool consisting of needle or scalpel comprising a radio frequency reception coil configured to receive radio frequency signals corresponding to the excited magnetization in the field of view; receiving radio frequency signals from the radio frequency reception coil to provide for real time tracking; reconstructing an image of a portion of the ROI from the RF signals with a distal end portion of the tool and the RF reception coil both positioned proximate a region of interest in the field of view, and fuse the reconstructed image with imaging data from a primary RF reception coil not proximate to the region of interest or patient head. However, Hoshino teaches the surgical tool comprising a radio frequency reception coil configured to receive radio frequency signals corresponding to the excited magnetization in the field of view; receiving radio frequency signals from the radio frequency reception coil, reconstructing an image of a portion of the ROI from the RF signals with a distal end portion of the tool and the RF reception coil both positioned proximate a region of interest in the field of view, and fuse the reconstructed image with imaging data from a primary RF reception coil not proximate to the region of interest or patient head [0070-0073, 0082, 0101, 0102; see the magnetic resonance imaging system to image the catheter with coil 18 and the and see the primary reception RF coil 7R that obtains a reference image; the image of the catheter tip position is performed in real time as the tool is navigated relative a target region of interest such as cancer within the patient; the catheter image is proximate the ROI within the body and the reference image obtained from coil 7R is external to the patient which is not proximate the ROI]. It would have been obvious to the skilled artisan to modify Nacev, to use the tool with coil as taught by Hoshino, in order to facilitate a procedure via tracking of a surgical implement.
Re claim 12: Nacev discloses the memory further stores instructions executable by the processor to reconstruct an image of the region of interest [0040; see the ‘image construction’].
Re claim 17: Nacev/Hoshino disclose all features except that the coil loop has an outer diameter of less than 2 mm and more than 1 mm. However, it would have been obvious to the skilled artisan to configure the diameter to be less than 2 mm and more than 1 mm, or 1.2 mm, as such would result in predictable outcomes and would improve performance due to the size of the surgical tool.
Response to Arguments
Applicant's arguments filed 9/22/25 have been fully considered but they are not persuasive. Applicant has amended the independent claims to recite that an intraoperative image of the RF coil proximate a ROI is fused with imaging data from a primary RF coil not proximate the ROI. Applicant specifically contends that Hoshino discloses RF coil 18 and RF coil 7R are used to image different regions of interest rather than the same area for fusion. Respectfully, the Examiner disagrees. Hoshino’s MR gantry images the catheter with coil 18 as a “catheter image” and the also images the anatomy as “reference image IM” [0082]. The ROI is the same for each obtained image (such as the abdominal cavity), wherein the image FOV (i.e. the area that is scanned) of the MRI gantry captures an enhanced image of the catheter when navigated relative the target and an enhanced image of the anatomy containing the target. While different portions are enhanced, the ROI is still the region of the patient containing the target. It is also noted that the claims recite a positioning of the coils relative a region of interest, which is disclosed by Hoshino. Furthermore, RF coil 7R is not proximate the ROI because it is external to the patient, while the target is within the patient. This is consistent with the instant invention wherein the limitation of “not proximate to the region of interest” appears to mean that the primary coil is external to the patient [see instant published paragraphs 0065, 0081].
The 112 rejection is withdrawn due to Applicant arguments.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797