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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2021/0068699 to Liu et al. “Liu”.
As for Claims 1, 18 and 19, Liu discloses a magnetic resonance imaging (MRI) scanning system and method including a pre-screen procedure to identify an implant within the patient and set “guidelines” for the MRI scan (Abstract; Fig. 6 and corresponding descriptions). Liu teaches the presence of an implant may preclude the patient from MRI scanning or “demand scanning parameters (e.g. magnetic spatial gradient limit) to accommodate potential interactions of the implant with a magnetic field” and provides a guide for adjusting operation of the MRI scanner including adjusting scan parameters to accommodate the implant (emphasis added, Paragraph [0014]). In one embodiment, data obtained from the implant screening scanner may be sent to controller 214 and used to guide a scanning procedure (Paragraph [0032]) such that parameters of the MRI scan may be adjusted to accommodate the implant (Paragraphs [0035). Further regarding preconfigured scan configurations comprising implant related parameters, Liu discloses
“For non-ferromagnetic implants, suitable scanning parameter(s) may be determined based on the identity of the implant additional preparation or post-examination procedures may be provided, spatial tolerance, and coil and landmark parameters may be set based on stored information in the implant database” (emphasis added-Paragraph [0041]),
“Additional guidance is provided including a suggestion for further preparation of the implant by adjusting a mode of the implant to enable MR scanning, guidelines for local energization of a transmit coil relative to the implant and corresponding region of the subject’s anatomy, as well as operating parameters regarding landmarks. The alert message 402 may relay data from the implant database associated with the specific type of implant, enabling suitable adjustments to be made for implant” (emphasis added-Paragraph [0045]),
“In some embodiments, if an exact match to the implant 306 based on shape and location is not found, the operator may choose an option to use a spatial gradient limit that is compatible with any type of implant. The controller unit may refer to information and instructions stored in a memory of the controller unit and display instructions for setting the spatial gradient limit as well as additional procedure adjustments to MRI operating parameters pertaining to a conservative MRI approach based on the unidentified implant” (Paragraph [0047]) and
“Operating parameters of the MRI scanner may be adjusted for each subject and each type of implant, if present in the subject. Information obtained via the pre-screen procedure may be used to provide recommendations as to specific MRI parameters, which may be displayed on the user interface” (Paragraph [0048]).
Thus, Liu’s system is considered to be preconfigured with a plurality of scan configurations comprising an implant related parameter for each identified implant or a “conservative MRI scanning parameters” if the implant cannot be identified in its broadest reasonable interpretation. Liu’s system allows the user to select the region or regions of the subject to be scanned with the aforementioned implanted related scan parameters (Fig. 3 and corresponding descriptions). For example, an MRI protocol basket may be created for different areas of the body (e.g. head, neck, upper extremities, chest, abdomen, spine, pelvis, low extremities). Such disclosures are considered to read on a plurality of scan ranges in its broadest reasonable interpretation. Once the parameters are set, the MRI scan is executed (Paragraphs [0014], [0016] and [0076]).
As for Claim 2, Liu’s Fig. 3 depicts a “Multi-Protocol Basket” which would sequentially execute multiple protocols (e.g. first and second scan configurations) in its broadest reasonable interpretation.
Regarding Claims 3-4, Liu discloses a step of acquiring implant information of the subject with a “pre-scan system” in communication with and/or connected to the MRI scanning system and pre-configuring the MRI parameters based on the implant information (Paragraphs [0014], [0017], [0023]-[0026]). The parameters may be displayed to an operator on a user interface (Figs. 3 and 5 and corresponding descriptions; Paragraphs [0021]-[0022]).
As for Claim 5, Liu’s system may automatically identify the implant based on a registration technique (Paragraph [0061]) or the system may accept user input (Paragraph [0028] and [0061]).
Regarding Claims 6-7, 9, 13 and 14, Liu’s pre-screen system identifies the implant location (Paragraphs [0014], [0030]) and displays the implant on an image with respect to the patient’s model (Paragraphs [0040] and [0042]; Figs. 3 and 5 and corresponding descriptions) along with a safety prompt (Fig. 4 and corresponding descriptions). Liu makes it clear that the image of the body model may be 2D images used to create a 3D body model (Paragraph [0056]).
With respect to Claims 8 and 10, Liu explains the patient image may include two images at different angles using various cameras (Paragraph [0056]). Examiner notes the images would be matched to the displayed model of the patient in order to convey the spatial location of the implant in the patient’s body.
Regarding Claims 11-12, Fig. 5 depicts a simulated image of the patient’s position through the scanner along with the implant location and a safety constraint region. Such depiction is considered to read on a simulation image and an implant safety constraint region as claimed in its broadest reasonable interpretation.
As for Claim 15, Examiner notes that any change of MRI parameters (Paragraph [0014]) based on the implant identification is considered an edit in its broadest reasonable interpretation.
Regarding Claims 16-17, Liu’s system “matches” the implant to an implant database based on implant shape (Abstract; Paragraph [0041]) which is considered to read on the claimed limitation of linking the implant identifier with corresponding implant parameter information in its broadest reasonable interpretation. Moreover, as described above, Liu’s system displays the MRI parameters on the user interface for user adjustment (if necessary) (Paragraphs [0021]-[0022]).
With respect to Claim 20, Liu’s system may automatically identify the implant based on a registration technique (Paragraph [0061]) or the system may accept user input (Paragraph [0028] and [0061]). Moreover, Liu’s pre-screen system identifies the implant location (Paragraphs [0014], [0030]) and displays the implant on an image with respect to the patient’s model (Paragraphs [0040] and [0042]; Figs. 3 and 5 and corresponding descriptions) along with a safety prompt (Fig. 4 and corresponding descriptions). Liu makes it clear that the image of the body model may be 2D images used to create a 3D body model (Paragraph [0056]).
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive. Regarding the prior art rejections, Applicant argues Lui does not teach each and every limitation of independent claims 1, 18 and 19 and specifically the limitation of “preconfiguring the plurality of scan configurations corresponding to a plurality of scan ranges of a subject to be scanned” (REMARKS, Page 8) because the pending application requires that a plurality of scan configurations be preconfigured for a plurality of scan ranges of the subject and for the same scan session (e.g, claims recite “plurality of scan ranges of a subject to be scanned”). In other words, the pending application and the claims do not cover different scan configurations for different implants, but rather pre-configuring for multiple scan ranges of a single subject (e.g., above and below C7 regions for a patient having implant 210 in Fig. 2 of the pending application) for the same scan. Liu by contrast, does not teach or suggest preconfiguring multiple scan configurations for multiple scan ranges of a subject before scanning begins. Instead, Liu describes adjusting parameters for a given implant, but does not disclose or suggest the advance setup of all scan configurations for all relevant scan ranges of a subject as required by the claims (REMARKS, Page 8).
Examiner respectfully disagrees. First, it must be noted that Applicant’s arguments are not commensurate with the scope of the claim as the claim does not use the words, “multiple anatomical scan ranges of a single subject”. Thus, a scan range of a subject need not relate to an anatomical scan range in its broadest reasonable interpretation. Nonetheless, as explained above, Liu’s MRI system is pre-configured with implant related MRI scan parameters such that the system can change MRI parameters (e.g. from a non-implant related MRI scan) to accommodate the implant. Liu’s system allows the user to preconfigure a protocol basket which would carry out the aforementioned implant related MRI scan on various body regions of the subject (Fig. 3 and corresponding descriptions). Paragraph [0045] also makes it clear that the displayed tabs 310 may be used to select anatomical regions. Such disclosures are considered to read on the claimed limitations of preconfiguring a plurality of scan configurations corresponding to a plurality of scan ranges where the scan configurations comprise an implant-related MRI scan parameter in its broadest reasonable interpretation. Thus, the rejections have been maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. NPL “Guideline Use of MRI in Patients with Implants” Dutch Guideline which discloses examples MRI parameter ranges for MRI safe and MRI conditional implants (Pages 19-20) and “conservative” MRI approaches (Page 6).
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797